NDLI: ω-3 Fatty Acid Treatment in Multiple Sclerosis (OFAMS Study): A Randomized, Double-Blind, Placebo-Controlled Trial

Content Provider	JAMA Network
Author	Torkildsen, Øivind Wergeland, Stig Bakke, Søren Beiske, Antonie G. Bjerve, Kristian S. Hovdal, Harald Midgard, Rune Lilleås, Finn Pedersen, Tom Bjørnarå, Bård Dalene, Frøydis Kleveland, Grethe Schepel, Jan Olsen, Inge Christoffer Myhr, Kjell-Morten
Copyright Year	2012
Abstract	Objective: To 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. Design: Multicenter, randomized, double-blind, placebo-controlled clinical trial conducted from 2004 to 2008. Setting: Thirteen public neurology departments in Norway. Participants: Patients 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). Interventions: Administration 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 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 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. 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. Trial Registrationclinicaltrials.gov Identifier: NCT00360906
Ending Page	1051
Starting Page	1044
Page Count	8
File Format	PDF HTM / HTML
ISSN	00039942
DOI	10.1001/archneurol.2012.283
Issue Number	8
Journal	Archives of Neurology
Volume Number	69
Language	English
Publisher	American Medical Association
Publisher Date	2012-08-01
Access Restriction	Open
Subject Keyword	fatty acids multiple sclerosis magnetic resonance imaging
Content Type	Text
Resource Type	Article
Subject	1200/1201 Neurology (clinical)

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