• Oivind Torkildsen, Stig Wergeland, Søren Bakke, Antonie G Beiske, Kristian S Bjerve, Harald Hovdal, Rune Midgard, Finn Lilleås, Tom Pedersen, Bård Bjørnarå, Frøydis Dalene, Grethe Kleveland, Jan Schepel, Inge Christoffer Olsen, and Kjell-Morten Myhr.
• Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital, Norway. oivind.torkildsen@gmail.com
• Arch. Neurol. 2012 Aug 1; 69 (8): 1044-51.

ObjectiveTo investigate whether ω-3 fatty acids reduce magnetic resonance imaging (MRI) and clinical disease activity in patients with multiple sclerosis, both as monotherapy and in combination with interferon beta-1a treatment.DesignMulticenter, randomized, double-blind, placebo-controlled clinical trial conducted from 2004 to 2008.SettingThirteen public neurology departments in Norway.ParticipantsPatients 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 patients were randomized to ω-3 fatty acids (n = 46) or placebo capsules (n = 46).InterventionsAdministration of 1350 mg of eicosapentaenoic acid and 850 mg of docosahexaenoic acid daily or placebo. After 6 months, all patients in addition received subcutaneously 44 μg of interferon beta-1a 3 times per week for another 18 months.Main Outcome MeasureThe 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.ResultsThe 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 patients 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 patients treated with ω-3 fatty acids compared with the placebo group.ConclusionNo 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. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00360906.

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