Administration of omega-3 fatty acid supplements did not appear to improve the rate of relapse in patients with Crohn’s disease, according to a study released on April 9, 2008 in JAMA.
Crohn’s Disease is a gastrointestinal disorder which is indicated by chronic inflammation of the wall of the digestive tract, usually in the ileum or large intestines. The disease involves constant cycles of flare-ups and remission throughout the life of the patient, and without proper treatment, must be addressed surgically. It is considered an inflammatory bowel disease (IBD), similar to ulcerative colitis. Therapy to induce remission in Crohn’s disease is an unmet medical need, usually attempted with the use of certain immunosuppressive drugs, which are associated with infection and other risks. Many Crohn’s patients turn to alternative medications in the face of disappointing overall results.
Omega-3 fatty acids unsaturated fatty acids usually found in marine fish. They have anti-inflammatory properties, and have been used to treat some inflammatory disorders such as rheumatoid arthritis. Earlier studies have evalued omega-3 fatty acids for the maintenance of remission in Crohn’s disease, but have had inconsistent results.
To attempt to rectify this, Brian G. Feagan, M.D., of the Robarts Research Institute, University of Western Ontario, London, Ontario, and colleagues performed two large trials of high-dose omega-3 free fatty acids as therapy in Crohn’s patients who were in remission. The studies, called the Epanova Program in Crohn’s Study 1 and 2 [EPIC-1 and EPIC-2], were conducted between January 2003 and February 2007 at 98 different centers in Canada, Europe, Israel, and the United States. There were 363 and 375 patients involved respectively, all with Crohn’s disease which was in remission at the time. Patients were randomly assigned in approximately equal numbers to either a group administered four grams per day of omega-3 fatty acids or a placebo, to be taken for up to 58 weeks.
There was no significant difference found in the relapse rates between the two treatment groups in either of the trials. In EPIC-1, 54 patients treated with the fatty acids and 62 patients with placebo experienced a clinical relapse. The set of patients experiencing a relapse within 360 days in the omega-3 group was estimated to be 31.6%, compared with 35.7% in the placebo group. EPIC-2 had 84 patients who were treated with omega-3 fatty acids and 94 who took the placebo experienced relapse. The set of patients experiencing a relapse within 360 days in the omega-3 group was estimated to be 47.8%, in contrast with 48.8% in the placebo group.
Any serious adverse events were uncommon, and those that did occur were mostly related to Crohn’s disease itself.
The researchers believe that this conclusion is significant because it has serious implications on the self treatment of Crohn’s patients. “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,” they write.
Omega-3 Free Fatty Acids for the Maintenance of Remission in Crohn Disease: The EPIC Randomized Controlled Trials
Brian G. Feagan; William J. Sandborn; Ulrich Mittmann; Simon Bar-Meir; Geert D’Haens; Marc Bradette; Albert Cohen; Chrystian Dallaire; Terry P. Ponich; John W. D. McDonald; Xavier Hébuterne; Pierre Paré; Pavel Klvana; Yaron Niv; Sandro Ardizzone; Olga Alexeeva; Alaa Rostom; Gediminas Kiudelis; Johannes Spleiss; Denise Gilgen; Margaret K. Vandervoort; Cindy J. Wong; Guang Yong Zou; Allan Donner; Paul Rutgeerts
JAMA. 2008;299(14):1690-1697.
Written by Anna Sophia McKenney