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Botulinum Toxin Reduces Chronic Migraine Attacks, Compared to Placebo

A growing body of evidence supports the effectiveness of botulinum toxin injections in reducing the frequency of chronic migraine headaches, concludes an updated review and analysis in the January issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS).

Based on meta-analysis of pooled clinical trial data, botulinum toxin is superior to inactive placebo for preventive treatment of migraine, report Prof. Benoit Chaput, MD, PhD, of University Hospital Rangueil, Toulouse, France, and colleagues. "Botulinum toxin is a safe and well-tolerated treatment that should be proposed to patients with migraine," the researchers write.

Assembled Evidence Supports Effectiveness of Botox for Chronic Migraine

Prof. Chaput and colleagues identified and analyzed data from 17 previous randomized trials comparing botulinum toxin with placebo for preventive treatment of migraine headaches. Botulinum toxin – best known by the brand name Botox – was approved by the US Food and Drug Administration (FDA) for treatment of chronic migraine in 2010. Since then, a growing number of patients have reported successful results with botulinum toxin injections to alleviate chronic migraine headaches.

The 17 studies included nearly 3,650 patients, about 1,550 of whom had chronic migraine: defined as at least 15 headache attacks per month for more than three months, with migraine symptoms on at least eight days per month. The remaining patients had less-frequent episodic migraine headaches. On pooled data analysis, botulinum toxin injections significantly reduced the frequency of chronic migraine attacks with. Three months after injection, patients treated with botulinum toxin had an average of 1.6 fewer migraine attacks per month, compared to those treated with inactive placebo.

The improvement was apparent within two months of botulinum toxin treatment. To sustain the effects of treatment, botulinum toxin injections are typically repeated every three months.

There was also a "statistical tendency" toward less-frequent attacks with botulinum toxin in patients with episodic migraine. Again, improvement occurred within two months. Although botulinum toxin had a higher rate of adverse effects compared to placebo, none of these were serious.

The pooled data also showed significant improvement in quality of life in patients treated with botulinum toxin. This improvement was directly linked to a reduction in depressive symptoms. "It can be explained by the reduced impact of headaches and migraine-related disability, thus reducing symptoms of depression and anxiety," Prof. Chaput and coauthors write.

Migraine headaches are an increasingly common condition, leading to significant disability and increased use of healthcare resources. Although botulinum toxin injection for chronic migraine is FDA-approved, there are still conflicting data regarding its effectiveness. The new report provides a comprehensive analysis of the highest-quality evidence to date, including three randomized trials not included in previous reports.

The results strongly support the effectiveness of botulinum toxin injection as preventive treatment for chronic migraine, with significant reductions in headache frequency at both two and three months. Prof. Chaput and colleagues add, "For the first time, our analysis highlights the significant improvement in patients' quality of life at three months in the Botox group – which exhibited few and mild adverse events."

Plastic and Reconstructive Surgery® is published by Wolters Kluwer.

Click here to read "Botulinum Toxin versus Placebo: A Meta-Analysis of Prophylactic Treatment for Migraine"

Article: "Botulinum Toxin versus Placebo: A Meta-Analysis of Prophylactic Treatment for Migraine" (doi: 10.1097/PRS.0000000000005111)

About Plastic and Reconstructive Surgery

For more than 70 years, Plastic and Reconstructive Surgery® has been the one consistently excellent reference for every specialist who uses plastic surgery techniques or works in conjunction with a plastic surgeon. The official journal of the American Society of Plastic Surgeons, Plastic and Reconstructive Surgery® brings subscribers up-to-the-minute reports on the latest techniques and follow-up for all areas of plastic and reconstructive surgery, including breast reconstruction, experimental studies, maxillofacial reconstruction, hand and microsurgery, burn repair, and cosmetic surgery, as well as news on medico-legal issues.

About ASPS

The American Society of Plastic Surgeons (ASPS) is the world's largest organization of board-certified plastic surgeons. Representing more than 8,000 Member Surgeons, the Society is recognized as a leading authority and information source on aesthetic and reconstructive plastic surgery. ASPS comprises more than 93 percent of all board-certified plastic surgeons in the United States. Founded in 1931, the Society represents physicians certified by The American Board of Plastic Surgery or The Royal College of Physicians and Surgeons of Canada. ASPS advances quality care to plastic surgery patients by encouraging high standards of training, ethics, physician practice and research in plastic surgery.

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