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ω-3 Fatty Acid Treatment in Multiple Sclerosis (OFAMS Study): A Randomized, Double-Blind, Placebo-Controlled Trial.
MedLine Citation:
PMID:  22507886     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
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 Registration  clinicaltrials.gov Identifier: NCT00360906.
Authors:
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; Kjell-Morten Myhr
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-4-16
Journal Detail:
Title:  Archives of neurology     Volume:  -     ISSN:  1538-3687     ISO Abbreviation:  -     Publication Date:  2012 Apr 
Date Detail:
Created Date:  2012-4-17     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372436     Medline TA:  Arch Neurol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Department of Neurology, HaukelandUniversity Hospital (Drs Torkildsen, Wergeland, and Myhr), and Kristian Gerhard Jebsen MS Research Centre, Department of Clinical Medicine, University of Bergen (Dr Myhr), Bergen, Department of Neuroradiology, Oslo University Hospital (Dr Bakke), Curato Oslo (Dr Lilleås), and Smerud Medical Research International (Dr Olsen), Oslo, MS-Senteret Hakadal AS, Hakadal (Dr Beiske), Departments of Medical Biochemistry (Dr Bjerve) and Neurology (Dr Hovdal), Trondheim University Hospital, and Norwegian University of Science and Technology, Trondheim (Dr Bjerve), Department of Neurology, Molde Hospital, Molde (Dr Midgard), Unilabs Drammen, Drammen (Dr Pedersen), Helsehuset Kongsberg, Kongsberg (Dr Bjørnarå), Department of Neurology, Telemark Hospital, Skien (Dr Dalene), Department of Neurology, Lillehammer Hospital, Lillehammer (Dr Kleveland), and Department of Neurology, Haugesund Hospital, Haugesund (Dr Schepel).
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