Randomised clinical trial comparing melatonin 3 mg, amitriptyline 25 mg and placebo for migraine prevention

Randomised clinical trial comparing melatonin 3 mg, amitriptyline 25 mg and placebo for migraine prevention

Author Goncalves, Andre Leite Autor UNIFESP Google Scholar
Ferreira, Adriana Martini Google Scholar
Ribeiro, Reinaldo Teixeira Autor UNIFESP Google Scholar
Zukerman, Eliova Google Scholar
Cipolla-Neto, Jose Google Scholar
Prieto Peres, Mario Fernando Google Scholar
Abstract Introduction Melatonin has been studied in headache disorders. Amitriptyline is efficacious for migraine prevention, but its unfavourable side effect profile limits its use. Methods A randomised, double-blind, placebo-controlled study was carried out. Men and women, aged 18-65 years, with migraine with or without aura, experiencing 2-8 attacks per month, were enrolled. After a 4-week baseline phase, 196 participants were randomised to placebo, amitriptyline 25 mg or melatonin 3 mg, and 178 took a study medication and were followed for 3 months (12 weeks). The primary outcome was the number of migraine headache days per month at baseline versus last month. Secondary end points were responder rate, migraine intensity, duration and analgesic use. Tolerability was also compared between groups. Results Mean headache frequency reduction was 2.7 migraine headache days in the melatonin group, 2.2 for amitriptyline and 1.1 for placebo. Melatonin significantly reduced headache frequency compared with placebo (p=0.009), but not to amitriptyline (p=0.19). Melatonin was superior to amitriptyline in the percentage of patients with a greater than 50% reduction in migraine frequency. Melatonin was better tolerated than amitriptyline. Weight loss was found in the melatonin group, a slight weight gain in placebo and significantly for amitriptyline users. Conclusions Melatonin 3 mg is better than placebo for migraine prevention, more tolerable than amitriptyline and as effective as amitriptyline 25 mg.
xmlui.dri2xhtml.METS-1.0.item-coverage London
Language English
Sponsor Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)
Grant number FAPESP: 0854258-0
FAPESP: 2014/50457-0
Date 2016
Published in Journal Of Neurology Neurosurgery And Psychiatry. London, v. 87, n. 10, p. 1127-1132, 2016.
ISSN 0022-3050 (Sherpa/Romeo, impact factor)
Publisher Bmj Publishing Group
Extent 1127-1132
Origin http://dx.doi.org/10.1136/jnnp-2016-313458
Access rights Closed access
Type Article
Web of Science ID WOS:000383991400014
URI https://repositorio.unifesp.br/handle/11600/57036

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