OBJECTIVE: To investigate whether ω-3 fatty acids reduce magnetic resonance imaging (MRI) and clinical disease activity in MSers, both as monotherapy and in combination with interferon beta-1a treatment.
SETTING: Thirteen public neurology departments in Norway.
PARTICIPANTS: MSers aged 18 to 55 years with active relapsing-remitting multiple sclerosis, with a disability score equivalent to 5.0 or less on the Kurtzke Expanded Disability Status Scale. Ninety-two MSers were randomized to ω-3 fatty acids (n = 46) or placebo capsules (n = 46).
INTERVENTIONS: Administration of 1350 mg of eicosapentaenoic acid and 850 mg of docosahexaenoic acid daily or placebo. After 6 months, all MSers in addition received subcutaneously 44 μg of interferon beta-1a 3 times per week for another 18 months.
MAIN OUTCOME MEASURE: The primary outcome measure was MRI disease activity as measured by the number of new T1-weighted gadolinium-enhancing lesions during the first 6 months. Secondary outcome measures included MRI disease activity after 9 months and 24 months, relapse rate, disability progression, fatigue, quality of life, and safety.
RESULTS: The cumulative number of gadolinium-enhancing MRI lesions during the first 6 months were similar in the ω-3 fatty acids and placebo groups (median difference, 1; 95% CI, 0 to 3; P = .09). No difference in relapse rate was detected after 6 (median difference, 0; 95% CI, 0 to 0; P = .54) or 24 (median difference, 0; 95% CI, 0 to 0; P = .72) months. The proportion of MSers without disability progression was 70% in both groups (P > .99). No differences were detected in fatigue or quality-of-life scores, and no safety concerns appeared. Serum analyses of fatty acids showed an increase in ω-3 fatty acids (mean difference, 7.60; 95% CI, 5.57 to 7.91; P < .001) in the MSers treated with ω-3 fatty acids compared with the placebo group.
CONCLUSION: No beneficial effects on disease activity were detected from ω-3 fatty acids when compared with placebo as monotherapy or in combination with interferon beta-1a. Magnetic resonance imaging disease activity was reduced as expected by interferon beta-1a.