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Effect of an enteric-coated fish-oil preparation on relapses in Crohn's disease.

Abstract

BACKGROUND

Patients with Crohn's disease may have periods of remission, interrupted by relapses. Because fish oil has antiinflammatory actions, it could reduce the frequency of relapses, but it is often poorly tolerated because of its unpleasant taste and gastrointestinal side effects.

METHODS

We performed a one-year, double-blind, placebo-controlled study to investigate the effects of a new fish-oil preparation in the maintenance of remission in 78 patients with Crohn's disease who had a high risk of relapse. The patients received either nine fish-oil capsules containing a total of 2.7 g of n-3 fatty acids or nine placebo capsules daily. A special coating protected the capsules against gastric acidity for at least 30 minutes.

RESULTS

Among the 39 patients in the fish-oil group, 11 (28 percent) had relapses, 4 dropped out because of diarrhea, and 1 withdrew for other reasons. In contrast, among the 39 patients in the placebo group, 27 (69 percent) had relapses, 1 dropped out because of diarrhea, and 1 withdrew for other reasons (difference in relapse rate, 41 percentage points; 95 percent confidence interval, 21 to 61; P < 0.001). After one year, 23 patients (59 percent) in the fish-oil group remained in remission, as compared with 10 (26 percent) in the placebo group (P = 0.003). Logistic-regression analysis indicated that only fish oil and not sex, age, previous surgery, duration of disease, or smoking status affected the likelihood of relapse (odds ratio for the placebo group as compared with the fish-oil group, 4.2; 95 percent confidence interval, 1.6 to 10.7).

CONCLUSIONS

In patients with Crohn's disease in remission, a novel enteric-coated fish-oil preparation is effective in reducing the rate of relapse.

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  • Authors+Show Affiliations

    ,

    Institute of Clinical Medicine and Gastroenterology, University of Bologna, Italy.

    , , , ,

    Source

    The New England journal of medicine 334:24 1996 Jun 13 pg 1557-60

    MeSH

    Adult
    Aged
    Anti-Inflammatory Agents
    Biomarkers
    Capsules
    Crohn Disease
    Double-Blind Method
    Fatty Acids, Omega-3
    Fatty Acids, Omega-6
    Fatty Acids, Unsaturated
    Female
    Fish Oils
    Humans
    Logistic Models
    Male
    Middle Aged
    Multivariate Analysis
    Recurrence
    Tablets, Enteric-Coated
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    8628335

    Citation

    Belluzzi, A, et al. "Effect of an Enteric-coated Fish-oil Preparation On Relapses in Crohn's Disease." The New England Journal of Medicine, vol. 334, no. 24, 1996, pp. 1557-60.
    Belluzzi A, Brignola C, Campieri M, et al. Effect of an enteric-coated fish-oil preparation on relapses in Crohn's disease. N Engl J Med. 1996;334(24):1557-60.
    Belluzzi, A., Brignola, C., Campieri, M., Pera, A., Boschi, S., & Miglioli, M. (1996). Effect of an enteric-coated fish-oil preparation on relapses in Crohn's disease. The New England Journal of Medicine, 334(24), pp. 1557-60.
    Belluzzi A, et al. Effect of an Enteric-coated Fish-oil Preparation On Relapses in Crohn's Disease. N Engl J Med. 1996 Jun 13;334(24):1557-60. PubMed PMID: 8628335.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Effect of an enteric-coated fish-oil preparation on relapses in Crohn's disease. AU - Belluzzi,A, AU - Brignola,C, AU - Campieri,M, AU - Pera,A, AU - Boschi,S, AU - Miglioli,M, PY - 1996/6/13/pubmed PY - 1996/6/13/medline PY - 1996/6/13/entrez SP - 1557 EP - 60 JF - The New England journal of medicine JO - N. Engl. J. Med. VL - 334 IS - 24 N2 - BACKGROUND: Patients with Crohn's disease may have periods of remission, interrupted by relapses. Because fish oil has antiinflammatory actions, it could reduce the frequency of relapses, but it is often poorly tolerated because of its unpleasant taste and gastrointestinal side effects. METHODS: We performed a one-year, double-blind, placebo-controlled study to investigate the effects of a new fish-oil preparation in the maintenance of remission in 78 patients with Crohn's disease who had a high risk of relapse. The patients received either nine fish-oil capsules containing a total of 2.7 g of n-3 fatty acids or nine placebo capsules daily. A special coating protected the capsules against gastric acidity for at least 30 minutes. RESULTS: Among the 39 patients in the fish-oil group, 11 (28 percent) had relapses, 4 dropped out because of diarrhea, and 1 withdrew for other reasons. In contrast, among the 39 patients in the placebo group, 27 (69 percent) had relapses, 1 dropped out because of diarrhea, and 1 withdrew for other reasons (difference in relapse rate, 41 percentage points; 95 percent confidence interval, 21 to 61; P < 0.001). After one year, 23 patients (59 percent) in the fish-oil group remained in remission, as compared with 10 (26 percent) in the placebo group (P = 0.003). Logistic-regression analysis indicated that only fish oil and not sex, age, previous surgery, duration of disease, or smoking status affected the likelihood of relapse (odds ratio for the placebo group as compared with the fish-oil group, 4.2; 95 percent confidence interval, 1.6 to 10.7). CONCLUSIONS: In patients with Crohn's disease in remission, a novel enteric-coated fish-oil preparation is effective in reducing the rate of relapse. SN - 0028-4793 UR - https://www.unboundmedicine.com/medline/citation/8628335/full_citation L2 - https://www.nejm.org/doi/10.1056/NEJM199606133342401?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=www.ncbi.nlm.nih.gov DB - PRIME DP - Unbound Medicine ER -