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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.

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  • Authors+Show Affiliations

    ,

    Department of Neurology, University of Essen, Hufelandstrasse 55, DE-45122 Essen, Germany. h.diener@uni-essen.de

    ,

    Source

    European neurology 51:2 2004 pg 89-97

    MeSH

    Adolescent
    Adult
    Case-Control Studies
    Double-Blind Method
    Drug Administration Schedule
    Female
    Follow-Up Studies
    Humans
    Male
    Middle Aged
    Migraine Disorders
    Petasites
    Phytotherapy
    Plant Preparations
    Prospective Studies
    Statistics, Nonparametric
    Treatment Outcome

    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 -