Grossmann M, Schmidramsl H
Department of Neurology, Municipal Hospital, München-Harlaching, Germany.
Int J Clin Pharmacol Ther. 2000 Sep;38(9):430-5. doi: 10.5414/cpp38430.
Migraine is still an unsolved problem. This clinical trial investigates the efficacy and tolerance of Petasites hydridus in the prophylaxis of migraine.
A randomized, group-parallel, placebo-controlled, double-blind clinical study was carried out with a special CO2 extract from the rhizome of Petasites hybridus. Following a 4-week run-in phase, 60 patients received either the special Petasites hybridus extract petadolex or placebo at a dosage of 2 capsules (each capsule contains 25 mg) twice daily over 12 weeks. Outcome variables included the frequency, intensity and duration of migraine attacks as well as any accompanying symptoms.
The frequency of migraine attacks decreased by a maximum of 60% compared to the baseline. This reduction in migraine attacks with petadolex was significant (p < 0.05) compared to placebo. No adverse events were reported. Petasites was exceptionally well tolerated.
The results suggest that migraine patients can benefit from prophylactic treatment with this special extract. The combination of high efficacy and excellent tolerance emphasizes the particular value that Petasites hydridus has for the prophylactic treatment of migraine.
偏头痛仍是一个尚未解决的问题。本临床试验研究了蜂斗菜在偏头痛预防中的疗效和耐受性。
采用来自蜂斗菜根茎的一种特殊二氧化碳提取物进行了一项随机、组平行、安慰剂对照、双盲临床研究。在为期4周的导入期后，60例患者在12周内每天两次服用2粒胶囊（每粒胶囊含25毫克）的特殊蜂斗菜提取物petadolex或安慰剂。结果变量包括偏头痛发作的频率、强度和持续时间以及任何伴随症状。
与基线相比，偏头痛发作频率最多降低了60%。与安慰剂相比，petadolex治疗偏头痛发作频率的降低具有显著性（p<0.05）。未报告不良事件。蜂斗菜耐受性特别好。
结果表明偏头痛患者可从这种特殊提取物的预防性治疗中获益。高效性和良好耐受性的结合强调了蜂斗菜在偏头痛预防性治疗中的特殊价值。
