Efficacy of Buspirone Hydrochloride in Migraineurs with Anxiety: 
a Randomized Double Blind, Parallel Group, Placebo-controlled Study

J Korean Neurol Assoc > Volume 22(4); 2004 > Article

Journal of the Korean Neurological Association 2004;22(4): 328-333.

불안증을 동반한 편두통 환자에서 부스피론의 편두통 감소 효과에 대한 무작위배정 이중맹검 위약 대조 연구

이순태, 김만호

서울대학교 의과대학 신경과학교실

Efficacy of Buspirone Hydrochloride in Migraineurs with Anxiety: a Randomized Double Blind, Parallel Group, Placebo-controlled Study

Soon-Tae Lee

Department of Neurology, Seoul National University College of Medicine, Seoul, Korea

Abstract

Background: Migraine is commonly associated with anxiety disorder. However, whether anxiolytic medicine or changes in anxiety levels affect the migraine attack is unclear. Buspirone, the agonist for 5-HT1A receptor, is effective in treating generalized anxiety disorder. In this study, we attempted to test the efficacy of buspirone for migraine combined with anxiety disorder.
Methods: 111 outpatients aged 20 to 70 years (mean, 46.4; SD, 12.8), were analyzed. The diagnosis of migraine was made according to the HIS (International Headache Society) criteria, and the level of anxiety was rated by the Hamiton Anxiety Rating Scale (HAM-A). The migraineurs were randomly assigned to treatment with either buspirone (15 mg/day) or placebo for 6 weeks. The efficacy variables included changes in headache frequency, headache intensity, Headache Index, Headache Management Self-Efficacy Scale (HMSE), Headache Disability Inventory (H야), and the Hamilton Anxiety Rating Scale (HAM-A). The correlation between headache improvement and the anxiolytic effect were analyzed.
Results: Headache frequency showed a 43.3% reduction (from 6.7/2 weeks to 3.8/2 weeks) in the buspirone-treated group, whereas a 10.3% reduction (from 6.8 to 6.1/2 weeks) in the placebo group. The Headache Index, HDI, and HAM-A were also significantly lowered in buspirone-treated patients than in placebo-treated patients. However, the headache intensity or the HMSE score were not changed. Correlation analysis between the change of Headache Index and that of HAM-A revealed no significant association.
Conclusions: Buspirone is an effective prophylactic agent in migraine combined with anxiety disorder. This prophylactic effect is not secondary to the anxiolytic effect. This suggests that the agonistic action for 5-HT1A is primarily effective in migraine prophylaxis.Key Words: Buspirone, Migraine, Anxiety disorder, 5-HT1A