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2008 Annual Meeting Abstracts

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A Placebo Controlled Surgical Trial for the Treatment of Migraine Headaches
Bahman Guyuron, MD1, Deborah Reed, MD2, Jennifer Kriegler, MD3, Janine Davis, RN1, Saeid Amini, MBA, JD, PhD1.
1Case Western Reserve University, Cleveland, OH, USA, 2The American Migraine Center, Cleveland, OH, USA, 3Cleveland Clinic Foundation, Cleveland, OH, USA.

PURPOSE: One third of the 28 million Americans suffering with migraine headache (MH) are not helped by standard therapies. The present study was conducted to demonstrate the efficacy of independent surgical deactivation of three common MH trigger sites through a double-blind, sham-surgery controlled clinical trial.
METHODS:: Patients with moderate to severe MH who met International Classification of Headache Disorders II (ICHDII) criteria were included in this study. A positive response to injection of botulinum toxin type A into the compressing muscles determined patient eligibility for this study. Trigger sites were identified (frontal, temporal, occipital) and patients were randomly assigned to receive either actual or sham surgery in their predominant trigger site. Patients completed the MIDAS, MSQ, and SF-36 health questionnaires prior to treatment and at 1 year follow-up.
RESULTS: When the total group of 75 patients was considered, 28 of 49 (57%) patients in the actual surgery group reported complete elimination of MH at 12 months compared to only 1 of 26 patients (3.8%) in the sham surgery group (p<0.0001, Fisher’s Exact Test). Eleven of 26 patients (42.3%) in the sham surgery group reported no change in MH at 12 months which was significantly higher than the 8 of 49 patients (16.3%) in the actual surgery group (p=0.02, Fisher’s Exact Test). Forty one of 46 (83.7%) patients in the actual surgery group reported significant improvement at 12 months compared to 15 of 26 (57.8%) patients in the sham surgery group (p=0.014). Compared to baseline values, all of the MH measures were significantly improved at 1 year in the actual surgery group, while only some of the MH measures were significantly improved in the sham surgery group. Additionally, the extent of improvements in frequency, intensity, MIDAS and MSQ scores was significantly higher in the actual surgery group compared to the sham surgery group (p<0.05). The most common surgical complication was slight hollowing of the temple in the group with temporal MH.
CONCLUSION: This study confirms that surgical deactivation of peripheral MH trigger sites is an effective alternative treatment for patients who suffer from frequent moderate to severe MH that are difficult to manage with standard protocols.


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