April 9/New York/Reuters Health Medical News -- Treatment with high-dose omega-3 free fatty acids does not prevent relapse in patients with quiescent Crohn disease, according to results of two multinational clinical trials reported in the April 9 issue of the Journal of the American Medical Association.

Dr. Brian G. Feagan, at the University of Western Ontario in London, and colleagues conducted the randomized, double-blind, placebo-controlled trials at sites in Canada, the U.S., Europe and Israel. Study subjects were patients with Crohn disease in remission.

Active treatment comprised four daily 1g delayed-release soft gelatin capsules of omega-3 free fatty acids (Epanova), consisting of 50-60% eicosapentaenoic acid and 15-25% docosahexanoic acid. The placebo capsules contained 1g of medium-chain triglyceride oil.

The Epanova Program in Crohn's Study 1 (EPIC-1) included 363 patients. EPIC-2 included 375 patients whose disease activity was low after eight weeks of corticosteroid treatment; doses of corticosteroid were tapered and discontinued by week eight.

In neither trial was there a significant difference in relapse rates between the active treatment and placebo groups. Specifically, in ERIC-1, 32% of those receiving omega-3 fatty acids and 36% receiving placebo experienced a relapse within 360 days (p = 0.30). Corresponding rates in ERIC-2 were 48% and 49% (p = 0.48).

Dr. Feagan and his team contrast these findings with those obtained in a clinical trial reported in 1996, in which treatment with omega-3 fatty acids was associated with a 33% reduction in the Crohn disease relapse rate. They maintain that that study, which included 78 patients, was statistically underpowered.

"Our results are important," they say, "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." Given the negative EPIC results, "patients with Crohn disease who are at risk for relapse would be better served by taking medications of known efficacy."

From the April 14, 2008, Prepared Foods e-Flash