A META-ANALYSIS OF RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALS OF THE EFFICACY OF BOTULINUM TOXIN A FOR THE PROPHYLAXIS OF CHRONIC MIGRAINE HEADACHES

Author(s)

Adam J Shuhendler, MSc, MSc student, Soyoung Lee, MSc, MSc student, Michelle Siu, MSc, MSc student, Stephanie L Ondovcik, MSc, MSc student, Kyla Lam, MSc, MSc student, Awatif Alabdullatif, MSc, MSc student, Xiaochu Zhang, MSc, MSc student, Márcio Machado, PhD, Post Doctoral Fellow, Thomas R. Einarson, PhD, Associate ProfessorUniversity of Toronto, Toronto, ON, Canada

Objective: To assess the ability of BTX-A injections to lower migraine frequency in chronic sufferers. Methods: Two reviewers independently searched PubMed, Google Scholar and Cochrane Library to locate randomized, double-blind, placebo-controlled trials of BTX-A for chronic migraines. Differences were settled via consensus. Data extraction/verification were managed similarly. The primary outcome was baseline-endpoint change in migraine frequency (number/month). Heterogeneity was assessed using c2 and I-squared. Two raters assessed study quality using the Downs-Black scale, with adjudication via consensus. A fixed-effects model combined study results using the standardized mean difference (Cohen's d) in monthly migraine frequency between placebo and BTX-A groups. Results: Nine trials (N=2114; BTX-A=1388, placebo=726; 2059 completed their trials) provided data in 19 study arms and 9 placebo arms. The average age was 43+/-3, duration of illness was 20+/-3 years, average number of migraines was 6.0+/-2.1/month, 84% were females. All c2 were non-significant; all I-suared were 0, suggesting combinability and confirmed using a fixed-effects model. Quality scores averaged 67%+/-4% ("fair"; range:62%-75%). The weighted average treatment effect (Cohen's d) of BTX-A over placebo was -0.05 (CI95%=-0.13, 0.03) when measured 30 days after injection, -0.04 (CI95%=-0.12, 0.04) at 60 days, and -0.04 (CI95%=-0.12, 0.04) at 90 days post-injection. Two comparisons out of 57 were significant; one by Relja after 60 days and one by Vo after 90 days. Controlling for placebo effect and stratifying by dose stratification found no significant effect of BTX-A in reducting migraine frequency per month over saline vehicle. Conclusion: BTX-A used as prophylactic treatment of chronic migraine headaches does not decrease monthly numbers of migraines.

Conference/Value in Health Info

2008-05, ISPOR 2008, Toronto, Ontario, Canada

Value in Health, Vol. 11, No. 3 (May/June 2008)

Code

PSY3

Topic

Clinical Outcomes

Topic Subcategory

Comparative Effectiveness or Efficacy

Disease

Systemic Disorders/Conditions

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