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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the effects of beta-sitosterols on urinary symptoms and flow measures in men with benign prostatic hyperplasia (BPH) as assessed in the systematic review? Please answer this question based on the information provided below:
Randomised, placebo-controlled, double-blind clinical trial of beta-sitosterol in patients with benign prostatic hyperplasia. Beta-sitosterol Study Group.
Medical treatments have become available for benign hypertrophy of the prostate, including alpha-receptor blocking agents and 5-alpha-reductase inhibitors. Drugs derived from plants, for which no precise mechanism of action has been described, are widely used for this purpose in Europe. In a randomised, double-blind, placebo-controlled multicentre study, 200 patients (recruited between April and October 1993) with symptomatic benign prostatic hyperplasia were treated with either 20 mg beta-sitosterol (which contains a mixture of phytosterols) three times per day or placebo. Primary end-point was a difference of modified Boyarsky score between treatment groups after 6 months; secondary end-points were changes in International Prostate Symptom Score (IPSS), urine flow, and prostate volume. Modified Boyarsky score decreased significantly with a mean of -6.7 (SD 4.0) points in the beta-sitosterol-treated group versus -2.1 (3.2) points in the placebo group p < 0.01. There was a decrease in IPSS (-7.4 [3.8] points in the beta-sitosterol-treated group vs -2.1 [3.8] points in the placebo group) and changes in urine flow parameters: beta-sitosterol treatment resulted in increasing peak flow (15.2 [5.7] mL/s from 9.9 [2.5] mL/s), and decrease of mean residual urinary volume (30.4 [39.9] mL from 65.8 [20.8] mL). These parameters did not change in the placebo group (p < 0.01). No relevant reduction of prostatic volume was observed in either group. Significant improvement in symptoms and urinary flow parameters show the effectiveness of beta-sitosterol in the treatment of benign prostatic hyperplasia.
A double-blind trial of the effect of beta-sitosteryl glucoside (WA184) in the treatment of benign prostatic hyperplasia.
Cholesterol-lowering agents are still used in some countries for the treatment of benign prostatic hyperplasia (BPH). A randomized, double-blind, placebo-controlled urodynamic study, carried out on 53 patients with proven outflow obstruction, has failed to prove that the drug, beta-sitosteryl beta-D-glucoside (WA184), is superior to placebo in the treatment of outflow obstruction due to BPH when administered at a dose of 0.3 mg/day. Possible reasons for this include an insufficient dose and duration of treatment (this drug is known to have a potent effect on cholesterol metabolism in the prostate) and the predominantly stromal pathological changes which characterize BPH and which may be unaffected by such agents.
A multicentric, placebo-controlled, double-blind clinical trial of beta-sitosterol (phytosterol) for the treatment of benign prostatic hyperplasia. German BPH-Phyto Study group.
OBJECTIVE: To report the results of a double-blind, placebo-controlled trial to evaluate Azuprostat, a beta-sitosterol, in patients with symptoms of outlet obstruction caused by benign prostatic hyperplasia (BPH).
PATIENTS AND METHODS: A randomized, double-blind and placebo-controlled clinical trial was conducted to assess the efficacy and safety of 130 mg free beta-sitosterol (phytosterol) daily, using the international prostate symptom score (IPSS) as the primary outcome variable. In total, 177 patients with BPH were recruited for 6 months of treatment in 13 study centres. In addition to the relative difference in the IPSS, changes in quality of life, peak urinary flow rate (Qmax) and post-void residual urinary volume (PVR) were recorded. The drug used in the trial consisted of a chemically defined extract of phytosterols, derived for example from species of Pinus, Picea or Hypoxis, with beta-sitosterol as the main component.
RESULTS: There were significant (P < 0.01) improvements over placebo in those treated with beta-sitosterol; the mean difference in the IPSS between placebo and beta-sitosterol, adjusted for the initial values, was 5.4 and in the quality-of-life index was 0.9. There were also significant improvements in the secondary outcome variables, with an increase in Qmax (4.5 mL/s) and decrease in PVR (33.5 mL) in favour of beta-sitosterol when adjusted for the changes after placebo.
CONCLUSION: These results show that beta-sitosterol is an effective option in the treatment of BPH.
Options:
A: Beta-sitosterols significantly improved urinary symptom scores and flow measures, but did not reduce prostate size.
B: Beta-sitosterols had no significant effect on urinary symptom scores, flow measures, or prostate size.
C: Beta-sitosterols significantly reduced prostate size but had no effect on urinary symptom scores or flow measures.
D: Beta-sitosterols significantly improved urinary symptom scores and reduced prostate size, but had no effect on flow measures.
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A
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101
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the effectiveness of pool fencing in preventing drowning among young children, and which type of fencing is considered superior? Please answer this question based on the information provided below:
Risks of drowning in fenced and unfenced domestic swimming pools.
A method for estimating the risks of drowning in fenced and unfenced domestic swimming pools is presented. Application of this method suggests that the probability of drowning occurring in an unfenced pool is between two to five times higher than that of a fenced pool. It is also estimated that the introduction of pool fencing would reduce the number of drownings in domestic swimming pools by 40% to 67%.
Childhood drowning and near-drowning in Brisbane: the contribution of domestic pools.
OBJECTIVE: To describe the epidemiology of domestic swimming pool drowning and near-drowning in Brisbane and to examine the efficacy of a broad range of preventive options, including pool fences.
DESIGN: A prospective, hospital-based, injury surveillance system to describe the epidemiology of drowning and near-drowning and a community survey to describe pool fencing.
SETTING: The surveillance questionnaire was completed at presentation in the Emergency Department by the parent, nurse and doctor. Personal interviews in households that were randomly selected by means of a stratified sampling scheme provided the pool fencing description.
PARTICIPANTS: All 139 children suffering from an immersion injury resulting in presentation at a hospital in the catchment area of The Mater Children's Hospital were included. There were 204 households with a swimming pool in the 1024 households interviewed in the community survey.
RESULTS: The 100 domestic pool drownings and near-drownings were equivalent to 15.5 incidents per year per 100,000 children aged 0-13 years and 64.9 per year per 100,000 for the critical 1-3 years age group. Of 72 children who gained unintended access to a domestic pool, 88.9% were less than 3 years of age and 52.8% were less than 2 years. All 10 of the children who drowned and five who were severely brain damaged (age range, 12-32 months) were in this group. The risk of a drowning or near-drowning involving unintended access to an unfenced pool is 3.76 times higher than the risk associated with a fenced pool (95% confidence limits for relative risk: 2.14, 6.62).
CONCLUSIONS: Pool fences are an effective method of preventing child drownings and near-drownings. This effectiveness can be further improved if compliance with gate closure can be enhanced. This should be emphasised in health promotion accompanying the introduction of universal pool fencing.
Options:
A: Pool fencing does not significantly reduce the risk of drowning, and perimeter fencing is superior to isolation fencing.
B: Pool fencing significantly reduces the risk of drowning, and isolation fencing is superior to perimeter fencing.
C: Pool fencing significantly reduces the risk of drowning, but perimeter fencing is superior to isolation fencing.
D: Pool fencing does not significantly reduce the risk of drowning, and both types of fencing are equally effective.
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B
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102
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What were the findings regarding the effectiveness and safety of Baclofen, Dantrolene, Tizanidine, and other drugs for treating long-term spasticity in spinal cord injury (SCI) patients? Please answer this question based on the information provided below:
An objective assessment of a gamma aminobutyric acid derivative in the control of spasticity.
A new agent for the control of spasticity.
In a preliminary controlled trial, CIBA 34,647-Ba, a gamma aminobutyric acid derivative, was found to be more effective than placebo in reducing spasticity due to spinal injuries. In an uncontrolled trial, 34,647-Ba also appeared more effective than diazepam. The intensity of spasticity was measured electromyographically by the amplitude of the stretch reflex at various velocities, and the results were correlated with those obtained by clinical assessment. 34,647-Ba was effective in both complete and incomplete spinal cord lesions and it is suggested that it has an action at the spinal level. No significant side-effects were encountered.
A double blind, cross-over trial of Valium in the treatment of spasticity.
Gabapentin for the treatment of spasticity in patients with spinal cord injury.
Our serendipitous observations suggested that some patients with spasticity appeared to have improved following the administration of the anticonvulsant drug gabapentin. As some patients with spasticity are either refractory to or intolerant of established medical treatments, we conducted this study to investigate the effect of gabapentin on spasticity in patients with spinal cord injury. Twenty-five patients with spinal cord injury and spasticity received oral gabapentin (2400 mg over 48 h) in a randomized, double blind, placebo-controlled crossover study. We assessed responses by measuring the Ashworth spasticity scale, muscle stretch reflexes, presence of clonus and reflex response to noxious stimuli. Patient ratings were obtained using a Likert Scale. Administration of gabapentin, but not placebo, was associated with an 11% reduction in spasticity as measured by the Ashworth Scale (P = 0.04) and by a 20% reduction in the Likert Scale (P = 0.0013). Significant changes were not obtained for the other measures. The data obtained suggest that gabapentin may be useful in the management of spasticity associated with spinal cord injury.
Intrathecal baclofen for intractable spinal spasticity--a double-blind cross-over comparison with placebo in 6 patients.
A group of six subjects with intractable spinal spasticity completed a double-blind cross-over paradigm in which they received two intrathecal bolus injections of baclofen solution five hours apart on two different days and two intrathecal bolus injections of placebo saline five hours apart on two other days. Each subject was repeatedly tested with a battery of clinical and physiological tests. In contrast to the placebo injections, the group responded to the baclofen injections with subjective and objective, clinically significant improvement in parameters of spasticity in their lower limbs, including muscle tone, frequency of spasms, hyperreflexia and passive range of joint motion. Furthermore, this improvement was maintained following thirty consecutive days of intrathecal bolus injections of baclofen at a fixed dose.
Intrathecal baclofen. Effects on nocturnal leg muscle spasticity.
Electromyographic activity was recorded from tibialis anterior during nocturnal polysomnography in six patients with severe spasticity of spinal origin. The patients had a baclofen reservoir system implanted subcutaneously into their lumbar subarachnoid space and were studied for two nights in a double-blind, placebo controlled, crossover design. Tibialis anterior electromyographic activity per hour of sleep was reduced on the night of baclofen infusion. In particular, less electromyographic activity occurred after arousal from sleep.
A comparison of clonidine, cyproheptadine and baclofen in spastic spinal cord injured patients.
In twenty-five SCI subjects, antispasticity effects of three putative antispasticity agents [clonidine (an alpha-2 noradrenergic agonist), cyproheptadine (a 5-HT2 antagonist) and baclofen (a GABA-B agonist)] were tested in terms of changes in leg tone as graded by the Ashworth scale (AS), in terms of the vibratory inhibition of the H-reflex (VII) and in terms of the ability of the knee to swing passively in the pendulum test as quantified by video motion analysis. When compared to the no drug period, all three drug treatments showed an antispasticity effect on the AS, the VII and the amplitude of the first swing and the relaxation index of the pendulum test, p. < 0001. Surprisingly, cyproheptadine and baclofen produced a greater reduction in the VII than clonidine, p. < 01. The amplitude of the first swing in the pendulum test correlated well with the AS, r = .88, and the antispasticity effects of the drugs produced improvements in both measures, a reduced AS and increased amplitude of knee swing in the pendulum test. Therefore, video motion analysis of the pendulum test is as valid a measure of spasticity as the Ashworth scale and is not limited by subjectivity of the examiner.
Intrathecal baclofen for severe spinal spasticity.
We studied the effect of the intrathecal infusion of baclofen, an agonist of gamma-aminobutyric acid, on abnormal muscle tone and spasms associated with spinal spasticity, in a randomized double-blind crossover study. Twenty patients with spinal spasticity caused by multiple sclerosis or spinal-cord injury who had had no response to treatment with oral baclofen received an intrathecal infusion of baclofen or saline for three days. The infusions were administered by means of a programmable pump implanted in the lumbar subarachnoid space. Muscle tone decreased in all 20 patients (mean [+/- SD] Ashworth score for rigidity, from 4.0 +/- 1.0 to 1.2 +/- 0.4; P less than 0.0001), and spasms were decreased in 18 of the 19 patients who had spasms (mean [+/- SD] score for spasm frequency, from 3.3 +/- 1.2 to 0.4 +/- 0.8; P less than 0.0005). Tests for motor function, neurologic examination, and assessments by the patients correctly indicated when baclofen was being infused in all cases. All patients were then entered in an open long-term trial of continuous infusion of intrathecal baclofen. During a mean follow-up period of 19.2 months (range, 10 to 33), muscle tone has been maintained within the normal range (mean Ashworth score, 1.0 +/- 0.1) and spasms have been reduced to a level that does not interfere with activities of daily living (mean spasm score, 0.3 +/- 0.6). No drowsiness or confusion occurred, one pump failed, and two catheters became dislodged and had to be replaced. No infections were observed. Our observations suggest that intrathecal baclofen is an effective long-term treatment for spinal spasticity that has not responded to oral baclofen.
Modulation of locomotor patterns and spasticity with clonidine in spinal cord injured patients.
This double blind cross-over study, involving 9 chronic spinal cord injured (SCI) patients (6 paraplegic and 3 paretic), was a first attempt to investigate the effects of the noradrenergic agonist, clonidine, on the modulation of the locomotor pattern and spasticity in patients with spinal cord lesions. Electromyographic (EMG), footswitch and video recordings were made as the patients walked on a treadmill with the support of an overhead harness if needed. Overground locomotion was also assessed in the paretic patients. All 3 spastic paretic patients had kinematic deviations and abnormal EMG recruitment profiles during the premedication or placebo sessions. With clonidine therapy one patient demonstrated a marked improvement in locomotor function. This patient progressed from non-ambulation to limited independent ambulation as the extent of coactivation in antagonist muscles decreased. The other 2 paretics who presented limited spasticity showed minimal changes while on clonidine. In the paraplegic patients, clonidine did not elicit locomotor activity, although there were marked reductions in stretch reactions and clonus during assisted locomotion. They remained incapable of locomotion, either during the control period or during the clonidine therapy. These results indicate that clonidine may be a potentially useful medication for both locomotion and certain manifestations of spasticity in SCI patients but further investigation is warranted.
Options:
A: Intrathecal Baclofen significantly reduced spasticity and improved ADL performances without side effects, while Tizanidine improved spasticity but had significant adverse effects.
B: Oral Baclofen and Dantrolene were found to be the most effective in reducing spasticity with minimal side effects.
C: All drugs, including Gabapentin, Clonidine, Diazepam, and Amytal, showed significant effectiveness in reducing spasticity without any adverse effects.
D: There was no significant evidence supporting the effectiveness of any of the drugs in reducing spasticity in SCI patients.
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A
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103
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What conclusion can be drawn about the efficacy and safety of adjunct bromocriptine therapy compared to placebo in the treatment of Parkinson's disease patients with motor complications? Please answer this question based on the information provided below:
Treatment of the on-off syndrome in Parkinsonism with low dose bromocriptine in combination with levodopa.
The addition of bromocriptine, given in divided doses up to 30 mg per day, to conventional anti-Parkinsonism therapy has been studied in a double-blind placebo controlled clinical trial in 11 patients with Parkinsonism with the "on-off" syndrome. Four patients withdrew because of side effects. Of the seven remaining, three had clinical benefit from bromocriptine with reduction in severity and frequency of fluctuations. There was, however, no statistically significant benefit of bromocriptine when the group as a whole was assessed in terms of severity or frequency of fluctuations measured by three different methods. The mean frequency of major fluctuations on placebo was 2.9/day and on bromocriptine 1.8/day (P less than 0.1 greater than 0.05). There appears to be a limited role for bromocriptine as additional therapy in the management of some patients with the on-off syndrome.
Bromocriptine versus placebo in levodopa treated patients with Parkinson's disease.
Twenty patients with idiopathic parkinsonism who had been on optimal levodopa therapy for at least 3 months prior to the investigation and where effect of the treatment was decreasing or side effects were increasing, were treated with bromocriptine in a double-blind crossover trial during a 12 + 12 weeks period. Reduction in disability scores was found significant. Hyperkinesia was more frequent in the bromocriptine period than in the placebo period, but reduction of dose in six patients for this reason was not followed by deterioration. Both hyperkinesia and other side effects disappeared after dose reduction. Doses were 2.5 mg-40 mg. Bromocriptine seems a valuable supplement to previous therapy in these patients.
Low dosages of bromocriptine added to levodopa in Parkinson's disease.
Thirty-six patients with Parkinson's disease, on levodopa, were admitted to a double-blind, parallel, 40-week study of adjunct bromocriptine in dosages increased by 2.5 mg every 4 weeks. A 37% improvement of the mean neurologic deficit score was obtained at the maximal daily dosage of 20 mg. Improvement was greatest in patients with mild disease. The wearing-off effect, off-dose abnormal involuntary movements, and leg pains, associated with levodopa, improved in over 70% of patients at an average dosage of 13 mg. Only 15% of patients had adverse reactions severe enough to necessitate discontinuance of the drug. Abnormalities of mental state were less severe than expected, but two patients had exacerbations of angina pectoris.
Bromocryptine in levodopa response-losing parkinsonism. A double blind study.
23 patients with advanced Parkinson's disease were allocated in a double-blind study of bromocryptine. These patients had an insufficient or deteriorating response to levodopa treatment. The dosages of levodopa were optimal and stabilized 3 months prior to and during this 5-month study. The addition of bromocryptine in high doses (average daily dose 71 mg) induced a significant improvement in the total score of the Webster and the NUDS scales. The global assessment, both by the investigator and by the patients, also showed significant improvement. The efficacy of bromocryptine in these type of parkinsonian patients in a double-blind trial has not yet been established. The conclusion of this trial is that bromocryptine significantly increases the therapeutic effectiveness in these poorly levodopa responding parkinsonian patients.
[Bromocriptin in the treatment of progressive stages of Parkinson's disease (author's transl)].
Forty patients with severe Parkinson's disease (23 men, 17 women) who had been treated for six years with L-dopa-decarboxylase inhibitor, were part of a placebo-controlled double-blind trial to test the effectiveness of bromocriptin. In all patients the effectiveness of L-dopa had been decreasing, 34 patients had L-dopa-induced dyskinesias, 35 "on-off" symptoms. Bromocriptin dosage was gradually increased to a total dose of 30 - 40 mg daily. This led to a 25% reduction in L-dopa requirements. The symptoms of Parkinson's disease were favourably influenced, with rigor, tremor and also walking disturbances responding better than bradykinesia of the hands. At the same time, there was a marked prolongation of the periods of good mobility ("on" time) from 7 to 10.8 hours without influence on other "on-off" symptoms such as paradoxical akinesia. Two patients had to be excluded from the trial because the treatment caused side effects (orthostatic hypotension, exogenous psychotic symptoms). Other side effects, such as nausea and mild forms of collapse, could be controlled by drugs.
Adjunctive therapy with bromocriptine in Parkinson's disease.
Patients with moderately severe Parkinson's disease complicated by the adverse effects of chronic levodopa use benefited from the addition of bromocriptine (Parlodel; Sandoz) in doses up to 26 mg daily, which allowed an approximate 30% reduction of levodopa dose. This resulted in a significant decrease in the amount of levodopa side-effects while maintaining or improving the original parkinsonian clinical stage. Increased effectiveness in these patients was not associated with increased dosage beyond 25-30 mg daily. When the doses of bromocriptine were increased slowly, the adverse reactions were minor and usually transient.
Effects of bromocriptine on parkinsonism. A nation-wide collaborative double-blind study.
The effects of bromocriptine in patients with Parkinson's disease manifesting various problems in levodopa therapy were tested in a double-blind manner with the collaboration of 59 institutions. The slow and low principle was in part adopted. Either bromocriptine or placebo was added to levodopa. Twenty-nine % of the bromocriptine-treated patients (n = 108), in contrast to 14.8% of the placebo-treated (n = 108), showed either marked or moderate improvement (P less than 0.05). Twenty to 37% improvement was noted in most of the symptoms studied in those treated with bromocriptine. The significant superiority of bromocriptine was also noted in the effects on wearing-off phenomena and frozen gait. No irreversible side effects were noted. It is concluded that bromocriptine is useful in patients who are manifesting various difficulties in levodopa therapy. Our results are comparable to those using higher maintenance doses. Dopamine antagonistic actions were not observed. This is unlike the case with experimental animals.
Options:
A: Adjunct bromocriptine therapy is conclusively effective and safe for treating motor complications in Parkinson's disease patients.
B: There is insufficient evidence to determine the efficacy and safety of adjunct bromocriptine therapy for motor complications in Parkinson's disease patients due to major methodological problems and heterogeneity in trials.
C: Adjunct bromocriptine therapy is conclusively ineffective and unsafe for treating motor complications in Parkinson's disease patients.
D: Adjunct bromocriptine therapy is more effective but less safe compared to placebo for treating motor complications in Parkinson's disease patients.
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B
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104
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evidence_summarization
|
You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What is the efficacy of corticosteroids in resolving malignant bowel obstruction in patients with advanced gynaecological and gastrointestinal cancer? Please answer this question based on the information provided below:
Chronic nausea in advanced cancer patients: a retrospective assessment of a metoclopramide-based antiemetic regimen.
The purpose of this retrospective study is to assess the frequency and intensity of chronic nausea in patients admitted to the Palliative Care Unit and the results of a metoclopramide-based treatment regimen. We reviewed the medical records of 100 consecutive patients admitted to the Palliative Care Unit at the Edmonton General Hospital until death during 1992-1993. All patients had terminal cancer and normal cognitive function. All patients completed the Functional Analogue Scale for appetite, nausea, pain, activity, shortness of breath, and sensation of well-being at 1000 and 1600 hours every day. Patients who complained of nausea initially received metoclopramide 10 mg every 4 hr orally or subcutaneously (Step 1). If nausea persisted, dexamethasone 10 mg twice daily was added (Step 2). Step 3 consisted of a continuous subcutaneous infusion of metoclopramide of 60-120 mg/day plus dexamethasone. If no response was observed, other antiemetics were administered (Step 4). Upon admission to the unit, 32 patients (32%) presented with nausea. During the average admission of 25 +/- 13 days, 98 patients (98%) developed nausea. Twenty-five patients (25%) required other antiemetics because of bowel obstruction (18), extrapyramidal side effects (3), or other reasons (4). Most patients without bowel obstruction achieved excellent control of nausea using the metoclopramide-based regimen. During the first 5 days and last 5 days of admission, nausea had significantly lower intensity than the rest of the symptoms that were monitored. Our results suggest that, although nausea is very frequent, it can be well controlled in the majority of patients using safe and simple antiemetic regimens.
Symptom control in terminally ill patients with malignant bowel obstruction (MBO).
The inadequacy of prolonged conservative management with nasogastric suction and intravenous fluids for terminally ill patients with bowel obstruction has long been recognized. Using previous reports and our experience on the Palliative Care Unit at the Edmonton General Hospital, we have developed a basic approach to bowel obstruction management. In a review of 100 consecutive patients who died on our Palliative Care Unit, 15 required medical management for bowel obstruction. Evaluation of these cases suggests that intensive medical management can provide good symptom control without using intravenous lines and with minimal use of nasogastric tubes.
The use of corticosteroids for symptom management in terminally ill patients.
Pitfalls in placebo-controlled trials in palliative care: dexamethasone for the palliation of malignant bowel obstruction.
To determine the effect of dexamethasone when treating malignant bowel obstruction, 35 patients were randomized to receive intravenous dexamethasone or a placebo, crossing over to the alternate treatment arm if there had been no resolution of obstruction by day 5. This was done in two consecutive studies. Patients were stratified according to whether or not they had received specific anticancer therapy within 28 days of study. In trial 1, 15 out of 22 patients 'responded' (resolution of obstruction by day 5; 10 on dexamethasone, five on placebo). Eleven out of 15 patients were 'on treatment'. In trial 2, six out of 13 responded (three on dexamethasone, three on placebo); three out of six were 'on treatment'. When both studies are combined, 60% (21/35) patients responded (13 on dexamethasone, eight on placebo). Poor patient accrual terminated both studies. Numbers are too small to allow a combination of studies or formal statistical analysis. We are unable to make any conclusion as to the effectiveness of dexamethasone in the palliation of malignant bowel disease.
Pitfalls in placebo-controlled trials in palliative care: dexamethasone for the palliation of malignant bowel obstruction.
To determine the effect of dexamethasone when treating malignant bowel obstruction, 35 patients were randomized to receive intravenous dexamethasone or a placebo, crossing over to the alternate treatment arm if there had been no resolution of obstruction by day 5. This was done in two consecutive studies. Patients were stratified according to whether or not they had received specific anticancer therapy within 28 days of study. In trial 1, 15 out of 22 patients 'responded' (resolution of obstruction by day 5; 10 on dexamethasone, five on placebo). Eleven out of 15 patients were 'on treatment'. In trial 2, six out of 13 responded (three on dexamethasone, three on placebo); three out of six were 'on treatment'. When both studies are combined, 60% (21/35) patients responded (13 on dexamethasone, eight on placebo). Poor patient accrual terminated both studies. Numbers are too small to allow a combination of studies or formal statistical analysis. We are unable to make any conclusion as to the effectiveness of dexamethasone in the palliation of malignant bowel disease.
Administration of drugs by infusion pumps in palliative medicine.
A retrospective study was carried out in 100 adult patients with advanced malignant disease. They were given subcutaneous continuous infusions of medication for symptom relief. The drugs were administered through a butterfly needle inserted subcutaneously in the anterior chest wall using a battery-operated infusion pump. The indications for using this technique were inability to swallow due to deteriorating general condition, oesophageal obstruction, intestinal obstruction, severe nausea and vomiting, terminal dyspnoea and poor pain control with oral opiates. All patients received morphine; other drugs administered through the syringe driver included hyoscine, metoclopramide, cyclizine, dexamethasone and midazolam. Ninety-four patients continued subcutaneous infusion until death. The mean duration of treatment was 9.1 days. The treatment was well tolerated by the patients and controlled their symptoms satisfactorily in the great majority. The use of continuous subcutaneous infusion via a syringe driver gives good symptom control. In the last days of life when the patients have difficulty tolerating oral medication, continuous subcutaneous infusion is a superior alternative to frequent intermittent parenteral injections.
Options:
A: Corticosteroids significantly resolve bowel obstruction and improve survival rates.
B: Corticosteroids show a trend towards resolving bowel obstruction but do not significantly improve survival rates.
C: Corticosteroids have no effect on bowel obstruction resolution or survival rates.
D: Corticosteroids significantly increase the incidence of side effects without resolving bowel obstruction.
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B
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105
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evidence_summarization
|
You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What is the effectiveness of prophylactic antibiotic administration before intrauterine device (IUD) insertion in reducing IUD-related complications and discontinuations within three months of insertion? Please answer this question based on the information provided below:
Prevention of IUD-related pelvic infection: the efficacy of prophylactic doxycycline at IUD insertion.
It is believed that much of the small increased risk for developing pelvic inflammatory disease (PID) associated with the use of an intrauterine device (IUD) appears to be caused by bacterial contamination of the endometrial cavity at the time of insertion. Previous research suggests that use of prophylactic antibiotics immediately prior to IUD insertion may reduce the risk of developing PID. This paper presents results from a randomized clinical trial of 1485 women in Ibadan, Nigeria evaluating the effectiveness of 200 mg of doxycycline (versus placebo) given orally at the time of IUD insertion in reducing the incidence of PID during the first three months of IUD use. Rate of PID infection in the doxycycline-treated group was not significantly lower than that in the placebo-treated group. The rate of unscheduled IUD-related visits to the clinic also was not significantly lower among the doxycycline-treated group. However, the incidence of PID was low (21 cases) for both study groups. Aseptic conditions during IUD insertion, follow-up visits with short intervals to monitor health, and treatment of opportunistic infections may have reduced the potential of PID within this population.
Preventing IUCD-related pelvic infection: the efficacy of prophylactic doxycycline at insertion.
Most of the small increased risk in pelvic inflammatory disease (PID) associated with the intrauterine contraceptive device (IUCD) appears to be caused by bacterial contamination of the endometrial cavity at the time of insertion. This randomized clinical trial of 1813 women in Nairobi, Kenya, assessed the effectiveness of 200 mg of doxycycline given orally at the time of insertion in reducing the occurrence of PID. The rate of this infection in the doxycycline-treated group was 31% lower than that in the placebo-treated group (1.3 and 1.9%, respectively; RR 0.69; 95% CI 0.32 to 1.5). The rate of an unplanned IUCD-related visit to the clinic was also 31% lower in the doxycycline-treated group (RR 0.69; 95% CI 0.52 to 0.91). Although the significance level (P = 0.17) for the reduction is PID does not meet the conventional standard of 0.05, the results may be suggestive of an effect. Moreover, the reduction in IUCD-related visits (P = 0.004) not only represents an important decrease in morbidity but also substantiates the reduction found for PID. Further studies are needed to corroborate these results. Consideration should be given to the prophylactic use of doxycycline at the time of IUCD insertion as an approach to preventing PID and other IUCD-related morbidity.
Effect of prophylactic antibiotics on morbidity associated with IUD insertion: results of a pilot randomized controlled trial. IUD Study Group.
The efficacy of administering an antibiotic prior to IUD insertion to reduce the risk of introducing an upper genital tract infection during the procedure has not yet been established. Two double-blind randomized studies conducted in Africa comparing a 200 mg prophylactic dose of doxycycline with a placebo did not conclusively identify a reduced risk of post-insertion pelvic inflammatory disease (PID). A clinical trial of comparable design is currently under way in the US. This multi-site trial will evaluate whether use of an antibiotic prior to insertion reduces the risk of IUD removal for all medical reasons, including upper genital tract infection, within the first three months after insertion. This paper reports on the pilot phase of this study, which was designed to test the protocols and data collection instruments in advance of the full-scale clinical trial. A total of 447 prospective IUD (TCu-380A) users were randomly assigned to receive either a 200 mg dose of doxycycline or a placebo one hour before IUD insertion. 3.6% (8/219) of participants who received the antibiotic had the device removed for medical reasons (infection, bleeding, cramping, etc.) within three months post-insertion compared to 4.5% (10/223) of participants who received the placebo. This reduction in the removal rate was not statistically significant given the limited size of the pilot study (RR = 0.81; 95% CI 0.28-2.29). Only two subjects, one from each treatment group, met the diagnostic criteria for acute PID. The overall three-month retention rate was 91.8% for the antibiotic group and 89.7% for the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)
Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group.
BACKGROUND: The value of antibiotic prophylaxis before insertion of an intrauterine device (IUD) remains uncertain. We undertook a triple-masked, randomised, placebo-controlled trial to find out whether such prophylaxis reduces the rate of IUD removal within 90 days.
METHODS: 11 clinic sites in southern California enrolled women who requested IUD insertion and were at low risk of sexually transmitted infection according to self-reported medical history. We randomly assigned 1985 participants either 500 mg azithromycin or placebo capsules of identical appearance taken about 1 h before insertion of a Copper T 380A IUD. 118 women did not have an IUD inserted. We followed up 1833 of the remaining 1867 (98%) participants for at least 90 days after insertion.
FINDINGS: The rate of IUD removal for any reason other than partial expulsion was 3.8% (35/918) in the antibiotic group and 3.4% (31/915) in the placebo group (relative risk 1.1 [95% CI 0.7-1.8]). The two treatment groups sought medical attention with equal frequency (mean 38 visits per 100 women). During the 90 days after IUD insertion, only one woman from each assignment group had salpingitis, as defined by established criteria.
INTERPRETATION: Prophylaxis with azithromycin did not affect the likelihood that a woman would retain her IUD at 90 days or the frequency of postinsertion medical attention. In appropriately screened women, the risk of upper-genital-tract infection is negligible after IUD insertion, with or without the administration of prophylactic antibiotics.
Pelvic inflammatory disease and intrauterine devices: prophylactic antibiotics to reduce febrile complications.
In the present study, we tried to determine whether IUD insertion related PID and febrile complications could be prevented by prophylactic use of antibiotics. We studied 300 patients who were admitted to our family planning clinic for IUD contraception. Of these, 150 patients received prophylactic Doxycycline (group 1) and the second 150 received no therapy (group 2). Five cases experienced fever with or without leucocytosis and none required hospitalization. PID was observed in one woman in each group. Positive culture (gonorrhea) was obtained in one woman who was then treated by relevant antibiotics; the other woman required hospitalization for two days. The overall infection rates for group 1 and 2 were 2.1% and 2.9%, respectively and this difference was not significant. The incidence of PID infection and febrile complications was found to be very low for both groups when compared to other studies, suggesting that aseptic conditions with proper insertion reduce the risk of infection.
Options:
A: Prophylactic antibiotics significantly reduce the risk of pelvic inflammatory disease and early removals of the IUD.
B: Prophylactic antibiotics have no significant effect on the risk of pelvic inflammatory disease but slightly reduce unscheduled visits to the provider.
C: Prophylactic antibiotics significantly increase the risk of pelvic inflammatory disease and early removals of the IUD.
D: Prophylactic antibiotics significantly reduce the risk of pelvic inflammatory disease but have no effect on unscheduled visits to the provider.
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B
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106
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the analgesic efficacy and adverse effects of a single dose of dextropropoxyphene alone and in combination with paracetamol for postoperative pain? Please answer this question based on the information provided below:
Relief of severe pain with acetaminophen in a new dose formulation versus propoxyphene hydrochloride 65 mg. and placebo: a comparative double-blind study.
Nefopam and propoxyphene in episiotomy pain.
To evaluate relative efficacy, safety, and time course of analgesia, nefopam (45 and 90 mg), a new centrally acting nonnarcotic analgesic, was compared with propoxyphene (65 mg) and placebo in a single oral dose, parallel, stratified, randomized, double-blind trial with 100 hospitalized postpartum women with medium or severe episiotomy pain. Using subjective reports as indices of response, patients rated pain intensity and side effects at periodic interviews for 6 hr. After 45 and 90 mg nefopam, 21 of 25 and 20 of 25 patients (p less than 0.01) reported more than 50% reduction of pain, whereas after 65 mg propoxyphene 18 of 25 (p less than 0.05) and after placebo 11 of 25 reported reduction in pain. Relative efficacy, based on summed pain intensity differences, showed measurable but modest dose-dependent analgesia with nefopam, suggesting that the effectiveness of 65 mg propoxyphene lay between 45 mg nefopam and placebo. Side effects included mild dizziness and hypothermia after nefopam and mild elevation of diastolic arterial pressure after nefopam and propoxyphene. Our results suggest that 45- and 90-mg doses of nefopam induced more analgesia than 65 mg propoxyphene in the relief of episiotomy pain.
The relative efficacy of indoprofen compared with opioid-analgesic combinations.
This double-blind, parallel-design study used postsurgical dental outpatients as subjects. The patients self-administered a single dose of one of the study medications when they estimated their pain to be of moderate or severe intensity. The study medications were 200 mg of indoprofen, 650 mg of acetaminophen, 650 of acetaminophen with 60 mg of codeine, 650 mg of acetaminophen with 100 mg of d-propoxyphene N, and a placebo. On a report form, data were recorded on baseline pain and then hourly for four hours, intensity of pain, relief of pain, and side effects were reported. Also, an overall evaluation was recorded. Data were analyzed with the use of analysis of variance and Duncan's Multiple Range test. All four active treatments were statistically superior to placebo for sum pain intensity difference, total relief of pain, and overall evaluation parameters. Both opioid-analgesic combinations showed small additive effects over acetaminophen alone, and indoprofen was superior to both combination treatments and acetaminophen alone.
The analgesic efficacy of suprofen in periodontal and oral surgical pain.
Suprofen is a new, orally effective nonsteroidal antiinflammatory analgesic of the propionic acid chemical class. Three separate single-dose studies were performed to evaluate the efficacy of suprofen in acute pain associated with periodontal surgery and removal of impacted third molars. Study medications were: A--suprofen 200 mg, codeine 60 mg, propoxyphene HCl 65 mg, and placebo; B--suprofen 400 mg and 200 mg, aspirin 650 mg, and placebo; C--suprofen 400 mg and 200 mg, aspirin 650 mg with codeine 60 mg, aspirin 650 mg alone, and placebo. Analgesic and side effect data were collected over a 6-hour period after patients medicated for moderate to severe pain. All studies were randomized, double-blinded, and parallel-group in design. Suprofen was significantly more effective than codeine 60 mg, propoxyphene HCl 65 mg, and aspirin 650 mg. Suprofen 400 mg appeared to be clinically more effective than the aspirin-codeine combination and the difference was statistically significant for most of the analgesic variables. Of the 224 patients who received suprofen in the 3 studies, 16 reported drowsiness and 1 reported constipation.
A double-blind comparative study of the analgesic effects of fenbufen, codeine, aspirin, propoxyphene and placebo.
Zomepirac, placebo and paracetamol/dextropropoxyphene combination compared in orthopaedic postoperative pain.
Postsurgical pain: zomepirac sodium, propoxyphene/-acetaminophen combination, and placebo.
Zomepirac sodium, a new, nonnarcotic analgesic agent, was compared with the combination of propoxyphene/acetaminophen in a placebo-controlled, double-blind, single-dose study in 196 hospitalized postsurgical patients with pain severe enough to require a prescription analgesic. Patients received 100 mg zomepirac sodium, 50 mg zomepirac sodium, 100 mg propoxyphene napsylate with 650 mg acetaminophen, or placebo. Total pain relief during the 6-hour observation period showed that 100 mg zomepirac sodium was significantly more effective than the propoxyphene combination. All active drugs were superior to placebo. Percentages of patients requiring remedication before the end of the study were: 77 per cent for placebo, 48 per cent for propoxyphene/acetaminophen, 43 per cent for 50 mg zomepirac sodium, and 29 per cent for 100 mg zomepirac sodium. The numbers of patients reporting side effects were not significantly different among the treatment groups. These results confirm those of other single-dose pain studies which showed 100 mg zomepirac sodium significantly more efficacious than the propoxyphene/acetaminophen combination.
Single-patient data meta-analysis of 3453 postoperative patients: oral tramadol versus placebo, codeine and combination analgesics.
The analgesic effectiveness and safety of oral tramadol were compared with standard analgesics using a meta-analysis of individual patient data from randomised controlled trials in patients with moderate or severe pain after surgery or dental extraction. Calculation of %maxTOTPAR from individual patient data, and the use of > 50%maxTOTPAR defined clinically acceptable pain relief. Number-needed-to-treat (NNT) for one patient to have > 50%maxTOTPAR compared with placebo was used to examine the effectiveness of different single oral doses of tramadol and comparator drugs. Eighteen randomised, double-blind, parallel-group single-dose trials with 3453 patients using categorical pain relief scales allowed the calculation of %maxTOTPAR. The use of > 50%maxTOTPAR was a sensitive measure to discriminate between analgesics. Tramadol and comparator drugs gave significantly more analgesia than placebo. In postsurgical pain tramadol 50, 100 and 150 mg had NNTs for > 50%maxTOTPAR of 7.1 (95% confidence intervals 4.6-18), 4.8 (3.4-8.2) and 2.4 (2.0-3.1), comparable with aspirin 650 mg plus codeine 60 mg (NNT 3.6 (2.5-6.3)) and acetaminophen 650 mg plus propoxyphene 100 mg (NNT 4.0 (3.0-5.7)). With the same dose of drug postsurgical patients had more pain relief than those having dental surgery. Tramadol showed a dose-response for analgesia in both postsurgical and dental pain patients. With the same dose of drug postsurgical pain patients had fewer adverse events than those having dental surgery. Adverse events (headache, nausea, vomiting, dizziness, somnolence) with tramadol 50 mg and 100 mg had a similar incidence to comparator drugs. There was a dose response with tramadol, tending towards higher incidences at higher doses. Single-patient meta-analysis using more than half pain relief provides a sensitive description of the analgesic properties of a drug, and NNT calculations allow comparisons to be made with standard analgesics. Absolute ranking of analgesic performance should be done separately for postsurgical and dental pain.
Analgesic oral efficacy of tramadol hydrochloride in postoperative pain.
Tramadol hydrochloride is a synthetic opiate agonist with a plasma elimination half-life of 5 to 6 hours and peak plasma levels at about 1 1/2 hours. It derives its activity from attachment to the mu-receptor and blockage of norepinephrine reuptake. The purpose of this single-dose, double-blind, placebo-controlled study was to determine the analgesic effectiveness of an oral administration of two dose levels of tramadol hydrochloride (75 or 150 mg) compared with the combination of 650 mg acetaminophen plus 100 mg propoxyphene napsylate in 161 patients with severe postoperative pain after cesarean section. Analgesia was assessed over a 6-hour period. Treatments were compared on the basis of standard scales for pain intensity and relief and a number of derived variables based on these data. A global rating of the study medication was also used to compare treatments. The three active treatments were effective analgesics, statistically superior to placebo for many hourly and summary measures. A dose response was seen between the two tramadol doses, with the 150 mg dose providing significantly greater analgesia over the lower dose. The 75 mg dose of tramadol was generally more effective than the acetaminophen-propoxyphene combination after hour 2, and significantly so for some hourly time points, as well as for the global rating of the medication. The 150 mg dose of tramadol was significantly more effective than the acetaminophen-propoxyphene combination from hour 2 through hour 6 for the sum of pain intensity differences and total pain relief scores, as well as for the global rating of the medication. Tramadol hydrochloride at both dose levels is an effective analgesic agent and at 150 mg is statistically superior to the acetaminophen-propoxyphene combination. No serious adverse effects were observed; however, dizziness was more frequently reported with 150 mg tramadol.
Comparison of nefopam hydrochloride and propoxyphene hydrochloride in the treatment of postoperative pain.
The use of glifanan in postoperative pain.
Options:
A: Dextropropoxyphene alone is highly effective for postoperative pain with minimal adverse effects.
B: Dextropropoxyphene combined with paracetamol shows similar efficacy to tramadol but with a lower incidence of adverse effects.
C: Dextropropoxyphene combined with paracetamol is less effective than tramadol and has more adverse effects.
D: Dextropropoxyphene alone is more effective than when combined with paracetamol.
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B
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107
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What were the findings regarding the efficacy and safety of lisuride compared to bromocriptine as adjunct therapy in patients with Parkinson's disease experiencing long-term complications from levodopa therapy? Please answer this question based on the information provided below:
Comparison of lisuride and bromocriptine in the treatment of advanced Parkinson's disease.
Twenty patients with advanced idiopathic Parkinson's disease were studied, all having a deteriorating response to levodopa and suffering from daily fluctuations in disability. A double-blind randomized cross-over study was conducted. Basic levodopa and anticholinergic treatment was continued unchanged in all patients. The dose increment period of 4-8 weeks was followed by a 4 week treatment period on a fixed optimal dose. In both treatment groups the mean optimal daily dose of lisuride was 1.3 mg (range 0.2-2.4 mg) and that of bromocriptine about 15 mg (range 3.75-30.0), without any significant differences between the treatment groups. The addition of lisuride or bromocriptine to levodopa treatment resulted in a significant and equal further improvement of parkinsonian disability. The therapeutic profiles of both lisuride and bromocriptine were similar. There was significantly more improvement in tremor than in other parkinsonian symptoms. Both lisuride and bromocriptine elicited a significant improvement in fluctuations of disability. No significant differences between the treatments were observed. The occurrence of clinical side effects seemed to be similar with both treatment regimens. In advanced parkinsonian patients the therapeutic efficacy of lisuride seems to be equal to that of bromocriptine as far as parkinsonian disability and fluctuations in disability are concerned.
Options:
A: Lisuride was found to be significantly more effective than bromocriptine in improving motor fluctuations.
B: Bromocriptine was found to be significantly more effective than lisuride in improving motor fluctuations.
C: Both lisuride and bromocriptine showed similar efficacy in improving motor fluctuations, but the study's small size and methodological issues prevent firm conclusions.
D: Lisuride was associated with significantly fewer adverse events compared to bromocriptine.
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C
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108
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What are the benefits and limitations of palliative chemotherapy for patients with advanced or metastatic colorectal cancer? Please answer this question based on the information provided below:
Quality of life and survival with continuous hepatic-artery floxuridine infusion for colorectal liver metastases.
Very few patients with liver metastases from colorectal cancer can be cured. We have investigated whether a treatment to slow the growth of liver metastases, hepatic-artery infusion of floxuridine, improves palliation in this setting. In a randomised study of 100 patients, we compared quality of life and survival in patients who received hepatic-artery infusion of floxuridine and in those who received conventional symptom palliation. 95% of control patient survival time was spent with normal quality-of-life scores, which suggests that the aim of treatment should be to prolong normal-quality survival rather than merely to sustain quality of life. There was a significant prolongation (p = 0.03) in overall survival in floxuridine-treated patients compared with controls (median 405 vs 226 days). There were similar significant prolongations in normal-quality (ie, normal symptom scores) survival for physical symptoms (p = 0.04), anxiety (p = 0.04), and depression (p = 0.04). This survival benefit was associated with significant reductions in metastasis size on computed tomography (p = 0.001) and in serum carcinoembryonic antigen concentration (p = 0.006) in floxuridine-treated patients. There was no evidence of treatment-related hepatotoxicity as assessed by serum aspartate aminotransferase and bilirubin measurements. This is the first demonstration that survival can be prolonged with normal quality of life in patients with colorectal liver metastases. We conclude that hepatic-artery floxuridine infusion can be recommended for suitable patients.
Effect of regional and systemic fluorinated pyrimidine chemotherapy on quality of life in colorectal liver metastasis patients.
PURPOSE: Since systemic and regional (HAI) fluorinated pyrimidine chemotherapies offer similar survival benefit in treatment of colorectal liver metastases (CLM), we sought to identify their impact on quality of life (QoL), which might be a useful indicator of treatment preference.
METHODS: We compared QoL in 135 CLM patients managed by symptom control (n = 49 patients), systemic fluorouracil (5FU)/folinic acid (n = 35), or hepatic arterial floxuridine (FUDR) (n = 51). Full blood count and liver function tests, World Health Organization (WHO) toxicity criteria, and QoL (Rotterdam Symptom Checklist [RSC], the Sickness Impact Profile [SIP], and the Hospital Anxiety and Depression scale [HAD]) were measured monthly in all patients.
RESULTS: The HAD anxiety score was significantly increased in symptom control compared with chemotherapy patients 1 month after randomization. There was a significant increase in RSC physical score (repeated measures, P = .05), and in scores for sore mouth (P < .01), dry mouth (P < .01), and tingling hands and feet (P < .01) in systemic chemotherapy compared with symptom control patients. Significant QoL differences (repeated measures and Mann-Whitney U [MWU]) between HAI and symptom control patients were not detected. Systemic chemotherapy patients lived for significantly longer (log-rank test, P < or = .0001) with abnormal HAD anxiety, RSC psychosocial, or RSC sore mouth scores compared with HAI patients, but there were no overall survival differences.
CONCLUSION: Randomization to symptom control only was associated with increased anxiety. QoL with systemic chemotherapy was impaired by side effects. HAI was associated with similar survival to systemic chemotherapy but with better sustained QoL.
Randomised trial of irinotecan plus supportive care versus supportive care alone after fluorouracil failure for patients with metastatic colorectal cancer.
BACKGROUND: In phase II studies, irinotecan is active in metastatic colorectal cancer, but the overall benefit has not been assessed in a randomised clinical trial.
METHODS: Patients with proven metastatic colorectal cancer, which had progressed within 6 months of treatment with fluorouracil, were randomly assigned either 300-350 mg/m2 irinotecan every 3 weeks with supportive care or supportive care alone, in a 2:1 ratio.
FINDINGS: 189 patients were allocated irinotecan and supportive care and 90 supportive care alone. The mean age of the participants was 58.8 years; 181 (65%) were men and 98 (35%) were women. WHO performance status was 0 in 79 (42%) patients, 1 in 77 (41%) patients, and 2 in 32 (17%) patients. Tumour-related symptoms were present in 134 (71%) patients and weight loss of more than 5% was seen in 15 (8%) patients. With a median follow-up of 13 months, the overall survival was significantly better in the irinotecan group (p=0.0001), with 36.2% 1-year survival in the irinotecan group versus 13.8% in the supportive-care group. The survival benefit, adjusted for prognostic factors in a multivariate analysis, remained significant (p=0.001). Survival without performance-status deterioration (p=0.0001), without weight loss of more than 5% (p=0.018), and pain-free survival (p=0.003) were significantly better in the patients given irinotecan. In a quality-of-life analysis, all significant differences, except on diarrhoea score, were in favour of the irinotecan group.
INTERPRETATION: Our study shows that despite the side-effects of treatment, patients who have metastatic colorectal cancer, and for whom fluorouracil has failed, have a longer survival, fewer tumour-related symptoms, and a better quality of life when treated with irinotecan than with supportive care alone.
Hepatic artery ligation with and without portal infusion of 5-FU. A randomized study in patients with unresectable liver metastases from colorectal carcinoma. The E.O.R.T.C. Gastrointestinal Cancer Cooperative Group (G.I. Group).
The aim of this multicentric prospective randomized clinical trial was to study the efficacy of hepatic artery ligation (HAL) with and without portal infusion (PI) of 5-FU in patients with liver metastasis of colorectal origin. Seventy-four patients were randomized. Sixty-seven were fully evaluable. Thirty-five patients were eligible in the HAL + PI of 5-FU group and 32 in the HAL alone group. The 5-FU infusion had to be discontinued for technical reasons in 13 patients. Complications of HAL were relatively high, including four hepatic failures (WHO grading greater than 2). Side effects of chemotherapy were limited. Five patients out of 30 had a partial response (WHO criteria) and one patient had a complete response in the group treated by HAL and PI of 5-FU. Only one patient had a partial response in the HAL alone group. Median survival for both groups was 12 months. Median time to progression for both groups was 6 months. This study did not show any advantage of delivery using the portal route in addition to hepatic artery ligation in terms of progression nor in survival of patients.
Cost-effectiveness of palliative chemotherapy in advanced gastrointestinal cancer.
BACKGROUND: Chemotherapy may relieve tumor-related symptoms, may improve quality of life and prolong survival in advanced gastrointestinal cancer. The extent of such improvements is unclear despite the extensive use of this treatment modality, and there are no studies concerning the economic cost of any gain achieved in the quantity and quality of life by chemotherapy.
PATIENTS AND METHODS: Between January 1991 and May 1992, 61 patients with inoperable cancer (18 gastric, 22 pancreatic or biliary, and 21 colorectal) were randomized to either primary chemotherapy in addition to best supportive care or to best supportive care. Chemotherapy was allowed in the latter group if the supportive measures did not achieve palliation. All economic costs for medical care were prospectively recorded, and marginal cost-effectiveness analyses were performed.
RESULTS: More patients in the primary chemotherapy group (19/33, 58%) had improved/prolonged high quality of life (QoL-patient, minimum duration 4 months) than in the best supportive care group (8/28, 29%, p < 0.05). Overall survival and quality-adjusted survival were significantly longer in the primary chemotherapy group (median 9 vs. 4 months, p < 0.05), and median 7 vs. 2 months, p < 0.05, respectively). When analysed by cancer site, survival was significantly prolonged in gastric cancer patients (median 10 vs. 4 months, p < 0.02), but not in colorectal (median 12 vs. 6 months, p = 0.1) and pancreatic-biliary cancer patients (median 8 vs. 5 months, p = 0.8). The average cost for all medical care was approximately 50% higher in the primary chemotherapy group, but the average cost per day was the same in the two groups. Hospitalization accounted for most of the costs in both groups. The incremental costs per gained year of life was SEK 166,400 ($21,300), per gained quality-adjusted year of life SEK 157,200 ($20,200), and per QoL-patient SEK 160,300 ($20,600). These costs were lower for gastric and colorectal cancer patients, and much higher for pancreatic-biliary cancer patients.
CONCLUSIONS: The results of this study suggest that palliative chemotherapy is cost-effective in patients with advanced gastric and colorectal cancer. Knowledge about survival and quality of life benefits is still limited in patients suffering from gastric and pancreatic-biliary cancer.
Treatment of liver metastases from colorectal cancer with hepatic artery occlusion, intraportal 5-fluorouracil infusion, and oral allopurinol. A randomized clinical trial.
BACKGROUND: Regional therapy for colorectal liver metastases aimed at prolonging survival has not been tested fully in a randomized trial with untreated control subjects. This study explored the efficacy of temporary hepatic artery occlusion followed by intraportal infusion of 5-fluorouracil (5-FU) and oral allopurinol as biochemical modulators in prolonging the survival of patients with nonresectable liver metastases and no extrahepatic cancer.
METHODS: Eighty-four patients were considered for randomization, of whom 24 were excluded at laparotomy because of extrahepatic cancer (n = 17) or resectable lesions (n = 5). In two patients, no cancer was identified in the liver. Thirty-two patients were allocated to receive treatment, and 28 were allocated to receive no regional or systemic treatment. Six patients were excluded after randomization because of major protocol violations.
RESULTS: The median survival time for patients was 17 months (range, 0-66), and for control subjects, the median was 8 months (range, 0-31). Log rank analysis demonstrated a significant survival benefit for treatment versus no treatment (P = 0.0039). (In two patients, early death was due to toxicity from the wrong dose of 5-FU and the wrong route of administration, respectively; the mean and median survival were reduced by 1 month).
CONCLUSION: This study identified a treatment modality that prolongs survival in patients with nonresectable liver metastases and no extrahepatic metastases from colorectal cancer, suggesting that control subjects receiving no therapy may not be necessary in future randomized trials.
Prospective randomized controlled trial of hepatic arterial embolization or infusion chemotherapy with 5-fluorouracil and degradable starch microspheres for colorectal liver metastases.
Survival benefit from hepatic artery embolization (HAE) or hepatic arterial infusion chemotherapy (HAI) in patients with unresectable colorectal liver metastases has not previously been assessed in a randomized controlled trial. Sixty-one patients were randomized, 20 to receive no treatment, 22 to receive HAE, and 19 to receive HAI with 5-fluorouracil and degradable starch microspheres. Both treatments were acceptable to the patients in terms of low treatment morbidity rate. Median survival from diagnosis of metastases was 9.6 months for controls, 8.7 months for the HAE group and 13.0 months in the HAI group. There was no apparent survival benefit for the HAE group. The increased survival in the HAI group was observed in all the subgroups analysed but failed to reach statistical significance. The greatest observed benefit was achieved in the subgroup with less than 50 per cent hepatic replacement with tumour at presentation (median survival from diagnosis 10.0 months for controls, 10.2 months for HAE and 23.6 months for HAI); 36 per cent of patients developed extrahepatic disease recurrence. No significant benefit has been shown from either HAE or HAI, but a more carefully selected group of patients with only low volume hepatic disease may benefit from HAI therapy.
General condition of asymptomatic patients with advanced colorectal cancer receiving palliative chemotherapy. A longitudinal study.
A Nordic multicenter study in asymptomatic patients with advanced colorectal cancer compared initial chemotherapy with sequential methotrexate-5-FU with leucovorin rescue (MFL) for 6 months versus primary expectancy with chemotherapy only after the appearance of symptoms. The study (183 patients randomized between January 1985 and February 1990) showed that symptom-free survival, progression-free survival and survival respectively were about 6 months longer in the group of patients randomized to initial MFL. Whether these prolongations could be achieved without an impaired 'quality of life' was studied in an associated study. Between January 1985 and March 1987, 43 patients were randomized at one of the hospitals, 36 of which were interviewed with a questionnaire at randomization. Even if all these patients were considered, by the physician, to be 'free of symptoms from their disease', 16/36 (44%) had symptoms that could be referred to the disease. In spite of this, the patients were in a good general condition, and considerably better off than patients considered to have 'symptoms from the disease' who were interviewed with the same questionnaire when randomized in a parallel study of symptomatic patients. Patients randomized to initial chemotherapy and interviewed longitudinally maintained their good condition throughout treatment. Toxicity was mild, although the patients expressed more adverse effects than the physicians recorded. Since symptom-free survival, progression-free survival and survival were statistically significantly longer in the group of patients randomized to MFL also in this associated study, it is concluded that initial chemotherapy can prolong symptom-free survival and survival without reduced 'quality of life' during the treatment period.
Expectancy or primary chemotherapy in patients with advanced asymptomatic colorectal cancer: a randomized trial.
PURPOSE: The advantage of chemotherapy in asymptomatic patients with advanced colorectal cancer is debatable. Whether early chemotherapy improves survival and the length of the symptom-free period versus no therapy until symptoms appear was studied in a randomized trial.
PATIENTS AND METHODS: A total of 183 patients with advanced, but asymptomatic colorectal cancer were randomly allocated to receive either initial treatment with sequential methotrexate 250 mg/m2 during the first 2 hours, and fluorouracil (5-FU) 500 mg/m2 at hours 3 and 23 followed by leucovorin rescue initiated at hour 24 (MFL) for 12 courses or to primary expectancy with chemotherapy not considered until symptoms appeared. One patient was ineligible and excluded from analysis. Nine patients did not fulfill the inclusion criteria and five patients refused treatment allocation; these patients were not excluded from the study population so as not to introduce bias. So far, 51 of 90 (60%) patients in the expectancy group have received chemotherapy.
RESULTS: Overall survival was better in the MFL group than in the expectancy group (Breslow-Gehan, P less than .02; log-rank, P = .13) with a difference in median survival of approximately 5 months. Also the symptom-free period and the time to disease progression were longer in the MFL group (P less than .001), with median differences of 8 and 4 months, respectively. Toxicity to MFL treatment was low; however, three patients died because of toxicity--none of them should have received therapy because of poor performance or S-creatinine elevation. The patients maintained an excellent performance throughout the MFL treatment unless the disease was progressive.
CONCLUSION: We concluded that early treatment with MFL in asymptomatic patients with advanced colorectal cancer prolongs survival, the asymptomatic period, and the time to disease progression by approximately 6 months over primary expectancy.
Hepatic arterial infusion of floxuridine in patients with liver metastases from colorectal carcinoma: long-term results of a prospective randomized trial.
PURPOSE: A multicentric randomized study that compared patients who received intrahepatic arterial infusion (HAI) to a group of patients who did not receive HAI (control group) was performed for unresectable hepatic metastases from primary colorectal carcinoma.
PATIENTS AND METHODS: One hundred sixty-six patients were assigned randomly to HAI of floxuridine (5 fluoro-2'deoxyuridine [FUDR]) 0.3 mg/kg/d for 14 days every 4 weeks or to the control group; this latter group, depending on the investigator's choice, was either under observation or received systemic fluorouracil (5-FU). The same regimen of systemic 5-FU also was administered to the HAI group in the event of extrahepatic progression. No crossover from the control group to the HAI group was permitted. The mean duration of follow-up was 54 months (range, 31 to 72), and 163 patients were analyzed.
RESULTS: A significant improvement was observed in the survival rate for the 81 patients assigned to HAI group (P less than .02) with a 1-year survival rate of 64% versus 44% in the control group (82 patients). The 2-year survival rate was 23% versus 13%. The median survival was 15 months versus 11 months for the HAI group and the control group, respectively. Survival was better for patients with a less than 30% liver involvement, and for those treated in more specialized centers. The hepatotoxic effects of HAI were observed in 47 patients (chemical hepatitis [n = 28], and biliary sclerosis [n = 19]). The 1-year rate of sclerosing cholangitis was equal to 25%. Gastrointestinal toxicity was infrequent and consisted of gastritis or diarrhea.
CONCLUSIONS: Therapy with HAI of FUDR improves the survival of patients with liver metastases over colorectal carcinoma. However, the methods that are used to diminish the toxicity of HAI and efficient systemic chemotherapy, such as a combination of 5-FU and leucovorin, are required to prevent extrahepatic metastases.
Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer.
OBJECTIVES: To compare the length of survival and quality of life in patients given combination chemotherapy in addition to supportive care and in patients given only supportive care.
DESIGN: Randomised study.
SETTING: Gastrointestinal oncology departments.
PATIENTS: 40 previously untreated patients with histologically confirmed, measurable colorectal cancer that was locally recurrent or metastatic.
INTERVENTIONS: Patients were allocated randomly to receive chemotherapy or only supportive care in a ratio of 2:1 according to performance status, metastatic disease of the liver, and weight loss in the six months before entering the study. Chemotherapy consisted of four week cycles of intravenous leucovorin (200 mg/m2/day) followed by 5-fluorouracil (550 mg/m2/day) and cisplatin (20 mg/m2/day), each drug being given on the first four days of the cycle.
MAIN OUTCOME MEASURES: Length of survival and quality of life score with an optimised functional living index-cancer scale.
RESULTS: Overall survival was significantly longer for patients given chemotherapy (11.0 months) than for those receiving supportive care alone (5.0 months; p = 0.006). Despite common association of chemotherapy with mild to moderate gastrointestinal symptoms, there was no significant difference between the two groups in global or subgroup quality of life scores. In patients with abnormal scores before treatment, quality of life seemed better in the chemotherapy arm.
CONCLUSIONS: In this sample of patients with disseminated colorectal cancer the chemotherapy regimen was an effective form of palliative treatment.
Two phase III trials of tauromustine (TCNU) in advanced colorectal cancer.
Chemotherapy after palliative resection of colorectal cancer. Yorkshire Gastrointestinal Tumour Group.
Patients with residual disease after palliative resection of colorectal cancer were randomly allocated to receive methyl CCNU and 5-Fluorouracil or followed conventionally. There was a short term improvement in overall survival at 2 years significant at the 5 per cent level but ultimately all patients died. Chemotherapy did not significantly delay progression or prolong survival in patients with local residual disease. Although patients with more disseminated disease had a poorer prognosis than those with more limited disease, survival at 18 months was significantly prolonged (P less than 0.02 greater than 0.01) by chemotherapy.
Options:
A: Palliative chemotherapy significantly reduces the risk of death and improves survival, but the evidence on treatment toxicity, symptom control, and quality of life is poor.
B: Palliative chemotherapy does not significantly impact survival, but it greatly improves quality of life and symptom control.
C: Palliative chemotherapy significantly reduces the risk of death and improves survival, with strong evidence supporting its benefits on quality of life and symptom control.
D: Palliative chemotherapy has no significant impact on survival, quality of life, or symptom control.
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A
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109
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the effectiveness of bicycle helmets in reducing head, brain, and facial injuries for bicyclists of all ages involved in crashes? Please answer this question based on the information provided below:
Injury patterns in cyclists attending an accident and emergency department: a comparison of helmet wearers and non-wearers.
OBJECTIVES: To study circumstances of bicycle accidents and nature of injuries sustained and to determine effect of safety helmets on pattern of injuries.
DESIGN: Prospective study of patients with cycle related injuries.
SETTING: Accident and emergency department of teaching hospital.
SUBJECTS: 1040 patients with complete data presenting to the department in one year with cycle related injuries, of whom 114 had worn cycle helmets when accident occurred.
MAIN OUTCOME MEASURES: Type of accident and nature and distribution of injuries among patients with and without safety helmets.
RESULTS: There were no significant differences between the two groups with respect to type of accident or nature and distribution of injuries other than those to the head. Head injury was sustained by 4/114 (4%) of helmet wearers compared with 100/928 (11%) of non-wearers (P = 0.023). Significantly more children wore helmets (50/309 (16%)) than did adults (64/731 (9%)) (P < 0.001). The incidence of head injuries sustained in accidents involving motor vehicles (52/288 (18%)) was significantly higher than in those not involving motor vehicles (52/754 (7%)) (chi 2 = 28.9, P < 0.0001). Multiple logistic regression analysis of probability of sustaining a head injury showed that only two variables were significant: helmet use and involvement of a motor vehicle. Mutually adjusted odds ratios showed a risk factor of 2.95 (95% confidence interval 1.95 to 4.47, P < 0.0001) for accidents involving a motor vehicle and a protective factor of 3.25 (1.17 to 9.06, P = 0.024) for wearing a helmet.
CONCLUSION: The findings suggest an increased risk of sustaining head injury in a bicycle accident when a motor vehicle is involved and confirm protective effect of helmet wearing for any bicycle accident.
The effectiveness of bicyclist helmets: a study of 1710 casualties.
During the 1980s, a sustained campaign increased the rates of helmet use of Victorian bicyclists. The efficacy of helmet use was evaluated by comparison of crashes and injuries (AIS-1985) in 366 helmeted (261 Australian Standard approved and 105 non-approved) and 1344 unhelmeted casualties treated from 1987 through 1989 at Melbourne and Geelong hospitals or dying before hospitalization. Head injury (HI) occurred in 21.1% of wearers of approved helmets and in 34.8% of non-wearers (p < 0.001). The AIS scores were decreased for wearers of approved helmets (p < 0.001), face injuries were reduced (p < 0.01), and extremity/pelvic girdle injuries increased (p < 0.001) and the overall risk of HI was reduced by at least 39% and face injury by 28%. When casualties with dislodged helmets were excluded, HI was reduced 45% by approved helmets. Head injury reduction by helmets, although substantial, was less than that found in a similar study in Seattle, Washington.
Effectiveness of bicycle helmets in preventing head injury in children: case-control study.
OBJECTIVE: To examine the risk of injury to the head and the effect of wearing helmets in bicycle accidents among children.
DESIGN: Case-control study by questionnaire completed by the children and their carers.
SETTING: Two large children's hospitals in Brisbane, Australia.
SUBJECT: 445 children presenting with bicycle related injuries during 15 April 1991 to 30 June 1992. The cases comprised 102 children who had sustained injury to the upper head including the skull, forehead and scalp or loss of consciousness. The controls were 278 cyclists presenting with injuries other than to the head or face. A further 65 children with injuries to the face were considered as an extra comparison group.
MAIN OUTCOME MEASURES: Cause and type of injury, wearing of helmet.
RESULTS: Most children (230) were injured after losing control and falling from their bicycle. Only 31 had contact with another moving vehicle. Children with head injury were significantly more likely to have made contact with a moving vehicle than control children (19 (19%) v 12 (4%), P < 0.001). Head injuries were more likely to occur on paved surfaces than on grass, gravel, or dirt. Wearing a helmet reduced the risk of head injury by 63% (95% confidence interval 34% to 80%) and of loss of consciousness by 86% (62% to 95%).
CONCLUSIONS: The risk of head injury in bicycle accidents is reduced among children wearing a helmet. Current helmet design maximises protection in the type of accident most commonly occurring in this study. Legislation enforcing helmet use among children should be considered.
A case-control study of the effectiveness of bicycle safety helmets.
Bicycling accidents cause many serious injuries and, in the United States, about 1300 deaths per year, mainly from head injuries. Safety helmets are widely recommended for cyclists, but convincing evidence of their effectiveness is lacking. Over one year we conducted a case-control study in which the case patients were 235 persons with head injuries received while bicycling, who sought emergency care at one of five hospitals. One control group consisted of 433 persons who received emergency care at the same hospitals for bicycling injuries not involving the head. A second control group consisted of 558 members of a large health maintenance organization who had had bicycling accidents during the previous year. Seven percent of the case patients were wearing helmets at the time of their head injuries, as compared with 24 percent of the emergency room controls and 23 percent of the second control group. Of the 99 cyclists with serious brain injury only 4 percent wore helmets. In regression analyses to control for age, sex, income, education, cycling experience, and the severity of the accident, we found that riders with helmets had an 85 percent reduction in their risk of head injury (odds ratio, 0.15; 95 percent confidence interval, 0.07 to 0.29) and an 88 percent reduction in their risk of brain injury (odds ratio, 0.12; 95 percent confidence interval, 0.04 to 0.40). We conclude that bicycle safety helmets are highly effective in preventing head injury. Helmets are particularly important for children, since they suffer the majority of serious head injuries from bicycling accidents.
A case-control study of the effectiveness of bicycle safety helmets in preventing facial injury.
In a case-control study we sought to assess the potential effectiveness of helmets in preventing facial injuries. Our study included 212 bicyclists with facial injuries and 319 controls with injuries to other body areas, who were treated in emergency rooms of five Seattle area hospitals over a one-year period. Using regression analyses to control for age, sex, education and income, accident severity, and cycling experience we found no definite effect of helmets on the risk of serious facial injury (odds ratio 0.81; 95 percent confidence interval = 0.45, 1.5), but protection against serious injuries to the upper face (odds ratio 0.27; 95% CI = 0.1, 0.8). No protection was found against serious injuries to the lower face. The independent effect of helmet use on facial injury was difficult to isolate due to the association of head and facial injuries. Our results suggest that bicycle helmets as presently designed may have some protective effect against serious upper facial injuries.
Effectiveness of bicycle safety helmets in preventing head injuries. A case-control study.
OBJECTIVES: To examine the protective effectiveness of bicycle helmets in 4 different age groups of bicyclists, in crashes involving motor vehicles, and by helmet type and certification standards.
RESEARCH DESIGN: Prospective case-control study
SETTING: Emergency departments (EDs) in 7 Seattle, Wash, area hospitals between March 1, 1992, and August 31, 1994.
PARTICIPANTS: Case subjects were all bicyclists treated in EDs for head injuries, all who were hospitalized, and all who died at the scene. Control subjects were bicyclists treated for nonhead injuries.
MAIN RESULTS: There were 3390 injured bicyclists in the study; 29% of cases and 56% of controls were helmeted. Risk of head injury in helmeted vs unhelmeted cyclists adjusted for age and motor vehicle involvement indicate a protective effect of 69% to 74% for helmets for 3 different categories of head injury: any head injury (odds ratio [OR], 0.31; 95% confidence interval [CI], 0.26-0.37), brain injury (OR, 0.35; 95% CI, 0.25-0.48), or severe brain injury (OR, 0.26; 95% CI, 0.14-0.48). Adjusted ORs for each of 4 age groups (<6 y, 6-12 y, 13-19 y, and > or = 20 years) indicate similar levels of helmet protection by age (OR range, 0.27-0.40). Helmets were equally effective in crashes involving motor vehicles (OR, 0.31; 95% CI, 0.20-0.48) and those not involving motor vehicles (OR, 0.32; 95% CI, 0.20-0.39). There was no effect modification by age or motor vehicle involvement (P=.7 and P=.3). No significant differences were found for the protective effect of hard-shell, thin-shell, or no-shell helmets (P=.5).
CONCLUSIONS: Bicycle helmets, regardless of type, provide substantial protection against head injuries for cyclists of all ages involved in crashes, including crashes involving motor vehicles.
Effectiveness of bicycle safety helmets in preventing serious facial injury.
OBJECTIVE: To assess the effectiveness of helmets in preventing facial injuries.
DESIGN: Case-control study between March 1, 1992, and August 31, 1994.
SETTING: Seven Seattle, Wash, area hospitals including the regional trauma center and a large staff-model health maintenance organization.
PATIENTS: Cases were patients with serious facial injury, ie, fractures or lacerations; controls were patients who had injuries other than facial. Minor facial injuries were excluded to avoid ascertainment bias in those seeking care for serious injuries to other areas.
RESULTS: Serious facial injuries occurred to 700 (20.7%) patients. Helmets were used by 47% of cases and 57% of controls. After adjusting for age, sex, speed, and surface, we found that helmets reduced the risk of injury to the upper face (odds ratio [OR], 0.36; 95% confidence interval [CI], 0.26-0.49) and middle face (OR, 0.35; 95% CI, 0.24-0.50) but had no significant effect on serious injury to the lower face (OR, 0.88; 95% CI, 0.72-1.07).
CONCLUSIONS: Bicycle helmets offer substantial protection for the upper and mid face in addition to their known protection against head injuries. Helmets do not appear to offer any protection for the lower face.
Options:
A: Helmets provide a 63%-88% reduction in the risk of head, brain, and severe brain injury, and a 65% reduction in upper and mid facial injuries.
B: Helmets provide a 50%-70% reduction in the risk of head, brain, and severe brain injury, and a 55% reduction in upper and mid facial injuries.
C: Helmets provide a 40%-60% reduction in the risk of head, brain, and severe brain injury, and a 45% reduction in upper and mid facial injuries.
D: Helmets provide a 30%-50% reduction in the risk of head, brain, and severe brain injury, and a 35% reduction in upper and mid facial injuries.
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A
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110
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the impact of using medical anti-shock trousers (MAST) or pneumatic anti-shock garments (PASG) on mortality and morbidity in trauma patients? Please answer this question based on the information provided below:
PASG: does it help in the management of traumatic shock?
A prospective, randomized study was designed to determine the efficacy of pneumatic antishock garment (PASG) in the treatment of traumatic shock in a medium-size urban community. A total of 291 traumatic shock patients were assigned to either the PASG or No-PASG treatment groups. Of these, data from 248 patients were analyzed in detail. Analysis of demographic factors--such as age, sex, and mechanism of injury--as well as prehospital evaluative tools--such as trauma and CRAMS scores, and injury severity scores--revealed that the two groups were well-matched. This study did not demonstrate significant differences in hospital stay or mortality between PASG and No-PASG patients. Similarly, in the subset of patients with blunt trauma, PASG was not found to be beneficial.
Prospective MAST study in 911 patients.
Nine hundred eleven patients with systolic blood pressures less than or equal to 90 mm Hg were randomized to MAST and No-MAST groups, and all taken to a single Level I Trauma Center. Epidemiologic analysis of etiology, age, race, sex, Trauma Scores, and Injury Severity Scores revealed the two groups to be statistically identical. Seven hundred eighty-four patients were analyzed in detail. The principal injury location was thorax in 41%, abdomen in 32%, extremity in 16%, head in 7%, and neck in 4%. In patients with head and extremity wounds, the mortality rate was clearly not a function of MAST use. In the chest, abdomen, and neck, MAST did not improve survival. Although the total prehospital time was 35.8 + 10.4 minutes for MAST patients and 32.5 +/- 10.7 minutes for No-MAST patients, 70% of patients with MAST had prehospital times greater than 30 minutes compared to 55% of the No-MAST patients. When the prehospital time was greater than 30 minutes, 31% of the MAST patients died, compared to 21% of the No-MAST patients. MAST application adversely affected the outcome most significantly for patients with cardiac and thoracic vascular injury. The overall mortality of 31% in the MAST group, compared to 25% in the No-MAST group was statistically significant (p = 0.05).
Options:
A: MAST/PASG significantly reduces mortality and shortens the length of hospitalisation and ICU stay.
B: MAST/PASG has no significant effect on mortality but may increase the length of hospitalisation and ICU stay.
C: MAST/PASG significantly increases mortality and shortens the length of hospitalisation and ICU stay.
D: MAST/PASG has no significant effect on mortality, length of hospitalisation, or ICU stay.
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B
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111
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the effectiveness of perioperative local anaesthesia in reducing post-operative pain for patients undergoing tonsillectomy? Please answer this question based on the information provided below:
The effect of glossopharyngeal nerve block on pain after elective adult tonsillectomy and uvulopalatoplasty.
This controlled, randomised, double-blind study compared whether glossopharyngeal nerve block and intravenous morphine administered peri-operatively, decreased pain following elective adult tonsillectomy and uvulopalatoplasty more than morphine alone. Sixteen of 30 patients undergoing uvulopalatoplasty and 38 of 78 patients having tonsillectomy received bilateral glossopharyngeal nerve blocks, using bupivacaine 0.5% and adrenaline 1:200,000, or no intervention. There were no differences in postoperative analgesic consumption between the two groups. Visual analogue pain scores measured during swallowing in the recovery room and on the ward postoperatively were significantly less overall in uvulopalatoplasty patients who had received a block (p = 0.004). This difference was not found for tonsillectomy. We found no significant differences between groups, in pain scores recorded during the first 5 days at home. We conclude that glossopharyngeal block does not improve analgesia following tonsillectomy although there is short-lived benefit following uvulopalatoplasty.
Effect of pre- vs postoperative tonsillar infiltration with local anesthetics on postoperative pain after tonsillectomy.
BACKGROUND: Since pre-incisional peritonsillar infiltrations of local anesthetic solutions have been suggested to reduce postoperative pain after tonsillectomy, we compared the efficacy of either pre- or postoperative local anesthetic infiltration upon post-tonsillectomy pain.
METHODS: After the induction of general anesthesia, 68 consecutive healthy patients, ranging in age from 8 to 65 years, were randomly allocated to either receive peritonsillar infiltration with 0.25% bupivacaine (group 1) or normal saline (group 2) before incision. A third group (group 3) had their peritonsillar region infiltrated with 0.25% bupivacaine after the completion of surgery but before the patients were awakened from anesthesia. All the patients were treated in the same way in the postoperative period: NSAIDs were given intravenously to adults and rectally to children. Acetaminophen was given intravenously or rectally (children aged < 15 yr) if additional analgesic support was requested by the patient. Additional acetaminophen consumption was recorded daily. Pain scores were assessed on every patient with the use of a visual analogue scale (VAS) at rest, 1, 5, 9, 13, 17, 21 and 36 h after surgery, and also on swallowing during the first postoperative day.
RESULTS: Global VAS pain scores were lower in the groups treated with bupivacaine infiltration during the first 24 h after surgery (P < 0.05). Supplementary analgesic consumption was lower in group 3 than in group 2 during the 0-9 h interval immediately following surgery (P < 0.05). There were no statistically significant differences for any other parameters between the 3 groups.
CONCLUSION: These results suggest that the timing of peritonsillar infiltration with bupivacaine is not of clinical importance and does not affect the quality of postoperative analgesia in patients undergoing tonsillectomy.
Control of early postoperative pain with bupivacaine in adult local tonsillectomy.
Early postoperative pain following tonsillectomy remains a significant obstacle to speedy recovery and smooth convalescence. Inadequate analgesia causes poor oral intake and occasionally requires overnight hospitalization in same-day surgery practices. Although several otolaryngologists anecdotally support intraoperative infiltration with long-acting anesthetic agents for postoperative pain control, to our knowledge, no previous study confirms this claim. In a prior investigation, we found no difference between bupivacaine hydrochloride and saline placebo in pediatric patients undergoing tonsillectomy. In this trial, we performed a similar study in an adult population. Fifty-one patients undergoing tonsillectomy with local anesthesia were randomized into bupivacaine or saline placebo groups. Patients provided the following data: (1) pain level; (2) oral intake; (3) number of pain medication doses; and (4) level of pain on jaw opening, all at 10 hours postoperatively. Bupivacaine administration resulted in no adverse effects. No difference was noted in pain level, amount of oral intake, or pain on full jaw opening. Bupivacaine group patients received fewer though not statistically significant doses of pain medication than placebo group patients. We conclude that bupivacaine is a safe medication but offers no advantage in the control of early postoperative pain in adult patients undergoing local tonsillectomy.
Pain relief after tonsillectomy. Effect of benzydamine hydrochloride spray on postoperative pain relief after tonsillectomy.
The efficacy of benzydamine hydrochloride (Difflam) spray to relieve pain from postoperative tonsillectomy was assessed, but it was found that it did not relieve the symptoms after operation when compared to matching placebo.
A comparison of pre- and postoperative tonsillar infiltration with bupivacaine on pain after tonsillectomy. A pre-emptive effect?
Thirty-five healthy patients aged 15-36 years scheduled for bilateral tonsillectomy were randomly allocated to receive the following treatments: tonsillar infiltration with 0.25% bupivacaine 5 min before surgical incision (n = 12); identical tonsillar infiltration administered after both tonsils had been surgically removed (n = 12); infiltration with isotonic saline 5 min before the operation (n = 11). There were no significant differences between groups in pain scores (VAS) at rest or during drinking of 100 ml of water as measured at 4 h postoperatively or on the 1st, 2nd, 3rd and 8th postoperative days. Four, five and three patients in the pre-operative bupivacaine, postoperative bupivacaine, and saline groups, respectively, received one dose of 0.1 mg.kg-1 morphine intravenously (p = 0.76). Cumulative acetylsalicylic acid requirements during the observation period were not significantly different between groups (p = 0.78). These results suggest that pre-operative infiltration of 0.25% bupivacaine has no beneficial pre-emptive analgesic action compared to both an identical treatment administered after tonsillectomy and a placebo.
Options:
A: Perioperative local anaesthesia significantly reduces post-operative pain and the need for additional analgesia.
B: Perioperative local anaesthesia has no significant effect on post-operative pain control.
C: Perioperative local anaesthesia increases the risk of post-operative complications without affecting pain levels.
D: Perioperative local anaesthesia is effective only when combined with other pain management techniques.
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B
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112
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the clinical effectiveness of radical surgical resection compared to simple biopsy in patients with malignant glioma? Please answer this question based on the information provided below:
Debulking or biopsy of malignant glioma in elderly people - a randomised study.
BACKGROUND: Patients with radiologically (MRI and/or CT images) suspected malignant glioma is referred to radiotherapy after craniotomy and resection of the tumour or after diagnostic biopsy. Patients with poor preoperative status and elderly patients are diagnosed more often by biopsy and treated by radiotherapy rather than by craniotomy and tumour resection. However, based on previous retrospective studies it is not possible to conclude which procedure is better for elderly patients. Thus a prospective study comparing these two procedures with elderly patients was planned.
METHODS: 30 patients older than 65 years with radiologically (CT and/or MRI) obvious malignant glioma were randomised into two groups: I) stereotactic biopsy and II) open craniotomy and resection of the tumour. Nineteen patients were diagnosed to have grade IV glioma and four patients grade III glioma. Seven out of 30 (23%) were followed in the "intention-to-treat" group with diagnosis of stroke (n=3), metastasis (n=2), malignant lymphoma (n=1) and one with out histological diagnosis. Patients with histologically verified malignant glioma (grade III-IV) were diagnosed by stereotactic biopsy (n=13) or by open craniotomy and resection (n=10) and all the patients were referred to radiotherapy. Survival and time of deterioration were followed.
FINDINGS: The overall median survival time was 146 (95% CI 89-175) days after the procedure. The estimated median survival time was 171 (95% CI 146-278) days after the craniotomy versus 85 (95% CI 55-157) days after the biopsy (p=0.035). The estimated survival time was 2.757 times longer (95% CI 1.004-7.568, p=0.049) after craniotomy. However, there was no significant difference in the time of deterioration between these two treatments (p=0.057). Amount of radiotherapy given had a significant effect on survival (p=0.001).
INTERPRETATION: Longer survival time is achieved after open craniotomy and resection of tumour. However, overall benefit of open surgery to patient seems to be modest, while time of deterioration did not differ between two treatment groups. Our results support previous studies on the benefit of radiotherapy in the treatment of malignant glioma.
Options:
A: Radical surgical resection was found to be significantly more effective than simple biopsy.
B: Simple biopsy was found to be significantly more effective than radical surgical resection.
C: No qualifying studies were identified to determine the clinical effectiveness of either procedure.
D: Both procedures were found to be equally effective.
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C
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113
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What are the findings regarding the safety and effectiveness of different surgical interventions for early squamous cell carcinoma of the vulva? Please answer this question based on the information provided below:
Surgical therapy of T1 and T2 vulvar carcinoma: further experience with radical wide excision and selective inguinal lymphadenectomy.
Radical wide excision and selective inguinal node dissection provide a more conservative and less morbid surgical option for women with vulvar carcinoma than en bloc radical vulvectomy with bilateral inguinofemoral lymphadenectomy. We have expanded our initial experience with this approach to 76 patients with T1 (n = 33) and T2 (n = 43) squamous carcinomas with invasion > 1 mm and clinically negative groin nodes treated between 1978 and 1994. Lateral tumors (n = 53) were more frequent than midline lesions (n = 23). Tumors were excised with a measured gross margin of 2 cm, and dissection was carried to the deep perineal fascia. The mean largest tumor dimension was 26 mm; the mean depth of invasion was 4.4 mm. Superficial inguinal lymphadenectomy, unilateral or bilateral depending on lesion location, was performed. Perioperative complications occurred on the vulva in 8% of cases and in the groin in 11%. Delayed complications, all related to groin treatment, were seen in 29%. The median follow-up interval was 38 months. Seven patients (9%) had inguinal lymph node metastases identified at their primary operation. Most received additional therapy; one has died of disease. Nine women (12%) developed recurrent disease in the vulva: all were controlled by additional resection. Four (5%) developed recurrence in a previously negative groin: three of these are dead of disease. Actuarial 4-year survival is 81%. Radical wide excision and selective inguinal lymphadenectomy can be safely offered to women with T1 and T2 vulvar cancers. Patients with known positive nodes or vulvar failure can be salvaged by further therapy. Women with unanticipated groin failure usually die of disease. These experiences are similar to those observed in more radically resected patients.
Vulvar carcinoma. The price of less radical surgery.
BACKGROUND: The objective of this study was to determine whether modifications in the treatment of patients with vulvar carcinoma influence the rates of recurrence and survival.
METHODS: Between 1982 and 1997, 253 patients with T1 and T2 invasive squamous cell carcinoma of the vulva were treated by essentially the same team of gynecologic oncologists, and 168 patients (Group I) underwent radical vulvectomy with en bloc inguinofemoral lymphadenectomy. Standard therapy was changed in 1993, and 85 patients (Group II) underwent wide local excision with inguinofemoral lymphadenectomy through separate incisions. The rates of recurrence and survival were compared between both groups.
RESULTS: In Group II, the overall recurrence rate (33.3%) within 4 years was increased compared with Group I (19.9%; P = 0.03). In Group II, 5 of 79 patients (6.3%) developed fatal groin or skin bridge recurrences compared with 2 of 159 patients (1.3%) in Group I (P = 0.029); this did not result in a difference in overall survival. In Group II, 40 of 79 patients had tumor free margins measuring <or= 8 mm, resulting in 9 local recurrences; whereas 39 of 79 patients had tumor free margins measuring > 8 mm, resulting in no local recurrences (P = 0.002).
CONCLUSIONS: The current study showed that fatal recurrences in either the groin or the skin bridge were more frequent after wide local excision and inguinofemoral lymphadenectomy through separate incisions; however, probably due to lack of power, this did not result in shorter survival. In 40 of 79 patients, the histologic margins measured <or= 8 mm, resulting in a high risk of local recurrences. Therefore, the authors recommend obtaining surgical margins of 2 cm for the local treatment of patients with vulvar carcinoma.
An alternate approach to early cancer of the vulva.
Early invasive squamous cell carcinoma of the vulva has emerged as a controversial issue in recent literature. Reports illustrating metastatic disease in the inguinal lymph nodes have conflicted with other reports suggesting local treatment only. The morbidity produced by radical vulvectomy to both body image and sexual function make this issue worthy of serious consideration. This report deals with an alternate approach to this disease entity which attempts to preserve vulvar tissue without sacrificing curability where possible metastatic disease exists. The concept is proposed of utilizing the superficial inguinal nodes as sentinel nodes in the treatment planning. The results of 20 patients treated in this manner are presented.
Options:
A: Radical local excision is as safe as radical vulvectomy, and ipsilateral lymph node dissection is safe for well lateralized tumors.
B: Superficial groin node dissection is safer than full femoro-inguinal groin node dissection.
C: Triple incision technique is less safe than en bloc dissection.
D: Radical vulvectomy is the only safe option for early vulvar cancer.
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A
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114
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the effects of combining zidovudine (AZT) with didanosine (ddI) or zalcitabine (ddC) on HIV disease progression and survival in HIV-infected adults? Please answer this question based on the information provided below:
Combination and monotherapy with zidovudine and zalcitabine in patients with advanced HIV disease. The NIAID AIDS Clinical Trials Group.
OBJECTIVE: To compare the safety and efficacy of continuing zidovudine therapy with that of zalcitabine alone or zalcitabine and zidovudine used together.
DESIGN: A randomized, double-blind, controlled trial.
SETTING: AIDS Clinical Trials units and National Hemophilia Foundation sites.
PATIENTS: 1001 patients with symptomatic human immunodeficiency (HIV) disease and 300 or fewer CD4 cells/mm3 or asymptomatic HIV disease and 200 or fewer CD4 cells/mm3 who had tolerated zidovudine therapy for 6 months or more.
INTERVENTION: Patients were randomly assigned to receive zidovudine, 600 mg/d; zalcitabine, 2.25 mg/d; or zidovudine, 600 mg/d, and zalcitabine, 2.25 mg/d.
MEASUREMENTS: The primary end point was time to disease progression or death.
RESULTS: The median follow-up time was 17.7 months. The estimated 12-month event-free rates were 70%, 67%, and 73%, respectively, for the zidovudine, zalcitabine, and combination groups (P = 0.26). A trend analysis showed significantly lower progression rates for combination therapy compared with zidovudine therapy as the pretreatment CD4 cell count increased (P = 0.027). For patients with 150 or more CD4 cells/mm3, those receiving combination therapy were less likely to have disease progression or to die than were those receiving zidovudine (relative risk, 0.51; 95% CI, 0.28 to 0.93; P = 0.029). We observed no difference between the zalcitabine and zidovudine groups (relative risk, 0.74; CI, 0.40 to 1.36; P = 0.33). For patients with 50 to 150 CD4 cells/mm3 or fewer than 50 CD4 cells/mm3, we found no differences among the treatment groups (P = 0.69 and P = 0.57, respectively). Severe toxic effects occurred less frequently among patients with 150 or more CD4 cells/mm3.
CONCLUSIONS: We found no overall benefits of zalcitabine used alone or with zidovudine. However, a trend analysis suggested a better outcome for combination therapy compared with zidovudine as the pretreatment CD4 cell count increased.
A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 to 500 per cubic millimeter. AIDS Clinical Trials Group Study 175 Study Team.
BACKGROUND: This double-blind study evaluated treatment with either a single nucleoside or two nucleosides in adults infected with human immunodeficiency virus type 1 (HIV-1) whose CD4 cell counts were from 200 to 500 per cubic millimeter.
METHODS: We randomly assigned 2467 HIV-1--infected patients (43 percent without prior antiretroviral treatment) to one of four daily regimens: 600 mg of zidovudine; 600 mg of zidovudine plus 400 mg of didanosine; 600 mg of zidovudine plus 2.25 mg of zalcitabine; or 400 mg of didanosine. The primary end point was a > or = 50 percent decline in the CD4 cell count, development of the acquired immunodeficiency syndrome (AIDS), or death.
RESULTS: Progression to the primary end point was more frequent with zidovudine alone (32 percent) than with zidovudine plus didanosine (18 percent; relative hazard ratio, 0.50; P<0.001), zidovudine plus zalcitabine (20 percent; relative hazard ratio, 0.54; P<0.001), or didanosine alone (22 percent; relative hazard ratio, 0.61; P<0.001). The relative hazard ratios for progression to an AIDS-defining event or death were 0.64 (P=0.005) for zidovudine plus didanosine, as compared with zidovudine alone, 0.77 (P=0.085) for zidovudine plus zalcitabine, and 0.69 (P=0.019) for didanosine alone. The relative hazard ratios for death were 0.55 (P=0.008), 0.71 (P=0.10), and 0.51 (P=0.003), respectively. For zidovudine plus zalcitabine, the benefits were limited to those without previous treatment.
CONCLUSIONS: Treatment with zidovudine plus didanosine, zidovudine plus zalcitabine, or didanosine alone slows the progression of HIV disease and is superior to treatment with zidovudine alone. Antiretroviral therapy can improve survival in patients with 200 to 500 CD4 cells per cubic millimeter.
A randomized, controlled, double-blind study comparing the survival benefit of four different reverse transcriptase inhibitor therapies (three-drug, two-drug, and alternating drug) for the treatment of advanced AIDS. AIDS Clinical Trial Group 193A Study Team.
OBJECTIVE: The primary objective was to compare the effects of dual or triple combinations of HIV-1 reverse transcriptase inhibitors with respect to survival. The time to new HIV disease progression or death, toxicities, the change in CD4 cells, and plasma HIV-1 RNA concentrations in a subset of study subjects were evaluated.
DESIGN: This was a multicenter randomized, double-blind, placebo-controlled study.
SETTING: The study was conducted among 42 adult AIDS Clinical Trials Group sites and 7 National Hemophilia Foundation centers.
PATIENTS: 1313 HIV-infected patients with CD4 counts < or = 50 cells/mm3 participated in this study, which was conducted from June 1993 to June 1996.
INTERVENTION: Patients were randomized to one of four daily regimens containing 600 mg of zidovudine: zidovudine alternating monthly with 400 mg didanosine; zidovudine plus 2.25 mg of zalcitabine; zidovudine plus 400 mg of didanosine; or zidovudine plus 400 mg of didanosine plus 400 mg of nevirapine (triple therapy).
MAIN OUTCOME MEASURES: The main outcome was survival (i.e., time to death).
RESULTS: A significant difference in survival time was found between the four treatment groups, favoring those assigned to triple therapy (p = .02). A significant difference was also found in the delay of disease progression or death among the four treatment arms favoring the group assigned to triple therapy (p = .002). Baseline CD4 cell counts and plasma HIV-1 RNA concentrations as well as changes of CD4 counts at week 8 predicted survival for subjects in the virology substudy.
CONCLUSIONS: In the pre-protease inhibitor era, a combination of triple reverse transcriptase inhibitors prolonged life and delayed disease progression in AIDS patients with advanced immune suppression.
Zidovudine alone or in combination with didanosine or zalcitabine in HIV-infected patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter. Investigators for the Terry Beirn Community Programs for Clinical Research on AIDS.
BACKGROUND: We compared two combinations of nucleosides with zidovudine alone in patients with advanced human immunodeficiency virus (HIV) infection.
METHODS: A total of 1102 patients with the acquired immunodeficiency syndrome or fewer than 200 CD4 cells per cubic millimeter were randomly assigned to receive zidovudine alone or zidovudine combined with either didanosine or zalcitabine. Disease progression, survival, toxic effects, and the CD4 cell response were assessed.
RESULTS: After a median follow-up of 35 months, disease progression or death occurred in 62 percent of the 363 patients assigned to zidovudine plus didanosine, 63 percent of the 367 assigned to zidovudine plus zalcitabine, and 66 percent of the 372 assigned to zidovudine only (P=0.24). As compared with zidovudine therapy, treatment with zidovudine plus didanosine was associated with a relative risk of disease progression or death of 0.86 (95 percent confidence interval, 0.71 to 1.03), and treatment with zidovudine plus zalcitabine was associated with a relative risk of 0.92 (95 percent confidence interval, 0.76 to 1.10). Survival was similar in the three groups. In a subgroup analysis, combination therapy delayed disease progression or death in patients who had previously received zidovudine for 12 months or less. Therapy with zidovudine plus didanosine resulted in more gastrointestinal adverse effects, and treatment with zidovudine plus zalcitabine, more neuropathy. The mean increases in CD4 cell counts at two months were higher with combination therapy than with zidovudine alone.
CONCLUSIONS: In patients with advanced HIV infection, combination therapy with zidovudine and either didanosine or zalcitabine is not superior to zidovudine therapy alone. However, these combinations may be more effective than zidovudine monotherapy in patients with little or no previous zidovudine treatment.
Delta: a randomised double-blind controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine with zidovudine alone in HIV-infected individuals. Delta Coordinating Committee.
BACKGROUND: Because the benefits of zidovudine (AZT) in HIV-infected individuals are small and do not last long the Delta trial was designed to test whether combinations of zidovudine with didanosine (ddl) or zalcitabine (ddC) were more effective than AZT alone in extending survival and delaying disease progression.
METHODS: The trial was randomised, double blind, and international. 3207 participants were allocated to either AZT (600 mg per day) alone (1055), AZT plus ddl (400 mg per day) (1080), or AZT plus ddC (2.25 mg per day) (1072). Participants either had symptoms of HIV disease (if AIDS, with a CD4 cell count of > 50 x 10(6)/L) or a CD4 count of less than 350 x 10(6)/L; 2124 had not had zidovudine before (Delta 1) and 1083 had for at least 3 months (Delta 2).
FINDINGS: Over a median follow-up of 30 months, 699 participants died, and 936 of the 2765 without AIDS at entry developed AIDS or died. In participants who had not had AZT before, both combination regimens had substantial benefits in terms of survival (regardless of disease stage at entry); a relative reduction in mortality of 42%, compared to AZT alone (95% Cl 25% to 55%), for AZT plus ddl and of 32% (95% Cl 22% to 47%) for AZT plus ddC. In participants who had had AZT before, the addition of ddl improved survival (p = 0.05; relative reduction 23% [95% Cl 0% to 41%]) but there was no direct evidence of benefit from the addition of ddC (p = 0.47; relative reduction 9% [95% Cl--17% to 29%]). The overall difference in survival between the treatment groups was significant (p < 0.0001; a relative reduction in mortality, compared to AZT alone, of 33% (95% Cl 20% to 44%) for AZT plus ddl and 21% (95% Cl 6% to 34%) for AZT plus ddC). Benefit in terms of disease progression was seen mainly in participants not previously treated with AZT and overall. There was no unexpected toxicity from the combination treatments.
INTERPRETATION: Initiation of treatment with combinations of AZT plus ddl or ddC prolongs life and delays disease progression compared with AZT alone. The addition of ddl to participants already treated with AZT also improves survival, although the benefit appears less.
Virologic and immunologic benefits of initial combination therapy with zidovudine and zalcitabine or didanosine compared with zidovudine monotherapy. Wellcome Resistance Study Collaborative Group.
A randomized controlled study was done to determine whether initial combination therapy with zidovudine and zalcitabine or zidovudine and didanosine would delay the emergence of zidovudine-resistant virus. Human immunodeficiency virus (HIV)-1-infected patients with <300 CD4 cells/mm3 and <4 weeks of prior zidovudine therapy were randomized to zidovudine, zidovudine plus zalcitabine, or zidovudine plus didanosine. Combination therapy did not delay the emergence of zidovudine-resistant virus isolates. However, combination therapy resulted in a significant increase in CD4 cells through 72 weeks compared with zidovudine monotherapy and a greater and more sustained decline in serum HIV-1 RNA. Although this trial was not designed as a clinical end-point study, patients assigned to zidovudine plus didanosine combination therapy experienced a significant delay in time to first AIDS-defining event or death compared with those assigned to zidovudine monotherapy.
Options:
A: Both combinations delayed disease progression and death, with AZT+ddI showing greater effects than AZT+ddC.
B: Only the combination of AZT and ddI delayed disease progression and death, while AZT+ddC had no significant effect.
C: Neither combination had any significant effect on disease progression or survival.
D: Both combinations accelerated disease progression and increased the risk of death.
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A
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the effectiveness of prompted voiding for the management of urinary incontinence in adults? Please answer this question based on the information provided below:
Effectiveness of prompted voiding in treating urinary incontinence in cognitively impaired homebound older adults.
OBJECTIVE: The objective of this study was to examine the short-term effectiveness of prompted voiding (PV) in cognitively impaired homebound older adults.
DESIGN: This was a prospective, controlled exploratory study with a cross-over design where usual care controls crossed-over to the intervention following an 8-week observation period.
SETTING: Adults aged 60 years and older with urinary incontinence and who met Center for Medicare and Medicaid Services criteria for being homebound were referred to the study by home care nurses from 2 large Medicare-approved home health agencies in a large metropolitan county in southwestern Pennsylvania. Nineteen cognitively impaired older adults were randomly assigned to either the PV intervention or a usual care attention control group.
MEASURES: Measures used included structured continence and medical histories. Older American Research and Service Physical and Instrumental Activities of Daily Living scales, Folstein Mini Mental State Examination, Clock Drawing Test, Geriatric Depression Scale, Performance-Based Toileting Assessment, bladder diaries, and physical examination.
RESULTS: Nineteen subjects were randomly assigned to a PV (n = 9) or delayed attention-control group (n = 10). Treatment subjects with complete pretreatment and posttreatment data (n = 6) experienced a mean 60% reduction in daytime incontinent episodes compared with a mean 37% reduction among control subjects (n = 10). Following the control phase, subjects crossed over to the treatment protocol. A total of 15 subjects completed the PV protocol. Among all subjects completing the treatment protocol, there was a 22% reduction in daytime incontinent episodes compared with true baseline (immediately following the control phase for those crossing over from the control group).
CONCLUSIONS: The PV intervention resulted in clinically significant reductions in urinary incontinence for many of the participants, which may be achievable for many cognitively impaired homebound older adults.
A clinical trial of a behavioral therapy to reduce urinary incontinence in nursing homes. Outcome and implications.
One hundred thirty-three incontinent women in seven nursing homes were assigned randomly to a 13-week behavior therapy program for urinary incontinence or to a control group that received usual incontinence-related care. The therapy became effective after 6 weeks of training. By the final month of training, the treatment women's wet episodes had been reduced by 0.6 episodes per day, a 26% reduction over baseline. This reduction in the number of wet episodes was statistically significant, both with respect to this group's baseline levels of incontinence and in comparison with the performance of the control women. The number of wet episodes in the control group remained about the same throughout training and the 22-week follow-up period. The treatment women improved partly because they learned to request help, a response prompted and reinforced by the program. Trainees with a high frequency of incontinence during baseline, the more cognitively intact residents, and residents with normal bladder capacity responded better to this behavior therapy program.
Cost effectiveness of training incontinent elderly in nursing homes: a randomized clinical trial.
This study used a randomized clinical trial with 133 incontinent elderly in seven nursing homes to evaluate the effectiveness of a behavioral training therapy and its cost implications. The training program lasted three months, and a 22-week follow-up period examined the durability of the treatment effect. The therapy became effective after six weeks of training. By the final months of training, the treatment participants' wet episodes had been reduced by 0.6 episode per day, or a 26 percent reduction over baseline, and improvement was maintained during the follow-up period. Trainees with a high frequency of incontinence during baseline, relatively more cognitive residents, and residents with a normal bladder capacity responded better to this behavioral program. The cost of training was the equivalent of about one hour of nursing aide time per patient day. The reduction in incontinence during the follow-up period resulted in some small savings in laundry costs and supplies used, and some quantitatively unmeasurable but detectable improvement in psychosocial well-being among the trainees. Since the central figure in implementing this training protocol is the nursing aide, it is important to find an organizational management scheme that will stimulate nursing aides to reduce incontinence among nursing home residents.
Functional Incidental Training: applicability and feasibility in the Veterans Affairs nursing home patient population.
OBJECTIVE: To examine the applicability and feasibility of an intervention directed at improving continence, endurance, and strength (Functional Incidental Training [FIT]), for older patients in Veterans Administration (VA) nursing homes.
DESIGN: Data were collected during a randomized, controlled, crossover trial.
SETTING: Four VA nursing homes.
PARTICIPANTS: All 528 patients in the nursing homes were screened, 178 were eligible, and 107 were randomized into the trial. A total of 64 participants completed the intervention phase of the trial.
INTERVENTION: Trained research staff provided the FIT intervention, which included prompted voiding combined with individualized, functionally oriented endurance and strength training exercises offered four times per day, 5 days per week, for 8 weeks.
MEASURES: Descriptive data were collected relevant to the translation of the FIT intervention into everyday practice, including number of patients eligible and reasons for ineligibility, attrition rates and reasons for attrition, participant adherence to and satisfaction with FIT, and the costs of FIT relative to usual care.
RESULTS: One third of the 528 patients met the eligibility criteria. The major reasons for ineligibility were being continent, age under 60, and a short anticipated length of stay. Of the 146 patients enrolled in the trial, 85 (58%) dropped out during the 9- to 10-month project. Deterioration in health status, death, and discharge accounted for two thirds of the attrition. Adherence to FIT was in general high but variable. Participants completed prompted voiding plus at least one exercise in 75% of the FIT rounds offered. Of the 60 participants who completed the protocol and who could answer simple questions, 75% indicated they enjoyed FIT, but 62% indicated that the exercise was too frequent, and 28% indicated they were offered opportunities to toilet too often. Based on timed observations, the costs of FIT are about four times as high as usual continence care.
CONCLUSIONS: FIT is applicable to a substantial number of patients in VA nursing homes. The FIT protocol tested in this trial can be further refined and individualized based on patient preferences and adherence to various components of FIT in order to make it more feasible, efficient, and cost-effective in practice. The costs of maintaining an intervention such as FIT in all VA nursing home patients who may benefit, however, are high and must be justified largely by potential positive effects on function and quality of life, as opposed to cost savings resulting from the intervention.
Functional incidental training: a randomized, controlled, crossover trial in Veterans Affairs nursing homes.
OBJECTIVES: To test the effects of a rehabilitative intervention directed at continence, mobility, endurance, and strength (Functional Incidental Training (FIT)) in older patients in Department of Veterans Affairs (VA) nursing homes.
DESIGN: Randomized, controlled, crossover trial.
SETTING: Four VA nursing homes.
PARTICIPANTS: All 528 patients in the nursing homes were screened; 178 were eligible, and 107 were randomized to an immediate intervention group (Group 1; n=52) and a delayed intervention group (Group 2; n=55).
INTERVENTION: Trained research staff provided the FIT intervention, which included prompted voiding combined with individualized, functionally oriented endurance and strength-training exercises offered four times per day, 5 days per week, for 8 weeks. Group 1 received the intervention while Group 2 served as a control group; then Group 2 received the intervention while Group 1 crossed over to no intervention. A total of 64 subjects completed the intervention phase of the trial.
MEASUREMENTS: Timed measures of walking or wheeling a wheelchair (mobility), sit-to-stand exercises, independence in locomotion and toileting as assessed using the Functional Independence Measure (FIM), one-repetition maximum weight for several measures of upper and lower body strength, frequency of urine and stool incontinence, and appropriate toileting ratios.
RESULTS: There was a significant effect of the FIT intervention on virtually all measures of endurance, strength, and urinary incontinence but not on the FIM for locomotion or toileting. The effects of FIT were observed when Group 1 received the intervention and was compared with the control group and when Group 2 crossed over to the intervention. Group 1 deteriorated in all measures during the 8-week crossover period. Within-person comparisons also demonstrated significant effects on all measures in the 64 participants who completed the intervention; 43 (67%) of these participants were "responders" based on maintenance or improvement in at least one measure of endurance, strength, and urinary incontinence. No adverse events related to FIT occurred during the study period.
CONCLUSION: FIT improves endurance, strength, and urinary incontinence in older patients residing in VA nursing homes. Translating these positive benefits achieved under research conditions into practice will be challenging because of the implications of the intervention for staff workload and thereby the costs of care.
Management of geriatric incontinence in nursing homes.
A behavioral management system designed to reduce urinary incontinence was evaluated in two nursing homes with a pretest-posttest control group design with repeated measures. The primary components of the system were prompting and contingent social approval/disapproval which required approximately 2.5 minutes per patient per hour to administer. The frequency of correct toileting for experimental subjects increased by approximately 45%. The experimental groups were significantly different from the control groups on both incontinence and correct toileting measures. The results are discussed in view of the management issues inherent in nursing home settings.
Treatment of urinary incontinence in nursing home patients by prompted voiding.
Prompted voiding treatment of urinary incontinence in nursing home patients. A behavior management approach for nursing home staff.
This study evaluated a treatment procedure in which 126 incontinent nursing home patients were checked on an hourly basis, asked if they needed toileting assistance (prompted), and socially reinforced for appropriate toileting. Urodynamic analysis (including cystometrogram), provocative stress test, and behavioral assessment revealed that the nursing home patients were severely debilitated, with 65% demonstrating bladder abnormalities, 87% incapable of independent toileting, and 25% failing to score on the Mini-Mental Status Exam (average score, 8.0). The treatment procedures were evaluated with a multiple baseline design in which subjects were randomly divided into immediate or delayed treatment groups after a baseline observation period. During treatment, the frequency of incontinence per 12 hours changed from a baseline average of 3.85 to a treatment average of 1.91. Three behavioral measures that can be easily collected by nursing staff significantly predicted continence levels during treatment (multiple R, 0.79) and change in incontinence during treatment (multiple R, 0.64). These prognostic criteria offer nursing staff a cost-effective method for selecting the most responsive patients for prompted-voiding treatment.
The effects of an exercise and incontinence intervention on skin health outcomes in nursing home residents.
OBJECTIVES: To examine skin health outcomes of an exercise and incontinence intervention.
DESIGN: Randomized controlled trial with blinded assessments of outcomes at three points over 8 months.
SETTING: Four nursing homes (NHs).
PARTICIPANTS: One hundred ninety incontinent NH residents.
INTERVENTION: In the intervention group, research staff provided exercise and incontinence care every 2 hours from 8:00 a.m. to 4:30 p.m. (total of four daily care episodes) 5 days a week for 32 weeks. The control group received usual care from NH staff.
MEASUREMENTS: Perineal skin wetness and skin health outcomes (primarily blanchable erythema and pressure ulcers) as measured by direct assessments by research staff, urinary and fecal incontinence frequency, and percentage of behavioral observations with resident engaged in standing or walking.
RESULTS: Intervention subjects were significantly better in urinary and fecal incontinence, physical activity, and skin wetness outcome measures than the control group. However, despite these improvements, differences in skin health measures were limited to the back distal perineal area, which included the sacral and trochanter regions. There was no difference between groups in the incidence rate of pressure ulcers as measured by research staff, even though those residents who improved the most on fecal incontinence showed improvement in pressure ulcers in one area.
CONCLUSION: A multifaceted intervention improved four risk factors related to skin health but did not translate into significant improvements in most measures of skin health. Even if they had adequate staffing resources, NHs might not be able to improve skin health quality indicators significantly if they attempt to implement preventive interventions on all residents who are judged at risk because of their incontinence status.
Translating clinical research into practice: a randomized controlled trial of exercise and incontinence care with nursing home residents.
OBJECTIVES: To examine clinical outcomes and describe the staffing requirements of an incontinence and exercise intervention.
DESIGN: Randomized controlled trial with blinded assessments of outcomes at three points over 8 months.
SETTING: Four nursing homes.
PARTICIPANTS: Two hundred fifty-six incontinent residents.
INTERVENTION: Research staff provided the intervention, which integrated incontinence care and exercise every 2 hours from 8:00 a.m. to 4:00 p.m. 5 days a week.
MEASUREMENTS: Average and maximum distance walked or wheeled, level of assistance required to stand, maximum pounds lifted by arms, fecal and urinary incontinence frequency, and time required to implement intervention.
RESULTS: Intervention residents maintained or improved performance whereas the control group's performance declined on 14 of 15 outcome measures. Repeated measures analysis of variance group-by-time significance levels ranged from P <.0001 to.05. The mean time required to implement the intervention each time care was provided was 20.7 +/- 7.2 minutes. We estimate that a work assignment of approximately five residents to one aide would be necessary to provide this intervention.
CONCLUSIONS: The incontinence care and exercise intervention resulted in significant improvement for most residents, and most who could be reliably interviewed expressed a preference for such care. Fundamental changes in the staffing of most nursing homes will be necessary to translate efficacious clinical interventions into everyday practice.
Does an exercise and incontinence intervention save healthcare costs in a nursing home population?
OBJECTIVES: To determine whether an intervention that combines low-intensity exercise and incontinence care offsets some of its costs by reducing the incidence of selected health conditions in nursing home residents.
DESIGN: Randomized, controlled trial with the incidence and costs of selected, acute conditions compared between a 6-month baseline and an 8-month intervention phase.
SETTING: Four nursing homes.
PARTICIPANTS: One hundred ninety incontinent, long-stay nursing home residents.
INTERVENTION: Low-intensity, functionally oriented exercise and incontinence care were provided every 2 hours from 8:00 a.m. to 4:00 p.m. for 5 days a week for 8 months.
MEASUREMENTS: Predefined acute conditions hypothesized to be related to physical inactivity, incontinence, or immobility were abstracted from residents' medical records by blinded observers during a 6-month baseline period and throughout the 8-month intervention. Conditions included those in the dermatological, genitourinary, gastrointestinal, respiratory and cardiovascular systems; falls; pain; and psychiatric and nutritional disturbances. Costs were determined using Current Procedural Terminology Center and Medicare allowable cost reimbursement at a rate of 80%.
RESULTS: The intervention group had significantly better functional outcomes than the control group (strength, mobility endurance, urinary and fecal incontinence) and a reduction of 10% in the incidence of the acute conditions, which was not significant. There were no significant differences between groups in the cost of assessing and treating these acute conditions between baseline and intervention.
CONCLUSION: The intervention, which is consistent with federal and clinical practice guidelines, significantly improved functional outcomes but did not reduce the incidence and costs of selected acute health conditions. The cost of implementing these labor-intensive interventions for frail nursing home residents will have to be justified based on functional and quality-of-life outcomes and are unlikely to be offset by savings in medical care costs in this population.
Resident and family satisfaction with incontinence and mobility care: sensitivity to intervention effects?
PURPOSE: This study evaluated whether the satisfaction levels of long-term-care residents and their family members concerning incontinence and mobility care were sensitive to an improvement intervention.
DESIGN AND METHODS: A randomized, controlled intervention trial with incontinent long-term-care residents was conducted wherein research staff provided toileting and walking assistance. The frequency of assistance was of sufficient intensity to significantly improve continence and mobility outcomes in the treatment group as a whole. Interviews were conducted with residents and family members at baseline and after 8 weeks of intervention to assess their satisfaction with and preferences for incontinence and mobility care, using two question types: (a) direct satisfaction and (b) a discrepancy index of "met needs" reflecting the difference between perceived and preferred care frequencies.
RESULTS: Both residents and family members reported high rates of satisfaction to direct satisfaction questions. Residents' reports were sensitive to care improvements based only on the discrepancy index measure. Few family members were able to answer specific questions about incontinence and mobility care frequencies, and their reports were insensitive to care improvements.
IMPLICATIONS: The majority of incontinent long-term-care residents were able to reliably answer questions about their perceived and preferred care frequencies related to incontinence and mobility care. A discrepancy index based on these questions was sensitive to care frequency improvements. Family members' reports were not sensitive to improvements, and direct satisfaction questions were misleading for both residents and family members.
Effects of an exercise and scheduled-toileting intervention on appetite and constipation in nursing home residents.
PURPOSE: To evaluate the effects of an exercise and scheduled-toileting intervention on appetite and constipation in nursing home (NH) residents.
METHODS: A controlled, clinical intervention trial with 89 residents in two NHs. Research staff provided exercise and toileting assistance every two hours, four times per day, five days a week for 32 weeks. Oral food and fluid consumption during meals was measured at baseline, eight and 32 weeks. Bowel movement frequency was measured at baseline and 32 weeks.
RESULTS: The intervention group showed significant improvements or maintenance across all measures of daily physical activity, functional performance, and strength compared to the control group. Participants in both groups consumed an average of approximately 55% of meals at all three time points (approximately 1100 calories/day) with no change over time in either group. There was also no change in the frequency of bowel movements in either group, which averaged less than one in two days for both groups; and, approximately one-half of all participants had no bowel movement in two days.
CONCLUSIONS: An exercise and scheduled-toileting intervention alone is not sufficient to improve oral food and fluid consumption during meals and bowel movement frequency in NH residents.
Options:
A: Prompted voiding showed significant long-term benefits in reducing incontinent episodes.
B: Prompted voiding showed short-term benefits in increasing self-initiated voiding and reducing incontinent episodes, but there was no evidence about long-term effects.
C: Prompted voiding had no impact on urinary incontinence in adults.
D: Prompted voiding was only effective when combined with the muscle relaxant, Oxybutinin, for long-term management.
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B
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What are the effects of doxorubicin-based adjuvant chemotherapy on recurrence and survival in adults with localized resectable soft tissue sarcoma after local treatment? Please answer this question based on the information provided below:
Preliminary results of a randomized trial of adjuvant doxorubicin for sarcomas: lack of apparent difference between treatment groups.
Forty-two patients with localized intermediate and high-grade sarcoma were randomized after optimal primary treatment to receive five cycles of adjuvant doxorubicin 90 mg/m2 every three weeks (20 patients) or observation (22 patients). Patients were stratified for grade, size, extent of surgical margin, and soft tissue versus other sarcomas. Groups appeared balanced for histology and superficial versus deep lesions. Eight patients (19%) have died. Follow-up times range from two to 69 months (median, 16 months). Two patients receiving doxorubicin (10%) developed cardiotoxicity presenting as pulmonary edema. One patient returned to normal activity on digoxin and diuretics; the other (age, 28 years) died of intractable failure and arrhythmias after four weeks. While a nonsignificant difference in local control, metastasis-free survival, disease-free survival, and survival was observed for extremity lesions, the advantage may be outweighed by the risk of cardiotoxicity. Seventy-six percent of the control patients with extremity lesions remain disease free. Because control patients do well, a very large study is required to define the role of adjuvant doxorubicin.
Eastern Cooperative Oncology Group: a comparison of adjuvant doxorubicin and observation for patients with localized soft tissue sarcoma.
Forty-seven patients with stage I, II, or III soft tissue sarcoma were entered into a prospective randomized Eastern Cooperative Oncology Group (ECOG) adjuvant protocol. Eligibility included conservative or radical primary treatment for local cure. Patients were then randomized to control or Adriamycin (Adria Laboratories, Columbus, OH). Adriamycin was administered at 70 mg/m2 (slow push, every 3 weeks for seven courses for a maximum of 550 mg/m2). To date, 32 patients, 17 males and 15 females, with an age range of 17 to 75 years (median, 44 years) have been followed sufficiently long to be included in this analysis. Nine patients have died. The median follow-up of the remaining 23 patients is 30 months (range, 2 to 50 months). Survival was not significantly different between Adriamycin or control. However, the disease-free interval was slightly different in favor of observation. This preliminary report does not support the hypothesis that Adriamycin is an effective adjuvant therapy for soft tissue sarcoma. Due to the small numbers, these results must be interpreted in relation to our ability to detect a difference, if in fact one existed. These preliminary data suggest that adjuvant Adriamycin not be used outside the confines of a clinical trial such as the current intergroup adjuvant sarcoma study.
Adjuvant CYVADIC chemotherapy for adult soft tissue sarcoma--reduced local recurrence but no improvement in survival: a study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group.
PURPOSE: To evaluate the benefit of adjuvant chemotherapy in adult patients with soft tissue sarcomas. The principal end points were freedom from local recurrence and/or metastases and overall survival.
PATIENTS AND METHODS: Between January 1977 and June 1988, 468 patients entered this randomized study and 317 were considered eligible. Following complete surgical resection with or without radiotherapy, outcome in 145 eligible patients receiving cyclophosphamide 500 mg/m2 intravenously (IV) bolus on day 1, vincristine 1.4 mg/m2 IV bolus on day 1, doxorubicin (Adriamycin; Adria Laboratories, Columbus, OH) 50 mg/m2 IV bolus on day 1, and dacarbazine (DTIC) 400 mg/m2 by 1-hour infusion on days 1 to 3 (CYVADIC) cycles repeated every 28 days for eight courses was compared with that in 172 control patients.
RESULTS: With a median follow-up duration of 80 months (range, 39 to 165), actuarial percentage survival figures at 7 years were compared. Relapse-free survival rates were higher for CYVADIC, 56% versus 43% (P = .007), and local recurrence was significantly reduced in the CYVADIC arm at 17% versus 31% (P = .004). In contrast, distant metastases occurred with similar frequency in both arms, 32% for CYVADIC versus 36% for control patients (P = .42), and overall survival rates were not significantly different at 63% versus 56% (P = .64). A reduction in local recurrence was only apparent in the group of head, neck, and trunk sarcomas (P = .002), but not in limb tumors (P = .31).
CONCLUSION: Adjuvant chemotherapy with CYVADIC cannot be recommended outside the context of a clinical trial. Experience from this study has been used to plan a trial of neoadjuvant chemotherapy with doxorubicin/ifosfamide, which is currently in progress.
A randomized clinical trial of adjuvant adriamycin in uterine sarcomas: a Gynecologic Oncology Group Study.
After hysterectomy, 156 evaluable patients with stage I (limited to the corpus) or stage II (limited to the corpus and cervix) uterine sarcomas were randomly assigned to adjuvant chemotherapy with Adriamycin (Adria Laboratories, Columbus, Ohio) for six months or to no further treatment. Pelvic irradiation (external or intracavitary) was optional before randomization. Of 75 patients receiving Adriamycin, 31 have suffered recurrences compared with 43 of 81 receiving no adjuvant chemotherapy. This difference is not statistically significant. Moreover, there is no difference in progression-free interval or survival. The optional radiotherapy did not influence the outcome although there was a suggestion that vaginal recurrence was decreased by pelvic radiotherapy. The recurrence rates in specific cell types (leiomyosarcoma, homologous mixed mesodermal sarcoma, or heterologous mixed mesodermal sarcoma) were not significantly different although the pattern of recurrence differed, with pulmonary metastases being more common in leiomyosarcoma and extrapulmonary recurrence being more common in mixed mesodermal sarcoma. The outcome with respect to chemotherapy was not altered even after adjusting for maldistribution of cases. Thus, we could not show a benefit for this dose schedule of Adriamycin as adjuvant treatment for uterine sarcomas.
Randomized study of systemic chemotherapy following complete excision of nonosseous sarcomas.
Between June 1975 and April 1981, 61 of the 177 eligible patients whose nonosseous sarcomas of extremity or trunk origin had been completely excised primarily or after local recurrences agreed to participate in a randomized study of adjuvant chemotherapy. Dermatofibrosarcoma, lymphomas, myeloma, Kaposi's sarcoma, and embryonal rhabdomyosarcoma were excluded as were patients with significant second primary cancers and those who received either preoperative or postoperative radiation therapy. After stratification by anatomic status of disease, site of origin, and histologic grade, a random one half of the 61 participants began alternating courses of vincristine/cyclophosphamide/dactinomycin, and vincristine/doxorubicin/dacarbazine at six-week intervals for one year. The control group was evaluated at six-week intervals without adjuvant chemotherapy, but these patients were offered this chemotherapy later if they had progressive disease excised. Although 30% of the 61 patients experienced local recurrence of disease within the first five years after randomization, and only 54% were continuously disease free for five or more years, 82% were surviving at five years (Kaplan-Meier calculations) with a median follow-up of 64.3 months. Partial suppression of distant metastasis by adjuvant chemotherapy was apparent in the overall study, in the extremity tumor category, and in the subgroup of patients who had received limb-sparing surgery; however, no survival advantage for chemotherapy-treated patients was demonstrated. The 30 adjuvant chemotherapy-treated patients received a total of three thoracotomies as compared with 17 salvage thoracotomies for the 31 control patients; however, salvage surgery for local recurrences has been similar in the two groups. Recent improvement in the survival of patients with soft-tissue sarcomas is not necessarily a result of adjuvant chemotherapy or radiation therapy.
Adjuvant chemotherapy for patients with high-grade soft-tissue sarcomas of the extremity.
We have previously reported the results of a randomized trial that demonstrated the survival benefit of adjuvant chemotherapy in the treatment of patients with high-grade extremity sarcomas compared with no chemotherapy. This regimen included doxorubicin, cyclophosphamide, and methotrexate. This report updates and extends our experience. The median follow-up of this trial is now 7.1 years and reveals a 5-year disease-free survival of 75% and 54% for chemotherapy and no chemotherapy groups, respectively (two-sided P [P2] = .037). The 5-year overall survival for patients in this trial was 83% and 60% for the chemotherapy and no chemotherapy groups, respectively, with a trend towards improved survival in the chemotherapy arm (P2 = .124). Because of doxorubicin-induced cardiomyopathy we performed a subsequent randomized trial comparing this high-dose regimen to reduced cumulative doses of doxorubicin and cyclophosphamide without methotrexate. Eighty-eight patients were entered into this trial which has a median follow-up of 4.4 years. The 5-year disease-free and overall survival for patients treated with the reduced doses of chemotherapy was 72% and 75%, respectively, and was not significantly different from the high-dose regimen. No patients developed congestive heart failure on this study. We conclude that adjuvant chemotherapy improves disease-free survival in patients with extremity soft-tissue sarcomas. The overall survival advantage in patients receiving adjuvant chemotherapy in our initial randomized high-dose chemotherapy trial has diminished though it continues to favor the chemotherapy group. A reduced-dose chemotherapy regimen was found to be comparable to the high-dose regimen.
Prospective randomized evaluation of adjuvant chemotherapy in adults with soft tissue sarcomas of the extremities.
Sixty-five patients with high-grade soft tissue sarcomas of the extremities were treated in a prospective randomized trial evaluating the efficacy of adjuvant chemotherapy with doxorubicin, cyclophosphamide, and high-dose methotrexate. Local therapy was administered using either amputation or wide local resection plus radiation therapy and the chemotherapy was begun in the immediate postoperative period. Actuarial analysis with median follow-up of 653 days revealed an advantage in continuous disease-free and overall survival in the patient group receiving chemotherapy (P = 0.0008 and P = 0.04, respectively, one-sided Mantel-Haenszel test). The continuous disease-free survival at three years is 92% in the chemotherapy group compared to 60% in the no chemotherapy group. Overall survival is 95% and 74% in these two patient groups. Fifty-eight percent of patients had limb-sparing surgery plus radiation therapy and 42% underwent amputation. In both treatment subgroups analyzed separately, chemotherapy resulted in an improvement in disease-free survival compared to randomized controls not receiving chemotherapy (P = 0.006 and P = 0.04 for groups receiving amputation and limb sparing, respectively). There were no local failures in the patients receiving chemotherapy and two local failures in the no chemotherapy group. The results of this trial confirm the historically controlled pilot trial performed in 26 patients between 1975 and 1977. A current update of the patients in the pilot trial, with a minimum four-year follow-up, reveals an improvement in disease-free and overall survival due to chemotherapy (P less than 0.002). Analysis of the previous pilot trial indicates that only few recurrences are seen beyond three years. Thus, it appears that adjuvant chemotherapy should be a part of the treatment adult patients with soft tissue sarcomas of the extremities.
A randomized, prospective trial of adjuvant chemotherapy in adults with soft tissue sarcomas of the head and neck, breast, and trunk.
Since 1977, 31 patients were entered in a randomized, prospective study testing the efficacy of adjuvant chemotherapy after aggressive local treatment of high-grade sarcomas of the head, neck, breast, and trunk (excluding retroperitoneal sarcomas). All patients had complete resection of gross tumor and underwent postoperative radiotherapy (6000-6300 rads over 7-8 weeks). Seventeen patients received adjuvant chemotherapy consisting of doxorubicin (less than or equal to 550 mg/m2), cyclophosphamide (less than or equal to 5500 mg/m2), and methotrexate (less than or equal to 1000 mg/kg). Three-year actuarial disease-free survival in the chemotherapy arm was 77%, compared to 49% in the no-chemotherapy arm (P = 0.075). Three-year overall actuarial survivals in the two treatment arms, however, were 68% and 58%, respectively (P = 0.38). Considering only patients with tumors of the trunk (22 patients), 3-year actuarial disease-free survival in the chemotherapy arm was 92%, compared to 47% in the no-chemotherapy arm (P = 0.006). Actuarial 3-year overall survival in the chemotherapy arm was 82%, compared to 61% in the no-chemotherapy arm (P = 0.18). An additional 26 patients were treated in an identical fashion, but were not part of the randomized trial because of contraindications to chemotherapy, refusal to enter the randomized trial, or because they were treated before 1977 in a trial in which all patients received chemotherapy. Considering the entire group of 57 patients, follow-up ranged from 10 to 86 months (median, 35 months). Local control was achieved in 46 patients (81%); 3-year actuarial disease-free and overall survivals were 67% and 77%, respectively. A tendency toward improved disease-free survival was apparent among patients treated with chemotherapy (P = 0.018), but there was no statistically significant improvement in overall actuarial survival (P = 0.46). The subgroup of patients with sarcomas of the trunk (39 patients) demonstrated the greatest benefit from chemotherapy, with regard to disease-free survival (P less than or equal to 0.001). The most significant toxicity associated with chemotherapy was doxorubicin-induced cardiomyopathy, which resulted in clinically apparent congestive heart failure in five patients. Thus, the use of chemotherapy when combined with aggressive local measures appears to improve disease-free survival, but additional patients and longer follow-up are necessary to determine if improved overall survival will result.
Results of multimodality therapy of resectable soft-tissue sarcomas of the retroperitoneum.
Thirty-seven patients with resectable retroperitoneal sarcomas were studied prospectively to determine the efficacy of aggressive multimodality treatments. No patients was lost to follow-up, which ranged from 11 to 85 months (median 29 months). All patients received radiotherapy and some received postoperative chemotherapy (doxorubicin, cyclophosphamide, and high-dose methotrexate). A subset of 15 patients were entered into a prospective, randomized study testing the efficacy of adjuvant chemotherapy (eight received chemotherapy; seven did not). Two-year actuarial survival rates were inferior in the chemotherapy arm (100% versus 47%; p = 0.06), but the small number of patients precluded drawing definitive conclusions from this randomized study alone. Among the entire 37 patients (21 received chemotherapy; 16 did not) the actuarial 3-year survival rate was 43% and appeared unaffected by chemotherapy. Two patients suffered doxorubicin infiltration, three sustained cardiac toxicity, two developed cyclophosphamide-induced cystitis, and three withstood transient, severe bone marrow suppression. Eight patients suffered severe radiation enteritis, and one patient died after bowel resection for this problem. Thus the chemotherapy regimen we administered did not appear to improve survival but was associated with major morbidity. Radiotherapy was also associated with major complications, and since all patients received radiotherapy, it remains to be established if this modality is beneficial in improving survival.
Adjuvant chemotherapy for patients with high-grade soft-tissue sarcomas of the extremity.
We have previously reported the results of a randomized trial that demonstrated the survival benefit of adjuvant chemotherapy in the treatment of patients with high-grade extremity sarcomas compared with no chemotherapy. This regimen included doxorubicin, cyclophosphamide, and methotrexate. This report updates and extends our experience. The median follow-up of this trial is now 7.1 years and reveals a 5-year disease-free survival of 75% and 54% for chemotherapy and no chemotherapy groups, respectively (two-sided P [P2] = .037). The 5-year overall survival for patients in this trial was 83% and 60% for the chemotherapy and no chemotherapy groups, respectively, with a trend towards improved survival in the chemotherapy arm (P2 = .124). Because of doxorubicin-induced cardiomyopathy we performed a subsequent randomized trial comparing this high-dose regimen to reduced cumulative doses of doxorubicin and cyclophosphamide without methotrexate. Eighty-eight patients were entered into this trial which has a median follow-up of 4.4 years. The 5-year disease-free and overall survival for patients treated with the reduced doses of chemotherapy was 72% and 75%, respectively, and was not significantly different from the high-dose regimen. No patients developed congestive heart failure on this study. We conclude that adjuvant chemotherapy improves disease-free survival in patients with extremity soft-tissue sarcomas. The overall survival advantage in patients receiving adjuvant chemotherapy in our initial randomized high-dose chemotherapy trial has diminished though it continues to favor the chemotherapy group. A reduced-dose chemotherapy regimen was found to be comparable to the high-dose regimen.
Prospective randomized evaluation of adjuvant chemotherapy in adults with soft tissue sarcomas of the extremities.
Sixty-five patients with high-grade soft tissue sarcomas of the extremities were treated in a prospective randomized trial evaluating the efficacy of adjuvant chemotherapy with doxorubicin, cyclophosphamide, and high-dose methotrexate. Local therapy was administered using either amputation or wide local resection plus radiation therapy and the chemotherapy was begun in the immediate postoperative period. Actuarial analysis with median follow-up of 653 days revealed an advantage in continuous disease-free and overall survival in the patient group receiving chemotherapy (P = 0.0008 and P = 0.04, respectively, one-sided Mantel-Haenszel test). The continuous disease-free survival at three years is 92% in the chemotherapy group compared to 60% in the no chemotherapy group. Overall survival is 95% and 74% in these two patient groups. Fifty-eight percent of patients had limb-sparing surgery plus radiation therapy and 42% underwent amputation. In both treatment subgroups analyzed separately, chemotherapy resulted in an improvement in disease-free survival compared to randomized controls not receiving chemotherapy (P = 0.006 and P = 0.04 for groups receiving amputation and limb sparing, respectively). There were no local failures in the patients receiving chemotherapy and two local failures in the no chemotherapy group. The results of this trial confirm the historically controlled pilot trial performed in 26 patients between 1975 and 1977. A current update of the patients in the pilot trial, with a minimum four-year follow-up, reveals an improvement in disease-free and overall survival due to chemotherapy (P less than 0.002). Analysis of the previous pilot trial indicates that only few recurrences are seen beyond three years. Thus, it appears that adjuvant chemotherapy should be a part of the treatment adult patients with soft tissue sarcomas of the extremities.
A randomized trial for the treatment of high-grade soft-tissue sarcomas of the extremities: preliminary observations.
A new trial for evaluating the effectiveness of adjuvant chemotherapy in high-grade soft-tissue sarcomas of the extremities in adult patients is presented. All patients after local treatment were randomized into two arms, one without further therapy and the other to receive adjuvant chemotherapy (Adriamycin [Farmitalia-Carlo Erba, Milan, Italy], 450 mg/m2). The preliminary results of the study are reported at a median observation period of 27.6 months. Of the 59 patients who entered the study, 79.1% in the chemotherapy group are without sign of disease, whereas the corresponding figure in the nonadjuvant chemotherapy group is 54.3%. The difference between the two groups is statistically significant (P less than .005, log rank test). These preliminary observations encourage continuation of the study.
Adjuvant chemotherapy with doxorubicin in high-grade soft tissue sarcoma: a randomized trial of the Scandinavian Sarcoma Group.
From January 1981 to February 1986, a total of 240 patients with primary, malignancy-grade III or IV soft tissue sarcoma were entered into an adjuvant chemotherapy multicenter trial conducted by the Scandinavian Sarcoma Group (SSG). Of these patients, 181 were evaluable. The tumor was located in the extremities in 155 patients. After radical surgery (wide and compartmental) the patients were randomized to treatment with single-agent doxorubicin 60 mg/m2 administered as an intravenous (IV) bolus once a month for 9 months (group 1, n = 77) or to control (group 2, n = 77). If the surgical procedure was marginal, the patients initially received postoperative radiotherapy, followed by doxorubicin (group 3, n = 16) or control (group 4, n = 11). The control groups did not receive any adjuvant chemotherapy. Adjuvant therapy was initiated within 6 weeks of surgery (group 1) or within 10 weeks of surgery for patients receiving postoperative radiotherapy (group 3). With a median follow-up of 40 months, there was no significant difference between the four treatment groups in overall survival (group 1, 75%; group 2, 70%; group 3, 69%; group 4, 73%), disease-free survival (group 1, 62%; group 2, 56%; group 3, 62%; group 4, 64%), or local tumor control (group 1, 92%; group 2, 92%; group 3, 87%; group 4, 90%). The conclusions were the same whether the total group or evaluable patients only were included in the analysis. The local recurrence rate for patients undergoing radical surgery was 8% and for patients undergoing marginal surgery followed by radiotherapy was 12%. This study indicates that the use of single-agent doxorubicin as postoperative adjuvant chemotherapy has no significant clinical benefit in patients with high-grade soft tissue sarcoma.
Options:
A: It significantly improves time to local and distant recurrence and overall recurrence-free survival, with a trend towards improved overall survival.
B: It significantly improves overall survival but has no effect on recurrence-free survival.
C: It has no significant effect on either recurrence-free survival or overall survival.
D: It significantly improves overall survival and recurrence-free survival, with no trend towards improved time to local and distant recurrence.
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A
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117
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the impact of target payments on the professional practice of primary care physicians and health care outcomes? Please answer this question based on the information provided below:
Performance-based physician reimbursement and influenza immunization rates in the elderly. The Primary-Care Physicians of Monroe County.
OBJECTIVE: To investigate the effect of performance-based financial incentives on the influenza immunization rate in primary care physicians' offices.
DESIGN: Randomized controlled trial during the 1991 influenza immunization season.
SETTING: Rochester, New York, and surrounding Monroe County during the Medicare Influenza Vaccine Demonstration Project.
PARTICIPANTS: A total of 54 solo or group practices that had participated in the 1990 Medicare Demonstration Project.
INTERVENTIONS: All physicians in participating practices agreed to enumerate their ambulatory patients aged 65 or older who had been seen during the 1990 or 1991 calendar years, and to track the immunization rate on a weekly basis using a specially designed poster from September 1991 to January 1, 1992. Additionally, physicians agreed to be randomized, by practice group, to the control group or to the incentive group, which could receive an additional $.80 per shot or $1.60 per shot if an immunization rate of 70% or 85%, respectively, was attained.
MEASUREMENTS: The main outcome measures are the 1991 immunization rate and the improvement in immunization rate from the 1990 to 1991 influenza seasons for each group practice.
RESULTS: For practices in the incentive group, the mean immunization rate was 68.6% (SD 16.6%) compared with 62.7% (SD 18.0%) in the control group practices (P = .22). The median practice-specific improvement in immunization rate was +10.3% in the incentive group compared with +3.5% in the control group (P = .03).
CONCLUSIONS: Despite high background immunization rates, this modest financial incentive was responsible for approximately 7% increase in immunization rate among the ambulatory elderly.
Primary and preschool immunisation in Grampian: progress and the 1990 contract.
OBJECTIVE: To examine changes in immunisation performance in Grampian region after the introduction of the 1990 contract for general practitioners.
DESIGN: Retrospective descriptive study using data held on the Grampian immunisation record system's computer.
SETTING: All 95 general practices in Grampian region (313 general practitioners).
PATIENTS: All children in the primary immunisation and preschool booster age groups. This formed two groups of children for each of the four calendar quarters of 1990 and first three quarters of 1991 analysed as (a) those aged 2 years on the first day of the relevant quarter and (b) those aged 5 years on the first day of the relevant quarter, with an average population of 6600 and 6400 respectively.
MAIN OUTCOME MEASURE: Percentage immunised by practice.
RESULTS: For primary immunisation the number of practices achieving immunisation rates of at least 95% increased from 29 (31%) to 76 (81%), and practices achieving 90% rates rose from 69 (73%) to 87 (93%). For preschool boosters, the number of practices achieving at least 95% immunisation rates increased from 22 (23%) to 61 (64%). By the end of September 1991, 76 (80%) practices were achieving at least 90% levels compared with 36 (39%) at the beginning of 1990. Since the beginning of 1989 the proportion of immunisations not given by general practitioners declined from 14% to 2%.
CONCLUSIONS: Primary and preschool immunisation rates for preschool children in Grampian showed a sustained improvement during 1990 and consolidation in 1991. Although overall trends were unchanged, 18 months after the introduction of the 1990 contract only one practice failed to meet lower target levels of 70% for both primary and preschool immunisation. By September 1991 more than three out of four practices had reached levels of at least 95% for primary immunisation.
Options:
A: Target payments significantly improved immunisation rates in all studies reviewed.
B: Target payments had no impact on immunisation rates or other health care outcomes.
C: Target payments were associated with improvements in immunisation rates, but the increase was statistically significant in only one of the two studies.
D: Target payments significantly decreased the quality of care provided by primary care physicians.
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C
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118
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the effectiveness of cognitive rehabilitation techniques for people with schizophrenia and related conditions? Please answer this question based on the information provided below:
Effectiveness of attention training in schizophrenia.
This study assessed the impact of attention training on information processing in schizophrenia. Fifty-four inpatients with chronic schizophrenia were randomly assigned to two groups after baseline assessment with the Continuous Performance Test (CPT). Patients in the experimental group participated in individual sessions of computerized attention remediation, while patients in the control group participated in individual sessions during which they viewed video documentaries. After 18 sessions, reassessment with the CPT showed that patients in the experimental group had made significantly more improvement than the control group, which made no significant change. Brief Psychiatric Rating Scale assessments before and after the study phase indicated that both groups improved on the total score but the experimental group made significantly more improvement. These results suggest that it is feasible to use practice and behavioral learning to remediate a core attention deficit in chronic schizophrenia.
Modifiability of neuropsychological dysfunction in schizophrenia.
Schizophrenia is often characterized by compromised neuropsychological functioning, especially on tasks sensitive to frontal and temporohippocampal functions but the extent to which cognitive dysfunction can be modified in schizophrenics remains unclear. Twenty-four inpatient schizophrenics and 24 intellectually and demographically matched, inpatient mood-disordered controls were randomly assigned to one of two conditions. Subjects assigned to the cued condition received instructional cues on measures of visual and semantic memory, executive function, and constructional ability. Subjects in the standard condition performed the same neuropsychological measures without cues. The present study revealed some degree of plasticity of neurobehavioral function in schizophrenia.
The effects of neurocognitive remediation on executive processing in patients with schizophrenia.
Approaches to cognitive remediation have differed across studies. Most of the larger studies have concentrated on group treatments designed without the benefit of recent laboratory-based studies. The current study describes a randomized trial of an intensive cognitive remediation program involving individual daily sessions of 1 hour for up to 3 months. It targets executive functioning deficits (cognitive flexibility, working memory, and planning) that are known to be problematic in people with schizophrenia. Procedural learning, as well as the principles of errorless learning, targeted reinforcement, and massed practice, was the basis of the intervention. The program was compared with an alternative therapy (intensive occupational therapy) to control for some of the effects of therapeutic contact. Some improvements in cognition followed both therapies. A differential effect in favor of cognitive remediation therapy was found for tests in the cognitive flexibility and the memory subgroups. There was a trend for those receiving atypical antipsychotic medication to benefit more from cognitive remediation for tests of cognitive flexibility. Although there were no consistent changes in symptoms or social functioning between groups, if improvement in cognitive flexibility tasks reached a threshold then there is some evidence that social functioning improved, even over the short duration of the trial. In addition, cognitive remediation differentially improved self-esteem. This study supports the view that cognitive remediation can reduce cognitive deficits and that this reduction may affect social outcome, at least in the short term.
Options:
A: Cognitive rehabilitation techniques significantly improved mental state, social behavior, and cognitive functioning.
B: Cognitive rehabilitation techniques were found to be as acceptable as placebo and occupational therapy, but no significant effects were demonstrated on mental state, social behavior, or cognitive functioning.
C: Cognitive rehabilitation techniques significantly improved self-esteem, mental state, social behavior, and cognitive functioning.
D: Cognitive rehabilitation techniques were found to be ineffective and had high attrition rates compared to placebo and occupational therapy.
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B
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119
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy and safety of ropinirole compared to bromocriptine in patients with Parkinson's disease who were already on levodopa therapy and experiencing motor complications? Please answer this question based on the information provided below:
A six-month multicentre, double-blind, bromocriptine-controlled study of the safety and efficacy of ropinirole in the treatment of patients with Parkinson's disease not optimally controlled by L-dopa.
OBJECTIVES: To compare the safety and efficacy of ropinirole and bromocriptine as adjunct therapy in patients with Parkinson's disease (PD) not optimally controlled by L-dopa.
METHODS: A randomised, double-blind trial in which 555 patients were assigned to three treatment groups according to the level of daily dosage of L-dopa, presence of motor fluctuations, and use of dopamine agonist before study entry. Patient response was defined as at least a 20% reduction in daily L-dopa dose plus: for patients with no prior treatment and no motor fluctuations, a 20% reduction in UPDRS motor score; for patients with motor fluctuations, a 20% reduction in time spent "off"; and for patients already taking an agonist, an improvement on the CGI scale.
RESULTS: Safety assessments showed no significant differences in the two treatment groups for patients without prior dopamine-agonist therapy. In the group of patients with prior dopamine-agonist therapy, more patients reported adverse events in the ropinirole group (90% versus 79%, p < 0.001). The proportions of responders tended to be higher in ropinirole groups compared with bromocriptine groups and, in the subgroup with motor fluctuations, this difference was statistically significant (9.1% versus 0.0%, respectively; p < 0.05).
CONCLUSIONS: Both drugs were well tolerated. In patients receiving a relatively high dose of L-dopa and requiring the addition of a dopamine agonist to control motor fluctuations or dyskinesias, ropinirole was significantly more effective than bromocriptine.
Options:
A: Ropinirole significantly reduced off time and dyskinesia compared to bromocriptine.
B: Bromocriptine was more effective than ropinirole in reducing levodopa dosage and improving motor impairment.
C: There were no significant differences between ropinirole and bromocriptine in off time reduction, dyskinesia, motor impairment, or levodopa dose reduction, but ropinirole caused significantly less nausea.
D: Ropinirole was less effective than bromocriptine in managing motor complications and had a higher frequency of adverse events.
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C
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120
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What does the evidence suggest about the timing of surgical repair for newborn infants with congenital diaphragmatic hernia in terms of survival to hospital discharge? Please answer this question based on the information provided below:
Is delayed surgery really better for congenital diaphragmatic hernia?: a prospective randomized clinical trial.
Delayed surgery has become widely accepted in the management of congenital diaphragmatic hernia after comparing outcomes only with historical retrospective controls. It was the aim of this study to compare early and delayed hernia repair in a randomized prospective clinical trial. Fifty-four infants were randomized to receive either early repair (within 4 hours of admission) or delayed repair (more than 24 hours after birth). The survival rate was higher for the delayed group (57% v 46%), but the difference was not significant (difference: -11; 95% confidence limits: -37.5, 15.5). There were no significant differences between the two groups with respect to length of hospital stay, ventilator dependency, or survival time. Recorded preoperative risk factors were similar for the two groups. Eight infants in the delayed repair group died without having undergone surgery. The optimum time for surgery still needs clarification.
A prospective randomized trial of delayed versus immediate repair of congenital diaphragmatic hernia.
From March 1990 to January 1993, a randomized prospective study was performed to determine the optimal timing of surgery for infants with high-risk congenital diaphragmatic hernia (CDH). Thirty-two CDH patients who presented with respiratory distress within 12 hours after birth were randomly divided into two groups: Group A had early repair (within 6 hours), and group B had delayed repair (at 96+ hours). Extracorporeal membrane oxygenation (ECMO) was initiated in both groups as necessary. Fourteen patients were assigned to group A, and 18 were assigned to group B. Two patients initially assigned to group A had acute deterioration, and their operations had to be postponed. Data were collected, but these patients were eliminated from the study. The two groups were comparable based on gestational age, birth weight, Bohn's criteria, and oxygenation and ventilatory index. Nine of 12 group A patients (75%) survived, and 13 of 18 group B patients (72%) survived (P > .05, not significant). The ECMO requirements for the two groups were not significantly different (8 of 12 (67%) v 16 of 18 (89%); P > .05). Surgical intervention for bleeding complications related to ECMO was required in three of eight (38%) with immediate repair and seven of 16 (44%) with delayed repair (P > .05). There was no difference in survival nor incidence of ECMO between the two groups. This is the first prospective study of timing of hernia repair that supports the conclusions of earlier reports of retrospective studies.
Options:
A: Immediate surgical repair within the first 24 hours significantly improves survival compared to delayed repair.
B: Delayed surgical repair after stabilization significantly improves survival compared to immediate repair within the first 24 hours.
C: There is no clear evidence to support that either immediate or delayed surgical repair significantly improves survival.
D: Immediate surgical repair within the first 24 hours significantly increases mortality compared to delayed repair.
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C
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121
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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In preterm infants being weaned from intermittent positive pressure ventilation (IPPV) and undergoing endotracheal extubation, what is the effect of doxapram compared to placebo in terms of reducing the use of intubation and IPPV, or reducing other morbidity, without clinically important side effects? Please answer this question based on the information provided below:
Randomized, controlled, blinded trial of doxapram for extubation of the very low birthweight infant.
The objective of the study was to determine whether administering doxapram by infusion to the very low birthweight infant, prior to extubation during the first 3 weeks of life, would increase the incidence of successful extubation. The study patients, 56 infants of less than 1251 g birthweight and less than 30 weeks' gestation, were entered in the first 3 weeks of life when lung disease had started to improve. A randomized blinded trial was performed, with infants receiving 3.5 mg kg(-1) doxapram bolus, followed by an infusion at 1 mg kg(-1) h(-1), or placebo. Weaning from positive pressure ventilation was standardized and extubation occurred after a 12 h trial of an intermittent mandatory ventilation (IMV) rate of 6 breaths min(-1), if PCO2 < 55 mmHg, pH > 7.26, and FiO2 < 0.45. Study drug was continued for 48 h postextubation, and the infants were placed on nasopharyngeal continuous positive airway pressure (CPAP) for 72 h postextubation. Extubation failure within the first 72 h after extubation was objectively defined in terms of acidosis (pH < 7.26), hypercarbia (PCO2 > 55 mmHg), excessive oxygen requirement (FiO2 > 0.8) or frequent apnoea (more than three in 12 h, or more than two requiring face mask IMV in 24 h). No difference was noted in the frequency of successful extubation between the groups. Fifteen infants in each group were successfully extubated before the 10th day of the study. In conclusion, when given in accordance with this protocol doxapram does not increase the likelihood of successful extubation in the very low birthweight infant. Increasing successful extubations in this group of infants will require other strategies.
Aminophylline versus doxapram in weaning premature infants from mechanical ventilation: preliminary report.
A small, double-blind crossover study compared the efficacy of aminophylline and doxapram in ventilator weaning of eight premature infants recovering from respiratory distress syndrome (RDS). Although neither drug was significantly better than the other, four infants were weaned from mechanical ventilation after drug administration. It is suggested that drugs stimulating the respiratory center may aid in shortening the duration of mechanical ventilation in premature infants recovering from RDS.
Use of preestablished criteria for deciding on extubation in the very low birthweight newborn. Preliminary analysis of a randomized study.
The duration of mechanical ventilation (MV) in very low birthweight infants can sometimes be very prolonged, even in the absence of any respiratory disease. To avoid this, we have developed a double-blind study protocol of the concomitant use of caffeine and doxapram or caffeine and placebo as an aid to early weaning from MV. This protocol necessitated the definition of very precise ventilatory criteria for extubation. Even before the double-blind code has been broken, we can note that the duration of ventilation was very significantly reduced (p < 0.001) from 27.5 days (median; range 1-99) in infants of the retrospective study group to 4 days (median: range 1-34) in the prospective study group (extubation according to strict criteria). This reduction in duration of MV cannot be explained by a difference in the severity of the initial pathology, or by the treatment of some of the infants with doxapram (the difference would not be so marked), but, probably, to the definition of strict criteria concerning extubation.
Low-dose doxapram for treatment of apnoea following early weaning in very low birthweight infants: a randomized, double-blind study.
The effects of low-dose doxapram (0.5 mg kg(-1)h(-1)) in combination with caffeine were evaluated on apnoea frequency following weaning from mechanical ventilation, and on blood pressure, in very low birthweight (BW) premature infants. Twenty-nine infants with BW < or=1250 g, gestational age at birth (GA) <34 weeks and postnatal age <5 d, who required minimal respiratory support, were included. Following randomization, they received a loading dose of caffeine citrate and a continuous infusion of doxapram (doxapram, n=14) or placebo (n=15) was started. They were extubated 8 h after starting the infusion, which was continued for 5 d. During this period, weaning was well tolerated in both groups, apnoeas occurred less frequently and there was a greater increase in systolic blood pressure in infants treated with doxapram than in controls. Plasma doxapram levels were also higher than expected. It is therefore suggested that doxapram, even at low doses, should not be used during the first few days of life. Careful monitoring of blood pressure is required if doxapram is used later.
Options:
A: Doxapram significantly reduces the use of intubation and IPPV and decreases morbidity without any side effects.
B: Doxapram significantly reduces the use of intubation and IPPV but increases the risk of side effects.
C: Doxapram does not significantly reduce the use of intubation and IPPV and does not significantly affect morbidity, but there is a trend towards increased side effects.
D: Doxapram significantly increases the use of intubation and IPPV and increases morbidity with significant side effects.
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C
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the effectiveness of multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain among working age adults? Please answer this question based on the information provided below:
Controlled two year follow up of rehabilitation for disorders in the neck and shoulders.
OBJECTIVE: To evaluate the effects of an early, active, and multidisciplinary rehabilitation programme for neck and shoulder disorders.
METHODS: Primary health care and industrial health care of a nonrandomised, controlled, cohort was followed up over two years in a geographically defined area. The cohort consisted of working people who consulted a physician about disorders of the neck or shoulders from 1 August 1988 to 31 October 1989. Criteria for acceptance; not chronic symptoms, patients had sick leave of no more than four weeks. Disorders were not caused by trauma, infections, malignancy, rheumatic diseases, abuse, or pregnancy. 107 people qualified for the study, 87% were followed up for two years. They were divided into two groups. One group obtained active, multidisciplinary rehabilitation for eight weeks that comprised physical training, information, education, social interaction, and work place visits. Controls were given traditional treatment; physiotherapy, medication, rest, and sick leave. The main outcome measures were: average number of days of sick leave for the two years after rehabilitation, subjective pain on a visual analogue scale, and ratings on seven subscales of the sickness impact profile.
RESULTS: At 12 and 24 months of follow up effects of the active rehabilitation programme did not differ from traditional treatment in any of the outcome measures. New work task (P < 0.05) or changed work place (P < 0.001) during the follow up period were associated with decreased sick leave, independent of treatment.
CONCLUSIONS: Active, multidisciplinary rehabilitation of neck and shoulder disorders was not more effective than traditional treatment. Changed work conditions were associated with decreased sick leave, independent of type of treatment provided.
The role of the psychologist in multidisciplinary treatments for chronic neck and shoulder pain: a controlled cost-effectiveness study.
This study was designed to determine a cost-effective use of psychologist resources in multimodal cognitive-behavioural treatments (MMCBT) for chronic neck/shoulder pain. A randomised controlled trial was conducted with 66 patients divided in two groups. The first group (A) was treated following the approach of MMCBT with the clinical psychologist only functioning as a "coach" to the other health professionals. In this group, the psychologist had on average 5 hours of input per patients. The second group (B) was treated with the same inpatient MMCBT but with the behavioural component administered by the clinical psychologist directly to the patients. In this second group the psychologist had on average 17 hours of input per patient in the entire intervention. The outcome variables included physical, emotional and social factors, and sick-leave. Both groups showed significant improvements over time. The improvements were evident only in sub-groups, specifically in women. The only significant difference between the groups was in "perceived helplessness" favouring the "psychologist contact" setting. It is concluded that in terms of input of clinical psychology, the treatment setting with the "coaching" technique proved to be the most cost-effective use of the psychologist in the two treatment settings investigated.
Options:
A: There is strong scientific evidence supporting the effectiveness of multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain.
B: There is limited scientific evidence supporting the effectiveness of multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain.
C: There is no scientific evidence supporting the effectiveness of multidisciplinary biopsychosocial rehabilitation for neck and shoulder pain.
D: There is conclusive scientific evidence that multidisciplinary biopsychosocial rehabilitation is ineffective for neck and shoulder pain.
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B
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What impact do different payment methods (capitation, salary, fee-for-service, and mixed systems) have on the clinical behavior of primary care physicians? Please answer this question based on the information provided below:
Prepayment with office-based physicians in publicly funded programs: results from the Children's Medicaid Program.
This paper is a report of the results of a demonstration designed to provide empirical evidence regarding the effects of alternative approaches to paying physicians for serving children in the Medicaid program: (1) visit fees set at twice regular Medicaid fees in return for physician agreement to manage utilization and (2) capitation and financial risk-sharing along with the same physician agreement to manage utilization. Participating physicians were assigned randomly to either of the two payment groups. Comparisons of utilization and expenditures were made between these two plans and the regular Medicaid program (fee-for-service, low fees). Results showed no adverse effect of capitation payments on primary care visits to office-based physicians. Capitation physician referrals to specialists decreased relative to all other groups studied, consistent with the theory that the financial incentives in capitation will lead primary care physicians to reduce referrals to specialists.
Access to office-based physicians under capitation reimbursement and Medicaid case management. Findings from the Children's Medicaid Program.
This study reports the effects of a voluntary Medicaid case-management demonstration on the primary care provided to young children by office-based physicians. The MDs who participated were reimbursed at rates higher than the regular Medicaid fee schedule, either through augmented fees for specific services or through monthly capitation payments. Using the Medicaid Management Information System (MMIS) claims data, we compared the rates at which children in the experimental program and children in the regular Medicaid program were seen by a physician during a one-year period. The majority of experimental children received regular and frequent care from primary care physicians during the demonstration. After controlling for race and prior utilization differences, we found that augmented fee-for-service children received more primary care from office-based physicians than children in the regular Medicaid program. Capitation children received at least the same amount of primary care as children in the regular Medicaid program. We interpret our data to mean that capitation payment, untied to the delivery of services, does not necessarily reduce access to primary care and that higher fees for physicians who treat children may, in fact, increase access.
Physician reimbursement by salary or fee-for-service: effect on physician practice behavior in a randomized prospective study.
We used a resident continuity clinic to compare prospectively the impact of salary v fee-for-service reimbursement on physician practice behavior. This model allowed randomization of physicians into salary and fee-for-service groups and separation of the effects of reimbursement from patient behavior. Physicians reimbursed by fee-for-services scheduled more visits per patient than did salaried physicians (3.69 visits v 2.83 visits, P less than .01) and saw their patients more often (2.70 visits v 2.21 visits, P less than .05) during the 9-month study. Almost all of this difference was because fee-for-service physicians saw more well patients than salaried physicians (1.42 visits and .99 visits per enrolled patient, respectively, P less than .01). Evaluating visits by American Academy of Pediatrics' guidelines indicated that fee-for-service physicians saw more patients for well-childcare than salaried physicians because they missed fewer recommended visits and scheduled visits in excess of those recommendations. Fee-for-service physicians also provided better continuity of care than salaried physicians by attending a larger percentage of all visits made by their patients (86.6% of visits v 78.3% of visits, P less than .05), and by encouraging fewer emergency visits per enrolled patient (0.12 visits v 0.22 visits, P less than .01). Physicians' interest in private practice, as determined by their career plans, correlated significantly with total number of patients enrolled (r = .48, P less than .05) and total clinic patients seen by each resident during the study (r = .40, P less than .05).(ABSTRACT TRUNCATED AT 250 WORDS)
Do physician-payment mechanisms affect hospital utilization? A study of Health Service Organizations in Ontario.
OBJECTIVES: To determine whether payment of primary care physicians based on capitation, with an additional incentive payment for low hospital-utilization rates, resulted in lower hospital-utilization rates among patients of these physicians than among patients of physicians still paid on a fee-for-service basis.
DESIGN: Retrospective cohort study.
SETTING: Capitation-based and fee-for-service primary care practices in Ontario.
SUBJECTS: Thirty-nine physicians whose method of payment was converted from fee-for-service to capitation during the period from June 1985 to January 1989 and 7 physicians who remained in fee-for-service practice, two of whom were matched with one physician in capitation-based practice on the basis of practice location, type of practice (academic v. community), hours of practice (part-time v. full-time), years since graduation, physician group size, practice size (number of patients), type of group (primary care v. multispecialty), sex, certification in family medicine, country of graduation (Canada v. other) and age. One physician in capitation-based practice was matched with only one physician in fee-for-service practice.
OUTCOME MEASURES: Annual hospital-utilization rates (hospital separations or hospital days per 1000 patients in each practice) for the physicians paid on a capitation basis 3 years before, 1 year before and 3 years after they converted from fee-for-service payment and at corresponding periods for the matched physicians still paid on a fee-for-service basis.
RESULTS: The mean annual rate of hospital days used, adjusted for the age and sex of patients as well as for their social-program-recipient status, fell from 1085 per 1000 patients (3 years before the conversion date) to 1030 (1 year before conversion) and to 954 (3 years after conversion) in capitation-based practices. For the matched physicians in fee-for-service practice, the rates during the corresponding periods were 1085, 1035 and 956 hospital days per 1000 patients. The pattern was similar for rates of hospital separations, adjusted for patient's age, sex and social-program-recipient status. There were no statistically significant differences between the rates of hospital utilization among patients of physicians in capitation-based practices and the rates among those of physicians in fee-for-service practices during each of the three periods, nor were there significant differences in the changes in rates.
CONCLUSION: Capitation payment, with an additional incentive payment to encourage low hospital-utilization rates, did not reduce hospital use. Factors other than the method of physician payment appear to be responsible for the variations in hospital utilization among practices.
Introducing fees for services with professional uncertainty.
A change in payment system of general practitioners from capitation to a mix of one-half capitation and one-half fee for service in Copenhagen, Denmark, resulted in a significant overall increase in diagnostic and curative services. The rate of increase differs between services. In this article, it is assumed that the rate of increase varies with doctors' professional uncertainty relative to the services studied. Professional uncertainty is measured as the degree to which performances of a service are determined by diagnoses made. The data validate the measure given the assumption.
Doctor and patient characteristics as modifiers of the effect of a changing remuneration system in general practice.
The objectives of the study was to investigate the effects on general practitioners' activities of a change in their remuneration system from a capitation-based system to a mixed fee-per-item and capitation-based system. It was our hypothesis that the effect of the change in remuneration varied between subgroups of doctors and patients as a result of the modifying effect of the doctors' age, sex, practice facilities, assistance, side jobs, and size of practice as well as patients' age, sex, and diagnostic group. The study was carried out as a follow-up with data collected from contact sheets completed by general practitioners in one period before a change in remuneration and two periods after. These data were supplemented by a questionnaire on doctors' characteristics as well as by health insurance data on population characteristics. The general increases in diagnostic and curative activities and reductions in referrals by general practitioners as a result of the change were found to be quite similar across subgroups of doctors and patients. While, total contact rates changed little, the sex of doctors showed a modifying effect: male doctors tended to increase their contact rates compared to female doctors. This tendency was most prominent among female patients with non-infectious diseases.
Changing remuneration systems: effects on activity in general practice.
OBJECTIVE: To investigate the effects on general practitioners' activities of a change in their remuneration from a capitation based system to a mixed fee per item and capitation based system.
DESIGN: Follow up study with data collected from contact sheets completed by general practitioners in one period before (March 1987) a change in their remuneration system and two periods after (March 1988, November 1988), with a control group of general practitioners with a mixed fee per item and capitation based system throughout.
SETTING: General practices in Copenhagen city (index group) and Copenhagen county (control group).
SUBJECTS: 265 General practitioners in Copenhagen city, of whom 100 were selected randomly from the 130 who agreed to participate (10 exclusions) and 326 general practitioners in Copenhagen county.
MAIN OUTCOME MEASURES: Number of consultations (face to face and by telephone) and renewals of prescriptions, diagnostic and curative services, and specialist and hospital referrals per 1000 enlisted patients in one week.
RESULTS: Of the 75 general practitioners who completed all three sheets, four were excluded for incomplete data. Total contact rates per 1000 patients listed rose significantly compared with the rates before the change index in the city (100.0 before the change v 111.7 (95% confidence interval 106.4 to 117.4 after the change) and over the same time in the control group (100.0 v 106.0), but within a year these rates fell (to 104.2(99.1 to 109.6) and 104.0 respectively). There was an increase in consultations by telephone initially but not thereafter. Rates of examinations and treatments that attracted specific additional remuneration after the change rose significantly compared with those before (diagnostic services, 138.1 (118.7 to 160.5) and 159.5 (137.8 to 184.7) and curative services 194.6 (152.2 to 248.9) and 194.8(152.3 to 249.2) for second and third data collections respectively) and with the control group (diagnostic services 105.3, 107.6 and curative services 106.0, 115.0) whereas referral rates to secondary care fell (specialist referrals 90.1 (80.7 to 100.6) and 77.0 (68.6 to 86.4) and hospital referrals 87.4 (71.1 to 107.5) and 68.4 (54.7 to 85.4] in doctors in the city.
CONCLUSIONS: Introducing a partial fee for service system seemed to stimulate the provision of services by general practitioners, resulting in reduced referral rates. The concept of a "target income" which doctors aim at, rather than maximising their income seemed to play a part in adjustment to changing the system of remuneration.
Options:
A: Fee-for-service results in fewer primary care visits and lower compliance with recommended visits compared to capitation.
B: Capitation leads to more patient visits and higher patient satisfaction with access to their physician compared to fee-for-service.
C: Fee-for-service results in more primary care visits, greater continuity of care, higher compliance with recommended visits, but lower patient satisfaction with access to their physician compared to salaried payment.
D: Salaried payment results in more diagnostic and curative services and higher patient satisfaction with access to their physician compared to fee-for-service.
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C
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy and safety of pramipexole compared to bromocriptine in patients with Parkinson's disease who were already on levodopa and experiencing motor complications? Please answer this question based on the information provided below:
Double-blind comparison of pramipexole and bromocriptine treatment with placebo in advanced Parkinson's disease. International Pramipexole-Bromocriptine Study Group.
Pramipexole is a new, selective, nonergoline dopamine agonist that acts on D2 and preferentially on D3 dopamine receptors. Phase II and III clinical trials have shown this drug to be useful in treating both early and advanced Parkinson's disease (PD) patients. A double-blind, randomized, multicenter study was performed to compare the safety, tolerance, and efficacy of pramipexole versus placebo in patients with advanced PD with motor fluctuations. A bromocriptine treatment group was included to enable comparisons between bromocriptine and placebo groups, but the study was not powered to show statistical differences between the active treatment groups. The study included 247 patients with "wearing off." Patients were Hoehn and Yahr stages II to IV during "on" times. The trial included three phases: dose escalation, 6 months' maintenance, and dose reduction. The primary end points were the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III. Up to 4.5 mg per day of pramipexole and 30 mg per day of bromocriptine were used. The results of the study showed that the UPDRS part II improved by 26.7% for pramipexole (p = 0.0002) and 14% for bromocriptine (p = 0.02) versus 4.8% for placebo. The UPDRS part III showed improvements of 34% for pramipexole (p = 0.0006) and 23.8% for bromocriptine (p = 0.01) versus 5.7% for placebo. There were no major differences in safety data. In the active treatment groups there were more reports of dyskinesia and nausea compared with placebo. In regard to comparison of the Global Clinical Assessment of Efficacy between active treatment groups, there was a trend to significance (p = 0.056) in favor of pramipexole. We conclude that pramipexole-treated patients with advanced PD improved significantly more than placebo for both primary end points.
Options:
A: Pramipexole significantly reduced off time compared to bromocriptine, but no differences were found in dyskinesia ratings, UPDRS scores, or levodopa dose reduction.
B: Bromocriptine significantly reduced off time compared to pramipexole, and showed better outcomes in dyskinesia ratings and UPDRS scores.
C: Both pramipexole and bromocriptine showed no significant differences in off time reduction, dyskinesia ratings, UPDRS scores, or levodopa dose reduction.
D: Pramipexole and bromocriptine both significantly improved off time and reduced parkinsonian motor impairments, but pramipexole had a higher rate of adverse events.
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A
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the main findings regarding the efficacy and safety of pramipexole as an adjuvant therapy in patients with Parkinson's disease who were already on levodopa? Please answer this question based on the information provided below:
Double-blind comparison of pramipexole and bromocriptine treatment with placebo in advanced Parkinson's disease. International Pramipexole-Bromocriptine Study Group.
Pramipexole is a new, selective, nonergoline dopamine agonist that acts on D2 and preferentially on D3 dopamine receptors. Phase II and III clinical trials have shown this drug to be useful in treating both early and advanced Parkinson's disease (PD) patients. A double-blind, randomized, multicenter study was performed to compare the safety, tolerance, and efficacy of pramipexole versus placebo in patients with advanced PD with motor fluctuations. A bromocriptine treatment group was included to enable comparisons between bromocriptine and placebo groups, but the study was not powered to show statistical differences between the active treatment groups. The study included 247 patients with "wearing off." Patients were Hoehn and Yahr stages II to IV during "on" times. The trial included three phases: dose escalation, 6 months' maintenance, and dose reduction. The primary end points were the Unified Parkinson's Disease Rating Scale (UPDRS) parts II and III. Up to 4.5 mg per day of pramipexole and 30 mg per day of bromocriptine were used. The results of the study showed that the UPDRS part II improved by 26.7% for pramipexole (p = 0.0002) and 14% for bromocriptine (p = 0.02) versus 4.8% for placebo. The UPDRS part III showed improvements of 34% for pramipexole (p = 0.0006) and 23.8% for bromocriptine (p = 0.01) versus 5.7% for placebo. There were no major differences in safety data. In the active treatment groups there were more reports of dyskinesia and nausea compared with placebo. In regard to comparison of the Global Clinical Assessment of Efficacy between active treatment groups, there was a trend to significance (p = 0.056) in favor of pramipexole. We conclude that pramipexole-treated patients with advanced PD improved significantly more than placebo for both primary end points.
Clinical evaluation of pramipexole in advanced Parkinson's disease: results of a double-blind, placebo-controlled, parallel-group study.
We compared the efficacy, safety, an tolerability of pramipexole, an aminobenzathiazol-derived dopamine agonist with novel properties, with those of placebo in advanced PD patients with motor fluctuations under levodopa treatment. Pramipexole improved motor function of patients during "on" and "off" periods, decreased the time spent in "off" periods, reduced the severity of "off" periods, decreased disability and PD severity during "on" and "off" periods, as assessed by the Unified Parkinson Disease Rating Scale, and permitted a reduction in levodopa dosage. Adverse effects related to the central nervous system were similar to those reported with other dopamine agonists, and the gastrointestinal and cardiovascular tolerability of the compound was satisfactory.
Efficacy, safety, and tolerance of the non-ergoline dopamine agonist pramipexole in the treatment of advanced Parkinson's disease: a double blind, placebo controlled, randomised, multicentre study.
OBJECTIVES: Pramipexole, a non-ergot dopamine D2/D3 receptor agonist, was investigated as an add on drug in advanced parkinsonian patients with motor fluctuations to assess efficacy, safety, and tolerance.
METHODS: Seventy eight patients of either sex with advanced Parkinson's disease and treatment complications such as motor fluctuations were enrolled into a double blind, placebo controlled, randomised, multicentre study (phase II) and assigned to add on treatment with pramipexole (n=34) versus placebo (n=44) to a previously stabilised antiparkinsonian medication (7 week dose titration interval, 4 week maintenance period). The primary end point of efficacy was the change from baseline in the total score of the unified Parkinson's disease rating scale (UPDRS) in the on "period" (2 hours after intake of study medication). Safety and tolerability were assessed on the basis of adverse events, vital signs, laboratory measurements, and ECG recordings.
RESULTS: There was a significant improvement of the pramipexole group in UPDRS total scores, subscores part II, III (activities of daily living and motor examination), and IV (complications of therapy). Mean UPDRS total score decreased by 37.3% under pramipexole compared with 12.2% under placebo (p<0.001). Patients under pramipexole reported an overall reduction in "off" periods of 12%--resulting in 1.7 more hours "on" time a day--compared with an increase in "off" periods of 2% under placebo. There were no unexpected safety results. The adverse event profile disclosed a high tolerability. The most important adverse events under pramipexole were fatigue, dyskinesia, and vivid dreams.
CONCLUSION: Pramipexole administration is an efficacious and well tolerated add on therapy in patients with advanced Parkinson's disease with an improvement in activities of daily living, motor function, and treatment associated complications.
A double-blind, placebo-controlled, randomized, multi-center study of pramipexole in advanced Parkinson's disease.
Pramipexole (SND 919), a potent non-ergot dopamine agonist, or placebo, was administered to 69 patients with advanced Parkinson's disease (33 received placebo, 36 received pramipexole) in a double-blind, randomized, multi-center study in which individually optimized doses of L-dopa plus a dopa decarboxylase inhibitor were associated with dyskinesia, "on-off" fluctuation, dystonia, akinesia, or end-of-dose deterioration. Study medication was titrated over 7 weeks to the maximal tolerated dose or to the maximal dose allowed by the study (5 mg/day in four divided doses). Dosing was maintained for 4 weeks and then tapered during the final week. Total score on the Unified Parkinson's Disease Rating Scale (UPDRS) for the intent-to-treat population was significantly improved in the pramipexole-treated group compared with the placebo-treated group (16.9 +/- 14.9 vs 9.0 +/- 16.1; p = 0.0184). By the end of maintenance, the mean reduction in L-dopa requirement was -150.7 mg for pramipexole-treated patients compared to -10.6 for placebo-treated patients. The most common adverse events (< 10%) were dizziness, insomnia, nausea, and postural hypotension. Aggravated parkinsonism occurred only after withdrawal of the study medication. Treatment with pramipexole in doses up to 5 mg/day was safe and well tolerated by patients with advanced Parkinson's disease.Copyright Lippincott-Raven Publishers
Options:
A: Pramipexole significantly reduced off time, improved motor impairments and disability, and allowed for a reduction in levodopa dosage, but increased the incidence of dyskinetic adverse events.
B: Pramipexole had no significant effect on off time, motor impairments, or levodopa dosage, and did not increase the incidence of adverse events.
C: Pramipexole significantly increased off time, worsened motor impairments and disability, and required an increase in levodopa dosage, with no change in adverse events.
D: Pramipexole had mixed results, with some studies showing improvements in off time and motor impairments, but no significant changes in levodopa dosage or adverse events.
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A
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the main findings of the comparison between carbamazepine and valproate monotherapy for epilepsy in terms of treatment withdrawal, 12-month remission, and first seizure post-randomization? Please answer this question based on the information provided below:
A prospective study between carbamazepine, phenytoin and sodium valproate as monotherapy in previously untreated and recently diagnosed patients with epilepsy.
One hundred and eighty one patients with previously untreated epilepsy were randomised to sodium valproate, phenytoin or carbamazepine as monotherapy and followed up for a median period which ranged from 14 to 24 months. All three drugs were highly effective in the control of generalised seizures but less effective for partial seizures. Excellent or good control was achieved with therapeutic levels of sodium valproate and carbamazepine, but with subtherapeutic levels of phenytoin.
Randomised comparative monotherapy trial of phenobarbitone, phenytoin, carbamazepine, or sodium valproate for newly diagnosed childhood epilepsy.
BACKGROUND: The medical treatment of childhood epilepsy is largely influenced by clinical trials in adult patients. We know of only one randomised comparative trial (of two drugs) in newly diagnosed childhood epilepsy. We have undertaken a long-term, prospective, randomised, unmasked, pragmatic trial of the comparative efficacy and toxicity of four standard antiepileptic drugs used as monotherapy in children with newly diagnosed epilepsy.
METHODS: Between 1981 and 1987, 167 children aged 3-16 years, who had had at least two previously untreated tonic-clonic or partial seizures, with or without secondary generalisation, were randomly allocated treatment with phenobarbitone, phenytoin, carbamazepine, or sodium valproate. The protocol was designed to conform to standard clinical practice. Efficacy was assessed by time to first seizure after the start of treatment and time to achieving 1-year remission.
FINDINGS: The overall outcome with all four drugs was good. 20% of children remained free of seizures and 73% had achieved 1-year remission by 3 years of follow-up. We found no significant differences between the drugs for either measure of efficacy at 1, 2, or 3 years of follow-up. The overall frequency of unacceptable side-effects necessitating withdrawal of the randomised drug was 9%. This total included six of the first ten children assigned phenobarbitone; no further children were allocated this drug. Of the other three drugs, phenytoin (9%) was more likely to be withdrawn than carbamazepine (4%) or sodium valproate (4%). INTERPRETATION Our data will inform choice of drug and outcome with four of the standard drugs available for newly diagnosed tonic-clonic or partial seizures with or without secondary generalisation in children.
Phenobarbitone, phenytoin, carbamazepine, or sodium valproate for newly diagnosed adult epilepsy: a randomised comparative monotherapy trial.
Recent studies have shown that most newly diagnosed epileptic patients can be satisfactorily treated with a single antiepileptic drug. We therefore undertook a prospective randomised pragmatic trial of the comparative efficacy and toxicity of four major antiepileptic drugs, utilised as monotherapy in newly diagnosed epileptic patients. Between 1981 and 1987 243 adult patients aged 16 years or over, newly referred to two district general hospitals with a minimum of two previously untreated tonic-clonic or partial with or without secondary generalised seizures were randomly allocated to treatment with phenobarbitone, phenytoin, carbamazepine, or sodium valproate. The protocol was designed to conform with standard clinical practice. Efficacy was assessed by time to first seizure after the start of treatment and time to enter one year remission. The overall outcome with all of the four drugs was good with 27% remaining seizure free and 75% entering one year of remission by three years of follow up. No significant differences between the four drugs were found for either measure of efficacy at one, two, or three years of follow up. The overall incidence of unacceptable side effects, necessitating withdrawal of the randomised drug, was 10%. For the individual drugs phenobarbitone (22%) was more likely to be withdrawn than phenytoin (3%), carbamazepine (11%), and sodium valproate (5%). In patients with newly diagnosed tonic-clonic or partial with or without secondary generalised seizures, the choice of drug will be more influenced by considerations of toxicity and costs.
[Efficacy of sodium valproate in partial epilepsy. Crossed study of valproate and carbamazepine].
An open response-conditional cross-over study of valproate versus carbamazepine has been done in previously untreated patients with partial seizures. Thirty-one patients entered the study. Nineteen were followed up to one year. It appeared that valproate was at least as effective as carbamazepine: at one year, 11 patients were seizure-free on valproate and only 8 were seizure-free on carbamazepine. Furthermore no side-effect was noted in valproate therapy, whereas carbamazepine was stopped in 2 patients because of skin rashes. The efficacy of sodium valproate in partial epilepsy remains controversial. It is of course limited when given as co-therapy in severe epilepsies, uncontrolled with other major antiepileptic drugs. However in naive patients, with recent and previously untreated partial epilepsies, a one-drug treatment with valproate appears to be as effective as carbamazepine or phenytoin. It has less unwanted side-effects and should be prescribed as first line treatment.
A comparison of valproate with carbamazepine for the treatment of complex partial seizures and secondarily generalized tonic-clonic seizures in adults. The Department of Veterans Affairs Epilepsy Cooperative Study No. 264 Group.
BACKGROUND: Valproate is approved for use primarily in patients with absence seizures, but the drug has a broad spectrum of activity against seizures of all types. Partial or secondarily generalized tonic-clonic seizures are often difficult to control adequately with standard treatment, usually carbamazepine or phenytoin.
METHODS: We conducted a multicenter, double-blind trial that compared valproate with carbamazepine in the treatment of 480 adults with complex partial seizures (206 patients) or secondarily generalized tonic-clonic seizures (274 patients). The patients were randomly assigned to treatment with carbamazepine or divalproex sodium (valproate) at doses adjusted to achieve blood levels in the middle of the therapeutic range. Patients were followed for one to five years or until seizures became uncontrollable, treatment had unacceptable adverse effects, or both these events occurred.
RESULTS: For the control of secondarily generalized tonic-clonic seizures, carbamazepine and valproate were comparably effective (in 136 patients and 138 patients, respectively). For complex partial seizures, four of five outcome measures favored carbamazepine (100 patients) over valproate (106 patients): the total number of seizures (2.7 vs. 7.6, P = 0.05), the number of seizures per month (0.9 vs. 2.2, P = 0.01), the time to the first seizure (P less than 0.02), and the seizure-rating score (P = 0.04). Carbamazepine was also superior according to a composite score that combined scores for the control of seizures and for adverse effects (P less than 0.001). Valproate was associated more frequently than carbamazepine with a weight gain of more than 5.5 kg (12 lb) (20 percent vs. 8 percent, P less than 0.001), with hair loss or change in texture (12 percent vs. 6 percent, P = 0.02), and with tremor (45 percent vs. 22 percent, P less than 0.001). Rash was more often associated with carbamazepine (11 percent vs. 1 percent, P less than 0.001).
CONCLUSIONS: Valproate is as effective as carbamazepine for the treatment of generalized tonic-clonic seizures, but carbamazepine provides better control of complex partial seizures and has fewer long-term adverse effects.
A multicentre comparative trial of sodium valproate and carbamazepine in adult onset epilepsy. Adult EPITEG Collaborative Group.
The long-term efficacy and safety of sodium valproate and carbamazepine in adult outpatients with newly diagnosed primary generalised or partial and secondarily generalised seizures were compared in a randomised, open, multicentre study at 22 neurology outpatient clinics. Patients were randomised to oral sodium valproate (Epilim EC enteric coated 200 mg tablets twice daily, n = 149) or oral carbamazepine (100 mg twice daily increasing to 200 mg twice daily in week 2, n = 151) and followed up for three years. If clinically necessary, dosages were regularly increased until seizures were controlled or toxicity developed. Sodium valproate and carbamazepine controlled both primary generalised and partial seizures equally effectively overall. Significantly more patients on sodium valproate than carbamazepine (126/140 (90%) v 105/141 (75%), p = 0.001) remained on randomised treatment for at least six months. Skin rashes occurred significantly more often in carbamazepine recipients than in sodium valproate recipients (11.2% v 1.7%, p < 0.05) and carbamazepine was associated with a higher withdrawal rate because of adverse events (15% v 5% on sodium valproate) in the first six months of treatment. There was no difference between the drugs in the rate of withdrawal because of poor seizure control at any stage, regardless of seizure type. At the end of the three year trial period, over 70% of the available patients were still on randomised treatment or had recently stopped treatment after achieving full seizure control. Sodium valproate and carbamazepine were both associated with a high degree of overall seizure control regardless of seizure type and both have good long-term tolerability in adult patients with newly diagnosed epilepsy. Recommendations are made for a higher initial dosage regime for sodium valproate in partial seizures.
A multicentre comparative trial of sodium valproate and carbamazepine in paediatric epilepsy. The Paediatric EPITEG Collaborative Group.
The long-term efficacy and adverse-event profiles of sodium valproate and carbamazepine in children with newly diagnosed primary generalised or partial epilepsy were compared at 63 outpatient clinics. Children with two or more generalised tonic-clonic or partial seizures in the previous six months were randomised to oral sodium valproate (N = 130) or oral carbamazepine (N = 130) and followed for three years as outpatients. Dosages were increased as needed until seizures were controlled or toxicity developed. Sodium valproate and carbamazepine were equally effective in achieving high levels of seizure control in both primary generalised seizures and partial seizures with or without generalisation. Adverse events were mostly mild, few necessitating drug withdrawal. Those particularly associated with valproate were weight increase, alopecia and appetite increase, and with carbamazepine, rashes, somnolence, diplopia and abnormal gait/ataxia.
Options:
A: Carbamazepine was significantly more effective than valproate for all outcomes.
B: Valproate was significantly more effective than carbamazepine for all outcomes.
C: There was no overall difference between carbamazepine and valproate for treatment withdrawal, 12-month remission, and first seizure post-randomization.
D: Carbamazepine was more effective for partial epilepsies, while valproate was more effective for generalized epilepsies.
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C
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the effects of carnitine supplementation on weight gain, lipid utilization, and ketogenesis in parenterally fed neonates? Please answer this question based on the information provided below:
Effects of parenteral L-carnitine supplementation on fat metabolism and nutrition in premature neonates.
The effects of parenteral L-carnitine supplementation on fat metabolism, nutrient intake, and plasma and erythrocyte carnitine concentrations were studied in 43 very low birth weight infants. Infants were randomly assigned to control or carnitine-supplemented (50 mumol/kg per day) groups within two weight categories: group 1, 750 to 1000 gm, and group 2, 1001 to 1500 gm. Plasma total, free, and acyl carnitine levels, erythrocyte carnitine levels, serum beta-hydroxybutyrate and triglyceride levels, and total fat intake were monitored weekly until 50% of total caloric intake was met enterally. Neonates receiving carnitine had higher plasma carnitine levels than control groups (total carnitine: group 1, 75.2 +/- 22.9 vs 9.6 +/- 2.7 mmol/ml; group 2, 61.6 +/- 31.2 vs 13.0 +/- 9.2 nmol/ml). Levels of beta-OH-butyrate decreased from baseline in control neonates (group 1, 0.12 +/- 0.06 to 0.03 +/- 0.02 mmol/L; group 2, 0.11 +/- 0.03 to 0.05 +/- 0.02 mmol/L); they remained unchanged in supplemented groups. Thus ketogenesis appeared less impaired in infants receiving supplements. Supplemented group 2 tolerated more fat than control group 2; triglyceride levels remained acceptable in all groups. Carnitine group 2 had greater weight gain than control group 2 during the first 2 weeks of life. We conclude that very low birth weight infants requiring prolonged parenteral nutrition have carnitine deficiency with impaired ketogenesis. Parenteral administration of carnitine appears to alleviate this metabolic disturbance.
Effects of parenteral L-carnitine supplementation on fat metabolism and nutrition in premature neonates.
The effects of parenteral L-carnitine supplementation on fat metabolism, nutrient intake, and plasma and erythrocyte carnitine concentrations were studied in 43 very low birth weight infants. Infants were randomly assigned to control or carnitine-supplemented (50 mumol/kg per day) groups within two weight categories: group 1, 750 to 1000 gm, and group 2, 1001 to 1500 gm. Plasma total, free, and acyl carnitine levels, erythrocyte carnitine levels, serum beta-hydroxybutyrate and triglyceride levels, and total fat intake were monitored weekly until 50% of total caloric intake was met enterally. Neonates receiving carnitine had higher plasma carnitine levels than control groups (total carnitine: group 1, 75.2 +/- 22.9 vs 9.6 +/- 2.7 mmol/ml; group 2, 61.6 +/- 31.2 vs 13.0 +/- 9.2 nmol/ml). Levels of beta-OH-butyrate decreased from baseline in control neonates (group 1, 0.12 +/- 0.06 to 0.03 +/- 0.02 mmol/L; group 2, 0.11 +/- 0.03 to 0.05 +/- 0.02 mmol/L); they remained unchanged in supplemented groups. Thus ketogenesis appeared less impaired in infants receiving supplements. Supplemented group 2 tolerated more fat than control group 2; triglyceride levels remained acceptable in all groups. Carnitine group 2 had greater weight gain than control group 2 during the first 2 weeks of life. We conclude that very low birth weight infants requiring prolonged parenteral nutrition have carnitine deficiency with impaired ketogenesis. Parenteral administration of carnitine appears to alleviate this metabolic disturbance.
The metabolic effects of oral L-carnitine administration in infants receiving total parenteral nutrition with fat.
beta-Oxidation, an important pathway in the metabolism of free fatty acids, occurs within the mitochondria in mammals. L-Carnitine is an essential cofactor in the transfer of long-chain fatty acids across the inner mitochondrial membrane. Maintenance of normal carnitine concentrations in whole blood and tissues, either through diet or biosynthesis, would appear necessary for adequate utilization of fat as an energy source. Infants, especially premature ones, without an exogenous dietary source of carnitine, have decreased plasma carnitine levels compared with infants receiving carnitine-supplemented feedings. To determine the importance of carnitine supplementation in a total parenteral nutrition program in infants in which a fat emulsion serves as a major calorie source, the following study was undertaken. Twelve infants receiving total parenteral nutrition (TPN) with fat for seven days were divided into two treatment groups. Group 1 was orally supplemented for seven days with carnitine (70 mumol/l/kg/24 h in 24 mL of 5% dextrose), while the second group received seven days of placebo supplementation (dextrose 5%, 24 cc/24 h). Plasma carnitine levels in the carnitine-supplemented group were significantly higher (29 +/- 8 nmol/mL) than in the control group (12.4 +/- 3.5 nmol/mL) after seven days of treatment. However, clearance of serum triglycerides and free fatty acids was not significantly different between the two groups. Baseline triglyceride levels in the carnitine-supplemented group were 96 +/- 42 mg/dL, increased to 242 +/- 101 mg/dL after the lipid challenge and decreased to 121 +/- 47 mg/dL two hours after the lipid infusion.(ABSTRACT TRUNCATED AT 250 WORDS)
Effect of intravenous L-carnitine on growth parameters and fat metabolism during parenteral nutrition in neonates.
To determine whether intravenous carnitine can improve nutritional indices, neonates requiring parenteral nutrition were randomized into carnitine treatment (n = 23) and control (n = 20) groups. Observed plasma lipid indices, carnitine and nitrogen balances, and plasma carnitine concentrations were not different in the prestudy period. Under standardized, steady-state conditions, 0.5 g/kg Intralipid was administered intravenously over 2 hr prior to carnitine administration, after infants received 7 days of 50 mumol/kg/day, and after a second 7 days of 100 mumol/kg/day of continuous intravenous L-carnitine as part of parenteral nutrition. Triglyceride (TGY), free fatty acid (FFA), acetoacetate (AA), beta-hydroxybutyrate (BOB), and plasma carnitine concentrations were measured prior to and at 2, 4, and 6 hr after the initiation of the lipid bolus. Twenty-four-hour urine collections for nitrogen and carnitine balance were obtained on days 7 and 14. Neonates receiving carnitine had significantly greater concentrations of plasma carnitine on days 7 and 14 (p less than 0.001). Greater nitrogen (p less than 0.05) and carnitine (p less than 0.001) balances and weight gain (week 2, p less than 0.05) were found in the carnitine-supplemented group when compared with controls. On day 14, (BOB + AA)/FFA ratios were significantly higher (p less than 0.05), and peak TGY concentrations and 6-hr FFA concentrations were significantly lower (p less than 0.05) in the treatment group. Carnitine supplementation was associated with modest increases in growth and nitrogen accretion possibly by enhancing the neonate's ability to utilize exogenous fat for energy.
Parenteral nutrition in preterm neonates with and without carnitine supplementation.
The effects of carnitine supplementation on fat and glucose metabolism and carnitine balance were studied in 12 preterm neonates receiving full or partial parenteral nutrition (PN) for 5 to 21 days. The gestational age ranged from 27 to 32 weeks and the birth weight from 790 to 2090 g. The neonates were assigned at random to receive either L-carnitine 10 mg/kg (n = 6) or saline (n = 6). In the carnitine group, increased concentrations in plasma of total and free carnitine were observed. Less than 50% of the given dose was recovered in urine. In the placebo group no changes in the total plasma carnitine concentration were seen. In all neonates plasma triglycerides, free fatty acids, glycerol, alanine, 3-hydroxybutyrate (BOB), glucose and lactate were measured at predetermined intervals. The only significant difference between the groups was higher BOB-concentrations in the carnitine group 2 days after the start of parenteral nutrition. Elevated BOB concentrations are an indicator of improved fatty acid oxidation in the carnitine group. In this study, only a temporary effect of the carnitine supplementation was found.
Carnitine deficiency in premature infants receiving total parenteral nutrition: effect of L-carnitine supplementation.
To investigate whether L-carnitine supplementation may correct nutritional carnitine deficiency and associated metabolic disturbances in premature infants receiving total parenteral nutrition, an intravenous fat tolerance test (1 gm/kg Intralipid over four hours) was performed in 29 premature infants 6 to 10 days of age (15 receiving carnitine supplement 10 mg/kg . day L-carnitine IV, and 14 receiving no supplement). Total carnitine plasma values were normal or slightly elevated in supplemented but decreased in nonsupplemented infants. In both groups, fat infusion resulted in an increase in plasma concentrations of triglycerides, free fatty acids, D-beta-hydroxybutyrate, and short-chain and long-chain acylcarnitine, but total carnitine values did not change. After fat infusion, the free fatty acids/D-beta-hydroxybutyrate ratios were lower and the increase of acylcarnitine greater in supplemented infants of 29 to 33 weeks' gestation than in nonsupplemented infants of the same gestational age. This study provides evidence that premature infants of less than 34 weeks' gestation requiring total parenteral nutrition develop nutritional carnitine deficiency with impaired fatty acid oxidation and ketogenesis. Carnitine supplementation improves this metabolic disturbance.
Carnitine deficiency in premature infants receiving total parenteral nutrition: effect of L-carnitine supplementation.
To investigate whether L-carnitine supplementation may correct nutritional carnitine deficiency and associated metabolic disturbances in premature infants receiving total parenteral nutrition, an intravenous fat tolerance test (1 gm/kg Intralipid over four hours) was performed in 29 premature infants 6 to 10 days of age (15 receiving carnitine supplement 10 mg/kg . day L-carnitine IV, and 14 receiving no supplement). Total carnitine plasma values were normal or slightly elevated in supplemented but decreased in nonsupplemented infants. In both groups, fat infusion resulted in an increase in plasma concentrations of triglycerides, free fatty acids, D-beta-hydroxybutyrate, and short-chain and long-chain acylcarnitine, but total carnitine values did not change. After fat infusion, the free fatty acids/D-beta-hydroxybutyrate ratios were lower and the increase of acylcarnitine greater in supplemented infants of 29 to 33 weeks' gestation than in nonsupplemented infants of the same gestational age. This study provides evidence that premature infants of less than 34 weeks' gestation requiring total parenteral nutrition develop nutritional carnitine deficiency with impaired fatty acid oxidation and ketogenesis. Carnitine supplementation improves this metabolic disturbance.
Randomised controlled trial of L-carnitine as a nutritional supplement in preterm infants.
AIMS: To evaluate the effect of L-carnitine supplementation (25 mg/kg/d) on the growth and incidence of hypoglycaemia in preterm infants.
METHODS: A double blind, placebo controlled randomised trial, stratified for gestational age, was conducted of 86 preterm infants between 28 and 34 gestational weeks. The median gestational ages in the carnitine group and placebo groups were 30.7 weeks (range 28.0 to 33.6) and 31.4 weeks (range 28.0 to 33.9), respectively. The median birthweights were 1.557 kg (range 0.944 to 2.275) and 1.645 kg (range 0.885 to 2.545), respectively.
RESULTS: Mean plasma free carnitine concentrations were below values for normal term infants in both groups on day 1 (carnitine group 44.8 mumol/l, placebo group 25.5 mumol/l) in the placebo group on day 7 (50.7 mumol/l), but in neither group on days 14 and 28. Total, free, and acylcarnitine concentrations were significantly increased in both urine and blood in the L-carnitine group. There was no significant difference between the placebo and carnitine supplemented groups in growth rate, as assessed by weight, length, skinfold thickness and head circumference measurements, or in the incidence of episodes of hypoglycaemia.
CONCLUSION: The addition of carnitine as a nutritional supplement at a dose of 25 mg/kg/day did not improve growth in our group of preterm infants nor protect them from episodes of hypoglycaemia.
Options:
A: Carnitine supplementation significantly improved weight gain, lipid utilization, and ketogenesis.
B: Carnitine supplementation had no effect on weight gain, lipid utilization, or ketogenesis.
C: Carnitine supplementation significantly improved weight gain but had no effect on lipid utilization or ketogenesis.
D: Carnitine supplementation significantly improved lipid utilization and ketogenesis but had no effect on weight gain.
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B
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128
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the effect of marine n-3 fatty acid (fish oil) supplementation on asthma control based on the review of randomised controlled trials? Please answer this question based on the information provided below:
Effect of dietary supplementation with fish oil lipids on mild asthma.
Recruitment of inflammatory leucocytes to the airways may play a part in the pathogenesis of asthma. As dietary enrichment with fish oil lipids can suppress leucocyte function, the effect of these lipids on asthma control and neutrophil function was studied in 20 subjects with mild asthma. Twelve subjects received capsules containing 3.2 g of eicosapentaenoic acid and 2.2 g of docosahexaenoic acid daily and eight subjects received placebo capsules containing olive oil for 10 weeks in a double blind fashion. Baseline specific airways conductance, airways responsiveness to histamine and exercise, diurnal peak expiratory flow, symptom scores, and bronchodilator use were measured. Neutrophil fatty acid composition was evaluated by gas chromatography, calcium ionophore induced neutrophil leukotriene (LT)B4 and LTB5 generation were measured by reverse phase high performance liquid chromatography and radioimmunoassay, and neutrophil chemotactic responses to formyl-methionyl-leucyl-phenylalanine (FMLP) and LTB4 were assessed by a microchemotaxis technique. Although the fish oil supplemented diet produced a greater than 10 fold increase in the eicosapentaenoic acid content of neutrophil phospholipids, there was no significant change in airways responsiveness to histamine or any change in any of the clinical measurements. After dietary supplementation with fish oil there was a 50% inhibition of total LTB (LTB4 + LTB5) generation by ionophore stimulated neutrophils and neutrophil chemotaxis was substantially suppressed. Neutrophil function remained unchanged in the placebo group. It is concluded that in subjects with mild asthma a fish oil enriched diet attenuates neutrophil function without changing the severity of asthma.
The effects of dietary supplementation with fish oil lipids on the airways response to inhaled allergen in bronchial asthma.
The effects of dietary supplementation with fish oil lipids on the airways responses to allergen and neutrophil biochemistry and function have been studied in 17 atopic asthmatic subjects. Nine subjects received 18 capsules of Max-EPA (3.2 g eicosapentaenoic acid and 2.2 g docosahexaenoic acid) a day and eight subjects received identical capsules containing olive oil, for 10 wk in a double-blind fashion. There were no differences between prediet values and those observed after dietary supplementation with Max-EPA or placebo in the dose of allergen causing an acute asthmatic response as assessed by a 35% fall in specific airways conductance (PD35), the extinction dose of allergen on skin prick testing, the histamine PD35, or the total serum IgE concentrations. Twelve of the 17 subjects developed late asthmatic responses after allergen challenge prediet. Six of these subjects received Max-EPA, and six received placebo capsules. As compared to prediet values, the magnitude of the allergen-induced late asthmatic response was significantly attenuated from 2 to 7 h after allergen challenge following dietary supplementation with Max-EPA (p less than 0.005) but not with placebo. The attenuation of the late response was not accompanied by any significant change in the clinical severity of disease as assessed by diurnal peak expiratory flow rates, symptom scores, or bronchodilator drug usage.(ABSTRACT TRUNCATED AT 250 WORDS)
Effect of a fish oil diet on asthma: results of a 1-year double-blind study.
Airway inflammation is a major component of asthma. Food intake of N-3 fatty acids (FA) is associated with a low incidence of inflammatory diseases, such as asthma. We treated 12 asthmatic patients with FA and report the positive results of this 1-year double-blind study. A positive effect on forced expiratory volume in 1 s was observed after the 9 month of treatment. Our results are in favor of the use of FA, but have to be confirmed by other studies.
Effect of dietary intake of omega-3 and omega-6 fatty acids on severity of asthma in children.
We assessed the clinical and biochemical effects in asthmatic children of fish oil supplementation and a diet that increases omega-3 and reduces omega-6 fatty acids. Thirty nine asthmatic children aged 8-12 yrs participated in a double-blind, randomized, controlled trial for 6 months during which they received fish oil capsules plus canola oil and margarine (omega-3 group) or safflower oil capsules plus sunflower oil and margarine (omega-6 group). Plasma fatty acids, stimulated tumour necrosis factor alpha (TNFalpha) production, circulating eosinophil numbers and lung function were measured at baseline and after 3 and 6 months of dietary modification. Day and night symptoms, peak flow rates and medication use were recorded for 1 week prior to laboratory visits. Plasma phospholipid omega-3 fatty acids were significantly greater in the omega-3 group at 3 and 6 months compared to the omega-6 group (p<0.001). In the omega-3 group TNFalpha production fell significantly compared with baseline (p=0.026), but the magnitude of change between groups did not reach significance (p=0.075). There were no significant changes in clinical outcome measures. Dietary enrichment of omega-3 fatty acids over 6 months increased plasma levels of these fatty acids, reduced stimulated tumour necrosis factor alpha production, but had no effect on the clinical severity of asthma in these children.
Effect of eicosapentaenoic acid in asthma.
The role of arachidonic acid metabolites in the pathogenesis of airway inflammation and clinical asthma is currently unknown. The addition of eicosapentaenoic acid (EPA) to the diet of humans has been shown to generate metabolites that are less potent than their arachidonic acid counterparts. The substitution of EPA for arachidonic acid metabolites in patients might cause a decrease in airway inflammation and an improvement in clinical asthma. We studied the effect of addition of EPA to the diet of twelve asthmatic patients. Standard clinical evaluations and pulmonary function tests were done on weeks 0, 3, 6, 10, 12 and 14. Patients ingested either low-dose EPA (0.1 g/day) or high-dose EPA (4.0 g/day) from weeks 6-14 (total of 8 weeks). There was no difference in clinical status or pulmonary function between groups at the start of the study. There was no change in clinical status or pulmonary function between or within groups at the end of 8 weeks of EPA ingestion.
Dietary supplementation with fish oil rich in omega-3 polyunsaturated fatty acids in children with bronchial asthma.
Omega-3 polyunsaturated fatty acids have anti-inflammatory effects in vitro, and high dietary levels are associated with a lower incidence of inflammatory diseases. However, only limited effects have been demonstrated in asthma. The effects of dietary supplementation with fish oil for 10 months in 29 children with bronchial asthma was investigated in a randomized controlled fashion. In order to minimize the effects of environmental inhaled allergens and diet, this study was performed in a long-term treatment hospital. Subjects received fish oil capsules containing 84 mg eicosapentaenoic acid (EPA) and 36 mg docosahexaenoic acid (DHA) or control capsules containing 300 mg olive oil. The daily dosages of EPA and DHA were 17.0-26.8 and 7.3-11.5 mg x kg body weight(-1), respectively. Asthma symptom scores decreased and responsiveness to acetylcholine decreased in the fish oil group but not in the control group. In addition, plasma EPA levels increased significantly only in the fish oil group (p<0.0088). No significant side-effects were observed. The present results suggest that dietary supplementation with fish oil rich in the omega-3 polyunsaturated fatty acids eicosapentaenoic acid and docosahexaenoic acid is beneficial for children with bronchial asthma in a strictly controlled environment in terms of inhalant allergens and diet.
Evening primose oil and fish oil are ineffective as supplementary treatment of bronchial asthma.
The effect of daily dietary supplementation with 15 to 20 mL of evening primrose seed oil or fish oil was assessed by comparison with olive oil as placebo in a cross-over study in 29 asthmatics. During 10 weeks of each regimen, the patients kept record of symptoms, peak expiratory flow rates and medication. Plasma and urine TxB2, PGE2, PGF2 alpha and 6 keto-PGF1 alpha and plasma fatty acid composition of plasma cholesterol esters were measured at the end of each treatment period. There were no differences between regimes with regard to peak flow rates, symptoms, or drug consumption. Plasma PGE2 levels increased during the fish oil treatment but there were no changes in other prostanoids in plasma or urine. The fatty acid pattern of plasma cholesterol esters showed significant differences between the supplementation periods. We conclude that moderate doses of evening primrose oil or fish oil are ineffective as a supplementary treatment of bronchial asthma.
Dietary fish oil effects on seasonal hay fever and asthma in pollen-sensitive subjects.
The effects of taking 18 capsules a day of Max-EPA (3.2 g/day eicosapentaenoic acid) on clinical symptoms and bronchial hyperresponsiveness were studied in pollen-sensitive subjects over a pollen season in a parallel, double-blind, placebo-controlled (olive oil) fashion. The study was conducted over the 1990 and 1991 pollen seasons in London, England. A total of 37 nonsmoking pollen-sensitive asthmatic subjects were entered into the trial, and 25 completed the 6-month study period over the 2 yr. The preseasonal geometric mean PD35 SGaw of histamine for the fish oil (n = 12) and placebo (n = 9) groups were 0.62 and 0.42 mumol, respectively. During the middle of the pollen season, histamine PD35 SGaw fell significantly for both the fish oil (0.11 mumol, p < 0.0001) and placebo groups (0.10 mumol, p < 0.007), indicating increased bronchial reactivity compared with preseasonal values, but there was no significant difference between the groups. Similarly, morning and evening peak expiratory flow (PEF), diurnal variability in PEF, nocturnal cough and wheeze, daytime wheeze, and activity, as well as nasal symptoms and increased usage of medication, were not significantly different between the groups. Compliance was confirmed by neutrophil and plasma phospholipid analysis, which showed significant rises in eicosapentaenoic acid content in the fish oil group but not in the placebo group. We conclude that dietary fish oil supplementation does not prevent seasonal hay fever and asthma in pollen-sensitive subjects during the pollen season.
Options:
A: Marine n-3 fatty acid supplementation significantly improves asthma control, including FEV1, peak flow rate, asthma symptoms, and medication use.
B: Marine n-3 fatty acid supplementation has no consistent effect on asthma control, including FEV1, peak flow rate, asthma symptoms, and medication use.
C: Marine n-3 fatty acid supplementation significantly worsens asthma control, including FEV1, peak flow rate, asthma symptoms, and medication use.
D: Marine n-3 fatty acid supplementation leads to adverse events in people with asthma.
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B
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129
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the efficacy and safety of corticosteroids or ACTH in reducing short and long-term morbidity in multiple sclerosis patients experiencing acute exacerbations? Please answer this question based on the information provided below:
Early immunosuppressive effect of parenteral methylprednisolone in the treatment of multiple sclerosis.
High-dose intravenous methylprednisolone in the treatment of multiple sclerosis: clinical-immunologic correlations.
We conducted a double-blind trial of high-dose parenteral 6-methylprednisolone (MP) and placebo on 23 patients with acute MS. After the double-blind trial, the patients were given corticosteroids in gradually decreasing doses. The frequency of improvement was significantly higher and the bout duration significantly lower in the MP group than in the placebo group. The first signs of improvement (3 to 6 days after starting MP) were associated with a marked decrease in the rate of CNS IgG synthesis, but IgG CSF oligoclonal bands did not change. CNS IgG production slowly returned toward baseline despite progressive clinical improvement.
The effects of high-dose intravenous methylprednisolone on event-related potentials in patients with multiple sclerosis.
The aim of this study was to assess the effects of high-dose (i.e. 1000 mg per day) intravenous methylprednisolone (HDMP) on event-related potentials (ERPs), elicited by a standard auditory 'oddball' paradigm, in patients with clinically active multiple sclerosis. In a double-blind study design, forty-four consecutive inpatients were randomly assigned in two clinically similar groups of 22 subjects each; one treated with HDMP for five days, and other with placebo. ERPs were recorded before and after the treatment. After HDMP therapy the P3 peak latency was significantly shortened (P=0.006), while peak latencies of other waves (i.e. N1, P2, and N2) remained unchanged. On the other hand, ERPs were uninfluenced by placebo treatment. Our results suggest the beneficial effect of intravenous HDMP therapy on, at least some aspects of, cognitive processing capabilities (as assessed by the auditory ERPs) in patients with multiple sclerosis.
Multiple sclerosis. Treatment of acute exacerbations with corticotrophin (A.C.T.H.).
A double-blind controlled trial of high dose methylprednisolone in patients with multiple sclerosis: 1. Clinical effects.
A randomised double-blind, placebo-controlled trial of high-dose, pulsed intravenous methylprednisolone was carried out in 50 individuals with multiple sclerosis; 22 patients were in acute relapse and 28 had chronic progressive disease. After a baseline assessment using the Kurtzke functional and expanded disability status scales each patient was randomly allocated to intravenous treatment with methylprednisolone (500 mg) or a saline placebo administered as a single daily dose for 5 days. Clinical assessments were repeated at 1 and 4 weeks after starting treatment. The results from all 50 patients showed a highly significant effect in favour of methylprednisolone treatment (p less than 0.001). In patients with relapse, there was a significant decrease in clinical disability scores at 1 and 4 weeks in the methylprednisolone treated group compared with controls (p less than 0.05 for each comparison). In the chronic progressive group, disability scores at 4 weeks only were significantly lower after treatment with methylprednisolone (p less than 0.01), mainly attributable to improvement in pyramidal function.
Cooperative study in the evaluation of therapy in multiple sclerosis. ACTH vs. placebo--final report.
Cooperative study in the evaluation of therapy in multiple sclerosis; ACTH vs placebo in acute exacerbations. Preliminary report.
Double-blind, randomized, placebo-controlled study of oral, high-dose methylprednisolone in attacks of MS.
OBJECTIVE: There is only limited evidence from adequately controlled clinical trials to support high-dose methylprednisolone therapy for attacks of multiple sclerosis (MS) and none supporting oral administration. We assessed the effect of oral high-dose methylprednisolone therapy in attacks of MS.
METHODS: Twenty-five patients with an attack of MS lasting less than 4 weeks were randomized to placebo treatment. Twenty-six patients received oral methylprednisolone (500 mg once a day for 5 days with a 10-day tapering period). The patients received scores on the Scripps Neurological Rating Scale (NRS) and Kurtzke Expanded Disability Status Scale. The symptoms were scored on a visual analog scale (VAS) before treatment and after 1, 3, and 8 weeks of treatment. Primary efficacy measures were NRS and VAS scores in the first 3 weeks and changes in NRS score and answers to an efficacy questionnaire administered after 8 weeks of treatment.
RESULTS: Changes in NRS scores among methylprednisolone- and placebo-treated patients differed significantly in the first 3 weeks and after 8 weeks (p = 0.005 and p = 0.0007). VAS scores the first 3 weeks and treatment efficacy after 8 weeks also favored a beneficial effect of methylprednisolone treatment (p = 0.02 and p = 0.05). After 1, 3, and 8 weeks, 4%, 24%, and 32% in the placebo group and 31%, 54%, and 65% in the methylprednisolone group had improved one point on the Expanded Disability Status Scale score (all p < 0.05). No serious adverse events were seen.
CONCLUSION: Oral high-dose methylprednisolone is recommended for managing attacks of MS.
[Randomized controlled trial of high-dose peroral methylprednisolone in attacks of multiple sclerosis].
The efficacy of glucocorticoid treatment in multiple sclerosis (MS) is uncertain. We assessed the effect of oral high-dose methylprednisolone in attacks of MS. Twenty-five patients with an attack of MS with a duration of less than four weeks were randomized to placebo, 26 patients received oral methylprednisolone (500 mg once daily for five days with a 10 days tapering period). Scripps Neurological rating scale scores differed significantly in methylprednisolone and placebo-treated patients the first three weeks (p = 0.005) and after eight weeks (p = 0.0007). Subjective symptom assessment on a visual analogue scale the first three weeks (p = 0.02) and the answers to an efficacy questionnaire administered after eight weeks (p = 0.05) also favoured a beneficial effect of methylprednisolone treatment. The risk of a new attack of MS was not influenced by the treatment at short-term follow up. No serious adverse events were seen. Oral high-dose methylprednisolone is recommended for treatment of attacks of MS.
Gadolinium-enhanced magnetic resonance imaging predicts response to methylprednisolone in multiple sclerosis.
Oral high-dose methylprednisolone treatment is efficacious in acute optic neuritis (ON) and attacks of multiple sclerosis (MS). The responses to treatment in subgroups of patients participating in two randomized, controlled trials were assessed. Fifty-eight patients with ON and 51 patients with attacks of MS were treated with placebo or oral methylprednisolone (500 mg daily for five days with a 10-day tapering period). A gadolinium (Gd)-enhanced magnetic resonance imaging (MRI) scan was obtained at baseline in 66 patients, and 29 patients underwent repeated MRI studies. Seventy-four patients underwent lumbar puncture before treatment. The odds ratio (OR) of improvement after methylprednisolone treatment (a one point change in the visual function system score of the Kurtzke Expanded Disability Status Scale (EDSS) in ON or in the EDSS score in attacks of MS) was higher in patients with enhancing lesions on baseline MRI (one week: OR 15, P = 0.02; eight weeks: OR 4.6, P = 0.02). Methylprednisolone treatment suppressed Gd-enhancement after one week (P < 0.001) and three weeks (P = 0.001). Cerebrospinal fluid measures of intrathecal inflammation correlated with the area of Gd-enhancement but did not correlate as closely with the treatment response as did the results of Gd-enhanced MRI. These findings suggest that the resolution of intrathecal inflammation as assessed by Gd-enhanced MRI is a major effect of oral high-dose methylprednisolone.
Options:
A: Corticosteroids, specifically methylprednisolone (MP), showed a protective effect against the disease worsening or remaining stable within the first five weeks of treatment, but there was no significant difference in long-term outcomes.
B: Corticosteroids and ACTH were found to be ineffective in reducing both short-term and long-term morbidity in multiple sclerosis patients.
C: ACTH was found to be more effective than corticosteroids in reducing short-term morbidity, but both were ineffective in the long term.
D: Corticosteroids, specifically methylprednisolone (MP), showed significant long-term benefits in preventing new exacerbations and reducing long-term disability.
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A
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130
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the effectiveness and safety of aminosteroids in the treatment of acute traumatic brain injury? Please answer this question based on the information provided below:
A multicenter trial on the efficacy of using tirilazad mesylate in cases of head injury.
OBJECT: The authors prospectively studied the efficacy of tirilazad mesylate, a novel aminosteroid, in humans with head injuries.
METHODS: A cohort of 1120 head-injured patients received at least one dose of study medication (tirilazad or placebo). Eighty-five percent (957) of the patients had suffered a severe head injury (Glasgow Coma Scale [GCS] score 4-8) and 15% (163) had sustained a moderate head injury (GCS score 9-12). Six-month outcomes for the tirilazad- and placebo-treated groups for the Glasgow Outcome Scale categories of both good recovery and death showed no significant difference (good recovery in the tirilazad-treated group was 39% compared with the placebo group in which it was 42% [p=0.461]; death in the tirilazad-treated group occurred in 26% of patients compared with the placebo group, in which it occurred in 25% [p=0.750]). Subgroup analysis suggested that tirilazad mesylate may be effective in reducing mortality rates in males suffering from severe head injury with accompanying traumatic subarachnoid hemorrhage (death in the tirilazad-treated group occurred in 34% of patients; in the placebo group it occurred in 43% [p=0.026]). No significant differences in frequency or types of serious adverse events were shown between the treatment and placebo groups.
CONCLUSIONS: Striking problems with imbalance concerning basic prognostic variables were observed in spite of the large population studied. These imbalances concerned pretreatment hypotension, pretreatment hypoxia, and the incidence of epidural hematomas. In future trials of pharmacological therapy for severe head injury, serious consideration must be given to alternative randomization strategies. Given the heterogeneous nature of head injury and the identification of populations that do relatively well with standard therapy, target populations with a higher risk for mortality and morbidity may be more suitable for clinical trials of such agents.
Options:
A: Aminosteroids significantly reduce the risk of death and severe disability following head injury.
B: Aminosteroids significantly increase the risk of death and severe disability following head injury.
C: There is no evidence to support the routine use of aminosteroids in the management of traumatic head injury.
D: Aminosteroids have been proven to have moderate but clinically important benefits in the treatment of traumatic head injury.
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C
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131
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy of surface electrical stimulation (ES) in the prevention and treatment of shoulder pain after stroke? Please answer this question based on the information provided below:
The effects of functional electrical stimulation on shoulder subluxation, arm function recovery, and shoulder pain in hemiplegic stroke patients.
The purpose of this study was to evaluate the effectiveness of a functional electrical stimulation (FES) treatment program designed to prevent glenohumeral joint stretching and subsequent subluxation and shoulder pain in stroke patients. Twenty-six recent hemiplegic stroke patients with shoulder muscle flaccidity were randomly assigned to either a control group (n = 13; 5 female, and 8 male) or experimental group (n = 13; 6 female, and 7 male). Both groups received conventional physical therapy. The experimental group received additional FES therapy where two flaccid/paralyzed shoulder muscles (supraspinatus and posterior deltoid) were induced to contract repetitively up to 6 hours a day for 6 weeks. Duration of both the FES session and muscle contraction/relaxation ratio were progressively increased as performance improved. The experimental group showed significant improvements in arm function, electromyographic activity of the posterior deltoid, range of motion, and reduction in subluxation (as indicated by x-ray) compared with the control group. We concluded that the FES program was effective in reducing the severity of shoulder subluxation and pain, and possibly facilitating recovery of arm function.
Comparison of TENS treatments in hemiplegic shoulder pain.
The aim of this paper is to evaluate the effectiveness of high-intensity versus low-intensity transcutaneous electrical nerve stimulation (TENS) and versus placebo for treatment of hemiplegic shoulder pain. Three groups of 20 patients each (A, B, C) were studied. In group A high-intensity TENS was delivered at 3 times the sensory threshold with frequency of 100 Hz; in group B low-intensity TENS was delivered at the sensory threshold with frequency of 100 Hz. Group C received placebo stimulation. The treatment protocol consisted of 12 sessions (4 weeks). Before treatment, at the end of it and one month after, passive range of motion (PROM) for flexion, extension, abduction and external rotation were evaluated. Statistically significant improvements of PROMs were recorded for group A, but not for groups B or C.
Prevention of shoulder subluxation after stroke with electrical stimulation.
BACKGROUND AND PURPOSE: Subluxation is a significant problem in poststroke hemiplegia, resulting in pain and loss of function. Current treatments are not proved and not considered effective. It has been demonstrated that cyclical electrical stimulation of the shoulder muscles can reduce existing subluxation. The purpose of this study was to determine whether electrical stimulation could prevent subluxation in both the short and long terms.
METHODS: A prospective, randomized controlled study was used to determine the efficacy of electrical stimulation in preventing shoulder subluxation in patients after cerebrovascular accidents. Forty patients were selected and randomly assigned to a control or treatment group. They had their first assessment within 48 hours of their stroke, and those in the treatment group were immediately put on a regimen of electrical stimulation for 4 weeks. All patients were assessed at 4 weeks after stroke and then again at 12 weeks after stroke. Assessments were made of shoulder subluxation, pain, and motor control.
RESULTS: The treatment group had significantly less subluxation and pain after the treatment period, but at the end of the follow-up period there were no significant differences between the 2 groups.
CONCLUSIONS: Electrical stimulation can prevent shoulder subluxation, but this effect was not maintained after the withdrawal of treatment.
Stimulation with low frequency (1.7 Hz) transcutaneous electric nerve stimulation (low-tens) increases motor function of the post-stroke paretic arm.
The object of this study is to determine if the functional motor capacity of the paretic extremity can be improved by stimulation with low intensity low frequency (1.7 Hz) transcutaneous electric nerve stimulation (Low-TENS), started 6-12 months after a stroke. Forty-four patients who had a paretic arm as a consequence of their first stroke were included and randomly assigned to either a treatment group (n = 26) or a control group (n = 18). Patients in both groups received physiotherapy at a day-care center, usually twice a week. The treatment group received, in addition, Low-TENS for 60 min, five days a week for three months. Results showed that motor function increased significantly in the treatment group, compared to controls. The Low-TENS did not decrease either pain or spasticity. It is concluded that stimulation by means of Low-TENS could be a valuable complement to the usual training of arm and hand function in the rehabilitation of stroke patients.
Options:
A: ES significantly reduced the incidence and intensity of shoulder pain after stroke.
B: ES had no significant effect on the incidence or intensity of shoulder pain, but improved passive humeral lateral rotation and reduced glenohumeral subluxation.
C: ES significantly improved upper limb motor recovery and reduced spasticity in stroke patients.
D: ES had significant negative effects on shoulder function and increased the severity of shoulder pain.
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B
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132
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the effect of adding intravesical Bacillus Calmette-Guerin (BCG) to transurethral resection (TUR) in patients with medium or high risk Ta or T1 bladder cancer on the incidence of tumour recurrence at 12 months? Please answer this question based on the information provided below:
A randomized multicenter trial of adjuvant therapy in superficial bladder cancer: transurethral resection only versus transurethral resection plus mitomycin C versus transurethral resection plus bacillus Calmette-Guerin. Participating Clinics.
PURPOSE: A randomized multicenter trial was done to compare transurethral resection only to transurethral resection plus adjuvant mitomycin C and bacillus Calmette Guerin (BCG) instillation for treatment of superficial bladder cancer (stage pTa/1 grades 1 to 3 except primary stage pTa grade 1).
MATERIALS AND METHODS: Included in the study were 337 patients with superficial stage pTa/1 grades 1 to 3 bladder cancer except primary stage pTa grade 1 tumors. One group underwent transurethral resection alone. Mitomycin C (20 mg./50 ml. sodium chloride) was given every 2 weeks during year 1 and once a month during year 2. BCG (120 mg/50 ml. sodium chloride was instilled once a week for 6 weeks and once a month for 4 months.
RESULTS: At a median followup of 20.2 months, a decrease in recurrence rate was noted for both drug instillations compared to transurethral resection only. The relative risk of recurrence was 0.508 after mitomycin C and 0.618 after BCG instillation compared to transurethral resection alone. There was no significant difference between the mitomycin C and BCG instillations. The progression rate was comparable in all 3 therapy groups, with an estimated common progression rate of 4.22% per year. Side effects occurred most frequently during or after BCG instillation, most often consisting of cystitis. One patient required cystectomy because of ulcerating cystitis and a prostatic abscess subsequent to unsuccessful tuberculostatic therapy. There were no systemic complications.
CONCLUSIONS: Our study showed a positive effect of adjuvant chemotherapy and immunotherapy on decreasing tumor recurrence rate. No influence was observed concerning progression rate, which was low overall.
Bacillus Calmette-Guerin immunotherapy for bladder cancer.
Bacillus Calmette-Guerin immunotherapy has been found by a number of investigators to be effective in the treatment and prevention of superficial bladder cancer. While the optimal protocol for bacillus Calmette-Guerin remains to be determined, experience with 92 randomized and 30 nonrandomized (high risk) patients followed for up to 5 years provides information that may improve future protocols. Side effects of bacillus Calmette-Guerin are observed to increase with increasing frequency and duration of treatment. The protection from tumor recurrence has persisted: only 6 of 30 patients (20 per cent) treated with bacillus Calmette-Guerin have had recurrent tumor compared to 14 of 27 controls (52 per cent, p equals 0.008, chi-square test), and mean time to recurrence increased from 24 to 48 months (p less than 0.005, Savage). Skin test reactivity to purified protein derivative is particularly useful in predicting response to bacillus Calmette-Guerin immunotherapy. Currently, 60 patients have been randomized to receive bacillus Calmette-Guerin immunotherapy and only 1 of 22 patients (4.5 per cent) in whom the purified protein derivative skin test results converted from negative to positive has had recurrent tumor, compared to 12 recurrences (32 per cent) in patients whose skin tests were positive before treatment or failed to convert following treatment (p equals 0.014, chi-square). Seven recurrences (33 per cent) developed in 21 patients whose skin tests remained negative (p equals 0.015) and 5 recurrences (29 per cent) developed in 17 patients whose tests previously were positive (p equals 0.068, Fisher's test, not significant). The benefit of percutaneous bacillus Calmette-Guerin is suggested by the observations that the recurrence rate in patients treated with intravesical bacillus Calmette-Guerin alone is 40 per cent, and all 7 patients whose purified protein derivative skin tests were negative continued to have negative results when percutaneous bacillus Calmette-Guerin was omitted (p equals 0.003). Among high risk patients a marked decrease in or complete prevention of recurrent tumor was observed in 82 per cent of 22 patients treated previously with chemotherapy and 11 of 14 (78 per cent) with carcinoma in situ have had a complete response.
Intravesical Bacillus Calmette-Guérin prophylactic treatment for superficial bladder tumors: results of a controlled prospective study.
A controlled prospective study in 100 patients evaluated the efficacy of intravesical bacillus Calmette-Guérin (BCG) administration as prophylactic treatment on tumor recurrence and tumor progression rate after endoscopic resection of superficial transitional cell carcinoma of the bladder. There were 27 recurrences in 22 of 67 evaluable patients (33%) who received BCG, compared to 27 recurrences in 19 of 33 control patients (58%) (p less than 0.05). The mean follow-up periods for the tumor-free patients in the BCG and control groups were 29 and 30 months, respectively, while the mean times to tumor recurrences for the above groups were 13.36 +/- 6 and 9.94 +/- 5 months, respectively (p less than 0.05). The recurrence rates per 100 patient months for the BCG and control patients were 1.69 and 4.41 recurrences, respectively (p less than 0.05), while 7 patients of the BCG group showed recurrent tumors of higher stage or grade, compared to 13 of the controls (p less than 0.05). This study confirms that Pasteur strain BCG is safe and efficacious in the prevention of superficial bladder tumor recurrence and tumor progression.
Intravesical administration of bacillus Calmette-Guérin in patients with recurrent superficial carcinoma of the urinary bladder: report of a prospective, randomized trial.
In an attempt to prevent, delay, or reduce further tumor occurrence, 88 patients with recurrent, superficial carcinoma of the urinary bladder were randomly assigned to receive either standard therapy (cystoscopy with fulguration) or standard therapy and bacillus Calmette-Guérin (BCG). BCG was administered intravesically and percutaneously once weekly for 6 weeks. No serious toxicity was seen. There were 43 evaluable patients in each of the two groups. Results in the BCG group versus the control group were as follows: reduction in the number of recurrent tumors (43 vs 27 patients [P less than 0.001] ); conversion to negative cytology (11 of 33 vs three of 34 patients [P less than 0.05] ); and tumor progression requiring cystectomy (three vs 15 patients [P less than 0.001] ). Disease-free interval (P less than 0.001), time with negative cytology (P less than 0.001), and time to progression of disease (P less than 0.003) were longer in patients treated with BCG. These results indicate that the combination of standard therapy and BCG is more effective than standard therapy alone in patients with recurrent superficial bladder tumors.
[Intravesical bacillus Calmette-Guerin (BCG) in the treatment of superficial bladder cancer. Prospective randomized study for prophylactic effect].
We report the results of prospective randomized study which was designed to evaluate prophylactic effects of intravesical bacillus Calmette-Guerin (BCG) in the treatment of superficial transitional cell carcinoma of the bladder. A total of 44 cases who had no previous treatment of bladder cancer were randomly assigned to BCG or control groups after TUR. BCG group (23 cases) received intravesical instillation of 80 mg BCG (Tokyo strain) at one week intervals for 6 weeks, at two week intervals for 12 weeks, and at one month intervals for 20 months. In BCG groups, 3 cases had recurrence at 6 months and 1 case at 9 months, while the other 19 cases had no recurrent disease for 3 to 34 months (average 20.3 months) of follow-up. Control group (21 cases) had no further treatment after TUR. In control group, recurrence was seen at 3 months in 3 cases, at 6 months in 5 cases, at 9 months in 2 cases, at 12 months in 3 cases and at 21 months in 1 case. Only 7 cases in the control group were free of recurrence for 8 to 45 months (average 32.3 months) of follow-up. One and two year-recurrence rates in BCG group (18.4%, 18.4%) was significantly (p less than 0.01) lower than those in control group (63.2%, 68.9%). Among the complications of intravesical BCG were cystitis (76.2%), low grade fever (13.0%), and several days' persistent gross hematuria (13.0%). Most of these signs were self-limited and only in 2 cases instillation of BCG was discontinued.(ABSTRACT TRUNCATED AT 250 WORDS)
Options:
A: There was no significant difference in tumour recurrence between the two groups.
B: The addition of BCG to TUR significantly reduced the incidence of tumour recurrence.
C: The addition of BCG to TUR significantly increased the incidence of tumour recurrence.
D: The addition of BCG to TUR had no effect on the incidence of tumour recurrence but increased the severity of side effects.
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B
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133
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What were the findings regarding the effectiveness of nedocromil sodium compared to sodium cromoglycate in preventing exercise-induced bronchoconstriction in asthmatics? Please answer this question based on the information provided below:
Comparison of nedocromil sodium and sodium cromoglycate administered by pressurized aerosol, with and without a spacer device in exercise-induced asthma in children.
To compare the effectiveness of nedocromil sodium (NS) and sodium cromoglycate (SCG) administered by metered dose inhaler (MDI) in preventing exercise-induced asthma (EIA), 12 asthmatic children with EIA were studied in a randomized, double-blind, cross-over, placebo-controlled study. NS and SCG were given by MDI alone, and by MDI with a 700 ml spacer device (Fisonair, Fisons, UK), in order to assess the benefit of using such a device. Following a baseline exercise challenge, the protective effect of NS, SCG or placebo was evaluated in each subject. The percentage fall in forced expiratory volume in one second, and percentage protection were measured. NS and SCG provided a significant and comparable protection from EIA, and both were better than placebo. No further improvement was observed after drug administration via the spacer. Both NS and SCG are effective in preventing EIA in children, when administered at the recommended clinical dose, and the use of a spacer for administering the drug provides no advantage if the technique of inhalation is good.
Comparison of the protective effects of cromolyn sodium and nedocromil sodium in the treatment of exercise-induced asthma in children.
Seventeen children with asthma were studied in a double-blind, crossover, placebo-controlled study designed to compare the efficacy of cromolyn sodium with that of nedocromil sodium in preventing exercise-induced asthma. All drugs were delivered through a metered-dose inhaler (cromolyn sodium, 10 mg; nedocromil sodium, 4 mg; placebo, two puffs). Nedocromil sodium and cromolyn sodium provided significant, comparable protection from exercise-induced asthma, and both drugs were better than placebo. We conclude that nedocromil sodium and cromolyn sodium administered by a pressurized aerosol provide equal protection against exercise-induced asthma in children.
The Effect of Cromolyn Sodium and Nedocromil Sodium Administered by A pressurized Aerosol with A spacer Device on Exercise-Induced Asthma in Children.
To compare the effectiveness of cromolyn sodium (CS) (10 mg) and nedocromil sodium (NS) (4 mg) administered by a metered dose inhaler (MDI) with a spacer device in preventing exercise-induced asthma (EIA), eight asthmatic children with EIA were studied in a randomized double-blind, cross-over, placebo-controlled study, CS and NS provided significant, comparable protection from EIA and both were better than placebo. We conclude that CS and NS administered by a pressurized aerosol with a spacer device provide equal protection against EIA in children.
Cromolyn versus nedocromil: duration of action in exercise-induced asthma in children.
Cromolyn sodium (10 mg), nedocromil sodium (4 mg), and placebo, all delivered by a metered dose inhaler, were compared in their efficacy and duration of action in preventing exercise-induced asthma in children. After a screening test was performed, 13 patients with asthma performed standard exercise tests 20 minutes and 140 minutes after drug inhalation in a randomized, double-blind, crossover study. Both drugs were significantly more protective than placebo after 20 minutes, but no significant difference was seen between cromolyn sodium and nedocromil sodium. No difference between active drugs and placebo was found 140 minutes after inhalation. At these clinically recommended doses both cromolyn sodium and nedocromil sodium provide equal protection against exercise-induced asthma, and the duration of action of both lasts for less than 2 hours.
The preventive effect and duration of action of nedocromil sodium and cromolyn sodium on exercise-induced asthma (EIA) in adults.
Nedocromil sodium, 4 mg, from a metered-dose inhaler, cromolyn sodium, (cr) 20 mg, from a Spinhaler, and placebo (pl) were compared in their efficacy and duration of action in preventing exercise-induced asthma. Twelve patients with asthma performed treadmill exercise tests 20 minutes, 2 hours, and 4 hours after a single dose of drug in a double-blind, crossover trial. Both active drugs were significantly better than pl at 20 minutes. Two hours after drug administration, only cr was significantly different from pl. The direct comparison between nedocromil and cr demonstrated no significant difference on FEV1, and the only significant difference was with forced expiratory flow between 25% and 75% of vital capacity at 2 hours. It is concluded that at these clinically recommended doses, both drugs are equally effective in preventing exercise-induced asthma with cr possibly having a somewhat longer duration of action.
Effects of nedocromil sodium, cromolyn sodium, and a placebo in exercise-induced asthma.
The incidence and severity of exercise-induced asthma were determined in nineteen asthmatic patients who performed eight minutes of exercise following four treatments administered in a random order. The treatments were nedocromil sodium, cromolyn sodium, placebo, and no treatment. It was concluded that nedocromil sodium (8 mg) and cromolyn sodium (4 mg) provide equal protection against exercise-induced asthma.
Inhibition of exercise-induced-asthma (EIA) by nedocromil sodium and sodium cromoglycate in children.
Nedocromil sodium (Ned) 4 mg, sodium cromoglycate (SCG) 10 mg, and placebo were compared for their efficacy in preventing exercise-induced asthma. Nineteen asthmatic children aged six to 15 years performed a treadmill exercise test before and 20' after a single dose of drug in a double-blind trial. Both active drugs performed significantly better than placebo; in fact the exercise challenge resulted in a mean maximum fall in FEV1 of 26.1 +/- 14.9% after placebo, but only of 14.6 +/- 11.5% after SCG (P < 0.05), and 11.0 +/- 12.4% after Ned (p < 0.01). Measurements of PEFR gave similar results, while the effect of treatment on FEF 25-75 was significant for Ned alone (p < 0.05). Direct comparison between Ned and SCG at different time points demonstrated significant differences in FEV1 at 1 min (p < 0.05) with a better overall performance of Ned. In individual patients, complete protection was provided in 9 patients with SCG, in 14 patients with Ned and in 2 with placebo. No side effects were observed. This study suggests that at the dosages used there are only slight differences between SCG and Ned activity in the prevention of exercise-induced asthma.
Attenuation of exercise induced asthma by nedocromil sodium and sodium cromoglycate.
A randomized double blind cross over trial to compare nedocromil sodium and sodium cromoglycate with placebo in the prevention of exercise induced asthma was conducted. Twenty asthmatics received nedocromil sodium, sodium cromoglycate or placebo via metered dose inhalers on successive days 30 minutes before exercise in a randomized order. Nedocromil sodium and sodium cromoglycate gave sufficient protection (P less than 0.05) compared to placebo as assessed by the reduction in the maximum percentage fall in the forced expiratory volume in 1 second (FEV1). The protective effect of nedocromil sodium and sodium cromoglycate varied in individuals.
Options:
A: Nedocromil sodium was significantly more effective than sodium cromoglycate in reducing the severity of exercise-induced bronchoconstriction.
B: Sodium cromoglycate was significantly more effective than nedocromil sodium in reducing the severity of exercise-induced bronchoconstriction.
C: There was no significant difference between nedocromil sodium and sodium cromoglycate in reducing the severity of exercise-induced bronchoconstriction.
D: Both nedocromil sodium and sodium cromoglycate were ineffective in reducing the severity of exercise-induced bronchoconstriction.
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C
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134
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the efficacy of a single 30 mg dose of dihydrocodeine for moderate to severe postoperative pain compared to placebo and ibuprofen 400 mg? Please answer this question based on the information provided below:
A comparison of ibuprofen and dihydrocodeine in relieving pain following wisdom teeth removal.
Although dihydrocodeine (DF118) is widely prescribed by general dental practitioners, there is little evidence that it is successful in controlling post-operative dental pain. Ibuprofen is known to be effective in this situation. A single dose, double-blind study was carried out in 148 patients to compare 400 mg ibuprofen with 30 mg dihydrocodeine and placebo for treating moderate to severe pain following the removal of unilateral, impacted mandibular third molar teeth under local anaesthesia. An additional dose of either ibuprofen or dihydrocodeine was available after 2 hours. The post-operative ibuprofen reduced pain and produced more pain relief than dihydrocodeine or placebo. Furthermore, fewer patients receiving ibuprofen took additional analgesic at 2 hours. Patients who received ibuprofen as supplementary medication also experienced less pain and had greater pain relief than those receiving dihydrocodeine as supplementary medication, even when their post-operative treatment had been placebo. More patients reported the medication as having been effective if they took ibuprofen either post-operatively or as supplementary analgesia. Ibuprofen is an appropriate analgesic for treating post-operative dental pain.
Zomepirac, dihydrocodeine and placebo compared in postoperative pain after day-case surgery. The relationship between the effects of single and multiple doses.
Zomepirac 100 mg and dihydrocodeine 30 mg were compared with placebo in a controlled randomized, double-blind, single-dose postoperative study. Patients continued to receive either zomepirac or dihydrocodeine for pain relief for 5 days at home in a double-blind study, being allowed to titrate the consumption of tablets to their degree of pain. The efficacy and side effects of the medication were evaluated. In the single-dose phase, both active treatments were significantly better than placebo. In the multiple dosing phase, zomepirac was statistically better than dihydrocodeine. Non-parametric statistical tests indicated highly significant correlations between single- and multiple-dose analgesic measurements for both zomepirac and dihydrocodeine.
A multiple dose comparison of ibuprofen and dihydrocodeine after third molar surgery.
The objectives were to compare the relative merits of ibuprofen 400 mg and dihydrocodeine 30 mg or 60 mg taken up to four times daily for up to 6 days in the treatment of pain after third molar removal. A randomised, double-blind, multiple dose, crossover study was undertaken in 68 patients undergoing two-stage bilateral lower third molar removal. The results showed that ibuprofen produced significantly greater analgesia than either of the dihydrocodeine treatments on the day of surgery. Ibuprofen and dihydrocodeine 60 mg produced significantly greater analgesia than dihydrocodeine 30 mg on the day after surgery, and on days 4 and 5 ibuprofen was again significantly superior to dihydrocodeine 60 mg. Roughly half the patients taking dihydrocodeine stopped the study on the day after surgery, because of adverse effects and/or inadequate relief, compared with 6 out of 44 taking ibuprofen. Dihydrocodeine 60 mg produced four times the number of patients affected by adverse effects compared with ibuprofen, and dihydrocodeine 30 mg three times as many. The principal adverse effects were nausea, vomiting and drowsiness. In conclusion, ibuprofen produced better analgesia than dihydrocodeine with significantly fewer adverse effects and is therefore a better choice for pain relief after oral surgery.
Options:
A: A single 30 mg dose of dihydrocodeine provides adequate pain relief and is superior to ibuprofen 400 mg.
B: A single 30 mg dose of dihydrocodeine does not provide adequate pain relief and is inferior to ibuprofen 400 mg.
C: A single 30 mg dose of dihydrocodeine provides adequate pain relief but is inferior to ibuprofen 400 mg.
D: A single 30 mg dose of dihydrocodeine does not provide adequate pain relief but is superior to ibuprofen 400 mg.
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B
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135
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What was the conclusion regarding the efficacy and safety of single-dose piroxicam for treating moderate to severe postoperative pain? Please answer this question based on the information provided below:
Evaluation of piroxicam-beta-cyclodextrin, piroxicam, paracetamol and placebo in post-operative oral surgery pain.
Two hundred ninety-eight patients with post-operative pain after the surgical removal of an impacted third molar were randomly assigned, on a double-blind basis, to receive a single oral dose of piroxicam 20 mg, or piroxicam-beta-cyclodextrin equivalent to 20 mg piroxicam, or paracetamol 500 mg, or placebo. Using a semi-quantitative self-rating scale, patients rated their pain and its relief at 30-min intervals for the first 2 h, and then hourly for 4 h after treatment administration. All active medications were reported to be significantly superior to placebo. The three active drugs were comparable for the degree of analgesia up to the third hour, after which the effect of paracetamol decreased significantly as compared to piroxicam-beta-cyclodextrin and piroxicam. Piroxicam-beta-cyclodextrin and paracetamol were more rapid than piroxicam in inducing analgesia. The tolerability for the active drugs was comparable to that for placebo.
Analgesic efficacy of piroxicam in the treatment of postoperative pain.
Two randomized, double-blind, single-dose studies were conducted to assess the analgesic efficacy and safety of piroxicam for the treatment of moderate or severe postoperative pain. Study 1 evaluated the analgesic efficacy of piroxicam 20 mg compared with that of codeine sulfate 60 mg and placebo. A final patient population of 149 subjects rated pain intensity and pain relief at one half hour and one hour following treatment and then hourly for six hours, with a global assessment made at the completion of 24 hours. Piroxicam 20 mg was significantly more efficacious than placebo for all analgesic variables, including the sum of the pain intensity differences (SPID), total pain relief (TOTAL), percent SPID, duration of effect, and time to remedication. Codeine 60 mg was significantly superior to placebo for percent SPID and some hourly measures. Piroxicam 20 mg was significantly more effective than codeine 60 mg for percent SPID and a few hourly measures including time to remedication. Study 2 assessed the efficacy of piroxicam 20 mg or 40 mg compared with aspirin 648 mg and placebo. Sixty patients rated their pain intensity and relief hourly for 12 hours and at 24 hours after administration of study medication. Both doses of piroxicam were significantly more effective than placebo from Hours 2 to 12 for pain intensity difference (PID) and relief scores, as well as for SPID and TOTAL. Aspirin was significantly more effective than placebo from Hours 2 to 8 for relief and Hours 2 to 10 for PID as well as SPID and TOTAL. Piroxicam 40 mg was significantly more effective than aspirin 648 mg for SPID, TOTAL, and hourly measures beginning with Hour 6 through Hour 12. Piroxicam 20 mg was significantly better than aspirin for a few hourly measures: Hours 7 to 9 for relief and Hour 7 for PID. In addition, effects of piroxicam 20 mg had a significantly longer duration than aspirin. Similarly, piroxicam 20 mg had a significantly longer time to remedication compared with aspirin and placebo. The results of these studies provide evidence in support of the longer duration of analgesic efficacy of piroxicam compared with codeine or aspirin in patients with postoperative pain.
Analgesic efficacy of piroxicam in the treatment of postoperative pain.
Two randomized, double-blind, single-dose studies were conducted to assess the analgesic efficacy and safety of piroxicam for the treatment of moderate or severe postoperative pain. Study 1 evaluated the analgesic efficacy of piroxicam 20 mg compared with that of codeine sulfate 60 mg and placebo. A final patient population of 149 subjects rated pain intensity and pain relief at one half hour and one hour following treatment and then hourly for six hours, with a global assessment made at the completion of 24 hours. Piroxicam 20 mg was significantly more efficacious than placebo for all analgesic variables, including the sum of the pain intensity differences (SPID), total pain relief (TOTAL), percent SPID, duration of effect, and time to remedication. Codeine 60 mg was significantly superior to placebo for percent SPID and some hourly measures. Piroxicam 20 mg was significantly more effective than codeine 60 mg for percent SPID and a few hourly measures including time to remedication. Study 2 assessed the efficacy of piroxicam 20 mg or 40 mg compared with aspirin 648 mg and placebo. Sixty patients rated their pain intensity and relief hourly for 12 hours and at 24 hours after administration of study medication. Both doses of piroxicam were significantly more effective than placebo from Hours 2 to 12 for pain intensity difference (PID) and relief scores, as well as for SPID and TOTAL. Aspirin was significantly more effective than placebo from Hours 2 to 8 for relief and Hours 2 to 10 for PID as well as SPID and TOTAL. Piroxicam 40 mg was significantly more effective than aspirin 648 mg for SPID, TOTAL, and hourly measures beginning with Hour 6 through Hour 12. Piroxicam 20 mg was significantly better than aspirin for a few hourly measures: Hours 7 to 9 for relief and Hour 7 for PID. In addition, effects of piroxicam 20 mg had a significantly longer duration than aspirin. Similarly, piroxicam 20 mg had a significantly longer time to remedication compared with aspirin and placebo. The results of these studies provide evidence in support of the longer duration of analgesic efficacy of piroxicam compared with codeine or aspirin in patients with postoperative pain.
Options:
A: Single-dose piroxicam is less effective than placebo and has a higher incidence of adverse effects.
B: Single-dose piroxicam is more effective than placebo and has a similar incidence of adverse effects.
C: Single-dose piroxicam is equally effective as placebo but has a higher incidence of adverse effects.
D: Single-dose piroxicam is less effective than other NSAIDs and has a higher incidence of adverse effects.
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B
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the effectiveness of a single dose of intramuscular vitamin K given after birth in preventing classic Hemorrhagic Disease of the Newborn (HDN), and how does it compare to oral vitamin K in terms of biochemical indices of coagulation status? Please answer this question based on the information provided below:
Prevention of subclinical vitamin K deficiency based on PIVKA-II levels: oral versus intramuscular route.
Effects of oral and intramuscular vitamin K prophylaxis on vitamin K1, PIVKA-II, and clotting factors in breast fed infants.
A randomised clinical trial was conducted to establish the effects of oral and intramuscular administration of vitamin K at birth on plasma concentrations of vitamin K1, proteins induced by vitamin K absence (PIVKA-II), and clotting factors. Two groups of about 165 healthy breast fed infants who received at random 1 mg vitamin K1 orally or intramuscularly after birth were studied at 2 weeks and 1 and 3 months of age. Although vitamin K1 concentrations were statistically significantly higher in the intramuscular group, blood coagulability, activities of factors VII and X and PIVKA-II concentrations did not reveal any difference between the two groups. At 2 weeks of age vitamin K1 concentrations were raised compared with reported unsupplemented concentrations and no PIVKA-II was detectable. At 3 months vitamin K1 concentrations were back at unsupplemented values and PIVKA-II was detectable in 11.5% of infants. Therefore, a repeated oral prophylaxis will be necessary to completely prevent (biochemical) vitamin K deficiency beyond the age of 1 month.
A new mixed micellar preparation for oral vitamin K prophylaxis: randomised controlled comparison with an intramuscular formulation in breast fed infants.
OBJECTIVE: To compare a new oral preparation of vitamin K1 (Konakion MM) containing lecithin and glycocholic acid with a standard intramuscular (IM) preparation during the first 8 weeks of life in exclusively breast fed infants.
METHODS: Infants were randomised at birth to the IM group (1 mg vitamin K) or the oral group (2 mg given at birth and repeated at 7 and 30 days of life). Prothrombin time (INR), plasma vitamin K1, and PIVKA II (undercarboxylated prothrombin) were monitored at 14, 30, and 56 days of age.
RESULTS: Seventy nine infants were randomised to the oral group and 77 to the IM group. Sixty seven infants in each group completed eight weeks of the study. Prothrombin times did not differ between the two groups. Mean (SD) plasma vitamin K1 values (in ng/ml) decreased in both groups over time, but were higher in the oral group at 14 and 56 days: 2.0 (1.6) v 1.3 (1.1) at 14 days; 0.5 (0.3) v 0.5 (0.7) at 30 days; and 0.5 (0.8) v 0.2 (0.2) at 56 days of life. PIVKA II was raised (> or = 0.1 AU/ml) in cord blood in 47% of the infants. By 14 days, only one infant in each group had a raised PIVKA II value and both of these initially had high concentrations of PIVKA II in cord blood. At 30 days, there were no raised PIVKA II values. At 56 days, there were no raised PIVKA II values in the oral group, although three infants in the IM group had raised values.
CONCLUSIONS: Plasma vitamin K concentrations were at least equal or significantly higher in babies given oral vitamin K supplements compared with IM treated babies at the time points measured. Through the first 8 weeks of life, multiple doses of the new oral preparation maintain haemostasis and vitamin K status in breast fed infants at least equal to that of the intramuscular preparation.
Comparison of oral and parenteral vitamin K prophylaxis for prevention of late hemorrhagic disease of the newborn.
Vitamin K to neonates. Peroral versus intramuscular administration.
In a randomized study of 300 infants, the effect of 1 mg of peroral vitamin K given at birth was compared to the same dose given as an intramuscular injection. The combined activity of coagulation factor II + VII + X taken after 48 and before 72 hours after delivery served as the primary endpoint. Prothrombin (antigen) and PIVKA II (acarboxyprothrombin) were also measured. All infants were observed for events of bleeding until discharge from the hospital, normally on the fifth day. No significant differences between the groups in any of the biochemical markers were observed. The 95% confidence limits of the differences were very narrow for all factors. No cases of bleeding were observed. We conclude that administration of 1 mg peroral vitamin K is as efficient as intramuscular administration of the same dose in the prevention of classical hemorrhagic disease of the newborn.
Comparative study of oral versus injectable vitamin K in neonates.
One hundred term exclusively breast fed babies weighing more than 2.5 kg were evaluated to determine the efficacy of various modes and doses of Vitamin K to prevent hemorrhagic disease of newborn (HDN). The babies were grouped into four categories of 25 each: Group A--1 mg Vitamin K intramuscular (Menadione sodium disulphite) at birth; Group B--0.5 mg Vitamin K intramuscular; Group C--1 mg Vitamin K orally, and group D--no Vitamin K. The prothrombin index was estimated in all babies between 36-72 hours of age. The results revealed a prothrombin index in Groups A, B, C and D as 94.98 +/- 7.64%, 95.08 +/- 9.91%, 92.51 +/- 10.10% and 80.39 +/- 15.90%, respectively. The differences between Groups A, B and C were insignificant. However, Group D, prothrombin index was significantly reduced as compared with the other three groups. It is, therefore, concluded that oral Vitamin K is as effective as injectable Vitamin K and its usage is recommended in our country to reduce complications and costs of parenteral therapy.
[Efficacy of oral administration of a micellaar solution of vitamin K during the neonatal period].
BACKGROUND: Oral administration of vitamin K to neonates is quite satisfactory for preventing hemorrhagic disease of the newborn. The aim of this study is to test efficacy of a micellar solution of vitamin K at birth.
POPULATION AND METHODS: Thirty full term infants, exclusively breast-fed during the first month of life, were included in this study. Seven of them (control group Cos) were given oral supplementation with 5 mg vitamin K1, cremophor; 15 other infants were given oral supplementation with 3 mg micellar solution of vitamin K1 (group MMos) and 7 were given an intramuscular injection of 1.5 mg micellar solution of vitamin K1 (group MMim). Prothrombin time activity and plasma vitamin K concentration were measured in the cord blood, 24 +/- 12 hours and 1 month after supplementation.
RESULTS: No hemorrhage was seen and tolerance to vitamin K was good in the 3 groups. Mean prothrombin time activity was 54% in the cord blood, around 55% and 75%, 24 hrs and 1 month after supplementation, respectively; only one infant had low value (41%) by 1 month despite normal plasma vitamin K concentration. Two infants had low plasma vitamin K1 concentration by the second control despite normal prothrombin time activity; one belonged to the MMos group and the other to the Cos group. Mean values of plasma vitamin K1 concentration were higher by 1 month in the MMos group.
CONCLUSION: A unique dose of micellar solution of vitamin K given orally at birth seems effective to prevent hemorrhagic disease.
Effect of vitamin K administration on acarboxy prothrombin (PIVKA-II) levels in newborns.
PIVKA-II (protein induced by vitamin K absence or antagonist-II) was measured in two groups of newborns, one group being given 5 mg vitamin K at birth and the other untreated. The untreated group had a significantly higher proportion of PIVKA-II positive babies at 3 and 5 days of age than did the treated group. When vitamin K was administered to newborn babies whose normotest levels were less than 30%, it was found that the higher the pre-treatment PIVKA-II levels the greater the response to vitamin K, as monitored by the normotest. Thus PIVKA-II levels might be more useful than a coagulation test, since the low activity of vitamin K dependent coagulation factors sometimes reflects not vitamin K deficiency but impaired production of these factors because of immaturity. The findings support the view that vitamin K given prophylactically at birth will help to prevent neonatal bleeding.
Use of oral vitamin K1 to prevent hemorrhagic disease of the newborn infant.
Effect of oral water soluble vitamin K on PIVKA-II levels in newborns.
Intramuscular administration of vitamin K for prophylaxis against hemorrhagic disease of the newborn has the disadvantage of increased cost, pain, anxiety to parents and risk of transmission of infection. Oral route is a better alternative. Oral absorption of vitamin K has been shown to be equally good using special oral preparations. However, this preparation is not available in India. A prospective study was carried out on 51 full term, healthy breastfed newborns to evaluate if the injectable water soluble preparation of vitamin K (menadione sodium bisulphite) could be as effective. Fourteen babies received 1 mg vitamin K intramuscularly, 24 received 2 mg vitamin K orally while 13 controls did not receive vitamin K at birth. PIVKA-II levels were measured in cord blood and at 72-78 hours of age in all babies as a marker of vitamin K deficiency. The overall PIVKA-II prevalence in cord blood was 64.7%. At 72-78 hours, PIVKA-II was present in 50% of babies in IM group, 58.3% of babies in oral group and in 76.9% of babies in 'no vitamin K' group (p > 0.05). The PIVKA-II levels decreased or did not change at 72-78 hours in 91.6% of babies in oral group versus 92.8% of babies in IM group (p > 0.05). On the other hand, PIVKA-II levels increased in 30.7% of babies who did not receive vitamin K as against in 7.8% of babies receiving vitamin K in either form (p < 0.05). Hence, vitamin K prophylaxis is required for all newborns at birth and injectable vitamin K (menadione sodium bisulphite) given orally to term healthy babies is effective in preventing vitamin K deficiency state.
Hemorrhagic disease of the newborn. Breast feeding as a necessary factor in the pathogenesis.
Effects of oral and intramuscular vitamin K prophylaxis on PIVKA-II assay parameters in breastfed infants in Turkey.
Protein induced by vitamin K absence (PIVKA-II) has been used for the evaluation of vitamin K deficiency in the newborn. Differing PIVKA-II detection rates in various studies on hemorrhagic disease of the newborn have not been explained satisfactorily. In this study we investigated the PIVKA-II values of 44 healthy breastfed infants, of whom 29 received vitamin K1 either orally (N = 13) or intramuscularly (n = 16), and the remaining 15 constituted the control group. PIVKA-II was detected in 15.3 percent (2/13) of the oral and 25 percent of the (4/16) intramuscular group on the third day of life. The detection rate was 93.3 percent (14/15) in the control group. However, at the one-month follow-up, there were no PIVKA-II positive infants. In conclusion, PIVKA-II positivity among breastfed Turkish infants on the third day of life was high compared to that in other studies, perhaps due to a delay in enzyme maturation related to racial, environmental and nutritional factors.
Observations on the prophylactic use of vitamin Kin the newborn infant.
Options:
A: A single dose of intramuscular vitamin K is effective in preventing classic HDN and improves biochemical indices of coagulation status at 1-7 days, with no significant difference between oral and intramuscular routes in biochemical indices.
B: A single dose of intramuscular vitamin K is not effective in preventing classic HDN, but it improves biochemical indices of coagulation status at 1-7 days, with oral vitamin K being more effective.
C: A single dose of intramuscular vitamin K is effective in preventing classic HDN, but it does not improve biochemical indices of coagulation status at 1-7 days, with oral vitamin K being more effective.
D: A single dose of intramuscular vitamin K is not effective in preventing classic HDN and does not improve biochemical indices of coagulation status at 1-7 days, with no significant difference between oral and intramuscular routes in biochemical indices.
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A
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137
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What are the effects of fluoride therapy on bone mineral density, vertebral and non-vertebral fractures, and side effects in postmenopausal women after two and four years of treatment? Please answer this question based on the information provided below:
Prevention of early postmenopausal bone loss: controlled 2-year study in 315 normal females.
With the aim of preventing postmenopausal bone loss, a placebo-controlled double-blind trial of 2 years duration was performed. We randomized 315 healthy volunteers in their early natural menopause to seven treatment and three placebo groups: 17 beta-oestradiol, oestriol and sequential norethisteron (hormones); bendroflumethiazide 5 mg/day (thiazide); hormones and thiazide; sodium fluoride 20 mg/day; vitamin D3 2000 IU/day (D3); fluoride and D3; and 1 alpha (OH) vitamin D3 0.25 microgram/day (1 alpha D3). All participants were given daily calcium supplement of 500 mg. Every 3 months we measured the bone mineral content (BMC) of both forearms by photon absorptiometry and chemical quantities in blood and 48 h urinary collections. The study was completed by 264 (84%). The combined placebo groups showed a linear fall in BMC reaching 3.3% after 2 years (P < 0.001). Hormones and hormones and thiazide led to a 2.5% gain in BMC (P < 0.01). Thiazide alone postponed the BMC fall for 6 months. After 2 years the thiazide group showed a BMC fall of 1.5% (P < 0.05), less than that of the placebo group (P < 0.05). BMC declined by 3.6%, 4.5%, 3.7% and 3.7% during the respective use of fluoride, D3, fluoride and D3 and 1 alpha D3. Nevertheless, the urinary calcium excretion during 1 alpha D3 and D3 treatment was 1--1.5 mmol/day higher than in the placebo groups. Apparently, there is no real alternative to oestrogen/gestagen in the prevention of postmenopausal osteoporosis.
Treatment of postmenopausal vertebral osteopenia with monofluorophospate: a long-term calcium-controlled study.
The aim of the present study was to assess the effects of the new fluorine pro-drug monofluorophosphate (MFP) in postmenopausal women with vertebral osteopenia and high bone turnover. We enrolled postmenopausal women (PMW, 43-59 years) who had had a natural menopause 2-5 years before the study, had vertebral bone mineral density (BMD) < 1 SD from the premenopausal mean, and had at least one of the biochemical markers of bone remodeling > 1 SD over the mean for premenopausal women. Patients were randomly divided into two treatment groups (group 1, 500 mg/day of oral calcium; group 2, MFP at the dose of 20 mg F-equivalents + 600 mg calcium/day) for 2 years (n = 21 in each group). The lumbar vertebral (L2-4) BMD and total body bone mineral (TBBM) were measured by dual-energy X-ray absorptiometry (Lunar DPX, Lunar Corporation, USA). Urinary hydroxyproline excretion (OH-P/Cr), plasma bone Gla protein (BGP) and serum alkaline phosphatase (AP) were assayed. In group 1 the markers of bone turnover and vertebral BMD did not show any significant modification, while TBBM showed a significant (p < 0.05) decrease after 24 months. In group 2 a significant (p < 0.05) decrease in OH-P/Cr (-23.9 +/- 2.0%), and an increase in both BGP (+19.4 +/- 2.6%) and AP (+10.3 +/- 2.6%) levels were observed after 24 months of MFP administration. In this group, both vertebral BMD (+5.01 +/- 0.9%, p < 0.01) and TBBM (+4.0 +/- 0.6%, p < 0.05) showed a significant increase after 24 months. Present results suggest that, in osteopenic PMW, MFP administration induces a significant increase in vertebral BMD without impairment of cortical bone, with a reduction in bone resorption and an increase in bone formation rate.
Relief of osteoporotic backache with fluoride, calcium, and calciferol.
In a prospective randomized clinical trial comprising 22 postmenopausal women with backache and a halisteretic spine with crush fracture(s), 12 women completed a 12-week therapy with sodium fluoride, calcium and calciferol and 10 with placebo. A statistically significant improvement (p less than 0.05), evaluated by a four-stage scale on pains, infirmity, and consumption of analgesics, was observed in the actively treated patients.
The effect of fluoride and calcium on spinal bone mineral content: a controlled, prospective (3 years) study.
Daily treatment with 30 mg of sodium fluoride (NaF) and 1 g of calcium over a 3-year period increased the bone mineral content (BMC) in the spines of women (n = 25) with osteoporosis. Determination of the BMC was followed with dual photon absorptiometry (137Cs-241Am) in the third lumbar vertebra. No increase in BMC was found with only 10 mg sodium fluoride in combination with calcium (n = 25), with calcium alone (n = 25), or with placebo (n = 25). No serious side effects were registered. There was, however, minor gastrointestinal distress in one-fifth of the patients taking 30 mg NaF daily.
A randomized trial of sodium fluoride as a treatment for postmenopausal osteoporosis.
The anti-fracture efficacy of sodium fluoride (NaF) was evaluated in 84 postmenopausal white women with spinal osteoporosis. The dose of NaF used was 75 mg/day and all patients in this prospective, randomized, double-blind, placebo-controlled clinical trial received calcium supplements (carbonate salt) 1500 mg/day in addition to participating in a structured physical therapy program. For each of the outcome measures (change in stature, change in cortical bone mass in the forearm and development of new vertebral fractures determined by change in vertebral morphometry and by scintigraphy) there was no significant difference between the fluoride or placebo treated groups. Side effects, predominantly gastrointestinal symptoms and the development of the painful lower extremity syndrome, occurred significantly more frequently in the fluoride group (P less than 0.05). Peripheral fractures were not more frequent in the fluoride group. We conclude that, in the dose and manner used in this study, NaF is no more effective than placebo in retarding the progression of spinal osteoporosis. There is no role for NaF in the treatment of osteoporosis outside the confines of clinical research.
Fluoride salts are no better at preventing new vertebral fractures than calcium-vitamin D in postmenopausal osteoporosis: the FAVOStudy.
Although fluoride salts have been shown to be capable of linearly increasing spinal bone mineral density (BMD) in postmenopausal osteoporosis, the effects of this gain in density on the vertebral fracture rate remain controversial. We conducted a 2-year multicenter, prospective, randomized, double-masked clinical trial in 354 osteoporotic women with vertebral fractures (mean age 65.7 years). They received either fluoride (208 patients), given as sodium fluoride (50 mg/day) or as monofluorophosphate (200 mg/day or 150 mg/day), or a placebo (146 patients). All patients received daily supplements of 1 g of calcium (Ca) and 800 IU of vitamin D2 (D). A 1-year open follow-up on Ca-D was obtained in 124 patients. After 2 years the fluoride group and the Ca-D group had increased their lumbar BMD by 10.8% and 2.4% respectively (p = 0.0001). However, the rate of patients with at least one new vertebral fracture, defined by semiquantitative assessment and evaluable on an intention-to-treat basis in 89% of patients, was similar in the fluoride groups and the Ca-D group. No difference between the three fluoride regimens was found. The percentage of patients with nonvertebral fractures was not different in the fluoride and Ca-D groups (1.9% and 1.4% respectively for hip fractures). A lower limb pain syndrome occurred more frequently in the fluoride groups. In the 124 patients followed for 1 year after cessation of fluoride therapy, the percentage of patients with at least one new vertebral fracture after 36 months was identical to the percentages in the previous fluoride group and the Ca-D group. We conclude that fluoride-Ca-D regimen was no more effective that Ca-D supplements for the prevention of new vertebral fractures in women with postmenopausal osteoporosis.
Slow-release sodium fluoride in the management of postmenopausal osteoporosis. A randomized controlled trial.
OBJECTIVE: To test whether intermittent treatment with slow-release sodium fluoride and continuous calcium citrate supplementation inhibits vertebral fractures without causing fluoride complications.
DESIGN: A placebo-controlled, randomized trial.
SETTING: Outpatient setting of specialty clinics in Dallas and Temple, Texas.
INTERVENTIONS: Slow-release sodium fluoride (25 mg twice daily) in repeated 14-month cycles (12 months on treatment followed by 2 months off treatment) compared with placebo. Both groups took calcium citrate (400 mg calcium twice daily) continuously.
PATIENTS: 110 patients with postmenopausal osteoporosis were randomly assigned to two groups. In the slow-release sodium fluoride group, 48 of 54 patients completed more than 1 cycle of treatment (mean, 2.44 cycles/patient), whereas 51 of 56 patients in the placebo group completed at least 1 cycle (mean, 2.14 cycles/patient) in this interim analysis.
MEASUREMENTS: Vertebral fracture rate and lumbar bone mineral content. Vertebral fractures were quantified from yearly radiographs. Bone mass was determined annually by densitometry.
RESULTS: In the sodium fluoride group, the mean L2 to L4 bone mineral content increased by 4% to 6% in each cycle and the mean femoral neck bone density increased by 4.1% and 2.1% during the first two cycles, but the radial bone density did not change. The placebo group showed no statistical change in bone mass at any site. Compared with the placebo group, the sodium fluoride group had a lower individual new vertebral fracture rate (0.057/patient cycle compared with 0.204/patient cycle, P = 0.017), a higher fracture-free rate (83.3% compared with 64.7%, P = 0.042), and a lower group fracture rate (0.085/patient cycle compared with 0.239/patient cycle, P = 0.006). The side-effect profile was similar for the two groups; no patient developed microfractures, hip fractures, or blood loss anemia.
CONCLUSIONS: Intermittent slow-release sodium fluoride plus continuous calcium citrate, administered for about 2.5 years, inhibits new vertebral fractures, increases the mean spinal bone mass without decreasing the radial shaft bone density, and is safe to use.
Treatment of postmenopausal osteoporosis with slow-release sodium fluoride. Final report of a randomized controlled trial.
OBJECTIVE: To test whether slow-release sodium fluoride inhibits spinal fractures and is safe to use.
DESIGN: Placebo-controlled randomized trial.
INTERVENTIONS: Slow-release sodium fluoride, 25 mg twice daily, in four 14-month cycles (12 months receiving sodium fluoride followed by 2 months not receiving it) compared with placebo. Calcium citrate, 400 mg calcium twice daily, continuously in both groups.
PATIENTS: 48 of 54 patients who received sodium fluoride and 51 of 56 patients who received placebo completed at least 1 year of the study. All patients had postmenopausal osteoporosis.
RESULTS: Compared with the placebo group, the fluoride group had a lower individual vertebral fracture rate (0.064 +/- 0.182 per patient-year compared with 0.205 +/- 0.297 per patient-year; P = 0.002), a higher unadjusted fracture-free rate (85.4% compared with 56.9%; P = 0.001), and a greater survival estimate (relative risk, 0.3 [95% CI, 0.12 to 0.76]) for new fractures. The recurrent spinal fracture rate did not differ between the two groups. The fluoride group had a substantial increase in L2-L4 bone mass of 4% to 5% per year for 4 years, a mean increase in femoral neck bone density of 2.38% +/- 3.33% per year, and no change in radial shaft bone density. The frequency with which minor side effects and appendicular fractures occurred was similar in the two groups; no patients developed microfractures or gastric ulcers.
CONCLUSION: Slow-release sodium fluoride and calcium citrate administered for 4 years inhibits new vertebral fractures (but not recurrent fractures), augments spinal and femoral neck bone mass, and is safe to use.
The effect of sodium monofluorophosphate plus calcium on vertebral fracture rate in postmenopausal women with moderate osteoporosis. A randomized, controlled trial.
BACKGROUND: Fluoride is effective in increasing trabecular bone mineral density (BMD) in the spine, but its efficacy in reducing vertebral fracture rates and its effect on BMD at cortical sites are controversial.
OBJECTIVE: To study the effect of low-dose fluoride (sodium monofluorophosphate [MFP]) plus a calcium supplement over 4 years on vertebral fractures and BMD at the lumbar spine and total hip in postmenopausal women with moderately low BMD of the spine.
DESIGN: Randomized, double-blind, controlled clinical trial.
SETTING: Outpatient clinic for osteoporosis at a university medical center.
PATIENTS: 200 postmenopausal women with osteoporosis (according to the World Health Organization definition) and a T-score less than -2.5 for BMD of the spine.
INTERVENTION: Women were randomly assigned (100 patients per group) to continuous daily treatment for 4 years with 1) oral MFP (20 mg of equivalent fluoride) plus 1000 mg of calcium (as calcium carbonate) or 2) calcium only.
MEASUREMENTS: Lateral spine radiographs were taken at enrollment and at each year of follow-up for detection of new vertebral fractures (defined as a reduction > or =20% and > or =4 mm from baseline in any of the heights of a vertebral body). Nonvertebral fractures were also recorded. All analyses were done with the intention-to-treat approach.
RESULTS: Radiologic follow-up was possible for 164 of 200 patients (82%). The rate of new vertebral fractures during the 4 years of the study was lower in the MFP-plus-calcium group (2 of 84 patients; 2.4% [95% CI, 0.3% to 8.3%]) than in the calcium-only group (8 of 80 patients; 10% [CI, 4.4% to 18.8%]). The difference between the groups was 7.6 percentage points (CI, 0.3 to 15 percentage points) (P = 0.05). A moderate but progressive increase in BMD of the spine (10.0% +/- 1.5% at 4 years) was found for MFP plus calcium compared with calcium only (P < 0.001), whereas the more modest increase in BMD of the total hip seen with MFP plus calcium (1.8% +/- 0.6%) did not differ from the increase seen with calcium only.
CONCLUSIONS: Low-dose fluoride (20 mg/d) given continuously with calcium for prolonged periods can decrease vertebral fracture rates compared with calcium alone in patients with mild to moderate osteoporosis.
Effect of the fluoride/calcium regimen on vertebral fracture occurrence in postmenopausal osteoporosis. Comparison with conventional therapy.
We assessed the rates of vertebral fracture in patients with postmenopausal osteoporosis. Forty-five patients were not treated (91 person-years of observation); 59 were treated conventionally, with calcium (alone or combined with estrogen) or vitamin D or both (218 years); and 61 were treated with sodium fluoride combined with conventional therapy (251 years). The fracture rate (per thousand person-years) was 834 in untreated patients, 419 in those given calcium with or without vitamin D, 304 in those given fluoride and calcium with or without vitamin D, 181 in those given estrogen and calcium with or without vitamin D, and 53 in those given fluoride, estrogen, and calcium with or without vitamin D. It was reduced in all treatment groups (P less than 0.001 for calcium and P less than 1 x 10(-6) for other combinations); fluoride (one years of treatment) and estrogen (but not vitamin D) independently reduced the rate from that observed with calcium alone (P less than 0.001). The combination of calcium fluoride, and estrogen was more effective than any other combination (P less than 0.001). These results provide grounds for optimism about the efficacy of combinations of available agents with sodium fluoride for fracture in postmenopausal osteoporosis.
Effect of fluoride treatment on the fracture rate in postmenopausal women with osteoporosis.
Although fluoride increases bone mass, the newly formed bone may have reduced strength. To assess the effect of fluoride treatment on the fracture rate in osteoporosis, we conducted a four-year prospective clinical trial in 202 postmenopausal women with osteoporosis and vertebral fractures who were randomly assigned to receive sodium fluoride (75 mg per day) or placebo. All received a calcium supplement (1500 mg per day). Sixty-six women in the fluoride group and 69 women in the placebo group completed the trial. As compared with the placebo group, the treatment group had increases in median bone mineral density of 35 percent (P less than 0.0001) in the lumbar spine (predominantly cancellous bone), 12 percent (P less than 0.0001) in the femoral neck, and 10 percent (P less than 0.0001) in the femoral trochanter (sites of mixed cortical and cancellous bone), but the bone mineral density decreased by 4 percent (P less than 0.02) in the shaft of the radius (predominantly cortical bone). The number of new vertebral fractures was similar in the treatment and placebo groups (163 and 136, respectively; P not significant), but the number of nonvertebral fractures was higher in the treatment group (72 vs. 24; P less than 0.01). Fifty-four women in the fluoride group and 24 in the placebo group had side effects sufficiently severe to warrant dose reduction; the major side effects were gastrointestinal symptoms and lower-extremity pain. We conclude that fluoride therapy increases cancellous but decreases cortical bone mineral density and increases skeletal fragility. Thus, under the conditions of this study, the fluoride-calcium regimen was not effective treatment for postmenopausal osteoporosis.
Monofluorophosphate increases lumbar bone density in osteopenic patients: a double-masked randomized study.
To assess the efficacy of combined sodium monofluorophosphate and calcium therapy (FC) in increasing lumbar bone mineral density (BMD) in patients with low bone mass, we conducted a prospective double-masked randomized study in 94 patients aged 50-70 years. Patients were selected on the basis of a lumbar BMD at least 2 standard deviations (SD) below the young adult mean (T-score) but without evidence of previous vertebral fracture (severe osteopenia). They were randomly assigned to receive for 2 years, twice a day, either FC (13.2 mg F-, i.e. 100 mg sodium monofluorophosphate, and 500 mg Ca2+) or C (500 mg Ca2+). Vertebral BMD was measured by dual photon absorptiometry from L2 to L4. Comparison at final assessment in the 76 eligible patients (Student's t-test) showed a statistically significant difference between the two groups in the mean BMD increase in favour of FC. Furthermore, Student's t-test showed a significantly greater increase in lumbar BMD in FC-treated patients at 1 year, at 18 months and after 2 years (mean increase of 7.1%/year). These results were confirmed by ANOVA at 1 year, at 18 months and after 2 years of treatment. Of the FC-treated patients, 71.4% were considered to have responded (i.e. they showed an increase in lumbar BMD of more than 0.034 g/cm2). The dosage of 26.4 mg fluoride ion/day (i.e. 200 mg monofluorophosphate/day) therefore appears to be safe and to increase the BMD effectively in patients with low bone mass prior to vertebral fracture.
Options:
A: Fluoride therapy significantly increases lumbar spine bone mineral density but does not reduce the risk of vertebral fractures. It increases the risk of non-vertebral fractures and gastrointestinal side effects, especially at high doses and in non-slow release forms.
B: Fluoride therapy significantly reduces the risk of both vertebral and non-vertebral fractures and has no significant side effects.
C: Fluoride therapy has no significant effect on bone mineral density, vertebral fractures, non-vertebral fractures, or side effects.
D: Fluoride therapy significantly increases lumbar spine bone mineral density and reduces the risk of vertebral fractures without any increase in non-vertebral fractures or side effects.
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A
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138
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the effects of heat and cold therapy on objective and subjective measures of disease activity in patients with rheumatoid arthritis? Please answer this question based on the information provided below:
Effect of active hand exercise and wax bath treatment in rheumatoid arthritis patients.
The effect of active hand exercise and warm wax treatment was evaluated in 52 rheumatoid arthritis patients randomized into four groups: (1) both exercise and wax bath, (2) exercise only, (3) wax bath only, and (4) controls. Treatment was given three times a week for 4 weeks. Deficits in flexion and extension in digits II-V bilaterally, grip function, grip strength, pain, and stiffness were measured before and after the treatment period. The control group was measured at corresponding times. Wax bath treatment followed by active hand exercise resulted in significant improvements of range of motion (ROM) and grip function. Active hand exercise alone reduced stiffness and pain with nonresisted motion and increased ROM. Wax bath alone had no significant effect.
Cryotherapy for postoperative pain relief following knee arthroplasty.
Ninety consecutive patients undergoing primary knee arthroplasty received local cryotherapy 72 hours after surgery for pain relief. Thermal-pad circulating temperatures were randomly assigned to 50 degrees, 60 degrees, or 70 degrees F (room temperature). Pain relief was monitored using patient-controlled analgesia machines. The amount of morphine received and number of attempts per hour were statistically analyzed with relation to temperature group, age, sex, weight, side, and diagnosis. The amount of morphine injected was positively correlated to the number of attempts per hour and moderately correlated to body weight. There was no correlation between thermal-pad temperature or any other parameter and the amount of morphine injected after surgery.
Heat and cold in the physical treatment of rheumatoid arthritis of the knee. A controlled clinical trial.
Use of cryotherapy on the postsurgical rheumatoid hand.
Options:
A: Heat and cold therapy significantly reduced inflammation, pain, and joint destruction.
B: Heat therapy was preferred by patients over no therapy, but neither heat nor cold therapy had an effect on objective measures of disease activity.
C: Cold therapy was more effective than heat therapy in reducing pain and inflammation.
D: Both heat and cold therapy had harmful effects and should be avoided.
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B
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139
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the effectiveness of anxiolytic drugs in aiding long-term smoking cessation? Please answer this question based on the information provided below:
A placebo-controlled evaluation of the effects of buspirone on smoking cessation: differences between high- and low-anxiety smokers.
One hundred one smokers were divided into high and low trait anxiety groups on the basis of a normalized score on the Profile of Mood States Anxiety/Tension Scale and were randomly assigned to receive buspirone or placebo in a double-blind fashion. After a 1-week baseline, smokers were exposed to an 8-week drug and behavioral intervention involving buspirone or placebo (up to 60 mg/day) with concurrent group cognitive behavioral intervention. All smokers were to quit smoking on the target date, set at 4 weeks after the program began. Medication was provided for an additional 4 weeks after group treatment ended. The results showed that buspirone had a beneficial effect on smoking abstinence but only among smokers who were already relatively high in anxiety and only for as long as the drug was available. Moreover, when provided to smokers who were relatively low in anxiety, the drug appeared to interfere with abstinence, although these effects also reversed when the drug was withdrawn. These effects were associated with an attenuation of the expected rise in anxiety before the quit date and its actual reversal thereafter, but only in the buspirone high-anxiety group. One-month abstinence averaged 88, 61, 60, and 89% for the buspirone high-anxiety, placebo high-anxiety, buspirone low-anxiety, and placebo low-anxiety groups, respectively. By 12 months, abstinence for the buspirone and placebo high- and low-anxiety groups fell to 12, 23, 41, and 36%, respectively. No differences were observed for measures of self-efficacy, symptoms of withdrawal, medication side effects, or compliance.
A placebo-controlled evaluation of the effects of buspirone on smoking cessation: differences between high- and low-anxiety smokers.
One hundred one smokers were divided into high and low trait anxiety groups on the basis of a normalized score on the Profile of Mood States Anxiety/Tension Scale and were randomly assigned to receive buspirone or placebo in a double-blind fashion. After a 1-week baseline, smokers were exposed to an 8-week drug and behavioral intervention involving buspirone or placebo (up to 60 mg/day) with concurrent group cognitive behavioral intervention. All smokers were to quit smoking on the target date, set at 4 weeks after the program began. Medication was provided for an additional 4 weeks after group treatment ended. The results showed that buspirone had a beneficial effect on smoking abstinence but only among smokers who were already relatively high in anxiety and only for as long as the drug was available. Moreover, when provided to smokers who were relatively low in anxiety, the drug appeared to interfere with abstinence, although these effects also reversed when the drug was withdrawn. These effects were associated with an attenuation of the expected rise in anxiety before the quit date and its actual reversal thereafter, but only in the buspirone high-anxiety group. One-month abstinence averaged 88, 61, 60, and 89% for the buspirone high-anxiety, placebo high-anxiety, buspirone low-anxiety, and placebo low-anxiety groups, respectively. By 12 months, abstinence for the buspirone and placebo high- and low-anxiety groups fell to 12, 23, 41, and 36%, respectively. No differences were observed for measures of self-efficacy, symptoms of withdrawal, medication side effects, or compliance.
Use of beta-blocking agents with group therapy in a smoking withdrawal clinic.
A controlled trial was carried out into the relative efficacy of two beta-blocking agents (oxprenolol and metoprolol) as adjuncts to group therapy in a smoking withdrawal clinic. There was no evidence to indicate that these were of specific value in assisting smoking withdrawal.
Effect of clonidine on cigarette cessation and in the alleviation of withdrawal symptoms.
Comparison of fixed-dose transdermal nicotine, tapered-dose transdermal nicotine, and buspirone in smoking cessation.
The authors compared the outcome of 208 smokers treated with fixed-dose transdermal nicotine (n = 69), tapered-dose transdermal nicotine (n = 71), or buspirone (n = 68). At baseline, there were no significant differences among the three treatment groups with regard to age, gender, educational level, duration of smoking, number of cigarettes smoked per day, concomitant disease states or drug use, or Fagerstrom score. All smokers participated in a behavior modification program. Fixed-dose transdermal nicotine was given at a dose of 21 or 22 mg/day for 6 weeks. Tapered-dose transdermal nicotine was given at a dose of 21 or 22 mg/day for 4 weeks, 14 mg/day for 4 weeks and 7 mg/day for 4 weeks. Both transdermal nicotine regimens were initiated on the evening before the attempted quit date. Buspirone was started 21 days before the quit attempt and continued for 7 days after the quit attempt. Buspirone was initiated at 5 mg TID for 7 days and then 10 mg TID for 21 days. Smoking cessation was assessed by patient diaries and random plasma thiocyanate determinations. Dropouts for any reason were considered treatment failures. Quit rates were as shown in the Table I. Discontinuation of treatment for perceived side effects and dropouts for all reasons were not significantly different among the treatment groups. The authors conclude that fixed-dose transdermal nicotine, tapered-dose transdermal nicotine, and buspirone are associated with similar efficacy and safety when combined with behavior modification in smoking cessation.
Efficacy of buspirone in smoking cessation: a placebo-controlled trial.
Buspirone, a non-sedating anxiolytic, has yielded contradictory results in smoking cessation pilot studies and trials. We tested buspirone (n = 51) versus placebo (n = 49) in a placebo-controlled, double-blind trial of smoking cessation. Survival analyses were performed with use of strict abstinence criteria for efficacy (carbon monoxide levels < or = 8 ppm; no self-reported slips to smoking). No treatment differences were observed between active and placebo groups. There were also no differences among "anxiety" level groups formed post hoc from high versus low, pre-quit anxiety test scores. A number of withdrawal symptoms increased significantly after subjects quit smoking for both the active drug and placebo groups, but these symptoms were not relieved by treatment. There appears to be little evidence that buspirone is effective in smoking cessation or in the relief of withdrawal associated with cessation in a general sample. Selecting for generalized anxiety or anxiety related to cessation is suggested for future testing.
One-year follow-up results of a smoking cessation program.
The smoking control research project: purpose, design, and initial results.
Options:
A: Anxiolytic drugs have been proven to significantly aid in long-term smoking cessation.
B: There is no consistent evidence that anxiolytic drugs aid in long-term smoking cessation, but a possible effect cannot be ruled out.
C: Anxiolytic drugs have been proven to be ineffective in aiding long-term smoking cessation.
D: Anxiolytic drugs have been shown to worsen smoking cessation outcomes.
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B
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140
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the effectiveness of amniotomy alone for third trimester labour induction in women with a live fetus? Please answer this question based on the information provided below:
Role of the cervix in the induction of labor.
A study on induction of labor was carried out to test the hypothesis that changing the cervix will enhance the effectiveness of induction of labor. Fifty pregnant women near term with Bishop scores of 4 or less were divided into 5 study groups, in which a 12-hour preparation phase procedure was carried out to produce cervical or myometrial changes. All women had continuous measurement of uterine activity by an extraovular catheter. The patients were divided into 1) control subjects, and into groups treated with 2) laminaria, 3) Foley catheter, 4) amniotomy, and 5) oxytocin infusion. These preparation techniques were used for 12 hours, after which rupture of membranes was carried out in all cases. Although all procedures significantly changed the cervix, none but oxytocin affected the induction-to-delivery interval. The authors concluded that when a study design rigidly controls for cervical Bishop score, timing of rupture of membranes, and oxytocin infusion rates, the cervical preparation alone will not enhance inducibility.
A randomized prospective trial comparing single dose prostaglandin E2 vaginal gel with forewater amniotomy for induction of labour.
A prospective randomized parallel-group study was carried out to compare the efficacy of a single dose vaginal prostaglandin E2 gel with forewater amniotomy for induction of labour at term in 260 parturients (110 primigravid and 150 parous women) with low risk pregnancy and favourable cervix. In the prostaglandin E2 (PGE2) managed group, the primigravidae were treated with 2 mg PGE2 gel and parous patients with 1 mg PGE2 gel. Forewater amniotomy was performed 4 h later, or sooner if women requested analgesia. In the amniotomy group, artificial forewater amniotomy was carried out and a repeat cervical assessment done 4 h later, or sooner if women requested analgesia. In both groups, intravenous oxytocin was established if there was evidence of disordered uterine activity, 6 h after the start of initial intervention. An assessment of consumers' views was carried out by using a standardized questionnaire completed 48 h after delivery. There was a significant reduction in the requirement for oxytocin augmentation in women treated with PGE2: primigravidae, odds ratio (OR), 0.27 and 95% confidence interval (CI), 0.12-0.61; multiparae, OR, 0.19 and 95% CI, 0.08-0.45. Fewer primigravidae managed with PGE2 gel required epidural analgesia (OR, 0.16; 95% CI, 0.06-1.00). Fewer parous women managed with PGE2 gel required parenteral opiates (OR, 0.44; 95% CI, 0.23-0.85) and more women required inhalation analgesia or no analgesia (OR, 2.22; 95% CI, 1.76-2.79). The intervention to delivery intervals were shortened in PGE2 groups independent of parity but the differences were not significant.(ABSTRACT TRUNCATED AT 250 WORDS)
Options:
A: Amniotomy alone was found to be highly effective and led to a significant reduction in the need for oxytocin augmentation.
B: Amniotomy alone showed no significant difference in outcomes compared to no intervention or oxytocin alone, and data was insufficient to draw conclusions.
C: Amniotomy alone was found to be less effective than a single dose of vaginal prostaglandins, with a significant increase in the need for oxytocin augmentation.
D: Amniotomy alone was found to be more effective than intracervical prostaglandins, leading to quicker labour induction.
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B
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141
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What are the effects of using intravenous prostaglandin for third trimester cervical ripening or induction of labour compared to intravenous oxytocin? Please answer this question based on the information provided below:
Induction of labor with low-dose prostaglandin F2 alpha and oxytocin.
A double-blind study was performed in 50 patients with the use of low-dose intravenous oxytocin or PGF2 alpha for the induction of labor for elective or high-risk indications. Both agents were equally effective for the induction of labor. No major complications were encountered with either drug in mother or infant. The ability to induce labor with relatively small, infrequently increased doses of either inducing agent was an unexpected finding.
Double-bli trial of prostaglandin E2 and oxytocin in induction of labour.
Comparison of intravenous oxytocin and prostaglandin E2 for induction of labour using automatic and non-automatic infusion techniques.
A double blind trial of prostaglandin E2 and oxytocin given by intravenous infusion after amniotomy for induction of labour in 100 primigravidae with unfavourable induction features is reported. No clear-cut advantage of either drug emerged although PGE2 was perhaps superior when the cervix was highly unfavourable. Prostaglandin E2 appeared to produce less deleterious effects on the fetus but was associated with a higher incidence of maternal side effects. The automatic Cardiff Infusion apparatus was found to be a safe means of PGE2 infusion and to have advantages over the use of non-automatic techniques both for PGE2 and for oxytocin infusion.
Biochemical and haematological changes during the induction of labour at term with oxytocin, prostaglandin E-2 and prostaglandin F-2alpha.
A total of 75 patients had labour induced near term using intravenous oxytocin, prostaglandin E-2 or prostaglandin F-2alpha. Biochemical and haematological investigations were performed to assess hepatic, renal and adrenocortical function and changes in platelet adhesiveness. In doses which were similarly effective in inducing labour, both prostaglandins were without the water-retaining effect of oxytocin. Adrenocortical stimulation was greatest with oxytocin. No difference between these agents was observed for the other measurements made.
A comparison of the efficacy and safety of extra-amniotic prostaglandin E2 and intravenous prostaglandin E2 for the induction of labour in patients with unripe cervices.
In a study comparing intravenous prostaglandin E2 (PGE2) with extra-amniotic PGE2 for the induction of labour, in patients with unfavourable induction features, we found no difference between the two methods in either safety or efficacy. However, we would not recommend the use of the extra-amninotic route as a routine method because of some technical difficulties.
Oxytocin- or low-dose prostaglandin F2 alpha-infusion for stimulation of labor after primary rupture of membranes. A prospective, randomized trial.
One hundred consecutive women with singleton pregnancies and primary rupture of membranes (PROM) after 36 weeks of gestation were included in a prospective, randomized trial of intravenous infusion of oxytocin (up to 30 mIU/min) versus low-dose prostaglandin F2 alpha(PGF2 alpha, up to 6.0 micrograms/min). Cesarean section was performed in 12 patients because of suspected disproportion or intra-uterine asphyxia. Effective contractions or labor progress failed to become established within 8 hours in another 4 women stimulated with PGF2 alpha and 2 stimulated by oxytocin. The stimulation delivery time (hours) for the remaining 82 women treated with PGF2 alpha or oxytocin, respectively was 8.7 against 12.1 for initial Bishop score less than 5 (p less than 0.01), (Mann-Whitney test), 7.2 vs. 7.1 for Bishop score 5-8 and 5.7 vs. 4.2 for Bishop score greater than 8. Patients with initial Bishop score less than 5 seemed to need analgetics less often when treated with PGF2 alpha than with oxytocin. Frequencies of side effects and instrumental deliveries as well as the fetal outcome were similar for the two treatment schedules. The results of the study suggest that low-dose PGF2 alpha infusion may be the more appropriate treatment for women with an unfavorable initial Bishop score.
Induction of labour by simultaneous intravenous administration of prostaglandin E 2 and oxytocin.
In a group of 20 matched primigravid patients labour was induced by forewater amniotomy followed by intravenous oxytocin (Syntocinon) administered in escalating doses. Ten of these patients, in a double-blind trial, also received prostaglandin E(2) infused simultaneously with the oxytocin. In the combined prostaglandin-oxytocin group there was a noticeable reduction in the dosage of oxytocin required to produce effective uterine action, and the duration of labour was also reduced. No side effects were observed.
Comparison of intravenous prostaglandins F 2 and E 2 with intravenous oxytocin in the induction of labour.
Induction of labor with prostaglandin.
The induction of labor at term. Comparisons between prostaglandin F 2 and oxytocin infusions.
Prostaglandin F 2 for induction of labor.
Double-blind trial of prostaglandin F2alpha and oxytocin in the induction of labour.
In a random double-blind trial in 28 pregnant women at term, labour was induced with either prostaglandin F2alpha or oxytocin given by intravenous infusion. The results showed that prostaglandin F2alpha was as active as oxytocin and induction was successfully carried out in 24 patients; 3 patients had a caesarean section because of an obstructed labour and 1 patient on oxytocin did not have regular contractions after 10-hours' infusion although she delivered spontaneously 2 days later. No difference was found in the induction--delivery interval in the 8 patients in each group who had early amniotomy (first 90 minutes). No adverse effects were noted in either mother or the child. The authors recommend that to avoid side-effects the dosage of 20 mug prostaglandin F2alpha per minute should not be exceeded and that, although no cardiotocographic abnormalities were noted, this method of control should be used.
Options:
A: Intravenous prostaglandin is more efficient than intravenous oxytocin for inducing labour and has fewer maternal side effects.
B: Intravenous prostaglandin is no more efficient than intravenous oxytocin for inducing labour but is associated with higher rates of maternal side effects and uterine hyperstimulation.
C: Intravenous prostaglandin is less efficient than intravenous oxytocin for inducing labour and has similar rates of maternal side effects.
D: Intravenous prostaglandin is no more efficient than intravenous oxytocin for inducing labour and has fewer maternal side effects.
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B
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142
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the effectiveness of dietary advice given by dietitians compared to other health professionals or self-help resources in reducing blood cholesterol in adults? Please answer this question based on the information provided below:
Evaluating a 'non-diet' wellness intervention for improvement of metabolic fitness, psychological well-being and eating and activity behaviors.
CONTEXT: Current public health policy recommends weight loss for obese individuals, and encourages energy-restricted diets. Others advocate an alternative, 'non-diet' approach which emphasizes eating in response to physiological cues (eg hunger and satiety) and enhancing body acceptance.
OBJECTIVE: To evaluate the effects of a 'health-centered' non-diet wellness program, and to compare this program to a traditional 'weight loss-centered' diet program.
DESIGN: Six-month, randomized clinical trial.
SETTING: Free-living, general community.
PARTICIPANTS: Obese, Caucasian, female, chronic dieters, ages 30-45 y (n=78).
INTERVENTIONS: Six months of weekly group intervention in a non-diet wellness program or a traditional diet program, followed by 6 months of monthly after-care group support.
OUTCOME MEASURES: Anthropometry (weight, body mass index); metabolic fitness (blood pressure, blood lipids); energy expenditure; eating behavior (restraint, eating disorder pathology); psychology (self-esteem, depression, body image); attrition and attendance; and participant evaluations of treatment helpfulness. Measures obtained at baseline, 3 months, 6 months and 1 y.
RESULTS: (1 y after program initiation): Cognitive restraint increased in the diet group and decreased in the non-diet group. Both groups demonstrated significant improvement in many metabolic fitness, psychological and eating behavior variables. There was high attrition in the diet group (41%), compared to 8% in the non-diet group. Weight significantly decreased in the diet group (5.9+/-6.3 kg) while there was no significant change in the non-diet group (-0.1+/-4.8 kg).
CONCLUSIONS: Over a 1 y period, a diet approach results in weight loss for those who complete the intervention, while a non-diet approach does not. However, a non-diet approach can produce similar improvements in metabolic fitness, psychology and eating behavior, while at the same time effectively minimizing the attrition common in diet programs.
Work-site cholesterol screening and dietary intervention: the Staff Healthy Heart Project. Steering Committee.
OBJECTIVES: The Staff Healthy Heart Project was established to run a work-site cholesterol screening project and a randomized controlled trial of dietary interventions.
METHODS: Screening was offered to all staff at six Australian hospitals. Participants with blood cholesterol of 5.2 mmol/L (200 mg/dL) or above were randomly allocated to receive screening only (control group), a self-help package, or a nutrition course. Participants were seen 3 and 6 months after intervention to measure blood cholesterol and dietary changes.
RESULTS: Eighty percent of available staff (n = 2638) were screened. Of those eligible, 67% (n = 683) entered the trial. Follow-up measures of blood cholesterol and dietary intake were obtained for 63% and 38% of trial participants, respectively. A reduction in reported dietary fat was found for all groups, but there were no significant differences between groups. Reported dietary fiber rose by 0.6 g/MJ/day for those in the nutrition course. There were no changes in total blood or high-density lipoprotein cholesterol.
CONCLUSIONS: Cholesterol reduction was not demonstrated, but this result is difficult to interpret given the poor ongoing participation rates. Strategies to improve ongoing participation in work-site projects are needed to achieve adequate assessment of dietary interventions used in cholesterol screening.
Cholesterol-lowering intervention program. Effect of the step I diet in community office practices.
BACKGROUND: A randomized study was conducted to test the feasibility of cholesterol lowering in physician office practices using the National Cholesterol Education Program Adult Treatment Panel 1 guidelines.
METHODS: Twenty-two physician practices in phase 1 and 23 in phase 2 were recruited from communities in Western Pennsylvania and West Virginia. These physicians treated a total of 450 adults in phase 1 (190 men and 260 women) and 480 adults in phase 2 (184 men and 296 women) with hypercholesterolemia. Three models (Usual Care [phase 1], Office Assisted [phase 2], and Nutrition Center [phase 2]) for implementing the National Cholesterol Education Program Adult Treatment Panel 1 guidelines were tested over an 18-month period. The baseline serum cholesterol levels were as follows: 6.51 mmol/L (252 mg/dL) in the Usual Care Model; 6.80 mmol/L (262 mg/dL) in the Office Assisted Model; and 6.96 mmol/L (269 mg/dL) in the Nutrition Center Model.
RESULTS: In the patients who were not taking lipid-lowering medication, the mean cholesterol response was significantly different between the 3 models (P < .01). Serum cholesterol levels declined by 0.14 mmol/L (5.4 mg/dL) in the Usual Care Model; by 0.31 mmol/L (12 mg/dL) in the Office Assisted Model; and by 0.54 mmol/L (20.9 mg/dL) in the Nutrition Center Model. Two factors-length of time to follow-up measurement and change in weight-were independently related to cholesterol response across all models. African Americans demonstrated a significantly smaller response than whites in the Usual Care Model, while men demonstrated greater declines in serum cholesterol levels than women in the Office Assisted Model. Patient satisfaction was very favorable in both enhanced conditions; however, those treated in the the Nutrition Center Model were more satisfied (P < .05) with program components.
CONCLUSIONS: The impact of nutrition intervention delivered through physician practices on serum cholesterol levels is less than clinically desirable, and new approaches with more aggressive therapy should be tested and implemented.
Nutritional counseling in community office practices.
The Fasting Hyperglycaemia Study: II. Randomized controlled trial of reinforced healthy-living advice in subjects with increased but not diabetic fasting plasma glucose.
Self-referred subjects (N = 227) thought to be at risk of developing non-insulin-dependent diabetes mellitus (NIDDM) and with fasting plasma glucose (FPG) in the range of 5.5 to 7.7 mmol.L-1 on two consecutive tests 2 weeks apart were randomized to reinforced or basic healthy-living advice. They were simultaneously allocated either to a sulfonylurea group or a control group in a two-by-two factorial design. A total of 201 subjects in three English and two French centers completed 1 year's follow-up study. Reinforced advice recommending dietary modification and increased exercise was given every 3 months, and basic advice was given once at the initial visit. Glycemia was monitored by FPG, dietary compliance by body weight and food diaries, and fitness compliance by bicycle ergometer assessment and exercise diaries. Both reinforced and basic advice groups had a significant mean reduction in body weight (1.5 kg) at 3 months, although the weight subsequently returned to baseline. After 1 year, subjects allocated to reinforced advice versus basic advice (1) reported a lower fat intake (34.1% v 35.8%, P = .04) with no difference in lipid profiles, (2) had improved fitness as shown by increased calculated maximal oxygen uptake ([Vo2max] 2.39 v 2.18 L.min-1, P = .007) with no change in insulin sensitivity, (3) showed no change in FPG, glucose tolerance, or hemoglobin A1c (HbA1c), and (4) showed a greater tendency to withdraw from the study (16% v 7%, P = .03). In conclusion, reinforced healthy-living advice given to self-referred subjects with increased FPG did not encourage sufficiently pronounced life-style changes for significantly greater effects on body weight and glycemia in a 1-year study than basic healthy-living advice.
Plasma lipid changes in the normal population following behavioral treatment.
[Dietary treatment of mild to moderate hypercholesterolemia. Effectiveness of different interventions].
OBJECTIVE: To compare the efficacy of brief dietary intervention by family physicians in their daily practice and in group sessions to standard dietetic treatment in mild to moderate hypercholesterolemia.
DESIGN: Randomised clinical trial.
SETTING: Family practice clinic in a remote community.
PARTICIPANTS: Between September 1, 1991 and September 30, 1992, 135 men and women between 20 and 60 years old with mild to moderate hypercholesterolemia were recruited and randomly assigned to three treatment groups to be taught the American Heart Association low fat diet. Each participant had an LDL-C reading higher than the desirable level set by the Canadian Consensus Conference on Cholesterol.
INTERVENTIONS: The three treatment groups received different interventions: individual consultations with a family physician in his office (phase I); group sessions with a physician and a dietician (phase II); and individual consultations with a dietician (phase II). Participants were followed for 6 months with visits and blood tests every 2 months.
MAIN OUTCOME MEASURES: Reduction in serum levels of total cholesterol, LDL-C, HDL-C, and triglycerides was measured after 2, 4, and 6 months of dietary treatment. Changes in risk factors (smoking, weight, level of physical activity) and patients' cholesterol/saturated fat index were also measured.
RESULTS: Ninety-nine subjects completed the 6-month regimen. The mean reduction in serum LDL-C was 0.08 mmol/L (1.8%) in Group I, 0.07 mmol/L (1.6%) in Group II, and 0.28 mmol/L (6.3%) in Group III (P = 0.94). An LDL-C reduction of 10% or more relative to initial level was observed in 27% of participants in Group I and approximately 40% of subjects in the other two groups (P = 0.41). Counseling resulted in a decrease in body weight, smoking, and dietary fat consumption and an increase in physical activity.
CONCLUSIONS: Treatment by a dietician achieved better results and should remain the standard. Physicians should focus on the detection and control of other heart disease risk factors.
Reducing blood cholesterol: dietitian or diet fact sheet?
Reducing blood cholesterol levels in patients with peripheral vascular disease: dietitian or diet fact sheet?
A randomized trial was performed to test the hypothesis that, among patients with peripheral vascular disease, no difference is achieved in the magnitude of the reduction in blood cholesterol levels as a result of advice which is provided by a dietitian and that which is provided by a diet fact sheet. Fifty-nine patients were allocated at random either to a "dietitian" group (n = 31) or to a "diet fact sheet" group (n = 28). Dietary advice which was provided by a dietitian involved two personal interviews; the diet fact sheet was prepared by the NSW Department of Health. Twenty-two and 23 members of each group, respectively, returned for follow-up at three months. The mean cholesterol level fell by 8.5% among the "dietitian" group but only by 1.9% among the "diet fact sheet" group. The difference of 0.47 mmol/L in the total cholesterol level reduction between the two groups was statistically significant (P = 0.02; 95% confidence interval, -0.88 to -0.07 mmol/L). It appears that individual advice which is provided by a dietitian is more successful in leading to a reduction in blood cholesterol levels than is the administration of a diet fact sheet, even though this particular diet fact sheet appears to be excellent and is used widely. In view of the large numbers of patients and of persons in the population as a whole who would benefit from a reduction in blood cholesterol levels, and the expense of individual advice to be provided by a dietitian, explorations of cost-effective methods of providing dietary advice are needed.
Management of hypercholesterolemia: evaluation of practical clinical approaches in healthy young adults.
A work site-located clinic screened 6,000 employees (91 percent participation) and identified 146 hypercholesterolemic subjects (100 percent initial participation, 12 percent subsequent dropout rate). The subjects, aged 20 to 50 years, were randomly classified into four groups: Group A, treatment in a lipid intervention clinic with diet for 6 weeks, then diet plus clofibrate for the subsequent 18 weeks; Group B, diet treatment from a clinic nutritionist with the cooperation of the subject's private physician; Group C, referral for treatment by a private physician; and Group D, no intervention. Initial mean cholesterol was 294 mg/100 ml. At 24 weeks, all intervention groups had decreases in serum cholesterol (Group A, 12 percent; Group B, 15 percent; Group C, 17 percent; P less than 0.001). The control group (D) had a small decrease in cholesterol (4 percent). Decreases in cholesterol were correlated with weight loss and decrease in fasting serum triglycerides but not with the use of clofibrate. Serum cholesterol can be reduced in healthy young adults by several practical methods.
Randomised trial of lipid lowering dietary advice in general practice: the effects on serum lipids, lipoproteins, and antioxidants.
OBJECTIVE: To determine the relative efficacy in general practice of dietary advice given by a dietitian, a practice nurse, or a diet leaflet alone in reducing total and low density lipoprotein cholesterol concentration.
DESIGN: Randomised six month parallel trial.
SETTING: A general practice in Oxfordshire.
SUBJECTS: 2004 subjects aged 35-64 years were screened for hypercholesterolaemia; 163 men and 146 women with a repeat total cholesterol concentration of 6.0-8.5 mmol/l entered the trial.
INTERVENTIONS: Individual advice provided by a dietitian using a diet history, a practice nurse using a structured food frequency questionnaire, or a detailed diet leaflet sent by post. All three groups were advised to limit the energy provided by fat to 30% or less and to increase carbohydrate and dietary fibre.
MAIN OUTCOME MEASURES: Concentrations of total cholesterol and low density and high density lipoprotein cholesterol after six months; antioxidant concentration and body mass index.
RESULTS: No significant differences were found at the end of the trial between groups in mean concentrations of lipids, lipoproteins, and antioxidants or body mass index. After data were pooled from the three groups, the mean total cholesterol concentration fell by 1.9% (0.13 mmol/l, 95% confidence interval 0.06 to 0.22, P < 0.001) to 7.00 mmol/l, and low density lipoprotein cholesterol also fell. The total carotenoid concentration increased by 53 nmol/l (95% confidence interval 3.0 to 103, P = 0.039).
CONCLUSIONS: Dietary advice is equally effective when given by a dietitian, a practice nurse, or a diet leaflet alone but results in only a small reduction in total and low density lipoprotein cholesterol. To obtain a better response more intensive intervention than is normally available in primary care is probably necessary.
Management of type IV hyperlipoproteinemia. Evaluation of practical clinical approaches.
A lipid intervention clinic screened 4000 employees (89% participation) and identified 150 type IV subjects (top 5 percentile triglyceride values, 100% initial participation, 6% drop out). The 150 healthy type IV subjects, ages 20 to 49, were randomly divided into treatment subgroups: A, treatment by clinic nutritionist and physician with the National Heart and Lung Institute's type IV diet for 6 weeks, then diet plus clofibrate for 18 weeks; B, same treatment by private physician; C, no intervention for 24 weeks, subjects advised of abnormality. The group A mean fasting serum triglyceride of 407 mg/dl declined 50% at 6 weeks, 61% at 12 weeks, and was unchanged at 24 weeks (P less than 0.0005 at 6, 12, 24 weeks). Group B triglyceride decreased 42%, 50%, 41% (P less than 0.0005 at 6, 12, 24 weeks). Group C triglyceride declined 20%, 1st to 24th week. Body weight decreased 8% (A) and 4% (B) at 6 weeks (P less than 0.0005) and was unchanged at 24 weeks. The maximum cholesterol decrease (A) was 11% (P less than 0.0005). Type IV hyperlipoproteinemia can readily be identified in a working population; treatment by clinic or private physician will markedly lower fasting serum triglyceride values in apparently healthy type IV subjects for at least 24 weeks.
The costs and effects of two different lipid intervention programmes in primary health care.
OBJECTIVE: To compare the costs and effects of two different intervention strategies for the nonpharmacological treatment of hypercholesterolaemia.
DESIGN: Randomized, controlled trial. Subjects were randomly allocated to one of two intervention models and followed up for 1 year.
SETTING: Vårby Health Centre, a primary care practice located in a suburb of Stockholm.
SUBJECTS: Subjects with a total serum cholesterol in the range 7.0-7.8 mmol L-1 and no signs of ischaemic heart disease or diabetes mellitus, randomized to a low-intensity (n = 35) or medium-intensity (n = 41) intervention.
INTERVENTION: Two strategies were used, one labelled medium-intensity strategy which followed national current guidelines for nonpharmacological treatment of hypercholesterolaemia, the other was a low-intensity strategy.
MAIN OUTCOME MEASURES: Total serum cholesterol and intervention costs.
RESULTS: Both intervention strategies resulted in small (mean 3.5%) decreases in total cholesterol with no significant difference between the groups. The cost per subject in the low-intensity group was SEK 753 and in the medium-intensity group SEK 3614.
CONCLUSIONS: Because the effect of the two intervention programmes did not differ, the low-intensity programme is to be preferred from a cost-effectiveness point of view. If only one-third of the population in Stockholm county with cholesterol levels > or = 6.5 mmol L-1 are discovered by the primary health care system, and follow the treatment advice, the net savings in the low-intensity model compared to the current guidelines here presented as the moderate-intensity model, would be SEK 93 million.
Lifestyle intervention in overweight individuals with a family history of diabetes.
OBJECTIVE: To assess the effect of lifestyle intervention over 2 years on changes in weight, coronary heart disease (CHD) risk factors, and incidence of diabetes in overweight individuals with a parental history of diabetes.
RESEARCH DESIGN AND METHODS: Participants (n = 154), who were 30-100% over ideal body weight, had one or both parents with diabetes, and were currently nondiabetic, were randomly assigned to 2-year treatments focused on diet (decreasing calories and fat intake), exercise (goal of 1,500 kcal/week of moderate activity), or the combination of diet plus exercise or to a no-treatment control group. Subjects were reassessed at 6 months, 1 year, and 2 years.
RESULTS: At 6 months, the groups differed significantly on measures of eating, exercise, and fitness; weight losses in the diet and diet-plus-exercise groups were significantly greater than in the exercise and control conditions. Weight losses were associated with positive changes in CHD risk factors. After 6 months, there was gradual deterioration of behavioral and physiological changes, so that at 2 years, almost no between-group differences were maintained. Differences between groups in risk of developing diabetes were of borderline significance (P = 0.08). Strongest predictors were impaired glucose tolerance at baseline, which was positively related to risk of developing diabetes, and weight loss from baseline to 2 years, which was negatively related; in all treatment groups, a modest weight loss of 4.5 kg reduced the risk of type 2 diabetes by approximately 30% compared with no weight loss.
CONCLUSIONS: Although initially successful, the interventions studied here were not effective in producing long-term changes in behavior, weight, or physiological parameters. However, weight loss from 0 to 2 years reduced the risk of developing type 2 diabetes. Since modest weight loss significantly reduced risk of type 2 diabetes, further research is needed to determine how best to increase the percentage of subjects achieving at least a modest weight loss.
Options:
A: Dietitians were more effective than doctors at lowering blood cholesterol, but not more effective than self-help resources.
B: Dietitians were more effective than both doctors and self-help resources at lowering blood cholesterol.
C: Dietitians were less effective than doctors but more effective than self-help resources at lowering blood cholesterol.
D: Dietitians were equally effective as doctors and self-help resources at lowering blood cholesterol.
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A
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy and safety of cabergoline as an adjuvant therapy for patients with Parkinson's disease who are already on levodopa and experiencing motor complications? Please answer this question based on the information provided below:
Adjunctive cabergoline therapy of Parkinson's disease: comparison with placebo and assessment of dose responses and duration of effect.
Adjunctive cabergoline or placebo, in doses up to 5 mg daily, were administered to Parkinson's disease patients with short-duration levodopa responses in a 6-month double-blind trial. The 13 patients randomized to cabergoline and completing the study had significantly improved Unified Parkinson's Disease Rating Scale (UPDRS) motor scores and timed hand-tapping test scores. Serial measurements on test days documented improved scores: (a) before the first levodopa (and cabergoline) dose of the day, (b) at the time of the peak levodopa effect, and (c) at the end of the levodopa response cycle, 5 h after test doses. Continued testing verified that these therapeutic responses were sustained for at least 48 h after the last cabergoline dose. Patients randomized to placebo failed to improve on any of these measures. In a subsequent open-label dose-escalation phase, further improvement was documented as the dosage was gradually raised to 10 mg daily. As in the double-blind phase, levodopa reduction allowed the improvement to occur in the absence of significantly increased dyskinesias. Other side effects were more substantial with higher doses, however, including two of 11 patients with hallucinations and confusion. In summary, adjunctive single-daily-dose cabergoline therapy resulted in long-lasting, dose-related improvement in parkinsonism not seen in patients receiving placebo.
Multicenter, placebo-controlled trial of cabergoline taken once daily in the treatment of Parkinson's disease.
Cabergoline is a dopaminergic agonist relatively specific for the D2 receptor and much longer-acting than other dopamine agonists. We conducted a randomized, placebo-controlled, double-blind study of cabergoline in 188 levodopa/carbidopa-treated patients with suboptimally controlled Parkinson's disease (PD). The cabergoline patients had significantly better Activities of Daily Living (p = 0.032) and Motor Examination (p = 0.031) scores at the conclusion of the trial compared with the placebo group. The daily levodopa dose for the cabergoline patients decreased 18% compared with a 3% reduction for the placebo group (p < 0.001). The amount of time in the "on" state increased more in the cabergoline group (p = 0.022). The side-effect was similar to that seen with other dopamine agonists, and cabergoline was generally well tolerated. We conclude that cabergoline is an effective adjunct to levodopa for the treatment of PD.
Double-blind study of the activity and tolerability of cabergoline versus placebo in parkinsonians with motor fluctuations.
The use of a dopamine agonist with a long duration of action has theoretical advantages in attempting to reduce the motor fluctuations in Parkinson's disease. We report the results of a double-blind controlled study of adding cabergoline, an ergot derivative with potent long-lasting high affinity for the D2 receptor, to levodopa therapy in 37 patients with severe fluctuations in response to treatment. Increasing dosages of cabergoline (19 patients) or placebo (18 patients) were added to each patient's stable levodopa regime. The two patient groups were similar at baseline in terms of age, disease duration, duration of levodopa treatment, and average hours "off" per day. Following incremental dose titration, patients in the cabergoline group had a significant reduction in hours "off" per day from 5.0 (SD 2.1) to 3.0 (SD 2.5), but there was no change in this measure in the placebo group [4.0 (2.2) and 3.3 (2.3) respectively]. This was not at the expense of a significant increase in dyskinesia. However, there was no difference between the groups when comparing their average Hoehn and Yahr stage of disease, and Schwab and England activities of daily living index.
Options:
A: Cabergoline significantly reduced off time and improved motor scores without increasing adverse events.
B: Cabergoline modestly improved motor impairment and reduced levodopa dosage, with a trend towards more dopaminergic adverse events.
C: Cabergoline had no significant impact on motor scores or levodopa dosage and increased the frequency of adverse events.
D: Cabergoline significantly increased off time and had no impact on motor scores or levodopa dosage.
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B
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy and safety of cabergoline compared to bromocriptine in patients with Parkinson's disease who were already on levodopa therapy and experiencing motor complications? Please answer this question based on the information provided below:
Double-blind comparison of cabergoline and bromocriptine in Parkinson's disease patients with motor fluctuations.
In the present study we compared the efficacy and safety of the new dopamine agonist cabergoline (CBG) with bromocriptine (BCR) in Parkinson's disease (PD). CBG has a very long half-life and can be administered as a single daily dose. Forty-four PD patients with uncontrolled motor fluctuations participated in the study. Patients were randomly and blindly assigned to equivalent doses of either CBG or BCR in addition to preexisting levodopa. Dosage was titrated to optimal, using up to 6 mg of CBG or 40 mg of BCR daily. CBG was given as a single morning dose whereas BCR was administered tid. Sixteen patients were followed for 1 year and 16 additional patients for 6 months. The mean follow-up duration was 9 +/- 5 months. The main effect of both drugs was observed on motor UPDRS scores, rigidity, bradykinesia items, and the percentage of awake hours spent during "on" and "off". In general, the effect of CBG was similar to that of BCR. The percentage of awake hours spent during "on" was higher with CBG as compared with BCR. Adverse events included dyskinesias, orthostatism, confusion, edema, and paresthesias in limbs. These effects were seen at similar frequencies with both drugs. The study shows that CBG given as a single morning dose is at least as efficacious as BCR given tid. CBG is a promising dopamine agonist for the treatment of motor fluctuations in PD.
Options:
A: Cabergoline significantly reduced off time and motor impairment compared to bromocriptine, with fewer adverse events.
B: Cabergoline and bromocriptine had similar effects on off time reduction, motor impairment, and levodopa dose reduction, but cabergoline was associated with increased dyskinesia and confusion.
C: Bromocriptine was more effective than cabergoline in reducing off time and motor impairment, with fewer adverse events.
D: Cabergoline had no effect on off time reduction or motor impairment compared to bromocriptine, but had significantly fewer adverse events.
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B
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145
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the effectiveness of oral melatonin in preventing or reducing jet-lag for air travelers crossing multiple time zones? Please answer this question based on the information provided below:
Alleviation of jet lag by melatonin: preliminary results of controlled double blind trial.
Melatonin and jet lag: confirmatory result using a simplified protocol.
This study replicates the alleviation of jet-lag with melatonin in a simplified protocol for eastward flight. At 22-n hr (n is the time-lag between the North American departure point and France), subjects took either melatonin (8 mg, n = 15), or placebo (n = 15) on the day of the return flight and for 3 consecutive days. On day 8, self-ratings significantly discriminated between melatonin and placebo for global treatment efficacy, morning fatigue, and evening sleepiness.
Use of melatonin in recovery from jet-lag following an eastward flight across 10 time-zones.
Subjective, physiological and physical performance variables are affected following travel across multiple time-zones (jet-lag). The objective of the study was to examine the effects of oral melatonin in alleviating jet-lag by investigating its effects on subjects who had flown from London to Eastern Australia, 10 time-zones to the east. Melatonin (5 mg day(-1)) or placebo capsules were administered to 14 experimental (13 males and 1 female) and 17 control subjects (15 males and 2 females), respectively, in a double-blind study; the time of administration was in accord with the current consensus for maximizing its hypnotic effect. Grip strength and intra-aural temperature were measured on alternate days after arrival at the destination, at four different times of day (between the times 07:00 - 08:00 h, 12:00 - 13:00 h, 16:00 - 17:00 h and 19:00 - 20:00 h local time). In addition, for the first 6 - 7 days after arrival in Australia, subjective ratings of jet-lag on a 0 - 10 visual analogue scale and responses to a Jet-lag Questionnaire (incorporating items for tiredness. sleep, meal satisfaction and ability to concentrate) were recorded at the above times and also on retiring (at about midnight). Subjects continued normally with their work schedules between the data collection times. Subjects with complete data (13 melatonin and 13 placebo subjects), in comparison with published data, showed partial adjustment of the diurnal rhythm in intra-aural temperature after 6 days. A time-of-day effect was evident in both right and left grip strength during adjustment to Australian time; there was no difference between the group taking melatonin and that using the placebo. Right and left grip strength profiles on day 6 were adjusted either by advancing or delaying the profiles, independent of whether subjects were taking melatonin or placebo tablets. Subjects reported disturbances with most measures in the Jet-lag Questionnaire but, whereas poorer concentration and some negative effects upon sleep had disappeared after 3 - 5 days, ratings of jet-lag and tiredness had not returned to 'zero' (or normal values), respectively, by the sixth day of the study. Subjects taking melatonin showed no significant differences from the placebo group in perceived irritability, concentration, meal satisfaction, ease in getting to sleep and staying asleep, frequency of bowel motion and consistency of the faeces. These results suggest that, in subjects who, after arrival, followed a busy schedule which resulted in frequent and erratic exposure to daylight, melatonin had no benefit in alleviating jet-lag or the components of jet-lag, and it did not influence the process of phase adjustment.
Effect of melatonin on jet lag after long haul flights.
OBJECTIVE: To determine whether doses of the pineal hormone melatonin alleviate jet lag.
DESIGN: Double blind, placebo controlled crossover trial.
SETTING: Long haul return flights from Auckland, New Zealand, to London and back.
SUBJECTS: Twenty volunteers with experience of transcontinental flights (eight women and 12 men aged 28 to 68).
INTERVENTIONS: Melatonin (or placebo) 5 mg three days before flight, during flight, and once a day for three days after arrival.
END POINT: Symptoms of jet lag.
MEASUREMENTS AND MAIN RESULTS: Visual analogue scale for feelings of jet lag and tiredness; profile of moods states questionnaire for vigour-activity and fatigue-inertia; and retrospective ratings 10 days after arrival of sleep pattern, energy, and daytime tiredness. Feelings of jet lag were less for subjects taking melatonin (mean score 2.15 v 3.4); these subjects took fewer days than the placebo group to establish a normal sleep pattern (2.85 v 4.15), to not feel tired during the day (3.0 v 4.6), and to reach normal energy levels (3.25 v 4.7). Results for fatigue-inertia and vigour-activity were similar. For all subjects jet lag was more severe on the return (westward) than the outward (eastward) journey.
CONCLUSIONS: Melatonin can alleviate jet lag and tiredness after long haul flights.
A double-blind trial of melatonin as a treatment for jet lag in international cabin crew.
This study investigated the efficacy of oral melatonin in alleviating jet lag in flight crew after a series of international flights. The optimal time for taking melatonin in this group was also investigated. In a double-blind placebo-controlled trial, 52 international cabin crew were randomly assigned to three groups; early melatonin (5 mg started 3 days prior to arrival until 5 days after return home); late melatonin (placebo for 3 days then 5 mg melatonin for 5 days); and placebo. Daily ratings showed a trend in jet lag, mood, and sleepiness measures toward an improved recovery in the late melatonin group and a worse recovery in the early melatonin group as compared to placebo. Retrospective ratings made 6 days after arrival showed the late melatonin group reported significantly less jet lag and sleep disturbance following the flight compared to placebo. The late melatonin group also showed a significantly faster recovery of energy and alertness than the early melatonin group, which reported a worse overall recovery than placebo. These findings show melatonin may have potential benefits for international aircrew.
Jet lag: clinical features, validation of a new syndrome-specific scale, and lack of response to melatonin in a randomized, double-blind trial.
OBJECTIVE: The goals of this study were to validate a new rating scale for measuring severity of jet lag and to compare the efficacy of contrasting melatonin regimens to alleviate jet lag.
METHOD: This was a randomized, double-blind trial of placebo and three alternative regimens of melatonin (5.0 mg at bedtime, 0.5 mg at bedtime, and 0.5 mg taken on a shifting schedule) for jet lag. The subjects were 257 Norwegian physicians who had visited New York for 5 days. Jet lag ratings were made on the day of travel from New York back to Oslo (6 hours eastward) and for the next 6 days in Norway. The main outcome measures were scale and item scores from a new, syndrome-specific instrument, the Columbia Jet Lag Scale, that identifies prominent daytime symptoms of jet lag distress.
RESULTS: There was a marked increase in total jet lag score in all four treatment groups on the first day at home, followed by progressive improvement over the next 5 days. However, there were no significant group differences or group-by-time interactions. In addition, there was no group effect for sleep onset, time of awakening, hours slept, or hours napping. Ratings on a summary jet lag item were highly correlated with total jet lag scores (from a low of r = 0.54 on the day of travel to a high of r = 0.80 on day 3). The internal consistency of the total jet lag score was high on each day of the study.
CONCLUSIONS: The use of melatonin for preventing jet lag needs further study.
Comparative study to determine the optimal melatonin dosage form for the alleviation of jet lag.
To compare the impact of various dosage forms of melatonin and placebo on jet lag symptoms, 320 volunteers who had flights over 6 to 8 time zones were recruited for a double-blind, randomized, placebo-controlled study. The volunteers received either melatonin 0.5-mg fast-release (FR) formulation, melatonin 5-mg FR formulation, melatonin 2-mg controlled-release (CR) formulation, or placebo. The study medication was taken once daily at bedtime during 4 days after an eastward flight. The volunteers completed the Profile of Mood States (POMS), sleep log, and symptoms questionnaires once daily and the Karolinska Sleepiness Scale (KSS) three times daily prior to departure and during the 4 days of medication intake postflight. A total of 234 (73.1%) participants were compliant and completed the study. The FR melatonin formulations were more effective than the slow-release formulation. The 5-mg FR formulation significantly improved the self-rated sleep quality (p < .05), shortened sleep latency (p < .05), and reduced fatigue and daytime sleepiness (p < .05) after intercontinental flight. The lower physiological dose of 0.5 mg was almost as effective as the pharmacological dose of 5.0 mg. Only the hypnotic properties of melatonin, sleep quality and sleep latency, were significantly greater with the 5.0-mg dose.
Options:
A: Melatonin is ineffective in preventing or reducing jet-lag.
B: Melatonin is effective in preventing or reducing jet-lag, especially when taken close to the target bedtime at the destination.
C: Melatonin is only effective for westward flights and not for eastward flights.
D: Melatonin is effective only when taken in doses above 5mg.
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B
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146
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the conclusion regarding the effectiveness of betahistine in treating Menière's disease based on the analysis of multiple trials? Please answer this question based on the information provided below:
Double-blind evaluation of a new treatment for Ménière's syndrome.
Betahistine dihydrochloride in the treatment of peripheral vestibular vertigo.
The present study compares the efficacy and safety of betahistine dihydrochloride to that of a placebo in recurrent vertigo resulting from Meniere's disease (MD) or in paroxysmal positional vertigo (PPV) of probable vascular origin. The design was double-blind, multicentre and parallel-group randomised. Eleven Italian centres enrolled 144 patients: 75 of the patients were treated with betahistine (41 MD/34 PPV) and 69 with placebos (40 MD/29 PPV). The betahistine dosage was 16 mg twice per day for 3 months. Compared to the placebo, betahistine had a significant effect on the frequency, intensity and duration of vertigo attacks. Associated symptoms and the quality of life also were significantly improved by betahistine. Both the physician's judgement and the patient's opinion on the efficacy and acceptability of the treatment were in agreement as to the superiority of betahistine. The effective and safe profile of betahistine in the treatment of vertigo due to peripheral vestibular disorders was confirmed.
[Therapeutic results of betahistine on Meniere's disease. Multi-variable analysis of the results of the double blind test and Fisher's evaluation method].
The clinical drug trial in Menière's disease with emphasis on the effect of betahistine SR.
Options:
A: Betahistine significantly reduces vertigo, tinnitus, and hearing loss in Menière's disease patients.
B: Betahistine has no adverse effects but there is insufficient evidence to confirm its effectiveness in treating Menière's disease.
C: Betahistine is highly effective in reducing vertigo and tinnitus but not hearing loss in Menière's disease patients.
D: Betahistine causes significant adverse effects and is not recommended for Menière's disease.
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B
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147
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the safety and effectiveness of eversion carotid endarterectomy (CEA) compared to conventional CEA in terms of perioperative stroke, restenosis, and local complications? Please answer this question based on the information provided below:
Carotid endarterectomy with patch closure versus carotid eversion endarterectomy and reimplantation: a prospective randomized study.
BACKGROUND: Although carotid eversion endarterectomy (CEE) has obtained consensus providing excellent early and late results, conventional carotid endarterectomy (CEA) with or without patching continues to be considered the gold standard surgical procedure. The few studies published to date comparing CEE with CEA in a small series of patients have failed to show substantial advantages of one technique over the other, and further randomized comparative studies are still required. The purpose of this study was to compare the outcome of CEA with routine patch closure (CEAP) with that of CEE and reimplantation (CEER) of the internal carotid artery in the common carotid artery.
METHODS: Three hundred thirty-six primary CEAs performed in 310 patients were randomized into 2 groups, 167 CEAPs and 169 CEERs. Surviving patients underwent duplex ultrasound scan control at 30 days, 6 months, 12 months, and every postoperative year thereafter. The mean follow-up was 34 months (range, 1 to 69 months). Demographic characteristics, risk factors, associated diseases, and indications for surgery were comparable in the 2 groups.
RESULTS: Although the rate of intraoperative electroencephalogram changes was comparable in the 2 groups, the incidence of shunting was statistically higher in the CEAP group (28.1% vs 1.2%, P < .00001). The carotid cross-clamping time was significantly lower in the CEER group (P = .01). Although all deaths were in the CEAP group, the overall perioperative death and stroke-related death rates were comparable in the 2 groups. The perioperative stroke rate was statistically higher in the CEAP group (2.9% vs 0%, P = .03). Although the recurrent stenosis rate was comparable in the 2 groups (1.2% vs 0%), the CEAP group had a statistically higher rate of combined recurrent stenoses and occlusions (4.9% vs 0%, P = .003). The late mortality rate was similar in both groups.
CONCLUSIONS: Although the outcome of CEAP in this series is consistent with that of the main reported trials, the CEER procedure is less likely than CEAP to cause perioperative stroke and death and seems superior in reducing the incidence of recurrent stenosis and late occlusive events.
A prospective randomized study on bilateral carotid endarterectomy: patching versus eversion.
OBJECTIVE: To compare the clinical outcome and restenosis incidence of patients who underwent carotid endarterectomy with patch closure (CEAP) on one side and carotid eversion endarterectomy (CEE) on the other.
SUMMARY BACKGROUND DATA: Although a few investigators have compared the results of CEAP versus CEE, no reports have compared the outcome of CEAP versus CEE in the same patient.
METHODS: Eighty-six patients were randomly selected for sequential surgical treatment involving either CEAP/CEE or CEE/CEAP. All patients underwent postoperative duplex ultrasound study and clinical follow-up at 1, 6, and 12 months and every year thereafter. Various factors were analyzed to ascertain any association with restenosis, and Kaplan-Meier analysis was used to estimate the risk of restenosis.
RESULTS: Demographic and clinical data were similar in the CEAP and CEE groups. The selective shunting rate was statistically higher in the CEAP group. There were no perioperative deaths. Although the incidence of perioperative ipsilateral stroke was not significant, CEAP patients had a rate of combined transient ischemic attacks and strokes that approached statistical significance. The mean follow-up was 40 months. CEAP patients had a significantly higher incidence of restenosis and combined occlusive events and restenoses. Kaplan-Meier analysis showed that CEE had a significantly better cumulative patency rate than CEAP and that freedom from restenoses at 24 and 36 months was 87% and 83% for CEAP and 98% and 98% for CEE, respectively.
CONCLUSIONS: CEE is less likely to cause perioperative neurologic complications and restenoses than CEAP. The significantly higher rate of unilateral recurrence suggests that local factors play a more important role than systemic factors in the occurrence of restenosis.
A randomized study on eversion versus standard carotid endarterectomy: study design and preliminary results: the Everest Trial.
PURPOSE: The EVEREST Trial was designed to determine whether the surgical technique influences the durability and complications of carotid endarterectomy (CEA). The current report focuses on the study design and preliminary results.
METHODS: EVEREST is a randomized multicenter trial. A total of 1353 patients with carotid stenosis requiring surgical treatment were randomly assigned to received standard (n = 675) or eversion (n = 678) CEA. Primary end points included carotid occlusion, major stroke, death, and restenosis rate.
RESULTS: The rate of perioperative major stroke and death (1.3 for each study group) and the incidence of early carotid occlusion (0.6% for eversion vs 0.4% for standard) were similar. No significant differences were found between eversion and standard CEA with respect to incidence of perioperative transient ischemic accident, minor stroke, cranial nerve injuries, neck hematoma, myocardial infarction, or surgical defects as detected with intraoperative quality controls. Clamping time was significantly shorter for eversion CEA compared with patch standard procedures (31.7 +/- 15.9 vs 34.5 +/- 14.4 minutes, p = 0.02). A shunt was inserted in 11% of patients undergoing eversion CEAs and in 16% of patients undergoing standard procedures. Overall 30-day events occurred in 13.3% of the eversion group and in 11.4% of the standard group (p = 0.3). At a mean follow-up of 14.9 months (range, 1 to 38 months), 16 (2.4%) restenoses occurred in the eversion group and 28 (4.1%) occurred in the standard group (odds ratio, 0.56; 95% confidence interval, 0.3 to 1.1; p = 0.08).
CONCLUSION: The preliminary results of the EVEREST Trial suggest that eversion CEA is a safe and rapid procedure with low major complication rates. No significant differences in restenosis rates were observed between eversion and standard CEA at the available follow-up. Longer-term results are necessary to assess whether the eversion technique influences the durability of CEA.
Division-endarterectomy-anastomosis of the internal carotid artery: a prospective randomized comparative study.
Saphenous vein patch angioplasty is reported to yield superior results for carotid endarterectomy. In order to evaluate an alternative technique, which leaves the saphenous vein intact for other possible graft purposes, 200 carotid endarterectomies were included in a prospective randomized comparative study. Patients were randomized to two statistically equivalent groups: one group underwent classical carotid endarterectomy through a longitudinal incision with saphenous vein patch angioplasty; the other had endarterectomy through an oblique division of the internal carotid followed by in situ anastomosis. Cross-clamping time was approximately 5min shorter with the division-endarterectomy-anastomosis technique. The overall perioperative (< 30 days) mortality rate was 2.5% and cumulative mortality-morbidity rate 8% in the patch group compared with 4% in the other (P > 0.05). There were significantly more cranial nerve injuries in the patch group, most of which were transient (P < 0.01). The mean follow-up was 365 days. The late mortality rate was 5.5%. There were no late permanent or fatal strokes, but 3% of patients sustained mild transient neurological events. Only three significant (> 60%) stenoses developed during follow-up, all within 9 months. Dilatation and disturbed flow were more pronounced in the patch group (P < 0.05). There were no statistically significant differences between both techniques on mortality, disabling neurological morbidity and recurrent stenosis. In conclusion, the results of the division-endarterectomy-anastomosis technique are equivalent to those with patch angioplasty, leaving the patient's venous capital intact.
Options:
A: Eversion CEA was associated with a significantly higher rate of perioperative stroke and local complications compared to conventional CEA.
B: Eversion CEA showed a significantly lower rate of perioperative stroke and death, but a higher rate of restenosis compared to conventional CEA.
C: Eversion CEA had a significantly lower rate of restenosis during follow-up, but no significant differences in perioperative stroke, death, or local complications compared to conventional CEA.
D: Eversion CEA demonstrated a significantly higher rate of local complications and no difference in restenosis rates compared to conventional CEA.
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C
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148
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy of traditional Chinese medicinal herbs in the treatment of chronic hepatitis B infection? Please answer this question based on the information provided below:
[Clinical study of 96 cases with chronic hepatitis B treated with jiedu yanggan gao by a double-blind method].
This paper reported 96 cases with chronic hepatitis B treated by a double-blind method. There were 51 cases of observation group(OG) and 45 cases of control group (CG). OG was treated with Jiedu Yanggan Gao consisting of Artemisia capillaris, Taraxacum mongolicum, Plantago seed, Cephalanoplos segetum, Hedyotis diffusa, Flos Chrysanthemi Indici, Smilax glabra, Astragalus membranaceus, Salviae miltiorrhizae, Fructus Polygonii Orientalis, Radix Paeoniae Alba, Polygonatum sibiricum, etc.). CG was prescribed with three charred medicinal herbs (charred Fructus Crataegi, charred Fructrus Hordei Germinatus, charred fermented mixture of several medical herbs and wheat bran). The average duration of treatment was five months. All 96 cases belong to the virus-duplication-type with positive HBsAg for over one year. Among them 65.5% of cases HBeAg, DNAP and HBV-DNA were positive. 20.8% of cases were positive in two out of the above tests. 13 data were compared statistically between two groups, and proved to be comparable (P greater than 0.05) before treatment. 27.3% and 66.7% of cases' ALT, AST returned to normal respectively in OG after treatment. However, in CG they were 9.1% and 22.2% (P less than 0.05). TTT returned to normal in 52% cases of OG and 44% in CG (P greater than 0.05). 20% cases HBeAg shifted to negative in OG, but 6.7% in CG. Cases with negative DNAP in OG occupied 34.2%, but 10.8% in CG. 31.6% cases' HBV-DNA changed to negative in OG, while 17.6% in CG. After comprehensive judgement, the total effective rate was 74.5% in OG and 24.4% in CG respectively (P less than 0.001). Eight cases were basically cured in OG and one case in CG. After one year's follow-up, one recurred in eight patients of OG, however the only one cured in CG still relapsed.
A randomized controlled trial of kurorinone versus interferon-alpha2a treatment in patients with chronic hepatitis B.
It has recently been shown that a Chinese traditional medicine, kurorinone, extracted from Sophora Flavescens Ait, possesses antiviral properties. We evaluated the efficacy and safety of kurorinone treatment in patients with chronic hepatitis B. Ninety-four patients with abnormal alanine transaminase (ALT) levels and hepatitis B e antigen (HBeAg) and/or hepatitis B virus (HBV) DNA-positivity were randomly assigned to receive either kurorinone 400 mg daily (45 patients) or 3 million units (MU) of interferon-alpha (IFN-alpha) (49 patients, daily for 1 month, every other day for 2 months) for 3 months. Patients were followed-up for 12 months. At baseline, both groups were comparable regarding age, gender and serological parameters. At the end of treatment, complete response (defined as ALT normalization and HBeAg and/or HBV DNA loss) occurred in 50% of the kurorinone group and in 61.3% of the IFN-alpha-treated group (P > NS). At the end of the 12-month follow-up period, a complete response (sustained response) occurred in 26.7-36.7% of kurorinone-treated patients with moderate or mild liver damage and in 44.4-46.7% of IFN-alpha-treated patients with similar liver injury. In kurorinone- as well as in IFN-alpha-treated patients, there was no statistical significant difference with respect to complete response rates between HBeAg-positive and hepatitis B e antibody-positive subgroups. Kurorinone had no untoward side-effects except for local pain at injection sites. The results of this trial suggest that kurorinone is able to inhibit HBV replication and improve disease remission in patients with chronic hepatitis B.
A multicenter randomized controlled clinical trial of Shosaiko-to in chronic active hepatitis.
The efficacy of Shosaiko-to (SST) on 222 patients with chronic active hepatitis was studied in a double-blind multicenter clinical study. One hundred and sixteen patients received SST in a daily oral dose of 5.4 g for 12 weeks, followed by the same dose for a further 12 weeks. One hundred and six patients received a placebo containing 0.5 g of SST for 12 weeks, followed by a cross-over to SST for a further 12 weeks. Among the liver tests, serum AST and ALT values decreased significantly with the administration of SST. The difference of the mean value between the SST group and the placebo group was significant after 12 weeks. In patients with chronic active type B hepatitis, a tendency towards a decrease of HBeAg and an increase of Anti-HBe antibodies was also observed. No remarkable side effects were noticed.
Herbs of the genus Phyllanthus in the treatment of chronic hepatitis B: observations with three preparations from different geographic sites.
It has been suggested that herbs of the Phyllanthus family may have antiviral activity. We therefore tested the effects of three different Phyllanthus extracts on the serologic status of 123 patients with chronic hepatitis B. Eleven patients received an extract of Phyllanthus amarus (L) provided by S.P. Thyagarajan, Madras, India. Forty-two patients received Phyllanthus niruri (L), gathered from Hainan Province in China, and 35 patients received an extract of Phyllanthus urinaria (L), which had been gathered in Henan Province. Thirty-five control patients received no herbal therapy. The patients receiving Phyllanthus urinaria (L) were both more likely to lose detectable hepatitis B e-antigen from their serum and more likely to seroconvert hepatitis B e-antibody status from negative to positive than were patients given either of the other two preparations. No patient changed status with respect to hepatitis B s-antigen.
[Efficacy of Phyllanthus spp. in treating patients with chronic hepatitis B].
The efficacy of Phyllanthus amarus produced in india, P. niruri gathered from hainan province and P. urinaria from henan province was assessed in a total of 88 cases of chronic hepatitis B with 11.42 and 35 each. It was shown that P. urinaria had the effect of seroconversion on HBeAg from positive to negative as well as on HBeAb from negative to positive, while the other two herbs had not. In addition none of these three herbs had similar effect on HBsAg.
[Clinical and experimental research on Polyporus umbellatus polysaccharide in the treatment of chronic viral hepatitis].
[A preliminary clinical observation on the effect of kang du wan on chronic HBV infection].
Options:
A: All tested Chinese medicinal herbs showed significant positive effects on the clearance of serum HBsAg, HBeAg, and HBV DNA.
B: Some Chinese medicinal herbs showed significant positive effects on the clearance of serum HBsAg, HBeAg, and HBV DNA, but the evidence is too weak to recommend any single herb.
C: No Chinese medicinal herbs showed any significant effects on the clearance of serum HBsAg, HBeAg, and HBV DNA.
D: Chinese medicinal herbs were found to be more effective than interferon treatment in all trials.
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B
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149
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the efficacy of exogenously administered superoxide dismutase in preventing chronic lung disease and other related outcomes in mechanically ventilated preterm infants? Please answer this question based on the information provided below:
Safety and pharmacokinetics of multiple doses of recombinant human CuZn superoxide dismutase administered intratracheally to premature neonates with respiratory distress syndrome.
OBJECTIVES: To examine the safety and pharmacokinetics of multiple intratracheal (IT) doses of recombinant human CuZn superoxide dismutase (rhSOD) in premature infants with respiratory distress syndrome who are at risk for developing bronchopulmonary dysplasia (BPD). Methods. Thirty-three infants (700 to 1300 g) were randomized and blindly received saline, 2.5 mg/kg or 5 mg/kg rhSOD IT within 2 hours of surfactant administration. Infants were treated every 48 hours (as long as endotracheal intubation was required) up to 7 doses. Serial blood and urine studies, chest radiographs, neurosonograms, SOD concentration and activity measurements, and tracheal aspirate (TA) inflammatory markers were assessed throughout the 28-day study.
RESULTS: SOD concentrations in serum (0.1 [0.05/0.15] microg/mL-geometric mean with lower/upper confidence intervals), tracheal aspirates (TA) (0.2 [0.1/0.3] microg/mL) and urine (0.3 [0.2/0.4] microg/mL) were similar at baseline in all 3 groups and did not change significantly in the placebo group. In the rhSOD treatment groups, SOD concentrations were increased on day 3 and did not change significantly thereafter over the 14-day dosing period (also measured on days 5, 7, and 13). SOD concentrations averaged 0.4 [0.3/0.5] microg/mL in serum, 0.8 [0.6/1.2] microg/mL in TA and 1.1 [1.0/1.3] microg/mL in urine for the low-dose group and 0.6 [0.5/0.7] microg/mL in serum, 1.1 [0.9/1.5] microg/mL in TA, and 2.2 [1.6/2.9] microg/mL in urine for the high-dose group over the 14-day dosing period. Enzyme activity directly correlated with SOD concentration and rhSOD was active even when excreted in urine. TA markers of acute lung injury (neutrophil chemotactic activity, albumin concentration) were lower in the rhSOD agroups compared with placebo. No significant differences in any clinical outcome variable were noted between groups.
CONCLUSIONS: These data indicate that multiple IT doses of rhSOD increase the concentration and activity of the enzyme in serum, TA and urine, reduce TA lung injury markers and are well-tolerated. Further clinical trials examining the efficacy of rhSOD in the prevention of BPD are warranted.
Prevention of bronchopulmonary dysplasia by administration of bovine superoxide dismutase in preterm infants with respiratory distress syndrome.
The effectiveness of bovine superoxide dismutase (SOD) in the prevention of bronchopulmonary dysplasia was evaluated in a prospective double-blind controlled study in 45 neonates (mean gestational age 28.7 weeks, mean weight 1154 gm) with severe respiratory distress syndrome. All were ventilator dependent with FiO2 greater than or equal to 0.7 at 24 hours of age. Either bovine SOD (0.25 mg/kg) or saline solution was administered subcutaneously every 12 hours according to random selection until patients could be maintained in room air without ventilatory or continuous positive airway pressure (CPAP) support. SOD levels were detected in all patients given treatment. Mean peak values at 4 hours after dose ranged from 0.15 micrograms/ml (dose 1) to 0.45 micrograms/ml (dose 10). The drug was well tolerated, and no side effects were detected. Among the 31 survivors (SOD 14, placebo 17) radiologic evidence of BPD was significantly less in patients given SOD (3/14 vs 12/17, P = 0.008). Clinical signs of bronchopulmonary dysplasia (wheezing, pneumonia) were less in patients given SOD (3/14 vs 11/17, P = 0.019). Patients given SOD required fewer days of CPAP (P less than 0.003). There were no differences in days of O2 therapy, intermittent positive pressure breathing, or incidence and severity of patent ductus arteriosus or intraventricular hemorrhage. This preliminary study suggests that SOD may be helpful in reducing the severity of bronchopulmonary dysplasia in infants with respiratory distress syndrome.
Options:
A: Superoxide dismutase significantly reduces the incidence of chronic lung disease and other related outcomes in preterm infants.
B: Superoxide dismutase shows no significant difference in preventing chronic lung disease and other related outcomes compared to placebo or no treatment.
C: Superoxide dismutase significantly increases the incidence of adverse effects in preterm infants.
D: Superoxide dismutase significantly reduces mortality rates in preterm infants.
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B
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150
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the conclusion regarding the effectiveness of various therapies for chronic abacterial prostatitis based on the review of existing treatment trials? Please answer this question based on the information provided below:
Research in 'prostatitis syndromes': the use of alfuzosin (a new alpha 1-receptor-blocking agent) in patients mainly presenting with micturition complaints of an irritative nature and confirmed urodynamic abnormalities.
A double-blind, placebo-controlled study in 20 patients with 'prostatitis syndromes' and confirmed urodynamic abnormalities using the alpha 1-receptor-blocking compound alfuzosin is reported. Flow rate recordings are probably the most reliable and useful objective variables in this type of investigation. There is a significant beneficial effect in the group using an active compound concerning maximal flow (p = 0.01), flow time (p = 0.03) and time to maximal flow (p = 0.01). However, compared with the group using a placebo, only the change in the maximal flow rate appeared to be significantly different. Subjective effects were more pronounced in the alfuzosin group, but the spurious nature of the subjective observations is stressed. Based on objective parameters, alfuzosin seems to be effective compared to placebo in the treatment of these patients with micturition complaints of an irritative nature and urodynamic abnormalities, while only minor side effects were noticed.
Effects of finasteride in patients with inflammatory chronic pelvic pain syndrome: a double-blind, placebo-controlled, pilot study.
OBJECTIVES: To investigate whether treatment of inflammatory chronic pelvic pain syndrome (ICPPS) with finasteride has any influence on symptoms associated with ICPPS.
METHODS: Forty-one patients with ICPPS were randomized (1:3) to treatment with either placebo (25%, n = 10) or finasteride 5 mg daily (75%, n = 31 ) for 1 2 months. Efficacy was evaluated by analysis of symptomatic improvement through responses to symptom questionnaires, pain evaluation on an analytical visual scale, analgesic use as reported in patient diaries, urine flow and residual volume, and prostate volume.
RESULTS: Prostatitis Symptom Severity Index and prostatism scores dropped significantly in patients in the finasteride group (P < 0.001 and P < 0.05, respectively). There were no statistically significant differences in pain between the groups. There were significant differences in the changes of prostate volume and in serum prostate-specific antigen concentrations between the finasteride and placebo groups (P < 0.03 and P < 0.02, respectively). The groups did not differ with regard to side effects.
CONCLUSIONS: Our results indicate that finasteride has an effect in ICPPS. The mechanisms by which finasteride works in these patients are unclear and could not be solved in this pilot study, which had relatively few patients. A further trial with larger numbers is required to confirm these results.
Is there a role for transrectal microwave hyperthermia of the prostate in the treatment of abacterial prostatitis and prostatodynia?
Transrectal microwave hyperthermia of the prostate was administered to 54 patients with chronic abacterial prostatitis or prostatodynia, who failed to respond to several courses of conventional therapies. Hyperthermia was delivered in 60-min long sessions with three randomly chosen regimens (1 session/week for 4 weeks; 1 session/week for 6 weeks; 2 sessions/week for 3 weeks). A prostatic temperature of 42.5 +/- 0.5 degrees C was maintained throughout the entire duration of each session. Patients were assessed pre- and postoperatively by scoring of subjective symptoms, uroflowmetry with flow nomograms, determination of residual urine volume, and transrectal ultrasonography of the prostate. At the long-term follow-up, the subjective symptom score was significantly improved in all patients. Fifty percent of the patients also reported an improvement of life quality, 47% reported their condition unchanged, and 3% reported deterioration, despite therapy. Urodynamic parameters improved but did not reach statistical significance. No major complications were encountered. Our preliminary data indicate that transrectal microwave hyperthermia of the prostate is a safe therapy that can be beneficial as a second line treatment in selected patients with recurring symptoms of abacterial prostatitis or prostatodynia, which do not respond to medical therapy.
Transurethral microwave thermotherapy for nonbacterial prostatitis: a randomized double-blind sham controlled study using new prostatitis specific assessment questionnaires.
PURPOSE: We investigated the effectiveness and durability of transurethral microwave thermotherapy in the treatment of chronic nonbacterial prostatitis using 2 new prostatitis specific assessments in a randomized, double-blind, sham controlled trial.
MATERIALS AND METHODS: Patients with nonbacterial prostatitis were randomly assigned to receive either transurethral microwave thermotherapy or sham therapy. Patients were assessed using a symptom severity index and symptom frequency questionnaire. These 2 new prostatitis symptom assessment tools were validated by applying them to 30 similar patients without prostatitis. All nonresponders received transurethral microwave thermotherapy at 3 months and were reassessed at 6 months. Long-term followup of the responder group averaged 21 months.
RESULTS: The symptom severity index and symptom frequency questionnaire were confirmed to be valid for symptom assessment in prostatitis patients. The transurethral microwave thermotherapy group benefited from therapy compared to the sham group. Of the sham group 50% had a favorable response after subsequent transurethral microwave thermotherapy. The 7 responders in the treatment group continued to improve during the subsequent 21 months.
CONCLUSIONS: Transurethral microwave thermotherapy appears to be an effective, safe and durable treatment for some patients with nonbacterial prostatitis unresponsive to traditional therapy.
[Clinical application of PPC for nonspecific chronic prostatitis].
The clinical effectiveness of PPC, amino acid preparation, on nonspecific chronic prostatitis was evaluated by the double-blind test method. A mixture of two pollen extracts which has been widely employed for the treatment of chronic prostatitis was used as a control. Neither antibiotics nor anti-inflammatory drug was administered during the investigation. A total of 76 cases was reported from six facilities but 14 of them were excluded or dropped out. In 32 cases in the PPC group, subjective symptoms such as discomfort after urination, discomfort in the perineal region, pollakisuria, sense of residual urine and dysuria were improved in 50.0 approximately 61.9% and 70.0 approximately 83.3% after 2- and 4-week administrations, respectively. Similar results regarding each subjective symptom were obtained in 30 cases of the control group and there was no significant difference between the two groups. In the overall clinical effectiveness concerning subjective symptoms, the effective rate including excellently, moderately and slightly effective was 81.3% with PPC and 83.3% with control drug. However when the effective rate was limited to excellently and moderately effective, PPC was slightly superior to the control drug (50.5% versus 36.7%). In regard to prostatic tenderness by the digital examination, both PPC and control drug induced relatively good improvement after 2-week administration. The degree of improvement, however, was not increased in the subsequent 2 weeks. Sclerotic change of the prostate was poorly recovered in both groups even after 4-week treatment. Swelling of the prostate was alleviated in 12.5% of the control group after 2 weeks and in 31.8% after 4 weeks.(ABSTRACT TRUNCATED AT 250 WORDS)
Prostatodynia--physiological characteristics and rational management with muscle relaxants.
Patients with a clinical diagnosis of prostatodynia were evaluated by bacteriological, urodynamic and psychological means. In a prospective study 27 patients were entered on a trial of phenoxybenzamine, baclofen and placebo. A 50% symptomatic response was reported with phenoxybenzamine.
Ameliorative effect of allopurinol on nonbacterial prostatitis: a parallel double-blind controlled study.
PURPOSE: Nonbacterial prostatitis is a common problem in young men. It is a disease that is often recurrent and each episode lasts for several months. Different causative mechanisms of the disease have been discussed, including identified and unidentified microorganisms, stone formation and psychological factors. We have demonstrated in a previous study that urinary reflux (as shown by a high creatinine concentration in prostatic fluid) occurs to a varying extent into the prostatic ducts, and this reflux has been related to prostatic pain and urate concentration in expressed prostatic secretion.
MATERIALS AND METHODS: We performed a paralled double-blind controlled study of the objective and subjective effects of allopurinol on patients with nonbacterial prostatitis. Twenty patients received placebo, 18 received 300 mg. allopurinol daily and 16 received 600 mg allopurinol daily for 240 days. All patients began medication at the same time regardless of whether the disease was in an active state. No side effects were noted in the treatment groups.
RESULTS: Significant effects were noted on the concentrations of serum urate, urine urate, expressed prostatic secretion urate, expressed prostatic secretion xanthine and subjective discomfort.
CONCLUSIONS: Allopurinol has a significant, positive effect on nonbacterial prostatitis. It is safe and worthy of trial for all at least a 3-month period at each episode to relieve the symptoms of nonbacterial prostatitis.
Quercetin in men with category III chronic prostatitis: a preliminary prospective, double-blind, placebo-controlled trial.
OBJECTIVES: The National Institutes of Health (NIH) category III chronic prostatitis syndromes (nonbacterial chronic prostatitis and prostatodynia) are common disorders with few effective therapies. Bioflavonoids have recently been shown in an open-label study to improve the symptoms of these disorders in a significant proportion of men. The aim of this study was to confirm these findings in a prospective randomized, double-blind, placebo-controlled trial.
METHODS: Thirty men with category IIIa and IIIb chronic pelvic pain syndrome were randomized in a double-blind fashion to receive either placebo or the bioflavonoid quercetin 500 mg twice daily for 1 month. The NIH chronic prostatitis symptom score was used to grade symptoms and the quality-of-life impact at the start and conclusion of the study. In a follow-up unblind, open-label study, 17 additional men received 1 month of a supplement containing quercetin, as well as bromelain and papain (Prosta-O), which enhance bioflavonoid absorption.
RESULTS: Two patients in the placebo group refused to complete the study because of worsening symptoms, leaving 13 placebo and 15 bioflavonoid patients for evaluation in the blind study. Both the quercetin and placebo groups were similar in age, symptom duration, and initial symptom score. Patients taking placebo had a mean improvement in NIH symptom score from 20.2 to 18.8 (not significant), while those taking the bioflavonoid had a mean improvement from 21.0 to 13.1 (P = 0.003). Twenty percent of patients taking placebo and 67% of patients taking the bioflavonoid had an improvement of symptoms of at least 25%. In the 17 patients who received Prosta-Q in the open-label study, 82% had at least a 25% improvement in symptom score.
CONCLUSIONS: Therapy with the bioflavonoid quercetin is well tolerated and provides significant symptomatic improvement in most men with chronic pelvic pain syndrome.
Minocycline in chronic abacterial prostatitis: a double-blind prospective trial.
In patients with chronic abacterial prostatitis, a double-blind trial of 3 months of treatment with minocycline 100 mg twice daily compared with diazepam 5 mg twice daily was undertaken. The percentage fall in polymorphonuclear leucocyte counts in the expressed prostatic secretions was much more marked after treatment with minocycline than with diazepam. Over a follow-up period of at least 12 months, further treatment was necessary in more patients originally treated with diazepam than with minocycline.
[Microwave hyperthermia in chronic prostatitis and prostatodynia--preliminary results].
Effects of sodium pentosanpolysulphate on symptoms related to chronic non-bacterial prostatitis. A double-blind randomized study.
A therapeutical trial was conducted with pentosanpolysulphate (Elmiron) in 24 patients with chronic non-bacterial prostatitis. The study was double-blind and 10 patients received Elmiron 200 mg X 2 daily while 14 received a placebo. A beneficial effect (p less than 0.01) was registered on symptoms from muscles and joints. A side-effect observed was a tendency to develop diarrhoea in a few patients prone to gastrointestinal disturbances previously.
Options:
A: The routine use of antibiotics and alpha blockers is supported by strong evidence.
B: Thermal therapy shows potential benefits and warrants further evaluation.
C: All treatment trials reviewed were methodologically strong and had large sample sizes.
D: There is conclusive evidence supporting the use of anti-inflammatory medications.
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B
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151
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the effectiveness and safety of terlipressin in the treatment of acute esophageal variceal hemorrhage? Please answer this question based on the information provided below:
A controlled study of glypressin versus vasopressin in the control of bleeding from oesophageal varices.
To evaluate the therapeutic effect of glypressin (triglycyl-lysine-vasopressin, C52H74N16O15S2.2C2H4O2.5H2O) in the treatment of oesophageal variceal bleeding, a randomized controlled trial of glypressin and vasopressin was conducted in 54 cirrhotic patients with oesophageal varices bleeding. Bleeding ceased within 24 h in 50% (13/26) of patients treated with glypressin and in 53.6% (15/28) of patients given vasopressin. Re-bleeding within 7 days occurred in 30.8% (4/13) of the glypressin group and in 20.0% (3/15) of the vasopressin group. There was no statistically significant difference in the therapeutic effect between glypressin and vasopressin. In the glypressin group, bleeding was more easily stopped in non-hepatocellular carcinoma (HCC) cirrhotic patients of Pugh's criteria A or B than in patients of Pugh's criterion C or HCC. We conclude that glypressin and vasopressin have similar therapeutic effect. In considering the application convenience, glypressin is an alternative to vasopressin in the treatment of bleeding varices in patients of good liver function reserve.
Terlipressin or vasopressin plus transdermal nitroglycerin in a treatment strategy for digestive bleeding in cirrhosis. A randomized clinical trial. Liver Study Group of V. Cervello Hospital.
Between 1988 and 1990 an unblinded, randomized trial of terlipressin or vasopressin plus transdermal nitroglycerin, as part of a treatment strategy including emergency sclerotherapy for actively bleeding varices, was conducted during 165 admissions in 137 patients with cirrhosis and upper digestive bleeding. Eighty-four patient admissions were assigned to terlipressin (2 mg every 6 h) and 81 to vasopressin (0.4 to 0.8 unit per min) plus transdermal nitroglycerin (20 to 80 mg). The two groups were comparable for relevant clinical data, but there were slightly more patients with hepatocellular carcinoma or terminal conditions in the terlipressin group. After the 24-h study period, failure to control bleeding was 20/84 (25%) in the vasopressin and 14/81 (17%) in the terlipressin group (p = 0.19). Corresponding figures for patients bleeding from varices (emergency sclerotherapy in 43 and 45, respectively) were 13/55 (24%) and 5/56 (9%; p = 0.035), from other sources 5/16 (31%) and 2/15 (13%; p = 0.23), from undefined sources 2/10 (20%) and 7/13 (54%; p = 0.1). In a logistic multivariate regression model the odds ratio for terlipressin adjusted for prognostic factors was 0.45 (p = 0.07). There were seven major side effects requiring treatment discontinuation in the vasopressin and one in the terlipressin group. These results suggest that terlipressin alone is as effective as vasopressin plus transdermal nitroglycerin, with less severe side effects, in 24-h control of upper gastrointestinal bleeding in patients with cirrhosis.
Multicenter randomized controlled trial of terlipressin versus sclerotherapy in the treatment of acute variceal bleeding: the TEST study.
Failure to control bleeding and early rebleeding account for the high mortality associated with variceal hemorrhage in cirrhosis. We compared endoscopic sclerotherapy to terlipressin, a drug that effectively controls acute bleeding while reducing in-hospital mortality. This multicenter randomized controlled trial included 219 cirrhotic patients admitted for endoscopy-proven acute variceal bleeding and randomized to receive repeated injections of terlipressin during 6 days (n = 105) or emergency sclerotherapy (n = 114). Success was defined as obtaining control of bleeding (24-hour bleeding-free period during the first 48 hours) and lack of early rebleeding (any further bleeding from initial control to 5 days later) and survival during the study. Both groups were similar at inclusion. Failure rate for terlipressin was 33% and 32% for sclerotherapy (not significant [NS]). Early rebleeding was responsible for 43% and 44% of failures, respectively. This high efficacy was observed in both Child-Pugh class A + B and Child-Pugh class C patients. Both treatments were similar regarding transfusion requirements, in-hospital stay, and 6-week mortality (26 vs. 19 patients). Side effects appeared in 20% of patients receiving terlipressin and in 30% of those on sclerotherapy (P =.06); being serious in 4% and 7%, respectively (NS). In conclusion, terlipressin and sclerotherapy are equally highly effective therapies achieving the initial control of variceal bleeding and preventing early rebleeding. Both treatments are safe, but terlipressin is better tolerated. Therefore, terlipressin may represent a first-line treatment in acute variceal bleeding until the administration of elective therapy, especially in hospitals where a skilled endoscopist is not available 24 hours a day.
Double-blind randomized controlled trial comparing terlipressin and somatostatin for acute variceal hemorrhage. Variceal Bleeding Study Group.
BACKGROUND & AIMS: Terlipressin and somatostatin decrease portal pressure and have been used to treat variceal hemorrhage, but they have not been adequately compared. The aim of this study was to compare the efficacy and safety of these drugs in the treatment of variceal bleeding in cirrhotic patients.
METHODS: Of 161 patients with variceal bleeding. 80 were randomized to receive (double-blind) intravenous terlipressin (2 mg/4 h) and 81 to receive somatostatin (continuous infusion of 250 micrograms/h after an intravenous injection of 250 micrograms). Success of therapy was defined as a 24-hour bleeding-free period within 48 hours from randomization.
RESULTS: Success of therapy was similar with terlipressin (80%) and somatostatin (84%). In patients with Child's class A and B disease, terlipressin was effective in 52 of 60 (87%) and somatostatin in 48 of 55 (87%). Success rates in class C were 60% and 77% (P = 0.33). No differences were observed in rebleeding rates (30% vs. 28.4%) and 6-week mortality rates (13 vs. 13 patients). Incidence of side effects was significantly higher in the terlipressin group (38.8% vs. 23.5%; P = 0.042). Severe side effects requiring intervention occurred in 5 of 80 and 4 of 81 patients, respectively.
CONCLUSIONS: Terlipressin and somatostatin are highly effective as first-line treatment of variceal hemorrhage in cirrhotic patients. The low incidence of severe side effects suggests that drug therapy may be maintained for longer periods to prevent early rebleeding.
A randomized trial of terlipressin plus nitroglycerin vs. balloon tamponade in the control of acute variceal hemorrhage.
A randomized trial was undertaken to determine the efficacy of nitroglycerin in addition to terlipressin infusion to improve the control of acute variceal hemorrhage compared with balloon tamponade. Forty-seven bleeding episodes in 34 cirrhotic patients were included, with terlipressin plus sublingual nitroglycerin in 23 episodes (group I) and balloon tamponade in 24 episodes (group II). At the end of the 12-hr period, hemorrhage had been equally controlled in both groups (18 of 23; 78% in group I and 19 of 24; 79% in group II). When attempted, balloon tamponade appeared more efficient in the failures of group I (4 of 4) than did terlipressin plus nitroglycerin in the failures of group II (0 of 3), although this difference was not significant. Major complications were rare (one in each group) and never required cessation of therapy. Thus terlipressin and nitroglycerin were as effective as balloon tamponade in controlling variceal hemorrhage and were associated with few minor complications.
Controlled trial of terlipressin ('Glypressin') versus vasopressin in the early treatment of oesophageal varices.
In a randomised controlled trial the effect of intermittent bolus injection of triglycyl lysine vasopressin (terlipressin 'Glypressin') (2 mg that 6-hourly), an analogue of vasopressin, was compared with that of a constant peripheral intravenous infusion of vasopressin (0.4 units/Min) in the initial management of bleeding oesophageal varices in nineteen patients. Failure of vasopressin therapy was defined as continued bleeding of sufficient severity to necessitate the passage of a Sengstaken tube. Bleeding was controlled in 70% of patients treated with glypressin but in only 9% of patients given vasopressin. The glypressin group required significantly less blood after randomisation than the vasopressin group. Because of its efficacy, lack of side-effects, and ease of administration, glypressin appears to be valuable in the management of bleeding varices.
Placebo-controlled trial of terlipressin (glypressin) in the management of acute variceal bleeding.
In a double-blind trial 60% of acute variceal bleeding episodes were controlled with terlipressin (glypressin) compared with 37% in patients given placebo (NS). Rebleeding was more common in the placebo group so that at 5 days bleeding remained under control in 54% of patients treated with terlipressin compared with only 19% after placebo therapy (p less than 0.025). Blood transfusion requirements were similar in the two groups. Terlipressin appeared to be the most effective in those patients with severe hepatic dysfunction.
Treatment of active gastroesophageal variceal bleeding with terlipressin or hemostatic balloon in patients with cirrhosis. A randomized controlled trial.
Gastroesophageal variceal bleeding due to portal hypertension should be treated by endoscopic sclerotherapy. This procedure, however, has some limitations. It has been established that vasoactive drugs are effective for controlling active variceal bleeding. We report the results of a randomized controlled trial comparing terlipressin to hemostatic tube (Linton-Michel tube) for the treatment of bleeding gastroesophageal varices in cirrhotic patients. Thirty-seven cirrhotic patients with a total of 40 episodes of gastroesophageal variceal bleeding were included in this trial. Patients were randomly assigned to intravenous terlipressin or Linton-Michel tube (LM tube), for 24 h. During this period, hemostasis was defined as obtaining of hemodynamic and hematocrit stabilization and/or absence of hematemesis or melena. Bleeding recurrence was assessed during a 1-month period after treatment. Twenty bleeding episodes were treated with terlipressin (Group I) and 20 with LM tube (Group II). Both groups of patients were similar in age, sex distribution, etiology of cirrhosis and degree of hepatic insufficiency. Bleeding was controlled in 70% of patients from Group I and in 95% from Group II (p < 0.05) during treatment. Bleeding recurred in 14% of patients in Group I vs. 36% in Group II 1 week following the treatment (p > 0.05) and in 16.6% in Group I vs. 83.3% in Group II 1 month after treatment (p < 0.05). Complications were more frequent in Group II than in Group I (65 vs. 15%, p < 0.05). Mortality rate was similar in both groups 1 month after treatment. In conclusion, hemostatic tubes were superior to terlipressin for the control of active gastroesophageal variceal bleeding within the first 24 h. Complications and bleeding recurrence were more frequent in patients treated by hemostatic tube within a period of 1 month after treatment. Mortality rate was similar in both groups of patients.
Early administration of terlipressin plus glyceryl trinitrate to control active upper gastrointestinal bleeding in cirrhotic patients.
Upper gastrointestinal bleeding (GIB) is a major complication in cirrhotic patients. Endoscopy and oesophageal sclerosis are reference treatments and must be done as soon as possible. However, such treatment is not possible unless the patient is admitted to hospital. In a prospective, randomised, double-blind trial, we compared the efficacy of terlipressin combined with glyceryl trinitrate (TER-GTN), administered as early as possible to 76 patients with cirrhosis who had active GIB (84 bleeding episodes). Infusion was done at the patient's home by the physician on the emergency team (a mobile intensive care unit) if the patient had GIB and a history and clinical signs of cirrhosis. Patients received either an intravenous injection (1 to 2 mg) of TER-GTN or a double-placebo injection, and then another injection at 4 and 8 h. Control of bleeding, rebleeding, and mortality rate at days 15 and 42 were evaluated. In most patients, endoscopy confirmed the rupture of oesophageal varices (75.7%). Bleeding control was significantly better in the TER-GTN group (n = 41) than in the double-placebo group (n = 43) (p = 0.034). Mortality due to bleeding episodes was significantly lower in the TER-GTN group than in the double-placebo group at day 15 (p = 0.035) and at day 42 (p = 0.06). There were no serious side-effects. Early administration of TER-GTN lowers the deleterious consequences of prolonged hypovolaemia on the hepatic function of these patients.
[Terlipressin and somatostatin in the treatment of hemorrhages from rupture of esophageal varices].
Octreotide versus terlypressin in acute variceal hemorrhage in liver cirrhosis. Emergency control and prevention of early rebleeding.
Sixty patients with endoscopically confirmed active variceal bleeding entered a randomized controlled clinical trial aimed at comparing the efficacy of octreotide vs. terlypressin in the control of acute variceal hemorrhage (period I, 24 h) and in the prevention of early rebleeding (period II, 6 days). Of the sixty 30 received octreotide (period I, 100 micrograms bolus followed by continuous intravenous infusion at 25 micrograms/h; period II, 100 micrograms t.i.d. subcutaneously), and 30 received terlypressin (period I, 2 mg intravenous bolus every 4 h; period II, 2nd day, 2 mg every 6 h; from 3th to 7th days, 1 mg every 6 h). Control of bleeding was achieved in 23 (76.6%) patients receiving octreotide and in 16 (53%) treated with terlypressin (NS); none of these patients suffered rebleeding during treatment. No significant difference in mortality was observed between the two groups during the hospitalization period. Complications due to therapy were lower with octreotide than with terlypressin (P < 0.01). Under the same effectiveness conditions the cost/benefit ratio must be taken into account.
Terlipressin plus transdermal nitroglycerin vs. octreotide in the control of acute bleeding from esophageal varices: a multicenter randomized trial.
We undertook a multicenter randomized trial to compare the efficacy of terlipressin combined with transdermal nitroglycerin and that of octreotide in the emergency control of acute variceal hemorrhage in cirrhosis. Over 16 mo, 87 patients with endoscopically proved active bleeding from esophageal or cardiac varices were enrolled in five centers in France and randomly assigned to receive intravenous terlipressin (2 mg and then 1 mg/4 hr over 24 hr) and transdermal nitroglycerin (10 mg/12 hr over 24 hr) (group 1) or octreotide (continuous intravenous infusion of 25 micrograms/hr over 12 hr and then 100 micrograms at hr 12 and hr 18 subcutaneously) (group 2). Initial control of bleeding was assessed at the end of 12 hr of treatment on the basis of stability of blood pressure and hematocrit level with no further transfusion requirements. At 12 hr, bleeding was controlled in 59% (24 of 41) in group 1 and 78% (36/46) of group 2 patients (Fisher's exact test, p = 0.064). Mean transfusion requirements over this 12-hr period were significantly greater in group 1 (three blood units; range = 0 to 13) than in group 2 (one blood unit; range = 0 to 5) (p = 0.002). After the first 12 hr, 20% of patients (5 of 24) had repeat bleeding in group 1 compared with 27% (10 of 36) in group 2. During the first 48-hr period, five patients (12%) died in group 1, compared with 3 (6%) in group 2. Few side effects were noted in either group. However, in group 1 two patients experienced severe bradycardia; it resulted in death in one patient.(ABSTRACT TRUNCATED AT 250 WORDS)
Terlipressin (triglycyl-lysine vasopressin) controls acute bleeding oesophageal varices. A double-blind, randomized, placebo-controlled trial.
The haemostatic effect of terlipressin (triglycyl-lysine vasopressin; Glypressin) on bleeding from oesophageal varices was evaluated in a placebo-controlled, double-blind, randomized clinical trial. Patients with clinically suspected liver cirrhosis were included in the study if they had been admitted to hospital with an extensive haemorrhage within the last 24h before diagnostic endoscopy. The patients randomized after stratification for severity of liver disease. Terlipressin or placebo was administered as intravenous bolus injections every 4th h during a period of 24 to 36 h or until the clinical course necessitated active intervention (failure or withdrawal). Sixty patients entered the study; 31 patients were allocated to receive terlipressin, and 29 patients to receive placebo. Bleeding from varices was arrested in 28 of the 31 receiving terlipressin, as compared with 17 of the 29 receiving placebo (p less than 0.01). Patients receiving active drug required significantly fewer blood transfusions (p less than 0.05). Most of the side effects were classified as mild and were registered in the terlipressin group.
Terlipressin in bleeding esophageal varices: a placebo-controlled, double-blind study.
The effect of terlipressin (N-alpha-triglycyl-8-lysine-vasopressin) in bleeding esophageal varices was evaluated in a prospective placebo-controlled study. Fifty bleeding episodes from esophageal varices in 34 patients were randomized. Standard therapy with transfusions, fluid and electrolyte correction, and lactulose was performed in both groups. Balloon tamponade was used in 20 bleeding episodes in the terlipressin group and in 19 bleeding episodes in the control group. In the terlipressin group, hemorrhage was controlled in all bleeding episodes (25/25) whereas in the placebo group, only 20 of 25 bleeding episodes could be stopped within 36 hr (p less than 0.05). Sclerotherapy was performed in five bleeding episodes in the terlipressin group and in seven bleeding episodes in the placebo group. Treatment failures, including patients who required sclerotherapy, occurred in five bleedings in the terlipressin group and in 12 in the control group (p less than 0.05). The hospital mortality rate was 12% (3/25) in the terlipressin group and 32% (8/25) in the control group. Patients in the terlipressin group required fewer transfusions, the balloon needed to be inflated for a shorter time and the duration of bleeding was shorter than in the control group. However, these differences were not significant. These data do not allow conclusions concerning monotherapy with terlipressin, but they indicate that the addition of terlipressin to standard therapy may increase the control rate in acute variceal hemorrhage.
Terlipressin (glypressin) versus somatostatin in the treatment of bleeding esophageal varices--final report of a placebo-controlled, double-blind study.
One hundred and six episodes of bleeding from esophageal or gastric varices in 72 patients with cirrhosis of the liver were randomized to treatment either with intravenous terlipressin 2 mg initially and 1 mg every four hours for 24 hours together with bolus injection and continuous infusion of placebo, or with somatostatin 250 micrograms as a bolus and continuous infusion of 250 micrograms/h somatostatin for 24 hours and placebo injections. Standard treatment with transfusions, fluid and electrolyte correction, and lactulose was administered in both groups. In the terlipressin group, 48 out of 53 bleeding episodes (91%) and in the somatostatin group 43 out of 53 bleeds (81%) were initially stopped by the vasoactive drugs. Four of the five bleeds not arrested by terlipressin, and nine of the ten bleeds not arrested by somatostatin, were stopped by balloon tamponade. In one patient in each group variceal bleeding could not be stopped initially, and both patients died. The failure rate of the vasoactive treatment alone, including rebleeds within the study period, was 17% in the terlipressin, and 28% in the somatostatin, group. The initial hemostasis, including balloon tamponade, were 98%, and the definitive bleeding control rates were 89% in both groups. The hospital mortality rate was 21% (11/53) in the terlipressin, and 21% (11/53) in the somatostatin, group. Blood transfusions and duration of bleeding did not differ significantly. The study indicates that a large proportion of bleeds from esophageal and fundic varices can be stopped initially (86%) and definitively controlled (77%) by vasoactive drugs alone.
Terlipressin vs. somatostatin in bleeding esophageal varices: a controlled, double-blind study.
Fifty episodes of bleeding from esophageal or gastric varices in 33 patients with cirrhosis were randomized to treatment with either intravenous terlipressin (2 mg initially and 1 mg every 4 hr for 24 hr together with bolus injection and continuous infusion of placebo) or with somatostatin (250 micrograms as a bolus and continuous infusion of 250 micrograms/hr somatostatin for 24 hr and placebo injections). Standard therapy with transfusions, fluid and electrolyte correction and lactulose was administered in both groups. In the terlipressin group, 22 of 25 bleeding episodes (88%) were initially stopped by the vasoactive drugs, and in the somatostatin group 19 of 25 bleeding episodes (76%) were initially stopped by the vasoactive drugs. Two of the three bleeding episodes not arrested by terlipressin and five of the six bleeding episodes not arrested by somatostatin were controlled by balloon tamponade. In one patient in each group variceal bleeding initially could not be stopped, and the patients died. The failure rate of the vasoactive treatment alone, including rebleeding episodes within the study period, was 20% in the terlipressin group and 32% in the somatostatin group. The control rate, including balloon tamponade, was 96% in both groups. The hospital mortality rate was 16% (4 of 25) in the terlipressin group and 24% (6 of 25) in the somatostatin group. Blood transfusions, use of balloon tamponade and duration of bleeding did not differ significantly.(ABSTRACT TRUNCATED AT 250 WORDS)
Options:
A: Terlipressin significantly reduces all-cause mortality compared to placebo and has a safer adverse reactions profile.
B: Terlipressin shows no significant difference in mortality compared to placebo but has a safer adverse reactions profile.
C: Terlipressin significantly reduces all-cause mortality compared to placebo but has a higher rate of adverse events.
D: Terlipressin shows no significant difference in mortality compared to placebo and has a higher rate of adverse events.
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A
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152
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the impact of methyl-xanthines on forced expiratory volume in one second (FEV1) and hospitalization rates in patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) compared to placebo? Please answer this question based on the information provided below:
Aminophylline for acute exacerbations of chronic obstructive pulmonary disease. A controlled trial.
STUDY OBJECTIVE: To determine the efficacy of intravenous aminophylline in the treatment of patients hospitalized for exacerbation of chronic obstructive pulmonary disease.
DESIGN: Randomized, double-blind, placebo-controlled trial during the first 72 hours of hospitalization.
PATIENTS: Thirty patients admitted from the emergency room or walk-in clinic with the primary diagnosis of an exacerbation of chronic obstructive pulmonary disease. Twenty-eight patients completed the study; 2 patients, 1 receiving placebo and 1 receiving aminophylline, were removed from the study because of respiratory failure requiring mechanical ventilation.
INTERVENTIONS: PATIENTS received either intravenous aminophylline or placebo, in addition to nebulized, inhaled 0.3 mL of a 5% solution every 6 hours; methylprednisolone, 0.5 mg/kg body weight every 6 hours intravenously; ampicillin, 500 mg orally every 6 hours (tetracycline or trimethoprim-sulfamethoxazole were substituted in penicillin-allergic patients); and supplemental oxygen as needed. Aminophylline infusion rates were adjusted by an unblinded investigator to achieve theophylline levels of 72 to 83 mumol/L. Changes were also made in placebo infusion rates to maintain the double-blind design.
MEASUREMENTS AND MAIN RESULTS: The forced expiratory volume in one second (FEV1) and forced vital capacity (FVC) before and after metaproterenol inhalation were measured twice daily by a blinded investigator, who also administered a verbal dyspnea index with a scale of 1 to 10 and questioned patients regarding possible side effects of treatment (tremor, palpitations, nausea, or vomiting). Arterial blood gas measurements at 72 hours were compared with those obtained on admission. Significant improvements in FEV1 and FVC measured before and after metaproterenol treatment and in dyspnea occurred over time in both treatment groups (p less than 0.05 for all measurements). However, there were no significant differences between the placebo and aminophylline groups in any of the spirometric measurements or the dyspnea indices (p greater than 0.5 in all five analyses). The mean increases (+/- SE) in Po2 of 1.9 (+/- 0.5) kPa with placebo and 1.7 (+/- 0.7) kPa with aminophylline and the mean decreases in PCO2 of 0.5 (+/- 0.4) kPa with placebo and 1.2 (+/- 0.4) kPa with aminophylline were not significantly different (p greater than 0.6 for PO2, p greater than 0.2 for PCO2).(ABSTRACT TRUNCATED AT 400 WORDS)
Intravenous aminophylline in the treatment of acute bronchospastic exacerbations of chronic obstructive pulmonary disease.
Often chronic obstructive pulmonary disease (COPD) patients treated for acute exacerbations receive intravenous (IV) aminophylline in addition to inhaled bronchodilators that may raise serum levels of theophylline into the toxic range. A double-blind, randomized study of 52 men with COPD who came to the emergency department for treatment of exacerbations was initiated to establish the efficacy and safety of this common practice. After history and physical examination, patients were treated with 28% oxygen by Venturi mask and 0.3 cc metaproterenol sulfate in 2.5 cc saline by nebulizer; an IV line was started and patients received either aminophylline or D5W. Measurements included baseline and two-hour serum theophylline levels, pulmonary function tests, and symptom questionnaires. Mean values from the entire group showed decreases in respiratory rate, cardiac rate, and pulsus paradoxus, and increases in forced expiratory volume in one second (FEV1) and vital capacity (VC) over a two-hour treatment period (P less than .01). Despite the increase in serum theophylline in the treatment group, the demographic, clinical, pulmonary function, and outcome data were found to have no statistically significant differences when compared to control patients. The data were then analyzed according to serum theophylline levels. Theophylline level greater than 20 micrograms/mL occurred in 15 patients with no untoward effects; premature ventricular contractions (PVCs) were no more frequent in this group than in those with lower serum theophylline levels. A theophylline level greater than 10 micrograms/mL after two hours of treatment resulted in the following differences, which were not statistically significant: mean FEV1 response less than or equal to 10 micrograms/mL vs greater than 10 micrograms/mL, 20% vs 28%; mean VC change, 17% vs 30%; or mean emergency department returns in one week, 0.1 vs 0.26. In our experience, oxygen and inhaled metaproterenol are effective treatment for exacerbations of COPD.
Aminophylline therapy for acute bronchospastic disease in the emergency room.
OBJECTIVE: To assess the role of aminophylline in the treatment of acute exacerbations of bronchospastic disease when used in addition to inhaled beta-agonists and intravenous corticosteroids.
DESIGN: Randomized, double-blind, placebo-controlled intervention study.
PATIENTS: One hundred thirty-three adult patients with either asthma or chronic obstructive pulmonary disease who presented to the emergency department with asthma or wheezing.
INTERVENTIONS: All patients received therapy with both aerosolized metaproterenol and intravenous methyl-prednisolone. Patients were randomly assigned to receive either a loading dose of aminophylline followed by a routine infusion (n = 65) or an equal volume of placebo as a loading dose and infusion (n = 68).
MEASUREMENTS AND MAIN RESULTS: At discharge from the emergency department, the median serum theophylline concentration for the aminophylline group was 54 mumol/L (9.7 mg/L). The two groups showed no differences (P greater than 0.2) in measurements of forced expiratory volume at 1 second (FEV1), forced vital capacity (FVC), or peak expiratory flow rate (PEFR) at baseline or at 60 or 120 minutes after aminophylline administration. Neither patient satisfaction nor physician assessment of response to therapy differed between the two groups. There was no difference (P greater than 0.2) in the frequency of side effects, except for a trend toward a higher frequency of nausea (P = 0.13) in the aminophylline group. There was, however, a threefold decrease in the hospital admission rate for patients treated with aminophylline (6%) compared with placebo recipients (21%) (P = 0.016).
CONCLUSION: Aminophylline, in doses producing levels just below the commonly accepted therapeutic range, appears to decrease hospital admissions in patients with acute exacerbation of asthma or chronic obstructive pulmonary disease. This finding, if confirmed in larger studies, may represent a substantial cost savings.
Options:
A: Methyl-xanthines significantly improve FEV1 and reduce hospitalization rates.
B: Methyl-xanthines do not significantly improve FEV1 but reduce hospitalization rates.
C: Methyl-xanthines do not significantly improve FEV1 and do not significantly reduce hospitalization rates.
D: Methyl-xanthines significantly improve FEV1 but do not significantly reduce hospitalization rates.
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C
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153
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the dose response relationship of beclomethasone dipropionate (BDP) in the treatment of long-term asthma? Please answer this question based on the information provided below:
Beclomethasone dipropionate dry-powder inhalation compared with conventional aerosol in chronic asthma.
In a double-blind study beclomethasone dipropionate inhaled as a dry powder in doses of 100 microgram four times daily and 150 microgram four times daily was compared with the conventional aerosol dose of 100 microgram four times daily in 20 outpatients with chronic asthma. Each of the three treatments was given for four weeks. The dry powder in a dose of 150 microgram four times daily had advantages over the other two treatments in terms of FEV1 and the number of exacerbations of asthma during the study. There were no adverse reactions to inhaling dry-powder beclomethasone. It was concluded that this new way of administering the drug was effective in chronic asthma, and should allow most patients with chronic asthma who cannot use conventional pressurised aerosols efficiently to benefit from inhaled corticosteroid treatment.
Dose-related effect of beclomethasone dipropionate on airway responsiveness in asthma.
The effects of twice daily inhaled beclomethasone dipropionate (BDP) at two dose levels (500 and 1,000 micrograms daily) on the airway responsiveness to inhaled histamine was evaluated by a randomized, single-blind, cross-over study in 10 patients with stable asthma. The 12-week study began with a 3-week run-in period of baseline treatment, which was continued unchanged throughout the study, and the two treatment periods were separated by a 3-week placebo period. Patients attended the laboratory every 3 weeks for spirometry and histamine inhalation tests to determine the provocative concentration of histamine causing a 20% fall in forced expiratory volume in 1 s (PC20 of FEV1). There was a similar significant improvement (p less than 0.05) in mean FEV1 after both treatments. There was no significant change in PC20 after treatment with 500 micrograms daily, the geometric mean being 0.587 mg/ml after the placebo period and 0.860 mg/ml after BDP treatment. There was a significant improvement in PC20 (1.930 mg/ml) after treatment with 1,000 micrograms BDP daily in comparison with the placebo and treatment periods with 500 micrograms BDP daily (p less than 0.001). These results suggest that higher doses than usual of inhaled BDP must be used to control airway responsiveness in asthmatics.
Beclomethasone dipropionate in asthma: a comparison of two methods of administration.
Beclomethasone dipropionate inhaled as a dry powder in doses of 200 microgram four times a day was compared with the usual dose of 100 microgram four times a day from a pressurized aerosol in 65 patients with asthma who used pressurized aerosols correctly. Each treatment was given for an eight-week period. The dry powder did not show any clinically significant advantage over the aerosol in terms of ventilatory function as measured by FEV1 and the daily peak flow measurements during both treatments did not differ. The incidence of oral candidiasis was low and no other side-effects were encountered. It was concluded that beclomethasone dipropionate in dry powder form was as effective as aerosol in the treatment of asthma.
Dose-dependent inhibitory effect of inhaled beclomethasone on late asthmatic reactions and increased responsiveness to methacholine induced by toluene diisocyanate in sensitised subjects.
To determine whether inhaled beclomethasone, both at low and at high doses, inhibits late asthmatic reactions and the associated increase in airway responsiveness induced by toluene diisocyanate (TDI), we studied 9 sensitised subjects. Low dose beclomethasone (200 micrograms bid), high dose beclomethasone aerosol (1000 micrograms bid), and placebo were administered for 7 days before TDI inhalation challenge to each subject, according to a double-blind, crossover study design. The washout period between the treatments was at least 1 week. When the subjects were treated with placebo, forced expiratory volume in 1 sec (FEV1) markedly decreased after exposure to TDI. By contrast, high dose beclomethasone prevented the late asthmatic reaction and the low dose partially inhibited the reaction. With placebo the mean (+/- SE) value of FEV1 4 h after exposure to TDI was 2.6 +/- 0.17 L, which went to 3.3 +/- 0.12 after low dose beclomethasone, and to 3.5 +/- 0.15 L after high dose of beclomethasone (significant difference in the decrease of FEV1 in the 8 h after exposure to TDI, between treatments: F = 9.87, (P less than 0.001), After treatment with placebo or with low dose beclomethasone, airway responsiveness to methacholine increased 8 h after exposure to TDI. With placebo, the PD20 decreased from 0.66 mg (Geometric Standard Error of the Mean [GSEM], 1.38) to 0.18 mg (GSEM, 1.46); with low dose inhaled beclomethasone, the PD20 decreased from 0.93 mg (GSEM, 1.42) to 0.36 mg (GSEM, 1.63).(ABSTRACT TRUNCATED AT 250 WORDS)
Comparison of oral-steroid sparing by high-dose and low-dose inhaled steroid in maintenance treatment of severe asthma.
It is not clear whether high doses of inhaled steroids have a greater sparing effect than low doses on the requirement for systemic steroids. In a randomised, double-blind, multicentre study, we compared the effects of high-dose (1500 micrograms/day) and low-dose (300 micrograms/day) inhaled beclomethasone dipropionate (BDP) in patients with severe asthma requiring a daily oral prednisolone dose of 10-40 mg. During a 3-month run-in period, we tried to achieve optimum asthma control by means of oral steroid and inhaled BDP 300 micrograms/day. The patients were then allocated to high-dose (n = 71) or low-dose (n = 72) treatment by an independent observer who took into account various prognostic factors. BDP was administered by means of an aerosol inhaler with a spacer device. The dose of systemic steroid was reduced as much as possible during the 6-month study period while keeping the peak expiratory flow (PEF) constant and asthma clinically stable. There was no difference between the low-dose and high-dose treatment groups in the mean reduction in oral prednisolone dose achieved by the end of the study (5.2[ SD 7.9] vs 5.0 [9.4] mg/day). The maximum response to inhaled steroid was seen, however, only after several months' therapy in both groups. There were no differences between the groups in use of on-demand beta-agonist inhalations or in asthma symptoms, and PEF values were constant throughout the study. Both doses of BDP were well tolerated. High doses of inhaled steroid offer no further benefit over low doses in the maintenance treatment of severe steroid-dependent asthma when the inhaled steroid is administered with a spacer device.
Beclomethasone dipropionate aerosol compared with dry powder in the treatment of asthma.
In a double-blind trial, beclomethasone dipropionate inhaled as a dry powder in doses of 200 micrograms three times a day was compared with the conventional aerosol of 100 micrograms three times a day, each for a period of 4 weeks. Neither the dry powder nor the aerosol showed any significant advantage over each other in terms of ventilatory function. Plasma cortisol levels were unaltered with the two medications in spite of the doubled dose of the corticosteroid powder. Choice of one or the other method of administration of medication depended on patient preference and the ease with which he could familiarize himself with either technique.
Effects of inhaled beclomethasone dipropionate on beta 2-receptor function in the airways and adrenal responsiveness in bronchial asthma.
Sixteen patients suffering from bronchial asthma, with or without chronic bronchitis, sufficiently severe to be treated with inhaled corticosteroids, were studied in a single-blind trial (blind observer) of beclomethasone dipropionate (BDP) given in three randomized dosage regimens: 500, 1000 and 2000 micrograms per day, each for 4 weeks. The beta 2-adrenergic agonist response curve showed a dose-dependent increase in FEV1 which was not affected by different doses of BDP. A small but significant reduction in basal cortisol levels was observed after BDP 500 micrograms/day. There was no significant difference between the various doses of BDP in reducing cortisol level and stimulation with tetracosactide remained unchanged. The study showed a gradual, dose-dependent improvement in lung function, statistically significant for morning peak expiratory flow rate at BDP 2000 micrograms/day. Dyspnoea score and beta 2-agonist use decreased, reflecting the anti-asthmatic effects. An increase in total leukocyte count was observed, together with a decrease in the eosinophil count. Oral candidiasis was seen in 2 out of 16 patients. It is concluded that the clinical anti-asthmatic effects of corticosteroid treatment by inhalation are not due to modulation of beta 2-receptor function in the airways.
A comparison of double-strength beclomethasone dipropionate (84 microg) MDI with beclomethasone dipropionate (42 microg) MDI in the treatment of asthma.
STUDY OBJECTIVE: To compare the efficacy and safety of a double-strength formulation of beclomethasone dipropionate (BDP 84) metered-dose inhaler (MDI) with that of beclomethasone dipropionate (BDP 42) MDI in the treatment of chronic asthma.
DESIGN: A 28-day, randomized, double-blind, double-dummy, placebo-controlled, multicenter study.
SETTING: Outpatient.
PATIENTS: A total of 423 patients aged 12 to 65 years (mean range, 34 to 36 years) with moderate asthma (FEV1, 50 to 80% of predicted) who required long-term inhaled corticosteroids were enrolled.
INTERVENTIONS: Patients were randomized to receive BDP 84, two oral inhalations bid (336 microg/d), BDP 42, four oral inhalations bid (336 microg/d), or placebo. A fourth treatment arm administering BDP 84, eight oral inhalations bid (HD BDP 84; 1,344 microg/d) was also included to determine whether a dose-response relationship could be demonstrated.
MEASUREMENTS: Spirometry, clinical observations.
RESULTS: The three active treatments were significantly more effective (p < or = 0.01) than placebo at all time points in improving FEV1, the primary efficacy parameter; BDP 42 and BDP 84 were comparable to each other at every time point. Secondary pulmonary function tests (FVC, forced expiratory flow at 25 to 75% of FVC, and peak expiratory flow rate) showed similar results. All three active treatments were well tolerated. A dose response between 336 microg/d and 1,344 microg/d was demonstrated.
CONCLUSION: In this well-controlled 28-day study, BDP 42 and BDP 84 were shown to be comparable in efficacy and safety on a microgram-for-microgram basis.
Twice daily beclomethasone dipropionate administered with a concentrated aerosol inhaler: efficacy and patient compliance.
The efficacy of twice daily inhaled beclomethasone dipropionate administered by a concentrated aerosol inhaler (one puff twice daily-500 micrograms/day) has been compared with that of treatment four times daily with a standard dose inhaler (two puffs four times daily-400 micrograms/day) in 21 patients with stable asthma. Double placebo inhalers were used in a randomised crossover fashion during two four week treatment periods. Mean peak expiratory flow (PEF), mean symptom scores, and number of extra salbutamol inhalations required were not significantly different between the two treatment periods. Local side effects were more common during treatment with the four times daily active preparation; overt oropharyngeal candidiasis, however, was not found in either group during the study. On completion of the crossover study patients were transferred to the twice daily regimen. At the three month follow up all patients had remained stable and the outpatient PEF was significantly higher (mean 382 (SD 26)l min-1) than at entry into the trial (mean 345 (24)l min-1) (p less than 0.05). Twice daily beclomethasone administered by a concentrated aerosol inhaler appears to be as effective as the standard four times daily regimen in controlling stable asthma.
Twice daily administration of beclomethasone dipropionate dry-powder in the management of chronic asthma.
In a double-blind cross-over study beclomethasone dipropionate inhaled as a dry-powder in a dose of 400 micrograms twice daily was compared with a conventional aerosol in a dose of 100 micrograms four times daily in 16 outpatients with chronic asthma. Each of the 2 treatments lasted for 4 weeks. There was no significant difference with respect to daily peak expiratory flow rates, symptom scores, bronchodilator usages and other lung function measurements between the 2 treatments. Tetracosactrin tests were within normal limits and no clinical oral candidiasis was observed throughout the study. In conclusion, beclomethasone dipropionate dry-power given twice daily was effective for the control of asthma and could be recommended for patients with poor drug compliance.
Six-month double-blind, controlled trial of high dose, concentrated beclomethasone dipropionate in the treatment of severe chronic asthma.
A six-month double-blind controlled trial compared a 2,000 microgram per day dose of beclomethasone dipropionate aerosol (BDP), with current upper level doses of 800 micrograms per day of the standard BDP, in asthmatics requiring oral corticosteroids in addition to BDP and bronchodilators. Both groups showed a significant reduction in their oral steroid requirements during the study, with a 34 percent reduction in the lower dose group and a 57 percent reduction in the high dose BDP group while maintaining good symptomatic control of asthma; there was an associated improvement in baseline serum cortisol levels. Over the same period, the pulmonary function of the lower dose group showed significant worsening relative to that of the group receiving the high dose BDP which improved. There was no increase in dysphonia or oropharyngeal candidiasis among those using the concentrated BDP. We conclude that high dose concentrated BDP appears to be a safe medication in long-term steroid-dependent asthma, and is effective in reducing dependence on the use of oral corticosteroid with associated improvement both in pulmonary and adrenal function.
Addition of salmeterol versus doubling the dose of beclomethasone in children with asthma. The Dutch Asthma Study Group.
Studies in adults revealed that addition of salmeterol to a moderate dose of inhaled corticosteroid resulted in better symptom control and higher PEF compared with doubling the dose of inhaled corticosteroid. The aim of this three group study was to compare the effects of a moderate dose of beclomethasone, the same dose of beclomethasone with salmeterol, and a doubling dose of beclomethasone on lung function and symptoms in children with moderate asthma. A total of 177 children already treated with inhaled corticosteroids, were randomized in a double-blind parallel study either to salmeterol 50 microg twice daily (BDP400+salm), beclomethasone 200 microg twice daily (BDP800), or placebo (BDP400) in addition to beclomethasone 200 microg twice daily. No significant differences between groups were found in FEV1, PD20 methacholine, symptom scores, and exacerbation rates after 1 yr. Salmeterol resulted in slightly better PEF in the first months of treatment. FEV1, and PD20 methacholine significantly improved in all groups. After 1 yr mean changes in FEV1, percent predicted were 4.3% (95% CI 1.3; 7.2), 5.8% (95% CI 2.9; 8.7), and 4.3% (95% CI 2.1; 6.5) for BDP400+salm, BDP800, and BDP400, respectively. Changes in airway responsiveness were 0.60 (95% CI 0.05; 1.14), 1.30 (95% CI 0.73; 1. 87), and 0.80 (95% CI 0.33; 1.27) doubling doses. Growth was significantly slower in the BDP800 group. We conclude that no additional benefit was found of adding either salmeterol or more beclomethasone to a daily dose of 400 microg beclomethasone in this group of children with excellent compliance of medication.
Short-term growth during treatment with inhaled fluticasone propionate and beclomethasone dipropionate.
Short-term lower leg growth was investigated with twice weekly knemometry measurements in 19 schoolchildren with mild asthma during treatment with daily doses of 200 micrograms fluticasone propionate, 400 micrograms, and 800 micrograms beclomethasone dipropionate from a dry powder inhaler. The design was a randomised, double blind, crossover trial. After a run in period of four days (period 1) the children were allocated to a sequence of active treatments in periods 2, 4, and 6. In periods 3 and 5 (wash out) placebo was given. All periods except the run in were two weeks long. The mean lower leg growth velocities during the wash out periods were 0.61 and 0.80 mm/week. Mean growth velocities during treatment with fluticasone propionate and low and high doses of beclomethasone dipropionate were 0.34, 0.09, and 0.06 mm/week respectively. Compared with fluticasone propionate, treatment with beclomethasone dipropionate 400 and 800 micrograms/day was associated with a statistically significant reduction in growth velocity.
Options:
A: Higher doses of BDP consistently showed significant clinical improvements across all measured outcomes.
B: BDP demonstrated a shallow dose response effect for a small number of efficacy outcomes, with questionable clinical significance of higher doses.
C: Lower doses of BDP were found to be more effective than higher doses in improving asthma control.
D: There was no observable difference in efficacy between different doses of BDP.
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B
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the effectiveness and safety of acetazolamide in the treatment of hypercapnic ventilatory failure due to chronic obstructive pulmonary disease (COPD)? Please answer this question based on the information provided below:
[Acetazolamide in hypercapnic chronic obstructive lung disease--a renaissance?].
The use of acetazolamide, a carbonic anhydrase inhibitor, in chronic obstructive pulmonary disease (COPD) remains controversial. A substantial improvement in blood gas values has been documented, with correction of metabolic alkalosis in COPD, in hypoxemic sleep apnea at high altitudes and in acute mountain sickness. This randomized, double-blind study examined the short and long term effects of acetazolamide (2 X 250 mg) on 14 patients with hypoxemia, hypercapnia and metabolic alkalosis (paO2 49 +/- 5.2 mm Hg, paCO2 50 +/- 3.6 mm Hg, base excess + 5.7 +/- 2.3). A crossover between acetazolamide and placebo occurred on days 3, 6 and 9. On day 12 the patients were again randomized and one group further treated with acetazolamide for 4 1/2 (1-7) months. During the short term phase, a significant rise in paO2 to 58 +/- 6.6 mm Hg with acetazolamide was noted, followed by a drop to 53 +/- 5.7 mm Hg with placebo. The paO2 of the five patients on long-term acetazolamide therapy remained unchanged (59 +/- 2.5 mm Hg) while the untreated patients showed a significant drop in paO2 to 46 +/- 8.2 mm Hg. No side effects and no severe metabolic acidosis were noted during acute or long term treatment. Acetazolamide appears to improve hypoxemic and hypercapnic COPD patients with metabolic alkalosis on short and long term therapy.
Relative effectiveness of acetazolamide versus medroxyprogesterone acetate in correction of chronic carbon dioxide retention.
Effects of chlormadinone acetate, acetazolamide and oxygen on awake and asleep gas exchange in patients with chronic obstructive pulmonary disease (COPD).
The purpose of this study was to assess the short-term effects of chlormadinone acetate (CMA), a synthetic progestogen, acetazolamide (ACET) and oxygen on awake and asleep blood gas values. The study was conducted according to a randomized, double-blind and placebo-controlled design in 53 hypoxaemic patients with chronic obstructive pulmonary disease. On the first two consecutive nights, all patients received either room air or oxygen, via a nasal cannula, in random order. They then received either CMA (25 mg), ACET (250 mg) or placebo twice a day, all in identical capsules. On the third study night, after one week of drug treatment, the patients were tested breathing room air. CMA and ACET therapy decreased mean daytime arterial carbon dioxide tension (PaCO2) by 0.7 and 0.5 kPa, respectively, and night-time end-tidal carbon dioxide tension (PETCO2) by 0.5 and 0.3 kPa, respectively. Supplemental oxygen caused increased CO2 retention during the day and night (0.6 and 0.3 kPa, respectively. Daytime arterial oxygen tension (PaO2) increased to the same extent during ACET (1.9 kPa) and oxygen (2.5 kPa). Asleep oxygen saturation improved most with oxygen supplementation (7%), although ACET also caused significant improvement (4%). CMA administration had virtually no effect on mean awake and asleep hypoxaemia. ACET therapy significantly improved subjective sleep quality. On CMA, minute ventilation increased in association with an augmentation of the hypercapnic ventilatory response. ACET treatment increased both hypercapnic and hypoxic ventilatory responses. We conclude from the group of patients with COPD studied, that the short-term effects of ACET treatment on gas exchange compare favourably with those of CMA. Oxygen therapy improves oxygenation slightly more than ACET, but aggravates CO2 retention.
Comparison of acetazolamide and medroxyprogesterone as respiratory stimulants in hypercapnic patients with COPD.
BACKGROUND: Acetazolamide and medroxyprogesterone acetate (MPA) are two respiratory stimulants that can be used in patients with stable hypercapnic COPD.
DESIGN AND METHODS: The effects of acetazolamide, 250 mg bid, and MPA, 30 mg bid, on daytime and nighttime blood gas values and the influences on the hypercapnic and hypoxic ventilatory and mouth occlusion pressure (P(0.1)) at 100 ms response were studied in a crossover design in 12 hypercapnic patients with stable COPD (FEV(1), 33 +/- 4% predicted [mean +/- SEM]).
RESULTS: Daytime PaCO(2) decreased from 47.3 +/- 0.8 mm Hg (placebo) to 42.0 +/- 1.5 mm Hg during acetazolamide treatment (p < 0.05) and to 42.8 +/- 1.5 mm Hg during MPA treatment (p < 0.05). Daytime PaO(2) improved with acetazolamide from 65.2 +/- 2.3 to 75.0 +/- 3.0 mm Hg (p < 0.05), whereas no significant changes were seen with MPA. Mean nocturnal end-tidal carbon dioxide tension decreased with both treatments, from 42.0 +/- 2.3 to 35.3 +/- 2.3 mm Hg with acetazolamide (p < 0.05) and to 34.5 +/- 0.8 mm Hg with MPA (p < 0.05). The percentage of time that the nocturnal arterial oxygen saturation was < 90% was reduced significantly with acetazolamide, from 34.9 +/- 10.7% to 16.3 +/- 7.5% (p < 0.05). Mean nocturnal saturation did not change with MPA. Resting minute ventilation increased significantly only with MPA from 9.6 +/- 0.7 to 10.8 +/- 0.8 L/min (p < 0.05). The slope of the hypercapnic ventilatory response did not change during acetazolamide and MPA therapy. The hypoxic ventilatory response increased from - 0.2 +/- 0.05 to - 0.4 +/- 0.1 L/min/% during acetazolamide (p < 0.05) and to - 0.3 +/- 0.1 L/min/% during MPA (p < 0.05). The hypoxic P(0.1) response improved with acetazolamide treatment from - 0.05 +/- 0.008 to - 0.15 +/- 0.02 mm Hg/% (p < 0.05).
CONCLUSIONS: This study shows that acetazolamide and MPA both have favorable effects on daytime and nighttime blood gas parameters in ventilatory-limited patients with stable COPD. However, the use of acetazolamide is preferred because of its extra effect on nocturnal saturation.
Options:
A: Acetazolamide significantly reduced arterial carbon dioxide levels (PCO2) and improved health status and symptoms.
B: Acetazolamide caused a significant rise in arterial oxygen levels (PO2) and a non-significant fall in arterial carbon dioxide levels (PCO2), with infrequent side effects.
C: Acetazolamide had no effect on arterial oxygen levels (PO2) or carbon dioxide levels (PCO2) and was associated with frequent side effects.
D: Acetazolamide significantly improved sleep and reduced hospital admissions and deaths.
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B
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What strategies have been found to be effective in increasing women's participation in community breast cancer screening programs? Please answer this question based on the information provided below:
Improving uptake of breast screening in multiethnic populations: a randomised controlled trial using practice reception staff to contact non-attenders.
OBJECTIVES: To determine whether a two hour training programme for general practice reception staff could improve uptake in patients who had failed to attend for breast screening, and whether women from different ethnic groups benefited equally.
DESIGN: Controlled trial, randomised by general practice.
SETTING: Inner London borough of Newham.
SUBJECTS: 2064 women aged 50-64 years who had failed to attend for breast screening. Women came from 26 of 37 eligible practices, 31% were white, 17% were Indian, 10% Pakistani, 14% black, 6% Bangladeshi, 1% Chinese, 4% were from other ethnic groups, and in 16% the ethnic group was not reported.
MAIN OUTCOME MEASURES: Attendance for breast screening in relation to ethnic group in women who had not taken up their original invitation.
RESULTS: Attendance in the intervention group was significantly better than in the control group (9% v 4%). The response was best in Indian women--it was 19% in the intervention group and 5% in the control group.
CONCLUSIONS: This simple, low cost intervention improved breast screening rates modestly. Improvement was greatest in Indian women--probably because many practice staff shared their cultural and linguistic background. This intervention could be effective as part of a multifaceted strategy to improve uptake in areas with low rates.
Does telephone contact with a physician's office staff improve mammogram screening rates?
BACKGROUND AND OBJECTIVES: Mammography is an important screening tool for the early detection of breast cancer. However, mammogram screening rates are low, despite interventions to improve them. We investigated two methods to improve mammogram screening and compared mammogram rates among women who received these interventions to mammogram screening rates in a control group. We also investigated the costs involved in these interventions.
METHODS: We studied mammogram screening rates of three randomized groups of women ages 50 and older from the Deighton Family Practice Center in Southfield, Mich. All women had had a mammogram 1 year previously and were due for another mammogram. Our control group (n = 110) received no intervention. The second group of women (n = 102) received a reminder letter from the radiology department. The third group (n = 86) received a reminder letter followed by a phone call from the physician's office staff if no mammogram had been obtained within 8 weeks after the due date for the mammogram. All three groups were monitored for 14 weeks after the due date to determine mammogram screening rates in each group.
RESULTS: A mammogram was obtained by 33% of women in group 1, 37% of women in group 2, and 57% of women in group 3. The mammogram screening rate of the third group was significantly greater than in the first two groups. In the third group, the additional cost added by the phone call intervention was $9 per mammogram obtained.
CONCLUSION: Mammogram screening rates are increased when patients are contacted by both a reminder letter and a phone call.
A randomized study of cancer screening in a family practice setting using a recall model.
A randomized controlled study that evaluated a recall system and patient education material by mail in 178 asymptomatic female family practice patients aged 50 to 69 years showed no effect on the proportion of patients who had cancer screening tests (P = .20) and a significant adverse effect on the mean number of tests performed (P = .05) after 4 months. In a subgroup of previous compliers (those who had one or more tests 12 months before the study), however, there was a lower proportion of patients receiving one or more tests (P = .019) with a lower mean number of tests (P = .007) than previous compliers in the control group. Recall strategies for cancer screening tests need to be more extensively studied in the United States before they are routinely adopted in family practice.
Evaluation of a phone intervention to promote mammography in a managed care plan.
Can the uptake of breast screening by Asian women be increased? A randomized controlled trial of a linkworker intervention.
This study investigates the effectiveness of a linkworker intervention, giving encouragement and explanations about breast screening, on the subsequent attendance for screening by 'Asian' women. The control group received no visits. The study population comprised all women with Asian names, from a batch of general practices where high proportions of patients were Asian, who were invited for screening. It was found that 59 per cent of the intervention group could be contacted by linkworkers. No difference in attendance was found between the intervention and control groups (49 per cent and 47 per cent). Twenty-five per cent of women were permanently or temporarily not resident at the invitation address. Attendance for screening was related to length of stay in the United Kingdom. This type of intervention was not a successful strategy for promoting uptake by Asian women, and indicates that it is essential to evaluate rigorously projects with such objectives.
A randomised trial of general practitioner-written invitations to encourage attendance at screening mammography.
The aim of this study was to examine the effectiveness of general practitioner-written invitations to the Breast X-Ray Programme of the Central Sydney Area Health Service. Five out of six randomly selected general practices in Drummoyne participated. Within each practice, women aged 45 to 70 were individually randomised to receive or not receive a letter from their general practitioner (GP). Thirty-two per cent of women attended if invited compared to 7 per cent if they were not sent an invitation. An attendance of 38 per cent was obtained for women whose GP chose to send a letter with an appointment compared to 24 per cent for women whose GP chose to send a general invitation without an appointment. Combining all practices, women who consulted their GP within the previous 6 months were more likely to attend in response to the invitation (38 per cent) than women whose last consultation was more remote, dropping to 15 per cent in those who last attended that GP over 2 years earlier. Women aged 65 to 70 years old were at least as likely to respond to the invitation as women aged 45 to 64. Reminder letters were subsequently sent to a random half of nonrespondents who had attended the practice in the previous 12 months. A further 18 per cent of women attended after the reminder letter was sent (8/45), compared with 2 per cent in the control group (1/48). Twenty-seven per cent of women in Drummoyne had already attended for screening mammography before the trial.(ABSTRACT TRUNCATED AT 250 WORDS)
A two-step intervention of increase mammography among women aged 65 and older.
OBJECTIVES: This study evaluated a two-step intervention for mammography screening among older women.
METHODS: Four hundred and sixty women, identified from physician practices, were randomized to a control or a two-step intervention (physician letter and peer counseling call) group. Women in the intervention group who obtained a mammogram received a grocery coupon.
RESULTS: Over the 12 months of the study, more women in the intervention group than in the control group obtained mammograms (38% vs 16%). The most dramatic difference was in the higher odds that women in the intervention group would obtain a mammogram within 2 months (odds ratio = 10.5).
CONCLUSIONS: The intervention significantly increased screening mammography. Future efforts must be multifaceted and incorporate the unique concerns of older women.
Breast and cervical cancer screening in a low-income managed care sample: the efficacy of physician letters and phone calls.
A randomized trial was conducted to evaluate the combined impact of a physician reminder letter and a telephone contact on the use of Pap tests and mammograms in a low-income managed care program. Women 40 to 79 years of age who were past due for cancer screening were randomly assigned to an intervention or control group. Medical claims were reviewed after 6 months to determine intervention effectiveness. The odds of receiving all needed cancer screening tests during follow-up were four times higher in the intervention group. Women who reported having to take time off from work to see a doctor had lower odds of getting screened.
The impact of mailing psychoeducational materials to women with abnormal mammograms.
A randomized trial was conducted to evaluate the impact of mailed psychoeducational materials on adherence to subsequent annual mammography among women with prior abnormal mammograms. The results showed a 13% increment in adherence among women who received this intervention. This effect was independent of all sociodemographic and medical variables examined. We conclude that mailed psychoeducational materials may be an effective mechanism to improve adherence among women with abnormal mammogram results.
Enhancing compliance with screening mammography recommendations: a clinical trial in a primary care office.
BACKGROUND AND OBJECTIVES: Despite consensus that screening mammography is an appropriate preventive tool, many women do not receive this examination. This study was undertaken to evaluate the relative efficacy and cost-effectiveness of three interventions designed to increase mammography rates.
METHODS: A total of 151 women, aged 50-59, were randomized into four groups: control, physician telephone call, medical assistant telephone call, and physician letter.
RESULTS: The women in the medical assistant telephone call group (16 of 37 = 43%) and the physician telephone call group (11 of 38 = 29%) responded significantly better than those in the control group (4 of 38 = 11%) (P < .05). None of the 10 widows in the entire study obtained a mammogram, compared with 38 of 141 (27%) women in all other marital groups (P < .05). The cost per intervention and cost per mammogram obtained were, respectively, physician telephone call: $15, $51.82; physician letter: $2.50, $13.57; medical assistant call: $1.30, $3.
CONCLUSIONS: Medical assistant telephone callers are a cost-effective strategy to encourage mammography adherence. Widows appear particularly resistant to all screening mammography interventions.
The effect of patient and provider reminders on mammography and Papanicolaou smear screening in a large health maintenance organization.
BACKGROUND: We evaluated the effectiveness of 2 reminder interventions to increase the use of screening mammograms and Papanicolaou (Pap) smears among female members of a large health maintenance organization.
METHODS: Seven thousand seventy-seven female health maintenance organization members (aged 50-74 years with no prior mammogram in the previous 30 months or aged 20-64 years with no prior Pap smear in the previous 36 months) were randomized to receive one of the following: a letter inviting them to make an appointment for a mammogram or a Pap smear; in addition to the letter, a reminder manually placed in the patient's medical chart alerting providers of that member's need for screening; or their usual care.
RESULTS: Compared with women who did not receive the reminder letter, women who did receive the letter were more likely to obtain mammograms (16.0% vs 25.5%, respectively; P < .001) or Pap smears (9.1% vs 19.5%, respectively; P < .001) in the 6 months following their entry into the study. Compared with women who received only the reminder letter, women who received a reminder letter and had a reminder placed in their medical chart were more likely to obtain mammograms (26.5% vs 30.9%, respectively; P = .02) and marginally more likely to receive Pap smears (19.5% vs 22.8%, respectively; P = .04).
CONCLUSIONS: We recommend the use of patient reminder letters as a first step in a mammography or Pap smear screening outreach program. Further research is needed to evaluate a cost-effective provider reminder system and additional outreach strategies directed to women who do not use health care services.
Cancer screening intervention among black women in inner-city Atlanta--design of a study.
This experimental study attempts to determine if an in-home educational intervention conducted by lay health workers (LHWs) can increase adherence among low-income, inner-city black women to schedules for screening for breast cancer and cervical cancer, as well as increase the women's knowledge and change their attitudes regarding these cancers. This paper is a description of the purposes, hypotheses, design, subject recruitment, intervention, and evaluation of the study conducted by Morehouse School of Medicine. Subjects were recruited from a variety of sources, including patients seen in a community health center, women referred by the National Black Women's Health Project (NBWHP), residents of public and senior citizen housing projects, and persons identified in various community settings. Fewer than half of those asked to participate agreed to do so. The 321 women who were recruited were demographically diverse. Overall, about half of these volunteer subjects self-reported at least one Papanicolaou (Pap) smear and one breast examination within a year before enrollment in the study. There was little variation by source of recruitment in compliance with screening recommendations, except that referrals from NBWHP were more likely (P less than 0.01) to have had a Pap test and breast self-examination, while residents of public housing projects were somewhat less likely to have done so. About 35 percent of participants ages 35 and older had a mammogram within an appropriate interval. Participants were randomly assigned to intervention and control groups. Women in the intervention group were visited in their homes by LHWs on three occasions; the LHWs provided education on cancer and reproductive health. The groups were comparable in their baseline sociodemographic status and previous screening history.
Prospective study of predictors of attendance for breast screening in inner London.
OBJECTIVE: To investigate the predictors of first-round attendance for breast screening in an inner city area.
DESIGN: Prospective design in which women were interviewed or completed a postal questionnaire before being sent their invitation for breast screening. Sociodemographic factors, health behaviours, and attitudes, beliefs, and intentions were used as predictors of subsequent attendance. A randomised control group was included to assess the effect of being interviewed on attendance.
SETTING: Three neighbouring health districts in inner south east London.
PARTICIPANTS: A total of 3291 women aged 50-64 years who were due to be called for breast screening for the first time. The analysis of predictors was based on a subsample of 1301, reflecting a response rate of 75% to interview and 36% to postal questionnaire.
MAIN RESULTS: Attendance was 42% overall, and 70% in those who gave an interview or returned a questionnaire. There was little evidence for an interview effect on attendance. The main findings from the analysis of predictors are listed below. (These were necessarily based on those women who responded to interview/questionnaire and so may not be generalisable to the full sample.) (1) Sociodemographic factors: Women in rented accommodation were less likely to go for screening but other indicators of social class and education were not predictive of attendance. Age and other risk factors for breast cancer were unrelated to attendance, as was the distance between home and the screening centre. Married or single women were more likely to attend than divorced, separated, or widowed women, and black women had a higher than average attendance rate; however, neither of these relationships was found in the interview sample. (2) Health behaviours: Attenders were less likely to have had a recent breast screen, more likely to have had a cervical smear, more likely to go to the dentist for check ups, and differed from non-attenders with regard to drinking frequency. Exercise, smoking, diet change, and breast self-examination were unrelated to attendance. (3) Attitudes, beliefs, and intentions: The two best predictors were measures of the perceived importance of regular screening for cervical and breast cancer and intentions to go for breast screening. Also predictive were beliefs about the following: the personal consequences of going for breast screening, the effectiveness of breast screening, the chances of getting breast cancer, and the attitudes of significant others (the woman's husband/partner and children). Women who reported a moderate amount of worry about breast cancer were more likely to attend than those at the two extremes.
CONCLUSIONS: Attenders and non-attenders differ in two broad areas: the health related behaviours they engage in and the attitudes, beliefs, and intentions they have towards breast cancer and breast screening. The latter are potentially amenable to change, and though different factors may operate among women who do not respond to questionnaires, the findings offer hope that attendance rates can be improved by targeting the relevant attitudes and beliefs. This could be done by changing the invitation letter and its accompanying literature, through national and local publicity campaigns, and by advice given by GPs, practice nurses, and other health professionals. It is essential that such interventions are properly evaluated, preferably in randomised controlled studies.
A randomised trial of invitations to attend for screening mammography.
The aim of this study was to evaluate the effectiveness of invitations for mammographic screening. Women aged 45 to 69 who had not attended for screening at the mobile Breast X-Ray Programme of the Central Sydney Area Health Service were randomly selected from the 1989 electoral listing. In the geographical area in which the study was conducted (Drummoyne local government area), 36 per cent of women had attended for screening before the intervention, indicating that the invitations were aimed at the reluctant participant. Women were randomly allocated to a control group who did not receive invitations (n = 80), and an intervention group who received letters from the Program inviting them to attend at a specified time (n = 163). Overall 33 per cent of women (53 of 163) who were sent invitations attended for screening compared to 9 per cent of those not invited (7 of 80) (P less than 0.001). Older women responded at least as well as younger women. In addition, the distribution of language spoken at home was similar for electoral listing attenders and the community as a whole, suggesting that this intervention works as well for women of English- and non-English-speaking backgrounds. The results suggest that the response to an invitation for screening from a source not personally known to women achieves comparable attendance to an invitation from their general practitioner, as assessed in a previous study.
Options:
A: Letter of invitation, mailed educational material, letter of invitation plus phone call, phone call, and training activities plus direct reminders.
B: Home visits and letters of invitation to multiple examinations plus educational material.
C: Only mailed educational material and phone calls.
D: No active strategies were found to be effective.
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A
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What are the recommended treatment regimens for the acute and maintenance phases of melioidosis based on evidence from randomised trials? Please answer this question based on the information provided below:
A comparison of chloramphenicol, trimethoprim-sulfamethoxazole, and doxycycline with doxycycline alone as maintenance therapy for melioidosis.
A prospective, open, randomized, comparative treatment trial was conducted to compare the therapeutic efficacy of the conventional four-drug combination (chloramphenicol, trimethoprim-sulfamethoxazole, and doxycycline) with that of doxycycline alone in oral maintenance treatment of melioidosis. Adult Thai patients with culture-confirmed melioidosis were randomized to receive treatment with either regimen for a minimum of 12 weeks, usually following intravenous treatment of severe disease. The main outcome measure was culture-confirmed relapse. One hundred sixteen patients were enrolled; 109 had culture-confirmed melioidosis, and 87 were considered evaluable (43 had received doxycycline). Culture-confirmed relapse occurred in one patient randomized to the conventional regimen and in 11 (25.6%) randomized to the doxycycline regimen (P = .009), and treatment failed for 8 (18.2%) versus 20 (46.5%), respectively (P = .009). Adverse effects occurred in 26% of patients overall. Doxycycline alone cannot be recommended for a first-line regimen of oral maintenance treatment of melioidosis.
Open-label randomized trial of oral trimethoprim-sulfamethoxazole, doxycycline, and chloramphenicol compared with trimethoprim-sulfamethoxazole and doxycycline for maintenance therapy of melioidosis.
Melioidosis (infection caused by Burkholderia pseudomallei) requires a prolonged course of oral antibiotics following initial intravenous therapy to reduce the risk of relapse after cessation of treatment. The current recommendation is a four-drug regimen (trimethoprim [TMP], sulfamethoxazole [SMX], doxycycline, and chloramphenicol) and a total treatment time of 12 to 20 weeks. Drug side effects are common; the aim of this study was to compare the efficacy and tolerance of the four-drug regimen with a three-drug regimen (TMP-SMX and doxycycline). An open-label, randomized trial was conducted in northeast Thailand. A total of 180 adult Thai patients were enrolled, of which 91 were allocated to the four-drug regimen and 89 to the three-drug regimen. The trial was terminated early due to poor drug tolerance, particularly of the four-drug regimen. The culture-confirmed relapse rates at 1 year were 6.6% and 5.6% for the four- and three-drug regimens, respectively (P = 0.79). The three-drug regimen was better tolerated than the four-drug regimen; 36% of patients receiving four drugs and 19% of patients receiving three drugs required a switch in therapy due to side effects (P = 0.01). The duration of oral therapy was significantly associated with relapse; after adjustment for confounders, patients receiving less than 12 weeks of oral therapy had a 5.7-fold increase of relapse or death. A combination of TMP-SMX and doxycycline is as effective as and better tolerated than the conventional four-drug regimen for the oral treatment phase of melioidosis.
A randomized controlled trial of granulocyte colony-stimulating factor for the treatment of severe sepsis due to melioidosis in Thailand.
BACKGROUND: Melioidosis is a tropical infectious disease associated with significant mortality. Most deaths occur early and are caused by fulminant sepsis.
METHODS: In this randomized, placebo-controlled trial, we assessed the efficacy of lenograstim (granulocyte colony-stimulating factor [G-CSF], 263 mu g per day administered intravenously) in ceftazidime-treated patients with severe sepsis caused by suspected melioidosis in Thailand.
RESULTS: Over a 27-month period, 60 patients were enrolled to receive either G-CSF (30 patients, 18 of whom had culture-confirmed melioidosis) or placebo (30 patients, 23 of whom had culture-confirmed melioidosis). Mortality rates were similar in both groups (G-CSF group, 70%; placebo group, 87%; risk ratio, 0.81; 95% confidence interval, 0.61-1.06; P=.2), including among patients with confirmed melioidosis (83% vs. 96%; P=.3). The duration of survival was longer for patients who received G-CSF than for patients who received placebo (33 h vs. 18.6 h; hazard ratio, 0.56; 95% confidence interval, 0.31-1.00; P=.05).
CONCLUSIONS: Receipt of G-CSF is associated with a longer duration of survival but is not associated with a mortality benefit in patients with severe sepsis who are suspected of having melioidosis in Thailand. We hypothesize that G-CSF may "buy time" for severely septic patients, but survival is more likely to be improved by management of associated metabolic abnormalities and organ dysfunction associated with severe sepsis.
Randomized, double-blind, controlled study of cefoperazone-sulbactam plus cotrimoxazole versus ceftazidime plus cotrimoxazole for the treatment of severe melioidosis.
We conducted a prospective randomized, double-blind, controlled study of cefoperazone-sulbactam (ratio, 1:1; cefoperazone 25 mg/kg/day) plus cotrimoxazole (trimethoprim-sulfamethoxazole [TMP-SMZ] at a ratio of 80:400; TMP, 8 mg/kg/day) versus ceftazidime (100 mg/kg/day) plus cotrimoxazole (TMP, 8 mg/kg/day) for the treatment of severe melioidosis. Of 219 patients enrolled in the study, 102 (47%) had culture-proven melioidosis. These patients were assigned randomly to 2 treatment groups, each with 50 patients (2 patients were excluded). Mortality rates were not significantly different between the 2 groups: 18% in the cefoperazone-sulbactam group versus 14% in the ceftazidime group. The crude difference in the mortality rate was 4%, but when adjusted for type of infection the difference was 0.9% (95% confidence interval, -3.6% to 5.4%; P = .696). The duration of defervescence and the bacteriological response of successfully treated patients were similar in both groups, and both treatment regimens were well tolerated. Cefoperazone-sulbactam plus cotrimoxazole might be used as an alternative to ceftazidime plus cotrimoxazole as treatment for severe melioidosis.
Maintenance therapy of melioidosis with ciprofloxacin plus azithromycin compared with cotrimoxazole plus doxycycline.
This is a report of a randomized, open, labeled study of the maintenance treatment of melioidosis using a combination of ciprofloxacin and azithromycin (Regimen A) for 12 weeks versus a combination of cotrimoxazole and doxycycline (Regimen B) for 20 weeks. The study was conducted at two tertiary-care hospitals in northeast Thailand. A total 65 patients were enrolled, 36 and 29, respectively, between August 1997 and July 1998. Subjects were randomly allocated to each arm of the trial, resulting in 32 treated under Regimen A and 33 in B. The main outcome was a culture-proven relapse in melioidosis. There were more relapses under Regimen A at 22% (7 of 32) than in Regimen B, 3% (1 of 33). The 19% difference in the rates was significant (95% confidence interval [CI]: 3% to 34%; exact P-value = 0.027). Based on our data, a combination of cotrimoxazole and doxycycline treatment for 20 weeks should be given further consideration as the maintenance therapy of choice for melioidosis.
Two randomized controlled trials of ceftazidime alone versus ceftazidime in combination with trimethoprim-sulfamethoxazole for the treatment of severe melioidosis.
BACKGROUND: Two antibiotic regimens are used commonly in Thailand for the initial treatment of severe melioidosis: ceftazidime in combination with trimethoprim-sulfamethoxazole (TMP-SMX) and ceftazidime monotherapy. It is not known whether TMP-SMX provides an additional benefit.
METHODS: Two prospective, randomized trials that compared these regimens for patients presenting with acute severe melioidosis were started independently at tertiary care hospitals in Ubon Ratchathani and Khon Kaen (in northeastern Thailand), and the results were analyzed together as a prospective, individual-patient data meta-analysis. The primary end point was in-hospital mortality rate.
RESULTS: The in-hospital mortality rate among all enrolled patients (n=449) was not significantly different between those randomized to ceftazidime alone (25.1%; 56 of 223 subjects) and those randomized to ceftazidime with TMP-SMX (26.6%; 60 of 226 subjects; odds ratio [OR], 1.08; 95% confidence interval [CI], 0.7-1.7; stratified P=.73). Of the 241 patients with culture-confirmed melioidosis, 51 (21.2%) died. Of these 241 patients, 31 (12.9%) died > or =48 h after the time of study entry. Among patients with melioidosis, there was no difference in death rate between the 2 treatment groups for either all deaths (OR, 0.88; 95% CI, 0.48-1.6; stratified P=.70) or for deaths that occurred > or =48 h after hospital admission (OR, 0.88; 95% CI, 0.41-1.9; stratified P=.73). Conditional logistic regression analysis revealed that bacteremia, respiratory failure, and renal failure were independently associated with death and treatment failure. Drug regimens were not associated with death or treatment failure in this model.
CONCLUSION: We conclude that the addition of TMP-SMX to ceftazidime therapy during initial treatment of severe melioidosis does not reduce the acute mortality rate.
A prospective comparison of co-amoxiclav and the combination of chloramphenicol, doxycycline, and co-trimoxazole for the oral maintenance treatment of melioidosis.
An open randomized comparison of the oral 'conventional' regimen (combination of chloramphenicol, cotrimoxazole and doxycycline) and co-amoxiclav for the maintenance treatment of melioidosis was conducted in Ubon Ratchatani, north-eastern Thailand, between 1989 and 1992. The total antibiotic treatment duration was 20 weeks. Of 101 patients followed, 10 (10%; 95% confidence interval [CI] 4.9-17.5%) subsequently relapsed: 2 of 52 patients (4%) in the oral 'conventional' group, and 8 of 49 patients (16%) receiving oral co-amoxiclav. This compares with a relapse rate of 23% in our previous study of 8 weeks' total therapy. Only 50% of patients complied with the 20 weeks' treatment regimen and poor compliance proved the most significant risk factor for subsequent relapse (relative risk [RR] 4.9, 95% CI 1.2-20.3). Neither the presence of known underlying disease nor choice of initial parenteral treatment was significantly associated with a higher risk of relapse. Co-amoxiclav is safer and better tolerated, but may be less effective (RR of relapse 0.4, 95% CI 0.2-1.2) than the oral 'conventional' regimen. The minimum duration of total treatment with either regimen should be 12-20 weeks, depending on clinical progress.
Comparison of imipenem and ceftazidime as therapy for severe melioidosis.
An open, prospective, randomized, comparative treatment trial was conducted to compare the therapeutic efficacy of high-dose intravenous imipenem and ceftazidime for acute severe melioidosis. Adult Thai patients with suspected acute, severe melioidosis were randomized to receive either imipenem, at a dosage of 50 mg/(kg x d), or ceftazidime, at a dosage of 120 mg/(kg x d), for a minimum of 10 days. The main outcome measures were death or treatment failure. Of the 296 patients enrolled, 214 had culture-confirmed melioidosis, and 132 (61.7%) of them had positive blood cultures. Mortality among patients with melioidosis was 36.9% overall. There were no differences in survival overall (P = .96) or after 48 hours (P = .3). Treatment failure after 48 hours was more common among patients treated with ceftazidime (P = .011). Both treatments were well tolerated. Imipenem is a safe and effective treatment for acute severe melioidosis and may be considered an alternative to ceftazidime.
Multicenter prospective randomized trial comparing ceftazidime plus co-trimoxazole with chloramphenicol plus doxycycline and co-trimoxazole for treatment of severe melioidosis.
A prospective randomized trial was conducted at Srinagarind and Khon Kaen hospitals. Ceftazidime (100 mg/kg of body weight per day) and co-trimoxazole (trimethoprim, 8 mg/kg/day; sulfamethoxazole, 40 mg/kg/day) therapy was compared with conventional therapy (chloramphenicol, 100 mg/kg/day; doxycycline, 4 mg/kg/day; trimethoprim, 8 mg/kg/day; sulfamethoxazole, 40 mg/kg/day) in the treatment of 64 patients with bacteriologically confirmed cases of severe melioidosis who were admitted during September 1986 to January 1989. Of 61 evaluable patients (3 were excluded because of severe drug allergies), 42 were septicemic, and 31 of these patients had the most severe form, disseminated septicemic melioidosis. Their cumulative mortalities on day 7 were compared. There were significantly lower overall mortalities from melioidosis, septicemic melioidosis, and disseminated septicemic melioidosis in the group receiving the new treatment compared with those in the group receiving the conventional treatment (47 versus 18.5% [P = 0.039], 57.7 versus 25% [P = 0.039], and 82.3 versus 30.7% [P = 0.006], respectively); but the differences could have been influenced by the greater severity of illness, e.g., shock at initial presentation, in the patients who received the conventional treatment. Among patients with disseminated septicemia and initial shock, there was no significant difference in mortality between the regimens. Both regimens effectively eradicated bacteria from the circulation within 24 h (97 versus 96%, respectively). We recommend ceftazidime and co-trimoxazole as the drugs of choice for treatment of severe melioidosis, especially in those patients with disseminated septicemia.
Ceftazidime vs. amoxicillin/clavulanate in the treatment of severe melioidosis.
An open, paired, randomized, controlled trial of high-dose parenteral ceftazidime (120 mg/[kg.d]) vs. amoxicillin/clavulanate (160 mg/[kg.d]) for the treatment of severe melioidosis was conducted in Ubon Ratchatani in northeastern Thailand. Of 379 patients enrolled in the study, 212 (56%) had culture-proven melioidosis; 106 patients were in each treatment group. The overall mortality rate (47%) was similar for both treatment groups. However, 4 of 75 surviving patients in the ceftazidime group compared with 16 of 69 surviving patients in the amoxicillin/clavulanate group were switched to the alternate regimen because of an unsatisfactory clinical response after > or = 72 hours of treatment (P = .004). The overall therapeutic failure rate (i.e., treatment failure or death due to uncontrolled melioidosis) was significantly higher for the amoxicillin/clavulanate group than for the ceftazidime group (P = .02). Clinical and bacteriologic responses for successfully treated patients were similar in both groups, and both treatments were well tolerated. Parenteral amoxicillin/clavulanate is a safe and effective initial treatment, but parenteral ceftazidime remains the treatment of choice for severe melioidosis.
Cefoperazone/sulbactam + co-trimoxazole vs ceftazidime + co-trimoxazole in the treatment of severe melioidosis: a randomized, double-blind, controlled study.
A prospective randomized, double-blind, controlled study of cefoperazone/sulbactam (cefoperazone 25 mg/kg/day) + co-trimoxazole (trimethoprim 8 mg/kg/day) vs ceftazidime (100 mg/kg/day) + co-trimoxazole (trimethoprim 8 mg/kg/day) in the treatment of severe melioidosis was conducted at Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand, from July 1995 to September 1996. A total of 84 patients were enrolled in the study. Forty of them (48%) had culture-proven melioidosis and were randomly assigned to one of the two treatment groups, each group with 20 patients. Two cases (one in each treatment group) were excluded from the final analysis due to incomplete data. There was no significant difference in the mortality rate between the two groups-16 per cent (3/19) in the cefoperazone/sulbactam group vs 21 per cent (4/19) in the ceftazidime group (p > 0.05). Bacteriological responses of successfully treated patients were similar in both groups, and both treatment regimens were well tolerated. Cefoperazone/sulbactam + co-trimoxazole can therefore be used as an alternative treatment for severe melioidosis. However, to further support this conclusion, a study with a larger patient population is needed.
Halving of mortality of severe melioidosis by ceftazidime.
An open randomised trial was conducted to compare ceftazidime (120 mg/kg/day) with "conventional therapy" (chloramphenicol 100 mg/kg/day, doxycycline 4 mg/kg/day, trimethoprim 10 mg/kg/day, and sulphamethoxazole 50 mg/kg/day) in the treatment of severe melioidosis. A paired restricted sequential trial designed to detect a reduction in mortality from 80 to 40% in culture-positive patients surviving greater than 48 hours was stopped after 22 months. Of the 161 patients entered into the study, 65 had bacteriologically confirmed melioidosis and 54 of these were septicaemic. Ceftazidime treatment was associated with a 50% (95% CI 19-81%) lower overall mortality than conventional treatment (74% vs 37%; p = 0.009) and should now become the treatment of choice for severe melioidosis.
Options:
A: For the acute phase, regimens should contain ceftazidime or imipenem. For the maintenance phase, conventional four drug regimens including chloramphenicol, doxycycline, and trimethoprim-sulphamethoxazole are recommended.
B: For the acute phase, regimens should contain chloramphenicol, doxycycline, and co-trimoxazole. For the maintenance phase, amoxycillin-clavulanic acid and doxycycline alone are recommended.
C: For the acute phase, regimens should contain beta lactam antibiotics only. For the maintenance phase, any antibiotic regimen is effective.
D: For the acute phase, regimens should contain ceftazidime or imipenem. For the maintenance phase, amoxycillin-clavulanic acid and doxycycline alone are recommended.
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A
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157
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the contraceptive effectiveness, safety, and acceptability of using a diaphragm with and without spermicide? Please answer this question based on the information provided below:
The diaphragm with and without spermicide. A randomized, comparative efficacy trial.
OBJECTIVE: To determine the relative contraceptive efficacy of a diaphragm used with spermicide as compared to one used without.
STUDY DESIGN: Two hundred sixteen women entered the study between September 1985 and December 1990. Of these, 84 were randomly assigned to the diaphragm-only group and 80 to the diaphragm-with-spermicide group as their primary method of contraception. In addition, a spermicide-only group was planned originally to serve as a control group to assess the contribution to efficacy made by a spermicide alone. Thirty-nine women were randomly assigned to this group, and 13 selected themselves for it. All were followed for a maximum of 12 months. The primary outcome variable was accidental pregnancy. The statistical difference between the two diaphragm groups was analyzed.
RESULTS: The 12-month "typical use" failure rates for the diaphragm-only group were 28.6 per 100 women and for the diaphragm-with-spermicide group, 21.2. The 12-month cumulative consistent-use failure rates were 19.3 per 100 women for the diaphragm-only group as compared to 12.3 per 100 women for users of a diaphragm with spermicide.
CONCLUSION: Although the consistent use rates were not significantly different, this study had low statistical power and hence gives no support to the hypothesis that adjunctive spermicide use fails to improve the effectiveness of the diaphragm method, especially in view of the magnitude and direction of the difference observed. Unless a study with sufficient power proves that the use of a diaphragm alone is statistically as effective as use of a diaphragm with spermicide, use of a spermicide in conjunction with the diaphragm continues to be the appropriate clinical recommendation.
Options:
A: The diaphragm with spermicide is significantly more effective than the diaphragm without spermicide.
B: The diaphragm without spermicide is significantly more effective than the diaphragm with spermicide.
C: There is no significant difference in the effectiveness, safety, and acceptability between the diaphragm with and without spermicide.
D: The study was inconclusive due to being underpowered and unable to recruit the planned number of participants.
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D
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158
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the effect of early volume expansion compared to inotrope in reducing morbidity and mortality in very preterm infants? Please answer this question based on the information provided below:
Randomised controlled trial of plasma protein fraction versus dopamine in hypotensive very low birthweight infants.
Around 20% of very low birthweight infants admitted to a neonatal intensive care unit become hypotensive within 24 hours of their admission. Standard treatment is either expansion of the circulating volume by the infusion of plasma protein fraction or by using dopamine to improve cardiac function. The purpose of this study was to investigate by a randomised controlled trial which was the most appropriate treatment. Thirty nine infants were randomised to receive either plasma protein fraction or dopamine as first line treatment if they became hypotensive within 24 hours of admission to the neonatal intensive care unit. Seventeen of 19 (89%) infants responded to dopamine, whereas only 9/20 (45%) responded to plasma protein fraction. The median dose of dopamine needed to increase the blood pressure to at least the 10th centile was 7.5 micrograms/kg/min and was infused for a median duration of 18 hours. These observations suggest that dopamine should be used earlier in the treatment of these infants than has previously been recommended.
The haemodynamic effects of dopamine and volume expansion in sick preterm infants.
AIM: To determine the haemodynamic effects of dopamine and volume expansion in preterm neonates. Effect parameters were mean arterial blood pressure (MABP), left ventricular output (LVO) and global cerebral blood flow (CBF).
METHODS: In a randomised, clinical control trial 36 preterm neonates were randomised to receive either dopamine 5 microg/kg per min, volume expansion with albumin 20% 15 ml/kg or no treatment. Parameters were measured before and 2 h after initiation of treatment.
RESULTS: Dopamine was effective in increasing MABP; both treatments increased LVO, whereas no significant difference between the treatment groups and the control group could be demonstrated with regard to CBF.
CONCLUSION: No effect on global cerebral blood flow could be demonstrated in this study, despite significant effects on systemic circulatory parameters. However, the variance on the measurement of cerebral blood flow indicates that a small but clinically significant effect may have been overlooked.
Options:
A: Early volume expansion was more successful than inotrope at correcting low blood pressure in hypotensive preterm infants.
B: Inotrope was more successful than early volume expansion at correcting low blood pressure in hypotensive preterm infants.
C: Early volume expansion and inotrope were equally successful at correcting low blood pressure in hypotensive preterm infants.
D: Neither early volume expansion nor inotrope had any effect on correcting low blood pressure in hypotensive preterm infants.
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B
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159
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the effectiveness of permissive hypercapnia in improving outcomes for mechanically ventilated newborn infants? Please answer this question based on the information provided below:
Randomized trial of permissive hypercapnia in preterm infants.
OBJECTIVE: To determine whether a ventilatory strategy of permissive hypercapnia (PHC) reduces the duration of assisted ventilation in surfactant-treated neonates weighing 601 to 1250 g at birth.
DESIGN: Forty-nine surfactant-treated preterm infants (birth weight: 854 +/- 163 g; gestational age: 26 +/- 1.4 weeks) receiving assisted ventilation were randomized during the first 24 hours of age to a PHC group (PaCO(2): 45-55 mm Hg) or to a normocapnia group (NC; PaCO(2): 35-45 mm Hg). The primary outcome measure was the total number of days on assisted ventilation. Uniform extubation and reintubation criteria were used for both groups. All patients received aminophylline before extubation.
RESULTS: The total number of days on assisted ventilation expressed as median (25th-75th percentiles) was 2.5 (1.5-11.5) in the PHC group and 9.5 (2.0-22.5) in the NC group (Mann-Whitney U test). The number of patients on assisted ventilation throughout the first 96 hours after randomization was lower in the PHC group (log rank test). During that period, the ventilated patients in the PHC group had a higher PaCO(2) and lower peak inspiratory pressure, mean airway pressure, and ventilator rate than did those in the NC group. The percentage of patients requiring reintubation within 24 hours postextubation (PHC 17% vs NC 28%) and supplemental oxygen at 28 days of life (PHC 43% vs NC 64%) and the total days of oxygen supplementation (PHC 15 [4-53] vs NC 32 [17-50]) did not differ between the groups. There were no differences in mortality, air leaks, intraventricular hemorrhage, periventricular leukomalacia, retinopathy of prematurity, or patent ductus arteriosus.
CONCLUSION: A ventilatory strategy of PHC in preterm infants who receive assisted ventilation is feasible, seems safe, and may reduce the duration of assisted ventilation. assisted ventilation, respiratory distress syndrome, gentle ventilation, lung injury.
Options:
A: Permissive hypercapnia significantly reduced the incidence of death and chronic lung disease.
B: Permissive hypercapnia significantly improved long-term neurodevelopmental outcomes.
C: Permissive hypercapnia showed no significant overall benefit in reducing mortality or pulmonary and neurodevelopmental morbidity.
D: Permissive hypercapnia was found to be harmful and increased the incidence of intraventricular hemorrhage.
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C
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160
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the effect of different types of prompts on clinic appointment attendance for people with serious mental illness? Please answer this question based on the information provided below:
Telephone prompting to increase attendance at a Psychiatric Outpatient Clinic.
Although it has been commonly taught and has been reported elsewhere that telephone prompting increases the rate at which patients keep their first outpatient clinic appointment, this study indicated that the increased rate at which patients kept their first appointment was more likely related to socioeconomic factors (such as having a telephone) than to telephone prompting. The authors conclude that measures to improve services to patients need to be carefully scrutinized before one can assume that results following initiation of a new procedure are in fact due to that procedure.
Does an encouraging letter encourage attendance at psychiatric out-patient clinics? The Leeds PROMPTS randomized study.
BACKGROUND: The aim was to reduce non-attendance for first-time consultations at psychiatric out-patient clinics.
METHOD: The study was a pragmatic randomized controlled trial; the setting was seven inner-city UK out-patient clinics in Leeds. The participants were 764 subjects of working age with an appointment to attend a psychiatric out-patient clinic for the first time. The intervention was an 'orientation statement' letter delivered 24-48 h before the first appointment compared with standard care. The primary outcome measure was attendance at the first appointment; secondary outcomes included hospitalization, transfer of care, continuing attendance, discharge, presentation at accident and emergency and death by 1 year.
RESULTS: Follow-up was for 763 out of 764 subjects (>99%) for primary and for 755 out of 764 subjects (98.8%) of secondary outcome data. The orientation statement significantly reduced the numbers of people failing to attend [79 out of 388 v. 101 out of 376 subjects, relative risk 0.76, 95% confidence interval (CI) 0.59-0.98, number needed to treat 16, 95% CI 10-187].
CONCLUSIONS: Prompting people to go to psychiatric out-patient clinics for the first time encourages them to attend. Pragmatic trials within a busy working environment are possible and informative.
Strategies for reducing missed initial appointments in a community mental health center.
The present study attempted to reduce the missed initial appointment rate of an urban CMHC through the use of several intervention strategies. Individuals who called for an intake appointment were randomly assigned to either a control group or one of the following treatment conditions: orientation statement at the time the appointment was made, orientation statement plus phone prompt, or phone prompt only. The orientation statement only group had significantly fewer missed initial appointments than the control group (28% vs. 56%). A client reachability factor also played a role in predicting missed initial appointments.
Interventions for reducing missed initial appointments at a community mental health center.
The present study attempted to reduce the initial appointment no-show rates at a CMHC through the use of several intervention techniques. One hundred-fifty individuals who called for an intake appointment were randomly assigned to either a control group or one of the following experimental groups: letter prompt received one day before appointment, letter prompt received three days before appointment, orientation letter received one day before appointment or orientation letter received three days before appointment. Individuals assigned to the one day orientation group had significantly lower no-show rates than individuals assigned to the control group (17% vs. 43%). The other groups were not significantly different from the control group. The effectiveness of the one day orientation letter for reducing no-show rates and its application at a CMHC was discussed.
Options:
A: Telephone prompts one or two days before the appointment significantly increase attendance compared to the standard appointment management system.
B: Text-based prompts a few days before the appointment significantly increase clinic attendance compared to no prompt.
C: A combination of telephone and text-based prompts significantly reduces missed appointments compared to no prompt.
D: A standard letter prompt is significantly more effective than a letter 'orientation statement' in encouraging attendance.
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B
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161
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the effectiveness and safety of Chinese medicinal herbs for treating asymptomatic carriers of hepatitis B virus? Please answer this question based on the information provided below:
Failure of Phyllanthus amarus to eradicate hepatitis B surface antigen from symptomless carriers.
Failure of New Zealand hepatitis B carriers to respond to Phyllanthus amarus.
Efficacy of Phyllanthus amarus for eradication of hepatitis B virus in chronic carriers.
Sixty-five adult asymptomatic chronic carriers of hepatitis B virus were enrolled to the randomized controlled efficacy study of Phyllanthus amarus. Thirty-four received Phyllanthus amarus 600 mg per day for 30 days and 31 received placebo in identical capsules. The conversion rate of HBsAg was 6 per cent in the study group at day 30. When 20 subjects in the Phyllanthus amarus group were given a further 30-day treatment and 22 placebo recipients given Phyllanthus amarus 1,200 mg per day for 30 days, the conversion was observed in 1 (5%) in the higher dose group. Adverse effects were not observed in all patients receiving the plant. The results indicated that Phyllanthus amarus, whole plant except root, grown in the central part of Thailand, given at the studied dosage and duration, had a very minimal effect on eradication of HBsAg from Thai adult asymptomatic chronic carriers.
Options:
A: Chinese medicinal herbs, particularly 'Jianpi Wenshen recipe', showed significant antiviral effects compared to interferon, but other herbs like Phyllanthus amarus and Astragalus membranaceus did not show significant effects compared to placebo.
B: All Chinese medicinal herbs tested, including 'Jianpi Wenshen recipe', Phyllanthus amarus, and Astragalus membranaceus, showed significant antiviral effects compared to placebo.
C: Chinese medicinal herbs showed no significant antiviral effects compared to placebo or interferon.
D: Chinese medicinal herbs were found to be unsafe for treating asymptomatic carriers of hepatitis B virus.
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A
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162
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the effectiveness and safety of acetazolamide and furosemide therapy in treating post-hemorrhagic ventricular dilatation in newborn infants? Please answer this question based on the information provided below:
Acetazolamide and furosemide for posthemorrhagic hydrocephalus of the newborn.
The authors evaluated the efficacy of acetazolamide (ACZ) and furosemide (FUR) in avoiding ventricular shunting procedures in preterm infants with posthemorrhagic hydrocephalus (PHH) and increased intracranial pressure (ICP). Preterm infants were screened for PHH (defined as ventriculomegaly [VM] and increased ICP measured with the Ladd fiberoptic monitor). PHH infants were randomized to ACZ and FUR treatment or serial lumbar puncture (LP) and monitored until not receiving medications or having undergone shunting. Of 69 infants with IVH screened for the study, 39 never developed VM, 14 developed VM, without increased ICP, and 16 developed PHH. Ten PHH infants were randomized to ACZ and FUR treatment and six to serial LP. Nine (90%) of the 10 infants assigned to the ACZ and FUR group avoided shunting. Nephrocalcinosis developed in a significant proportion of treated infants. Three (50%) of the six LP group infants did not require shunting procedures (P = 0.118). The authors conclude that ACZ and FUR therapy is useful in the treatment of preterm infants with PHH. Because a significant number of infants treated with both ACZ and FUR developed nephrocalcinosis, close monitoring for increased calcium excretion in the urine, or use of ACZ without FUR, is advised.
Nephrocalcinosis complicating medical treatment of posthemorrhagic hydrocephalus.
Furosemide and acetazolamide are often used concurrently to treat posthemorrhagic hydrocephalus in premature infants with intraventricular hemorrhage. Eleven premature infants with posthemorrhagic hydrocephalus were monitored for the development of hypercalciuria during treatment using urine calcium/creatinine (Ca/Cr) ratios (normal: less than or equal to 0.21). Seven of 11 infants (64%) developed hypercalciuria; 5 of those 7 infants had nephrocalcinosis on renal ultrasonography. Infants who developed nephrocalcinosis had urine Ca/Cr ratios of 0.5-4.0. In all 5 infants with nephrocalcinosis, renal calculi decreased and urine Ca/Cr improved after drug therapy was discontinued. The combined use of acetazolamide and furosemide as therapy for posthemorrhagic hydrocephalus places premature infants at high risk for nephrocalcinosis. It is suggested that urine Ca/Cr be monitored closely in infants receiving these drugs and that other treatment modalities be considered when the urine Ca/Cr ratio exceeds 0.21.
International randomised controlled trial of acetazolamide and furosemide in posthaemorrhagic ventricular dilatation in infancy. International PHVD Drug Trial Group.
BACKGROUND: Furosemide and acetazolamide are widely used in the treatment of posthaemorrhagic ventricular dilatation (PHVD) in the hope of avoiding the need for surgical management, but this approach has not been evaluated in a controlled trial. This multicentre randomised controlled trial tested the hypothesis that these drugs would reduce the rate of shunt placement and increase disability-free survival at 1 year of age.
METHODS: Between 1992 and 1996, 177 infants aged less than 3 months past term, and with ventricular width more than 4 mm above 97th centile after intraventricular haemorrhage, were randomly assigned standard therapy alone or standard therapy plus treatment with acetazolamide (100 mg/kg daily) and furosemide (1 mg/kg daily). A minimisation algorithm ensured balance between groups with respect to both referral centre and the presence of a cerebral parenchymal lesion on cerebral ultrasonography at enrolment. The trial was stopped in September, 1996, because the data showed a clear advantage with standard therapy.
FINDINGS: We report outcomes for 151 infants whose expected date of delivery was before the end of 1995, with complete information at 1 year for 129 infants. The median gestational age was 28 weeks, mean birthweight 1299 g, and mean postnatal age at enrolment 25 days. 44% had a parenchymal lesion at randomisation. Death or shunt placement occurred in 49 of 75 infants allocated drugs plus standard therapy, compared with 35 of 76 allocated to standard therapy alone. The relative risk was 1.42 (95% CI 1.06-1.90; p=0.026), which is equivalent to one extra death or shunt placement for every five infants allocated drug therapy. 84% (52/62) of infants assigned drug therapy had died or were disabled or impaired at 1 year, compared with 60% (40/67) of those assigned standard therapy (relative risk 1.40 [1.12-1.76]; p=0.012).
INTERPRETATION: These preliminary results suggest that the use of acetazolamide and furosemide in preterm infants with PHVD is associated with a higher rate of shunt placement and increased neurological morbidity, and so cannot be recommended.
Randomized, controlled trial of acetazolamide and furosemide in posthemorrhagic ventricular dilation in infancy: follow-up at 1 year.
OBJECTIVE: Posthemorrhagic ventricular dilation (PHVD) is a complication of intraventricular hemorrhage in preterm infants and is associated with a high risk of long-term disability. Furosemide and acetazolamide are used widely in the treatment of PHVD in the hope of avoiding the need for placement of a ventriculoperitoneal shunt, but these drugs have not been evaluated in a controlled trial. This article reports a multicenter, randomized, controlled trial designed to test the hypothesis that these drugs would reduce the rate of shunt placement (or death) and increase survival to 1 year of age without disability.
METHODS: Between 1992 and 1996, 177 infants who were less than 3 months past term and had ventricular width >4 mm above the 97th centile following intraventricular hemorrhage were assigned randomly to either standard therapy or standard therapy plus drug therapy with acetazolamide (100 mg/kg/d) plus furosemide (1 mg/kg/d). Infants who were enrolled in the trial had a median gestational age of 28.6 weeks and were enrolled at a mean postnatal age of 3.6 weeks. Forty-four percent were reported to have a cerebral parenchymal lesion on ultrasound scan at randomization. The primary outcome measure of death or shunt placement (known in all but 1 infant) occurred in 56 of 88 infants who were allocated to drug plus standard therapy compared with 46 of 88 who were allocated to standard therapy. The risk ratio was 1.23 (95% confidence interval: 0.95-1.59). Neurodevelopmental outcome information at a corrected age of 1 year (known in all but 3 of 149 surviving infants) included disability or neuromotor impairment in 54 of 67 infants (81%) who were allocated to drug plus standard therapy and 52 of 69 infants (66%) who were allocated to standard therapy. Seventy-two of 85 infants (85%) who were allocated to drug therapy either died or were disabled or impaired at 1 year compared with 62 of 89 infants (70%) who were treated with standard therapy (risk ratio: 1.22; 95% confidence interval: 1.03-1.4376). The excess risk of these adverse outcomes was greater among infants who did not have a cerebral parenchymal lesion seen on ultrasound examination at trial entry.
CONCLUSIONS: These results suggest that the use of acetazolamide and furosemide in preterm infants with PHVD is ineffective in decreasing the rate of shunt placement and is associated with increased neurologic morbidity. This treatment therefore cannot be recommended.
Options:
A: Acetazolamide and furosemide therapy significantly reduced the need for ventriculo-peritoneal shunting and improved overall outcomes.
B: Acetazolamide and furosemide therapy had no significant effect on the need for ventriculo-peritoneal shunting and was associated with an increased risk of motor impairment and nephrocalcinosis.
C: Acetazolamide and furosemide therapy significantly improved motor function and reduced the risk of nephrocalcinosis.
D: Acetazolamide and furosemide therapy had no significant impact on any outcomes and was found to be completely safe.
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B
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163
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings when comparing reduced osmolarity glucose-based oral rehydration salt solution to the standard WHO formulation in children with acute diarrhoea? Please answer this question based on the information provided below:
Alanine- and glucose-based hypo-osmolar oral rehydration solution in infants with persistent diarrhoea: a controlled trial.
To evaluate the efficacy of a hypo-osmolar and a standard (World Health Organization) oral rehydration salt (ORS) solution in persistent diarrhoea, a randomized controlled clinical trial was conducted in 55 children. After a 1-day observation period the children were assigned to one of three solutions: standard ORS (WHO-ORS) (osmolality 311 mosmol/l), hypo-osmolar ORS containing L-alanine and glucose (osmolality 255 mosmol/l) and i.v. polyelectrolyte solutions (osmolality 293 mosmol/l) for ongoing replacement of stool loss for the next 4 days. Excellent acceptability of ORS (101-160 ml/kg body weight/day) by the children was observed. There were no significant differences in the total intake of solutions and food, and frequency of stools among the groups. Stool outputs were significantly less in infants receiving hypo-osmolar ORS than in those receiving WHO-ORS for 0-24 h (p = 0.04), 0-48 h (p = 0.01), 0-72 h (p = 0.04) and 0-96 h (p = 0.03). The results indicate a sufficient scope of ORS practice in persistent diarrhoea. Furthermore, we found that a hypo-osmolar ORS containing L-alanine and glucose is as efficacious as an iv solution and more effective than WHO-ORS for replacement of ongoing stool loss in persistent diarrhoea.
Hypotonic oral rehydration solution in acute diarrhoea: a controlled clinical trial.
In a controlled trial, a hypotonic oral rehydration solution (ORS) (Na+67, K+20, Cl-66, citrate 7, glucose 89 mmol/l osmolality 249 mosmol/kg) was compared with a standard WHO-ORS (Na+90, K+20, Cl-80, citrate 10, glucose 111 mmol/l, osmolality 311 mosmol/kg) in 60 children aged 5-24 months with acute watery diarrhoea. In the hypotonic ORS group, stool frequency, proportion of children who vomited, ORS requirements and purging rate over 24-48 h were reduced by 33% (p = 0.01), 30% (p = 0.02), 21% (p = 0.067) and 21% (p = 0.03), respectively. The proportion of children who vomited and the purging rate over 48 h were reduced by 23% (p = 0.03) and 10% (p = 0.097), respectively. Serum electrolytes after 48 h were comparable. The beneficial effect of hypotonic ORS was most marked in, and largely contributed by, the subgroup negative for rotavirus.
Hypo-osmolar sucrose oral rehydration solutions in acute diarrhoea: a pilot study.
Based on studies showing improved absorption of hypo-osmolar oral rehydration solutions (ORS) with reduced glucose and sodium concentration, a hypo-osmolar ORS with sucrose replacing glucose (sodium 60, potassium 15, chloride 60, citrate 5, sucrose 58 mmol l-1, calculated osmolality 198 mOsm kg-1) was compared with mildly hyperosmolar glucose ORS (WHO) in 46 children aged 6-30 months with acute diarrhoea and dehydration. In the hypo-osmolar sucrose ORS group (n = 18) faecal output was less by 30% during the initial 24 and 48 h compared with controls, suggesting better absorption. Sucrose may be a suitable alternative to glucose in an absorption-efficient hypo-osmolar ORS.
Multicenter, randomized, double-blind clinical trial to evaluate the efficacy and safety of a reduced osmolarity oral rehydration salts solution in children with acute watery diarrhea.
OBJECTIVE: To compare the efficacy of a reduced osmolarity oral rehydration salts (ORS) solution (75 mmol/L of sodium [Na], 20 mmol/L of potassium [K], 65 mmol/L of chloride, 10 mmol/L of citrate, and 75 mmol/L of glucose; osmolarity, 245 mosm/L) with that of the standard World Health Organization (WHO) ORS solution.
DESIGN: A multicenter, double-blind, randomized, controlled clinical trial conducted in children with acute diarrhea in 5 developing countries to measure mean stool output in the 24 hours after randomization, proportion of children who required unscheduled intravenous therapy, proportion of children who vomited in the first 24 hours, and diarrhea duration after randomization.
RESULTS: A total of 675 children who ranged in age from 1 to 24 months and who had acute diarrhea and dehydration were enrolled in the trial; 341 were randomized to receive reduced osmolarity ORS solution, and 334 were randomized to receive the WHO ORS solution. The mean (SE) stool output (g/kg) in the first 24 hours (reduced osmolarity ORS solution vs WHO ORS solution = 114 [4] vs 125 [5]) and during the total study period (reduced osmolarity ORS solution vs WHO ORS solution = 320 [18] vs 331 [18]) were comparable. The proportion of children who vomited in the first 24 hours (reduced osmolarity ORS solution vs WHO ORS solution = 58% vs 62%) and the diarrhea duration in the 2 treatment groups, compared by log rank test, were similar. The proportion of children who required unscheduled intravenous therapy was significantly lower in children who received reduced osmolarity ORS solution (10%) as compared with those who received the WHO ORS solution (15%; odds ratio = 0.6, 95% confidence interval = 0.4-1.0). There was no significant difference in the incidence of hyponatremia (serum Na <130 mmol/L) at 24 hours between the 2 treatment groups (11% in reduced osmolarity ORS solution group vs 9% in the WHO ORS solution group; odds ratio = 1.3; 95% confidence interval = 0.8-2.2). The frequency of patients with serum Na <125 mmol/L at 24 hours was 13 of 341 (4%) in children who were treated with reduced osmolarity ORS solution versus 7 of 334 (2%) in children who received the WHO ORS solution.
CONCLUSIONS: Treatment with reduced osmolarity ORS solution was associated with a 33% reduction in the need for unscheduled intravenous therapy and had no apparent effect on stool output and illness duration when compared with treatment with the standard WHO ORS solution. Children with acute diarrhea, therefore, may benefit from a reduced osmolarity ORS solution. The results of trials that examine the efficacy and safety of reduced osmolarity ORS solution in adult patients with cholera have to be taken into consideration before consensus on composition of oral rehydration formulation can be reached.
[Oral hydratation with a low osmolality solution in dehydrated children with diarrheic diseases: controlled clinical trial].
A clinical trial was conducted to compare the efficacy of a low-osmolarity solution (245 mOsm/L), and a standard oral rehydration solution (ORS) recommended by WHO for children dehydrated by diarrhea. Group 1 (69 children) received WHO/ORS (311 mOsml/L) and group 2 (71 children) received a low-osmolarity solution (245 mOsm/L). Rehydration was successful in 88.4% in group 1 and 92.9% in group 2 (p = 0.35). Rehydration was completed in 5.2 h (SD +/- 1.8) in group 1 and 5.5 (SD +/- 1.7) in group 2 (p = 0.31). Stool output was 6.3 g/kg/h (SD +/- 5.0) in group 1 and 5.6 g/kg/h (SD +/- 5.1) in group 2 (p = 0.94). Sodium at rehydration-completion was 139.3 mEq/L (SD +/- 7.1) in group 1 and 136.7 mEq/L (SD +/- 4.3) in group 2 (p = 0.014). Group 1 was under observation for 21 hours (SD +/- 5.7) and group 2, for 22 hours (SD +/- 5.6). Stool output in group 1 was 5.2 g/kg/h (SD 4.1) and 4.2 gr./kg/h (SD +/- 4.1) in group 2 (p = 0.16). In group 1, 23.1% required intravenous solutions and 9.8% in group 2 (p = 0.03). In treating dehydrated children, the low-osmolarity solution diminished the need for intravenous solutions, corrected most plasmatic sodium disorders, and produced no-risk of developing hyponatremia.
Is a low-osmolarity ORS solution more efficacious than standard WHO ORS solution?
The clinical efficacy of a diluted oral rehydration salts (ORS) solution was compared in a pilot study with that of intravenous (i.v.) therapy and of standard World Health Organization (WHO)/United Nations Childrens Fund (UNICEF) ORS solution in children with acute diarrhea. Sixty-one boys aged 3 to 24 months, admitted to hospital with acute diarrhea and signs of dehydration, were randomly assigned to groups receiving standard ORS solution, diluted ORS solution, or i.v. therapy. In children treated with standard ORS solution and small amounts of plain water, the total fluid intake was 25-39% greater, the stool output was 58-77% greater (p < 0.01), and the duration of diarrhea was 30-55% greater than in the other treatment groups. Intake of plain water, taken separately or added to the ORS solution, was greater in children given diluted ORS solution (73 +/- 23 ml/kg) than in those given standard ORS solution (21 +/- 32 ml/kg) (p < 0.001). The mean serum sodium concentration increased by 2.2 mEq/L in children given standard ORS solution, whereas it decreased by 2.9 mEq/L in those given diluted ORS solution. This study shows that some children develop worsening diarrhea and increasing serum sodium concentrations when treated with standard ORS solution and given only small amounts of plain water. This is probably caused by the slight hypertonicity of standard ORS solution combined with transient partial glucose malabsorption. This can be avoided if water, breast milk, or another low-solute drink is given liberally during maintenance therapy with ORS solution, as recommended by the WHO.
A double-blind clinical trial comparing World Health Organization oral rehydration solution with a reduced osmolarity solution containing equal amounts of sodium and glucose.
OBJECTIVE: To compare the safety and efficacy of an oral rehydration solution (ORS) containing 75 mmol/L of sodium and glucose each with the standard World Health Organization (WHO) ORS among Egyptian children with acute diarrhea.
METHODS: One hundred ninety boys, aged 1 to 24 months, who were admitted to the hospital with acute diarrhea and signs of dehydration were randomly assigned to receive either standard ORS (311 mmol/L) or a reduced osmolarity ORS (245 mmol/L). Intake and output were measured every 3 hours.
RESULTS: In the group treated with reduced osmolarity ORS, the mean stool output during the rehydration phase was 36% lower (95% confidence interval, 1%, 100%) than in those treated with WHO ORS. The relative risk of vomiting during the rehydration phase was significantly lower in children treated with reduced osmolarity ORS (relative risk, 2.4; 95% confidence interval, 1.2, 4.8). During the maintenance phase, stool output, mean intake of food and ORS, duration of diarrhea, and weight gain were similar in the treatment groups. The relative risk of treatment failure (need for unscheduled administration of intravenous fluids) was significantly increased in children receiving standard WHO ORS (relative risk, 7.9; 95% confidence interval, 1.1, 60.9). The mean serum sodium concentration at 24 hours was significantly lower in children receiving the reduced osmolarity ORS solution (134 +/- 6 mEq/L) than in children receiving the standard WHO ORS (138 +/- 7 mEq/L) (p < 0.001). The relative risk of the development or worsening of hyponatremia was not increased in children given the reduced osmolarity ORS, and urine output was similar in the treatment groups.
CONCLUSION: The reduced osmolarity ORS has beneficial effects on the clinical course of acute diarrhea in children by reducing stool output, and the proportion of children with vomiting during the rehydration phase, and by reducing the need for supplemental intravenous therapy. These results provide support for the use of a reduced osmolarity ORS in children with acute noncholera diarrhea.
Oral rehydration of neonates and young infants with dehydrating diarrhea: comparison of low and standard sodium content in oral rehydration solutions.
Oral rehydration among infants aged 0-3 months has not been adequately investigated. A controlled, randomized study was thus conducted in 65 young infants hospitalized with acute noncholera dehydrating diarrhea. The study was designed to compare the efficacy and safety of the standard WHO oral glucose-electrolyte solution containing 90 mmol of sodium per liter (Group A: 22 infants) with that of an oral glucose-electrolyte solution containing 60 mmol of sodium per liter (Group B: 22 infants) and with standard intravenous therapy (Group C: 21 infants). Among the 44 infants in Groups A and B, none required intravenous therapy. Dehydration, acidosis, and initial hyponatremia or hypokalemia were corrected with equal efficacy in all the three groups. In the critical first 8 h, the mean sodium absorption was significantly higher (p less than 0.01) in Group A. This resulted in hypernatremia (50%), periorbital edema (50%), mild pedal edema (27%), excessive irritability, and convulsions (4.5%). The mean serum sodium levels at 8, 24, and even 48 h were significantly higher (p less than 0.05) than those in Groups B and C. It is concluded that glucose-electrolyte oral solution containing 60 mmol of sodium per liter is as safe and effective as intravenous rehydration for the treatment of noncholera neonatal and early infantile diarrhea, while the standard WHO solution carries a significant risk of hypernatremia under similar conditions.
Hypo-osmolar oral rehydration salts solution in dehydrating persistent diarrhoea in children: double-blind, randomized, controlled clinical trial.
UNLABELLED: A double-blind, randomized, controlled trial was conducted to compare the clinical efficacy of hypo-osmolar oral rehydration salts (ORS) solution (224 mmol/L) and standard ORS solution (311 mmol/L) in children with persistent diarrhoea who were prone to develop dehydration. Initially, 95 children aged between 3 and 24 mo were included in the study for overnight observation. Of these, 70 children who passed stool more than 2 g/kg/h were finally enrolled in the study and were randomly assigned either standard ORS or hypo-osmolar ORS. After decoding the identity of ORS, it was observed that 37 children were in the standard ORS group and 33 in the hypo-osmolar ORS group. Clinical parameters and microbiological findings of stool samples were comparable in the two groups at the time of enrolment. Total stool output (2.5+/-1.1 vs 3.2+/-1.6 kg; p = 0.04), duration of diarrhoea (114.8+/-38.3 vs 145.4+/-40.0 h; p = 0.002), total intake of ORS (5.4+/-1.6 vs 7.8+/-1.8 l; p = 0.002) and total fluid intake (7.9+/-2.6 vs 10.0+/-4.1 l, p = 0.01) were significantly less in the hypo-osmolar ORS group compared to the standard ORS group. However, the percentage of weight gain on recovery in the hypo-osmolar group was less compared to that of the standard ORS group, though the difference was statistically insignificant. Thirty-five (95%) children in the standard ORS and 33 (100%) children in the hypo-osmolar group recovered within 10 d of initiation of therapy and modified dietary management.
CONCLUSION: Our findings suggest that hypo-osmolar ORS has beneficial effects on the clinical course of dehydrating persistent diarrhoea.
Controlled trial of hypo-osmalar versus World Health Organization oral rehydration solution.
OBJECTIVE: To compare the safety and efficacy of a hyposmolar oral rehydration solution (H-ORS) (245 mmol/liter) with the World Health Organization oral rehydration solution (WHO ORS) in cholera and acute non-cholera diarrhea.
DESIGN: Controlled clinical trial.
SETTING: Diarrhea training and treatment unit.
METHODS: Thirty-five culture proven cholera and 135 acute non-cholera diarrheal patients randomly received H-ORS or WHO-ORS. Intake and output were measured every 4 hours.
RESULTS: Analysis of the total cases revealed rehydration phase (p=0.048, 95% CI 0.64-0.99) and overall (p=0.046, 95% CI 0.70-0.99) frequency of stools to be significantly less in the H-ORS group. In the severely malnourished, the rehydration phase (p=0.032, 95% CI 0.55-97), maintenance phase (p=0.035, 95% CI 0.51-0.97) and overall (p=0.011; 0.95% CI 0.55-0.93) stool frequency were significantly decreased in the H-ORS group. The amount of ORS consumed in the maintenance phase of the cholera cases was significantly (p=0.04, 95% CI 0.44-0.98) less in the H-ORS group. All other parameters, despite showing a decreasing trend, were statistically comparable in the cholera, non-cholera and total cases. The amount of intravenous fluid needed was significantly more in the noncholera and total cases on H-ORS. In the non-breastfed cases, under two years of age, the total duration of diarrhea was significantly decreased (p=0.03; 95% CI 11.07-11.45) but the need for intravenous fluids significantly increased (p=0.02; 95% CI 109.8-112.1) in the H-ORS group. The proportion of children vomiting, the weight gain, urine passed in 24 hours, serum sodium, caloric intake and failure rate were comparable.
CONCLUSIONS: H-ORS is as safe and effective as the WHO-ORS and may have some additional benefits in malnourished children.
[Comparative study of 2 oral rehydration solutions containing 60 or 90 mmol/L of sodium and with different osmolalities].
A total of 186 infants, suffering from acute diarrhea were studied and divided into two groups: 84 children were placed in group A and given the ORS recommended by the World Health Organization which contains sodium and glucose at concentrations of 60 and 90 mmol/L respectively and an osmolality of 311 mOsm/kg (mmol/kg) (ORS-90). Group B included 82 children who received an ORS containing sodium and glucose at concentrations of 60 and 90 mmol/L respectively and with an osmolality of 240 mOsm/kg (mmol/kg) (ORS-60). Seven belonging to group A (8.3%) required intravenous rehydration due to the severity of the diarrhea (three cases), persistent vomiting (three cases) and paralytic ileus (one case), while only two cases belonging to group B (2.5%) required intravenous rehydration due to severe losses through feces (one case) and another due to paralytic ileus (one case). No differences were observed due to the variations in sodium concentrations among either of the groups of patients, whether that be in the natremias when admitted or once rehydrated, with a general tendency towards the correction of the hypernatremia or hyponatremia seen during admittance with both types of ORS. A similar situation was observed with the variations in serum potassium. The results obtained from this study show the different advantages of using an ORS with lesser sodium and glucose concentrations as well as minor osmolality with those from using the solution recommended by the World Health Organization, when a lesser index of failures is observed in the treatment of children with acute diarrhea with oral rehydration therapy. Yet before widely recommending its' use, it should be demonstrated that the new ORS induces lesser losses through feces during the rehydrating period in children dehydrated due to acute diarrhea.
Oral rehydration therapy of infantile diarrhea: a controlled study of well-nourished children hospitalized in the United States and Panama.
Although oral glucose-electrolyte solutions containing 90 mmol of sodium per liter have been widely used in the treatment of acute diarrhea among under-nourished children in the developing world, they have rarely been studied in well-nourished children. We therefore conducted a controlled randomized study among well-nourished children three months to two years who were hospitalized with acute diarrhea (52 in the United States, and 94 in Panama), to compare the efficacy of this solution with that of one containing 50 mmol of sodium per liter and with standard intravenous therapy. Oral rehydration with both solutions according to protocol was successful in 97 of 98 children (one required unscheduled intravenous therapy), and in 87 (89 per cent) no intravenous therapy was required. All of six children admitted with hypernatremia were successfully treated with oral therapy alone. We conclude that glucose-electrolyte oral solutions containing either 50 or 90 mmol of sodium per liter are effective and safe in the treatment of well-nourished children hospitalized with acute diarrhea, and that they may completely replace the intravenous fluids in the majority of such children.
Oral rehydration therapy of infantile diarrhea: a controlled study of well-nourished children hospitalized in the United States and Panama.
Although oral glucose-electrolyte solutions containing 90 mmol of sodium per liter have been widely used in the treatment of acute diarrhea among under-nourished children in the developing world, they have rarely been studied in well-nourished children. We therefore conducted a controlled randomized study among well-nourished children three months to two years who were hospitalized with acute diarrhea (52 in the United States, and 94 in Panama), to compare the efficacy of this solution with that of one containing 50 mmol of sodium per liter and with standard intravenous therapy. Oral rehydration with both solutions according to protocol was successful in 97 of 98 children (one required unscheduled intravenous therapy), and in 87 (89 per cent) no intravenous therapy was required. All of six children admitted with hypernatremia were successfully treated with oral therapy alone. We conclude that glucose-electrolyte oral solutions containing either 50 or 90 mmol of sodium per liter are effective and safe in the treatment of well-nourished children hospitalized with acute diarrhea, and that they may completely replace the intravenous fluids in the majority of such children.
Multicentre evaluation of reduced-osmolarity oral rehydration salts solution. International Study Group on Reduced-osmolarity ORS solutions.
In developed countries, use of oral rehydration salts (ORS) solution with osmolarity lower than that of plasma has been recommended because of the risk of hypernatraemia. We compared the clinical efficacy of reduced-osmolarity ORS and standard ORS solutions in children with acute diarrhoea in four developing countries. 447 boys aged 1-24 months, admitted to hospitals in four countries with acute diarrhoea and signs of dehydration, were randomly assigned either standard ORS (311 mmol/L) or reduced-osmolarity ORS (224 mmol/L) solution. Total stool output was 39% greater (95% CI 11-75), total ORS intake 18% greater (3-33), and duration of diarrhoea 22% longer (2-45) in the standard ORS group than in the reduced-osmolarity ORS group. The risk of requiring intravenous infusion after completion of the initial oral rehydration was greater in children given standard ORS solution than in those given reduced-osmolarity ORS solution in three of the four countries (all-country relative risk 1.4 [0.9-2.4]). This relative risk was significantly increased only in non-breastfed children (2.0 [1.0-3.8], p < 0.05). In breastfed children, the relative risk of requiring intravenous infusion was not affected by the ORS solution (0.9 [0.4-2.0]). The mean sodium concentration 24 h after admission was significantly lower in the reduced-osmolarity ORS group than in the standard ORS group (135 [134-136] vs 138 [136-139] mmol/L, p < 0.01). Reduced-osmolarity ORS solution has beneficial effects on the clinical course of acute diarrhoea. Our findings support the use of reduced-osmolarity ORS solution in children with acute non-cholera diarrhoea in developing countries. Further studies are needed to find the best formulation and whether such a solution would be satisfactory for the treatment of cholera.
Options:
A: Reduced osmolarity ORS was associated with more unscheduled intravenous infusions and higher stool output.
B: Reduced osmolarity ORS was associated with fewer unscheduled intravenous infusions, smaller stool volume, and less vomiting, with no additional risk of hyponatraemia.
C: Reduced osmolarity ORS showed no significant difference in outcomes compared to the standard WHO ORS.
D: Reduced osmolarity ORS was associated with more frequent vomiting and higher risk of hyponatraemia.
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B
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164
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy of short-acting beta-2 agonists compared to ipratropium in the treatment of acute exacerbations of chronic obstructive pulmonary disease (COPD)? Please answer this question based on the information provided below:
A comparison of the effects of ipratropium bromide and metaproterenol sulfate in acute exacerbations of COPD.
Thirty-two patients presenting with acute exacerbations of chronic obstructive pulmonary disease were entered into the following double-blind, crossover study. First (time 0), patients inhaled either ipratropium bromide (54 micrograms) or metaproterenol sulfate (1.95 mg) via a metered dose inhaler (MDI) attached to a device (Inspirease) (phase 1). After 90 minutes, they inhaled whichever of the two medications they had not received in phase 1. This is referred to as phase 2. Pulmonary function (FEV1 and FVC) was measured at time 0, and at 30, 60, and 90 minutes following phase 1 treatment, and at 30, 60, and 90 minutes following phase 2 treatment (120, 150, and 180 minutes from the start of the study). Arterial blood gas samples (n = 20) were obtained at entry into the study and 30 and 90 minutes after phase 1 medication. The groups did not differ in age, degree of airway obstruction, hypoxemia, or theophylline usage at the start of the study. In phase 1, at 90 minutes, pulmonary function in both groups significantly and similarly improved. For ipratropium, FEV1 improved from 0.62 +/- 0.08 L to 0.88 +/- 0.11 L (p less than 0.01) and for metaproterenol FEV1 improved from 0.69 +/- 0.06 to 0.92 +/- 0.09 L (p less than 0.01). There was no further improvement with phase 2 treatment for either group. Thirty minutes after inhaling ipratropium, there was a small but significant rise in PO2 (5.8 +/- 3.0 mm Hg; p less than 0.05) while metaproterenol inhalation resulted in a 6.2 +/- 1.2 mm Hg decline in PO2 (p less than 0.05). These changes were not sustained at 90 minutes. We concluded that for acute exacerbations of COPD, both ipratropium and metaproterenol are effective medications when administered via an MDI attached to a device (Inspirease). However, ipratropium may be a safer choice as it initially did not cause a decline in blood oxygenation.
Nebulized anticholinergic and sympathomimetic treatment of asthma and chronic obstructive airways disease in the emergency room.
The effectiveness of nebulized anticholinergic and sympathomimetic regimens was evaluated in a double-blind study of 199 patients with acute airways obstruction. Patients were assigned to one of three treatment regimens according to a randomized schedule: 0.5 mg of ipratropium bromide, 1.25 mg of fenoterol hydrobromide, and 0.5 mg of ipratropium plus 1.25 mg of fenoterol. In 148 patients with acute exacerbations of asthma (mean one-second forced expiratory volume, 1.18 +/- 0.64 liters), all three regimens produced significant improvement in one-second forced expiratory volume (p less than 0.001). The greatest improvement followed treatment with the ipratropium-fenoterol combination (0.53 +/- 0.40 liters at 45 minutes; 0.57 +/- 0.51 liters at 90 minutes) and was significantly greater than that following either ipratropium alone (p less than 0.001) or fenoterol alone (p less than 0.05). In 51 patients with acute exacerbations of chronic obstructive pulmonary disease (mean one-second forced expiratory volume, 0.67 +/- 0.29 liter), each regimen produced significant improvement in one-second forced expiratory volume at both 45 and 90 minutes (for all, p less than 0.05), but there was no significant difference among the three treatment regimens. It is concluded that, in patients with acute asthma, combination therapy with sympathomimetic and anticholinergic agents is more efficacious than either one alone. In patients with acute exacerbations of chronic obstructive pulmonary disease, although either sympathomimetic or anticholinergic therapy provides bronchodilatation, no further benefit could be demonstrated from combination therapy.
Options:
A: Short-acting beta-2 agonists were significantly more effective than ipratropium in improving forced expiratory volume (FEV1).
B: Ipratropium was significantly more effective than short-acting beta-2 agonists in improving forced expiratory volume (FEV1).
C: Both short-acting beta-2 agonists and ipratropium produced similar improvements in forced expiratory volume (FEV1).
D: Neither short-acting beta-2 agonists nor ipratropium showed any improvement in forced expiratory volume (FEV1).
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C
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165
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the use of gold compounds as an addition to oral steroids in the treatment of chronic steroid dependent asthmatics? Please answer this question based on the information provided below:
A placebo-controlled multicenter study of auranofin in the treatment of patients with corticosteroid-dependent asthma. Auranofin Multicenter Drug Trial.
BACKGROUND: Previous clinical studies have demonstrated that injectable gold salts and the oral gold compound, auranofin, possess significant steroid-sparing effects in the treatment of asthma.
OBJECTIVES: The objectives of this investigation were to determine whether auranofin could reduce oral corticosteroid requirements and to evaluate the safety of auranofin in the treatment of chronic corticosteroid-dependent asthma.
METHODS: Patients with asthma were eligible if they required at least 10 mg of prednisone per day for control and prevention of asthma exacerbations. Two hundred seventy-nine patients with chronic corticosteroid-dependent asthma (requiring > or = 10 mg/day) were randomized to receive auranofin, 3 mg twice daily, or placebo during an 8-month clinical trial, which was divided into three phases including: a 4-week baseline period (phase I), a 6-month double-blind treatment and steroid reduction period (phase II), and a 4-week posttreatment observation period during which steroid and auranofin doses or placebo doses were maintained at levels achieved by the end of phase II (phase III). The primary efficacy variable was "therapeutic success" or reduction of daily corticosteroid use by 50% or more.
RESULTS: The proportion of patients in the auranofin group achieving therapeutic success (41%) was significantly higher than that in the placebo group (27%) (p = 0.01). This effect was greatest in patients requiring 10 to 19 mg of oral prednisone per day at baseline (p < 0.001). In all treated patients, including those who did and did not complete the trial, significant reduction (> or = 50% of baseline) in oral corticosteroid dosage was achieved in the auranofin group (60%) compared with the placebo group (32%) (p < 0.001). There were no significant differences between treatment groups in symptoms, concomitant medication use, or lung function. Mean serum total IgE levels decreased significantly from baseline in the auranofin group (-44.63 IU/ml) compared with the placebo group (p = 0.001). Gastrointestinal and cutaneous adverse events were greater in the auranofin group.
CONCLUSIONS: Auranofin demonstrated a steroid-sparing effect without concomitant worsening of symptoms or lung function and appeared to be more effective in patients dependent on 10 to 19 mg of prednisone per day. Therefore this study has demonstrated that auranofin is useful as a steroid-sparing agent in the treatment of chronic corticosteroid-dependent asthma.
Chrysotherapy in the treatment of corticosteroid-dependent asthma.
The efficacy of parenteral gold therapy was evaluated in patients with steroid-dependent asthma. Five of eight patients improved in terms of reduced steroid requirement while they were maintaining or improving lung function. Two patients developed significant proteinuria that resolved with cessation of gold. Chrysotherapy appears to have a corticosteroid-sparing effect in some patients and may have a useful role in the management of severe refractory asthma.
Auranofin in the treatment of steroid dependent asthma: a double blind study.
BACKGROUND: Long term administration of oral corticosteroids in patients with asthma may be associated with serious side effects. Non-steroidal anti-inflammatory drugs, including gold salts, have been shown to reduce the need for systemic corticosteroid treatment in uncontrolled studies. The effect of oral gold (auranofin) on asthma symptoms, lung function, and the need for oral prednisone treatment was investigated.
METHODS: A 26 week randomised, double blind, placebo controlled, parallel group trial of auranofin was performed in 32 patients with moderately severe chronic asthma who required an oral corticosteroid dose of at least 5 mg prednisone a day (or equivalent) or 2.5 mg/day prednisone plus more than 800 micrograms/day inhaled corticosteroids. Auranofin was given orally in a dose of 3 mg twice daily. Asthma symptoms, lung function, and adverse effects were assessed at regular intervals. After 12 weeks of treatment prednisone dosage was tapered down by 2.5 mg every two weeks if the patient was clinically stable. Asthma exacerbations were treated with short courses of high doses of oral steroids.
RESULTS: Twenty eight of the 32 patients, 13 in the placebo group and 15 in the auranofin group, completed the study. The total corticosteroid reduction achieved after 26 weeks of treatment was significantly greater (4 mg) in the auranofin group than in the placebo group (0.3 mg). The number of exacerbations requiring an increase of steroids was greater in the placebo group (2.1) than in the active group (0.9). A significant increase in FEV1 of 6.4% predicted occurred in the auranofin group during the study and there was a reduction of asthma symptoms such as wheezing and cough. There was no difference between the groups in peak flow measurements or in the number of asthma attacks. The incidence of side effects of auranofin was low, but exacerbations of constitutional eczema were noticeable.
CONCLUSION: Auranofin provides an effective adjunct to treatment for steroid dependent asthma, leading to a reduction of oral steroid dose.
Options:
A: Gold compounds significantly reduced the need for oral steroids without any adverse effects.
B: Gold compounds showed a small but significant reduction in steroid dose, but the clinical significance is limited and there are potential side effects.
C: Gold compounds had no effect on steroid dose reduction and were associated with severe adverse effects.
D: Gold compounds significantly improved lung function and had no adverse effects.
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B
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the effectiveness of adding troleandomycin to oral steroids in the treatment of chronic steroid dependent asthmatics? Please answer this question based on the information provided below:
Effect of low-dose troleandomycin on glucocorticoid pharmacokinetics and airway hyperresponsiveness in severely asthmatic children.
Fifteen hospitalized asthmatic children (8 to 18 years old) completed a 2-week randomized, parallel, double-blind placebo-controlled comparison of combination methylprednisolone and placebo troleandomycin, prednisone and troleandomycin (P-TAO) or methylprednisolone-TAO (MPn-TAO). Troleandomycin (250 mg once daily or every other day) and glucocorticoid doses were reduced by a standard protocol. Symptom scores, blood chemistries, pulmonary function tests, airway response to methacholine, and glucocorticoid pharmacokinetics were compared. In each group, a steroid dose reduction of 50% was achieved without a deterioration in symptom scores. Methacholine response was unchanged in all five on methylprednisolone alone, but decreased 3-fold to 30-fold in two of five on combination P-TAO, and four of five on combination MPn-TAO. Troleandomycin decreased MPn clearance by an average of 62% but did not alter prednisolone clearance. Low-dose TAO combined with MPn has a significant effect on methylprednisolone clearance in children, an effect equivalent to that reported with higher dose TAO (1000 mg/d) therapy. In addition, this preliminary study suggests that TAO may decrease bronchial hyperresponsiveness to methacholine in severely asthmatic children.
Efficacy and safety of low-dose troleandomycin therapy in children with severe, steroid-requiring asthma.
BACKGROUND: Troleandomycin (TAO), a macrolide antibiotic, was studied as an alternative treatment in 18 children with severe, steroid-requiring asthma.
METHODS: In this investigation three treatment arms were used in randomized, double-blind, parallel fashion: combination TAO and methylprednisolone (MPn), combination TAO and prednisone, and MPn alone.
RESULTS: All groups tolerated a considerable reduction in glucocorticoid dose over the 12 weeks of the study: 80% +/- 6% for TAO-MPn, 55% +/- 8% for TAO-prednisone, and 44% +/- 14% for MPn alone. These reductions are all statistically significant (p < 0.05) within groups, and the differences between groups were statistically significant between the TAO-MPn and MPn alone groups. The concentration of methacholine required to induce a 20% decrease in forced expiratory volume in 1 second and pulmonary function were not significantly improved in any treatment group. Safety parameters including blood chemistry and hematology, adrenal function assessment; bone densitometry, and muscle strength testing, were not altered significantly. Two patients who received TAO had elevated liver enzyme levels; one required discontinuation of TAO and one experienced spontaneous resolution without intervention. Lack of statistically significant changes in the efficacy parameters were likely a result of small sample size and effects of the glucocorticoid dose taper.
CONCLUSIONS: TAO is safe and may be a reasonable treatment alternative in a limited trial for patients who are unable to tolerate tapering of their glucocorticoid dosage. Therapy should be guided by the goal of treatment, that is, glucocorticoid dose reduction or improvement of pulmonary function with appropriate monitoring of pulmonary function and adverse effects.
A double-blind study of troleandomycin and methylprednisolone in asthmatic subjects who require daily corticosteroids.
A group of 75 subjects with asthma requiring daily corticosteroids for control were enrolled in a 2-yr, double-blind, placebo-controlled study of the use of troleandomycin combined with methylprednisolone, compared with methylprednisolone alone, for the management of their asthma. The primary outcome variables were determination of the lowest stable methylprednisolone dose and assessment of corticosteroid side effects. Methylprednisolone dose was adjusted to maintain optimal control of asthma symptoms. A total of 30 patients receiving TAO and 27 patients receiving placebo completed 1 yr; 17 on TAO and 8 on placebo completed 2 yr of double-blind participation. Control of asthma was equivalent in both groups. The vast majority of patients in both groups achieved alternate-day dosing (29 of 30 on TAO and 23 of 27 on placebo in the first year). The lowest stable doses of methylprednisolone achieved were 10.4 mg/day (placebo) versus 6.3 mg/day (TAO) in the 1-yr group (p = 0.03). However, the baseline dose was also significantly higher in the placebo group (22.8 versus 17.6 mg/day in the TAO group). Therefore, the reductions in methylprednisolone dose were not significantly different between treatment groups. Differences were observed between the two treatment groups in serum IgG, fasting blood sugar, serum cholesterol, and progression of osteoporosis. In each instance the more unfavorable response occurred in those subjects receiving TAO. We conclude that the addition of TAO to methylprednisolone was not accompanied by a reduction in corticosteroid side effects compared with treatment with methylprednisolone alone. Furthermore, no evidence was found for a subset of "TAO responders."(ABSTRACT TRUNCATED AT 250 WORDS)
Options:
A: Troleandomycin significantly reduced the required dose of oral steroids and improved lung function.
B: Troleandomycin had no significant effect on reducing the required dose of oral steroids or improving lung function.
C: Troleandomycin significantly reduced the required dose of oral steroids but had no effect on lung function.
D: Troleandomycin had no effect on the required dose of oral steroids but significantly improved lung function.
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B
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167
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the conclusion regarding the use of intravenous (IV) beta2-agonists for treating severe acute asthma in the emergency department? Please answer this question based on the information provided below:
Comparison of salbutamol given intravenously and by intermittent positive-pressure breathing in life-threatening asthma.
A double-blind crossover trial was carried out during 22 episodes of life-threatening asthma in 19 patients to compare salbutamol given as a 500 microgram intravenous injection and as a 0 . 5% solution administered by intermittent positive-pressure breathing (IPPB) for three minutes. Relief of pulsus paradoxus was significantly better after IPPB than the intravenous treatment. Both treatments significantly improved the peak expiratory flow rate. Salbutamol given intravenously produced a mean increase in heart rate of over 20 beats/min five minutes after treatment compared with the relief of tachycardia that occurred after administration by IPPB. Four patients had noticeable cardiovascular side effects after salbutamol given intravenously, but no such effects were noticed after administration by IPPB. Two patients withdrawn shortly after entry into the trial because of a worsening clinical condition had received intravenous salbutamol. It is concluded that salbutamol given by IPPB is better than that given by slow intravenous injection in severe acute asthma.
Randomised trial of intravenous salbutamol in early management of acute severe asthma in children.
BACKGROUND: The mainstay of treatment for acute asthma in children is nebulised beta 2-adrenergic agents such as salbutamol, given with corticosteroids. However, penetration of the drug to the small airways is impeded by obstruction so intravenous salbutamol may be more effective. We assessed the use of intravenous salbutamol in the management of children with acute severe asthma in a double-blind randomised study.
METHODS: Children who presented to the Emergency Department of Westmead Hospital, Sydney, Australia with asthma were assessed with a clinical assessment scale, and those with severe acute asthma were given nebulised salbutamol at a dose of 2.5 mg (age < or = 2 years) or 5.0 mg (age > 2 years), made up to 4 mL with saline. Children who did not improve were eligible to enter phase one of the study. In this phase (0 h-2 h) treatment was by a standard protocol: nebulised salbutamol at the above dose: 4 L/min or 6 L/min continuous oxygen until oxygen saturation reached 93% in room air for at least 30 min; a bolus of intravenous hydrocortisone 5 mg/kg given over 3 min; and then 15 micrograms/kg intravenous salbutamol or saline, depending on randomised allocation. In phase two (2 h-24 h) the children were given nebulised salbutamol continuously then at 30 min, 1 h, 2 h, 3 h, and 4 h, according to need. All children were transferred to the ward once they were ready to start hourly nebulisation. All patients were followed up until discharge. The primary endpoints were recovery time (no longer requiring inhaled salbutamol) and persistent moderate to severe asthma 2 h after randomisation. Analyses were by intention-to-treat although no withdrawals occurred.
FINDINGS: The recovery time (time to cessation of nebulised salbutamol every 30 min) was 4 h in the 14 children allocated intravenous salbutamol compared with 11.5 h for the 15 children in the control group. 2 (14%) of the intravenous salbutamol group compared with 8 (53%) of the control group needed oxygen to maintain oxygen saturation at 93% room air. The intravenous salbutamol group were ready for discharge from the emergency department 9.7 h earlier than the control group. No clinically significant side-effects were found in either group.
INTERPRETATION: Addition of a 10 min infusion of salbutamol in the early treatment of children with acute severe asthma has the potential to curtail the clinical progression of asthma, reduce demand placed on hospital resources, and improve the quality of health care provided to the acutely sick child with asthma.
Intravenous beta agonist in severe acute asthma.
STUDY OBJECTIVE: To determine whether salbutamol is more effective in treating severe asthma when given intravenously or by inhalation.
DESIGN: Randomised trial of short term response to intravenous versus nebulised salbutamol in acute severe asthma.
SETTING: District general hospital (secondary care centre).
PARTICIPANTS: 76 patients aged 16-70 admitted to hospital with acute severe asthma (peak expiratory flow rate less than 50% of predicted) during study period. Five withdrawn because of adverse effects of treatment or non-response. Of remaining 71, 34 allocated to nebuliser group and 37 to intravenous treatment group. Patients with history of cardiovascular disease or recent corticosteroid or intravenous bronchodilator treatment excluded. Admission characteristics similar in the two groups.
INTERVENTIONS: All patients given 5 mg nebulised salbutamol on admission before randomisation plus 200 mg hydrocortisone bolus intravenously and 35% inspired oxygen throughout. Nebuliser group received two more 5 mg doses of nebuliser salbutamol at 30 minutes and 2 hours; intravenous group received 4 hours' continuous salbutamol infusion (12 micrograms/min) starting at 30 minutes plus supplementary intravenous potassium chloride. No other bronchodilators used.
ENDPOINT: Change in peak expiratory flow rate over 4 hours.
MEASUREMENTS AND MAIN RESULTS: Peak expiratory flow rate improved more in intravenous group (25.2%) than in nebuliser group (14.3%) (p less than 0.01, 95% confidence interval 2.4 to 19.1%). Tachycardia caused two withdrawals from intravenous group; non-response caused three withdrawals from nebuliser group.
CONCLUSIONS: Intravenous salbutamol is more effective than nebulised salbutamol in acute severe asthma but may have unacceptable cardiovascular effects.
Comparison of intravenous aminophylline and salbutamol in severe asthma.
Comparison of intravenous aminophylline and salbutamol in severe asthma.
Comparison of IV salbutamol with IV aminophylline in the treatment of severe, acute asthma in childhood.
A double-blind test to compare IV aminophylline with salbutamol in the treatment of acute, uncontrolled asthma showed that both drugs were equally effective during the first 24 hours. Salbutamol caused a relative tachycardia. Hydrocortisone was given after 2 hours, but did not appear to affect the rate of recovery.
[Intravenous infusion of reproterol (a beta-2-mimetic agent) in the therapy of severe asthma attacks in childhood].
20 children (age range 0.8-14.7 years) with acute severe asthma were alternately randomized to receive one of two different treatment regimes. 10 children (control-group) received Salbutamol inhalation (75 micrograms/kg in 2 ml Saline every two hours). 10 children (reproterol-group) received reproterol infusion (0.2-2.0 micrograms/kg/min in Saline) and inhaled Saline only. Other therapy regimen were identical in both groups: Theophylline infusion, i.v. Prednisolone, adequate fluids intake and oxygen insufflation. Age, severity and maintenance therapy of asthma, and severity of the acute episode, were not significantly different in both groups. Treatment efficacy, assessed with a simple clinical score, the heart and respiratory rates, the peak expiratory flow (PEF) and the blood gases, was comparable in both groups. Side effects, i.e. tachycardia, blood pressure changes and tremor, were also similar and clinically not relevant in both groups. In two children, who previously needed repeated mechanical ventilation, severe respiratory failure could be successfully controlled only when the reproterol dose was raised 10 folds (2.0 micrograms/kg/min). Reproterol infusion can be recommended in children with acute severe asthma, who do not respond satisfactorily to current therapy regimen, particularly in children who previously experienced numerous intubations.
Intravenous infusion of salbutamol in severe acute asthma.
Out of 62 asthmatic patients admitted to hospital with an acute exacerbation of their disease, those whose symptoms had not sufficiently improved 15 minutes after an initial intensive regimen were randomly allocated to receive an intravenous infusion of either salbutamol 10 microgram/min (20 patients) or aminophylline 1 mg/min (19 patients). During the infusions, which lasted 36 hours, peak expiratory flow rates and spirometric values improved in both groups, but differences between the groups did not achieve statistical significance. Although salbutamol may be infused safely for a prolonged period to patients with acute asthma, it has no particular advantage over aminophylline. Furthermore, in patients who respond poorly to initial intensive treatment the subsequent infusion of a bronchodilator may not increase the rate of recovery from the rate that would occur naturally.
Comparison of intravenous and nebulised salbutamol in initial treatment of severe asthma.
Nebulized versus intravenous albuterol in hypercapnic acute asthma. A multicenter, double-blind, randomized study.
In a multicenter, randomized, double-blind study, we compared the effects of nebulized (5 mg x 2) and intravenous (0.5 mg) albuterol (salbutamol) over 1 h in 47 patients admitted to hospital with severe acute asthma defined as a peak expiratory flow (PEF) below 150 L/min and hypercapnia (Pa(CO2) > or = 40 mm Hg). Additional treatment included nasal oxygen and hydrocortisone succinate. The efficacy was assessed after 1 h. In the group treated by nebulization (NEB group, n = 22) 19 (86%) patients (95% confidence interval: 65 to 97%) had been treated successfully according to predefined criteria, versus 12 (48%) patients (95% confidence interval: 28 to 69%) in the intravenously treated group (i.v. group, n = 25), p = 0.006. The mean increase in PEF was greater in the NEB group than in the i.v. group (+107 +/- 94 L/min versus +42 +/- 66 L/min, p = 0.01) as well as the decrease in Pa(CO2) values (-10 +/- 5 mm Hg versus -2 +/- 12 mm Hg, p < 0.01). Beta agonist-induced hypokalemia was more pronounced in the i.v. group than in the NEB group. We conclude that, in hypercapnic acute asthma, the nebulized route has a greater efficacy and fewer side effects than the intravenous route.
Comparison of intravenous aminophylline, salbutamol and terbutaline in acute asthma.
Comparison of intravenous aminophylline, salbutamol and terbutaline in acute asthma.
High-dose inhaled versus intravenous salbutamol combined with theophylline in severe acute asthma. Swedish Society of Chest Medicine.
In a multicentre parallel group study we studied 176 adult patients (53% men) with severe acute asthma (peak expiratory flow (PEF), 15-50% of predicted values). The effect of two doses of inhaled salbutamol (0.15 mg.kg-1 x 2; 30 min apart) (n = 87) was compared with that of one dose of salbutamol given intravenously (5 micrograms.kg-1) (n = 89). There was a significantly larger increase in peak expiratory flow after the first inhaled dose in the group that received inhalation treatment than in the i.v. treated group (69 vs 41 l.min-1, p less than 0.05), but there was no difference in systemic side-effects between the groups. After the second inhaled dose there was a further increase in PEF, but also in systemic side-effects. These treatments were also compared in a cross-over study on 18 of the patients who returned with a second attack of severe acute asthma. The cross-over evaluation produced similar results, with a significantly larger increase in PEF after the first inhaled dose than after the i.v. treatment. Fifteen of the 18 patients found the inhalations more effective than the i.v. treatment. Theophylline (3-6 mg.kg-1) was infused i.v. 60 min after the start of salbutamol treatment, and a significant increase in PEF was observed in both groups. A correlation between the increase in PEF and the increase in plasma theophylline concentration was only found in the group that had received i.v. salbutamol.(ABSTRACT TRUNCATED AT 250 WORDS)
A controlled trial of intravenous salbutamol and aminophylline in acute asthma.
In a randomized double-blind trial an intravenous injection of salbutamol (100mug) was compared with an intravenous injection of aminophylline (250mg) in 23 patients with acute exacerbations of asthma. Salbutamol (11 cases) and aminophylline (12) produced a mean proportionate increase in FEV of 26% and 23% respectively. Blood gas pressures showed a trend to improvement with a mean rise in oxygen tension of 2mm Hg(0-2kPa) in the aminophylline group and of 6mm Hg (0-8kPa) in the salbutamol group. Electrocardiogram patterns also showed overall improvement, and mean decreases in pulse rate of 8 beats per minute and 2 beats per minute were noted in the aminophylline and salbutamol groups respectively. Differences in results did not reach conventional levels of significance and no serious side effects were noted. It was concluded that in the doses and routes of administration compared, salbutamol was as effective as aminophylline.
Intravenous versus nebulized terbutaline in patients with acute severe asthma; a double-blind randomized study.
Twenty-three patients with acute severe asthma were treated in a randomized double-blind way by either intravenous terbutaline two times at an hour interval 6 micrograms/kg or inhaled terbutaline two times 0.1 mg/kg. Peak expiratory flow rate in percent of expected value rose from 89 L/min to 128 L/min (P less than .01) in the intravenous group and from 97 L/min to 122 L/min (P less than .02) in the inhalation group; this was comparable for both groups. PaO2 initially was 7.55 kPa in the intravenous group and rose by 1.4 after 60 minutes (P less than .02) and by 1.33 after 120 minutes (P less than .01). The mean PaO2 did not change in the inhalation group. The pulse rate and blood pressure did not vary significantly in either of the two groups. We conclude that both the intravenous and inhalational administration of terbutaline are effective in acute severe asthma, but that the intravenous route is possibly better for increasing PaO2.
Comparison of inhaled and intravenous terbutaline in acute severe asthma.
In patients with acute severe asthma, 5 mg of terbutaline by inhalation and 500 microgram intravenously in divided doses both produced equally effective but not maximal bronchodilatation. There was no difference in the production of side-effects. These results support the view that inhaled therapy can be as effective in patients with acute severe asthma as injected treatment. In view of the risks of intravenous treatment, especially using high doses, inhaled bronchodilator therapy would seem advisable as initial treatment.
Comparison of intravenous aminophylline and salbutamol in severe asthma.
Options:
A: IV beta2-agonists are significantly more effective than inhaled beta2-agonists in improving pulmonary function.
B: IV beta2-agonists show no advantage over inhaled beta2-agonists and should not be used for severe acute asthma.
C: IV beta2-agonists are associated with fewer autonomic side effects compared to inhaled beta2-agonists.
D: IV beta2-agonists are recommended for specific subgroups of patients with severe acute asthma.
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B
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168
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the use of cyclosporin as an adjunct therapy to oral steroids in the treatment of chronic steroid dependent asthma? Please answer this question based on the information provided below:
Trial of cyclosporin in corticosteroid-dependent chronic severe asthma.
The treatment of chronic severe asthma is unsatisfactory for many patients. In a randomised, double-blind, placebo-controlled, crossover trial we have tested whether cyclosporin, which is thought to act primarily by inhibition of T lymphocyte activation, improves lung function in corticosteroid-dependent asthmatics. After a 4-week run-in period, 33 patients with longstanding asthma (mean duration 27 years), and who had required continuous oral corticosteroids for a mean of 9.3 years, were randomised to receive either cyclosporin (initial dose 5 mg/kg per day) or placebo for 12 weeks, crossing over after a 2-week washout period. Mean baseline forced expiratory volume in 1 s (FEV1) was 60.1% of the predicted value. 2 patients failed to complete the protocol and 1 withdrew because of hypertrichosis. Cyclosporin therapy resulted in a mean increase above placebo of 12.0% in morning peak expiratory flow rate (PEFR; p less than 0.004) and 17.6% in FEV1 (p less than 0.001). The frequency of disease exacerbations requiring an increased prednisolone dose was reduced by 48% in patients on cyclosporin compared with placebo (p less than 0.02). Diurnal variation in PEFR decreased by a mean of 27.6% (p = 0.04). Cyclosporin for 12 weeks was well tolerated by this group of chronic asthmatics, in whom the mean whole-blood trough concentration was 152 micrograms/l. These findings provide further evidence of a role for activated T lymphocytes in the pathogenesis of asthma. Specific pharmacological targeting of this cell could form the basis of a novel approach to the treatment of asthma.
Double-blind, placebo-controlled study of cyclosporin A as a corticosteroid-sparing agent in corticosteroid-dependent asthma.
Patients with severe asthma who require long-term oral corticosteroid therapy are at risk of unwanted effects. Several immunosuppressive drugs have been assessed as corticosteroid-sparing agents in chronic asthma. We previously showed that cyclosporin A (CsA) administered for 12 wk improved lung function in corticosteroid-dependent patients. We have now investigated the corticosteroid-sparing properties of CsA over a 36-wk period. Following a 4-wk run-in period, 39 corticosteroid-dependent asthmatic patients were randomized to receive CsA (19 patients, initial doses 5 mg/kg/d) or matched placebo (20 patients) for 36 wk. Attempts were then made by a physician ignorant of the trial therapy to reduce their prednisolone dosages at 14-d intervals, provided that a patient's asthma remained stable or improved. Three patients receiving CsA had to be withdrawn from the study before they completed 12 wk of therapy. The remaining 16 patients achieved a statistically significant reduction in median daily prednisolone dosage of 62% (10 to 3.5 mg), compared with a decrease of 25% (10 to 7.5 mg) in the patients taking placebo (p = 0.043). This reduction was most pronounced during the last 12 wk of active therapy. In addition, morning peak expiratory flow rate (PEFR) improved significantly (mean 9.4%, SEM 3.0%) in the active-treatment group but not in the placebo group (p = 0.026 between groups). Predictable changes in renal function and blood pressure, and an increased incidence of hypertrichosis and paresthesia, were observed in the patients treated with CsA, but these did not necessitate withdrawal from the study, and were reversed during a 4-wk run-out period. Thus, low-dose CsA therapy, as compared with placebo, allowed a significant reduction in oral corticosteroid dosages in patients with severe asthma, and also improved lung function.
Treatment of steroid-dependent bronchial asthma with cyclosporin.
The treatment of chronic severe asthma is unsatisfactory for many patients. The aim of the study was to determine the effects of treatment of steroid-dependent asthma with cyclosporin. We performed a double-blind, placebo-controlled, randomized, parallel group trial on the effect of cyclosporin on pulmonary function, asthma severity and tapering of prednisone in 34 steroid-dependent asthmatics (mean oral prednisone dose: 16 mg.day-1). The study consisted of: 1) baseline period (12 weeks); 2) experimental period divided into two parts: Part I (12 weeks) cyclosporin or placebo treatment; Part II (22 weeks) cyclosporin or placebo treatment and oral prednisone reduction; and 3) follow-up observation (8 weeks). Asthma symptoms score, pulmonary function tests (daily peak expiratory flow (PEF) and bi-weekly forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and maximal mid-expiratory flow (MEF50), biochemical profile and blood cyclosporin levels were monitored throughout the study. Following cyclosporin administration, a slight beneficial effect on some subjective parameters of asthma severity was observed. At the same time, no beneficial effect on pulmonary function was noted. The time trends analysis of mean daily prednisone doses between the treatment groups revealed a statistically significant difference indicating that, during prednisone reduction, cyclosporin seemed to be slightly more efficient than placebo in reducing the requirement for systemic corticosteroid, even though the steroid reduction was accompanied by slight impairment of some pulmonary function. However, there was no significant difference in the final dose reduction between the treatment groups. These data and the known toxicity of the drug suggest a limited place for cyclosporin treatment in steroid-dependent bronchial asthma.
Options:
A: Cyclosporin significantly reduced the need for oral steroids and showed substantial improvements in lung function.
B: Cyclosporin showed a small but significant reduction in steroid dose, with questionable clinical significance and potential side effects.
C: Cyclosporin had no effect on steroid dose reduction or lung function improvement.
D: Cyclosporin significantly improved lung function but had no effect on steroid dose reduction.
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B
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169
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What are the potential effects of family and parenting interventions on juvenile delinquents and their families? Please answer this question based on the information provided below:
Short-term behavioral intervention with delinquent families: impact on family process and recidivism.
Impact of family systems intervention on recidivism and sibling delinquency: a model of primary prevention and program evaluation.
Short-term family intervention: a therapy outcome study.
A comparative evaluation of parent-training interventions for families of chronic delinquents.
Fifty-five families of chronically offending delinquents were randomly assigned to parent-training treatment or to service traditionally provided by the juvenile court and community. The families in the parent-training group received an average of 44.8 hours of professional contact (23.3 hours of which were phone contacts), and each control group family received treatment estimated at more than 50 hours on the average. Comparisons of police contact data at baseline and subsequent years for the two groups showed that subjects in both groups demonstrated reduced rates of offending during the followup years. The finding most relevant was significant treatment-by-time effect for offense rates, with most of this effect accounted for by a greater reduction in serious crimes for the experimental group during the treatment year, and a similar reduction of the community control group occurring in the first of three followup years. These early decrements in offense rates persisted during followup for both groups. Throughout the study, boys in the experimental group spent significantly less time in institutional settings than did boys in the control group. Parent training had a significant impact, but the reduction in offending was produced at very high emotional cost to staff. Although it is clear that this population requires substantial treatment resources, this study underscores the need for more work on prevention.
Multisystemic treatment of serious juvenile offenders: long-term prevention of criminality and violence.
This article examined the long-term effects of multisystemic therapy (MST) vs. individual therapy (IT) on the prevention of criminal behavior and violent offending among 176 juvenile offenders at high risk for committing additional serious crimes. Results from multiagent, multimethod assessment batteries conducted before and after treatment showed that MST was more effective than IT in improving key family correlates of antisocial behavior and in ameliorating adjustment problems in individual family members. Moreover, results from a 4-year follow-up of rearrest data showed that MST was more effective than IT in preventing future criminal behavior, including violent offending. The implications of such findings for the design of violence prevention programs are discussed.
Comparison of two community alternatives to incarceration for chronic juvenile offenders.
The relative effectiveness of group care (GC) and multidimensional treatment foster care (MTFC) was compared in terms of their impact on criminal offending, incarceration rates, and program completion outcomes for 79 male adolescents who had histories of chronic and serious juvenile delinquency. Results show that boys who participated in MTFC had significantly fewer criminal referrals and returned to live with relatives more often. Multiple regression analyses showed that assignment to a treatment condition (i.e., GC or MTFC) predicted official and self-reported criminality in follow-up beyond other well-known predictors of chronic juvenile offending (i.e., age at 1st offense, number of previous offenses, age at referral).
Family preservation using multisystemic therapy: an effective alternative to incarcerating serious juvenile offenders.
Multisystemic therapy (MST) delivered through a community mental health center was compared with usual services delivered by a Department of Youth Services in the treatment of 84 serious juvenile offenders and their multiproblem families. Offenders were assigned randomly to treatment conditions. Pretreatment and posttreatment assessment batteries evaluating family relations, peer relations, symptomatology, social competence, and self-reported delinquency were completed by the youth and a parent, and archival records were searched at 59 weeks postreferral to obtain data on rearrest and incarceration. In comparison with youths who received usual services, youths who received MST had fewer arrests and self-reported offenses and spent an average of 10 fewer weeks incarcerated. In addition, families in the MST condition reported increased family cohesion and decreased youth aggression in peer relations. The relative effectiveness of MST was neither moderated by demographic characteristics nor mediated by psychosocial variables.
Multisystemic therapy with violent and chronic juvenile offenders and their families: the role of treatment fidelity in successful dissemination.
The effects of multisystemic therapy (MST) in treating violent and chronic juvenile offenders and their families in the absence of ongoing treatment fidelity checks were examined. Across 2 public sector mental health sites, 155 youths and their families were randomly assigned to MST versus usual juvenile justice services. Although MST improved adolescent symptomology at posttreatment and decreased incarceration by 47% at a 1.7-year follow-up, findings for decreased criminal activity were not as favorable as observed on other recent trials of MST. Analyses of parent, adolescent, and therapist reports of MST treatment adherence, however, indicated that outcomes were substantially better in cases where treatment adherence ratings were high. These results highlight the importance of maintaining treatment fidelity when disseminating complex family-based services to community settings.
Group versus individual applications of reciprocity training for parent-youth conflict.
Options:
A: Significantly reduce the time spent by juvenile delinquents in institutions and reduce the risk of re-arrest.
B: Significantly improve family functioning and child/adolescent behavior.
C: Have no significant impact on the time spent in institutions or the risk of re-arrest.
D: Increase the risk of juvenile delinquents being re-arrested and spending more time in institutions.
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A
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170
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the use of extra-amniotic prostaglandins for third trimester cervical ripening or induction of labour? Please answer this question based on the information provided below:
[Cervical ripening : comparison of three methods. Preliminary results of a randomized prospective study].
The authors report the preliminary results of a randomised prospective study begun in April 1992 at the maternity unit of the Caen Regional Hospital group. The aim of the study was to compare the efficacy and tolerability of three methods of cervical ripening in patients at term in whom there was an indication for the induction of labour while local conditions were unfavourable (Bishop score less than 6). In the first group, patients received an intracervical instillation of prostaglandins E2 (Prepidil), in accordance with the usual method of the department. In the patients of the second group, an intracervical Foley catheter with its balloon inflated to 50 cc was inserted and left under traction for 12 hours. Management of patients in the third group consisted of an extraamniotic injection of prostaglandins E2 via a Foley catheter previously inserted into the cervix and the balloon of which was also inflated with 50 cc of sterile water and which was left in place for 12 hours. Regardless of the method, each patient could undergo 3 ripening procedures separated by 24 hour intervals, provided the Bishop score did not reach 6. These results, which concern the first 184 patients enrolled in the protocol show the superior efficacy of the catheter + Prepidil method as compared with the other two (75% success rate after ripening as compared with 50% in each of the other two groups) as well as that intracervical Prepidil is equally effective in terms of success/failure as an intracervical catheter alone.(ABSTRACT TRUNCATED AT 250 WORDS)
[Cervical ripening : comparison of three methods. Preliminary results of a randomized prospective study].
The authors report the preliminary results of a randomised prospective study begun in April 1992 at the maternity unit of the Caen Regional Hospital group. The aim of the study was to compare the efficacy and tolerability of three methods of cervical ripening in patients at term in whom there was an indication for the induction of labour while local conditions were unfavourable (Bishop score less than 6). In the first group, patients received an intracervical instillation of prostaglandins E2 (Prepidil), in accordance with the usual method of the department. In the patients of the second group, an intracervical Foley catheter with its balloon inflated to 50 cc was inserted and left under traction for 12 hours. Management of patients in the third group consisted of an extraamniotic injection of prostaglandins E2 via a Foley catheter previously inserted into the cervix and the balloon of which was also inflated with 50 cc of sterile water and which was left in place for 12 hours. Regardless of the method, each patient could undergo 3 ripening procedures separated by 24 hour intervals, provided the Bishop score did not reach 6. These results, which concern the first 184 patients enrolled in the protocol show the superior efficacy of the catheter + Prepidil method as compared with the other two (75% success rate after ripening as compared with 50% in each of the other two groups) as well as that intracervical Prepidil is equally effective in terms of success/failure as an intracervical catheter alone.(ABSTRACT TRUNCATED AT 250 WORDS)
Comparative trial of extra-amniotic and vaginal prostaglandin E2 in tylose gel for induction of labor.
Two hundred and sixty-one patients of varying parity and cervical "ripeness" were given Prostaglandin E2 (PCE2) in tylose gel either vaginally (2.0 mgm) or extraamniotically (0.3 mgm) prior to planned surgical induction. Surgical inductions was avoided in 52 per cent of the vaginal group and 40 per cent of the extra-amniotic group. When subdivided according to parity and cervical ripeness, both groups were comparable except in the multigravid patients with high cervical 'scores', when the vaginal route was significantly more likely to establish labor. Both groups were without significant ill-effects to the mother or fetus.
Does cervical ripening with PGE2 affect subsequent uterine activity in labour?
Uterine activity was measured quantitatively during subsequent labor after prostaglandin E2 gel (PGE2). Thirty primigravidae with a low Bishop score were included in this randomized double-blind study. Fewer women who received PGE2 required subsequent surgical induction. The pattern of uterine activity was different. Cervical dilatation was achieved with less uterine activity in the PGE2 group, especially during the shorter latent phase.
Foley catheter under traction versus extra-amniotic prostaglandin gel in pre-treatment of unripe cervix--a randomised controlled trial.
Labor induction with vaginal misoprostol and extra-amniotic prostaglandin F2alpha gel.
OBJECTIVE: To compare the effectiveness of vaginally administered misoprostol with extra-amniotic prostaglandin F2alpha (PGF2alpha) gel for induction of labor.
METHOD: A randomized controlled trial, with women allocated to receive either misoprostol 50 microg intra-vaginally or extra-amniotic PGF2alpha gel 5 mg, was conducted in Harare Maternity Hospital. A total of 152 women were admitted for induction of labor with a term singleton, pregnancy and cephalic presentation were recruited. The main outcome was duration of induction.
RESULTS: There were no differences in the characteristics of women in the two groups at recruitment. In the misoprostol group there was a significantly reduced need for augmentation of labor with oxytocin (OR=0.36; 95% C.I. 0.17-0.73) and delivery by cesarean section for failure to progress (OR=0.11; 95% C.I. 0.00-0.88). The risk for duration of induction to vaginal delivery exceeding 12, 18 or 24 h was reduced by 18%, 38% and 68%, respectively, but only the risk for duration >24 h was significantly reduced (OR=0.32; 95%C.I. 0.11-0.91). The mean duration of induction was shorter in the misoprostol group, 15.2 vs. 23.6 h (P=0.02). There were no differences in fetal outcome.
CONCLUSION: Misoprostol 50 microg was associated with less use of oxytocin in labor, a shorter induction to delivery interval and fewer cesarean sections for failure to progress when compared with extra-amniotic PGF2alpha gel.
A double blind trial of extra-amniotic oestriol and prostaglandin F2 alpha gels in cervical ripening.
Forty nulliparous patients with Bishop score of 3 or less were given 15 mg oestriol gel, 10 mg PGF2 alpha gel or gel alone via the extra-amniotic route. Both the oestriol and prostaglandin treated patients had a significant increase in Bishop score and a significant reduction in induction-delivery interval compared to controls. Oestriol gel had significantly less stimulatory effect on uterine activity than prostaglandin gel, indicating a possible local action.
Extra-amniotic prostaglandin E2 and the unfavourable cervix.
A small dose of prostaglandin E2 suspended in a viscous medium was instilled as a single application into the extra-amniotic space of patients with unfavourable induction features the day before planned induction in an attempt to improve the condition of the cervix. Two groups of 15 patients were studied, one receiving prostaglandin E2 250 mug suspended in methyl ethyl cellulose ('Tylose') 6% solution, and the other tylose alone. Cervical status did not change in those receiving tylose alone, whereas a significant improvement occurred in 14 out of 15 patients receiving the prostaglandin. Labour began before formal induction in 1 patient receiving tylose and in 8 receiving prostaglandin.
Balloon cervical ripening with extra-amniotic infusion of saline or prostaglandin E2: a double-blind, randomized controlled study.
OBJECTIVE: To compare extra-amniotic infusion of diluted prostaglandin (PG) E2 solution with saline infusion in balloon cervical ripening and labor induction.
METHODS: Women with pregnancy complications and Bishop scores of 3 or lower (n = 116) were assigned randomly to receive extra-amniotic infusion (1 mL/minute) of normal saline or PGE2 in saline (0.5 microg/mL) through a Foley catheter with a 30-mL inflated balloon. We induced labor using intravenous oxytocin only when labor had not developed by 6 hours after balloon expulsion. Analysis was by intent-to-treat. We assessed ripening efficiency and course of labor in women who had spontaneous balloon expulsion (n = 110) and trial of labor (n = 107), respectively.
RESULTS: Ripening with PGE2 was associated with significantly shorter mean (+/- standard error of the mean [SEM]) time for balloon expulsion (4.7 +/- 0.4 versus 6.5 +/- 0.6 hours) and with significantly higher Bishop scores (P <.002), compared with ripening with saline. In the PGE2 group, rates of labor induction (15%) and oxytocin use (37%) were significantly lower than in the saline group (51% and 72%, respectively). The groups did not differ significantly in other labor abnormalities, labor duration, mode of delivery, birth weight, Apgar scores, and puerperal morbidity.
CONCLUSION: Cervical ripening by extra-amniotic balloon and PGE2 infusion is faster and more effective than by balloon and saline infusion, resulting in a higher rate of spontaneous labor and a lower rate of oxytocin use.
A comparison of four methods of ripening the unfavourable cervix.
A comparison was made between four methods of ripening the unfavourable cervix (extra-amniotic prostaglandin E2 gel, oral prostaglandin E2, intravaginal prostaglandin E2 and intravenous oxytocin) in a clinical trial involving 60 primigravidae. In all groups there was an improvement in cervical status. This was significantly greater in those patients who received extra-amniotic prostaglandin gel and they also showed significant decreases in the mean induction-delivery interval and in the incidence of Caesarean section.
Options:
A: Extra-amniotic prostaglandins significantly reduced the need for oxytocin to initiate or augment labour compared to placebo.
B: Extra-amniotic prostaglandins were found to be significantly more effective than all other methods of cervical ripening or induction of labour.
C: Extra-amniotic prostaglandins showed no significant differences in effectiveness compared to placebo or other methods of cervical ripening or induction of labour.
D: Extra-amniotic prostaglandins were associated with a higher rate of caesarean sections compared to other methods.
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A
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171
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What were the findings regarding the effectiveness and side effects of oral prostaglandin E2 for third trimester induction of labour? Please answer this question based on the information provided below:
Oral and intravaginal prostaglandin E2 for cervical ripening and induction of labour.
The effect of prostaglandin E2 (PGE2) in 'ripening' the cervix was studied in 33 patients who required surgical induction of labour. Patients included primigravidas and parous subjects between 36 and 42 weeks of gestation. Sixteen patients received a total oral dose of 5 mg PGE2 and 17 received 4 - 6 mg PGE2 intravaginally in the form of a gel. There was significant improvement in 'ripeness' of the cervix in all groups, the intravaginal route giving slightly better results than the oral route. Ten patients remained unsuitable for induction because of inadequate dilatation of the cervix or a high fetal head. Four patients on oral therapy developed late decelerations of the fetal heart and 3 of these were delivered by immediate caesarean section. The implications of this and the reasons for the inability to perform inductions after 'ripening' are discussed.
Uterine priming with oral prostaglandin E2 prior to elective induction with oxytocin.
Fifty pregnant women at term, with a cervix unfavorable for induction, were electively induced with intravenous oxytocin after priming with either oral prostaglandin E2 or a placebo. Oral PGE2 was effective in increasing the Bishop score and in inducing labor prior to the induction, but did not increase the incidence of successful inductions.
Early labor initiation with oral PGE2 after premature rupture of the membranes at term.
Two groups of healthy women at term, who were not in labor 3 hours after premature rupture of the membranes, were studied. In one group labor induction with oral prostaglandin E2 (PGE2) was begun 3 hours after rupture, and in the other group intravenous oxytocin induction was begun 12 hours after rupture. PGE2 was successful in initiating active labor in 88% of women treated. Of the women who were observed for 12 hours, one-half began labor spontaneously during that time. Women in whom labor was induced with PGE2 given 3 hours after rupture of the membranes had a shorter interval of rupture to delivery, a lower cesarean section rate, and shorter postpartum hospitalization. Although significant bradycardia did not occur in fetuses of those women given PGE2, 10% of infants whose mothers were receiving oxytocin were delivered by cesarean section for this reason. It is concluded that oral PGE2 is safe and effective for induction of labor in women with premature membrane rupture. The benefits, to both mother and fetus, of a shorter latent period are discussed.
A comparison of oral and intracervical prostaglandin E2 for ripening of the unfavourable cervix prior to induction of labour.
Stimulation of labor in cases of premature rupture of the membranes at or near term. A consecutive randomized study of prostaglandin E2-tablets and intravenous oxytocin.
Prostaglandin E2-tablets were compared to intravenous oxytocin for the stimulation of labor in 201 patients at or near term, with premature spontaneous rupture of the membranes without labor activity for 6 hours after the escape of fluid. The patients were randomly allocated; 99 were treated with PGE2-tablets (0.5-1.5 mg/hr) and 102 with intravenous oxytocin (7.5-45 mIU/min). The treatment was ineffective in the PGE2 group in 3 cases; these were treated successfully with intravenous oxytocin. In the oxytocin group, 3 patients were delivered by cesarean section for reasons not associated with the drug. A significant difference was found in the stimulation-delivery time, in favor of intravenous oxytocin. Although PGE2 tablets are a safe and convenient alternative to intravenous oxytocin, the investigation showed that intravenous oxytocin is preferable in cases of premature rupture of the membranes with more than 6 hours without labor activity.
Induction of labor with oral prostaglandin E2 and buccal demoxytocin without amniotomy.
The results of labor induction without primary amniotomy in 132 primi-parae are presented. Prostaglandin E2 was given orally to 40 patients, 45 were treated buccally with demoxytocin and 47 were given a combination consisting of demoxytocin on the first day and prostaglandin E2 on the second day. All patients had Bishop scores less than 7. No significant difference in the efficiency of induction between the three types of treatment was detected. The delivery rates 48 hours after the start of treatment were 45.0 per cent, 37.8 per cent and 46.8 per cent respectively. The incidence of complications was not increased in the group which received the combined treatment.
A comparison of oral prostaglandin E2 tablets with intravenous oxytocin for stimulation of labor after premature rupture of membranes at term.
Sixty-nine patients (48 primigravidae and 21 multigravidae) with 12 hours of spontaneous premature rupture of membranes (PROM) after 36 weeks gestation were randomly allocated to receive either prostaglandin E2 (PGE2) oral tablets or intravenous oxytocin to stimulate labor. The two treatments were compared regarding stimulation - delivery interval (SDI), analgesic requirements, maternal and fetal side effects, and patient acceptability. The mean SDI was shorter in the oxytocin group, but without statistical significance. Analgesic requirements and fetal side effects were similar in the two groups, but there was a higher incidence of nausea and vomiting in those patients receiving the maximum dose (1 mg hourly) of PGE2. On subjective assessment, clinicians considered oxytocin to be more effective (p less than 0.05), while midwives felt both regimes to be equally helpful. PGE2 oral tablets were significantly (p less than 0.05) more acceptable to the patients, who preferred the convenience of oral dosing, the absence of an i.v. line and the increased mobility. It is concluded that PGE2 tablets are a safe and effective method of stimulating labor following PROM, and highly acceptable to parturients. In those women in whom labor has not been established within 8 h of initiating PGE2 therapy, or in whom gastric side effects are troublesome, intravenous oxytocin should be substituted.
A randomised controlled trial of an oral solution of prostaglandin E2 and oral oxytocin used immediately after low amniotomy for induction of labour in the presence of a favourable cervix.
A randomised controlled trial was carried out in 50 primigravidae and 50 multigravidae to compare the effectiveness in induction of labour after low amniotomy of prostaglandin E2, given as an oral solution, and oxytocin, given as buccal tablets. The results showed that in dosages recommended by the manufacturers, both oxytocic preparations were almost equally effective. With oral oxytocin, once labour had been established and dosage was left to the discretion of the staff, there appeared to be a potentially dangerous tendency to continue giving large doses despite adequate uterine contractions. The authors comment that this was probably the reason why oxytocin-treated multigravidae having normal deliveries within 24 hours had labours significantly shorter on average than those of other successfully induced patients.
A comparison between intravenous oxytocin and oral prostaglandin E2 for the induction of labour in parous patients.
Induction of labor with and without primary amniotomy. A randomized study of prostaglandin E2 tablets and intravenous oxytocin.
A comparative study of labor induction has been performed on 471 consecutive patients. Primary amniotomy was performed in 227 cases, and 103 of these patients were stimulated, 57 patients with PGE2 tablets and 46 with oxytocin. In the remaining 124 cases labor was induced within 4 hours without medical stimulation. Primary amniotomy was omitted in 244 cases, as the head was not engaged and the cervix was unripe. After random allocation to the treatment groups 125 patients received PGE2 tablets (ProstinR), and 119 patients received oxytocin intravenously. After 2 days of stimulation without primary amniotomy, delivery was induced in 83 per cent of the patients receiving PGE2 and in 84 per cent of the patients receiving oxytocin. All patients on whom primary amniotomy had been performed were delivered on the first day. There was no difference in the success rate between PGE2 and oxytocin treatments in patients with the same Bishop score. The performance of amniotomy at the beginning of induction led to a significantly lower total dose as well as a lower maximal dose of PGE2 and oxytocin. There was no difference in the duration of active labor in patients receiving PGE2 or oxytocin. There were no differences in the incidence of fetal distress and low Apgar scores between the different groups. No serious side effects occurred. Vomiting and diarrhea in 14 patients (8 per cent) receiving PGE2 was in contrast to 3 patients with these symptoms (2 per cent) in the oxytocin group. Oral administration of PGE2 is a convenient, effective and safe alternative to oxytocin for the induction of labor; however, PGE2 was not found superior to oxytocin in cases with a low Bishop score.
Induction of labor and cervical ripening with oral PGE2 in risk pregnancies. A placebo-controlled study.
A double-blind, placebo-controlled study was undertaken to evaluate the priming effect on the cervix and also the effect on the subsequent induction of labor. 0.5 mg oral PGE2 or placebo was given hourly for two 12-h periods. A total of 191 women with risk pregnancies and Bishop score less than or equal to 5 were studied. The induction of labor was carried out with oxytocin or oral PGE2 in a randomized manner. Labor was induced in 39% of the women during the PGE2 priming. The best result, 71% vaginal deliveries, was achieved with the combination of PGE2 priming and induction of labor with oxytocin.
A comparative study of labor induced by oral prostaglandin E2 and buccal tablets of demoxytocin.
A comparative study of the efficacy of oral prostaglandin E2 and buccal tablets of demoxytocin for induction of labor in overdue pregnancies was made in groups of randomly selected patients. Labor was successfully induced in 95.7% of the women in the prostaglandin group and 92.1% of the women in the demoxytocin group. Although the operative delivery rate was low in both groups, it was significantly higher for the demoxytocin group. A low rate of perinatal distress was recorded and there were no serious side effects in either group. The time from start of induction until delivery, as well as the time from amniotomy until delivery, were compared for primiparae and multiparae separately. No significant differences were found. The blood loss during the third stage of labor was lower in the prostaglandin group. We find oral induction of labor in overdue pregnancies effective, safe and convenient.
Intravenous oxytocin and oral prostaglandin E2 for ripening of the unfavourable cervix.
A clinical trial involving 60 patients was conducted to assess the relative efficacy of intravenous oxytocin and oral prostaglandin E2 in ripening the unfavourable cervix, when given as a priming dose on the day before induction of labour. There was significant improvement in the Bishop score, and the subsequent induction-delivery interval following priming with prostaglandin. This improvement appeared to be dose-related.
Oral oxytocics for induction of labor. A randomized study of prostaglandin E2 tablets and demoxytocin resoriblets.
A randomized comparative study of 387 consecutive patients admitted for induction of labor was carried out using two orally administered oxytocics (prostaglandin E2 tablets (Prostin) or Demoxytocin resoriblets for buccal administration (Sandopart)), the results of which are reported here. One-hundred and twenty-three cases were suitable for primary amniotomy; of these 48 were given PGE2 tablets and 75 received demoxytocin resoriblets. In a further 264 cases, primary amniotomy was inadvisable and of these, 133 patients were allotted to the PGE2 treatment group and 131 to treatment with demoxytocin. A significantly higher success rate was observed (p less than 0.05) in the PGE2 group in cases where primary amniotomy had been carried out, as compared with the demoxytocin group. Parturition was successfully induced in 82.0% of the patients given PGE2 tablets, as against only 63.4% of those receiving demoxytocin following 2 days of stimulation without primary amniotomy. This difference is statistically significant at the 0.001 level, and presumably due to the highly significant difference (p less than 0.0001) between patients with a Bishop score of 5 or less, where induction was successful in 75.4% given PGE2 tablets, in contrast to a success rate of only 36.7% in patients receiving demoxytocin resoriblets. No difference was observed in the success rate between the two treatment groups when the Bishop score was 6 or more. No difference was recorded in the incidence of fetal distress, instrumental delivery or low Apgar score between the two treatment groups. However, a higher incidence of vomiting and diarrhea were observed in patients treated with PGE2 tablets (11%) as compared with those receiving demoxytocin (1.5%). There was no difference with regard to the induction-delivery time, nor to the different stages of labor between otherwise comparable treatment groups when the induction was successful. It is concluded in respect of induction of labor using orally administered oxytocics that PGE2 (tablets) are preferable to demoxytocin (resoriblets) as it is the more effective of the two.
Use of oral oxytocics for stimulation of labor in cases of premature rupture of the membranes at term. A randomized comparative study of prostaglandin E2 tablets and demoxytocin resoriblets.
The efficacy of oral PGE2 tablets and buccal demoxytocin (resoriblets) for the induction of labor in cases of premature rupture of the membranes (PROM) after the 37th week of gestation has been evaluated in a prospective, randomized investigation of 193 women. PGE2 tablets (Prostin) were given to 109 parturients and demoxytocin resoriblets (Sandopart) to 84. The former were given in increasing doses from an initial 0.5 mg to a maximum of 1.5 mg every hour. The demoxytocin was administered at a constant dosage of 50 I.U. every 30 min. The treatment was unsuccessful in 10 of the women treated with PGE2 tablets and in 19 women receiving demoxytocin resoriblets. In addition, the treatment had to be discontinued in 5 women in the PGE2 group due to gastrointestinal side effects. This gives a total success rate of 86.3% for treatment with PGE2 against 77.4% in respect of demoxytocin. This difference is not significant. No difference was observed between the two treatment groups as regards: the stimulation-delivery interval, duration of the various stages of labor, efficacy in primiparae and multiparae, efficacy in patients with a high/low Bishop score. A significantly higher frequency of gastro-intestinal side effects was seen in those treated with PGE2 (21.7%) as compared with demoxytocin (3.6%). The frequency of surgical intervention was 17% in the PGE2 group and 10% in the demoxytocin group. In 4 cases where the stimulation was successful, cesarean section was carried out for reasons unrelated to the drug therapy. Despite the fact that demoxytocin treatment results in fewer side effects than PGE2, the efficacy of the drug is not superior. Based on experience from previous investigations carried out in this department, where intravenous oxytocin was found to be clearly better than oral PGE2 for the induction of labor in cases of PROM, intravenous oxytocin will remain the method of choice due to the shorter period of treatment, which must take priority.
A comparison of four methods of ripening the unfavourable cervix.
A comparison was made between four methods of ripening the unfavourable cervix (extra-amniotic prostaglandin E2 gel, oral prostaglandin E2, intravaginal prostaglandin E2 and intravenous oxytocin) in a clinical trial involving 60 primigravidae. In all groups there was an improvement in cervical status. This was significantly greater in those patients who received extra-amniotic prostaglandin gel and they also showed significant decreases in the mean induction-delivery interval and in the incidence of Caesarean section.
Options:
A: Oral prostaglandin E2 was more effective than oxytocin treatments in achieving vaginal delivery within 24 hours and had fewer side effects.
B: Oral prostaglandin E2 was less effective than oxytocin treatments in achieving vaginal delivery within 24 hours and was associated with more frequent gastrointestinal side effects, particularly vomiting.
C: Oral prostaglandin E2 was equally effective as oxytocin treatments in achieving vaginal delivery within 24 hours and had no significant side effects.
D: Oral prostaglandin E2 was more effective than no treatment or placebo in reducing the rate of cesarean sections and had no significant side effects.
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B
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172
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What were the findings regarding the use of relaxin for third trimester cervical ripening or induction of labour in comparison with placebo or other methods? Please answer this question based on the information provided below:
A randomized, double-blind, placebo-controlled trial of the safety of vaginal recombinant human relaxin for cervical ripening.
OBJECTIVE: To assess the safety of vaginal recombinant human relaxin in pregnant women treated before the induction of labor and to collect preliminary data on the efficacy of recombinant human relaxin in promoting cervical ripening.
METHODS: In a multi-center, randomized, double-blind placebo-controlled trial, 40 women were studied before induction of labor because of post-dates. The women were randomized to receive either 1.5 mg recombinant human relaxin in 3% methylcellulose gel or gel only, placed into the posterior vaginal fornix after a cervical assessment on the evening before scheduled induction. If a subject did not go into spontaneous labor overnight, another cervical assessment was performed 15 hours following treatment, immediately before the standard induction regimen of the hospital.
RESULTS: No important maternal or fetal-neonatal complications could be attributed to the drug. The differences between the recombinant human relaxin group and the placebo group for all the outcome measures of efficacy did not achieve statistical significance. Placebo patients were more likely to report moderate or strong uterine contractions in the first 4 hours following treatment than were the recombinant human relaxin-treated patients.
CONCLUSIONS: The use of recombinant human relaxin at a dose of 1.5 mg was not associated with any significant maternal or fetal-neonatal complications. The relatively small number of subjects in this study was chosen deliberately because this was the first use of the drug in pregnant subjects. Assessment of efficacy will require studies that include more patients and a range of relaxin doses.
Recombinant human relaxin as a cervical ripening agent.
OBJECTIVE: The aim of this study was to investigate the efficacy and safety of recombinant human relaxin (rhRIx) as a cervical ripening agent in women with an unfavourable cervix before induction of labour at term.
DESIGN: A multi-centre, double-blind, placebo-controlled trial performed in Edinburgh, Glasgow and Oxford. Women were treated with 0, 1, 2 or 4 mg of rhRIx in a gel vehicle administered intravaginally. Analysis of variance tests were performed on all continuous variables, and Cochran Mantel-Haenszel tests employed for all discrete variables.
PARTICIPANTS: Ninety-six women at 37 to 42 weeks of gestation with a singleton pregnancy and a modified Bishop score of < or = 4 were recruited.
RESULTS: There was no significant difference in the change in modified Bishop score between the four treatment groups. The lengths of the first and second stages of labour were similar in all 4 groups. PGE2 and oxytocin requirements were similar in all groups, as was the mode of delivery. There was no evidence that relaxin was absorbed systemically when given in this way.
CONCLUSION: Recombinant human relaxin 1 to 4 mg, administered as an intravaginal gel, has no effect as a cervical ripening agent before induction of labour at term.
Ripening of the human cervix and induction of labour with purified porcine relaxin.
In a randomised double-blind trial 10 of 30 patients given 2 mg of intravaginal purified porcine relaxin on the evening before surgical induction of labour went into labour before the proposed induction. Of 30 control patients, none went into labour. Of the 30 patients treated with relaxin, 25 had improved cervical scores after treatment and significantly fewer required augmentation in labour with intravenous oxytocin than the control group. Administration of relaxin was associated with very little increase in uterine activity and no side-effects. The trial shows that exogenous relaxin causes cervical ripening and can initiate parturition. Endogenous relaxin may have a similar role.
Ripening of the human cervix and induction of labor with intracervical purified porcine relaxin.
In a randomized double-blind placebo-controlled trial involving 71 patients, a viscous gel containing distilled water or 1 or 2 mg pure porcine relaxin was instilled in the cervical canal on the evening before the surgical induction of labor. Eleven of 48 patients receiving relaxin labored overnight, whereas only one of 23 patients went into labor. Only the 2-mg dose significantly improved the mean cervical score compared with the placebo treatment; the effect was greatest in primigravid patients with unripe cervixes. Intracervical application appeared to confer no benefit over vaginal application in effecting cervical ripening or inducing labor. Systemic absorption of the porcine relaxin after its intracervical application was confirmed by the measurement of immunoreactive relaxin in a homologous porcine relaxin radioimmunoassay. Thus, the cervical ripening effect of exogenous relaxin may be mediated either systemically or by direct action at the site of local application. This trial confirms the responsiveness of the human term cervix to exogenous relaxin and supports the suggestion that endogenous relaxin may play a similar role at term in facilitating cervical ripening and parturition.
Options:
A: Relaxin significantly increased the rate of uterine hyperstimulation with fetal heart rate changes.
B: Relaxin significantly reduced the rate of caesarean sections compared to placebo.
C: Relaxin significantly reduced the risk of the cervix remaining unfavourable or unchanged.
D: Relaxin had no significant effect on cervical ripening or induction of labour.
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C
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173
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the effects of preoxygenation compared to no preoxygenation for endotracheal suctioning in ventilated newborn infants? Please answer this question based on the information provided below:
Controlled supplemental oxygenation during tracheobronchial hygiene.
The effect of controlled supplemental oxygenation without bag ventilation on transcutaneous partial pressure of oxygen (TcPO2) measurements during tracheobronchial hygiene was evaluated. Procedure A, no supplemental oxygenation, was compared to Procedure B, in which controlled supplemental oxygenation was used. For controlled supplemental oxygenation, the FiO2 was increased until TcPO2 measurements rose to levels between 90 and 100 torr. Sixteen premature infants who required mechanical ventilation were studied in the neonatal center. Both procedures were performed on each patient in random order. In both procedures, a precipitous decrease in TcPO2 was observed during chest vibration, and further decrease in TcPO2 was noted with endotracheal suctioning. Except for baseline readings, throughout the tracheobronchial hygiene TcPO2 measurements were significantly higher and more subjects maintained TcPO2 values greater than 40 torr in Procedure B. In Procedure A corresponding TcPO2 measurements were 40 torr or less. Mean recovery time was shorter in Procedure B, 2.1 +/- 2.3 minutes, than in Procedure A, 4.9 +/- 2.8 minutes, p less than .003. Thus, in most patients, controlled supplemental oxygenation without manual bag ventilation seems sufficient to prevent hypoxia during tracheobronchial hygiene; it also shortens recovery time from hypoxemia as a result of the bronchopulmonary hygiene procedure.
Options:
A: Preoxygenation significantly reduced the incidence of hypoxemia during and after suctioning.
B: Preoxygenation had no significant effect on the incidence of hypoxemia during and after suctioning.
C: Preoxygenation increased the incidence of hypoxemia during and after suctioning.
D: Preoxygenation had mixed effects, reducing hypoxemia in some cases but increasing it in others.
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A
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174
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the optimal prophylactic method to prevent postoperative thromboembolism in colorectal surgery? Please answer this question based on the information provided below:
Intermittent pneumatic calf compression for prevention of deep venous thrombosis in general abdominal surgery.
A prospective randomized trial is described in 119 patients undergoing major abdominal general surgical procedures. Half of the patients were treated prophylactically with intermittent pneumatic calf compression, begun after the induction of anesthesia and continued until the patient was walking; the other half acted as controls. Deep venous thrombosis was detected by iodine-125 fibrinogen scanning and confirmed by venography, and did not differ significantly in the control and treated groups. One fatal pulmonary embolism occurred in each group. The presence of malignancy of the gastrointestinal tract did not influence the results. The findings suggest that pneumatic compression delayed the development of deep venous thrombosis postoperatively and that perhaps it should be continued until discharge from hospital.
Low-dose heparin in postoperative patients: a prospective, coded study.
One hundred five patients over age 40 undergoing various major operations were randomly divided into control and treated groups; all were treated by subcutaneous injection containing either 5,000 international units aqueous heparin sodium or a placebo one hour prior to operation and every 12 hours thereafter for eight days. Deep vein thrombosis (DVT) was detected by daily -125I-fibrinogen injection and leg scanning, and confirmed by ascending phlebography. Both groups were comparably distributed by age, sex, variety of operation, incidence of previous thromboembolism, and myocardial and cerebrovascular disease. Blood loss was not increased in the treated group. Incidence of DVT was 8.6 percent for the total group, 7.5 percent in the heparin-tested group (four of 53), and 9.6 percent in the control group (five of 52), including one control patient with a normal scan (who later had a pulmonary embolus.
Low dose heparin versus low molecular weight heparin (Kabi 2165, Fragmin) in the prophylaxis of thromboembolic complications of abdominal oncological surgery.
Eighty patients undergoing pelvic or abdominal surgery for cancer were randomized in two groups for prevention of postoperative thromboembolism: 40 patients received a 15,000 IU day-1 Calciparine prophylaxis and 40 patients a 5000 anti-Xa U/d Fragmin prophylaxis for 10 days. In the Calciparine group, two patients (5%) developed postoperative pulmonary embolism but none developed it in the Fragmin group. Two patients in the Fragmin group (5%) developed isotopic DVT, which was not confirmed by phlebography. There was no deep vein thrombosis of the lower limbs in the two groups. Important postoperative bleeding (one patient in the Calciparine group and two patients in the Fragmin group) was similar in both groups. Moderate and minor bleeding were significantly lower in the Fragmin group. Haemoglobin and haematocrit changes, total blood loss and transfusion requirements were not different in both groups. It is concluded that, over a 10-day period, one daily 5000 U Fragmin prophylaxis was as effective and safe as three daily 5000 IU Calciparine injections.
Prevention of venous thrombosis with small, subcutaneous doses of heparin.
The effect of low-dose heparin prophylaxis on venous thrombosis and bleeding after major elective surgery was studied in a prospective controlled study of 820 patients. The total incidence of venous thrombosis detected with leg-scanning using fibrinogen labeled with radioactive iodine (125I) was reduced from 16.0% in the control group to 4.2% in treated patients. More important, the incidence of popliteal or femoral vein thrombosis was reduced from 2.9% to 1.0%. Prophylaxis resulted in a slight increase in bleeding-minor wound hematoma, mean volume of blood transfused, and a post-operative hematocrit fall in treated patients. However, increased bleeding was clinically minor, and prophylaxis was well tolerated.
Randomized, controlled trial of low molecular weight heparin vs. no deep vein thrombosis prophylaxis for major colon and rectal surgery in Asian patients.
PURPOSE: Routine deep venous thrombosis prophylaxis is controversial in Asian patients, because deep venous thrombosis incidence was considered negligible. Because of recent reports of significantly higher incidences, a randomized, controlled trial was conducted to assess the effectiveness and complications of enoxaparin prophylaxis (low molecular weight heparins) in major colorectal surgery.
METHODS: Three hundred twenty consecutive patients were randomly assigned to control or low molecular weight heparins groups. Patients in the low molecular weight heparins group were given perioperative enoxaparin starting 12 hours before surgery. The surgeon (blinded) assessed for difficulties related to possible enoxaparin administration. Independent blinded observers performed daily clinical assessments and Doppler studies (at the 3rd and 5th postoperative day). Deep venous thrombosis was confirmed by duplex ultrasound, and pulmonary embolism was confirmed by lung scans or postmortem examinations.
RESULTS: Deep venous thrombosis developed in 5 of 169 (3 percent) controls and 0 of 134 low molecular weight heparins patients (P = 0.045). Three of the deep venous thrombosis patients had pulmonary embolism, which was fatal in one patient. The surgeons were unable to perceive any increased surgical difficulties in the low molecular weight heparins group. The bleeding-related complications were significantly higher in the low molecular weight heparins patients (controls, n = 3 (1.8 percent); low molecular weight heparins, n = 9 (6.7 percent)). However, apart from one subdural hematoma and two abdominal hemorrhages needing re-exploration, which also occurred in one of the controls, these complications were minor bruises at the wounds, drains, or injection sites.
CONCLUSION: Deep venous thrombosis prophylaxis is needed in Asian patients undergoing major colorectal surgery.
Drug prevention of postoperative deep vein thrombosis. A compararative study of calcium heparinate and sodium pentosan polysulfate.
Deep vein thrombosis and its sequel, pulmonary embolus, are possibly the greatest threats to recovery after surgical operation. In a randomized, controlled clinical trial in which the 125I-fibrinogen uptake test, Doppler ultrasound, and phlebography were used for diagnosis, it was found that low doses of calcium heparinate administered subcutaneously and sodium pentosan polysulfate intramuscularly were effective in preventing deep vein thrombosis (DVT), postoperatively. The incidence of DVT was as follows: 9% in the group treated with heparinate; 15% in the group treated with sodium pentosan polysulfate; nad 51% in the untreated control group.
Low molecular weight heparin and prevention of postoperative thrombosis in abdominal surgery.
In a prospective, double-blind, randomized multicenter trial the efficacy and safety of low molecular weight heparin and unfractionated heparin were compared for the prevention of postoperative deep vein thrombosis in patients undergoing abdominal surgery. Six hundred and seventy-three patients were randomly allocated to the two prophylaxis groups; 20 of these, however, did not undergo surgery and did not receive any prophylaxis. Of the remaining 653 patients 323 received one subcutaneous injection of 3,000 anti-Xa units of low molecular weight heparin and 330 received subcutaneously 5,000 U heparin three times a day. Treatment was initiated 2 h preoperatively and continued for 7 to 10 days. The occurrence of DVT was determined by the 125I-labelled fibrinogen uptake test and phlebography. Venous thrombosis was diagnosed in 24 of 323 patients (7.4%) treated with low molecular weight heparin and in 26 of 330 patients (7.9%) treated with low-dose heparin. DVT of proximal veins was detected in four patients of the low molecular weight heparin group and in three patients of the low-dose heparin group. During the observation period three pulmonary emboli - one fatal and two non-fatal - occurred in patients receiving prophylaxis with low-dose heparin. No pulmonary embolism was found in patients treated with low molecular weight heparin. Both prophylactic schemes were well tolerated. Intra- and postoperative blood loss, incidence of wound hematoma, frequency and volume of intra- and postoperative blood transfusion were similar in both groups with a slight advantage for the low molecular weight heparin group.(ABSTRACT TRUNCATED AT 250 WORDS)
Is DVT prophylaxis overemphasized? A randomized prospective study.
This study was designed to prospectively evaluate a previously published prognostic index for predicting deep venous thrombosis (DVT) in general surgical patients with conventional prophylaxis. Patients undergoing procedures of at least 1 hr duration (abdominal, thoracic, head and neck, inguinal) requiring general or spinal anesthetic were prospectively randomized into the following groups: Group 1, sequential pneumatic compression devices during surgery and 2 days postoperatively; Group 2, subcutaneous heparin (5000 U q 12 hr) starting 1 hr before surgery and for 7 days postop; Group 3, control group. All patients underwent duplex evaluation of bilateral lower extremity deep venous systems preoperatively and on postoperative Days 1, 3, and 30. In addition, a previously developed predictive DVT incidence indicator, the prognostic index (PI), was calculated for each patient. A total of 137 patients were entered into the study with 29 removed for patient/staff reasons. There were no differences in PI among the three groups at the 0.05 level (ANOVA). The distribution of risk factors for DVT including increased age, body size, hemoglobin (Hb), and colorectal procedures were distributed evenly among the groups. Additional factors such as diabetes, COPD, PVD, immobilization, and cancer were also evenly distributed among the groups. The PI predicted a 20% incidence of DVT. For Groups 1 (n = 25), 2 (n = 38), and 3 (n = 45) no DVTs were detected over the 30 days of study. During the study period, 8 DVTs were detected by duplex evaluation in general surgical patients not in the study (1.5%). In conclusion, in a prospective randomized study using sequential pneumatic compression devices, subcutaneous heparin or no prophylaxis in matched general surgical patients at moderate to high risk for thromboembolism, no DVTs occurred for up to 30 days. Furthermore, neither a PI nor other factors associated with DVT accurately predicted the incidence of DVT in this patient population.
Effect of low-dose heparin on incidence of postoperative pulmonary embolism detected by photoscanning.
Prevention of postoperative deep vein thrombosis in cancer patients. A randomized trial with low molecular weight heparin (CY 216).
Sixty-one consecutive patients were enrolled in a randomized, controlled trial of thromboprophylaxis with a low molecular weight heparin (Seleparina, CY 216) in major abdominal oncological surgery. Thirty patients received 2 x 3,825 anti-Xa international units of CY 216 subcutaneously on the day of surgery followed by a single daily 3,825 anti-Xa international units injection for 7 days; thirty-one patients did not receive any form of prophylaxis. The occurrence of deep vein thrombosis (DVT) was detected by 125I-labelled fibrinogen leg scan. Postoperative DVT developed in 2 patients in the CY 216 group and in 11 patients in the control group (6.8% vs 35.4%, p < 0.01). Although there was a higher postoperative transfusional requirement in the group receiving CY216 (p < 0.05), the total number of patients transfused was similar in the two groups (14 vs 13). On day 1 after surgery, the two patients who later developed DVT in the CY216 group had plasma anti-Xa activity significantly lower (p < 0.01) than the remaining patients. As a good relationship was found between plasma anti-Xa activity and body weight, adoption of a personalized dosage schedule might improve efficacy of CY 216 prophylaxis.
Subcutaneous heparin versus low-molecular-weight heparin as thromboprophylaxis in patients undergoing colorectal surgery: results of the canadian colorectal DVT prophylaxis trial: a randomized, double-blind trial.
OBJECTIVE: To compare the effectiveness and safety of low-dose unfractionated heparin and a low-molecular-weight heparin as prophylaxis against venous thromboembolism after colorectal surgery.
METHODS: In a multicenter, double-blind trial, patients undergoing resection of part or all of the colon or rectum were randomized to receive, by subcutaneous injection, either calcium heparin 5,000 units every 8 hours or enoxaparin 40 mg once daily (plus two additional saline injections). Deep vein thrombosis was assessed by routine bilateral contrast venography performed between postoperative day 5 and 9, or earlier if clinically suspected.
RESULTS: Nine hundred thirty-six randomized patients completed the protocol and had an adequate outcome assessment. The venous thromboembolism rates were the same in both groups. There were no deaths from pulmonary embolism or bleeding complications. Although the proportion of all bleeding events in the enoxaparin group was significantly greater than in the low-dose heparin group, the rates of major bleeding and reoperation for bleeding were not significantly different.
CONCLUSIONS: Both heparin 5,000 units subcutaneously every 8 hours and enoxaparin 40 mg subcutaneously once daily provide highly effective and safe prophylaxis for patients undergoing colorectal surgery. However, given the current differences in cost, prophylaxis with low-dose heparin remains the preferred method at present.
Ultra-low dose intravenous heparin in the prevention of postoperative deep-vein thrombosis.
Heparin (1 IU kg-1 h-1) given intravenously for 3-5 days during and after operation in a double-blind randomised study, significantly reduced the frequency of deep-vein thrombosis detected by 125I-fibrinogen uptake, and pulmonary embolism. 22% (11/50) control patients and 4% (2/45) patients receiving heparin had deep-vein thrombosis or pulmonary embolism. Heparin administration was not associated with any increase in preoperative or postoperative bleeding.
Intermittent sequential pneumatic compression of the legs and thromboembolism-deterrent stockings in the prevention of postoperative deep venous thrombosis.
One hundred fifty patients over the age of 30 who had undergone major abdominal operations were stratified according to the risk of deep venous thrombosis and randomized into three groups to receive different prophylactic regimens: group A, electrical calf stimulation; group B, low-dose subcutaneous heparin; group C, intermittent sequential compression and thromboembolism-deterrent (TED) stockings. All the patients were scanned with the 125I-fibrinogen test for the whole stay in hospital. The incidence of 125I-fibrinogen detected deep venous thrombi was 18% in group A, 9% in group B, and 4% in group C. The results indicate that the regimen of intermittent sequential compression and TED stockings is as effective as low-dose subcutaneous heparin. Electrical calf stimulation is less effective.
A low molecular weight heparin (KABI 2165) for prophylaxis of postoperative deep venous thrombosis.
In a prospective double-blind trial, low molecular weight (LMW) heparin (KABI 2165) 5,000 U (anti-Xa) once daily was compared with conventional heparin 5,000 IU twice daily, both given subcutaneously, as regards prevention of postoperative deep venous thrombosis (DVT) in 52 patients undergoing major abdominal surgery. Radioactive fibrinogen uptake test (FUT) was used for DVT screening. DVT, diagnosed from positive FUT, developed in two patients from each group, but could be phlebographically confirmed in only one (LMW) case. No intergroup differences were found in peroperative blood loss or requirements for blood transfusion. Complications attributable to the prophylactic regimens were few. In the LMW-heparin group, the anti-Xa levels measured during operation showed considerable variation, the higher activities (greater than 0.30 U/ml) being nonsignificantly associated with increased blood loss. Studies with lower doses of LMW-heparin are recommended.
[Subcutaneous small heparin doses for the prevention of thrombosis in general surgery and urology].
1. The effectiveness of 3 X 5000 IU s. c. heparin daily (starting preoperatively) for the prevention of postoperative deep vein thrombosis was evaluated in a prospective, controlled, randomized study including general surgical and urological patients. 125I-fibrinogen test was performed daily in all patients. 2. 178 patients fulfilled the conditions of the protocol. 35.8% of the 95 patients in the control group developed deep vein thrombosis, but only 13.3% of 83 subjects in the heparin group did so. The difference is statistically highly significant (p less than 0.001). 3. The vast majority of all thrombi in both groups appeared before the 3rd postoperative day. 4. With 1 exception, all deep vein thrombi in the heparin group started in the mid-calf region. In the control group 5 deep thrombi originated in the popliteal vein. 5. Heparin displays a better effect in males (n = 34; p less than 0.01) than in females (n = 49; p less than 0.025). 6. In patients undergoing surgery for malignant disease heparin does not reduce the incidence of deep vein thrombosis. 7. Heparin is far more effective in patients under 60 years of age than in those over 60 (p less than 0.005). 8. Heparin is more effective in obese patients than in those of normal body build. 9. Heparin prophylaxis also reduces the incidence of deep vein thrombosis in patients who exhibit predisposing factors. In patients of the control group with preexisting disease of the venous system, there were significantly more deep vein thrombi (p less than 0.01) than in those without predisposing factors. 10. In the heparin group 29% of all thrombin time determinations show a definite prolongation of more than 26 sec (normal value 15 sec). 11. In 14 patients (=16.9%) of the heparin group, 21 side effects or complications were seen. Bleeding complications were the main problem, comprising 5 wound hematomas and hematomas at the injection site, 4 postoperative bleeding episodes and 2 reoperations. There were no complications in the control group. 12. According to the results of 10 well controlled studies, there is no doubt that in general surgery small doses of subcutaneous heparin, commencing preoperatively, do reduce the incidence of postoperative deep vein thrombosis to a significant degree. However, whether this form of prophylaxis is also effective in patients with fractures of the hip and in elective hip surgery cannot, on the evidence available, be decided. In the fields of gynecological surgery and urology as well, more data are needed before this form of heparin prophylaxis can be recommended.
Concentrated or diluted heparin prophylaxis of postoperative deep venous thrombosis.
A concentrated and a diluted heparin solution (Vitrum AB) have been evaluated in a controlled blind study, using a standard dosage of 5 000 IU, given every 12 hours subcutaneously. 167 patients undergoing abdominal surgery were randomized into three groups: 63 received diluted heparin 5 000 IU/ml, 43 received concentrated heparin 25 000 IU/ml and 61 patients served as controls. 80 per cent of the patients suffered from malignant disease. Deep venous thrombosis (DVT), diagnosed with the 125I-fibrinogen method, was found in 16% of the patients receiving diluted heparin, in 23% of those receiving concentrated heparin and in 33% of the controls. To evaluate the amount injected, an in vitro experiment was performed in which the intended dose was 5 000 IU. The measured amount of the concentrated heparin solution was significantly less than 5 000 IU. It is concluded that the frequency of DVT after gastrointestinal operations can be reduced significantly (in the present study from 33 to 16%) by administering diluted calcium heparin every 12 hours for 6--8 days. The concentrated heparin solution did not significantly reduce postoperative DVT, possibly on account of variations in the dosage. Diluted heparin prophylaxis can be achieved without serious side effects.
Controlled clinical study of the efficacy of a new low molecular weight heparin administered subcutaneously to prevent post-operative deep venous thrombosis.
A double-blind, placebo-controlled study was carried out in 100 patients undergoing major surgery to investigate the efficacy of a new low molecular weight heparin (LMWH) preparation in the prevention of deep venous thrombosis. Patients were allocated at random to receive either placebo or LMWH (7500 AXaU) each day by subcutaneous injection (abdominal fold method), starting 2 hours before the operation and continuing for the following 7 days. Clinical and laboratory tests revealed deep venous thrombosis in 3 (6%) patients in the placebo group whereas no thrombotic episodes were observed in any of the patients treated with LMWH. Blood loss during the peri-operative and post-operative period and the number of blood units transfused were not significantly different in the two groups. Moreover, no side-effects were revealed in the LMWH group that could be attributed to the drug.
[Low-dosage heparin combined with either dihydroergotamine or graduated supportive stockings. Combined prevention of thrombosis in colonic surgery].
Prophylaxis of deep venous thrombosis after acute abdominal operation.
Two hundred and forty-five patients who underwent acute extensive abdominal operations were randomized into three regimens to achieve optimal prophylaxis of postoperative thromboembolic complications. All of the patients were screened by the 125I-fibrinogen uptake test for seven days and if the phlebographic findings were positive. Of 81 patients receiving low dose heparin, 12 had thromboembolism. Of 79 receiving a combination of low dose heparin and graded compression stockings, two had thromboembolism, and of 85 receiving a combination of dextran and graded compression stockings, 13 had this complication. This difference is significant in favor of the second treatment (p = 0.013). It is concluded that the combination of low dose heparin and graded compression stockings is an effective way to prevent thromboembolism after acute abdominal operations.
Options:
A: No treatment or placebo
B: Low-dose unfractionated heparin alone
C: Graduated compression stockings alone
D: Combination of graduated compression stockings and low-dose unfractionated heparin
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D
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175
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What are the findings regarding the effectiveness of individual psychodynamic psychotherapy and psychoanalysis for people with schizophrenia or severe mental illness? Please answer this question based on the information provided below:
The role of the therapeutic alliance in the treatment of schizophrenia. Relationship to course and outcome.
This study examined the relationship of the therapeutic alliance to the treatment course and outcome of 143 patients with nonchronic schizophrenia. Results showed that patients who formed good alliances with their therapists within the first 6 months of treatment were significantly more likely to remain in psychotherapy, comply with their prescribed medication regimens, and achieve better outcomes after 2 years, with less medication, than patients who did not. These results underscored the prognostic value of assessing the alliance and the need to identify factors that contribute to its development and maintenance with schizophrenic patients.
Effects of psychotherapy in schizophrenia.
Fifty-one schizophrenic patients were randomly assigned to receive insight-oriented or supportive psychotherapy. After two years of treatment, their outcomes were compared on a broad range of measures. The results of the two therapies were, for the most part, similar. Some advantages for each were also seen in the sectors of outcome toward which the two treatments were focused. The supportive therapy group did better in areas of practical adaptation and the insight therapy group did better in areas of intrapsychic function.
Effects of psychotherapy in schizophrenia: II. Comparative outcome of two forms of treatment.
This study compares the effects of exploratory, insight-oriented (EIO) and reality-adaptive, supportive (RAS) forms of psychotherapy on a sample of 95 schizophrenic patients. Analyses of 2-year outcomes revealed a complex interaction between the type of psychotherapy provided and the domain of psychopathology affected. RAS psychotherapy exerted clear preferential effects in the areas of recidivism and role performance. The EIO psychotherapy exerted preferential, albeit more modest, action in the areas of ego functioning and cognition. Overall, however, the magnitude of the differences was low. The results highlighted the need for more focused studies of subgroups, and of process and contextual influences on outcome.
Effects of psychotherapy in schizophrenia: I. Design and implementation of a controlled study.
This article describes a 2-year, multi-hospital study on the effects of psychotherapy for nonchronic schizophrenic patients. The design and methods used to evaluate the relative benefits of exploratory, insight-oriented (EIO) psychotherapy and reality-adaptive, supportive (RAS) psychotherapy when both are provided by experienced therapists against the backdrop of good hospital and psychopharmacological management are presented. Similarities and differences between the two therapies and the therapists are outlined. Special attention is given to the problems in implementing research on long-term psychotherapy. Finally, the strengths and limitations of the present study are discussed.
The Paul H. Hoch Award Lecture: a followup study of the results of treatment of schizophrenia.
Schizophrenia--a follow-up study of results of treatment. I. Design and other problems.
This is the first of a series of articles on a follow-up study of the results of treatment of schizophrenia, studied over a period of two to five years after first admission and first release. The study compares the follow-up outcome of five different treatment methods given to first-admission male and female schizophrenic patients in the hospital. The design of the study is used as a basis for description and discussion of the practical, ethical, and statistical problems involved. A distinction is made between follow-up and continued treatment design, and it is concluded that both pose massive problems in execution, analysis, presentation, and interpretation.
Schizophrenia. A follow-up study of the results of five forms of treatment.
Two hundred twenty-eight first-admission schizophrenic patients were randomly assigned to the following five treatments: psychotherapy alone, drug alone, psychotherapy plus drug, electroconvulsive therapy (ECT, and milieu. A there- to five-year follow-up examined their course after release from the hospital. The drug alone and ECT groups tended to have the best outcome and the psychotherapy alone group the worst. The positive effect from prior drug treatment began to dissipate after three years postadmission. For the in-hospital treatment successes, the advantage from drug treatment and the disadvantage from psychotherapy were less apparent. Overall, the follow-up outcome is far from reassuring, whatever the type of treatment. Even though a few patients may do well, much remains to be done in and out of the hospital.
Schizophrenia--a follow-up study of results of treatment.
This is the second article from a study of the outcome of five different methods of treatment for schizophrenia; patients were followed up over a period of two to five years after first admission and the first release. Patients who had been originally treated in hospital with psychotherapy alone stayed longer in hospital over the follow-up period than those who had received electroconvulsive therapy (ECT), drug alone, or drug plus psychotherapy. Those who had been treated with milieu therapy also had a longer stay dated from the time of admission. Patients treated initially with drugs or ECT showed a trend toward spending less time in hospital after their release.
Therapist characteristics and the outcome of treatment in schizophrenia.
The broad task of identifying and characterizing specific components of personality and behaviours of therapists that may be differentially helpful in the treatment of schizophrenia still remains to be addressed. This report presents data systematically collected in the course of a controlled study of the outcome of five different treatment methods in schizophrenia. Therapists seem to play a significant role in determining the outcome of the treatment of schizophrenia by drugs and by psychotherapy plus drugs. The salient therapist behaviors that seem to make a difference in outcome are yet to be identified and studied. The A-B dimension as customarily defined seems of little value for this task. The findings show a distinct need to identify cognitive and affective personality characteristics of the therapist relevant to eliciting patient cooperation, and the degree of knowledge and sophistication in the use of particular methods of treatment necessary for good results.
Therapist experience, general clinical ability, and treatment outcome in schizophrenia.
Predicting the outcome of psychotherapy for schizophrenics. Relative contributions of patient, therapist, and treatment characteristics.
This study was designed to assess the relative prognostic importance of patient factors, therapist characterists, and treatment mode. The sample was 100 schizophrenic outpatients referred to a community mental health center following psychiatric hospitalization. Patients were randomly assigned to either group (N=50) or individual (N=50) psychotherapy. Criteria were rehospitalization and two clinician ratings--adjustment and social effectiveness--at a two-year follow-up. The best predictor of rehospitalization was the number of previous hospitalizations. The best predictor of adjustment status at two years was pretreatment adjustment level. Also, patients with good prognostic indices made relatively large gains. Predictors of outcome for group-treated patients did not differ from those for individually treated patients. Controlling for initial status, treatment mode was almost as good as predictor of adjustment gains as were other patient factors.
Group vs individual psychotherapy with schizophrenics. A controlled outcome study.
Options:
A: There is strong evidence supporting the positive effects of psychodynamic psychotherapy for people with schizophrenia.
B: There is no evidence of any positive effect of psychodynamic therapy, and the possibility of adverse effects has not been considered.
C: Psychoanalytic therapy has been proven to be effective for people with schizophrenia.
D: Psychodynamic therapy is more effective than pharmacological interventions for schizophrenia.
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B
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176
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings of the comparison between radical surgery (cystectomy) and radical radiotherapy in terms of survival for patients with muscle invasive bladder cancer? Please answer this question based on the information provided below:
Treatment of T3 bladder cancer: controlled trial of pre-operative radiotherapy and radical cystectomy versus radical radiotherapy.
Bladder cancer: superiority of preoperative irradiation and cystectomy in clinical stages B2 and C.
Treatment of advanced bladder cancer category T2 T3 and T4a. A randomized multicenter study of preoperative irradiation and cystectomy versus radical irradiation and early salvage cystectomy for residual tumor. DAVECA protocol 8201. Danish Vesical Cancer Group.
From 1983 to 1986 183 patients with transitiocellular carcinoma of the urinary bladder, category T2-T4a, entered a randomized study. The patients were allocated to receive either preoperative irradiation (40 Gy) followed by cystectomy or radical irradiation (60 Gy) followed by salvage cystectomy in cases of residual tumor. The two randomization groups were comparable in regard to sex, age, T-categories, tumor size, histological grade and concomitant dysplasia. The two randomization groups included 88 and 95 patients respectively. The treatment plan was followed by 66 patients (75%) in the planned cystectomy group and by 88 (92%) in the radical radiotherapy group of which 27 (28%) were treated with salvage cystectomy. The results showed a trend to a higher survival rate following the combined treatment with preoperative irradiation and cystectomy compared to radical irradiation followed by salvage cystectomy in case of residual tumor, but a statistical significant difference could not be demonstrated. The lack of difference also applied according to the actually given treatment. There was no difference in surgical complications between planned and salvage cystectomy and there were no postoperative deaths among the cystectomized patients. The type of late complications was different in the two treatment groups, but there were no major differences in the number of complications except for the fact that all male patients experienced erective impotence after cystectomy. The T-category, response to radiotherapy and frequency of lymph node metastases were found to be of prognostic importance.(ABSTRACT TRUNCATED AT 250 WORDS)
The management of deeply infiltrating (T3) bladder carcinoma: controlled trial of radical radiotherapy versus preoperative radiotherapy and radical cystectomy (first report).
The preliminary results are presented of a multicentre, co-operative randomised trial, sponsored by the Institute of Urology, London, in which radical irradiation (6,000 rads in 6 weeks) is compared with preoperative irradiation (4,000 rads in 4 weeks) plus radical cystectomy for deeply infiltrating carcinoma of the bladder (Stage T3 or B2C). 189 of the 199 cases entered into the trial between 1966 and 1975 were eligible for study. The overall 3- and 5-year survival rates for combined treatment were 41% and 33%, respectively, compared with 28% and 21% for radical radiotherapy. The operative mortality was 7.8%. The difference between the two treatments in favour of the combined treatment has not yet reached the generally accepted level of significance (P less than 0.05), the p factors for the 3- and 5-year results being 0.064 and 0.077, respectively. Of patients receiving the protocol combined treatment, reduction in tumour stage was found in the surgical specimen in 47% of cases. The overall incidence of nodal metastases was 23% (against the usual figure of 40-50%), and in the presence of a good response of the primary tumour to irradiation, only 8%. The 3- and 5-year survival rates for the down-staged cases were 66% and 55%, respectively, compared with 29% and 22% for patients showing no stage reduction in the surgical specimen. The aim of our future studies is to find effective radiosensitising and cytotoxic agents with which to try and increase the incidence and degree of tumour response to pre-operative irradiation in the combined modality treatment of T3 bladder cancers.
Options:
A: Radical radiotherapy showed a statistically significant survival benefit over radical surgery.
B: Radical surgery showed a statistically significant survival benefit over radical radiotherapy.
C: There was no overall statistically significant survival benefit for either treatment, but trends consistently favored radical surgery.
D: Both treatments showed equal survival benefits with no trends favoring one over the other.
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C
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177
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the efficacy of pneumococcal vaccine in reducing mortality or morbidity from pneumococcal disease in individuals with asthma? Please answer this question based on the information provided below:
Prophylaxis of otitis media in asthmatic children.
Seventy-two asthmatic children with recurrent otitis media were studied over a 2-year interval. They were randomly divided to receive either (1) no routine medication, (2) antihistamines whenever nasally congested, (3) daily sulfisoxazole at 500 mg twice a day, (4) pneumococcal immunization and (5) both pneumococcal vaccine and 500 mg sulfisoxazole twice daily. There was no apparent benefit in the antihistamine group. There was a mean yearly reduction in otitis media of 75% in the sulfisoxazole group, 38% in the pneumococcal vaccine group and 90% in the group treated with both agents. The latter group also had a 56% reduction in frequency of acute asthmatic attacks and a 90% decrease in hospitalizations associated with otitis media. In conclusion the use of sulfisoxazole and pneumococcal vaccine appears efficacious for management of asthmatic children with recurrent otitis media.
Options:
A: The review found strong evidence supporting the routine use of pneumococcal vaccine in people with asthma.
B: The review found very limited evidence to support the routine use of pneumococcal vaccine in people with asthma.
C: The review found no evidence to support the use of pneumococcal vaccine in people with asthma.
D: The review found that pneumococcal vaccine significantly increased the incidence of acute asthma exacerbations.
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B
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178
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the effectiveness of alpha 1 proteinase inhibitor (a1PI) in preventing chronic lung disease (CLD) and long-term adverse developmental outcomes in preterm neonates? Please answer this question based on the information provided below:
alpha1-Proteinase inhibitor therapy for the prevention of chronic lung disease of prematurity: a randomized, controlled trial.
BACKGROUND: An imbalance between increased neutrophil elastase and a decreased antiprotease shield has been suggested as a factor contributing to the development of chronic lung disease (CLD). We hypothesized that administration of alpha1-proteinase inhibitor (A1PI), also known as alpha1-antitrypsin, to premature neonates would prevent CLD.
DESIGN: A randomized, placebo-controlled, prospective study of A1PI supplementation was performed. Neonates <24 hours of age with birth weights 600-1000 g on respiratory support, and 1001-1250 g with respiratory distress syndrome (RDS) were eligible. Intravenous A1PI (60 mg/kg) or placebo was infused on days 0, 4, 7, and 14. Primary outcome was CLD in survivors, defined as the need for supplemental oxygen on day 28.
RESULTS: A total of 106 patients were recruited. There were no significant differences between groups in birth weight or incidence of RDS. The incidence of CLD in survivors was lower in the treated group, but the difference did not reach statistical significance (relative risk [RR], 0.79; confidence interval [CI], 0.60-1.02). This beneficial trend persisted at 36 weeks corrected gestational age (RR, 0.48; CI, 0.23-1.00). The incidence of pulmonary hemorrhage was lower in the treated group (RR, 0.22; CI, 0.05-0.98). Other complications were not significantly different between groups.
CONCLUSIONS: In this, the first trial of a protease inhibitor for the prevention of CLD in premature infants, the infusions were well-tolerated. A1PI therapy may impede the development of CLD and appears to reduce the incidence of pulmonary hemorrhage in some neonates born prematurely.
Options:
A: a1PI significantly reduced the risk of CLD at 36 weeks and long-term adverse developmental outcomes.
B: a1PI significantly reduced the risk of CLD at 36 weeks but had no effect on long-term adverse developmental outcomes.
C: a1PI did not reduce the risk of CLD at 36 weeks or long-term adverse developmental outcomes.
D: a1PI significantly reduced the risk of long-term adverse developmental outcomes but had no effect on CLD at 36 weeks.
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C
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179
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the effects of Methotrexate (MTX) on functional ability, range of motion, quality of life, overall well-being, and pain in patients with Juvenile Idiopathic Arthritis (JIA)? Please answer this question based on the information provided below:
Methotrexate in resistant juvenile rheumatoid arthritis. Results of the U.S.A.-U.S.S.R. double-blind, placebo-controlled trial. The Pediatric Rheumatology Collaborative Study Group and The Cooperative Children's Study Group.
BACKGROUND: The antimetabolite methotrexate has been shown in placebo-controlled trials to be effective in adults with rheumatoid arthritis. Methotrexate may also be effective in children with resistant juvenile rheumatoid arthritis, but the supporting data are from uncontrolled trials.
METHODS: Centers in the United States and the Soviet Union participated in this randomized, controlled, double-blind trial designed to evaluate the effectiveness and safety of orally administered methotrexate. Patients received one of the following treatments each week for six months: 10 mg of methotrexate per square meter of body-surface area (low dose), 5 mg of methotrexate per square meter (very low dose), or placebo. The use of prednisone (less than or equal to 10 mg per day) and two nonsteroidal antiinflammatory drugs was also allowed.
RESULTS: The 127 children (mean age, 10.1 years) had a mean duration of disease of 5.1 years; 114 qualified for the analysis of efficacy. According to a composite index of several response variables, 63 percent of the children who received low-dose methotrexate improved, as compared with 32 percent of those in the very-low-dose group and 36 percent of those in the placebo group (P = 0.013). As compared with the placebo group, the low-dose group also had significantly larger mean reductions from base line in the number of joints with pain on motion (-11.0 vs. -7.1), the pain-severity score (-19 vs. -11.5), the number of joints with limited motion (-5.4 vs. -0.7), and the erythrocyte sedimentation rate (-19.0 vs. -6 mm per hour). In the methotrexate groups only three children had the drug discontinued because of mild-to-moderate side effects; none had severe toxicity.
CONCLUSIONS: Methotrexate given weekly in low doses is an effective treatment for children with resistant juvenile rheumatoid arthritis, and at least in the short term this regimen is safe.
Randomized, placebo-controlled, crossover trial of low-dose oral methotrexate in children with extended oligoarticular or systemic arthritis.
OBJECTIVE: Juvenile idiopathic arthritis (JIA) can persist through adolescence and adulthood, resulting in significant disability. The use of low-dose oral methotrexate (MTX) for persistent polyarthritis has been shown to be effective by the USA/USSR collaborative study group. However, 2 of the most disabling subgroups of JIA, systemic and extended oligoarthritis, were underrepresented in that study. The present study was therefore conducted to investigate the efficacy of MTX in these 2 subgroups.
METHODS: Patients under the age of 16 years who fulfilled the International League of Associations for Rheumatology criteria for systemic or extended oligoarticular arthritis were eligible for this multicenter, double-blind, placebo-controlled crossover trial. Forty-five patients with systemic and 43 with extended oligoarticular arthritis were enrolled. The dosage of MTX or placebo was 15 mg/m2, which could be increased to 20 mg/m2 after 2 months. Core outcome variables were considered as primary measures, giving a final score of "improved" or "not improved." Secondary measures included scores of systemic features and biochemical laboratory measures. Assessment of function was not included since there were no validated functional measures at the start of this trial in 1991.
RESULTS: In the extended oligoarticular arthritis group, MTX treatment produced significant improvement in 3 of 5 core variables (erythrocyte sedimentation rate, physician's global assessment of disease activity, and parent's global assessment of disease activity). By the primary improvement criteria, there was significant overall improvement during MTX treatment. In the systemic arthritis group, only 2 of 5 core variables were significantly improved (physician's and parent's global assessment of disease activity). Systemic features were not part of the core variables, but the systemic feature score was not significantly different between MTX and placebo treatment. There was no significant overall improvement in this group during MTX treatment. However, no significant interaction between disease subgroup and treatment effect was demonstrated. When the data from both disease subgroups were combined, there was significant clinical improvement during MTX treatment (P = 0.006).
CONCLUSION: MTX 15-20 mg/m2 given orally once a week was found to be an effective treatment for both extended oligoarticular and systemic JIA in this shortterm trial. Long-term efficacy needs to be addressed in future studies.
Options:
A: MTX had large and clinically significant effects on patient centered disability measures in JIA patients.
B: MTX had small to moderate effects on patient centered disability measures, with improvements ranging from 3 to 18% greater than placebo.
C: MTX had no effect on patient centered disability measures in JIA patients.
D: MTX had clinically significant effects (>20%) on patient centered disability measures in JIA patients.
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B
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180
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the effectiveness and safety of 5-HTP and tryptophan in treating depressive disorders in adults? Please answer this question based on the information provided below:
The treatment of depression in general practice: a comparison of L-tryptophan, amitriptyline, and a combination of L-tryptophan and amitriptyline with placebo.
One hundred and fifteen patients from 5 general practices participated in a 12-week, double-blind study comparing L-tryptophan, amitriptyline, L-tryptophan-amitriptyline combination and placebo in the treatment of depression. Analysis of total score on the Hamilton Depression Scale and a global rating of depression showed that all 3 active treatments were more effective than placebo. Significantly more patients were withdrawn as treatment failures in the placebo group compared with the active treatment groups. Side-effects necessitated withdrawal of more patients from the amitriptyline group than from the other active treatment groups, but this difference was not significant. Plasma amitriptyline and nortriptyline levels were similar in the amitriptyline and combined treatment groups. Standard haematological and biochemical profiles did not alter significantly in any group, but mean heart rate was significantly increased in patients receiving amitriptyline. There was no change in free or total plasma tryptophan concentration with treatment or on remission of symptoms.
A pilot study of the predictive value of the probenecid test in application of 5-hydroxytryptophan as antidepressant.
Options:
A: 5-HTP and tryptophan are conclusively proven to be effective and safe for treating depressive disorders.
B: 5-HTP and tryptophan are better than placebo at alleviating depression, but the evidence is of insufficient quality to be conclusive.
C: 5-HTP and tryptophan are not effective at all in treating depressive disorders.
D: 5-HTP and tryptophan are effective, but their safety is well-established and they are recommended for widespread use.
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B
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181
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the impact of school-based driver education on the timing of licensing and the involvement in road traffic crashes among teenagers? Please answer this question based on the information provided below:
High school driver education: further evaluation of the DeKalb County study.
The DeKalb County, Georgia, study is the largest experimental evaluation of high school driver education to date. Detailed reanalyses of data from that study reveal that students assigned to an enhanced driver education program (Safe Performance Curriculum) were more likely to obtain drivers licenses, to be in car crashes and to have traffic violations than control students not assigned to driver education. Students assigned to a minimal program of high school driver education (Pre-Driver Licensing Curriculum) were also more likely than control students to obtain licenses, but the difference was smaller than for the enhanced program and they were not significantly more likely to be in crashes or to have violations. Students in the more limited course were less likely than those in the enhanced course to complete the course in a timely manner, which suggests that exposure differences may explain differences between the two groups. The results confirm that greater availability of driver education causes students to become licensed sooner, although the DeKalb study probably underestimates the effect. Because of this greater exposure, crashes and violations are incurred at an earlier age.
Options:
A: Driver education leads to earlier licensing and reduces the involvement in road traffic crashes.
B: Driver education does not affect the timing of licensing but reduces the involvement in road traffic crashes.
C: Driver education leads to earlier licensing but does not reduce the involvement in road traffic crashes.
D: Driver education does not affect the timing of licensing and does not reduce the involvement in road traffic crashes.
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C
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182
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy and safety of using amniotomy combined with intravenous oxytocin for induction of labour in the third trimester? Please answer this question based on the information provided below:
Assessment of a new prostaglandin E2 gel in labour induction.
Prostaglandin E2 in a new gel form (Prepidil; Upjohn) was found to be as efficient in inducing labour as artificial rupture of membranes combined with intravenous oxytocin administration. There were no side-effects in the 25 patients in the study group. Prepidil gel has the advantage of simplicity and patient acceptance.
Single shot prostaglandin gel for labor induction.
A viscous suspension of prostaglandin E2 was introduced endocervically to induce labor in patients with favourable induction features. The method was found to be effective and compared favourably with the conventional practices of amniotomy and intravenous oxytocin infusion or oral prostaglandin therapy. Several advantages were found including a high degree of patient acceptability.
Induction of labour: a comparison of a single prostaglandin E2 vaginal tablet with amniotomy and intravenous oxytocin.
In a randomized controlled study of 100 women of low parity and favourable induction features, induction of labour by means of a single vaginal tablet containing 3 mg of prostaglandin E2 (PGE2) was compared with the conventional method of amniotomy and intravenous oxytocin. Four of the patients (8%) who received the prostaglandin tablet required additional intravenous oxytocin to achieve delivery. The prostaglandin group had a longer mean overall induction-delivery interval but a shorter amniotomy-delivery interval than the oxytocin group. One patient in the PGE2 group and two in the oxytocin group required caesarean section. The PGE2 treated patients expressed a higher level of satisfaction with their method of induction, they required less analgesia, had less blood loss at delivery and their babies had a lower incidence of neonatal jaundice.
Intrauterine pressures in labours induced by amniotomy and oxytocin or vaginal prostaglandin gel compared with spontaneous labour.
Uterine activity during the first stage of labour was measured by an intrauterine transducer in 22 women induced with intravaginal PGE2 gel, in 37 induced by amniotomy and intravenous oxytocin, and in nine women in spontaneous labour. The nulliparous women in the PGE2 gel group had a significantly longer pre-established phase of labour and a significantly shorter established phase than nulliparae induced by amniotomy and oxytocin. The mean levels of total uterine activity (kPas) during labour and the uterine activity integrals (kPas/15 min) were significantly lower in nulliparae induced with PGE2 gel than in those induced by amniotomy and oxytocin. These findings suggest that PGE2 gel has a positive, beneficial effect on cervical compliance during the pre-established phase, resulting in less myometrial effort during established labour. These effects were less evident in parous women, probably because of an innate lower cervical resistance due to their previous labours. Uterine activity patterns during the 4 h leading to full cervical dilatation in nulliparae were similar in labours induced with PGE2 gel and spontaneous labours, whereas labours induced by amniotomy and oxytocin exhibited a significantly different pattern. Expulsion of the fetus during normal labour is a function of both uterine contractions and a decrease in the cervical resistance and the data suggest that induction by PGE2 gel more closely mimics spontaneous labour, whereas the predominant effect of oxytocin is to stimulate myometrial activity.
The effect of intravaginal prostaglandin F2 alpha on labour after spontaneous and artificial rupture of the membranes.
The effect on labour of 50 mg intravaginal PG F2 alpha or a standard intravenous oxytocin regimen was compared in 2 randomised trials involving a total of 83 patients, 23 of whom had experienced spontaneous rupture of the membranes (S.R.O.M.) and 60 of whom had artificial rupture of the membranes (A.R.M.) to induce labour. In each trial, labour had not been initiated by membrane rupture alone. In both trials only 20% of the patients receiving PG F2 alpha required further augmentation of labour with intravenous oxytocin. The mean length of labour in patients receiving PG F2 alpha was 2.5 hours shorter in the A.R.M. trial and 3.0 hours shorter in the S.R.O.M. trial than the mean length of labour in patients receiving intravenous oxytocin (P < 0.01). In the A.R.M. trial, the PG F2 alpha-treated group had significantly less analgesic requirements (P < 0.001). Although more normal deliveries occurred in the patients treated with PG F2 alpha than oxytocin in both trials, the numbers did not reach statistical significance. No side effects occurred in the PG F2 alpha-treated patients or their babies and this method was much preferred by patients and nursing staff alike.
Labour induction with low dose PGE2 vaginal gel: result of an Australian multicentre randomized trial.
An open-label, parallel, randomized study was conducted in 6 Australian hospitals involving 320 women near term who required induction of labour. Labour induction with 1 or 2mg of PGE2 in a vaginal triacetin gel repeated if necessary at 6 hours was compared to induction by amniotomy and intravenous oxytocin. Analysis of the 2 groups confirmed matching with regards demographic and clinical data. A significantly longer and more variable mean induction to onset of established labour interval was recorded in the PGE2 group (6.7 +/- 4.8 versus 2.0 +/- 1.1 hours. (p less than 0.001). The mean period of established labour was also longer (8.1 versus 6.0 hours, p less than 0.001) in the PGE2 group. However, 48% of PGE2 treated patients versus 29% oxytocin treated patients (p less than 0.01) were recorded as not experiencing strong contractions. Twelve hours after induction 65% of the PGE2 group and 93% of the oxytocin group were in established labour; 24% of the PGE2 treated group required subsequent augmentation with oxytocin. Spontaneous delivery occurred in 69% of PGE2 treated women and 62% of those treated with oxytocin (N.S.). Analgesic requirements were not statistically different between the groups. Fewer fetal heart rate abnormalities were recorded in the PGE2 treated group (p less than 0.02). No serious and only minimal adverse events were recorded in either treatment group.
A randomized controlled trial of selective planned delivery.
A prospective randomized controlled trial designed to investigate selective planned delivery is reported: 264 obstetrically normal women in the 38th week of pregnancy were admitted to this trial and 184 completed it. The infants of mothers in the planned delivery group had higher serum bilirubin levels on the fifth day post partum than control infants but no baby required treatment for hyperbilirubinaemia. Mothers in the planned delivery group required significantly greater amounts of pethidine while control mothers had a significantly higher incidence of meconium staining of the amniotic fluid. However, the infants in the two groups had similar Apgar scores at birth. There was one stillbirth in the control group; this was due to unrecognized fetal hypoxia during labour induced at 42 weeks for postmaturity.
[Artificial induction of labor at term for medical reasons. Comparison of 2 technics for labor induction, oxytocin + early artificial rupture of the membranes versus prostaglandin E2 vaginal gel. Open randomized controlled study].
Labor induction for medical reasons is a situation rather well-controlled by the combination: "oxytocin-amniotomy" when the cervix is favorably open. However, new induction techniques are currently under study, especially vaginal administration of PGE2 which presents the advantage of being simple to administer and better accepted by the patients. This study compared the classical technique, oxytocin perfusion and early artificial rupture of the membranes, with the vaginal administration of PGE2 gel (first dose: 1 mg, second dose 1 or 2 mg, six hours later). The success rate of both techniques is comparable, approximately 70 p. cent. Also, the times between amniotomy and delivery are identical, approximately 5 hours. On the contrary, the lapses of time between the onset of the induction and the delivery, vary significantly, being always longer in the PGE2 group. However, the dose of vaginal PGE2 gel as well as the time of artificial membrane rupture could be modified in order to decrease the delay of the effect.
Early versus late amniotomy for labor induction: a randomized trial.
OBJECTIVE: Our purpose was to determine the impact of early and late amniotomy on labor induction with continuous oxytocin infusion at term.
STUDY DESIGN: A total of 209 women admitted for labor induction were randomized to early or late amniotomy. The early amniotomy group (n = 106) had membranes ruptured as soon as it was deemed safe and feasible. The late amniotomy group (n = 103) had membrane rupture performed at > or = 5 cm dilatation. The first 103 women received a continuous oxytocin infusion with incremental adjustments at 60-minute intervals as required. The next 106 women had adjustments every 30 minutes as required. Statistical analysis was confined to concurrent groups.
RESULTS: Early amniotomy was associated with shorter labor (13.3 vs 17.8 hours, p = 0.001), chorioamnionitis (22.6% vs 6.8%, p = 0.002), and significant fetal umbilical cord compression (12.3% vs 2.9%, p = 0.017). The benefit regarding shortening of labor was limited to women having oxytocin increments every 30 minutes as required (13.3 vs 17.8 hours, p = 0.001). Alternatively, the increase in chorioamnionitis was confined to the 60-minute group (39% vs 11%, p < 0.001), which also demonstrated a trend toward increased moderate and severe variable decelerations (19.6% vs 6.4%, p = 0.08).
CONCLUSIONS: When a protocol of 60-minute increments in oxytocin infusion rate is desired, amniotomy should be performed late in labor to reduce chorioamnionitis and significant umbilical cord compression. Alternatively, if early amniotomy is necessary, oxytocin should be adjusted every 30 minutes as tolerated.
Induction of labour: a randomised clinical trial of amniotomy versus amniotomy with oxytocin infusion.
OBJECTIVE: To compare two methods of induction of labour-amniotomy with oxytocin infusion versus amniotomy alone.
DESIGN: Prospective randomised clinical trial.
SETTING: The department of obstetrics in a Swedish central hospital.
PARTICIPANTS: One hundred and ninety-six pregnant women with indication for induction of labour at term and a favourable cervix (modified Bishop score > or = 6).
INTERVENTIONS: The women were randomised to amniotomy followed by oxytocin infusion after 1 h (group A, n = 98) or amniotomy alone (group B, n = 98). If labour had not ensued on the following morning, after approximately 24 h, the women in group B were given an oxytocin infusion.
MAIN OUTCOME MEASURES: Induction-delivery interval, duration of labour, time spent in delivery ward, oxytocin use, maternal and neonatal clinical outcome.
RESULTS: Amniotomy combined with early oxytocin infusion resulted in shorter induction-delivery interval (median 6.0 h; 95% confidence interval (CI) 5.0 to 6.5 h) than amniotomy alone (median 9.0 h; 95% CI 7.5 to 10.0 h). This was due to a shorter latent period in the former group (median 2.3 h; 95% CI 2.0 to 3.0 h) compared to the latter (median 4.3 h; 95% CI 3.0 to 5.5 h). The duration of labour stages 1 and 2 were similar in both groups. The time spent in the delivery ward was slightly reduced for women managed by amniotomy alone (median 5.0 h; 95% CI 4.5 to 6.0 h) compared with those managed by the combination of amniotomy and oxytocin infusion (median 6.0 h; 95% CI 5.0 to 6.5 h). Eighty-seven percent in group A and 32% in group B were given oxytocin, and the total oxytocin infusion time was nearly five times longer in group A. No other important effect on maternal or fetal outcomes was demonstrated.
CONCLUSION: With regard to safety the results do not warrant recommending either type of labour induction. The minor differences observed between the induction groups justify an individual management policy, with attention paid to both the indication for induction of labour and the woman's choice.
Induction of labour at term in primigravidae with low Bishop's score: a comparison of three methods.
OBJECTIVE: To determine which of three methods of induction of labour at term in primigravidae with a low Bishop's score is effective and safe.
DESIGN: Random allocation to Prostin E2 and amniotomy later (Group A); low amniotomy and oxytocin titration (Group B); and intra-cervical Foley balloon overnight followed next morning by low amniotomy and oxytocin titration (Group C).
SUBJECTS AND SETTING: Primigravidae (n = 90) in the University Hospitals, Benin City, Nigeria.
MAIN OUTCOME MEASURE: (i) Time taken to achieve 3 uterine contractions in 10 min; (ii) induction-delivery interval.
RESULTS: The mean time interval between intervention and regular uterine contractions was shortest in Group C (A vs. C, P < 0.02; A vs. B, P < 0.02). The mean induction-delivery interval was shortest in Group C (11.1 h) followed by Group B (13.9 h) and Group C (17.9 h) P < 0.05-0.001.
CONCLUSION: The induction-delivery interval was shortest when using a Foley catheter for cervical ripening followed by amniotomy and oxytocin titration.
A randomized comparison of vaginal prostaglandin E2 with oxytocin plus amniotomy for induction of labour in women with intermediately ripe cervices.
OBJECTIVE: To compare the effects of oxytocin and amniotomy or vaginal prostaglandin E2 (PGE2) for induction of labour.
STUDY DESIGN: We conducted a randomized clinical trial. Eligible for the trial were women with normal pregnancy, parity 0-3, with intact membranes, >40 weeks of gestation documented by ultrasound examination before 20 weeks gestation, observed in a network of 13 general and teaching hospitals in Italy. Inclusion criteria were cervical Bishop's score 5-7, less than six uterine contractions per hour, single pregnancy, cephalic presentation, no history of cesarean section and uterine surgery. Eligible women were randomly assigned by phone to oxytocin plus amniotomy (163 women) or vaginal PGE2 2 mg, two doses at 6-h intervals (157 women).
RESULTS: Overall, 50 women (15.6%) delivered by cesarean section, 22 (13.5%) randomized to oxytocin, and 28 (17.8%) randomized to PGE2 (not significant). Twelve hours after randomization, induction had failed in 26 women of the 163 randomized to oxytocin plus amniotomy (21.6%) and 34 out of the 157 randomized to PGE2 (15.9%): the difference was not significant. Neonatal outcome was similar in the two groups.
CONCLUSIONS: This study did not find marked differences in labour and neonatal outcome between women randomized to oxytocin plus amniotomy or vaginal PGE2. A shorter induction delivery interval in the group receiving amniotomy and oxytocin after PGE2 priming was observed.
Amniotomy, with or without simultaneous oxytocin infusion. A prospective survey.
Options:
A: Amniotomy and intravenous oxytocin resulted in fewer women being undelivered vaginally at 24 hours compared to amniotomy alone, fewer instrumental vaginal deliveries than placebo, but more postpartum haemorrhage and dissatisfaction compared to vaginal prostaglandins.
B: Amniotomy and intravenous oxytocin resulted in more women being undelivered vaginally at 24 hours compared to amniotomy alone, more instrumental vaginal deliveries than placebo, and less postpartum haemorrhage and dissatisfaction compared to vaginal prostaglandins.
C: Amniotomy and intravenous oxytocin showed no significant difference in the number of women undelivered vaginally at 24 hours compared to amniotomy alone, no difference in instrumental vaginal deliveries compared to placebo, and no difference in postpartum haemorrhage and dissatisfaction compared to vaginal prostaglandins.
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A
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183
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the estimated effectiveness of consistent condom use in reducing the heterosexual transmission of HIV? Please answer this question based on the information provided below:
Effect of serotesting with counselling on condom use and seroconversion among HIV discordant couples in Africa.
OBJECTIVE: To determine whether HIV testing and counselling increased condom use and decreased heterosexual transmission of HIV in discordant couples.
DESIGN: Prospective study.
SETTING: Kigali, the capital of Rwanda.
SUBJECTS: Cohabiting couples with discordant HIV serology results.
MAIN OUTCOME MEASURES: Condom use in the couple and HIV seroconversion in the negative partners.
RESULTS: 60 HIV discordant couples were identified, of whom 53 were followed for an average of 2.2 years. The proportion of discordant couples using condoms increased from 4% to 57% after one year of follow up. During follow up two of the 23 HIV negative men and six of the 30 HIV negative women seroconverted (seroconversion rates of 4 and 9 per 100 person years). The rate among women was less than half that estimated for similar women in discordant couples whose partners had not been serotested. Condom use was less common among those who seroconverted (100% v 5%, p = 0.01 in men; 67% v 25%, p = 0.14 in women).
CONCLUSIONS: Roughly one in seven cohabiting couples in Kigali have discordant HIV serological results. Confidential HIV serotesting with counselling caused a large increase in condom use and was associated with a lower rate of new HIV infections. HIV testing is a promising intervention for preventing the spread of HIV in African cities.
Heterosexual transmission of HIV in Haiti.
BACKGROUND: Despite the importance of human immunodeficiency virus (HIV) transmission through heterosexual contact, the incidence of HIV infection in heterosexual cohorts has not been well studied, particularly in the developing world.
OBJECTIVE: To 1) determine the incidence of HIV infection in discordant heterosexual couples (couples in which one partner had HIV infection and the other did not) in Haiti and 2) assess risk factors for and methods of preventing HIV infection.
DESIGN: Prospective study.
SETTING: National Institute for Laboratory Research, Portau-Prince, Haiti.
PARTICIPANTS: 475 HIV-infected patients and their noninfected regular sex partners.
MEASUREMENTS: Patients and their partners were evaluated at 3- to 6-month intervals for HIV infection, sexually transmitted diseases, and sexual practices. The efficacy of counseling and provision of free condoms was also evaluated.
RESULTS: Among the 177 couples who remained sexually active during the prospective study period, 20 seroconversions to HIV positivity occurred, for an incidence rate of 5.4 per 100 person-years (95% CI, 5.16 to 5.64 per 100 person-years). Thirty-eight couples (21.5%) discontinued sexual activity during the study. Only 1 seroconversion occurred among the 42 sexually active couples (23.7% of the 177 sexually active couples) who always used condoms. In contrast, the incidence in sexually active couples who infrequently used or did not use condoms was 6.8 per 100 person-years (CI, 6.49 to 7.14 per 100 person-years). Transmission of HIV was associated with genital ulcer disease, syphilis, and vaginal or penile discharge in the HIV-negative partner and with syphilis in the HIV-infected partner.
CONCLUSION: Counseling and the provision of free condoms contributed to the institution of safe sex practices or abstinence in 45% of discordant heterosexual couples. However, 55% of couples reported that they continued to have unprotected sex, resulting in an incidence of HIV infection of 6.8 per 100 person-years.
A longitudinal study of human immunodeficiency virus transmission by heterosexual partners. European Study Group on Heterosexual Transmission of HIV.
BACKGROUND: Worldwide, the predominant mode of human immunodeficiency virus (HIV) transmission is heterosexual intercourse, but the risk of heterosexual transmission and the effectiveness of measures to prevent it are not well defined.
METHODS: We conducted a prospective study of HIV-negative subjects whose only risk of HIV infection was a stable heterosexual relationship with an HIV-infected partner. Every six months the subjects were interviewed, tested for HIV, and counseled about safe sexual practices.
RESULTS: A total of 304 HIV-negative subjects (196 women and 108 men) were followed for an average of 20 months. During the study, 130 couples (42.8 percent) ended their sexual relationships, most often because of the HIV-infected partner's illness or death. Of the 256 couples who continued to have sexual relations for more than three months after enrollment in the study, only 124 (48.4 percent) used condoms consistently for vaginal and anal intercourse. Among these couples, none of the seronegative partners became infected with HIV, despite a total of about 15,000 episodes of intercourse. Among the 121 couples who used condoms inconsistently, the rate of seroconversion was 4.8 per 100 person-years (95 percent confidence interval, 2.5 to 8.4). Eleven couples refused to answer questions about condom use. The risk of transmission increased with advanced stages of HIV infection in the index partners (P < 0.02) and with genital infection in the HIV-negative partners (P < 0.04). Withdrawal to avoid ejaculation in the vagina had a protective effect in uninfected women (P < 0.02).
CONCLUSIONS: Consistent use of condoms for heterosexual intercourse is highly effective in preventing the transmission of HIV. Among couples not using condoms regularly, the risk of HIV transmission varies widely.
Evaluation of heterosexual partners, children, and household contacts of adults with AIDS.
Forty-five adults with the acquired immunodeficiency syndrome (AIDS) and their 45 spouses, 109 children, and 29 household contacts were studied for evidence of heterosexual, perinatal, and household spread of human T-cell lymphotropic virus type III (HTLV-III) infection. Of the 45 spouses enrolled, 26 (58%) had antibody to HTLV-III, including 12 (71%) of 17 male spouses and 14 (50%) of 28 female spouses. Of the 12 seropositive male spouses, nine were seropositive at enrollment and three had seroconversion. Of the 14 seropositive female spouses, four were seropositive at enrollment and ten seroconverted. Lack of barrier contraceptive use and oral sex were associated with seroconversion. Of the 109 children enrolled, 15 had AIDS or an AIDS-related illness, two had evidence of passive transfer of maternal antibodies, and two had HTLV-III infection acquired outside the household. None of the 90 seronegative children seroconverted. Of 29 household contacts studied, none developed antibody to HTLV-III.
Documented male-to-female transmission of HIV-1 after minimal vaginal exposure in the absence of other cofactors for infection.
AIDS cases attributable to heterosexual vaginal intercourse constitute a growing proportion of new AIDS cases in the United States. Major cofactors that possibly increase the efficiency of heterosexual transmission of HIV-1 include genital ulcer disease, multiple sexual exposures, lack of male circumcision, and primary and advanced stages of HIV-1 disease. I report the case of a 33-year-old woman who was recently infected with HIV-1 after one to three nontraumatic episodes of vaginal intercourse with a healthy-appearing, HIV-1-infected, bisexual man. An investigation of her exposure history revealed the precise time frame during which infection occurred. The patient developed a primary HIV-1-infection syndrome and became seropositive for HIV-1 within eight weeks of her last sexual contact with the infected man. An epidemiological and laboratory evaluation of the index patient and her sexual partner identified only one risk factor for enhanced HIV-1 transmission: the patient's use of oral contraceptives. Her partner was immunologically intact, HIV-1 antigen negative, and circumcised. Both of the individuals were from Minnesota, as were their recent sexual partners. This case illustrates that HIV-1 infection by vaginal intercourse can occur in the absence of the major risk factors believed to increase the efficiency of transmission. Even in a low HIV-1 prevalence area like Minnesota, efforts to promote awareness of HIV-1 status, abstinence, non-penetrative sex, or barrier protection need to be expanded and the behaviors adopted by sexually active persons if HIV-1 transmission is to be minimized.
Condom and nonoxynol-9 use and the incidence of HIV infection in serodiscordant couples in Zambia.
We aimed to measure the effectiveness of latex condoms and of nonoxynol-9 [N-9] spermicides, in preventing HIV transmission in heterosexual serodiscordant couples in Lusaka. Each couple was examined at clinic visits scheduled at 3-month intervals for one year or more per couple, or until seroconversion or discontinuation. Couples were given condoms and their choice of 3 N-9 products and advised to use both at every intercourse. Sexual exposure was ascertained from coital logs that recorded coitus and barrier method use. HIV serological testing was done at each clinic visit (ELISA and Western blot if positive). One hundred and ten discordant couples were followed for a mean of 17.6 months. Seventy-eight per cent of coital episodes were protected by condoms, 85% by spermicides and 6.4% were unprotected. Fourteen seroconversions occurred (8.7 infections per 100 couple-years [c-y]). The rate was higher among seronegative men than seronegative women. Among couples who reported using condoms at every intercourse the infection rate was 2.3/100 c-y, compared with 10.7/100 c-y among couples using condoms less consistently (rate ratio [RR] 0.2; 95% confidence interval [CI] 0-1.6). Among couples who reported using N-9 at every intercourse, the seroconversion rate was 6.9/100 c-y; among couples who reported less than full-time N-9 use, the rate was 8.9/100 c-y (RR 0.8; 95% CI 0.2-2.8). Among the subset of female seronegatives, the N-9 RR was 0.5 (95% CI 0.1-3.8). But when we calculated HIV rates according to N-9 consistency in coital acts when condoms were not used, there was no evidence of protection with higher N-9 use. Consistent use of latex condoms reduces the incidence of HIV infection, but the association between N-9 spermicides and HIV is less clear. The current study could not provide compelling data on the impact of N-9 spermicide use on risk of HIV infection. The study's small size, as well as the consistency of concurrent condom use, limited our inferences. Available spermicide products must be studied further.
Evidence of marked sexual behavior change associated with low HIV-1 seroconversion in 149 married couples with discordant HIV-1 serostatus: experience at an HIV counselling center in Zaire.
To determine the effect of an HIV-1 counselling program on 149 married Zairian couples with discordant HIV-1 serology, the rates of HIV-1 seroconversion and reported condom utilization have been observed during 382.4 person-years of follow-up (minimum follow-up time per couple of 6 months). Before determination of HIV-1 serostatus and counselling, less than 5% of these couples had ever used a condom. One month after notification of HIV-1 serostatus and counselling, 70.7% of couples reported using condoms during all episodes of sexual intercourse. At 18 months follow-up, 77.4% of the 140 couples still being followed reported continued use of condoms during all episodes of sexual intercourse. At the time of notification of HIV-1 serostatus, 18 couples experienced acute psychological distress. Home-based counselling by trained nurses resolved these difficulties in all but three couples who subsequently divorced. Intensive counselling following notification of HIV-1 serostatus led to low rates of HIV-1 seroconversion (3.1% per 100 person-years of observation) in Zairian married couples with discordant HIV-1 serostatus who voluntarily attended an HIV counselling center.
HIV infection in sexual partners of HIV-seropositive patients with hemophilia.
Antiretroviral treatment of men infected with human immunodeficiency virus type 1 reduces the incidence of heterosexual transmission. Italian Study Group on HIV Heterosexual Transmission.
OBJECTIVE: To determine the incidence of heterosexual human immunodeficiency virus type 1 disease transmission and the effect of zidovudine therapy on this risk of transmission.
DESIGN: A cohort of 436 monogamous seronegative female sexual partners of human immunodeficiency virus type 1-infected males was followed up for 740 person-years with regular structured interviews and laboratory tests.
PATIENTS: At enrollment of the women, 50% of their infected partners had one or more signs of disease progression (symptoms of acquired immunodeficiency syndrome, p24 antigen positivity, or CD4+ cell counts lower than 0.4 x 10(9)/L) and 15% were treated with zidovudine.
MAIN OUTCOME MEASURE: Incidence rates of seroconversion were calculated and relative risks were estimated as incidence rate ratios.
RESULTS: Twenty-seven women seroconverted during follow-up, and the incidence of seroconversion was 3.7 per 100 person-years. Seroconversion was about six times more frequent (relative risk, 5.8; 95% confidence interval, 2.2 to 15.3) in couples not using condoms. Men with signs of disease progression transmitted infection to their partners more frequently and were more frequently treated with zidovudine. When the risk of transmission was estimated accounting for disease progression, the rate of transmission in zidovudine-treated men was lower than in untreated men (relative risk, 0.5; 95% confidence interval, 0.1 to 0.9).
CONCLUSION: Treatment of human immunodeficiency virus type-1 infected men with zidovudine reduces, but does not eliminate, heterosexual transmission of infection. Behavioral counseling that encourages sexual practices with a lower risk of transmission remains the most important method of prevention.
Heterosexual transmission of human immunodeficiency virus type 1 from transfusion recipients to their sex partners.
Using lookback procedures and other methods, we identified and then prospectively followed human immunodeficiency virus type 1 (HIV-1)-infected transfusion recipients and their sex partners to determine AIDS incidence and risks of heterosexual transmission of HIV-1. At enrollment, 7 of 32 (21.9%) female partners of male recipients were themselves infected with HIV-1, as compared with none of 14 male partners of female recipients (p = 0.08). No additional episodes of transmission were observed. The prevalence of advanced immunodeficiency at enrollment was similar in male and female recipients. Male recipients with advanced immunodeficiency (CD4+ lymphocyte count < or = 0.20 x 10(9)/L or a history of clinical AIDS) at enrollment were more likely to have infected their female partners (odds ratio = 7.9; p = 0.03) than men with neither condition. Similarly, AIDS-free survival, as estimated by the product-limit method, was lower among male transmitters than among male nontransmitters (p = 0.01). Transmission was not associated with frequency of unprotected vaginal intercourse. Our data suggest that HIV-1-infected men who develop immunodeficiency rapidly are more likely to infect their sex partners and that the greater efficiency of male-to-female HIV-1 transmission is not explained by a greater number of sexual contacts or more advanced immunodeficiency in index subjects.
Risk of human immunodeficiency virus transmission from heterosexual adults with transfusion-associated infections.
The risk of human immunodeficiency virus (HIV) transmission was studied by interviewing and testing the serum of heterosexual contacts and casual family contacts of adults with transfusion-associated HIV infections. Two (8%) of 25 husbands and ten (18%) of 55 wives who had had sexual contact with infected spouses were seropositive for HIV. Compared with seronegative wives, the seropositive wives were older (median ages, 54 and 62 years; P = .08) and actually reported somewhat fewer sexual contacts with their infected husbands (means, 156 and 82; P greater than .1). There was no difference in the types of sexual contact or methods of contraception of the seropositive and seronegative spouses. There was no evidence of HIV transmission to the 63 other family members. Although most husbands and wives remained uninfected despite repeated sexual contact without protection, some acquired infection after only a few contacts. This is consistent with an as yet unexplained biologic variation in transmissibility or susceptibility.
Man-to-woman sexual transmission of HIV: longitudinal study of 343 steady partners of infected men.
To study incidence and risk factors of heterosexually transmitted HIV infection, we followed a cohort of 343 seronegative women, stable, monogamous partners of infected men whose only risk of acquiring HIV was sexual exposure to the infected partner. Nineteen seroconversions occurred in 529.6 person years (py) of observation, yielding an incidence rate of 3.6 per 100 py. The incidence rate was 7.2 per 100 py among women who did not always use or never used condoms and 1.1 among those who always used them [relative risk (RR) 6.6, 95% confidence interval (CI) 1.9-21.9]. Anal sex was associated with a risk increase in only those women not always using condoms (RR 1.4, 95% CI 0.4-4.8). No seroconversions were observed among 22 women using oral contraceptives. One of the women using intrauterine devices seroconverted. In couples who did not always use condoms, seroconversions occurred more frequently in partners of men with symptomatic diseases, with a low CD4+ cell number (< 400 per mm3) or with a detectable p24 antigen. In couples not always using condoms and where the man had a low CD4+ cell count, the joint presence of blood viral antigens and AIDS symptoms conditioned a fivefold increased risk of seroconversion of the woman (RR 5.4, CI 1.4-20.3). At multivariate analysis, women with longer relationships (> or = 1 year) showed a lower risk of seroconversion (RR 0.3, CI 0.1-0.8), and those partners of men positive for p24 antigen in serum had an increased risk of seroconversion (RR = 4.0, CI 0.1-0.8).
No seroconversions among steady sex partners of methadone-maintained HIV-1-seropositive injecting drug users in New York City.
OBJECTIVE: To assess the incidence of heterosexual HIV-1 transmission from seropositive methadone-maintained injecting drug users (IDU) to their seronegative, non-IDU steady sex partners.
DESIGN: A prospective, longitudinal study.
SETTING: HIV-1-seropositive IDU and their HIV-1-seronegative, non-IDU steady sex partners were recruited from six methadone-maintenance clinics in the New York City boroughs of Brooklyn and Manhattan.
PATIENTS, PARTICIPANTS: Between December 1988 and October 1991, 60 research participants were recruited [30 methadone-maintained, HIV-1-seropositive IDU (index subjects) and their non-IDU HIV-1-seronegative steady partners]. Baseline and follow-up (every 3-4 months) data included a structured questionnaire and blood testing for HIV infection and CD4+ cell subsets.
RESULTS: Demographic characteristics of the 30 steady sex partners were evaluated as follows: sex (22 women, eight men); age (mean, 32 years; range, 21-55 years) and race (African-American, 13; Hispanic, 13; other, 4). The average duration of relationship between index subject and partner at study entry was 7.5 years (range, 4 months to 19.4 years). At entry, 27 of the 30 partners reported no or intermittent use of condoms with the index subject during a typical 12-month period. Follow-up data (median follow-up, 298 days; range, 85-992 days) were available for 22 partners. Of these, 15 reported no or intermittent condom use. For a total study observation time of 23 person-years, there were no seroconversions. The upper 95% confidence interval for the observed seroconversion rate of 0% is 13%.
CONCLUSIONS: These results suggest that the likelihood of heterosexual HIV-1 transmission from seropositive methadone-maintained IDU to their seronegative, non-IDU steady sex partners is low.
Heterosexual transmission of HIV by haemophiliacs.
Options:
A: Approximately 50%
B: Approximately 60%
C: Approximately 70%
D: Approximately 80%
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D
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184
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the main conclusion regarding the effectiveness of drug treatment for aphasia following stroke? Please answer this question based on the information provided below:
Acute treatment of stroke. PASS group. Piracetam Acute Stroke Study.
Treatment of acute ischemic stroke with piracetam. Members of the Piracetam in Acute Stroke Study (PASS) Group.
BACKGROUND AND PURPOSE: Piracetam, a nootropic agent with neuroprotective properties, has been reported in pilot studies to increase compromised regional cerebral blood flow in patients with acute stroke and, given soon after onset, to improve clinical outcome. We performed a multicenter, randomized, double-blind trial to test whether piracetam conferred benefit when given within 12 hours of the onset of acute ischemic stroke to a large group of patients.
METHODS: Patients received placebo or 12 g piracetam as an initial intravenous bolus, 12 g daily for 4 weeks and 4.8 g daily for 8 weeks. The primary end point was neurologic outcome after 4 weeks as assessed by the Orgogozo scale. Functional status at 12 weeks as measured by the Barthel Index was the major secondary outcome. CT scan was performed within 24 hours of the onset of stroke but not necessarily before treatment. Analyses based on the intention to treat were performed in all randomized patients (n = 927) and in an "early treatment" population specified in the protocol as treatment within 6 hours of the onset of stroke but subsequently redefined as less than 7 hours after onset (n = 452).
RESULTS: In the total population, outcome was similar with both treatments (the mean Orgogozo scale after 4 weeks: piracetam 57.7, placebo 57.6; the mean Barthel Index after 12 weeks: piracetam 55.8, placebo 53.1). Mortality at 12 weeks was 23.9% (111/464) in the piracetam group and 19.2% (89/463) in the placebo group (relative risk 1.24, 95% confidence interval, 0.97 to 1.59; P = .15). Deaths were fewer in the piracetam group in those patients in the intention-to-treat population admitted with primary hemorrhagic stroke. Post hoc analyses in the early treatment subgroup showed differences favoring piracetam relative to placebo in mean Orgogozo scale scores after 4 weeks (piracetam 60.4, placebo 54.9; P = .07) and Barthel Index scores at 12 weeks (piracetam 58.6, placebo 49.4; P = .02). Additional analyses within this subgroup, confined to 360 patients with moderate and severe stroke (initial Orgogozo scale score < 55), showed significant improvement on piracetam in both outcomes (P < .02).
CONCLUSIONS: Piracetam did not influence outcome when given within 12 hours of the onset of acute ischemic stroke. Post hoc analyses suggest that piracetam may confer benefit when given within 7 hours of onset, particularly in patients with stroke of moderate and severe degree. A randomized, placebo-controlled, multicenter study, the Piracetam Acute Stroke Study II (PASS II) will soon begin.
The clinical safety of high-dose piracetam--its use in the treatment of acute stroke.
Recent post-marketing surveillance reports have confirmed the benign safety profile and lack of organ toxicity shown by piracetam during its 25 years of clinical usage. Tolerance has proved equally good with the more recent use of larger doses (up to 24 g/day) for the long-term control of cortical myoclonus and when given intravenously to patients with acute stroke. This paper provides a brief review of these findings and records the safety of piracetam as found in the Piracetam in Acute Stroke Study (PASS), a randomized multicenter placebo-controlled study in 927 patients with acute ischemic stroke. Patients receive one intravenous bolus injection of placebo or 12 g piracetam, piracetam 12 g daily for 4 weeks and maintenance treatment for 8 weeks. The major results have been reported (De Deyn et al., Stroke 28 [1997] 2347-2352). Safety was assessed taking into account adverse events including abnormal laboratory test results and mortality. Death within 12 weeks occurred more frequently in the piracetam group but the difference from placebo was not significant. Of many potential risk, prognostic and treatment-related factors examined by logistic regression, 6 contributed significantly to death of which the most important were initial severity of stroke and age. Neither treatment nor any treatment-related factor contributed significantly to death. Adverse events were similar in frequency, type and severity in piracetam and placebo groups. Events of cerebral, non-cerebral and uncertain origin likewise occurred with similar frequency. Few patients discontinued because of adverse events. There was no difference between treatments in the frequency of events associated with bleeding, including hemorrhagic transformation of infarction. An important finding was that, of 31 patients with primary hemorrhagic stroke enrolled, 3 piracetam-treated patients died compared with 6 on placebo. The results suggest that piracetam in high dosage may be given to patients with acute stroke without significant adverse effects.
The role of piracetam in the treatment of acute and chronic aphasia.
Piracetam has been shown to improve speech in aphasic patients. This paper reviews the evidence for this benefit in aphasic patients with acute stroke and, in conjunction with language treatment, in post-acute and chronic aphasia. Early double-blind, placebo-controlled trials in acute stroke showed improvement in several neurologic parameters including aphasia. Subsequently two randomized double-blind placebo-controlled studies were performed which utilised the Aachen Aphasia Test (AAT), a validated and standardized procedure, to assess language function. Patients received placebo or piracetam 4.8g daily for 12 weeks in one study and for 6 weeks in the other. In both studies patients received concomitant intensive speech therapy; one included patients 6-9 weeks after stroke while in the other the duration of aphasia varied between 4 weeks and 3 years. Compared with placebo there was improvement in both studies on piracetam in all 5 subtests of the AAT and significant overall improvement in aphasia. This indicated that, given in conjunction with language therapy, piracetam improved speech in patients with post-acute and chronic aphasia. In the Piracetam in Acute Stroke Study (PASS), of 927 patients treated within 12 hours of the onset of acute ischemic stroke, 373 were aphasic. Treatment consisted of placebo or an intravenous bolus of 12g piracetam, 12g piracetam daily for 4 weeks and 4.8 g daily for a further 8 weeks. After 12 weeks significantly more patients (approximately 10%, P=0.04) had recovered from aphasia on piracetam than placebo while in 197 patients treated within 7 hours of stroke onset, the difference in favor of piracetam was 16% (P= 0.02). These studies indicate that piracetam improves aphasia in acute stroke and, as an adjuvant to language therapy, in post-acute and chronic aphasia.
Economic evaluation of Nootropil in the treatment of acute stroke in France.
The primary objective of this study was to investigate the economic impact of treatment of acute ischaemic stroke with piracetam vs placebo according to the societal perspective in France. Socio-demographic, clinical and resource utilisation data for piracetam and placebo patients during the acute phase following stroke was obtained from the Piracetam Acute Stroke Study (PASS) clinical trial database. The economic analysis was based on the population defined as being treated within 6 h 59 min following stroke and presenting an initial Orgogozo score of less than 55. Resource utilisation data concerning the rehabilitation phase, outpatient follow-up and institutionalisation was obtained from decision tree analysis. There was a higher percentage of autonomous patients in the piracetam group (27.8%) compared to placebo (22.9%). The mean duration of hospitalisation (autonomous 21.8 days; non-autonomous 30.3 days) and the cost of an autonomous patient was lower than a non-autonomous patient. The total cost per stroke patient receiving piracetam was estimated at 103 KF during the 6-month period, compared to 106 KF per placebo patient. The major cost driver was hospitalisation during the acute phase, representing approximately 50% of the total cost per patient. In patients with moderate to severe stroke treated within 6.59 h, piracetam was cost-effective compared to placebo over the 6-month study period.
Economic evaluation of Nootropil in the treatment of acute stroke in France.
The primary objective of this study was to investigate the economic impact of treatment of acute ischaemic stroke with piracetam vs placebo according to the societal perspective in France. Socio-demographic, clinical and resource utilisation data for piracetam and placebo patients during the acute phase following stroke was obtained from the Piracetam Acute Stroke Study (PASS) clinical trial database. The economic analysis was based on the population defined as being treated within 6 h 59 min following stroke and presenting an initial Orgogozo score of less than 55. Resource utilisation data concerning the rehabilitation phase, outpatient follow-up and institutionalisation was obtained from decision tree analysis. There was a higher percentage of autonomous patients in the piracetam group (27.8%) compared to placebo (22.9%). The mean duration of hospitalisation (autonomous 21.8 days; non-autonomous 30.3 days) and the cost of an autonomous patient was lower than a non-autonomous patient. The total cost per stroke patient receiving piracetam was estimated at 103 KF during the 6-month period, compared to 106 KF per placebo patient. The major cost driver was hospitalisation during the acute phase, representing approximately 50% of the total cost per patient. In patients with moderate to severe stroke treated within 6.59 h, piracetam was cost-effective compared to placebo over the 6-month study period.
Piracetam in the treatment of acute stroke.
The neuroprotective properties of the nootropic agent piracetam together with reported hemorrheologic and antithrombotic effects provided the rationale for the evaluation of piracetam in acute stroke. Pilot studies showed an increase in compromised regional cerebral blood flow and improvement in motor function, aphasia and level of consciousness. Subsequently the Piracetam in Acute Stroke Study (PASS) was performed and the chief results have recently been reported (Stroke 28 (1997) 2347-2352). This was a multicenter double-blind trial in 927 patients to determine whether, compared with placebo, piracetam improved outcome when given within 12 hours of the onset of acute ischemic stroke, confirmed by computed tomography within 24 hours of admission (but not necessarily prior to treatment). Patients received an initial iv bolus of placebo or 12g piracetam, 12g piracetam daily for 4 weeks and maintenance treatment for a further 8 weeks. Neurologic status at 4 weeks was the primary end point; secondary outcome measures were functional outcome and aphasia at 12 weeks. Results in aphasic patients have not previously been reported. Analysis was planned both in all patients (n = 927) and an early treatment subgroup (n = 460) treated within 6 hours of stroke onset. This period was subsequently redefined as 7 hours. Intention-to-treat analyses in the total population showed a significant (P = 0.04) increase compared with placebo in the number of patients recovered from aphasia but no significant neurologic or functional improvement. Post hoc analysis in the early treatment subgroup showed improved neurologic outcome (P = 0.07), better function (P = 0.02) and a greater recovery rate from aphasia (P = 0.02). Additional analysis in this early treatment subgroup confined to 360 patients with moderate and severe stroke showed significant improvement in all 3 outcomes. There was no significant difference in mortality between treatment groups after 12 weeks. There were fewer deaths in piracetam-treated patients in those patients in the intention-to-treat population admitted with primary hemorrhagic stroke.
Interaction between psychological and pharmacological treatment in cognitive impairment.
In contrast to other kinds of psychotropic drugs, nootropics or cognition enhancing drugs may be indicated, not for the direct treatment of the pathology itself, but for improving or restoring the remaining brain functions. Brain functions are normally trained during various kinds of non-medical therapy, such as physiotherapy, speech therapy, occupational therapy, memory training etc... In research little attention has been paid to the combination of both kinds of therapeutic approaches, probably because of the important methodological difficulties. This combination however, offers various interesting perspectives: L. ISRAEL examined in two placebo-controlled studies the effects of either 160 mg/d of ginkgo biloba extractum (GBE) or piracetam 2.4 or 4.8 g/d, combined with a memory training program, in nondemented patients complaining of memory problems. The results of both studies suggest that nootropic drug treatment and memory training have each an effect on different cognitive functions and, hence, are complementary. Some functions, like attention/perception in the GBE study and learning in the piracetam study, seem to benefit from both treatments, suggesting a mutually potentiating effect of drug treatment and training. This potentiation is very clear in the treatment of dyslexic children: in a placebo-controlled study piracetam 3.3 g/d, in combination with normal school teaching and more specific logopedic therapy, allowed a normal progression during the full school year in reading accuracy and reading comprehension, while the placebo treated children getting a similar training progressed only with 50%. Recently promising results were obtained in the treatment of dysphasic patients with a combination of speech therapy and piracetam 4.8 g/d, especially when given during the first months after the stroke, or otherwise in combination with an intensive speech training. In both double-blind studies the piracetam treated group improved about 60% more than the group who only got speech therapy and placebo. All these data may be explained by the restorative or enhancing influence of nootropic drugs on neurotransmitter systems closely related to learning and memory functions. E.g. piracetam restores the availability and function of muscarinic and NMDA receptors in aging animals, most probably through a modulation of the psychico-chemical properties of the neuronal membrane such as the membrane fluidity.
Effect of piracetam on recovery and rehabilitation after stroke: a double-blind, placebo-controlled study.
The nootropic agent piracetam has been shown to improve learning and memory, and it may, by this means, facilitate recovery and rehabilitation after a stroke. We report the results of a pilot study exploring its effects in patients undergoing rehabilitation after acute cerebral infarction in the carotid artery territory. We compared piracetam and placebo, each given for 12 weeks, in a multicenter, double-blind, randomized trial of parallel-group design; testing was performed at baseline (6-9 weeks poststroke), weeks 5 and 12, and, in fewer patients, 12 weeks after termination of treatment. Standardized tests of activities of daily living (Barthel Index, Kuriansky Test), aphasia (Aachen Aphasia Test), and perception (Rivermead Perception Assessment Battery) were the primary efficacy variables. Of 158 patients, 137 (81 males, 56 females) were studied after treatment and 88 at 24-week follow-up. Thirty patients on piracetam (45%) and 37 on placebo (53%) were aphasic on entry. Both groups, including the subgroups with aphasia, were well matched at baseline for demographic data, stroke sequelae, type and severity of aphasia, and prognostic parameters. Multivariate analysis of Aachen Aphasia subtest scores showed a significant overall improvement relative to baseline in favor of piracetam (p = 0.02) at 12 weeks. This was not seen at 24 weeks when, however, fewer patients were available for evaluation so that we could neither confirm nor deny whether improvement was maintained after cessation of piracetam. We were unable to demonstrate an effect on tests of activities of daily living and could neither confirm nor exclude an effect on perceptual deficit. We have shown an improvement in aphasia in patients undergoing rehabilitation after a stroke after 12 weeks' treatment with piracetam that requires confirmation in further studies.
Bromocriptine treatment of nonfluent aphasia.
Using a double-blind, placebo-controlled, crossover design, we studied the effect of bromocriptine (15 mg daily) in 20 men with chronic nonfluent aphasia. The study was conducted over a 28-week period in two phases. In phase I, the patients received either bromocriptine or placebo; in phase II the treatments were crossed over. We evaluated each patient's language and nonverbal cognitive skills at the beginning and end of each phase and 6 weeks after completion of phase II. When compared with placebo treatment, bromocriptine did not significantly improve the patient's speech fluency, language content, overall degree of aphasia severity, or nonverbal cognitive abilities. Based on these results, bromocriptine is not recommended as monotherapy for the treatment of chronic nonfluent aphasia.
[The effectiveness of piracetam in acute cerebral ischemia in the human. A clinical controlled double-blind study of piracetam/10% dextran 40 versus 10% dextran 40/placebo].
On the efficacy of piracetam in geriatric patients with acute cerebral ischemia: a clinically controlled double-blind study.
Using a randomized, double blind group comparison, the efficacy and tolerance of piracetam as an additional therapy of hydroxyethyl starch, venous infusion and low dose heparin treatment, which are the basis of therapy in our hospital, has been studied in patients displaying acute cerebral ischemia. A total of 56 patients were enrolled, of whom 27 were given piracetam and 29 served as a control during a 28-day period. Using single photon emission computer tomography (SPECT) analysis, we observed that in 23 piracetam-treated patients (85.2%) a reduction in the area of brain regions displaying an impaired flow rate occurred (P < 0.001; Fisher's exact two-sided test). Only six of placebo-treated patients (20.7%) showed an improved flow rate. Analysis of the recorded computer tomography map gave an improvement coefficient >2 (flow rate marginally or better improved) for 23 piracetam patients as compared with 5 placebo patients (P < 0.001, Uleman test).
Interaction between psychological and pharmacological treatment in cognitive impairment.
In contrast to other kinds of psychotropic drugs, nootropics or cognition enhancing drugs may be indicated, not for the direct treatment of the pathology itself, but for improving or restoring the remaining brain functions. Brain functions are normally trained during various kinds of non-medical therapy, such as physiotherapy, speech therapy, occupational therapy, memory training etc... In research little attention has been paid to the combination of both kinds of therapeutic approaches, probably because of the important methodological difficulties. This combination however, offers various interesting perspectives: L. ISRAEL examined in two placebo-controlled studies the effects of either 160 mg/d of ginkgo biloba extractum (GBE) or piracetam 2.4 or 4.8 g/d, combined with a memory training program, in nondemented patients complaining of memory problems. The results of both studies suggest that nootropic drug treatment and memory training have each an effect on different cognitive functions and, hence, are complementary. Some functions, like attention/perception in the GBE study and learning in the piracetam study, seem to benefit from both treatments, suggesting a mutually potentiating effect of drug treatment and training. This potentiation is very clear in the treatment of dyslexic children: in a placebo-controlled study piracetam 3.3 g/d, in combination with normal school teaching and more specific logopedic therapy, allowed a normal progression during the full school year in reading accuracy and reading comprehension, while the placebo treated children getting a similar training progressed only with 50%. Recently promising results were obtained in the treatment of dysphasic patients with a combination of speech therapy and piracetam 4.8 g/d, especially when given during the first months after the stroke, or otherwise in combination with an intensive speech training. In both double-blind studies the piracetam treated group improved about 60% more than the group who only got speech therapy and placebo. All these data may be explained by the restorative or enhancing influence of nootropic drugs on neurotransmitter systems closely related to learning and memory functions. E.g. piracetam restores the availability and function of muscarinic and NMDA receptors in aging animals, most probably through a modulation of the psychico-chemical properties of the neuronal membrane such as the membrane fluidity.
Piracetam as an adjuvant to language therapy for aphasia: a randomized double-blind placebo-controlled pilot study.
OBJECTIVE: To determine whether piracetam 4.8 g/day together with intensive language therapy improved language function more than language therapy alone.
DESIGN: Double-blind, placebo-controlled parallel group study.
SETTING: Referral speech and language clinic of a university department of neurology.
PATIENTS: Sixty-six inpatients with aphasia present between 4 weeks and 36 months.
INTERVENTIONS: Intensive language therapy for 6 weeks in all patients. Thirty-two patients received piracetam 4.8 g daily and 34 patients received placebo.
MAIN OUTCOME MEASURE: The Aachen Aphasia Test (AAT), a standardized procedure for evaluating the severity of aphasia, was performed at baseline and after 6 weeks' treatment.
RESULTS: In 50 patients evaluated for efficacy, a trend toward improvement in the active group was observed in all subtests of the AAT. This trend was statistically significant for absolute differences in recovery of "written language" and "profile level."
CONCLUSION: Piracetam appears to have a positive adjuvant effect on the recovery of aphasia in patients receiving intensive language therapy.
Management of completed strokes with dextran 40. A community hospital failure.
Effects of increased cholinergic activity on naming in aphasia.
Options:
A: Drug treatment with piracetam may be effective in improving language abilities in patients with aphasia after stroke.
B: Drug treatment with piracetam is definitively effective and safe for treating aphasia after stroke.
C: Drug treatment with piracetam is ineffective for treating aphasia after stroke.
D: Drug treatment with piracetam is more effective than speech and language therapy for treating aphasia after stroke.
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A
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185
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the conclusion regarding the effect of tartrazine exclusion or challenge on asthma management based on the review of randomized controlled trials? Please answer this question based on the information provided below:
Oral tartrazine challenge in childhood asthma: effect on bronchial reactivity.
Ten asthmatic children who gave a history of cough or wheeze after orange drinks, were tested for tartrazine sensitivity. On separate days, either oral tartrazine (1 mg) or a placebo capsule were administered double blind. Bronchial reactivity was measured before, 30 and 60 min after ingestion by means of a histamine-inhalation challenge test. There was no change in baseline lung function after tartrazine, but histamine sensitivity (PC20) increased significantly in four of the children. No response was obtained to a larger dose of tartrazine (10 mg) in four of the non-responders. Alteration in the bronchial reactivity after an oral challenge, appears to be a sensitive means of detecting tartrazine sensitivity.
Aspirin and concomitant idiosyncrasies in adult asthmatic patients.
The nasal and respiratory symptoms observed after oral challenge to aspirin (ASA), tartrazine, and other nonsteroidal anti-inflammatory substances are best described as idiosyncratic reactions. A positive response to oral challenge, defined as a 20% fall in forced expiratory volume in 1 sec (FEV1) from baseline for up to 4 hr, occurred in 44 of 230 patients with ASA, 11 of 277 with tartrazine, 2 of 93 with sodium salicylate, and 2 of 69 with acetaminophen. No one had a positive response to tartrazine, sodium salicylate, or acetaminophen who was not also positive to ASA. The dose of ASA causing a positive response was less than 5 grains in 95% of the patients. Of 50 patients with a suspicious history studied in detail, 96% of those with ASA idiosyncrasy had sinusitis and 71% had nasal polyps. Methacholine challenges and random circulating and sputum eosinophils did not differentiate patients with a negative challenge from those with a positive challenge. However, patients with a positive history and positive challenge had significantly more random nasal eosinophils than those with negative aspirin challenges. The term "aspirin triad" has outlived its usefulness since ASA idiosyncrasy can exist in patients lacking certain components of the triad. ASA idiosyncrasy is unsuspected in many patients and possibly overdiagnosed in others.
Tartrazine and benzoate challenge and dietary avoidance in chronic asthma.
This study undertook to determine the usefulness of tartrazine and benzoate challenge and dietary avoidance in the management of patients with chronic asthma. Double-blind ingestion-challenge tests were performed on separate days with lactose, tartrazine, benzoate and acetylsalicyclic acid (ASA). Of the twenty-eight subjects challenged, one responded to tartrazine and one to benzoate. Two additional subjects responded to ASA and a further eight were not tested with this material because of a definite history of sensitivity. Twenty-four subjects completed 1 month periods of observation while first on a normal diet and then while on a tartrazine-benzoate avoidance diet. No improvement occurred during the modified diet in anyone with positive challenge-tests or in all, but one, of those with a history of ASA idiosyncrasy; paradoxically, several of these subjects worsened during this period. We conclude that tartrazine-benzoate dietary avoidance was not of value in the management of the chronic asthmatic in this study, even among patients who respond to challenge with these substances or have ASA idiosyncrasy.
Aspirin and tartrazine oral challenge: incidence of adverse response in chronic childhood asthma.
Intolerance to tartrazine in aspirin-induced asthma: results of a multicenter study.
One hundred and fifty-six German, Italian and Polish patients with confirmed aspirin-induced asthma underwent open oral challenges with increasing doses of tartrazine up to 25 mg. All positive challenges were repeated under double-blind conditions. Only 4 of 156 patients (all Polish) had positive reactions in a double-blind test, as evidenced by a fall in FEV1 greater than 25% from baseline and corresponding clinical symptoms. Sixty-five patients who tolerated 25 mg tartrazine well received 50-3,000 mg tartrazine and none showed adverse reactions. Thus, intolerance to tartrazine appears to be rare among Central-European and South-European patients with aspirin-induced asthma, its frequency amounting to about 2.6%.
Incidence of bronchoconstriction due to aspirin, azo dyes, non-azo dyes, and preservatives in a population of perennial asthmatics.
Forty-five patients with moderately severe perennial bronchial asthma were challenged by ingestion of: acetylsalicyclic acid (ASA); 4 azo dyes (tartrazine, sunset yellow, amaranth, and ponceau); 3 non-azo dyes (erythrosine, brilliant blue, and indigotin); sodium benzoate (NaB); parahydroxybenzoic acid (OHBA); butylated hydroxyanisole (BHA); and butylated hydroxytoluene (BHT). A fall in forced expiratory volume is one second (FEV1) greater than 25% from baseline was considered positive. Seven patients who gave an unequivocal history of aspirin intolerance were not challenged with ASA; an additional 13 had positive open challenges to ASA, giving an apparent incidence of aspirin sensitivity of 20/45. The presence of nasal polyps, simusitis, or the regular use of corticosteroids, either singly or in combination, was not associated with an increased incidence of reactions to ASA. Significant bronchoconstriction to open challenges with agents other than ASA was less frequent. Positive open challenges to all substances except aspirin were followed by double-blind challenges which were positive in only 3 instances: 1 each with erythrosine, ponceau, and NaB/OHBA. Our findings confirm that ASA intolerance is relatively common but suggest on the other hand that reactions to dyes and preservatives are uncommon cause of clinically significant bronchoconstriction in moderately severe perennial asthmatics.
Options:
A: Tartrazine exclusion significantly improves asthma outcomes in most patients.
B: Tartrazine challenge significantly worsens asthma outcomes in most patients.
C: There is insufficient evidence to conclude that tartrazine exclusion or challenge significantly alters asthma outcomes.
D: Tartrazine exclusion benefits all patients with asthma.
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C
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What conclusions can be drawn about the efficacy and safety of aminopyridines for treating symptoms in people with multiple sclerosis based on the available studies? Please answer this question based on the information provided below:
The effects of 4-aminopyridine in multiple sclerosis patients: results of a randomized, placebo-controlled, double-blind, concentration-controlled, crossover trial.
Because 4-aminopyridine (AP) improves residual deficits in some multiple sclerosis (MS) patients but has a narrow toxic-to-therapeutic margin, we compared the safety and efficacy of two target peak serum concentration ranges (low: 30 to 59 ng/ml and high: 60 to 100 ng/ml). We enrolled eight MS patients with temperature-sensitive visual and motor deficits in a randomized, placebo-controlled, double-blind, crossover trial of short-term oral AP treatment. We randomized patients to a sequence of three treatments on three separate days: placebo, low serum concentration, and high serum concentration. We determined dosing to achieve the desired steady-state peak serum concentration ranges from a test dose and population pharmacokinetic parameters using bayesian estimation. Contrast sensitivity, standard neurologic examination, ratings of videotaped neurologic examinations, and quantitative strength assessment all improved with treatment, but flicker fusion frequency, visual evoked response latencies, and Expanded Disability Status Scale scores did not. All patients experienced side effects during the high-serum-concentration arm. A grand mal seizure occurred at a serum AP level of 104 ng/ml, and an acute confusional episode occurred at 114 ng/ml. AP treatment produced improvements in residual deficits in MS patients, but the occurrence of significant toxicity suggests that AP serum levels should be monitored and peak levels above 100 ng/ml should be avoided. Concentration-control methodology may be useful in testing putative treatments for other neurologic diseases.
Treatment with oral 3,4 diaminopyridine improves leg strength in multiple sclerosis patients: results of a randomized, double-blind, placebo-controlled, crossover trial.
To examine the efficacy and toxicity of oral 3,4 diaminopyridine (DAP) in dosages up to 100 mg/day, 36 patients with multiple sclerosis (MS) enrolled in a randomized, double-blind, placebo-controlled, crossover trial. The primary outcome measure was improvement of a prospectively defined neurologic deficit, which was leg weakness in 34 patients. Secondary outcome measures included the patient's subjective response, scored manual motor testing (MMT) of leg strength, scored leg strength from videotaped motor testing (VMT), quadriceps and hamstrings strength (QMT) measured by isometric dynamometry, neuropsychological testing (NPT), ambulation index (AI), and Expanded Disability Status Scale (EDSS) score. Paresthesias and abdominal pain were common and were dose limiting in eight patients. Three patients had episodes of confusion, and one patient had a seizure while on DAP. Eight patients withdrew from the study, leaving 28 evaluable patients for the efficacy analysis. The prospectively defined neurologic deficit improved in 24 patients-22 on DAP and 2 on placebo (p = 0.0005). All improvements were in leg weakness. Subjective response and measures of leg strength and function (MMT, VMT, QMT, and AI) improved on DAP compared with placebo. Neither NPT nor EDSS scores improved. DAP treatment can induce improvements in leg strength in MS patients, but toxicity is limiting in many patients.
Fatigue in progressive multiple sclerosis: results of a randomized, double-blind, placebo-controlled, crossover trial of oral 4-aminopyridine.
Previous studies suggest that aminopyridine may play a role in the symptomatic treatment of fatigue in multiple sclerosis. Although the mechanism underlying the beneficial effect on fatigue remains unclear, it has been proposed that aminopyridines may help to improve conduction in demyelinated central pathways, implicating both axonal and synaptic mechanisms. The objective of the present study is to determine whether 4-AP decreases daily-living fatigue in progressive multiple sclerosis. The effect of 4-AP on other neurophysiological and neuropsychological parameters was also considered. A 'double-blind', randomized, 'placebo-controlled', crossover trial was conducted on 54 patients with progressive multiple sclerosis. All patients received treatment with placebo and 32 mg per day of 4-AP, each for 6 months. The main outcome measure was the Fatigue Severity Scale. Secondary measures were EDSS, cognitive functions and neurophysiological parameters. Forty-nine patients (91%) completed the study. Changes in fatigue scores, EDSS and cognitive functions were not significantly different between 4-AP and placebo. However, when patients treated with 4-AP were divided into two groups according to the serum level of 4-AP, a significant effect on fatigue compared with placebo was observed in the 'high level' (>30 ng/ml) group (P=0.05). Synchronization of motor evoked potentials improved during 4-AP with respect to placebo (P=0.019) and this correlated positively with fatigue reduction (P=0.010). No relevant side effects were observed.
Quantitative assessment of sustained-release 4-aminopyridine for symptomatic treatment of multiple sclerosis.
OBJECTIVE: To evaluate the efficacy of 4-aminopyridine sustained release (4AP SR) (fampridine, EL-970) using quantitative measures of motor function in multiple sclerosis (MS) patients.
BACKGROUND: In vitro, 4AP improves conduction through demyelinated axons. A previous multicenter trial of 4AP SR using the Expanded Disability Status Scale (EDSS) as the primary outcome was unable to establish clinical efficacy.
DESIGN/METHODS: Ten MS patients with stable motor deficits (EDSS 6.0-7.5) were given 4AP SR 17.5 mg bid and placebo for 1 week each in a double-blind, placebo-controlled, crossover trial. Time to walk 8 meters, time to climb four stairs, maximum voluntary isometric contraction measured quantitatively (MVICT), manual muscle testing (MMT), grip strength, EDSS, and the patient's global impression were measured.
RESULTS: Timed gait was improved on 4AP SR compared with placebo in 9 of 10 subjects (p = 0.02). Timed stair climbing, MVICT, MMT, grip strength, and EDSS showed nonsignificant improvements on 4AP SR. Based on their global impressions, seven subjects preferred 4AP SR over placebo; only one preferred placebo. There were no serious side effects.
CONCLUSION: 4AP SR improved motor function in MS patients. The quantitative outcomes used in this study permit more sensitive evaluation of the therapeutic effect and promise to be useful in future trials of symptomatic treatments for MS.
The effects of 4-aminopyridine on cognitive function in patients with multiple sclerosis: a pilot study.
4-Aminopyridine (4-AP) has a favorable effect on the disability of certain patients with MS. We investigated the effect of 4-AP on neuropsychological performance in 20 MS patients using a randomized, double-blind, placebo-controlled, crossover design. Although there was a trend for improved performance with 4-AP for two of the tests, we could not demonstrate significant effects of 4-AP on cognitive function.
The effect of 4-aminopyridine on clinical signs in multiple sclerosis: a randomized, placebo-controlled, double-blind, cross-over study.
To find out whether treatment with 4-aminopyridine is beneficial in multiple sclerosis (MS), 70 patients with definite MS entered into a randomized, double-blind, placebo-controlled, cross-over trial in which they were treated with 4-aminopyridine and placebo for 12 weeks each (maximum dose, 0.5 mg/kg of body weight). The estimated effect of the treatment as measured with the Kurtzke expanded disability status scale, which was the main evaluation parameter, was 0.28 point (p = 0.001). A significant decrease in the scale score (1.0 point or more) was encountered in 10 patients (16.4%) during oral treatment with 4-aminopyridine whereas it was not seen during placebo treatment (p less than 0.05). A significant subjective improvement (defined as an improvement that significantly affected the activities of normal daily life) was indicated by 18 patients (29.5%) during 4-aminopyridine treatment and by 1 patient (1.6%) during placebo treatment (p less than 0.05). Significant improvements related to 4-aminopyridine occurred in a number of neurophysiological parameters. No serious side effects were encountered. However, subjective side effects such as paresthesias, dizziness, and light-headedness were frequently reported during 4-aminopyridine treatment. Analysis of subgroups revealed that there was no difference in efficacy between those patients randomized to receive 4-aminopyridine and then placebo and those randomized to receive placebo and then 4-aminopyridine or between patients with and those without subjective side effects. Especially patients with temperature-sensitive symptoms and patients characterized by having a longer duration of the disease and being in a progressive phase of the disease were likely to show clear clinical benefit.
4-Aminopyridine in patients with multiple sclerosis: dosage and serum level related to efficacy and safety.
In a recent randomized, double-blind, placebo-controlled crossover trial, we demonstrated efficacy of 4-aminopyridine (4-AP) in improving disability of patients with multiple sclerosis (MS). Here we describe the relationship between dosage, serum level, efficacy, and safety of intravenously and orally administered 4-AP in the same group of 70 MS patients. After both intravenous and oral administration there was a significant relationship between serum levels and 4-AP doses used (p < 0.001 and p < 0.01, respectively). The use of 4-AP in oral doses three times a day showed a large variation and fluctuation in serum levels. After 12 weeks of oral treatment (maximum daily dosage 0.5 mg/kg body weight), a statistically significant improvement was found for the smooth pursuit gain of the eye movements (estimated effect 0.14, 95% confidence interval 0.06-0.23, p < 0.001). The amount of improvement was significantly related to 4-AP serum levels (p = 0.0013). Side effects after intravenous 4-AP occurred frequently and were very troublesome (pain in infusion arm, dizziness). Side effects during oral treatment (dizziness, paresthesias) were very mild and occurred 30-45 min after intake of the medication and could be related to high serum levels.
Options:
A: Aminopyridines are conclusively effective and safe for treating MS symptoms.
B: Aminopyridines show some potential benefits, but there is insufficient evidence to make a definitive conclusion about their efficacy and safety.
C: Aminopyridines are ineffective and unsafe for treating MS symptoms.
D: Aminopyridines have no effect on MS symptoms and are completely safe.
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B
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187
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What are the comparative effects of ticlopidine plus aspirin versus oral anticoagulants after coronary stenting in terms of efficacy and safety? Please answer this question based on the information provided below:
Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting. The full anticoagulation versus aspirin and ticlopidine (fantastic) study.
BACKGROUND: Dual therapy with ticlopidine and aspirin has been shown to be as effective as or more effective than conventional anticoagulation in patients with an optimal result after implantation of intracoronary metallic stents. However, the safety and efficacy of antiplatelet therapy alone in an unselected population has not been evaluated.
METHODS: Patients were randomized to conventional anticoagulation or to treatment with antiplatelet therapy alone. Indications for stenting were classified as elective (decided before the procedure) or unplanned (to salvage failed angioplasty or to optimize the results of balloon angioplasty). After stenting, patients received aspirin and either ticlopidine or conventional anticoagulation (heparin or oral anticoagulant). The primary end point was the occurrence of bleeding or peripheral vascular complications; secondary end points were cardiac events (death, infarction, or stent occlusion) and duration of hospitalization.
RESULTS: In 13 centers, 236 patients were randomized to anticoagulation and 249 to antiplatelet therapy. Stenting was elective in 58% of patients and unplanned in 42%. Stent implantation was successfully achieved in 99% of patients. A primary end point occurred in 33 patients (13.5%) in the antiplatelet group and 48 patients (21%) in the anticoagulation group (odds ratio=0.6 [95% CI 0.36 to 0.98], P=0.03). Major cardiac-related events in electively stented patients were less common (odds ratio=0.23 [95% CI 0.05 to 0.91], P=0.01) in the antiplatelet group (3 of 123, 2.4%) than the anticoagulation group (11 of 111, 9.9%). Hospital stay was significantly shorter in the antiplatelet group (4.3+/-3.6 versus 6. 4+/-3.7 days, P=0.0001).
CONCLUSIONS: Antiplatelet therapy after coronary stenting significantly reduced rates of bleeding and subacute stent occlusion compared with conventional anticoagulation.
A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents.
BACKGROUND: The clinical benefit of coronary-artery stenting performed in conjunction with coronary angioplasty is limited by the risk of thrombotic occlusion of the stent as well as hemorrhagic and vascular complications of intensive anticoagulation. We compared antiplatelet therapy with conventional anticoagulant therapy with respect to clinical outcomes 30 days after coronary-artery stenting.
METHODS: After successful placement of Palmaz-Schatz coronary-artery stents, 257 patients were randomly assigned to receive antiplatelet therapy (ticlopidine plus aspirin) and 260 to receive anticoagulant therapy (intravenous heparin, phenprocoumon, and aspirin). The primary cardiac end point was a composite measure reflecting death from cardiac causes or the occurrence of myocardial infarction, aortocoronary bypass surgery, or repeat angioplasty. The primary noncardiac end point comprised death from noncardiac causes, cerebrovascular accident, severe hemorrhage, and peripheral vascular events.
RESULTS: Of the patients assigned to antiplatelet therapy, 1.6 percent reached a primary cardiac end point, as did 6.2 percent of those assigned to anticoagulant therapy (relative risk, 0.25; 95 percent confidence interval, 0.06 to 0.77). With antiplatelet therapy, there was an 82 percent lower risk of myocardial infarction than in the anticoagulant-therapy group, and a 78 percent lower need for repeat interventions. Occlusion of the stented vessel occurred in 0.8 percent of the antiplatelet-therapy group and in 5.4 percent of the anticoagulant-therapy group (relative risk, 0.14; 95 percent confidence interval, 0.02 to 0.62). A primary noncardiac end point was reached by 1.2 percent of the antiplatelet-therapy group and 12.3 percent of the anticoagulant-therapy group (relative risk, 0.09; 95 percent confidence interval, 0.02 to 0.31). Hemorrhagic complications occurred only in the anticoagulant-therapy group (in 6.5 percent). An 87 percent reduction in the risk of peripheral vascular events was observed with antiplatelet therapy.
CONCLUSIONS: As compared with conventional anticoagulant therapy, combined antiplatelet therapy after the placement of coronary-artery stents reduces the incidence of both cardiac events and hemorrhagic and vascular complications.
Randomized evaluation of anticoagulation versus antiplatelet therapy after coronary stent implantation in high-risk patients: the multicenter aspirin and ticlopidine trial after intracoronary stenting (MATTIS).
BACKGROUND: Although the association of ticlopidine and aspirin has been shown to be superior to anti-vitamin K agents and aspirin after coronary stent implantation in low-risk patients, the latter combination has remained an unproven reference regimen for high-risk patients until recently.
METHODS AND RESULTS: We randomized 350 high-risk patients within 6 hours after stent implantation to receive during 30 days either aspirin 250 mg and ticlopidine 500 mg/d (A+T group) or aspirin 250 mg/d and oral anticoagulation (A+OAC group) targeted at an international normalized ratio of 2.5 to 3. The primary composite end point was defined as the occurrence of cardiovascular death, myocardial infarction, or repeated revascularization at 30 days. Patients were eligible if (1) the stent(s) were implanted to treat abrupt closure after PTCA; (2) the angiographic result after implantation was suboptimal; (3) a long segment was stented (>45 mm and/or >/=3 stents); or (4) the largest balloon inflated in the stent had a nominal diameter of </=2.5 mm. The primary cardiac end point was reached for 10 patients (5.6%) in the A+T group and 19 (11%) in the A+OAC group (relative risk [RR], 1. 9; 95% CI, 0.9 to 4.1; P=0.07). Major vascular and bleeding complications were less frequent in the A+T group (3 patients, 1.7%) than in the A+OAC group (12 patients, 6.9%) (RR, 4.1; 95% CI, 1.2 to 14.3; P=0.02).
CONCLUSIONS: High-risk patients should be treated with A+T rather than A+OAC after coronary stenting because the bleeding and vascular complications are significantly reduced and there is a marked trend suggesting a decrease in cardiac events.
A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators.
BACKGROUND: Antithrombotic drugs are used after coronary-artery stenting to prevent stent thrombosis. We compared the efficacy and safety of three antithrombotic-drug regimens - aspirin alone, aspirin and warfarin, and aspirin and ticlopidine - after coronary stenting.
METHODS: Of 1965 patients who underwent coronary stenting at 50 centers, 1653 (84.1 percent) met angiographic criteria for successful placement of the stent and were randomly assigned to one of three regimens: aspirin alone (557 patients), aspirin and warfarin (550 patients), or aspirin and ticlopidine (546 patients). All clinical events reflecting stent thrombosis were included in the prespecified primary end point: death, revascularization of the target lesion, angiographically evident thrombosis, or myocardial infarction within 30 days.
RESULTS: The primary end point was observed in 38 patients: 20 (3.6 percent) assigned to receive aspirin alone, 15 (2.7 percent) assigned to receive aspirin and warfarin, and 3 (0.5 percent) assigned to receive aspirin and ticlopidine (P=0.001 for the comparison of all three groups). Hemorrhagic complications occurred in 10 patients (1.8 percent) who received aspirin alone, 34 (6.2 percent) who received aspirin and warfarin, and 30 (5.5 percent) who received aspirin and ticlopidine (P<0.001 for the comparison of all three groups); the incidence of vascular surgical complications was 0.4 percent (2 patients), 2.0 percent (11 patients), and 2.0 percent (11 patients), respectively (P=0.01). There were no significant differences in the incidence of neutropenia or thrombocytopenia (overall incidence, 0.3 percent) among the three treatment groups.
CONCLUSIONS: As compared with aspirin alone and a combination of aspirin and warfarin, treatment with aspirin and ticlopidine resulted in a lower rate of stent thrombosis, although there were more hemorrhagic complications than with aspirin alone. After coronary stenting, aspirin and ticlopidine should be considered for the prevention of the serious complication of stent thrombosis.
Options:
A: Ticlopidine plus aspirin significantly reduces the risk of non-fatal myocardial infarction, revascularization, and major bleeding, but increases the risk of haematological complications.
B: Ticlopidine plus aspirin significantly increases the risk of non-fatal myocardial infarction, revascularization, and major bleeding, but reduces the risk of haematological complications.
C: Ticlopidine plus aspirin has no significant effect on non-fatal myocardial infarction, revascularization, major bleeding, or haematological complications.
D: Ticlopidine plus aspirin significantly reduces the risk of non-fatal myocardial infarction, revascularization, major bleeding, and haematological complications.
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A
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188
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What is the most appropriate form of practice for women with loco-regional recurrence of breast cancer based on the findings of the systematic review? Please answer this question based on the information provided below:
A trial of human alpha interferon as an adjuvant agent in breast cancer after loco-regional recurrence.
Thirty-two women who had developed loco-regional recurrence of breast carcinoma were entered into a controlled trial of adjuvant alpha-interferon. All patients had histological confirmation of recurrence, local treatment with radiotherapy and negative staging investigations. They were then randomized to either observation alone, or treatment with human alpha interferon 3 x 10(6) units subcutaneously daily for 1 year. There were no differences detected in the rate of local or distant relapse. With this lack of clinically significant efficacy and a high incidence of side effects, it is concluded that alpha interferon is of doubtful value in the adjuvant treatment of breast cancer.
Review of local soft tissue recurrence of breast cancer irradiated with and without actinomycin-D.
Between 1962 and 1973, regionally recurrent breast cancer was treated in 156 patients by irradiation alone or irradiation with concurrent actinomycin-D. Thirty-two patients were entered into a randomized trial, and 124 patients were retrospectively reviewed. Local control with irradiation alone was achieved in 48 of 80 patients (60%) and in 60 of 76 patients (79%) treated with irradiation and actinomycin-D (p less than .05). Results were remarkably similar in the randomized and retrospective series.
First isolated locoregional recurrence following mastectomy for breast cancer: results of a phase III multicenter study comparing systemic treatment with observation after excision and radiation. Swiss Group for Clinical Cancer Research.
PURPOSE: We performed a randomized phase III multicenter study to compare systemic treatment versus no treatment after complete excision and radiotherapy for isolated first locoregional recurrence in patients with breast cancer.
PATIENTS AND METHODS: One hundred sixty-seven good-risk patients with an estrogen receptor (ER+) positive recurrence or, in case of unknown receptor status, a disease-free interval (DFI) of greater than 12 months and < or = three recurrent tumor nodules each < or = 3 cm in diameter were entered onto the study. They were randomized to observation subsequent to local treatment or to receive tamoxifen (TAM) until disease progression. Seventy-nine percent of the patients were postmenopausal.
RESULTS: The median observation period for the entire study population was 6.3 years. The median disease-free survival (DFS) duration was 26 months for observation and 82 months for TAM patients (P = .007). This was mainly due to the reduction of further local recurrences, whereas the occurrence of early distant metastases was delayed. A multivariate analysis identified DFI and treatment with TAM as significant prognostic factors for DFS. The 5-year overall survival (OS) rates were 76% and 74%, respectively (P = .77). DFI was also a prognostic factor for OS.
CONCLUSION: Systemic therapy with TAM after isolated locoregional recurrence of breast cancer significantly increased 5-year DFS rates from 36% to 59% compared with observation alone and prolonged median DFS by more than 4.5 years in patients with ER+ tumors or in the case of unknown ER status with a DFI of greater than 12 months and minimal tumor burden. Treatment with TAM currently has no significant impact on OS, but the median survival duration of the study population has not yet been reached.
First isolated locoregional recurrence following mastectomy for breast cancer: results of a phase III multicenter study comparing systemic treatment with observation after excision and radiation. Swiss Group for Clinical Cancer Research.
PURPOSE: We performed a randomized phase III multicenter study to compare systemic treatment versus no treatment after complete excision and radiotherapy for isolated first locoregional recurrence in patients with breast cancer.
PATIENTS AND METHODS: One hundred sixty-seven good-risk patients with an estrogen receptor (ER+) positive recurrence or, in case of unknown receptor status, a disease-free interval (DFI) of greater than 12 months and < or = three recurrent tumor nodules each < or = 3 cm in diameter were entered onto the study. They were randomized to observation subsequent to local treatment or to receive tamoxifen (TAM) until disease progression. Seventy-nine percent of the patients were postmenopausal.
RESULTS: The median observation period for the entire study population was 6.3 years. The median disease-free survival (DFS) duration was 26 months for observation and 82 months for TAM patients (P = .007). This was mainly due to the reduction of further local recurrences, whereas the occurrence of early distant metastases was delayed. A multivariate analysis identified DFI and treatment with TAM as significant prognostic factors for DFS. The 5-year overall survival (OS) rates were 76% and 74%, respectively (P = .77). DFI was also a prognostic factor for OS.
CONCLUSION: Systemic therapy with TAM after isolated locoregional recurrence of breast cancer significantly increased 5-year DFS rates from 36% to 59% compared with observation alone and prolonged median DFS by more than 4.5 years in patients with ER+ tumors or in the case of unknown ER status with a DFI of greater than 12 months and minimal tumor burden. Treatment with TAM currently has no significant impact on OS, but the median survival duration of the study population has not yet been reached.
Possible deleterious effect of tamoxifen in premenopausal women with locoregional recurrence of breast cancer.
Tamoxifen (TAM) treatment following isolated locoregional recurrence of breast cancer significantly increases 5-year disease-free survival rates compared with observation alone in potentially hormone-responsive patients [J Clin Oncol 1994, 12, 2071-2077]. The treatment outcome was re-analysed by menopausal status (stratification factor) in 35 premenopausal and in 132 postmenopausal patients. Disease progression was highly reduced by tamoxifen in the postmenopausal group and was similar to control in the premenopausal group. However, the 5-year cumulative incidence analysis of the type of first failure showed TAM to be associated with increased incidence of distant metastases (P = 0.01) in premenopausal patients. TAM reduced local progression (P = 0.40) in premenopausal and both types of failure (P = 0.16 and P = 0.001, respectively) in postmenopausal patients. Administration of TAM was associated with a decrease of 5-year overall survival from 90 +/- 7% to 60 +/- 14% in premenopausal patients. Although cautious interpretation of these results is highly recommended due to the small patient numbers and the retrospective subset analyses, these findings might be worthy of further investigation in larger trials. Prospective randomised studies to test hormonal treatment outcome by menopausal status should be encouraged in breast cancer.
Adjuvant therapy after excision and radiation of isolated postmastectomy locoregional breast cancer recurrence: definitive results of a phase III randomized trial (SAKK 23/82) comparing tamoxifen with observation.
BACKGROUND: Adjuvant systemic treatment for patients with isolated locoregional recurrence (ILRR) of breast cancer is based on a single reported randomized trial. The trial, conducted by the Swiss Group for Clinical Cancer Research, compared tamoxifen (TAM) with observation after complete excision of the ILRR and proper radiotherapy. We performed a definitive analysis of treatment outcome at >11 years of follow-up, after the majority of the patients had a subsequent event of interest. Patient and methods One hundred and sixty-seven patients with 'good-risk' characteristics of disease were randomized. 'Good-risk' was defined as estrogen receptor expression in the ILRR, or having a disease-free interval of >12 months and a recurrence consisting of three or less tumor nodules, each </=3 cm in diameter. Seventy-nine percent of the patients were postmenopausal at randomization.
RESULTS: The median follow-up time of the surviving patients was 11.6 years. The median post ILRR disease-free survival (DFS) was 6.5 years with TAM and 2.7 years with observation (P = 0.053). The difference was mainly due to reduction of further local relapses (P = 0.011). In postmenopausal patients, TAM led to an increase of DFS from 33% to 61% (P = 0.006). In premenopausal women, 5-year DFS was 60%, independent of TAM medication. For the whole study population, the median post-recurrence overall survival (OS) was 11.2 and 11.5 years in the observation and the TAM group, respectively; premenopausal patients experienced a 5-year OS of 90% for observation compared with 67% for TAM (P = 0.175), while the respective figures for postmenopausal patients were both 75%.
CONCLUSIONS: These definitive results confirmed that TAM significantly improves the post-recurrence DFS of patients after local treatment for ILRR. This beneficial effect does not translate into a detectable OS advantage.
Options:
A: Systemic therapy significantly improves overall survival and should be the standard treatment.
B: Observation alone is sufficient as systemic therapy does not provide any benefit.
C: Participation in randomised trials of systemic treatment versus observation is recommended due to insufficient evidence.
D: Immediate surgical intervention without systemic therapy is the best approach.
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C
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189
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the main findings when comparing phenobarbitone and phenytoin as monotherapy for patients with partial onset seizures or generalized tonic-clonic seizures? Please answer this question based on the information provided below:
Carbamazepine for epilepsy. A controlled prospective evaluation.
Randomised comparative monotherapy trial of phenobarbitone, phenytoin, carbamazepine, or sodium valproate for newly diagnosed childhood epilepsy.
BACKGROUND: The medical treatment of childhood epilepsy is largely influenced by clinical trials in adult patients. We know of only one randomised comparative trial (of two drugs) in newly diagnosed childhood epilepsy. We have undertaken a long-term, prospective, randomised, unmasked, pragmatic trial of the comparative efficacy and toxicity of four standard antiepileptic drugs used as monotherapy in children with newly diagnosed epilepsy.
METHODS: Between 1981 and 1987, 167 children aged 3-16 years, who had had at least two previously untreated tonic-clonic or partial seizures, with or without secondary generalisation, were randomly allocated treatment with phenobarbitone, phenytoin, carbamazepine, or sodium valproate. The protocol was designed to conform to standard clinical practice. Efficacy was assessed by time to first seizure after the start of treatment and time to achieving 1-year remission.
FINDINGS: The overall outcome with all four drugs was good. 20% of children remained free of seizures and 73% had achieved 1-year remission by 3 years of follow-up. We found no significant differences between the drugs for either measure of efficacy at 1, 2, or 3 years of follow-up. The overall frequency of unacceptable side-effects necessitating withdrawal of the randomised drug was 9%. This total included six of the first ten children assigned phenobarbitone; no further children were allocated this drug. Of the other three drugs, phenytoin (9%) was more likely to be withdrawn than carbamazepine (4%) or sodium valproate (4%). INTERPRETATION Our data will inform choice of drug and outcome with four of the standard drugs available for newly diagnosed tonic-clonic or partial seizures with or without secondary generalisation in children.
Comparison of the effectiveness of phenobarital, mephobarbital, primidone, diphenylhydantoin, ethotoin, metharbital, and methylphenylethylhydantoin in motor seizures.
Phenobarbitone, phenytoin, carbamazepine, or sodium valproate for newly diagnosed adult epilepsy: a randomised comparative monotherapy trial.
Recent studies have shown that most newly diagnosed epileptic patients can be satisfactorily treated with a single antiepileptic drug. We therefore undertook a prospective randomised pragmatic trial of the comparative efficacy and toxicity of four major antiepileptic drugs, utilised as monotherapy in newly diagnosed epileptic patients. Between 1981 and 1987 243 adult patients aged 16 years or over, newly referred to two district general hospitals with a minimum of two previously untreated tonic-clonic or partial with or without secondary generalised seizures were randomly allocated to treatment with phenobarbitone, phenytoin, carbamazepine, or sodium valproate. The protocol was designed to conform with standard clinical practice. Efficacy was assessed by time to first seizure after the start of treatment and time to enter one year remission. The overall outcome with all of the four drugs was good with 27% remaining seizure free and 75% entering one year of remission by three years of follow up. No significant differences between the four drugs were found for either measure of efficacy at one, two, or three years of follow up. The overall incidence of unacceptable side effects, necessitating withdrawal of the randomised drug, was 10%. For the individual drugs phenobarbitone (22%) was more likely to be withdrawn than phenytoin (3%), carbamazepine (11%), and sodium valproate (5%). In patients with newly diagnosed tonic-clonic or partial with or without secondary generalised seizures, the choice of drug will be more influenced by considerations of toxicity and costs.
Comparison of carbamazepine, phenobarbital, phenytoin, and primidone in partial and secondarily generalized tonic-clonic seizures.
We conducted a 10-center, double-blind trial to compare the efficacy and toxicity of four antiepileptic drugs in the treatment of partial and secondarily generalized tonic-clonic seizures in 622 adults. Patients were randomly assigned to treatment with carbamazepine, phenobarbital, phenytoin, or primidone and were followed for two years or until the drug failed to control seizures or caused unacceptable side effects. Overall treatment success was highest with carbamazepine or phenytoin, intermediate with phenobarbital, and lowest with primidone (P less than 0.002). Differences in failure rates of the drugs were explained primarily by the fact that primidone caused more intolerable acute toxic effects, such as nausea, vomiting, dizziness, and sedation. Decreased libido and impotence were more common in patients given primidone. Phenytoin caused more dysmorphic effects and hypersensitivity. Control of tonic-clonic seizures did not differ significantly with the various drugs. Carbamazepine provided complete control of partial seizures more often than primidone or phenobarbital (P less than 0.03). Overall, carbamazepine and phenytoin are recommended drugs of first choice for single-drug therapy of adults with partial or generalized tonic-clonic seizures or with both.
Comparative cognitive effects of anticonvulsants.
We investigated the neuropsychological effects of carbamazepine, phenobarbital, and phenytoin in 15 partial complex epilepsy patients treated with each drug for 3 months, using a randomized double-blind, triple crossover design. Neuropsychological evaluation at the end of each treatment period included Digit Span, Selective Reminding Test, Digit Symbol, Finger Tapping, Grooved Pegboard, Choice Reaction Time, P3 evoked potential, and Profile of Mood States. Employing anticonvulsant blood levels and seizure frequencies as covariates, the only significant difference was for Digit Symbol. Performance with phenobarbital was significantly worse than with the other 2 anticonvulsants despite phenobarbital's having had the lowest overall blood levels. Our data show that patients receiving carbamazepine, phenobarbital, and phenytoin have comparable neuropsychological performance on most measures. The results suggest that the differential cognitive effects of anticonvulsants may be subtle.
Randomised controlled trial to assess acceptability of phenobarbital for childhood epilepsy in rural India.
BACKGROUND: The use of phenobarbital for childhood epilepsy is controversial because of reported behavioural side-effects; however, whether this research can validly be extrapolated to developing countries is not clear. We undertook a randomised comparison of phenobarbital and phenytoin to assess the acceptability and efficacy of phenobarbital as monotherapy for childhood epilepsy in rural India.
METHODS: Between August, 1995, and February, 1996, 109 unselected children aged 2-18 years with partial and generalised tonic-clonic epilepsy were identified by population screening. 15 families declined to take part. 94 children were randomly allocated treatment with phenobarbital (1.5 mg/kg daily for 2 weeks; maintenance dose 3.0 mg/kg daily; n = 47) or phenytoin (2.5 mg/kg daily then 5.0 mg/kg daily; n = 47). Children were followed up for 12 months. The primary outcome measure was the frequency of behavioural side-effects; behaviour was assessed by the Conners parent rating scale for children aged 6 years and older, and by the preschool behaviour screening questionnaire (BSQ) for those aged 2-5 years, at 12 months or at withdrawal from treatment. Analysis was by intention to treat.
FINDINGS: The mean log-transformed scores on the behaviour rating scales did not differ significantly between the phenobarbital and phenytoin groups (Conners 2.64 [SD 0.71] vs 2.65 [0.89], p = 0.97; n = 32 in each group: BSQ 2.12 [1.31] vs 2.18 [1.02], p = 0.94; n = 4 vs 3). The odds ratio for behavioural problems (phenobarbital vs phenytoin) was 0.51 (95% CI 0.16-1.59). There was no excess in parental reports of side-effects for phenobarbital. We found no difference in efficacy between the study drugs (adjusted hazard ratio for time to first seizure from randomisation 0.97 [0.28-3.30]).
INTERPRETATION: This evidence supports the acceptability of phenobarbital as a first-line drug for childhood epilepsy in rural settings in developing countries.
Comparison of phenobarbitone, phenytoin with sodium valproate: randomized, double-blind study.
OBJECTIVE: To compare the efficacy and side effects of phenobarbitone (PB), phenytoin (PHT) and sodium valproate (SVP) in controlling generalized tonic-clonic convulsions (GTC).
DESIGN: Randomized, double blind clinical trial.
SETTING: Out-Patients in a tertiary care hospital.
PATIENTS: 151 children with GTC, aged 4-12 yrs, from Madras city were enrolled. At the end of 2 yrs, 127 children remained in the study.
INTERVENTION: Each child was given one active drug and 2 placebo tablets. Clinical, hematological and biochemical evaluations were done every month. Serum drug levels were assessed periodically.
MAIN OUTCOME MEASURES: Recurrence of convulsion and side effects.
RESULTS: The proportion of children with recurrence did not differ among the 3 groups. More than one side effect was observed in 16 (32%) children on PB, 20 (40%) children on PHT and 9 (19%) children on SVP and this difference was statistically significant (p < 0.05). Hyperactivity was the major side effect of PB, observed in 22% of children.
CONCLUSION: All 3 drugs were equally effective in controlling seizures. Side effects were minimal with SVP followed by PB. Though side effects were more frequent with PHT, most of them disappeared on adjusting drug dosage. Least expensive phenobarbitone may be preferred as the first drug of choice but, only for pre-school children. SVP is advised for school going children.
Options:
A: Phenobarbitone showed a significant advantage in terms of treatment withdrawal and seizure outcomes.
B: Phenytoin showed a significant advantage in terms of treatment withdrawal, with no significant differences in seizure outcomes.
C: Both phenobarbitone and phenytoin showed no significant differences in treatment withdrawal and seizure outcomes.
D: Phenobarbitone showed a significant advantage in terms of seizure outcomes, with no significant differences in treatment withdrawal.
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B
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What was the observed effect of second-line chemotherapy with doxetaxel on the survival of patients with non-small cell lung cancer (NSCLC) who had relapsed or failed to respond to first-line treatment? Please answer this question based on the information provided below:
Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy.
PURPOSE: To evaluate whether treatment with single-agent docetaxel would result in longer survival than would best supportive care in patients with non-small-cell lung cancer who had previously been treated with platinum-based chemotherapy. Secondary end points included assessment of response (docetaxel arm only), toxicity, and quality of life.
PATIENTS AND METHODS: Patients with performance statuses of 0 to 2 and stage IIIB/IV non-small-cell lung cancer with either measurable or evaluable lesions were eligible for entry onto the study if they had undergone one or more platinum-based chemotherapy regimens and if they had adequate hematology and biochemistry parameters. They were excluded if they had symptomatic brain metastases or if they had previously been treated with paclitaxel. Patients were stratified by performance status and best response to cisplatin chemotherapy and were then randomized to treatment with docetaxel 100 mg/m(2) (49 patients) or 75 mg/m(2) (55 patients) or best supportive care. Patients in both arms were assessed every 3 weeks.
RESULTS: One hundred four patients (103 of whom were eligible for entry onto the study) were well balanced for prognostic factors. Of 84 patients with measurable lesions, six (7. 1%) achieved partial responses (three patients at each dose level). Time to progression was longer for docetaxel patients than for best supportive care patients (10.6 v 6.7 weeks, respectively; P <.001), as was median survival (7.0 v 4.6 months; log-rank test, P =.047). The difference was more significant for docetaxel 75 mg/m(2) patients, compared with corresponding best supportive care patients (7.5 v 4.6 months; log-rank test, P =.010; 1-year survival, 37% v 11%; chi(2) test, P =.003). Febrile neutropenia occurred in 11 patients treated with docetaxel 100 mg/m(2), three of whom died, and in one patient treated with docetaxel 75 mg/m(2). Grade 3 or 4 nonhematologic toxicity, with the exception of diarrhea, occurred at a similar rate in both the docetaxel and best supportive care groups.
CONCLUSION: Treatment with docetaxel is associated with significant prolongation of survival, and at a dose of 75 mg/m(2), the benefits of docetaxel therapy outweigh the risks.
Prospective randomized trial of docetaxel versus best supportive care in patients with non-small-cell lung cancer previously treated with platinum-based chemotherapy.
PURPOSE: To evaluate whether treatment with single-agent docetaxel would result in longer survival than would best supportive care in patients with non-small-cell lung cancer who had previously been treated with platinum-based chemotherapy. Secondary end points included assessment of response (docetaxel arm only), toxicity, and quality of life.
PATIENTS AND METHODS: Patients with performance statuses of 0 to 2 and stage IIIB/IV non-small-cell lung cancer with either measurable or evaluable lesions were eligible for entry onto the study if they had undergone one or more platinum-based chemotherapy regimens and if they had adequate hematology and biochemistry parameters. They were excluded if they had symptomatic brain metastases or if they had previously been treated with paclitaxel. Patients were stratified by performance status and best response to cisplatin chemotherapy and were then randomized to treatment with docetaxel 100 mg/m(2) (49 patients) or 75 mg/m(2) (55 patients) or best supportive care. Patients in both arms were assessed every 3 weeks.
RESULTS: One hundred four patients (103 of whom were eligible for entry onto the study) were well balanced for prognostic factors. Of 84 patients with measurable lesions, six (7. 1%) achieved partial responses (three patients at each dose level). Time to progression was longer for docetaxel patients than for best supportive care patients (10.6 v 6.7 weeks, respectively; P <.001), as was median survival (7.0 v 4.6 months; log-rank test, P =.047). The difference was more significant for docetaxel 75 mg/m(2) patients, compared with corresponding best supportive care patients (7.5 v 4.6 months; log-rank test, P =.010; 1-year survival, 37% v 11%; chi(2) test, P =.003). Febrile neutropenia occurred in 11 patients treated with docetaxel 100 mg/m(2), three of whom died, and in one patient treated with docetaxel 75 mg/m(2). Grade 3 or 4 nonhematologic toxicity, with the exception of diarrhea, occurred at a similar rate in both the docetaxel and best supportive care groups.
CONCLUSION: Treatment with docetaxel is associated with significant prolongation of survival, and at a dose of 75 mg/m(2), the benefits of docetaxel therapy outweigh the risks.
Options:
A: Doxetaxel provided no significant survival benefit compared to best supportive care (BSC).
B: Doxetaxel increased survival by an average of 2.4 months compared to BSC.
C: Doxetaxel decreased survival compared to BSC due to high toxicity.
D: Doxetaxel had the same survival rate as BSC but with higher quality of life.
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B
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the safety and efficacy of different surgical methods for first trimester abortion, specifically comparing vacuum aspiration to dilatation and curettage (D&C), and flexible versus rigid vacuum aspiration cannula? Please answer this question based on the information provided below:
Similarities in women's perceptions and acceptability of manual vacuum aspiration and electric vacuum aspiration for first trimester abortion.
This paper examines women's acceptability of and experiences with manual vacuum aspiration (MVA) as compared with electric vacuum aspiration (EVA) for first trimester abortion. Women requesting pregnancy terminations were randomly assigned to either MVA (n = 64) or EVA (n = 63). Participants completed questionnaires before and after their abortions and approximately 2-4 weeks later. We observed some differences by group in participants' ratings of the importance of method characteristics and in their perceptions of their abortion methods after their abortions. The two groups did not, however, differ in their reports of pain, anxiety or bleeding or in the acceptability of their method.
First trimester abortion by vacuum aspiration.
To compare the efficacy and complications of using the 8 mm diameter metal and flexible plastic cannulae for performing abortions of pregnancies of 7--10 menstrual weeks' gestation by vacuum aspiration, a comparative study was conducted. Both types of cannulae were randomly assigned to 300 subjects in a study design where the physician who performed the abortion was not the same person who evaluated the subject after the abortion or at the time of the follow-up visit. All abortions were performed under paracervical block anesthetic after mechanical dilatation of the cervix to 8.6 mm. The rates of specific complications, blood loss and the need for secondary procedures to complete the abortion were not significantly different for the two types of cannulae. The amount of tissue obtained with a routine curette check following the vacuum aspiration, and the incidence of cannula obstruction were similar for the two types of cannulae.
Acceptability of manual versus electric aspiration for first trimester abortion: a randomized trial.
This study was conducted to compare the acceptability of manual and electric vacuum aspiration for first trimester elective abortion. Eighty-four women seeking abortions at less than 10 weeks gestation were randomized to abortion by manual or electric vacuum aspiration. Post-procedure questionnaires were administered to patients to assess pain, noise disturbance and overall satisfaction with the abortion procedure. Physicians reported procedural difficulty, their perceptions of patient discomfort and their overall acceptance of the procedure. Other outcomes included amounts of anesthesia required and complication rates. There were no significant differences in pain levels or satisfaction reported by patients; however, significantly more women in the electric group were bothered by noise (19% vs. 2%, p = 0.03). There were no differences in physician assessments of procedural difficulty; however, there were significantly more times in the electric group that physicians would have preferred manual aspiration (43% vs. 17%, p = 0.02). There were four crossovers from manual to electric, and none from electric to manual. It is concluded that physicians and patients find manual vacuum aspiration as acceptable as electric vacuum aspiration for elective abortions performed at less than 10 weeks gestation.
Comparison of pain and time of procedures with two first-trimester abortion techniques performed by residents and faculty.
OBJECTIVES: We compared pain perception and procedure time in abortions performed by residents and faculty using a manual vacuum aspirator and electric vacuum curettage devices.
STUDY DESIGN: We conducted a randomized trial of 114 women undergoing first-trimester abortions. Patients assessed the level of pain with visual analog scales.
RESULTS: The mean procedure times were 5.7 and 6.9 minutes, respectively, with electric vacuum curettage and manual vacuum aspirator. Faculty took less time than residents to perform both procedures. Patients reported a higher pain level with cervical dilatation before resident electric vacuum curettage procedures. Patients undergoing electric vacuum curettage thought that the procedure noise increased their pain.
CONCLUSIONS: First-trimester abortion procedures can be performed more quickly by experienced surgeons. The procedure time for the manual vacuum aspirator is greater than that for the electric vacuum curettage. Patient pain perception with aspiration by these two techniques is not different. The level of pain after aspiration did not vary significantly in patients who had abortions performed by residents or faculty.
Manual vacuum aspiration, a safe and effective alternative in early pregnancy termination.
BACKGROUND AND OBJECTIVE: Vacuum aspiration has become standard surgical procedure for safe early pregnancy termination. Most of these operations are performed in the operating theater using suction curettage and an electric vacuum pump. MVA (manual vacuum aspiration) is an alternative that is well suited for use as a clinical procedure, which could have advantages both for the patient and the health care system. In order to compare conventional VA and MVA in a Swedish setting, a randomized study was undertaken.
METHODS: Two hundred women requesting abortion in early pregnancy, gestational age less than 56 days, and choosing surgical termination, were randomized to VA or MVA. Main study outcome was frequency of complete abortion but also other variables were recorded.
RESULTS: There were no significant differences between the two groups regarding background characteristics. Altogether 91 MVA and 88 VA operations were performed. There was no significant difference in frequency of complete abortion; two patients in each group subsequently needed re-curettage because of incomplete evacuation. No case of ongoing pregnancy occurred. Two patients in each group received treatment for endometritis. No other complications were recorded.
CONCLUSION: This study indicates that MVA is effective in emptying the uterine cavity, on par with the standard vacuum aspiration. The rate of complications with MVA was on the same low level as with conventional VA.
A comparison of D & C and vacuum aspiration for performing first trimester abortion.
In a study of techniques for first trimester abortion conducted at Kandang Kerbau Hospital in Singapore from September 1973 to April 1975, 420 physically healthy gravidas were randomly assigned to one of two treatment groups either by D & C or vacuum aspiration. Half of the patients in each group were 6 to 10 menstrual weeks' gestation and half were 11 to 12 week's gestation. The numbers of women with one or more complications were the same for the two treatment groups, but were significantly less when termination was carried out at 11 to 12 weeks' gestation. Estimated blood loss was significantly lower for patients treated by VA (32.3 ml) than for patients treated by D & C (39.0 ml) at 6 to 10 week's gestation, but the difference in blood loss was not statistically significant at 11 to 12 weeks' gestation. Time from insertion to removal of the speculum was significantly less with VA than D & C at 6 to 10 weeks' gestation but not at 11 to 12 weeks' gestation. Since vacuum aspiration is at least as safe as D & C, and appears to be more convenient and costeffective, it should on the basis of this experience be accepted over D & C as the standard method for treatment of first trimester abortion.
[Abortion by means of suction curettage compared to the conventional metal curettage].
Options:
A: Vacuum aspiration showed statistically significant differences in excessive blood loss, blood transfusion, febrile morbidity, and post-operative abdominal pain compared to D&C.
B: Flexible vacuum aspiration cannula showed statistically significant differences in cervical injuries, febrile morbidity, and blood transfusion compared to rigid cannula.
C: Vacuum aspiration had a statistically significantly shorter duration of operation compared to D&C, but there were no significant differences in other outcomes.
D: The studies indicated a clear preference for vacuum aspiration over D&C due to better safety and efficacy outcomes.
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C
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy and safety of nicergoline in the treatment of dementia and other age-associated cognitive impairments? Please answer this question based on the information provided below:
Nicergoline in mild to moderate dementia. A multicenter, double-blind, placebo-controlled study.
In view of some controversies still existing about the real efficacy of ergot derivatives in the management of dementia, a double-blind, randomized, parallel group trial extending up to 6 months was carried out to compare the effects of nicergoline, 60 mg daily, and placebo in 315 patients suffering from mild to moderate dementia. Clinical evaluation was performed by the SCAG scale. The trial, which included a 1-month placebo run-in period, showed that both placebo and nicergoline were associated with some degree of improvement. The effect of nicergoline, however, was significantly greater and more sustained, steadily increasing with time. In particular, the difference between nicergoline and placebo in mean total SCAG score was 5.5 at 3 months (95% confidence interval: 3.6-7.4) and increased to 9.8 at 6 months (95% confidence interval: 7.8-11.8). A comparison of nicergoline versus placebo in the frequencies of changes in each item of the SCAG showed also a significant difference at 6 months, the percent of patients displaying an improvement by at least 2 points ranging from 13.5 (bothersome) to 30.2 (disorientation) in nicergoline group, against 4.1 (self-care) to 14.3 (fatigue) in placebo group. The safety of nicergoline, as judged by hemodynamic changes and drug-related adverse reactions, was quite satisfactory.
A 24-month, double-blind, placebo-controlled multicentre pilot study of the efficacy and safety of nicergoline 60 mg per day in elderly hypertensive patients with leukoaraiosis.
In this pilot study, 72 non-demented and non-depressive elderly hypertensive patients with evidence of leukoaraiosis on cerebral computed tomography scan (Rezek score: > 16) were randomly assigned to receive either nicergoline 30 mg b.i.d. (n = 36) or a placebo (n = 36) for 24 months. All patients received antihypertensives and their hypertension was controlled under treatment. They were evaluated by nine neuropsychological tests exploring memory, concentration, verbal and motor performances, administered at baseline and at every six-month interval during the study period. At baseline, the two groups were comparable for all demographic and clinical characteristics, including cognitive functions, except for the delayed recall of the Auditory Verbal Learning Test (AVLT), which was better in the placebo group (P = 0.04). Changes in scores over time were compared between the two groups. At the last visit, patients on nicergoline (n = 31) were found to have deteriorated less or to have improved more on test scores than the patients on placebo (n = 30). Significant differences were observed for memory function (AVLT short term recall, P = 0.026; AVLT delayed recall, P = 0.013; and, Benton Visual Retention Test, P = 0.002) and attention and concentration (Letter Cancellation Test, P = 0.043; and, WAIS-R Digit Symbol subtest, P = 0.006). The Rezek score remained unchanged in the two groups. Tolerance of nicergoline was similar to that of placebo. In conclusion, this study shows that nicergoline 30 mg b.i. d. administered over a 24-month period attenuates the deterioration in cognitive functions in elderly hypertensive patients with leukoaraiosis. Whether these effects were specific for this type of white matter changes could not be determined in the context of this pilot study.
[Effect of nicergoline on the intellectual performance (author's transl)].
A multicenter randomized double-blind study on the efficacy and safety of nicergoline in patients with multi-infarct dementia.
A 6-month double-blind, randomized, placebo-controlled clinical trial preceded by a 3-week single-blind, washout/run-in placebo phase was performed in male and female patients, 55-85 years of age with a clinical diagnosis of mild to moderate multi-infarct dementia according to DSM-III to evaluate the therapeutic efficacy and safety of nicergoline 30 mg b.i.d. Primary endpoints for efficacy were the changes in the Sandoz Clinical Assessment Geriatric Scale (SCAG) and Mini-Mental State Examination (MMSE) scores at the end of the treatment with respect to baseline. Secondary endpoints were Clinical Global Impression, 3 subtests of the Weschsler Adult Intelligence Scale and Blessed A scale for activities of daily living, and all endpoints in 2-month intervals. A total of 252 patients were screened, 136 patients entered the double-blind phase and were evaluated as intent-to-treat (ITT) patients. Fifteen patients were excluded from the efficacy analyses of valid cases (VC) due to protocol violations or because they dropped out of the study prematurely. Confirmatory efficacy analysis after 6 months of treatment revealed superiority of nicergoline treatment with p < 0.01 for both SCAG and MMSE scores (ITT and VC). Subsequent descriptive efficacy analysis resulted in significant differences in favor of nicergoline, in the majority of cases as early as 2 months after start of treatment. Nicergoline was well tolerated and a similar number of adverse events were observed in both the placebo and the nicergoline group.
Long-Term Nicergoline Treatment of Mild to Moderate Senile Dementia : Results of a Multicentre, Double-Blind, Placebo-Controlled Study.
The efficacy and tolerability of nicergoline were evaluated in a long-term, double-blind, placebo-controlled trial. 108 patients, fulfilling DSM III-R criteria for mild to moderate senile dementia of degenerative, vascular or mixed origin, were selected from a pool of outpatients attending five Italian neurological centres and randomised to receive nicergoline 30mg twice daily (54 patients) or placebo (54 patients) for 12 months. Treatment efficacy on cognitive and behavioural performances was assessed by the Sandoz Clinical Assessment Geriatric scale (SCAG) and Mini Mental State Examination (MMSE), at baseline and after 3, 6, 9 and 12 months of treatment. Investigators and patients or caregivers provided a global evaluation of treatment outcome at study end. The efficacy analysis was carried out on 101 patients (51 nicergoline; 50 placebo) who completed the 12-month study. At study end, the SCAG total score and its clusters showed statistically significant improvement in the nicergoline-treated group compared with placebo-treated patients. The MMSE total score was maintained with nicergoline treatment. Global treatment evaluations, both by physician and patients, were consistently in favour of nicergoline (p < 0.001). Nicergoline was well tolerated; incidence of adverse events (7% in the nicergoline and 2% in the placebo group), withdrawals and haemodynamic changes were comparable with placebo.
Nicergoline in senile dementia of Alzheimer type and multi-infarct dementia: a double-blind, placebo-controlled, clinical and EEG/ERP mapping study.
In a double-blind, placebo-controlled study on the therapeutic efficacy and central effects of nicergoline, an ergot alkaloid with metabolic, antithrombotic and vasoactive action, 112 patients with mild to moderate dementia, diagnosed according to DSM III-R criteria (MMS 13-25), living in pensioners' homes, were included. Fifty-six were subdiagnosed as senile dementia of the Alzheimer type (SDAT), 56 as multiinfarct dementia (MID), based on computed tomography and Hachinski scores (< or = 49 SDAT, > or = 7 MID). They received, after 2 weeks' run-in period (placebo), randomized for 8 weeks either 2 x 30 mg nicergoline (NIC) or 2 x 1 placebo (PLAC) orally. The four subgroups (SDAT/NIC. SDAT/PLAC, MID/NIC, MID/PLAC; 4 x 28 patients) were comparable in regard to age and sex. Only four, four, four and two patients of the respective groups did not finish the study for minor reasons. Confirmatory statistical analysis demonstrated in the target variable-the Clinical Global Impression (CGI)-a significant superiority of Global Impression (CGI)-a significant superiority of NIC over PLAC in both the SDAT and MID groups. Global improvement (CGI item 2) was seen in both nicergoline subgroups (3 and 3), while no changes occurred under placebo (4 and 4, respectively). The responder versus non-responder ratio was in the SDAT/NIC group 16/8, versus 8/16 in the SDAT/PLAC group (chi 2 = 4.1, P = 0.04); in the MID/NIC group 17/7, versus 7/19 in the MID/PLAC group (chi 2 = 7.96, P < 0.005). Furthermore, there was a significant improvement of the Mini-Mental State and the SCAG score in both the MID and SDAT group after 8 weeks of nicergoline, which was significantly superior to the minimal improvement or no change in placebo-treated SDAT and MID patients. EEG mapping demonstrated in NIC-treated SDAT and MID patients a significant decrease in delta and theta, increase in alpha 2 and beta activity and an acceleration of the centroid of the total power spectrum as compared with pretreatment, while opposite changes occurred in PLAC-treated SDAT and MID patients. The differences between PLAC and NIC reached the level of statistical significance. Event-related potential (ERP) recordings demonstrated a significantly shortened P300 latency under NIC treatment in both SDAT and MID patients, while there was a trend towards lengthening under PLAC. Thus, nicergoline improved vigilance and information processing at the neurophysiological level, which leads at the behavioural level to clinical improvement both in degenerative and vascular dementia.
Options:
A: Nicergoline showed no significant benefits in cognitive and behavioral outcomes, and had a high risk of adverse effects.
B: Nicergoline demonstrated positive effects on cognition and behavior, with a mild increase in the risk of adverse effects.
C: Nicergoline was effective in improving cognitive outcomes but had no impact on behavioral symptoms, and was associated with a high risk of adverse effects.
D: Nicergoline had significant benefits for Alzheimer's disease patients specifically, with no increase in adverse effects.
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B
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy and safety of medicinal herbs for treating hepatitis C virus (HCV) infection? Please answer this question based on the information provided below:
Preliminary report of a randomized, double-blind placebo-controlled trial of a Chinese herbal medicine preparation CH-100 in the treatment of chronic hepatitis C.
The treatment of chronic hepatitis C is relatively unsatisfactory and many patients have turned to unproven alternative medicines to modify the course of their illness. We report a study of a Chinese herbal medicine preparation CH-100 in the management of chronic hepatitis C. Patients with documented chronic hepatitis C were randomly allocated to receive active herbal or placebo tablets (five tablets thrice daily). Patients were followed monthly and evaluated by a Western and a traditional Chinese medical practitioner. Therapy was monitored by measurement of liver function tests, creatinine and full blood count on a monthly basis. Twenty patients in each group were well matched for age, sex, duration of illness, previous interferon therapy and alcohol intake. Active Chinese herbal medication was associated with a significant reduction in alanine aminotransferase (ALT) levels over the 6 month study period (P < 0.03). No patient cleared the virus but four normalized their ALT on treatment. Appropriately prescribed Chinese herbal medicine may have a role in the management of chronic hepatitis C and further controlled studies are indicated.
Preliminary report of a randomized, double-blind placebo-controlled trial of a Chinese herbal medicine preparation CH-100 in the treatment of chronic hepatitis C.
The treatment of chronic hepatitis C is relatively unsatisfactory and many patients have turned to unproven alternative medicines to modify the course of their illness. We report a study of a Chinese herbal medicine preparation CH-100 in the management of chronic hepatitis C. Patients with documented chronic hepatitis C were randomly allocated to receive active herbal or placebo tablets (five tablets thrice daily). Patients were followed monthly and evaluated by a Western and a traditional Chinese medical practitioner. Therapy was monitored by measurement of liver function tests, creatinine and full blood count on a monthly basis. Twenty patients in each group were well matched for age, sex, duration of illness, previous interferon therapy and alcohol intake. Active Chinese herbal medication was associated with a significant reduction in alanine aminotransferase (ALT) levels over the 6 month study period (P < 0.03). No patient cleared the virus but four normalized their ALT on treatment. Appropriately prescribed Chinese herbal medicine may have a role in the management of chronic hepatitis C and further controlled studies are indicated.
A pilot study on the liver protective effect of silybin-phosphatidylcholine complex (IdB1016) in chronic active hepatitis.
In order to assess the liver protective activity and the antioxidant properties of a new silybin complex (IdB1016), we carried out a short-term pilot study on 20 patients with chronic active hepatitis (CAH), randomly assigned to 240 mg of silybin b.i.d. (10 patients, 4 m/6 f, mean age: 50 years) or placebo (10 patients, 2 m/8 f, mean age: 55 years). Blood samples were collected before and after 7 days of treatment for liver function tests (LFTs), malonaldehyde (MDA) as an index of lipid peroxidation, and copper (Cu) and zinc (Zn), two trace elements involved in protecting cells against free radical-mediated lipid peroxidation. In the treated group, there was a statistically significant reduction of mean (+/- SEM) serum concentrations of aspartate aminotransferase (AST) from 88.0 (+/- 13.3) to 65.9 (+/- 7.5) u/l, (p < 0.01), of alanine aminotransferase (ALT) from 115.9 (+/- 12.9) to 82.5 (+/- 10.6) u/l (p < 0.01), of gamma-glutamyltranspeptidase (gamma-GT) from 51.4 (+/- 9.3) to 41.3 (+/- 4.2) u/l (p < 0.02) and of total bilirubin (TB) from 0.76 (+/- 0.08) to 0.53 (+/- 0.04) mg/dl (p < 0.05). Alkaline phosphatase (AP) fell slightly from 143.4 (+/- 6.4) to 137.5 (+/- 7.8) u/l. There were no significant changes in MDA, Cu or Zn serum concentrations. These results show that IdB1016 may improve LFTs related to hepatocellular necrosis and/or increases membrane permeability in patients affected by CAH.
Oral thymic extract for chronic hepatitis C in patients previously treated with interferon. A randomized, double-blind, placebo-controlled trial.
BACKGROUND: Hepatitis C is an important cause of chronic liver disease. It is claimed that Complete Thymic Formula, an over-the-counter herbal dietary supplement, is beneficial for patients with hepatitis C.
OBJECTIVE: To evaluate the efficacy and safety of Complete Thymic Formula.
DESIGN: Randomized, double-blind, placebo-controlled trial.
SETTING: Tertiary referral center.
PATIENTS: 38 patients with hepatitis C who did not respond to or were intolerant of interferon therapy.
INTERVENTION: Complete Thymic Formula for 3 to 6 months or placebo for 3 months.
MEASUREMENTS: Serial measurements of hepatitis C virus (HCV) RNA titers.
RESULTS: No differences were noted at 3 months between the placebo group (n = 13) and the treatment group (n = 19) in mean HCV RNA titers (4.06 +/- 1.52 x 10(6) copies/mL compared with 3.48 +/- 1.92 x 10(6) copies/mL; P > 0.2). The 19 patients who completed 6 months of treatment with Complete Thymic Formula remained positive for HCV, and their mean HCV RNA titers were similar at 6 months and at baseline (2.78 +/- 1.96 x 10(6) copies/mL compared with 3.12 +/- 1.94 x 10(6) copies/mL; P > 0.2).
CONCLUSIONS: Complete Thymic Formula did not benefit patients who had previously received interferon therapy. Patients should be advised about use of this over-the-counter compound.
Intravenous glycyrrhizin for the treatment of chronic hepatitis C: a double-blind, randomized, placebo-controlled phase I/II trial.
BACKGROUND: In Japan, glycyrrhizin therapy is widely used for chronic hepatitis C and reportedly reduces the progression of liver disease to hepatocellular carcinoma. The aims of this study were to evaluate the effect of glycyrrhizin on serum alanine aminotransferase (ALT), hepatitis C virus (HCV)-RNA and its safety in European patients.
METHODS: Fifty-seven patients with chronic hepatitis C, non-responders or unlikely to respond (genotype 1/cirrhosis) to interferon therapy, were randomized to one of the four dose groups: 240, 160 or 80 mg glycyrrhizin or placebo (0 mg glycyrrhizin). Medication was administered intravenously thrice weekly for 4 weeks; follow up also lasted for 4 weeks.
RESULTS: Within 2 days of start of therapy, serum ALT had dropped 15% below baseline in the three dosage groups (P < 0.02). The mean ALT decrease at the end of active treatment was 26%, significantly higher than the placebo group (6%). A clear dose-response effect was not observed (29, 26, 23% ALT decrease for 240, 160 and 80 mg, respectively). Normalization of ALT at the end of treatment occurred in 10% (four of 41). The effect on ALT disappeared after cessation of therapy. During treatment, viral clearance was not observed: the mean decrease in plasma HCV-RNA after active treatment was 4.1 x 10(6) genome equivalents/mL (95% confidence interval, 0-8.2 x 10(6); P > 0.1). No major side-effects were noted. None of the patients withdrew from the study because of intolerance.
CONCLUSIONS: Glycyrrhizin up to 240 mg, thrice weekly, lowers serum ALT during treatment, but has no effect on HCV-RNA levels. The drug appears to be safe and is well tolerated. In view of the reported long-term effect of glycyrrhizin, further controlled investigation of the Japanese mode of administration (six times weekly) for induction appears of interest.
Options:
A: All medicinal herbs showed significant positive effects on clearance of serum HCV RNA and normalization of liver enzymes.
B: Some medicinal herbs showed significant effects in specific trials, but there is no firm evidence of overall efficacy for HCV infection.
C: Medicinal herbs were found to be more effective than interferon and ribavirin in all trials.
D: Medicinal herbs were found to be completely ineffective and had no impact on HCV infection or liver enzyme levels.
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B
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194
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
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What were the findings regarding the efficacy and acceptability of antidepressants, psychological treatments, and their combination in the treatment of bulimia nervosa? Please answer this question based on the information provided below:
Pharmacologic and cognitive-behavioral treatment for bulimia nervosa: a controlled comparison.
OBJECTIVE: This study examined the relative effectiveness of desipramine, cognitive-behavioral therapy, and their combination in the treatment of bulimia nervosa, together with the effects of withdrawing medication after two different lengths of treatment.
METHOD: Seventy-one patients meeting DSM-III-R criteria for bulimia nervosa, recruited from an eating disorders clinic or by advertisements, were assigned at random to one of five groups: desipramine (withdrawn at 16 or 24 weeks), combined treatment (medication withdrawn at 16 or 24 weeks), and cognitive-behavioral therapy (15 sessions). All treatments were conducted individually in an outpatient clinic. The primary outcome measures were binge eating and purging rates assessed at pretreatment, 16, 24, and 32 weeks. The results were analyzed as three groups (medication, cognitive-behavioral therapy, and combined treatment) at 16 weeks and as five groups at subsequent assessments.
RESULTS: At 16 weeks, both cognitive-behavioral therapy and the combined treatment were superior to medication given for 16 weeks in reducing binge eating and purging. At 32 weeks, however, only the combined 24-week treatment was superior to medication given for 16 weeks. The combined treatment was also more effective in reducing dietary preoccupation and hunger. Continuing cognitive-behavioral therapy appeared to prevent relapse in patients withdrawn from medication at 16 weeks.
CONCLUSIONS: Overall, the results favor the use of a combination of medication and cognitive-behavioral therapy in the treatment of bulimia nervosa, with medication continued for at least 24 weeks.
Fluoxetine versus placebo: a double-blind study with bulimic inpatients undergoing intensive psychotherapy.
In a double-blind trial 40 patients with bulimia nervosa according to DSM III-R criteria were randomly assigned either to a 60 mg fluoxetine group or to a placebo control group. Fluoxetine or placebo was given over a period of 35 days. Parallel to the drug trial, patients participated in an intensive inpatient behavioral psychotherapy program. There were no dropouts at all in the study. Fluoxetine was well tolerated and had only minor adverse effects. In self-ratings and expert ratings concerning attitudes towards eating, eating behavior, and general psychopathology, significant improvements over time were observed in both groups. Using analysis of variance (ANOVA), however, there were no statistically significant "group by time" differences. Results show that the intensive inpatient-care and psychotherapy program was highly effective in changing eating behavior and attitudes as well as general psychopathology. Fluoxetine showed a significant reduction in body weight, especially during the first three weeks of fluoxetine treatment. It was not possible to demonstrate a statistically significant improvement in eating attitudes, eating behavior, and general psychopathology beyond that elicited by intensive inpatient psychotherapy and general inpatient care. These results can possibly be explained by the existence of a "ceiling effect".
A randomized controlled trial of fluoxetine and cognitive behavioral therapy for bulimia nervosa: short-term outcome.
This study compared and combined fluoxetine and individual cognitive behavioral therapy in the treatment of bulimia nervosa. Participants were 76 women who sought treatment at the Eating Disorders Program of the Toronto Hospital and who met DSM-III-R criteria for bulimia nervosa. Subjects were randomly assigned to receive fluoxetine alone, cognitive behavior therapy alone, or the two in combination and were treated over 16 weeks. Short-term outcome revealed that all three treatment conditions were associated with clinical improvement across a wide range of parameters. The combination of pharmacotherapy and psychotherapy was superior to pharmacotherapy alone on specific parameters and there was no statistically significant advantage to the combination over psychotherapy alone. Limitations to the study include the absence of a placebo pill group and a waiting list control group as well as a substantial dropout rate across all three treatment conditions.
Comparison of cognitive-behavior therapy and desipramine in the treatment of bulimia nervosa.
A comparison of cognitive-behavior therapy alone, desipramine alone, and cognitive-behavior therapy combined with desipramine was made in the treatment of bulimia nervosa. The study was terminated early with an N of only 7 subjects per condition because of a high drop-out rate and lack of positive response in the desipramine alone group compared to the other two groups. By this time it was also apparent that at posttreatment and at 6 months follow-up no benefit was being realized from combining cognitive-behavior therapy with desipramine.
A comparison study of antidepressants and structured intensive group psychotherapy in the treatment of bulimia nervosa.
Previous research on the treatment of outpatients with bulimia nervosa has focused on two treatment strategies: (1) drug therapy, primarily using tricyclic antidepressants, and (2) psychotherapy, often employing behavioral and cognitive behavioral techniques. We report here the short-term treatment outcome of a 12-week comparison trial of bulimic outpatients who were randomly assigned to one of four treatment cells: (1) imipramine hydrochloride treatment, (2) placebo treatment, (3) imipramine treatment combined with intensive group psychotherapy, and (4) placebo treatment combined with intensive group psychotherapy. All three active treatment cells resulted in significant reductions in target-eating behaviors and in a significant improvement in mood relative to placebo treatment. However, the results also suggested that the amount of improvement obtained with the intensive group psychotherapy component was superior to that obtained with antidepressant treatment alone. The addition of antidepressant treatment to the intensive group psychotherapy component did not significantly improve outcome over intensive group psychotherapy combined with placebo treatment in terms of eating behavior, but did result in more improvement in the symptoms of depression and anxiety.
Intensive nutritional counselling in bulimia nervosa: a role for supplementation with fluoxetine?
OBJECTIVE: The aims of the paper are to determine whether nutritional counselling is associated with an improvement in bulimic symptomatology, whether this improvement is maintained during post-treatment follow-up, and whether the addition of fluoxetine 3 x 20 mg/day confers additional benefit.
METHOD: Psychological, pharmacological and combined psychopharmacological treatments of bulimia nervosa were reviewed briefly. Sixty-seven patients referred to specialist eating disorder services who fulfilled strict diagnostic criteria were treated with intensive nutritional counselling and randomly assigned to either fluoxetine 3 x 20 mg/day or placebo. After a 1-week 'wash-out', active treatment was given over 8 weeks, followed by post-treatment interviews at 12 and 20 weeks.
RESULTS: Both groups of patients improved significantly during treatment. In some respects, the fluoxetine group did slightly better as demonstrated by the items 'restraint', 'weight concern' and 'shape concern' (p < 0.05 vs p < 0.0001) on the Eating Disorder Examination (EDE). Fluoxetine patients decreased their energy intake and lost a modest amount of weight. They went on to regain weight during the follow-up period, returning to levels higher than they were initially. These patients also appeared more likely to have a recurrence of symptoms, as shown by the fall in percentage of binge-free patients and by changes in the EDE.
CONCLUSION: Nutritional counselling is an effective means of treating bulimia nervosa, with improvement maintained up to 3 months follow-up. The addition of fluoxetine may confer some benefit during active treatment, but its discontinuation may contribute to a higher rate of recurrence of symptoms post treatment. Of course, this study cannot be extrapolated to the efficacy of fluoxetine when used as the only form of treatment in patients for whom intensive nutritional counselling or other structured psychological programs are not available.
Medication and psychotherapy in the treatment of bulimia nervosa.
OBJECTIVE: Two treatments for bulimia nervosa have emerged as having established efficacy: cognitive-behavioral therapy and antidepressant medication. This study sought to address 1) how the efficacy of a psychodynamically oriented supportive psychotherapy compared to that of cognitive-behavioral therapy; 2) whether a two-stage medication intervention, in which a second antidepressant (fluoxetine) was employed if the first (desipramine) was either ineffective or poorly tolerated, added to the benefit of psychological treatment; and 3) if the combination of medication and psychological treatment was superior to a course of medication alone.
METHOD: A total of 120 women with bulimia nervosa participated in a randomized, placebo-controlled trial.
RESULTS: Cognitive-behavioral therapy was superior to supportive psychotherapy in reducing behavioral symptoms of bulimia nervosa (binge eating and vomiting). Patients receiving medication in combination with psychological treatment experienced greater improvement in binge eating and depression than did patients receiving placebo and psychological treatment. In addition, cognitive-behavioral therapy plus medication was superior to medication alone, but supportive psychotherapy plus medication was not.
CONCLUSIONS: At present, cognitive-behavioral therapy is the psychological treatment of choice for bulimia nervosa. A two-stage medication intervention using fluoxetine adds modestly to the benefit of psychological treatment.
Options:
A: Antidepressants alone were more effective than psychological treatments alone, but had higher dropout rates.
B: Psychological treatments alone were more effective than antidepressants alone, and had lower dropout rates.
C: The combination of antidepressants and psychological treatments was more effective than either treatment alone, but had higher dropout rates compared to psychological treatments alone.
D: The combination of antidepressants and psychological treatments was less effective than either treatment alone, and had lower dropout rates compared to psychological treatments alone.
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C
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195
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What were the findings regarding the effectiveness and safety of oestrogens alone or with amniotomy for third trimester cervical ripening and induction of labour compared to other methods? Please answer this question based on the information provided below:
Effect of oestrogens on myometrial contractions.
Outpatient cervical ripening with prostaglandin E2 and estradiol.
OBJECTIVE: To determine whether weekly outpatient administration of prostaglandin gel or estrogen cream initiated labor in women with an unfavorable cervix.
METHODS: All uncomplicated pregnancies at term gestation who were candidates for a vaginal delivery with a Bishop score of < or = 6 were randomly assigned to receive on a weekly basis: prostaglandin E2 gel (n = 41); estrogen cream (n = 44); or inert lubricant jelly (n = 43).
RESULTS: In the three groups no differences were observed among 128 subjects in the weekly Bishop scores, cervical dilatation or gestational age upon admission to the labor and delivery suite, the percentage of patients presenting with spontaneous labor or ruptured membranes, the number of post-date inductions or neonatal outcome.
CONCLUSIONS: Weekly out-patient cervical ripening using either prostaglandin gel or estrogen in women with an unfavorable cervix at 37 weeks' gestation was no more effective than a placebo in Bishop score improvement or in preventing post-date inductions.
Cervical ripening before medical induction of labor: a comparison of prostaglandin E2, estradiol, and oxytocin.
OBJECTIVE: Our purpose was to evaluate the effectiveness of oxytocin, prostaglandin E2 intracervical gel, and estradiol cream for ripening the very unfavorable cervix in patients requiring induction of labor at term.
STUDY DESIGN: This prospective, randomized study was conducted in a population of women with a very unfavorable cervix (Bishop score < 4) requiring induction of labor. The patients received prostaglandin E2 gel (0.5 mg) intracervically (three doses 6 hours apart), 4 mg estradiol cream in the anterior fornix of the vagina (three doses 6 hours apart), or oxytocin at induction per protocol with an infusion pump.
RESULTS: Ninety-nine women were recruited into this trial and evenly distributed among the three groups. The demographics of maternal age, race, parity, gestational age, initial Bishop score, and indication for induction were similar among the groups. The incidence of cesarean deliveries was similar in the three groups with approximately 59% of pregnancies delivered abdominally. For patients undergoing abdominal delivery the maximum cervical dilatation among the oxytocin, estradiol, and prostaglandin E2 groups was similar (3.90 +/- 3.02 cm, 3.63 +/- 2.79 cm, and 4.65 +/- 2.78 cm, respectively; p > 0.05). For all patients birth weight and Apgar scores at 1 and 5 minutes were comparable across all regimens (p > 0.05). In the subset of patients delivered vaginally patients receiving oxytocin for cervical ripening had the greatest improvement in Bishop score over baseline (p = 0.023) with an improvement of 7.08 +/- 2.42.
CONCLUSION: No differences were detected among prostaglandin E2 gel, estrogen, and oxytocin in relation to cervical ripening in patients with an unfavorable cervix at term who require an induction of labor. Patients with a very unfavorable cervix at term who require delivery may benefit from serial ripening and inductions.
A randomized controlled trial of extra-amniotic ethinyloestradiol for cervical ripening in multiparas.
A double-blind randomized controlled trial was carried out to determine if ethinyloestradiol applied extra-amniotically would ripen the unfavourable cervix at term. Twenty five multiparas were given 150 mg ethinyloestradiol gel while 25 multiparas were given gel alone. There was no difference between the ethinyloestradiol and control groups in either mean change of Bishop score or the induction-to-delivery interval.
Action of estradiol-17-beta at term and at onset of labor.
A double blind trial of extra-amniotic oestriol and prostaglandin F2 alpha gels in cervical ripening.
Forty nulliparous patients with Bishop score of 3 or less were given 15 mg oestriol gel, 10 mg PGF2 alpha gel or gel alone via the extra-amniotic route. Both the oestriol and prostaglandin treated patients had a significant increase in Bishop score and a significant reduction in induction-delivery interval compared to controls. Oestriol gel had significantly less stimulatory effect on uterine activity than prostaglandin gel, indicating a possible local action.
Comparative study of oestradiol and prostaglandin E2 vaginal gel for ripening the unfavourable cervix before induction of labour.
Oestradiol 150 mg and prostaglandin E2 (PGE2) 4 mg suspended in viscous gel and applied intravaginally were compared with regard to ripening the unfavourable cervix of patients randomly allocated to two study groups. In primigravidae no significant difference was observed in the efficacy of the two substances. Some multiparous patients, however, had considerably more uterine sensitivity to PGE2 quickly developed decelerative cardiotocographic tracings after insertion of the gel. In the group given oestradiol there was a significant absence of uterine activity after gel application. The findings suggest that oestradiol applied vaginally is a safe, comfortable, cheap, and equally effective alternative to PGE2 for ripening the cervix, without the disadvantages of uterine stimulation frequently encountered with PGE2.
Options:
A: Oestrogens were found to be significantly more effective than placebo in inducing labour.
B: Oestrogens showed a significant reduction in the rate of caesarean sections compared to placebo.
C: There were no significant differences in the rate of caesarean sections, uterine hyperstimulation, or instrumental vaginal delivery between oestrogens and placebo.
D: Oestrogens were found to be less effective than other methods such as vaginal PGE2, intracervical PGE2, oxytocin alone, or extra amniotic PGF2a.
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C
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196
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What was the conclusion regarding the efficacy of interferon alfa in patients with transfusion-acquired acute hepatitis C? Please answer this question based on the information provided below:
Natural beta interferon in acute type-C hepatitis patients: a randomized controlled trial.
AIM OF THE STUDY: A multicentre randomized controlled trial to assess whether a short course of beta-interferon could reduce the rate of chronic evolution of acute hepatitis C, in line with recent observations, was started in Northern Italy in 1991.
METHODS: Forty acute hepatitis C patients were randomized to receive natural beta interferon 3,000,000 international units intramuscularly three times a week for 4 weeks or symptomatic drugs, and were followed up for a median period of 22.5 months.
RESULTS: The chronicity rate was 75% (15/20 patients) in the interferon-treated group, and 80% (16/20) in the untreated group. No difference in the duration of the acute phase of hepatitis was observed. Hepatitis C virus ribonucleic acid was determined in 21 cases and was positive in 19 cases at baseline and in 15/17 chronic and 1/4 non chronic cases at the end of follow-up. Side effects of therapy (flu-like syndrome in 40% of cases) were mild and short-lasting. No aminotransferase flare-ups were observed during treatment.
CONCLUSIONS: Beta interferon at the suggested regimen is well tolerated but does not seem to significantly influence the natural course of acute hepatitis C.
A randomized controlled trial of recombinant interferon alpha-2b in the treatment of Chinese patients with acute post-transfusion hepatitis C.
To evaluate the efficacy of recombinant interferon alpha-2b in the treatment of patients with acute post-transfusion hepatitis C, a randomized controlled trial was conducted in 33 acute post-transfusion hepatitis C patients; 16 patients received 3 million units of subcutaneously injected recombinant interferon alpha-2b 3 times a week for 3 months and 17 patients without specific treatment were used as controls. At the end of the interferon treatment, 13 (81%) patients in the interferon-treated group normalized serum alanine aminotransferase compared with only six (35%) patients in the control group (p < 0.01). One year after completion of the interferon treatment, nine (56%) patients in the interferon-treated group and six (38%) patients in the control group normalized serum alanine aminotransferase (p = 0.35). Serum HCV-RNA measured by reverse transcription-polymerase chain reaction was positive in all patients at the time of enrollment and then became undetectable in 13 (81%) patients in the interferon-treated group and two (12%) patients in the control group at the end of interferon treatment (p < 0.001). One year after completion of the interferon treatment, seven (44%) patients in the interferon-treated group and two (13%) patients in the control group had persistent undetectable serum HCV-RNA (p = 0.08). Using a logistic regression model, the lower pretreatment level of serum HCV-RNA measured by quantitative branched DNA signal amplification assay was the only predictor for a favorable response to the interferon treatment in acute hepatitis C patients.(ABSTRACT TRUNCATED AT 250 WORDS)
A multicenter randomized controlled trial of recombinant interferon-alpha 2b in patients with acute transfusion-associated hepatitis C.
To assess whether interferon-alpha might prevent non-A, non-B hepatitis from becoming chronic, 45 consecutive patients with transfusion-associated hepatitis were enrolled in a randomized clinical trial. Thirty-eight patients had hepatitis C virus infection, and 7 had non-A, non-B, non-C hepatitis. Twenty-six patients (22 with HCV) were given 3 MU of recombinant interferon-alpha 2b three times a week for 12 wk, whereas 19 (16 with HCV) were not. Biochemical and virological parameters were monitored at regular intervals during an 18-mo follow-up. At the end of the 3-mo therapy, 16 (73%) patients with hepatitis C had normal serum ALT activity, compared with 7 (44%) who were not treated (NS). Fifty-three percent of the treated patients and none of the untreated patients had normal ALT levels and no HCV RNA (p = 0.0087). At the end of the 18-mo follow-up, 13 (59%) treated patients had normal ALT levels, compared with 6 (37%) untreated controls (NS). Thirty-nine percent had normal ALT and no HCV RNA, compared with none of the controls (p = 0.035). Four patients (22%) had had sustained complete responses to interferon, defined as normal ALT levels and no HCV RNA at the end of the 3-mo treatment period and the 18-mo follow-up period. All seven patients with non-A, non-B, non-C hepatitis, treated and untreated, recovered uneventfully from hepatitis.(ABSTRACT TRUNCATED AT 250 WORDS)
[A report on therapy of interferon-A2b in patients with acute hepatitis C].
Sixteen patients with acute hepatitis C having a duration of illness more than three months without recovery were randomly assigned to treatment with interferon (IFN). 8 patients received 3 million units a day during the first week and 3 million units every other day for the following 11 weeks. Another 8 patients were given 3 million units every other day for 12 weeks. An additional 16 patients were chosen as controls. The effect of IFN therapy was 93.8% in the treated group and only 12.5% in the control group (P < 0.005). Among 11 patients who completed the course of therapy, only one had a recurrence in a follow-up of 18-86 weeks, while 13 of the 14 patients in the control group showed persistent liver damage. It is concluded that therapy with IFN can reduce the risk of chronic infection in patients with acute HCV infection.
Resolution of acute hepatitis C after therapy with natural beta interferon.
To test whether interferon can prevent acute non-A, non-B hepatitis from becoming chronic, a prospective controlled trial was conducted in 25 patients; 11 were treated for an average of 30 days with a mean of 52 megaunits of interferon and 14 acted as controls. 4 patients in the treatment group who continued to have raised serum aminotransferase concentrations after a year's follow-up were given a second course of interferon. Follow-up at 3 years has revealed that all but 1 of those treated showed normal serum aminotransferase, whereas only 3 controls showed such change (p less than 0.02). Serum hepatitis C virus RNA became undetectable in 10 of 11 treated and in only 1 of 12 control patients, which suggests that interferon prevents the progression of acute non-A, non-B hepatitis to chronicity by eradicating HCV.
Interferon-alpha in acute posttransfusion hepatitis C: a randomized, controlled trial.
To assess the efficacy of interferon-alpha in acute hepatitis C, 28 patients with acute posttransfusion hepatitis were randomized to receive 3 million units of recombinant interferon-alpha three times weekly for 12 wk or no treatment. Biochemical, histological and serological parameters were monitored during 1 yr of follow-up. Serum ALT levels were normal at the end of therapy in 73% of treated patients and only in 38% of control patients (p = 0.06); these differences disappeared at 6 and 12 mo of follow-up. Anti-hepatitis C virus seroconversion occurred later and at a lower rate in the group of patients who received interferon-alpha. Treated patients had a trend toward less severe hepatic lesions with lower histological activity as compared with the control group, but no statistical differences were observed. No severe side effects of interferon-alpha were detected during the study. In summary, a 3-mo course of interferon-alpha in acute hepatitis C is safe and might have some effect in diminishing disease activity only during the treatment period; however, and probably because of a small sample size, no benefit of interferon-alpha in the long-term outcome of this disease was demonstrated.
Options:
A: Interferon alfa was found to be ineffective in improving biochemical outcomes and achieving sustained virologic clearance.
B: Interferon alfa was effective in improving biochemical outcomes and achieving sustained virologic clearance.
C: Interferon alfa was effective in improving biochemical outcomes but not in achieving sustained virologic clearance.
D: Interferon alfa was effective in achieving sustained virologic clearance but not in improving biochemical outcomes.
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B
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197
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evidence_summarization
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You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What were the findings regarding the effectiveness and safety of Pygeum africanum in the treatment of benign prostatic hyperplasia (BPH) compared to placebo? Please answer this question based on the information provided below:
[Efficacy of Pygeum africanum extract in the medical therapy of urination disorders due to benign prostatic hyperplasia: evaluation of objective and subjective parameters. A placebo-controlled double-blind multicenter study].
The efficacy of an extract of Pygeum africanum in the treatment of micturitional disorders due to benign prostatic hyperplasia was tested in a multicentre double-blind trial versus placebo. Capsules containing 50 mg of Pygeum africanum extract or placebo were administered at a dosage of 1 capsule in the morning and 1 capsule in the evening over a period of 60 days. 263 patients were included in this study, which was carried out in 8 centres in Germany, France, and Austria. Evaluation was mainly based on quantitative parameters such as residual urine, uroflowmetry and the precise monitoring of diurnal and nocturnal pollakiuria. Treatment with the Pygeum africanum extract led to a marked clinical improvement: a comparison of the quantitative parameters showed a significant difference between the Pygeum africanum group and the placebo group with respect to therapeutic response. The characteristic subjective symptoms of micturitional disorders, which were evaluated by the patients in a qualitative manner, were also significantly improved by administration of Pygeum africanum extract. Overall assessment at the end of therapy, showed that micturition improved in 66% of the patients treated with Pygeum africanum extract, as compared with an improvement of 31% in the placebo group. The difference was significant at the statistical level of p less than 0.001. During therapy with Pygeum africanum extract, gastrointestinal side effects occurred in 5 patients. Treatment was discontinued in three of those cases.
[Standardized extract of Pygeum africanum in the treatment of benign prostatic hypertrophy. Controlled clinical study versus placebo].
[Tadenan in the treatment of prostatic adenoma. Anatomo-clinical study].
Comparison of once and twice daily dosage forms of Pygeum africanum extract in patients with benign prostatic hyperplasia: a randomized, double-blind study, with long-term open label extension.
OBJECTIVES: To compare the efficacy and safety of Pygeum africanum extract, 50 mg twice daily and 100 mg once daily.
METHODS: Patients with symptomatic benign prostatic hyperplasia (BPH) entered a 2-month randomized, parallel-group, double-blind, comparative phase (group A, 50 mg twice daily; group B, 100 mg once daily), followed by a 10-month, open phase (100 mg once daily). Main efficacy assessment parameters included International Prostate Symptom Score (IPSS), quality of life (QOL), and maximum urinary flow rate (Qmax).
RESULTS: Two hundred nine patients completed the comparative phase in compliance with the protocol; 174 were included in the open phase. Both treatments had similar efficacy. IPSS (baseline 17 in both groups) improved by 38% in group A and 35% in group B. QOL improved by 28% in both groups. Qmax increased by 1.63 mL/s (16%) in group A and 2.02 mL/s (19%) in group B. After 12 months, the IPSS fell from 16 (baseline) to 9 (-46%). Half of the patients had an IPSS below 8. Mean Qmax increased by 1.65 mUs (15%). The safety profile was similar between groups and study phases.
CONCLUSIONS: P. africanum extract at 50 mg twice daily and 100 mg once daily proved equally effective and safe at 2 months. Further improvements in efficacy with a satisfactory safety profile were documented after 12 months.
A clinical and urodynamic study of tadenan in the treatment of benign prostatic hypertrophy.
20 patients with benign prostatic hypertrophy were admitted to a double-blind noncrossover study for evaluation of the effect of Tadenan. Using either standard clinical criteria or urodynamic data obtained by the urinary drop spectrometer, no significant effect was found for the dosage and period of administration used.
[Controlled study of the effects of Pygeum africanum extract on the functional symptoms of prostatic adenoma].
Two random groups of sixty patients each were given an extract of pygeum africanum in one group, and a placebo in the other. The results highlight the placebo effect (50 per cent of cases), and that the extract provided an overall improvement in the functional symptoms. The differences between the two treatments were statistically significant for nocturnal frequency, difficulty in starting micturition, and incomplete emptying of the bladder.
Usefulness of Cernilton in the treatment of benign prostatic hyperplasia.
A total of 89 patients with benign prostatic hyperplasia (BPH) were treated pharmacologically for 4 months: 51 received Cernilton and 38 Tadenan (controls). Significant subjective improvement was found in 78% of the patients in the Cernilton group compared to only 55% of the Tadenan-treated patients. The obstructive and irritative symptoms responded best to the therapy. In the Cernilton-treated patients a significant improvement in the uroflow rate, decrease in residual urine and in prostate volume were found. This study shows that Cernilton is an effective therapy for patients with BPH.
Combined extracts of Urtica dioica and Pygeum africanum in the treatment of benign prostatic hyperplasia: double-blind comparison of two doses.
The 134 patients (aged 53 to 84 years) with symptoms of benign prostatic hyperplasia were drawn from two medical centers in Warsaw. The patients were randomly assigned to receive two capsules of the standard dose of an urtica/pygeum preparation (300 mg of Urtica dioica root extract combined with 25 mg of Pygeum africanum bark extract) or two capsules containing half the standard dose twice daily for 8 weeks. After 28 days' treatment, urine flow, residual urine, and nycturia were significantly reduced in both treatment groups. After 56 days' treatment, further significant decreases were found in residual urine (half-dose group) and in nycturia (both groups). There were no between-group differences in these measures of efficacy. Five patients reported adverse effects of treatment; treatment was not discontinued in any patient because of side effects. It is concluded that half doses of the urtica/pygeum extract are as safe and effective as the recommended full doses.
[Medical treatment of fibroadenomatous hypertrophy of the prostate with a new plant substance].
Options:
A: Pygeum africanum showed no significant improvement in urologic symptoms or flow measures compared to placebo, and had more adverse effects.
B: Pygeum africanum provided a moderately large improvement in urologic symptoms and flow measures compared to placebo, with mild and comparable adverse effects.
C: Pygeum africanum was less effective than placebo in improving urologic symptoms and flow measures, but had fewer adverse effects.
D: Pygeum africanum showed significant improvement in urologic symptoms and flow measures compared to placebo, but had more adverse effects.
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B
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198
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evidence_summarization
|
You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What were the effects of benzodiazepines compared to placebo in the treatment of neuroleptic-induced acute akathisia over a short follow-up period? Please answer this question based on the information provided below:
Successful clonazepam treatment of neuroleptic-induced akathisia in older adolescents and young adults: a double-blind, placebo-controlled study.
In a double-blind, placebo-controlled trial of clonazepam in the treatment of neuroleptic-induced akathisia in older adolescents, clonazepam was significantly more effective at reducing akathisia scores at the end of the first treatment week than placebo (p less than 0.0001). Clonazepam may be a safe and effective treatment for neuroleptic-induced akathisia in this age group.
A double-blind comparison of clonazepam and placebo in the treatment of neuroleptic-induced akathisia.
The present study was designed to investigate the efficacy of clonazepam in neuroleptic-induced akathisia. Twelve patients were treated during 2 weeks with clonazepam or placebo in a double-blind randomized design. Akathisia was scored by an independent rater before and after treatment, as well as 1 week after medication withdrawal. Clonazepam (0.5-2.5 mg/day) induced a significantly higher reduction in the akathisia scores than placebo (p < 0.05). One week after stopping the drug, there was a partial but significant relapse in the treated group as compared with controls, in whom the symptoms remained stable. In addition, the clinical improvement was significantly correlated with the daily dose of clonazepam (rs = 0.827; p < 0.002). These results support the potential usefulness of clonazepam in the treatment of neuroleptic-induced akathisia and suggest an optimal daily dose in the range of 10-40 micrograms/kg.
Options:
A: Benzodiazepines significantly reduced symptoms of acute akathisia with no significant difference in adverse events or need for anticholinergic medication.
B: Benzodiazepines had no effect on symptoms of acute akathisia and increased the incidence of adverse events.
C: Benzodiazepines significantly increased symptoms of acute akathisia and the need for anticholinergic medication.
D: Benzodiazepines had no effect on symptoms of acute akathisia but significantly reduced the need for anticholinergic medication.
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A
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199
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evidence_summarization
|
You are a clinical research expert specializing in evidence synthesis and systematic reviews. Based on the provided clinical evidence from multiple studies, please analyze the findings and select the most accurate summary of the evidence.
|
What were the findings regarding the effectiveness of high and low frequency transcutaneous electrical nerve stimulation (TENS) and acupuncture for the treatment of primary dysmenorrhoea? Please answer this question based on the information provided below:
Transcutaneous electrical nerve stimulation (TENS) for the treatment of primary dysmenorrhea: a randomized crossover comparison with placebo TENS and ibuprofen.
In a randomized four-way crossover study, 32 women with primary dysmenorrhea were treated with transcutaneous electrical nerve stimulation (TENS) for two cycles, placebo (sham) TENS for one cycle, or ibuprofen 400 mg four times a day for one cycle. The TENS setting used was 100 pulses per second with 100-microsecond pulse widths. The subjects were allowed to adjust the amplitude to a comfortable level. The pain rescue medication was ibuprofen 400 mg as needed, up to 1600 mg/day. Significantly more subjects who had TENS treatment did not require rescue medication or required less backup ibuprofen at 0-4, 4-8, and 8-12 hours after the onset of dysmenorrhea and starting treatment, as well as during the first 24 hours and for the duration of the menstrual flow, when compared with placebo TENS or ibuprofen-treated cycles (Tukey multiple comparison, P less than .01). Transcutaneous electrical nerve stimulation significantly delayed the need for ibuprofen by an average of 5.9 hours, compared with 0.7 hours when using ibuprofen alone (P less than .05, paired t test). Transcutaneous electrical nerve stimulation alone provided good to excellent subjective pain relief in 42.4% of subjects, compared with 3.2% with placebo TENS, and significantly reduced diarrhea, menstrual flow, clot formation, and fatigue compared with placebo TENS. Transcutaneous electrical nerve stimulation plus less ibuprofen provided pain relief equivalent to that obtained with ibuprofen alone (71 and 75% of the subjects, respectively). We conclude that TENS is a safe, effective, non-medication method for managing primary dysmenorrhea and that TENS plus ibuprofen was the best overall treatment, as indicated by pain relief.
Transcutaneous electrical nerve stimulation in the relief of primary dysmenorrhea.
The purpose of this study was to replicate a previous study to determine the effectiveness of acupuncture-like transcutaneous electrical nerve stimulation in treating primary dysmenorrhea. Twenty-one women with dysmenorrhea received a placebo pill or 30 minutes of acupuncture-like TENS. All subjects completed two pain questionnaires before treatment; immediately posttreatment; 30, 60, 120, and 180 minutes posttreatment; and the next morning upon awakening. Each woman also participated in a separate study measuring electrical resistance at four auricular acupuncture points before and immediately after treatment. The data were analyzed with a two-factor repeated-measures analysis of variance, which revealed statistical significance over time but not for group or interaction between group and time. Results revealed an average pain relief of at least 50% immediately posttreatment, indicating that acupuncture-like TENS may be useful for dysmenorrheic pain. This study also suggests that auriculotherapy via acupressure may relieve the pain of primary dysmenorrhea.
Relief of primary dysmenorrhea by transcutaneous electrical nerve stimulation.
In this study we describe the use of high-frequency transcutaneous electrical nerve stimulation (TENS) (100 Hz) and low-frequency TENS (lf-TENS) (2 Hz trains) as compared with placebo-TENS (p-TENS) in a group of 21 patients suffering from primary dysmenorrhea. Naloxone, a relatively pure opiate antagonist, was an additional test administered to 6 volunteer patients who had experienced an alleviation of pain with TENS. As will be seen, 14 out of 21 patients receiving high-frequency TENS (hf-TENS) experienced a pain reduction exceeding 50% of its original intensity. During lf-TENS or p-TENS, only 7 and 5 patients, respectively, obtained pain relief exceeding 50%. In 4 out of 6 volunteer patients, the relief of pain obtained with lf-TENS was counteracted by naloxone, whereas the relief experienced with hf-TENS in the same patients was, in general, unaffected by naloxone.
[TENS is effective in painful menstruation].
A comparative study of the effect of high-intensity transcutaneous nerve stimulation and oral naproxen on intrauterine pressure and menstrual pain in patients with primary dysmenorrhea.
OBJECTIVE: Our purpose was to compare the effects of high-intensity transcutaneous electrical nerve stimulation and oral naproxen (500 mg) on intrauterine pressure and menstrual pain.
STUDY DESIGN: An open, randomized crossover study was performed on 12 women with primary dysmenorrhea. Intrauterine pressure was recorded with a microtransducer catheter, and the pain score was assessed by a visual analog scale.
RESULTS: Before treatment all patients displayed signs of uterine hyperactivity as judged by a high resting pressure (7.5 +/- 0.4 kPa), high active pressure (24.0 +/- 0.8 kPa), and a high frequency of pressure cycles (13.3 +/- 0.5 contractions per 0.5 hour). Oral administration of naproxen suppressed (p < 0.01) all uterine activity parameters. Treatment with transcutaneous electrical nerve stimulation induced a prompt onset of pain relief in a strictly segmental manner, but there were no significant changes in uterine activity. The pain score was significantly reduced (p < 0.001) from 30 to 60 minutes after treatment with transcutaneous electrical nerve stimulation and from 19 to 120 minutes after naproxen administration.
CONCLUSIONS: Treatment with transcutaneous electrical nerve stimulation induced a prompt onset of pain relief without any significant changes in uterine activity. Possible mechanisms for the pain relief, decreased uterine ischemia or decreased activity in the pain transmission system at spinal or supraspinal levels, are discussed.
Options:
A: High frequency TENS was found to be more effective for pain relief than placebo TENS, while low frequency TENS was no more effective than placebo TENS. Acupuncture showed significant pain relief in one small trial.
B: Both high and low frequency TENS were found to be equally effective for pain relief compared to placebo TENS. Acupuncture was found to be ineffective in reducing pain.
C: High frequency TENS was found to be less effective than placebo TENS, while low frequency TENS was more effective than placebo TENS. Acupuncture showed no significant pain relief.
D: Neither high frequency TENS nor low frequency TENS were found to be effective for pain relief compared to placebo TENS. Acupuncture showed significant pain relief in multiple large trials.
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A
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