Rapid Review Alert April 18, 2012
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ADVANCES
 In EPA & DHA Research
Abstract

Objective:  To investigate whether omega-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 omega-3 fatty acids (n = 46) or placebo capsules (n = 46).

Interventions: Administration of 1350 mg of EPA and 850 mg of DHA 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 omega-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 omega-3 fatty acids (mean difference, 7.60; 95% CI, 5.57 to 7.91; P < .001) in the patients treated with omega-3 fatty acids compared with the placebo group.

Authors’ Conclusion: No beneficial effects on disease activity were detected from omega-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.

Rapid Review Alert
Sudden cardiac death
O-3s & Multiple Sclerosis

Review of:

Torkildsen O Wergeland S Bakke S Beiske AG Bjerve KS Hovdal H Midgard R Lilleas F Pedersen T Bjørnarå B Dalene F Kleveland G Schepel J Olsen IC and Myhr KM (published online April 16, 2012). w-3 fatty acid treatment in multiple sclerosis (OFAMS Study): A randomized, double-blind, placebo-controlled trial. Arch Neurol. doi:10.1001/archneurol.2012.283.


GOED Take-Aways

  • Results from past research (Mehta et al., 2009) investigating the potential benefits of EPA & DHA on Multiple Sclerosis (MS) disease progression are ambiguous at best and the results from the present study do nothing to clarify our understanding. 
  • The authors admitted that the “sample size did not have sufficient power to detect small and medium treatment effect sizes, both with respect to MRI and clinical disease activity.” Results from an under-powered study cannot be interpreted with any certainty.
  • As the authors mentioned, the data do not suggest that omega-3 fatty acid supplementation was harmful or interfered with the interferon beta-1a treatment.
  • Given that the totality of the scientific evidence on the cardiovascular benefits of EPA & DHA is overwhelmingly positive, the present results should not dissuade anyone with MS from taking EPA & DHA supplements or increasing their intake of fish high in EPA & DHA.

What Else Should You Know? 

  • The study was conducted in individuals diagnosed with relapsing-remitting MS only. There are three other courses of MS, including: primary progressive, secondary progressive and progressive relapsing. This study did not address the use of omega-3s in these three other courses.
  • Even if the ultimate conclusion is that EPA and DHA do not affect disease activity in relapsing-remitting MS, this does not mean that they don’t play a role in MS development. 

Suggested Citation

Global Organization for EPA and DHA Omega-3s (2012). Omega-3s & Multiple Sclerosis [Peer commentary on the paper “w-3 fatty acid treatment in multiple sclerosis (OFAMS Study): A randomized, double-blind, placebo-controlled trial” by Torkildsen O Wergeland S Bakke S Beiske AG Bjerve KS Hovdal H Midgard R Lilleas F Pedersen T Bjørnarå B Dalene F Kleveland G Schepel J Olsen IC and Myhr KM (published online April 16, 2012). Arch Neurol. doi:10.1001/archneurol.2012.283.].
 

Reference

Mehta LR Dworkin RH and Schwid SR (2009). Polyunsaturated fatty acids and their potential therapeutic role in multiple sclerosis. Nat Clin Pract Neurol 5(2):82-92.
 
 

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