What is the efficacy of botulinum toxin A (BTX-A) injections for the treatment of migraine headaches?

Updated: Jun 19, 2018
  • Author: Anthony H Wheeler, MD; Chief Editor: Meda Raghavendra (Raghu), MD  more...
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Dr. William Binder, a plastic surgeon, serendipitously observed that many of his patients who had undergone BTX-A injections for the treatment of cosmetically undesirable hyperfunctional facial lines reported improvement in their headaches with reduced frequency and duration that paralleled its adverse effect on experimentally discovered neural mechanisms.

As a result of this observation, he coordinated a multicenter, open-label trial of BTX-A in patients with migraine. [106] Thirty-six of seventy-seven patients (51%) with IHS-defined migraine noted complete relief of their headaches, with a mean duration effect of 4.1 months. Twenty-seven of seventy-seven patients (38%) reported a partial response. The site of injections varied from patient to patient, but most often included the frontalis, temporalis, corrugator, procerus muscles, and, in a few patients, the suboccipital muscles. The dose of BTX-A also varied between patients. Eyebrow ptosis was the only significant adverse effect experienced by some of the study participants.

Silberstein and colleagues reported the results of a multicenter, randomized, controlled study of BTXA involving 123 patients with IHS-defined migraine who experienced 2-8 severe migraine headaches each month. [107] Patients were randomized to 1 of 3 groups: placebo and 25 or 75 U of BTX-A. Eleven standard injection sites were used, including bilateral frontalis, temporalis, corrugator, and the procerus muscles. Compared with placebo, the patients receiving 25 U of BTX-A experienced significantly fewer and less severe migraine headaches, reduced acute headache medication usage, and decreased emesis. These differences were not significant when comparing the groups receiving 75 U of BTX-A versus those receiving placebo. Adverse events included 2 cases of diplopia and 13 cases of ptosis.

In a separate randomized, placebo-controlled, multicenter study, Brin and colleagues studied the efficacy of BTX-A for migraine prophylaxis. [108] Patients received BTX-A injections in the frontal and temporal regions, BTX-A frontal injections with placebo-temporal region injections, BTX-A temporal region injections with placebo-frontal injections, or placebo-frontal and temporal region injections. Only patients who received BTX-A injections into both temporal and frontal regions experienced significantly greater headache relief than the placebo-only group.

More recently, several important studies were reported as abstracts and cited interesting and potentially pertinent observations. In one study, 30 patients who were experiencing between 2-8 IHS-defined migraine attacks each month, were randomized to receive either 50 U of BTX-A or placebo injections. Fifteen injection sites were used, including the temporalis, frontalis, corrugator, procerus, trapezius, and splenius capitis muscles bilaterally. [109] Patient responses were followed for 90 days. Compared with placebo-treated patients, who did not experience any significant change in their headache frequency or severity, those who received BTX-A injections had a significant reduction in headache frequency and severity (at 90 d, 2.5 vs. 5.8; p< .01). No significant adverse effects were noted.

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