Botulinum toxin type-A in the prevention of migraine: A double-blind controlled trial

Introduction: 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. Methods: 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. Results: 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. Conclusions: 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.