Research Reviewer: Alan Gaby, M.D.
Author: Goncalves AL, et al
Reference: Randomised clinical trial comparing melatonin 3 mg, amitriptyline 25 mg and placebo for migraine prevention. J Neurol Neurosurg Psychiatry 2016;87:1127-1132.
Design: Randomized, double-blind, placebo-controlled trial.
Participants: One hundred ninety-six patients with recurrent migraines.
Study Medication and Dosage: Melatonin (3 mg), amitriptyline (25 mg), or placebo once a day at bedtime for 12 weeks.
Primary Outcome Measure: The number of migraine days per month during the last month of treatment compared with the number at baseline.
Key Findings: The mean reduction in the number of migraine days was 2.7 with melatonin, 2.2 with amitriptyline, and 1.1 with placebo (p < 0.01 for melatonin vs. placebo). The proportion of patients with a greater-than-50% reduction in the number of migraine days was 54.4% with melatonin, 39.1% with amitriptyline (p < 0.05 vs. melatonin), and 20.4% with placebo (p < 0.01 vs. melatonin). Practice Implications: Melatonin levels are low in patients with recurrent migraines. The results of the present study indicate that melatonin can decrease the frequency of migraines. The mechanism of action is not known.