Omega-3 Free Fatty Acids for the Maintenance of Remission in Crohn's Disease
Omega-3 Free Fatty Acids for the Maintenance of Remission in Crohn's Disease
Abstract & Commentary
By Malcolm Robinson MD, FACP, FACG, Emeritus Clinical Professor of Medicine, University of Oklahoma College of Medicine, Oklahoma City. Dr. Robinson reports no financial relationship to this field of study.
Synopsis: Despite previous positive reports and much lay enthusiasm, omega-3 fatty acid treatment did not prevent Crohn's disease relapse. (Arguments continue as to whether the correct usage should be "Crohn disease" or "Crohn's disease." Most of the literature seems to use the latter designation, and this review will do likewise.)
Source: Feagan Brian, et al. JAMA. 2008;299:14:1690-1697.
Current Crohn's disease treatment with steroids, antimetabolites, methotrexate, and TNFa antagonists can help maintain remission, but their use is hazardous (including risk of infection). Omega-3 fatty acids are anti-inflammatory components of marine fish that have been used for treatment of such diseases as rheumatoid arthritis. However, use of omega-3 fatty acids in Crohn's disease has not been consistently effective. One trial suggested that such therapy could reduce recurrence of active disease by 33%, but another found no benefit vs placebo. To definitively determine the utility of omega-3 fatty acids in the prophylaxis of recurrent disease, two randomized double-blind placebo-controlled international studies were conducted between 2003 and 2007 in 98 centers. Ultimately, 377 patients with currently inactive Crohn's disease (but who had had an exacerbation within the past year) received 1 gram q.i.d. of omega-3 fatty acids and 376 got matching placebo for up to 58 weeks. CDAI Crohn's Disease Activity Index had to be < 150 at baseline. About half of the patients had been treated with a tapering course of prednisone or budesonide to attain "inactive disease" status prior to entry. The manufacturer of the omega-3 fatty acid preparation financed this large trial and continued to be involved in the design of the study and its interpretation although the distinguished group of investigators seemed primarily responsible. Trials were designed to detect a 15% reduction in relapse rate with 80% power at the .05 significance level. Various problems were encountered including the exclusion of one site that frequently violated the terms of the protocol. The bottom line for results is that there was absolutely no difference between the omega-3 fatty acids and placebo in preserving Crohn's disease remission in these patients regardless of patient subgroups. Adherence to therapy was acceptably high.
As expected from the known properties of the active study drug, serum triglycerides fell vs placebo. Adverse events were uncommon. Authors speculated that the earlier successful report had involved only patients with elevated acute phase reactants at baseline, and the current study might not have enrolled patients at sufficiently high risk of relapse. However, the large subgroup brought into remission with steroids prior to enrollment should have been at an overall high risk of recurrence, and they did no better than the other subgroup that may have been less at risk.
Commentary
The authors of this manuscript commented on the wide use of alternative medicines such as omega-3 fatty acids (and many others) in inflammatory bowel disease patients. Furthermore, such usages are often taking place without the knowledge of treating physicians. Sadly, many patients are self-treating their inflammatory bowel disease with these unproved agents instead of medications that are of proven value for the acute and maintenance treatment of Crohn's disease and ulcerative colitis. We can conclude that omega-3 fatty acids are ineffective for the maintenance of remission in Crohn's disease. Perhaps even more important is the general principle that patients should be closely questioned about their possible use of herbal preparations and other forms of alternative therapy. Physicians should become aware of the literature in this area so they can speak with authority about the actual data that exists in this otherwise cloudy medical arena.
Despite previous positive reports and much lay enthusiasm, omega-3 fatty acid treatment did not prevent Crohn's disease relapse. (Arguments continue as to whether the correct usage should be "Crohn disease" or "Crohn's disease." Most of the literature seems to use the latter designation, and this review will do likewise.)Subscribe Now for Access
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