Epilepsy: Basic Designs, Sample Sizes and Experience with Large Multicentre Trials

摘要: There have been hundreds, perhaps thousands, of studies assessing the efficacy antiepileptic drugs (AEDs). Coatsworth [1] produced what could claim to be one first systematic reviews in medicine. Penry wrote foreword that “in keeping with general philosophy thorough documentation for better evaluation, a bibliography publications judged unworthy profile has included, addition profiled articles”. identified articles from 64 different journals published between 1920 and 1970. Of 120 articles, 43% were based on fewer than 50 patients, 27% more 100 nearly half did not report duration study. Three multiple crossover which employed randomisation, two double-blind was single-blind. One hundred six single group no information about patient evaluation 74. He concluded “the average reported clinical trial may characterised as study drug given over variable period 20–29 outpatients differing seizure types. No controls are used, is varied dosage by needs patient. Seizure counts, types side-effects data collected an unreported evaluator using examination laboratory his observational methods. The patients evaluated before irregularly during trial. results treatment percentage improved. In those fair good results, investigator’s opinion valuable present regimen antiepileptics.”