The Effect of Melatonin on Reducing the Frequency and Severity of Migraine Attacks: A Double-Blind, Randomized Clinical Trial.

IF 1.6 Q2 MEDICINE, GENERAL & INTERNAL Iranian Journal of Medical Sciences Pub Date : 2024-05-01 DOI:10.30476/ijms.2023.97782.2965
Asieh Mehramiri, Davood Shalilahmadi, Seyed Ehsan Mohamadianinejad, Leila Kouti, Yazdan Hosseinpour
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Abstract

Background: There is no definite recommendation for melatonin supplementation in episodic migraine. This study aimed to evaluate the effect of melatonin on reducing the frequency and severity of migraine attacks.

Methods: This randomized, double-blind clinical trial was conducted at Golestan Hospital of Ahvaz, Iran, in 2021. A total of 60 patients with episodic migraine were randomly assigned into 2 groups of receiving 3 mg melatonin (intervention group; n=30) or the same dose of placebo (control group; n=30) along with baseline therapy (propranolol 20 mg, BID) for two months. The attack frequency, attack duration, attack severity (based on VAS), the number of analgesic intakes, drug complications, Migraine Disability Assessment score (MIDAS), and Pittsburgh sleep quality index (PSQI) were evaluated at baseline and in the first, second, third, and fourth months of follow-up. The independent t test, chi-square, and analysis of variance (ANOVA) with repeated measures were used to compare variables between the two groups.

Results: In both groups, the frequency, duration, and severity of attacks, taking analgesics, MIDAS, and PSQI scores during follow-up decreased significantly (P<0.001). After treatment, the mean frequency (P=0.032) and duration of attacks (P=0.001), taking analgesic (P<0.001), and MIDAS (P<0.001) and PSQI scores (P<0.001) in the melatonin group were lower than placebo. Only the attack severity was not significantly different between the two groups (P=0.126). Side effects were observed in two patients (6.7%) in the melatonin group and one patient (3.3%) in the placebo group (P>0.999).

Conclusion: Our study shows that melatonin was more efficacious than the placebo in the reduction of frequency and duration of migraine attacks. It was equally safe as the placebo and might be effective in the preventive treatment of episodic migraine in adults.Trial Registration Number: IRCT20190107042264N5.

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褪黑素对降低偏头痛发作频率和严重程度的影响:双盲随机临床试验。
背景:对于发作性偏头痛患者补充褪黑素,目前还没有明确的建议。本研究旨在评估褪黑激素对降低偏头痛发作频率和严重程度的效果:这项随机双盲临床试验于 2021 年在伊朗阿瓦士戈勒斯坦医院进行。共有 60 名发作性偏头痛患者被随机分配到两组,分别接受 3 毫克褪黑素(干预组;30 人)或相同剂量的安慰剂(对照组;30 人),同时接受为期两个月的基线治疗(普萘洛尔 20 毫克,每日两次)。在基线期和随访的第一、第二、第三和第四个月,对患者的发作频率、发作持续时间、发作严重程度(基于 VAS)、镇痛剂服用次数、药物并发症、偏头痛残疾评估评分(MIDAS)和匹兹堡睡眠质量指数(PSQI)进行了评估。采用独立t检验、卡方检验和重复测量方差分析(ANOVA)来比较两组之间的变量:结果:两组患者在随访期间的发作频率、持续时间和严重程度、服用镇痛药、MIDAS 和 PSQI 评分均显著下降(P0.999):我们的研究表明,在减少偏头痛发作频率和持续时间方面,褪黑素比安慰剂更有效。试验登记号:IRCT20190107042264N5。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Iranian Journal of Medical Sciences
Iranian Journal of Medical Sciences MEDICINE, GENERAL & INTERNAL-
CiteScore
3.20
自引率
0.00%
发文量
84
审稿时长
12 weeks
期刊介绍: The Iranian Journal of Medical Sciences (IJMS) is an international quarterly biomedical publication, which is sponsored by Shiraz University of Medical Sciences. The IJMS intends to provide a scientific medium of com­muni­cation for researchers throughout the globe. The journal welcomes original clinical articles as well as clinically oriented basic science re­search experiences on prevalent diseases in the region and analysis of various regional problems.
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