Valproate versus flunarizine in migraine prophylaxis: a randomized, double-open, clinical trial.

The aim of this study was to compare the efficacy and safety of valproate versus flunarizine in migraine prophylaxis in a randomized double-open clinical trial. Twenty-two migraine sufferers were treated with valproate (1 g per day) for 8 weeks; a parallel group of 22 migraine sufferers was treated with flunarizine (10 mg per day). The main admission criterion was a minimum of 3 migraine (with, or without aura) attacks per month. The major clinical parameters evaluated were the frequency of headache attacks, the frequency of use of drugs for the acute management of migraine, the patients' opinion of treatment and the Hamilton anxiety and depression rating scales. During the study 3 patients dropped out (1 from the valproate and 2 from the flunarizine groups). Fifteen patients (71.4%) from the valproate group responded to therapy, compared to 14 patients (65%) from the flunarizine group. In the valproate group 12 patients (57.1%) reported various side effects (prevalently gastric symptoms) versus 10 patients (47.6%) in the flunarizine group (prevalently somnolence). The patients who were treated with flunarizine showed an increase in the mean score of the 21-item Hamilton rating scale for depression, but the difference was not significant; morning dysthymia however, was significantly more often observed in the flunarizine patients, compared to the valproate patients. These results suggest that both drugs are effective and safe in migraine prophylaxis.