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 REGISTRATION clinicaltrials.gov Identifier: NCT00360906.

Links

Publisher Full Text

Authors

Torkildsen O, Wergeland S, Bakke S, Beiske AG, Bjerve KS, Hovdal H, Midgard R, Lilleås F, Pedersen T, Bjørnarå B, Dalene F, Kleveland G, Schepel J, Olsen IC, Myhr KM

Institution

Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital, Norway. oivind.torkildsen@gmail.com

Source

Archives of neurology 69:8 2012 Aug pg 1044-51

MeSH

Adult
Dietary Supplements
Double-Blind Method
Drug Therapy, Combination
Fatty Acids, Omega-3
Female
Humans
Interferon-beta
Magnetic Resonance Imaging
Male
Middle Aged
Multiple Sclerosis
Treatment Outcome

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22507886