title: The first placebo-controlled trial of a special butterbur root extract for the prevention of migraine: reanalysis of efficacy criteria.
abstract: 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 > or =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.
authors.affiliation: Department of Neurology, University of Essen, Hufelandstrasse 55, DE-45122 Essen, Germany. h.diener@uni-essen.de
authors.forename: H C
authors.initials: HC
authors.lastname: Diener
authors.forename: V W
authors.initials: VW
authors.lastname: Rahlfs
authors.forename: U
authors.initials: U
authors.lastname: Danesch
mesh_terms: D000293:Adolescent; D000328:Adult; D016022:Case-Control Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D036901:Petasites / Q000737:chemistry*; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D011446:Prospective Studies; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: D028321:Plant Preparations