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

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 (HDI), 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.