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[Statistical meta-analysis of multicenter clinical studies of ibuprofen with regard to cohort size]
Abstract:
The metaanalysis can be either understood as a confirmatory analysis, i.e., imposing a requirement for reproducibility, or it can be rated as a descriptive analysis. To derive confirmatory statements from the statistical metaanalysis of comparative studies, the same requirements prevail as for every individual clinical study: The statistical metaanalysis must be planned prospectively, operational target criteria must be specified ex ante, requirements for inclusion for the individual studies must be fulfilled (comparability of aim, design, inclusion and exclusion criteria, investigational methods of the individual studies). The statistical metaanalysis of comparative studies especially undergoes criticism then, when after inspection of the individual studies that show non-significant results, the summarization, i.e., the compilation of these individual studies leads to a significant overall result in the metaanalysis, which is possibly medically irrelevant. In addition to the metaanalysis, reviews or synopses of a preparation or a substance are also important, in which all available reports on a topic are taken into consideration for a summarizing medical assessment. The results of 28 comparative studies with ibuprofen in the treatment of osteoarthritis are classified in a synopsis. The results of these studies are classified as "ibuprofen better, ibuprofen worse, or ibuprofen equivalent to the respective reference substance". These results lead to the conclusion that ibuprofen at a daily dose of 1200 mg or more is superior to placebo, equivalent or superior to acetylsalicylic acid and, at an appropriate dosage, is comparable to other NSAIDs with regards to the efficacy. The tolerance of ibuprofen must be classified as excellent. The results of six non-comparative studies with ibuprofen carried out from 1985-1990, on a total of 45742 patients in 9115 study centers can be presented in a descriptive statistical metaanalysis.(ABSTRACT TRUNCATED AT 250 WORDS)