title: ω-3 fatty acid treatment in multiple sclerosis (OFAMS Study): a randomized, double-blind, placebo-controlled trial.
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.
  
  
  METHODS
  Multicenter, randomized, double-blind, placebo-controlled clinical trial conducted from 2004 to 2008.
  
  
  METHODS
  Thirteen public neurology departments in Norway.
  
  
  METHODS
  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).
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Norwegian Multiple Sclerosis Competence Centre, Department of Neurology, Haukeland University Hospital, Norway. oivind.torkildsen@gmail.com
authors.forename: Oivind
authors.initials: O
authors.lastname: Torkildsen
authors.forename: Stig
authors.initials: S
authors.lastname: Wergeland
authors.forename: Søren
authors.initials: S
authors.lastname: Bakke
authors.forename: Antonie G
authors.initials: AG
authors.lastname: Beiske
authors.forename: Kristian S
authors.initials: KS
authors.lastname: Bjerve
authors.forename: Harald
authors.initials: H
authors.lastname: Hovdal
authors.forename: Rune
authors.initials: R
authors.lastname: Midgard
authors.forename: Finn
authors.initials: F
authors.lastname: Lilleås
authors.forename: Tom
authors.initials: T
authors.lastname: Pedersen
authors.forename: Bård
authors.initials: B
authors.lastname: Bjørnarå
authors.forename: Frøydis
authors.initials: F
authors.lastname: Dalene
authors.forename: Grethe
authors.initials: G
authors.lastname: Kleveland
authors.forename: Jan
authors.initials: J
authors.lastname: Schepel
authors.forename: Inge Christoffer
authors.initials: IC
authors.lastname: Olsen
authors.forename: Kjell-Morten
authors.initials: KM
authors.lastname: Myhr
mesh_terms: D000328:Adult; D019587:Dietary Supplements; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D000068556:Interferon beta-1a; D016899:Interferon-beta / Q000008:administration & dosage; D008279:Magnetic Resonance Imaging / Q000639:trends; D008297:Male; D008875:Middle Aged; D009103:Multiple Sclerosis / Q000188:drug therapy* / Q000453:epidemiology / Q000473:pathology*; D016896:Treatment Outcome
chemical_list: D015525:Fatty Acids, Omega-3; D016899:Interferon-beta; D000068556:Interferon beta-1a