OBJECTIVE: To evaluate the efficacy and safety of venlafaxine in the prophylaxis of migraine. BACKGROUND: The efficacy of venlafaxine, which is selectively effective on the serotonergic and noradrenergic mechanisms, on various headaches and chronic pain syndromes has been demonstrated. To our knowledge, this is the first placebo-controlled, double-blind, randomized study of two different doses of venlafaxine for migraine treatment. METHODS: In this prospective study, 60 migraine patients without aura were randomly assigned to venlafaxine XR 75 mg, venlafaxine XR 150 mg, or placebo. The frequency of headache attacks, the severity and the duration of attacks, and analgesic use were monitored every 2 weeks for 2 months. Adverse events and patient satisfaction were also evaluated during these visits. At the end of the 2 months, global efficacy and tolerance were investigated. RESULTS: A significant difference was observed between the venlafaxine 150 mg and placebo groups in the number of headache attacks (P= .006). According to patient satisfaction comparisons, the active drug groups were significantly different when compared with placebo (P= .001 at visit 2 and visit 6). When the global efficacy was considered, 80% of patients in the 75-mg group and 88.2% of the patients in the 150-mg group evaluated treatment benefits as either good or very good. CONCLUSIONS:Venlafaxine was more effective than placebo and is safe and well tolerated as migraine prophylaxis.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of venlafaxine in the prophylaxis of migraine. BACKGROUND: The efficacy of venlafaxine, which is selectively effective on the serotonergic and noradrenergic mechanisms, on various headaches and chronic pain syndromes has been demonstrated. To our knowledge, this is the first placebo-controlled, double-blind, randomized study of two different doses of venlafaxine for migraine treatment. METHODS: In this prospective study, 60 migrainepatients without aura were randomly assigned to venlafaxine XR 75 mg, venlafaxine XR 150 mg, or placebo. The frequency of headache attacks, the severity and the duration of attacks, and analgesic use were monitored every 2 weeks for 2 months. Adverse events and patient satisfaction were also evaluated during these visits. At the end of the 2 months, global efficacy and tolerance were investigated. RESULTS: A significant difference was observed between the venlafaxine 150 mg and placebo groups in the number of headache attacks (P= .006). According to patient satisfaction comparisons, the active drug groups were significantly different when compared with placebo (P= .001 at visit 2 and visit 6). When the global efficacy was considered, 80% of patients in the 75-mg group and 88.2% of the patients in the 150-mg group evaluated treatment benefits as either good or very good. CONCLUSIONS:Venlafaxine was more effective than placebo and is safe and well tolerated as migraine prophylaxis.