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.


CONCLUSIONS
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.
Guyuron
Bahman
B
Cleveland, Ohio From the Departments of Plastic Surgery and Neurology, Case Western Reserve University; the American Migraine Center; and the Center for Headache and Pain, Cleveland Clinic.
Reed
Deborah
D
Kriegler
Jennifer S
JS
Davis
Janine
J
Pashmini
Nazly
N
Amini
Saeid
S
D000328:Adult; D000368:Aged; D019274:Botulinum Toxins, Type A / Q000008:administration & dosage; D004311:Double-Blind Method; D005152:Facial Muscles / Q000601:surgery; D006305:Health Status Indicators; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000503:physiopathology / Q000601:surgery*; D009465:Neuromuscular Agents / Q000008:administration & dosage; D019635:Neurosurgical Procedures; D011788:Quality of Life; D016896:Treatment Outcome; D014276:Trigeminal Nerve / Q000601:surgery
D009465:Neuromuscular Agents; D019274:Botulinum Toxins, Type A