Botulinum Toxin Type A for the Treatment of Post-traumatic Headache: A Randomized, Placebo-Controlled, Cross-over Study

Abstract

Introduction: Botulinum toxin type A (BoNT/A) is an approved treatment for chronic migraine and has been shown to be effective in reducing number, days, and severity of headache in other headache disorders. Whether botulinum toxin is a safe and effective treatment specifically for post-traumatic headache (PTH), however, is unknown. This study sought to determine whether treatment with BoNT/A improved symptoms of PTH in military veterans. Materials and Methods: Forty subjects with PTH were randomized to receive treatment of either BoNT/A or a saline placebo. Sixteen weeks post-treatment or at return to baseline headache severity, subjects were crossed over to receive treatment with the other medication than previously treated with in the first session. Subjects recorded number of headaches, number of headache days, and headache pain severity in daily diaries. Outcome measures included change in the weekly number of headaches, number of headache days per week, and headache pain severity compared to baseline, and the change in number of headaches and number of headaches days at baseline compared to the rating scores averaged across weeks 6-11. Results: The number of headaches per week significantly decreased by 2.24 (43.3%) with BoNT/A treatment (P