R Shahien1, S A Saleh, A Bowirrat. 1. Department of Neurology, Ziv Medical Center, Safed, Israel. shahien.r@ziv.health.gov.il
Abstract
OBJECTIVES: This preliminary study was designed to evaluate the efficacy and safety of intravenous sodium valproate in managing severe migraine headache. DESIGN/ METHODS: In a preliminary prospective open-label study, we treated patients with severe migraine headache using intravenous sodium valproate, after obtaining written informed consent. Thirty-six patients, hospitalized with acute established migraine, were infused with sodium valproate. The diagnosis of migraine was based on the International Headache Society classification criteria. Severity of headache was reported on 10-point visual analog. Disability was assessed on a five-point scale. Primary and secondary endpoints were measured as sustained pain relief and symptoms improvement at 2 h, respectively. RESULTS: The study participants had a mean±SD age of 35.7±9.3 years. The loading dose of sodium valproate was 900-1200 mg, and the average time to best response for headache severity was 50 min. A reduction in pain from severe or moderate to mild or no pain in 60 min was reported in 75% of patients [OR=7.187 (95% confidence intervals: 1.32-38.95)]. After treatment with sodium valproate, headache severity was significantly decreased (P<0.0001). No serious adverse events were reported. CONCLUSIONS: Intravenous Sodium Valproate (iVPA) seems to be safe and rapidly effective for intractable migraine attack. Randomized, double-blinded, controlled studies are warranted.
OBJECTIVES: This preliminary study was designed to evaluate the efficacy and safety of intravenous sodium valproate in managing severe migraineheadache. DESIGN/ METHODS: In a preliminary prospective open-label study, we treated patients with severe migraineheadache using intravenous sodium valproate, after obtaining written informed consent. Thirty-six patients, hospitalized with acute established migraine, were infused with sodium valproate. The diagnosis of migraine was based on the International Headache Society classification criteria. Severity of headache was reported on 10-point visual analog. Disability was assessed on a five-point scale. Primary and secondary endpoints were measured as sustained pain relief and symptoms improvement at 2 h, respectively. RESULTS: The study participants had a mean±SD age of 35.7±9.3 years. The loading dose of sodium valproate was 900-1200 mg, and the average time to best response for headache severity was 50 min. A reduction in pain from severe or moderate to mild or no pain in 60 min was reported in 75% of patients [OR=7.187 (95% confidence intervals: 1.32-38.95)]. After treatment with sodium valproate, headache severity was significantly decreased (P<0.0001). No serious adverse events were reported. CONCLUSIONS: Intravenous Sodium Valproate (iVPA) seems to be safe and rapidly effective for intractable migraine attack. Randomized, double-blinded, controlled studies are warranted.