Amitriptyline vs divalproate in migraine prophylaxis: a randomized controlled trial

• Published in: Acta neurologica Scandinavica Vol. 128; no. 1; pp. 65 - 72
• Main Authors: Kalita, J., Bhoi, S. K., Misra, U. K.
• Format: Journal Article
• Language: English
• Published: Denmark Blackwell Publishing Ltd 01-07-2013; Hindawi Limited
• Subjects: Adolescent; Adult; amitriptyline; Amitriptyline - therapeutic use; Analgesics, Non-Narcotic - therapeutic use; Anticonvulsants - therapeutic use; antiepileptic; Cohort Studies; Delayed-Action Preparations; divalproate; Female; Humans; Male; Middle Aged; migraine; Migraine Disorders - diagnosis; Migraine Disorders - etiology; Migraine Disorders - prevention & control; Pain Measurement; prophylaxis; randomized controlled trial; sodium valproate; Treatment Outcome; tricyclic antidepressant; Valproic Acid - therapeutic use; Young Adult
• ISSN: 0001-6314; 1600-0404
• DOI: 10.1111/ane.12081

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.