Patients with Crohn disease who took omega-3 free fatty acids supplements did not have a significantly different rate of relapse compared to patients who took placebo, according to a study in the April 9 issue of JAMA.
Effective therapy to maintain remission in Crohn disease (a chronic inflammatory disease primarily involving the small and large intestine) is an unmet medical need, with the use of some immunosuppressive drugs associated with an increased risk of infection. Omega-3 free fatty acids are anti-inflammatory substances found in marine fish that have several health benefits and have been used to treat inflammatory disorders such as rheumatoid arthritis. Previous clinical trials that evaluated omega-3 free fatty acids for maintenance of remission in Crohn disease have yielded inconsistent results, according to background information in the article.
Brian G. Feagan, M.D., of Robarts Research Institute, University of Western Ontario, London, Ontario, and colleagues conducted two large-scale trials of high-dose omega-3 free fatty acids as maintenance therapy in patients with Crohn disease in remission. The studies (Epanova Program in Crohn's Study 1 [EPIC-1] and EPIC-2) were conducted between January 2003 and February 2007 at 98 centers in Canada, Europe, Israel and the United States. Data from 363 and 375 patients with Crohn disease in remission were evaluated in EPIC-1 and EPIC-2, respectively. Patients were randomly assigned to receive either 4 grams/day of omega-3 free fatty acids or placebo for up to 58 weeks. For EPIC-1, 188 patients were assigned to receive omega-3 free fatty acids and 186 patients to receive placebo. Corresponding numbers for EPIC-2 were 189 and 190 patients, respectively.
The researchers found that there was no significant difference in relapse rates observed between the two treatment groups in either trial. In EPIC-1, 54 patients treated with omega-3 free fatty acids and 62 patients treated with placebo experienced a clinical relapse. The proportion of patients assigned to receive omega-3 free fatty acids who experienced a relapse within 360 days was estimated to be 31.6 percent, compared with 35.7 percent for those who received placebo.
In EPIC-2, 84 patients treated with omega-3 free fatty acids and 94 patients treated with placebo experienced a clinical relapse. The proportion of patients assigned to receive omega-3 free fatty acids who experienced a relapse within 360 days was estimated to be 47.8 percent, compared with 48.8 percent of those who received placebo.
Serious adverse events were uncommon and mostly related to Crohn disease.
"Our results are important because the use of alternative medicines in general, and omega-3 free fatty acid formulations in particular, is widespread among patients with inflammatory bowel disease. This may be due, in part, to dissemination of the positive results obtained in [a trial by Belluzzi et al]. Given the negative results observed in the EPIC trials and in [a trial by Lorenz-Meyer et al], we do not endorse this practice, since patients with Crohn disease who are at risk for relapse would be better served by taking medications of known efficacy," the authors write.
(JAMA. 2008;299:1690-1697. Available pre-embargo to the media at www.jamamedia.org)
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