Friday, 26 April 2013

Negative omega-3 fatty acid trial

A omega-3 fatty acid trial in MS #MSBlog #MSResearch

"A negative omega-3 or fish oil study in MS. What do you make of  this? Could this study have been a type 2 error, i.e. a false negative study? Clearly more work needs to be done to sort out the issue. Essential fatty acids are complex oils and there is a lot of science that needs to be explained."

Torkildsen et al. ω-3 fatty acid treatment in multiple sclerosis (OFAMS Study): a randomized, double-blind, placebo-controlled trial. Arch Neurol. 2012 Aug;69(8):1044-51. 

OBJECTIVE: To investigate whether ω-3 fatty acids reduce magnetic resonance imaging (MRI) and clinical disease activity in MSers, 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: MSers 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 MSers 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 MSers 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 MSers 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 MSers 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.

3 comments:

  1. Could it be the trial wasn't long enough to see effects? Not sure you'd expect to see any difference on relapse rate but done for longer might see something on progression but effects likely to be subtle anyway.

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  2. What was the placebo? Also, perhaps w3's have a benefit when recovering from a relapse (remyelinating), how many relapses were there?

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  3. The placebo was corn oil in capsules. The Omega 6 to Omega 3 ratio is 49:1 in corn oil so a very low level of omega 3.
    A total of 65 relapses were recorded in 37 patients throughout the study period. There was no difference between the ω-3 fatty acids and placebo groups in number of relapses during the first 6 months of treatment or after 24 months. The proportion of relapse-free patients was 78% in the ω-3 fatty acids group and 82% in the placebo group after 6 months and 57% in the ω-3 fatty acids group vs 58% in the placebo group after 24 months.

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