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The First Placebo-Controlled Trial of a Special Butterbur Root Extract for the Prevention of Migraine: Reanalysis of Efficacy Criteria

Diener H.C.a · Rahlfs V.W.b · Danesch U.c
aDepartment of Neurology, University of Essen, Essen, bidv Data Analysis and Study Planning, Gauting, and cWeber & Weber GmbH, Inning, Germany Eur Neurol 2004;51:89–97 (DOI:10.1159/000076535)


This is an independent reanalysis of a randomised, placebo-controlled parallel-group study on the efficacy and tolerability of a special butterbur root extract (Petadolex®) for the prophylaxis of migraine. The original protocol and analysis had a number of major shortcomings. In order to follow regulatory requirements, an independent reanalysis of the original data was performed. Following a 4-week baseline phase, 33 patients were randomised to treatment with two capsules 25 mg butterbur twice a day and 27 to placebo. The mean attack frequency per month decreased from 3.4 at baseline to 1.8 after 3 months (p = 0.0024) in the verum group and from 2.9 to 2.6 in the placebo group (n.s.). The responder rate (improvement of migraine frequency ≧50%) was 45% in the verum group and 15% in the placebo group. Butterbur was well tolerated. This small trial indicates that butterbur may be effective in the prophylaxis of migraine.


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