Eicosapentaenoic acid versus placebo as adjunctive therapy in chronic migraine: A randomized controlled trial.

ABSTRACT

OBJECTIVE: This study was conducted to assess the efficacy of daily 2000 mg eicosapentaenoic acid (EPA) supplementation in individuals with chronic migraine. BACKGROUND: 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. METHODS: 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]). RESULTS: 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. CONCLUSIONS: 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.