A new study has found that omega-3 fatty acids don't prevent a relapse of symptoms for patients with Crohn's disease.

The study held two trials with more than 700 participants in Europe, Israel, Canada and the United States. The study subjects all had their symptoms in remission at the time of the study.

In both trials, the relapse rate after one year was similar for those taking omega-3 and those taking a placebo.

In the first trial, the one-year relapse rate was:

  • 32 per cent for those who took omega-3
  • 36 per cent for those who took a placebo

In the second trial, the one-year relapse rate was:

  • 48 per cent among those who took omega-3
  • 49 per cent for those who took a placebo

"A significant amount of time and money is spent annually on alternative therapies such as omega-3 fatty acids, without strong evidence that they are beneficial to patients with inflammatory bowel disease," gastroenterologist Dr. Brian Feagan, lead author on the study, said in a statement.

"I encourage Crohn's patients to focus on prescription medications that we know are effective for preventing relapse of disease, such as azathioprine, methotrexate and TNF blockers."

However, study subjects who took omega-3 were found to have very low triglyceride levels -- a high reading is known to be a risk factor for heart disease.

Omega-3 fatty acids, found in fatty fish such as salmon, mackerel, herring and sardines, offer anti-inflammatory benefits for a variety of inflammatory illnesses, such rheumatoid arthritis.

Crohn's disease is a chronic illness characterized by inflammation in the large and small intestine. It has no cure, and often a variety of treatments are tried on a patient, including immunosuppressive drugs, which can lead to infections.

More than 10 years ago, a small Italian study had suggested that omega-3 alleviates the symptoms of Crohn's disease. But Feagan and his team conducted a larger study to test this theory.

"Small, single-centre clinical trials often overestimate the true effects of treatment," Feagan said. "That's why it is important to conduct large-scale, randomized, multi-centre studies in order to confirm preliminary results."

The research, by an international team led by Feagan of Robarts Research Institute at the University of Western Ontario in London, Ont., was published in the April 9 edition of the Journal of the American Medical Association.

Abstract:

Omega-3 Free Fatty Acids for theMaintenance of Remission in Crohn Disease 

The EPIC Randomized Controlled Trials

Context Maintenance therapy for Crohn disease features the use of immunosuppressive drugs, which are associated with an increased risk of infection. Identification of safe and effective maintenance strategies is a priority.

Objective To determine whether the oral administration of omega-3 free fatty acids is more effective than placebo for prevention of relapse of Crohn disease.

Design, Setting, and Patients Two randomized, double-blind, placebocontrolled studies (Epanova Program in Crohn's Study 1 [EPIC-1] and EPIC-2) 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 quiescent Crohn disease were evaluated in EPIC-1 and EPIC-2, respectively.

Interventions Patients with a Crohn's Disease Activity Index (CDAI) score of less than 150 were randomly assigned to receive either 4 g/d of omega-3 free fatty acids or placebo for up to 58 weeks. No other treatments for Crohn disease were permitted.

Main Outcome Measure Clinical relapse, as defined by a CDAI score of 150 points or greater and an increase of more than 70 points from the baseline value, or initiation of treatment for active Crohn disease.

Results 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 rate of relapse at 1 year in EPIC-1 was 31.6% in patients who received omega-3 free fatty acids and 35.7% in those who received placebo (hazard ratio, 0.82; 95% confidence interval, 0.51-1.19; P=.30). Corresponding values for EPIC-2 were 47.8% and 48.8% (hazard ratio, 0.90; 95% confidence interval, 0.67-1.21; P=.48). Serious adverse events were uncommon and mostly related to Crohn disease.

Conclusion In these trials, treatment with omega-3 free fatty acids was not effective for the prevention of relapse in Crohn disease.