A Randomized Clinical Trial Comparing the Efficacy of Melatonin and Amitriptyline in Migraine Prophylaxis of Children
Abstract
Objective: The aim of the present research was to compare the effectiveness and tolerability of melatonin and amitriptyline in pediatric migraine prevention. Materials & Methods: In a parallel single-blinded randomized clinical trial, 5-15 yr old children with diagnosis of migraine that preventive therapy was indicated in whom and were referred to Pediatric Neurology Clinic of Shahid Sadoughi Medical Sciences University, Yazd-Iran from 2013-2014, were randomly allocated to receive 1 mg/kg amitriptyline or 0.3 mg/kg melatonin for three consecutive months. Results: Forty one girls (51.3%) and 39 boys (48.7%) with mean age of 10.44±2.26 yr were evaluated. Good response was seen in 82.5% of amitriptyline and 62%.5 of melatonin groups and amitriptyline was statistically significant more effective (P=0.04). Severity, duration and Pediatric Migraine Disability Assessment score (PedMIDAS) of headache reduced with melatonin from 6.05±1.63 to 4.03±1.54 scores, from 2.06±1.18 to 1.41± 0.41 hours, and from 33.13±9.17 to 23.38±9.51 scores, respectively. Severity, duration and PedMIDAS of headache decreased with amitriptyline from 6.41±1.67to 2.25±1.21, from 2.55 ±1.85to 0.56±0.51h, and from 31.4±9.33 to 8.28 ± 3.75, respectively (All P < 0.05). Both drugs were effective in reduction of monthly frequency, severity, duration and disability of headache. Daily sleepiness was seen in 7.5% of melatonin group as a side effect and adverse events were seen in 22.5% of amitriptyline group…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 15 participants or records.
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