The first placebo-controlled trial of a special butterbur root extract for the prevention of migraine: Reanalysis of efficacy criteria

被引:75
作者
Diener, HC
Rahlfs, VW
Danesch, U
机构
[1] Univ Essen Gesamthsch, Dept Neurol, D-45122 Essen, Germany
[2] Idv Data Anal & Study Planning, Gauting, Germany
[3] Weber & Weber GmbH, Inning, Germany
关键词
migraine; migraine prophylaxis; butterbur;
D O I
10.1159/000076535
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
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(R)) 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 greater than or equal to50%) 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. Copyright (C) 2004 S. Karger AG, Basel.
引用
收藏
页码:89 / 97
页数:9
相关论文
共 18 条
[1]  
AEBI A, 1955, PHARM ACTA HELV, V29, P277
[2]   GASTRO-PROTECTIVE EFFECTS BY EXTRACTS OF PETASITES-HYBRIDUS - THE ROLE OF INHIBITION OF PEPTIDO-LEUKOTRIENE SYNTHESIS [J].
BRUNE, K ;
BICKEL, D ;
PESKAR, BA .
PLANTA MEDICA, 1993, 59 (06) :494-496
[3]  
Bucher K., 1950, ARCH EXP PATHOL PH, V213, P69
[4]  
Colditz G A, 1988, Int J Technol Assess Health Care, V4, P637
[5]  
Grossmann M, 2000, INT J CLIN PHARM TH, V38, P430
[6]   Relaxant effects of petasins in isolated guinea pig trachea and their structure-activity relationships [J].
Ko, WC ;
Lei, CB ;
Lin, YL ;
Chen, CF .
PLANTA MEDICA, 2000, 66 (07) :650-652
[7]   Mechanisms of relaxant action of S-petasin and S-isopetasin, sesquiterpenes of Petasites formosanus, in isolated guinea pig trachea [J].
Ko, WC ;
Lei, CB ;
Lin, YL ;
Chen, CF .
PLANTA MEDICA, 2001, 67 (03) :224-229
[8]   SOME LARGE-SAMPLE DISTRIBUTION-FREE ESTIMATORS AND TESTS FOR MULTIVARIATE PARTIALLY INCOMPLETE DATA FROM 2 POPULATIONS [J].
LACHIN, JM .
STATISTICS IN MEDICINE, 1992, 11 (09) :1151-1170
[9]  
Lipton RB, 2002, NEUROLOGY, V58, pA472
[10]  
SCHEIDEGGER C, 1998, PHARM ACTA HELV, V72, P359