Shuhendler Adam J, Lee Soyoung, Siu Michelle, Ondovcik Stephanie, Lam Kyla, Alabdullatif Awatif, Zhang Xiaochu, Machado Márcio, Einarson Thomas R
Department of Pharmaceutical Sciences, Leslie Dan Faculty of Pharmacy, University of Toronto, Ontario, Canada.
Pharmacotherapy. 2009 Jul;29(7):784-91. doi: 10.1592/phco.29.7.784.
To assess the efficacy of botulinum toxin type A in lowering the frequency of migraine headaches in patients with episodic migraines.
Meta-analysis of eight randomized, double-blind, placebo-controlled trials.
A total of 1601 patients with a history of episodic migraine headaches classified as those experiencing headaches fewer than 15 times/month over a 3-month period.
PubMed, Google Scholar, and the Cochrane Library were searched from inception to October 2007 in order to locate randomized, double-blind, placebo-controlled trials that compared the efficacy of pericranial botulinum toxin A injections with placebo in the prevention of migraines in patients with a history of episodic migraine headaches. The primary outcome of interest was change from baseline to end point in migraine frequency (number of migraines/month). A random effects model was used to combine study results, and the standardized mean difference (Cohen's d) in migraine frequency between the placebo and botulinum toxin A groups was reported. Effect sizes (d) less than 0.2 were considered small. Quality assessment was performed by using the Downs and Black scale. Eight randomized, double-blind, placebo-controlled clinical trials (1601 patients) presented a quantitative assessment of the efficacy of botulinum toxin A versus placebo. The overall treatment effect size of botulinum toxin A over placebo for 30, 60, and 90 days after injection was d -0.06 (95% confidence interval [CI] - 0.14-0.03, z=1.33, p=0.18), d -0.05 (95% CI -0.14-0.03, z=1.22, p=0.22), and d -0.05 (95% CI -0.13-0.04, z=1.07, p=0.28), respectively. Even after controlling for a high placebo effect, and after dose stratification, no significant effect of botulinum toxin A in reducing migraine frequency/month was seen over placebo.
Botulinum toxin A for the prophylactic treatment of episodic migraine headaches was not significantly different from placebo, both from a clinical and statistical perspective.
评估A型肉毒杆菌毒素降低发作性偏头痛患者偏头痛发作频率的疗效。
对八项随机、双盲、安慰剂对照试验进行荟萃分析。
共有1601例有发作性偏头痛病史的患者，这些患者在3个月内每月头痛次数少于15次。
检索了PubMed、谷歌学术和考克兰图书馆自建库至2007年10月的文献，以查找比较经颅注射A型肉毒杆菌毒素与安慰剂预防发作性偏头痛病史患者偏头痛疗效的随机、双盲、安慰剂对照试验。主要关注的结果是从基线到终点偏头痛发作频率（每月偏头痛发作次数）的变化。采用随机效应模型合并研究结果，并报告安慰剂组和A型肉毒杆菌毒素组偏头痛发作频率的标准化平均差（科恩d值）。效应量（d）小于0.2被认为是小效应量。使用唐斯和布莱克量表进行质量评估。八项随机、双盲、安慰剂对照临床试验（1601例患者）对A型肉毒杆菌毒素与安慰剂的疗效进行了定量评估。注射后30、60和90天，A型肉毒杆菌毒素相对于安慰剂的总体治疗效应量分别为d=-0.06（95%置信区间[CI]-0.14-0.03，z=1.33，p=0.18）、d=-0.05（95%CI-0.14-0.03，z=1.22，p=0.22）和d=-0.05（95%CI-0.13-0.04，z=1.07，p=0.28）。即使在控制了高安慰剂效应并进行剂量分层后，与安慰剂相比，未观察到A型肉毒杆菌毒素在降低每月偏头痛发作频率方面有显著效果。
从临床和统计学角度来看，A型肉毒杆菌毒素预防性治疗发作性偏头痛与安慰剂无显著差异。
