Vo Alexander H, Satori Roberto, Jabbari Bahman, Green Jody, Killgore William D S, Labutta Robert, Campbell William W
AT&T Center for Telehealth Research & Policy, Electronic Health Network, University of Texas Medical Branch, William C. Levin Hall, Room 5.518, 301 University Blvd., Galveston, TX 77555-1042, USA.
Aviat Space Environ Med. 2007 May;78(5 Suppl):B113-8.
Migraine is a frequent medical complaint. In military populations, migraine can be detrimental to productivity and troop readiness, and can be disqualifying for service in some military duty specialties. This study assessed the effectiveness of botulinum neurotoxin type-A (BTX-A) in reducing the frequency of migraines in known migraineurs.
There were 32 subjects (control = 17, test n = 15) who completed the assessment battery at baseline and monthly for 3 mo. Adult subjects with migraine headaches occurring more than 5 times/month were recruited and randomized to receive placebo saline injection vs. BTX-A. The primary efficacy parameter was the average frequency of headache days for 3 mo. Secondary outcome measures were severity of attacks and quality of life.
Quadratic trends were noted for headache severity (F (2,29) = 14.1, p = 0.001) and headache indexes (F (2,29) = 4.5, p = 0.042) for both groups, suggesting changes in severity of head pain and overall intensity of headaches experienced over time; however, results were not significant for headache frequency and severity between groups. Paired t-tests of the headache index scores for the control group revealed a significant increase from the first to the third follow-up periods (t = -2.58, p = 0.020). Such a trend was not observed for the BTX-A group. Both groups, however, reported similarly low to moderate quality of life as a result of their migraines.
This controlled trial failed to demonstrate efficacy of BTX-A in reducing the frequency of migraine headaches. The pattern headache index in the botox group, however, suggested a protective effect for botox against the headache severity.
偏头痛是一种常见的医学病症。在军人中，偏头痛会影响工作效率和部队战备状态，在某些军事专业岗位上还可能导致无法服役。本研究评估了A型肉毒杆菌神经毒素（BTX-A）降低已知偏头痛患者偏头痛发作频率的有效性。
32名受试者（对照组 = 17名，试验组n = 15名）在基线时及之后3个月每月完成一次评估。招募每月偏头痛发作超过5次的成年受试者，并随机分为接受安慰剂盐水注射组和BTX-A组。主要疗效参数为3个月内头痛天数的平均频率。次要结局指标为发作严重程度和生活质量。
两组的头痛严重程度（F(2,29) = 14.1，p = 0.001）和头痛指数（F(2,29) = 4.5，p = 0.042）均呈现二次趋势，表明随着时间推移头痛疼痛严重程度和总体头痛强度发生了变化；然而，两组之间的头痛频率和严重程度结果无显著差异。对照组头痛指数评分的配对t检验显示，从第一次随访到第三次随访期间有显著增加（t = -2.58，p = 0.020）。BTX-A组未观察到这种趋势。然而，由于偏头痛，两组报告的生活质量均同样低至中等。
这项对照试验未能证明BTX-A在降低偏头痛发作频率方面的疗效。然而，肉毒杆菌素组的头痛指数模式表明肉毒杆菌素对头痛严重程度有保护作用。
