A Placebo-Controlled Surgical Trial of the Treatment of Migraine Headaches

Background: Many of the nearly 30 million Americans suffering with migraine headaches are not helped by standard therapies, a proportion of which can harbor undesirable side effects. The present study demonstrates the efficacy of independent surgical deactivation of three common migraine headache trigger sites through a double-blind, sham surgery, controlled clinical trial. Methods: Seventy-five patients with moderate to severe migraine headache who met International Classification of Headache Disorders II criteria were studied. Trigger sites were identified (frontal, temporal, and occipital), and patients were randomly assigned to receive either actual or sham surgery in their predominant trigger site. Patients completed the Migraine Disability Assessment, Migraine-Specific Quality of Life, and Medical Outcomes Study 36-Item Short Form Health Survey health questionnaires before treatment and at 1-year follow-up. Results: Of the total group of 75 patients, 15 of 26 in the sham surgery group (57.7 percent) and 41 of 49 in the actual surgery group (83.7 percent) experienced at least 50 percent reduction in migraine headache (p < 0.05). Furthermore, 28 of 49 patients in the actual surgery group (57.1 percent) reported complete elimination of migraine headache, compared with only one of 26 patients in the sham surgery group (3.8 percent) (p< 0.001). Compared with the control group, the actual surgery group demonstrated statistically significant improvements in all validated migraine headache measurements at 1 year. These improvements were not dependent on the trigger site. The most common surgical complication was slight hollowing of the temple in the group with temporal migraine headache. Conclusion: This study confirms that surgical deactivation of peripheral migraine headache trigger sites is an effective alternative treatment for patients who suffer from frequent moderate to severe migraine headaches that are difficult to manage with standard protocols.