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The first placebo-controlled trial of a special butterbur root extract for the prevention of migraine: reanalysis of efficacy criteria.
Eur Neurol 2004; 51(2):89-97EN

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+Show Affiliations

Department of Neurology, University of Essen, Hufelandstrasse 55, DE-45122 Essen, Germany. h.diener@uni-essen.deNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

14752215

Citation

Diener, H C., et al. "The First Placebo-controlled Trial of a Special Butterbur Root Extract for the Prevention of Migraine: Reanalysis of Efficacy Criteria." European Neurology, vol. 51, no. 2, 2004, pp. 89-97.
Diener HC, Rahlfs VW, Danesch U. The first placebo-controlled trial of a special butterbur root extract for the prevention of migraine: reanalysis of efficacy criteria. Eur Neurol. 2004;51(2):89-97.
Diener, H. C., Rahlfs, V. W., & Danesch, U. (2004). The first placebo-controlled trial of a special butterbur root extract for the prevention of migraine: reanalysis of efficacy criteria. European Neurology, 51(2), pp. 89-97.
Diener HC, Rahlfs VW, Danesch U. The First Placebo-controlled Trial of a Special Butterbur Root Extract for the Prevention of Migraine: Reanalysis of Efficacy Criteria. Eur Neurol. 2004;51(2):89-97. PubMed PMID: 14752215.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The first placebo-controlled trial of a special butterbur root extract for the prevention of migraine: reanalysis of efficacy criteria. AU - Diener,H C, AU - Rahlfs,V W, AU - Danesch,U, Y1 - 2004/01/28/ PY - 2003/09/15/received PY - 2003/12/05/accepted PY - 2004/1/31/pubmed PY - 2004/5/7/medline PY - 2004/1/31/entrez SP - 89 EP - 97 JF - European neurology JO - Eur. Neurol. VL - 51 IS - 2 N2 - 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. SN - 0014-3022 UR - https://www.unboundmedicine.com/medline/citation/14752215/full_citation L2 - https://www.karger.com?DOI=10.1159/000076535 DB - PRIME DP - Unbound Medicine ER -