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Vol. 51, No. 2, 2004
Issue release date: March 2004
Section title: Original Paper
Eur Neurol 2004;51:89–97
(DOI:10.1159/000076535)

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

Diener H.C. · Rahlfs V.W. · Danesch U.
aDepartment of Neurology, University of Essen, Essen, bidv Data Analysis and Study Planning, Gauting, and cWeber & Weber GmbH, Inning, Germany

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Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 9/15/2003
Accepted: 12/5/2003
Published online: 3/4/2004

Number of Print Pages: 9
Number of Figures: 4
Number of Tables: 3

ISSN: 0014-3022 (Print)
eISSN: 1421-9913 (Online)

For additional information: http://www.karger.com/ENE

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 ≧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.


  

Author Contacts

Hans-Christoph Diener, MD
Department of Neurology, University of Essen
Hufelandstrasse 55
DE–45122 Essen (Germany)
Tel. +49 201 723 2460, Fax +49 201 723 5901, E-Mail h.diener@uni-essen.de

  

Article Information

Received: September 15, 2003
Accepted: December 5, 2003
Published online: January 28, 2004
Number of Print Pages : 9
Number of Figures : 4, Number of Tables : 3, Number of References : 18

  

Publication Details

European Neurology
Founded 1897 as ‘Monatsschrift für Psychiatrie und Neurologie’

Vol. 51, No. 2, Year 2004 (Cover Date: Released March 2004)

Journal Editor: J. Bogousslavsky, Lausanne
ISSN: 0014–3022 (print), 1421–9913 (Online)

For additional information: http://www.karger.com/journals/ene


Article / Publication Details

First-Page Preview
Abstract of Original Paper

Received: 9/15/2003
Accepted: 12/5/2003
Published online: 3/4/2004

Number of Print Pages: 9
Number of Figures: 4
Number of Tables: 3

ISSN: 0014-3022 (Print)
eISSN: 1421-9913 (Online)

For additional information: http://www.karger.com/ENE


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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in goverment regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug.
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