Efficacy and Safety of Venlafaxine Versus Amitriptyline in Decreasing Severity and Frequency of Migraine Attacks: A Randomized Controlled Trial

Abstract

Objective: To compare the safety and efficacy of two anti-migraine Venlafaxine and Amitriptyline in migraine prophylaxis. Background of the study: The efficacy of Venlafaxine and Amitriptyline on various headache disorders has been proved in previous studies. This Open-Label Parallel group study of 12 weeks compares the safety and efficacy of Venlafaxine and Amitriptyline in migraine prophylaxis. Methods: 100 migraine patients were randomized and they were allocated equally to Venlafaxine XR and Amitriptyline group. The frequency, duration, severity of headache attacks and safety profiles were monitored for 3 months. Patient satisfaction and global tolerance were also evaluated during this period. Results: The statistical difference between the treatment groups in the number of headache attacks (p = 0.012) the duration of attacks (p=0.046) and the severity of the attacks (p=0.032) was notable at the end of the study period with Venlafaxine better than Amitriptyline. Side effects like hypersomnia and constipation were reported in both the groups. Analgesic consumption was also significant reduced in Venlafaxine group when compared with Amitriptyline (p=0.021). Venlafaxine has higher patient satisfaction when compared to Amitriptyline. Global efficacy and global tolerance were also higher in the Venlafaxine group. Conclusions: The results support the safety and efficacy profile of Venlafaxine as preventive therapy for migraine.