Are omega-3 free fatty acids useful in the prevention of relapse in Crohn disease?

Daily supplementation with omega-3 free fatty acids (FFAs) was no more effective than placebo in the prevention of relapse in Crohn disease. (LOE = 1b)

Feagan BG, Sandborn WJ, Mittmann U, et al. Omega-3 free fatty acids for the maintenance of remission in Crohn disease. The EPIC randomized controlled trials. JAMA 2008;299:1690-1697.  [PMID:18398081]

Randomized controlled trial (double-blinded)

Industry

Concealed

Outpatient (specialty)

Because of their anti-inflammatory effects omega-3 FFAs may be useful in the treatment of Crohn disease. These investigators, in 2 separate studies, randomized 363 patients (in study 1) and 375 patients (in study 2) with Crohn disease in a double-blind fashion (concealed allocation assignment) to receive four 1-g gelatin capsules of omega-3 FFAs or identical placebo daily for at least 52 weeks. Eligible patients included adults with confirmed Crohn disease and a score of less than 150 points on the previously validated Crohn Disease Activity Index (CDAI), consistent with disease remission for at least 3 months but not longer than 12 months. Individuals assessing outcomes remained masked to treatment group assignment. Complete follow-up occurred for 98% of patients for 1 year. Using intention-to-treat analysis, clinical relapse (defined as a CDAI score of 150 points or more and at least a 70-point increase from baseline value) occurred at a similar rate in both treatment groups of study 1 and study 2 (31.6% vs 35.7%; 47.8% vs 48.8%, respectively). Both studies were 80% powered to detect a 15% difference in relapse rates. No significant differences in adverse events were reported between the treatment groups.