Despite earlier promise from small trial, new study finds no effect
TUESDAY, April 8 (HealthDay News) -- Omega-3 free fatty acids don't help prevent relapses in patients with Crohn's disease, concluded two studies published in the April 9 issue of the Journal of the American Medical Association.
"These studies are quite definitive," said study lead author Dr. Brian Feagan, professor of medicine and director of Robarts Clinical Trials at the Robarts Research Institute, University of Western Ontario in London, Ontario, Canada. "The bottom line is, if you're looking to prevent a relapse of Crohn's disease, these are not effective and there are other drugs that work."
Other experts, however, wondered if the dosing used in the study had anything to do with it.
"Maybe there's a perfect dose and maybe this one was too high," said Dr. Timothy Pfanner, assistant professor of internal medicine at Texas A&M Health Science Center College of Medicine and a gastroenterologist with Scott & White. "There are a bunch of medications we use now in Crohn's disease that when you start going high, there's either no benefit or a diminishment of response."
Crohn's disease involves an inflammation of the gastrointestinal tract that most often affects the lower part of the small intestine. Swelling leads to pain and diarrhea. The disease can go into periodic remission but relapses can occur.
Although there are drugs available to help prevent relapse, there is still a need for safe and effective medications. "The drugs we use now, the toxicity can be pretty high," Pfanner said. "You add one more thing on and someone can get critically ill and it's not from the Crohn's disease."
Omega-3 free fatty acids are anti-inflammatory substances found in oily cold-water fish such as salmon, mackerel, herring and sardines. They are used to treat inflammatory disorders such as rheumatoid arthritis.
One small study, involving only 78 patients, was published previously in the New England Journal of Medicine and found a 33 percent reduction in the risk of relapse in Crohn's patients taking omega-3 free fatty acids daily. Another trial, however, found no effect.
Perhaps based on the promising results of the New England Journal trial, many people with Crohn's disease began taking omega-3 free fatty acids in the hopes of preventing a relapse.
But do the supplements really work? To test that out, Feagan and his colleagues conducted two similar trials.
For the first trial, known as EPIC-1 (Epanova Program in Crohn's Study), 363 patients in remission with Crohn's disease were randomly assigned to receive either four grams per day of omega-3 fatty acids or a placebo.
The second trial, EPIC-2, involved 375 patients who were also taking either the drugs prednisone or budesonide for their Crohn's.
Participants in the treatment arm of the trials took the supplements for up to 58 weeks.
The result: Rates of relapse (as measured by a Crohn's Disease Activity Index) scores were roughly the same in all groups, the researchers found.
There is some evidence that omega-3 free fatty acids are helpful in reducing the risk for heart disease. "It's attractive in that there's no evidence that omega-3 free fatty acids are harmful," Feagan said.
But according to the researchers, the message for Crohn's sufferers is clear: other, proven medications are a better bet for preventing relapse.
There's more on Crohn's disease at the U.S. National Institute of Diabetes and Digestive and Kidney Diseases.
SOURCES: Brian G. Feagan, M.D., professor, medicine, and director of Robarts Clinical Trials at Robarts Research Institute, University of Western Ontario, London, Ontario, Canada; Timothy Pfanner, M.D., assistant professor, internal medicine, Texas A&M Health Science Center College of Medicine, and gastroenterologist, Scott & White; April 9, 2008, Journal of the American Medical Association
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