Botox Superior to Placebo for Chronic Migraine, Meta-Analysis Finds

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A meta-analysis of 17 studies finds that botulinum toxin (Botox) is superior to placebo for the prophylactic treatment of chronic migraine.

While botulinum toxin, commonly known as Botox, has been approved for the treatment of chronic migraine since 2010, there are conflicting data on its efficacy. However, a new study providing a comprehensive analysis of existing data has concluded that botulinum toxin is superior to placebo for the treatment of chronic migraine.

The meta-analysis of 17 studies included data on nearly 3650 patients, of whom 1550 (43%) had chronic migraine; the remaining patients had episodic migraine. According to the researchers, among the studies were 3 randomized trials not included in previous reports. The median frequency of migraines per month was 6.5, and frequency ranged from 4.37 to 25.1 per month.

Compared with patients treated with placebo, patients treated with Botox had less frequent migraine at 3 months, with a mean difference of change in migraine frequency of —0.23. By migraine type, patients with chronic migraine saw a bigger decrease in migraine frequency than patients with episodic migraine. For patients with chronic migraine, the mean difference of change was –1.56. The improvement became apparent at month 2, with a mean difference of change in migraine frequency of –1.60.


While the frequency of episodic migraine was not significantly reduced, there was a tendency toward reduction, with a mean difference in change of migraine frequency of —0.17. Similar to chronic migraine, the reduction became apparent at month 2.

The decreases in migraine frequency among patients treated with Botox also came with increased quality of life. Specifically, there was a direct 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,” wrote the researchers.

While patients treated with Botox did experience more adverse events than those treated with placebo, no severe side effects were reported.

According to the researchers, the study has implications for medication overuse, which is common among patients with migraine. They noted a previous study that found a significant reduction in the consumption of drugs for acute pain even though reduction in overall headache days was not significant.


Bruloy E, Sinna R, Grolleau J, Bout-Roumazeilles A, Berard E, Chaput B. Botulinum toxin versus placebo: a meta-analysis of prophylactic treatment for migraine. Plast Reconstr Surg. 2019;143(1):239-250. doi: 10.1097/PRS.0000000000005111.