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Botulinum Toxin versus Placebo

A Meta-Analysis of Prophylactic Treatment for Migraine

Bruloy, Eva, M.D.; Sinna, Raphael, Ph.D., M.D., M.B.A.; Grolleau, Jean-Louis, M.D.; Bout-Roumazeilles, Apolline, M.D.; Berard, Emilie, M.D.; Chaput, Benoit, M.D., Ph.D.

Plastic and Reconstructive Surgery: January 2019 - Volume 143 - Issue 1 - p 239–250
doi: 10.1097/PRS.0000000000005111
Reconstructive: Head and Neck: Original Articles
Press Release

Background: The purpose of this study was to assess the efficacy of botulinum toxin in reducing the frequency of migraine headaches.

Methods: The MEDLINE, Embase, and Cochrane Library databases were searched to identify randomized, double-blind, placebo-controlled trials that compared patients receiving botulinum toxin versus placebo injections in the head and neck muscles, for the preventive treatment of migraine. The primary outcome was change in the number of headache episodes per month from baseline to 3 months.

Results: There were 17 studies including a total of 3646 patients. Overall analysis reported a tendency in favor of botulinum toxin over placebo at 3 months, with a mean difference in the change of migraine frequency of −0.23 (95 percent CI, −0.47 to 0.02; p = 0.08). The reduction in frequency of chronic migraines was significant, with a mean differential change of −1.56 (95 percent CI, −3.05 to −0.07; p = 0.04). Analysis of chronic migraine frequency was also significant after 2 months. The findings also highlighted an improvement of the patient’s quality of life at 3 months in the botulinum toxin group (p < 0.00001). Further adverse events were traced in the botulinum toxin type A group with a statistically significant risk ratio of 1.32 (p = 0.002).

Conclusions: This meta-analysis reveals that botulinum toxin type A injections are superior to placebo for chronic migraines after 3 months of therapy. For the first time, a real benefit in patient quality of life is demonstrated with only few and mild adverse events.


Amiens and Toulouse, France

From the Department of Plastic Reconstructive and Aesthetic Surgery, University Hospital of Picardie, Amiens Picardie University Hospital; the Department of Plastic, Reconstructive and Aesthetic Surgery, CHRU Rangueil; and the Department of Epidemiology, Health Economics and Public Health, UMR1027 INSERM-Université de Toulouse III, Centre Hospitalier Universitaire de Toulouse.

Received for publication December 6, 2017; accepted July 20, 2018.

This trial is registered under that name “Botulinum Toxin for Treatment of Migraine: A Meta-Analysis,” PROSPERO identification number CRD42016048772 (

Disclosure: None of the authors has a financial interest in any of the products, devices, or drugs mentioned in this article.

Benoit Chaput, M.D., Plastic and Reconstructive Surgery Unit, CHU Rangueil, 1, Avenue Jean Poulhès, Toulouse, France,

©2019American Society of Plastic Surgeons