"Omega-3 free fatty acids are found in marine fish"
"Phosphatidylcholine is effective"
Omega-3 Free Fatty Acids May Not Be Effective For Preventing Crohn
Disease Relapse
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OMEGA-3 FREE FATTY ACIDS, CROHN DISEASE
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Description
Patients with Crohn disease who took omega-3 free fatty acids
supplements did not have a significantly different rate of relapse
compared to patients who took placebo, according to a study in the
April 9 issue of JAMA.
Newswise -- Patients with Crohn disease who took omega-3 free fatty
acids supplements did not have a significantly different rate of
relapse compared to patients who took placebo, according to a study in
the April 9 issue of JAMA.
Effective therapy to maintain remission in Crohn disease (a chronic
inflammatory disease primarily involving the small and large
intestine) is an unmet medical need, with the use of some
immunosuppressive drugs associated with an increased risk of
infection. Omega-3 free fatty acids are anti-inflammatory substances
found in marine fish that have several health benefits and have been
used to treat inflammatory disorders such as rheumatoid arthritis.
Previous clinical trials that evaluated omega-3 free fatty acids for
maintenance of remission in Crohn disease have yielded inconsistent
results, according to background information in the article.
Brian G. Feagan, M.D., of Robarts Research Institute, University of
Western Ontario, London, Ontario, and colleagues conducted two large-
scale trials of high-dose omega-3 free fatty acids as maintenance
therapy in patients with Crohn disease in remission. The studies
(Epanova Program in Crohn's Study 1 [EPIC-1] and EPIC-2) were
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 Crohn disease in remission were evaluated in EPIC-1 and
EPIC-2, respectively. Patients were randomly assigned to receive
either 4 grams/day of omega-3 free fatty acids or placebo for up to 58
weeks. 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 researchers found that there was no significant difference in
relapse rates observed between the two treatment groups in either
trial. In EPIC-1, 54 patients treated with omega-3 free fatty acids
and 62 patients treated with placebo experienced a clinical relapse.
The pro****tion of patients assigned to receive omega-3 free fatty
acids who experienced a relapse within 360 days was estimated to be
31.6 percent, compared with 35.7 percent for those who received
placebo.
In EPIC-2, 84 patients treated with omega-3 free fatty acids and 94
patients treated with placebo experienced a clinical relapse. The
pro****tion of patients assigned to receive omega-3 free fatty acids
who experienced a relapse within 360 days was estimated to be 47.8
percent, compared with 48.8 percent of those who received placebo.
Serious adverse events were uncommon and mostly related to Crohn
disease.
"Our results are im****tant 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," the authors write.
(JAMA. 2008;299[14]:1690-1697. Available pre-embargo to the media at
www.jamamedia.org)
Editor's Note: Please see the article for additional information,
including other authors, author contributions and affiliations,
financial disclosures, funding and sup****t, etc.
--------------------------------------------------------------------------------
Retarded release phosphatidylcholine benefits patients with chronic
active ulcerative colitis.
Stremmel W, Merle U, Zahn A, Autschbach F, Hinz U, Ehehalt R
Gut. 2005 Jul ; 54(7): 966-71
BACKGROUND AND AIMS: We examined the hypothesis of an anti-
inflammatory
effect of phosphatidylcholine in ulcerative colitis. METHODS: A phase
IIA, double blind, randomised, placebo controlled study was performed
in 60 patients with chronic active, non steroid dependent, ulcerative
colitis, with a clinical activity index (CAI) of > or = 4. Retarded
release phosphatidylcholine rich phospholipids and placebo were
administered at a dose of 6 g daily over three months. The primary
end
point was a change in CAI towards clinical remission (CAI < or = 3)
or
CAI improvement by > or = 50%. Secondary end points included > or =
50%
changes in endoscopic activity index (EAI), histology, and quality of
life scores. RESULTS: Induction of clinical remission (CAI < or = 3)
as
the primary outcome variable was attained by 16 (53%) patients in the
phosphatidylcholine treated group compared with three (10%) in the
placebo group (p<0.00001). The rate of clinical remission and CAI
improvement was 90% in the phosphatidylcholine group and only 10% in
the placebo group. A median drop of seven points in the CAI score
(70%
improvement) was recorded in the phosphatidylcholine group compared
with no change in the placebo group. Secondary end point analysis
revealed concomitant drops in EAI and histology scores (p = 0.00016
and
p = 0.0067 compared with placebo, respectively). Improvement in
quality
of life was re****ted by 16 of 29 evaluated patients in the
phosphatidylcholine group compared with two of 30 in the placebo
group
(p = 0.00005). CONCLUSION: Retarded release oral phosphatidylcholine
is
effective in alleviating inflammatory activity caused by ulcerative
colitis.
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