The First Placebo-Controlled Trial of a Special Butterbur Root Extract for the Prevention of Migraine: Reanalysis of Efficacy Criteria
作者： H.C. Diener , V.W. Rahlfs , U. Danesch
DOI: 10.1159/000076535
关键词:
摘要: This is an independent reanalysis of a randomised, placebo-controlled parallel-group study on the efficacy and tolerability special butterbur root extract (Petadolex) for prophylaxis migraine. The original protocol analysis had number major shortcomings. In order to follow regulatory requirements, data was performed. Following 4-week baseline phase, 33 patients were randomised treatment with two capsules 25 mg twice day 27 placebo. mean attack frequency per month decreased from 3.4 at 1.8 after 3 months (p = 0.0024) in verum group 2.9 2.6 placebo (n.s.). responder rate (improvement migraine > or =50%) 45% 15% group. Butterbur well tolerated. small trial indicates that may be effective
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