Comparative Efficacy and Safety Melatonin vs Placebo or Amitriptyline in Migraine: A Systematic Review and Meta-Analysis
Mohamed A. Aldemerdash1, Moaz Elsayed2, Ahmed Aldemerdash1, Ahmed S.A. Osman3, Esraa M. AlEdani4, Abdallah Ahmad Khatatbeh5, Salma allam6, Abdallah Abbas7, Amro Elrefaei8
1Faculty of Medicine, Sohag University, Sohag, Egypt, 2Faculty of Medicine, Cairo University, Cairo, Egypt., 3Faculty of medicine Minia University Egypt, 4University of Basra-faculty of medicine, Basrah, Iraq, 5Faculty of medicine, Ain Shams university MD at Prince Al-Hussein bin Abdullah hospital Amman Jordan., 6Faculty of Medicine,Galala University, SuezEgypt, 7Faculty of Medicine, Al-Azhar University, Damietta, Egypt., 8Medical College of Wisconsin Affiliated Hospitals
Objective:
This study aimed to conduct a systematic review and meta-analysis to assess the safety and efficacy of melatonin in the treatment of migraine patients.
Background:
Migraine is a chronic, disabling condition affecting over a billion individuals worldwide. Melatonin, a naturally occurring hormone, has shown promise in managing migraine due to its antioxidant, analgesic, and anti-inflammatory properties.
Design/Methods:
A systematic search was performed across PubMed, Cochrane, Scopus, Embase, and Web of Science databases on September 29, 2024. We included randomized controlled trials (RCTs) comparing melatonin with placebo or amitriptyline. Eligible studies were screened using Rayyan.ai, and data were extracted and synthesized using R version 4.2.2.
Results:
Nine RCTs with 788 participants met the inclusion criteria. Compared to placebo, melatonin significantly reduced migraine attack duration (MD = -4.98 hours, 95% CI: -9.3, -0.67, p = 0.02), migraine headache days (MD=-1.89 days. ,95% CI: -2.69, -1.1, p < 0.01), headache severity (MD=-2.52 ,95% CI: -3.48, -1.56, p < 0.01), Number of analgesic usages by (MD=-1.38. ,95% CI: -2.41, -0.36, p < 0.01), and headache frequency (MD=-1.26. ,95% CI: -1.69, -0.83, p < 0.01) with no heterogeneity. It also improved the response rate (RR = 1.38, 95% CI: 1.11, 1.7, p < 0.01). Compared to amitriptyline, melatonin was less effective in reducing attack duration, frequency, and attack severity (P< 0.01). However, melatonin had a better safety profile, showing a 51% reduction in sleepiness compared to amitriptyline (RR = 0.49, 95% CI: 0.28, 0.87, p = 0.01).
Conclusions:
Melatonin is an effective and safe alternative to placebo for reducing migraine frequency and duration, with a better safety profile compared to amitriptyline. However, it may be less effective than amitriptyline for some efficacy outcomes. Further research is needed to explore melatonin’s role as a primary or adjunctive therapy in migraine management.
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