Botulinum Toxin as Preventive Treatment for Migraine: A Randomized Double-Blind Study
Botulinum Toxin as Preventive Treatment for Migraine: A Randomized Double-Blind Study
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DOI：
10.1159/000228987
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发表时间：
2009-01-01
影响因子：
2.4
通讯作者：
Ceballos-Baumann, Andres
中科院分区：
文献类型：
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作者：
Petri, Susanne;Toelle, Thomas;Ceballos-Baumann, Andres
目的：确定 A 型肉毒毒素 (BoNT-A) 注射是否可以降低偏头痛的频率和严重程度。方法：患者 (n = 127) 被随机分配接受安慰剂或两剂 BoNT-A (Dysport (R))。主要终点是注射后第 8 周以及第 8 周至 12 周之间偏头痛发作次数的减少。患者日记用于记录次要终点，包括偏头痛发作的频率、严重程度和持续时间。结果：安慰剂组和 BoNT-A 组的平均发作次数分别减少了 0.54 次和 0.94 次/月，verum 组的绝对发作次数较少（3.6 次与 4.2 次发作/月），但这并不具有统计学意义。高剂量组患者的总体疗效评估明显优于安慰剂（p = 0.02），但其他次要疗效参数未见影响。结论：我们的研究显示 Verum 具有降低发病率的趋势，但没有显示 BoNT-A 在预防性治疗偏头痛方面具有任何统计学上显着的功效。版权所有 (C) 2009 S. Karger AG，巴塞尔
Aim: To determine if botulinum toxin type A (BoNT-A) injections can reduce the frequency and severity of migraines. Methods: Patients (n = 127) were randomized to receive placebo or two doses of BoNT-A (Dysport (R)). The primary endpoint was reduction in number of migraine attacks up to week 8 and between weeks 8 and 12 after injection. Patient diaries were used to record secondary endpoints, including frequency, severity and duration of migraine attacks. Results: There was a mean reduction of 0.54 and 0.94 attacks/month with placebo and BoNT-A, respectively, and absolute attack count was less in the verum group (3.6 vs. 4.2 attacks/month), but this was not statistically significant. The patients' global assessment of efficacy was significantly better than placebo in the high-dose group (p = 0.02) but no effects were seen for the other secondary efficacy parameters. Conclusion: Our study showed a trend towards a reduced attack rate with verum but did not show any statistically significant efficacy of BoNT-A in the prophylactic treatment of migraine. Copyright (C) 2009 S. Karger AG, Basel