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PubMed1996

Meta-analysis of clinical trials: a consumer's guide.

Meta-analysis is a popular statistical tool allowing the synthesis of related research studies in a quantitative manner. Components of a good meta-analysis are first discussed, with a view toward critical reading of reports of meta-analyses. Examples include lipid-lowering drugs and coronary artery bypass graft surgery. A role for meta-analysis in the design and monitoring of clinical trials was examined at a workshop held at the National Institutes of Health and aspects of these uses of meta-analyses are considered. Basic analytical and graphical methods of meta-analysis are briefly reviewed. The goal is to encourage more thoughtful evaluation of the many meta-analyses that are published or are presented.

Clinical Trials as Topic↗
PubMed1995

Clinical trials of extended spectrum penicillin/beta-lactamase inhibitors in the treatment of intra-abdominal infections. European and North American experience.

The clinical results with the beta-lactam/beta-lactamase inhibitor class of antimicrobials in the treatment of intra-abdominal infections are reviewed. The three agents now in clinical use--ampicillin/sulbactam, ticarcillin/clavulanate, and piperacillin/tazobactam--are effective against a broad variety of gram-positive and gram-negative organisms. The beta-lactamase inhibitor is an irreversible inactivator of beta-lactamase enzymes, which are produced by many gram-negative and gram-positive organisms. Randomized, prospective, clinical trials of each agent indicate clinical cure rates > 85% that are not significantly different from those obtained with second-generation cephalosporin or aminoglycoside plus antianaerobic comparators, with the exception of one study. Piperacillin/tazobactam has also been compared with imipenem, with equivalent or superior outcomes, depending on the dose of the imipenem comparator. Side effects in the non-penicillin-allergic patient are few. The incidence of abnormal renal function tests are generally lower than that obtained with aminoglycoside plus antianaerobic therapy. Introduction of this new beta-lactam antimicrobial group provides another important strategy for the adjunctive management of surgically treated, community-acquired, intra-abdominal infection.

Abdomen↗
PubMed2003

Clinical trials of antiepileptic medications in newly diagnosed patients with epilepsy.

Results from add-on antiepileptic drug (AED) trials performed in patients with chronic refractory epilepsy cannot be directly extrapolated to newly diagnosed patients because of fundamental differences in disease characteristics between the two patient populations. This article reviews the results of randomized, controlled trials of AEDs as monotherapy in newly diagnosed patients, focusing on the newer drugs. None of the newer AEDs has shown superior efficacy when tested against established agents for the treatment of partial seizures and generalized tonic-clonic seizures, the most common seizure types. Some of the newer drugs have shown good tolerability, resulting in better overall effectiveness in the case of lamotrigine over carbamazepine and oxcarbazepine over phenytoin, whereas vigabatrin and remacemide were demonstrated to have inferior efficacy compared with carbamazepine. The difficulty in detecting differences in efficacy among the AEDs might be attributed to the strategies underlying their development and the characteristics of the patient population under investigation. A better understanding of the pathophysiology of seizures and its relationship to epileptogenesis, and the use of more innovative strategies to identify new molecular targets, are needed for the development of a new generation of more effective AEDs that are not merely antiseizure but will hinder or reverse the deleterious processes that underlie the genesis of refractory epilepsy.

Anticonvulsants↗
PubMed1990

Spironolactone and altizide versus converting enzyme inhibitor (enalapril).

The safety and antihypertensive effectiveness of a fixed-dose combination form of spironolactone + altizide (S/A) were compared with those of enalapril, an angiotensin-converting enzyme inhibitor in a randomized, double-blind, parallel-group study of 186 patients with moderate essential hypertension. The 2 treatment groups were comparable in terms of age, gender, duration and severity of hypertension, diastolic blood pressure (BP), serum potassium and creatinine, and 24-hour urinary sodium excretion after a 4-week washout phase. After 8 weeks of treatment, both S/A and enalapril decreased BP significantly and to about the same extent. Enalapril, however, was more effective in decreasing supine diastolic BP in patients younger than age 50, whereas S/A yielded better results in those older than 50. Laboratory values were similar after both drugs were administered, and there were no clinically significant changes. The study demonstrated that S/A safely reduces elevated BP, particularly in older patients.

Adult↗
PubMed1999

Handsearching the Journal of the Royal Army Medical Corps for trials.

As part of the Cochrane Collaboration's international research endeavour, the authors carried out a handsearch of the RAMC Journal from 1948 to 1998, searching for randomised controlled trials (RCTs) and controlled clinical trials (CCTs). Ten trials were identified, of which 6 were RCTs and 4 were CCTs. The first trial was published in 1967. Four of the 10 identified trials were in the field of respiratory medicine, and 2 were in obstetrics and gynaecology. Of the 10 trials, only 3 had been found through a rigorous interrogation of Medline. The 7 newly identified trials were reported to the UK Cochrane Centre, and summary details of these trials were entered into Medline for use by clinicians and investigators in the future.

Adult↗
PubMedDate not supplied

[Controlled clinical study on the effect of quazepam versus triazolam in patients with sleep disorders].

Quazepam (QZP), a new long half-life benzodiazepine, seems to have a more specific hypnotic activity and a "physiological" mechanism of action. This study assessed its clinical efficacy and any withdrawal symptoms occurring after the treatment with QZP and triazolam (TRZ). Sixty-five patients (mean age 41.4 yrs +/- 12.43 SD) with sleep disorders were included in the study. The patients were treated with placebo for 4 days (run-in period) and if no amelioration of insomnia was observed, were then randomly allocated to 15 mg QZP (33 patients) or TRZ (32 patients) for 8 weeks and finally placebo for another week. Sleep quality, efficiency, side-effects and withdrawal effects were assessed by specific rating scales. In comparing data obtained from the two treatments, the following conclusions were drawn: 1) both drugs showed a hypnoinductive efficacy but patients treated with QZP had significantly fewer night awakenings; 2) at the end of treatment only patients treated with TRZ had longer awakenings and rebound symptoms; 3) a lower withdrawal symptom incidence was observed in patients treated with QZP. Therefore, QZP seems to have a good hypnotic effect without inducing withdrawal symptoms. In contrast TRZ turned out to be a merely hypno-inducing drug presenting higher risks of rebound effects after withdrawal.

Adolescent↗
PubMed2001

[The use of state of the art statistical methodology in biomedical research: the example of methodology for interim analyses in clinical trials].

BACKGROUND: Clinical research stresses the need for evidence as a basis for setting research agendas. The extent to which current clinical research involves recent advances in biostatistics is not well known. AIM: This manuscript focuses on the use of interim analyses accumulating data in clinical trials. MATERIAL AND METHODS: A PubMed search was conducted for the period 1990-2000. Keywords used included 'interim analysis', 'alpha-spending function', and 'early termination', after subsetting to 'randomised controlled trials (RCT)' that were 'multicenter' since these particular studies are more likely to have external monitoring boards conducting interim analyses. Studies were grouped by clinical discipline and also by journals of high or low impact index. RESULTS: Thirteen thousand two hundred eighty two articles with both 'RCT' and 'multicenter' were found. Of these, the 'interim analysis' keyword yielded 879 articles, of which only 163 (19%) studies reported their methodology. The percentages varied by clinical discipline and by journal type. A 25% random sample of the articles were further reviewed to investigate the appropriateness of the interim analysis methods used. DISCUSSION: Recent articles in the medical literature attempt to make the interim analysis methods more accessible to clinicians. However, further training of statisticians involved in clinical trials is needed as well.

Clinical Trials as Topic↗
PubMed1998

Cardiac rehabilitation in the elderly.

Rehabilitation for patients with heart disease consists of exercise training, behavioral interventions, counseling, and education with the goal of improving physiologic and psychosocial status. The Cardiac Rehabilitation Clinical Practice Guidelines, recently published in the United States, list the most substantial benefits of cardiac rehabilitation as an improvement in exercise tolerance, symptoms, blood lipid levels, and psychosocial well-being, and a reduction in cigarette smoking, stress, and mortality. With the evidence-base on the elderly in the Guidelines derived from 1 non-randomized controlled trial and 7 observational studies, the efficacy and effectiveness of cardiac rehabilitation is based almost exclusively on data generated on young and middle-aged males. We have located an additional 10 randomized and 2 non-randomized controlled trials published since the Guidelines, but only one provided age-specific data. The elderly are the fastest growing segment of the population, and may be more responsive to the effects of cardiac rehabilitation as they often have greater initial disability and less independence than younger patients. While referral of elderly persons to cardiac rehabilitation services appears safe and warranted in the secondary prevention of heart disease, the lack of rigorous scientific evidence has created an important clinical research and clinical policy vacuum which urgently needs to be filled.

Adult↗