Double-Blind, Placebo Controlled, Randomized Clinical Trial Comparing Melatonin 3 mg, Amitriptyline 25 mg and Placebo for Migraine Prevention (S40.005)
Abstract
OBJECTIVE: To test the efficacy and tolerability of melatonin 3 mg and amitriptyline 25 mg compared to placebo in migraine prevention. BACKGROUND: Melatonin has been linked to migraine mechanisms in several ways. Previous reports have shown therapeutic effects on migraine and other headache disorders. Amitriptyline has been widely used for migraine prevention, but its unfavorable side effect profile limits its use. Better tolerable options in migraine prophylaxis are necessary. DESIGN/METHODS: A randomized, double-blind, placebo-controlled multicentric study was carried out. Men and women, aged 18-65 years, with migraine with or without aura, experiencing 2-8 attacks per month, were recruited from the general population. After a 4-week baseline phase, 196 subjects were randomized to receive either placebo, amitriptylne 25 mg or melatonin 3 mg for 3 months. The primary outcome was migraine frequency in number of headache days per month. Secondary endpoints were migraine intensity, duration, and analgesic use. Tolerability were also measured in the three groups. RESULTS: One hundred seventy nine subjects completed the study. Mean reduction in headache frequency was 2.7 in the melatonin group, 2.18 for amitriptyline, and 1.18 for placebo. Melatonin significantly reduced headache frequency compared to placebo (p=0,009), but not to amitriptyline (p=0,19). Melatonin was as tolerable as placebo and better tolerable when compared to amitriptyline. CONCLUSIONS: This study showed that…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 196 participants or records.
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