Randomized Clinical Trial of Intravenous Valproate (Orifil) and Dexamethasone in Patients with Migraine Disorder

Background: Intravenous Valproate (IVVP) has been used in the treatment of migraine in some studies; however, it is far better known in the management of status epilepticus. Methods: Consecutive patients with migraine in our Headache Clinic were enrolled in this prospective, randomized clinical trial in 2011. The patients were randomized into two therapeutic groups, one receiving 900 mg IVVP (Orifil) and the other 16 mg IV Dexamethasone (IVDEX) diluted in 150 CC normal saline and infused for 10 minutes. Worst severity of pain before treatment and least severity at 3 hours after the infusion using a 0-10 point numeric rating scale were recorded. An interview with the patient was performed 72 hours after treatment to detect a possible relapse of headache. Results: Thirty-one migraine status patients, comprising 28 women and 3 men at a mean±SD age of 33.355±12.373 SD, were investigated. Differences in the therapeutic effects of IVVP (Orifil) and IVDEX on pain score were not significant between the two groups (t=0.933, df=29; P=0.358). Relapse of headache occurred in 68.42% of the IVVP (Orifil) group and 66.67% of the IVDEX group. Distribution of relapse was not significantly different between the two therapeutic groups of patients (P=0.870). Conclusion: IVVP (Orifil) was similar in efficacy to IVDEX as abortive therapy in patients with migraine status. IVVP (Orifil) appears to offer a safe and well-tolerated abortive treatment. Trial Registration Number: IRCT13891146234N2