Amitriptyline vs divalproate in migraine prophylaxis: a randomized controlled trial

Objective This study compares efficacy and safety of divalproate extended release ( DVA ‐ ER ) and amitriptyline ( AMT ) in migraine .Materials and methods Three hundred migraineurs having >4 attacks monthly were randomized into DVA ‐ ER or AMT . The primary end points were >50% reduction in frequency, ≥1 grade improvement in the severity, and >50% improvement in a visual analogue scale ( VAS ). Secondary end points were functional disability, rescue medication, and adverse events. Results The median age was 32 years, and 241 were women. 150 patients each received DVA ‐ ER and AMT . At 3 months, 74.7% in DVA ‐ ER and 62% patients in AMT group improved in headache frequency ( P  = 0.02) and at 6 months, 65.3% and 54%, respectively ( P  = 0.90). At 3 months, the VAS score improved by >50% in 80.7% in DVA ‐ ER and 64% in AMT ( P  = 0.005). At 6 months, there was no significant difference between the two groups in VAS score (69.3% vs 56%; P  = 0.47) and other outcome parameters. The composite side effects were also not different between the two groups (68% vs 81%); however, hair fall, menstrual irregularity, polycystic ovary, and weight gain were commoner in DVA ‐ ER group. Conclusion Divalproate extended release is more effective at 3 months than AMT ; however, at 6 months, both are equally effective in migraine prophylaxis.