Mohammadnezhad Ghader, Assarzadegan Farhad, Koosha Mohsen, Esmaily Hadi
Clinical Research Development Center, Imam Hossein Educational Hospital, shahid Beheshti University of Medical Sciences, Tehran, Iran.
Student Research Committee, School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.
Headache. 2025 Jan;65(1):153-163. doi: 10.1111/head.14808. Epub 2024 Sep 2.
This study was conducted to assess the efficacy of daily 2000 mg eicosapentaenoic acid (EPA) supplementation in individuals with chronic migraine.
Chronic migraine is characterized by a minimum of 15 headache days/month, necessitating a focus on preventive treatment strategies. EPA, a polyunsaturated fatty acid recognized for its anti-inflammatory properties, is examined for its potential effectiveness in chronic migraine management.
A randomized, blinded, placebo-controlled trial of eligible participants with a confirmed diagnosis of chronic migraine were enrolled. The intervention group received 1000 mg of EPA twice daily for 8 weeks, while the control group received two placebo softgels. Symptoms were recorded at 4 and 8 weeks. The primary outcome was assessed using the Headache Impact Test-6 to evaluate changes in patients. Secondary outcomes encompassed migraine headache days, headache severity measured via a visual analog scale, and the number of consumed painkillers. Descriptive analyses were reported in mean (± standard deviation [SD]).
A total of 60 patients were included in the study and finally, 56 patients completed the study according to the protocol, including 47 (84%) females. The data comparison at baseline did not show any significant difference between the two groups except in the number of patients using valproic acid as prophylaxis (21 patients in the EPA group, and 13 in the placebo group; p = 0.037). The results showed after 8 weeks, a mean (SD) difference of Headache Impact Test-6 in the EPA and placebo groups was -6.96 (3.34) and -4.43 (5.24), respectively (p = 0.084). Regarding migraine headache days, participants reported a mean (SD) -9.76 (4.15) and -4.60 (4.87) decline in days with headache, respectively (p < 0.001). The number of attacks per month after 8 weeks was 3.0 (95% confidence interval [CI] 2.0-4.0) and 4.0 (95% CI 3.0-6.0), respectively (p < 0.001). Regarding severity, there was no significant difference between the two groups (mean [SD] difference: -0.76 [1.13] and -0.73 [1.04], respectively; p = 0.906). In terms of adverse events, two patients in the EPA group reported intolerable nausea and vomiting, and one patient in the placebo group reported dizziness.
This study's findings support the potential of a daily 2000 mg EPA as a prophylactic pharmacotherapy in chronic migraine management, specifically in mitigating migraine attacks, migraine headache days, and overall quality of life.
本研究旨在评估每日补充2000毫克二十碳五烯酸（EPA）对慢性偏头痛患者的疗效。
慢性偏头痛的特征是每月至少有15天头痛发作，因此需要关注预防性治疗策略。EPA是一种因其抗炎特性而闻名的多不饱和脂肪酸，现对其在慢性偏头痛管理中的潜在效果进行研究。
对确诊为慢性偏头痛的符合条件的参与者进行一项随机、双盲、安慰剂对照试验。干预组每天两次服用1000毫克EPA，持续8周，而对照组服用两粒安慰剂软胶囊。在第4周和第8周记录症状。使用头痛影响测试-6评估主要结局以评估患者的变化。次要结局包括偏头痛头痛天数、通过视觉模拟量表测量的头痛严重程度以及服用止痛药的数量。描述性分析以平均值（±标准差[SD]）报告。
共有60名患者纳入研究，最终，56名患者按照方案完成研究，其中包括47名（84%）女性。除了使用丙戊酸作为预防性药物的患者数量外，两组在基线时的数据比较未显示出任何显著差异（EPA组21名患者，安慰剂组13名患者；p = 0.037）。结果显示，8周后，EPA组和安慰剂组头痛影响测试-6的平均（SD）差异分别为-6.96（3.34）和-4.43（5.24）（p = 0.084）。关于偏头痛头痛天数，参与者报告头痛天数平均（SD）分别减少了-9.76（4.15）和-4.60（4.87）（p < 0.001）。8周后每月发作次数分别为3.0次（95%置信区间[CI] 2.0 - 4.0）和4.0次（95%CI 3.0 - 6.0）（p < 0.001）。关于严重程度，两组之间无显著差异（平均[SD]差异分别为-0.76[1.13]和-0.73[1.04]；p = 0.906）。在不良事件方面，EPA组有两名患者报告了无法忍受的恶心和呕吐，安慰剂组有一名患者报告了头晕。
本研究结果支持每日2000毫克EPA作为慢性偏头痛管理中的预防性药物治疗的潜力，特别是在减轻偏头痛发作、偏头痛头痛天数和总体生活质量方面。
