耐受性
偏头痛
安慰剂
医学
安慰剂组
随机对照试验
内科学
安慰剂对照研究
麻醉
不利影响
双盲
替代医学
病理
作者
Diener Hc,Volker W. Rahlfs,Ulrich Danesch
出处
期刊:European Neurology
[S. Karger AG]
日期:2004-01-01
卷期号:51 (2): 89-97
被引量:123
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) 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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