Fish oil, soluble fiber, and antioxidants for corticosteroid sparing in ulcerative colitis
04/24/05 03:33 PM
Loc: Seattle, WA
Clinical Gastroenterology and Hepatology
April 2005 • Volume 3 • Number 4
An oral supplement enriched with fish oil, soluble fiber, and antioxidants for corticosteroid sparing in ulcerative colitis: A randomized, controlled trial
Douglas L. Seidner ⁎ ⁎ [MEDLINE LOOKUP]
Bret A. Lashner ⁎ [MEDLINE LOOKUP]
Aaron Brzezinski ⁎ [MEDLINE LOOKUP]
Phillip L.C. Banks ‡ [MEDLINE LOOKUP]
John Goldblum § [MEDLINE LOOKUP]
Claudio Fiocchi ¶ [MEDLINE LOOKUP]
Jeffry Katz ¶ [MEDLINE LOOKUP]
Gary R. Lichtenstein ∥ [MEDLINE LOOKUP]
Peter A. Anton # [MEDLINE LOOKUP]
Lori Y. Kam ⁎⁎ [MEDLINE LOOKUP]
Keith A. Garleb ‡‡ 1 [MEDLINE LOOKUP]
Stephen J. Demichele ‡‡ 1 [MEDLINE LOOKUP]
The Enteral Nutrition in Ulcerative Colitis Study Group
Background & Aims: N-3 fatty acids from fish oil, antioxidants, and short-chain fatty acids (SCFAs) produced during the fermentation of soluble fiber may attenuate inflammation associated with ulcerative colitis (UC). We assessed the efficacy of a nutritionally balanced oral supplement enriched with fish oil, fructooligosaccharides, gum arabic, vitamin E, vitamin C, and selenium on disease activity and medication use in adults with mild to moderate UC.
Methods: A total of 121 patients with UC and a disease activity index (DAI) from 3–9 on a 12-point scale were block randomized for extent of disease and smoking status. In addition to their usual diet, patients consumed 18 oz of the oral supplement or a carbohydrate-based placebo formula each day for 6 months. Clinical and histologic responses were assessed at 3 and 6 months or at the final visit. A change in average prednisone use between groups was tested by using a linear mixed-effects model. Results: Eighty-six patients completed the study. Baseline characteristics were not different between groups except for a higher total DAI score in the oral supplement group (7.3 ± 1.3; n = 36) compared with the placebo group (6.2 ± 2.0; n = 50) (P < .05). Both groups showed significant and similar degree of improvement at 6 months in DAI (−2.5 for oral supplement and −2.8 for placebo) and histologic index (−1.9 for oral supplement vs. −2.0 for placebo). Both intent-to-treat and completed patients given oral supplement had a significantly greater rate of decrease in the dose of prednisone required to control clinical symptoms over 6 months as compared with the placebo group (P < .001).
Conclusions: The improvement in clinical response combined with a decreased requirement for corticosteroids suggest that this enriched oral supplement can be a useful adjuvant therapy in patients with UC.
Department of Gastroenterology, Cleveland Clinic Foundation, Cleveland, Ohio, USA
§Department of Anatomic Pathology, Cleveland Clinic Foundation, Cleveland, Ohio, USA
‡STATPROBE, Dublin, Ohio, USA
¶Department of Gastroenterology, Case Western Reserve University, Cleveland, Ohio, USA
∥Department of Gastroenterology, University of Pennsylvania, Philadelphia, Pennsylvania
#Department of Gastroenterology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, California
⁎⁎Department of Gastroenterology, University of Southern California Medical Center, Los Angeles, California
‡‡Strategic Discovery R&D, Ross Products Division, Abbott Laboratories, Columbus, Ohio, USA
Supported in part by a grant from Ross Products Division, Abbott Laboratories.
1Drs Garleb and Demichele are employees of Ross Products Division, Abbott Laboratories.
⁎Address requests for reprints to: Douglas L. Seidner, MD, Department of Gastroenterology\A30, Cleveland Clinic Foundation, 9500 Euclid Avenue, Cleveland, Ohio 44195fax: (216) 444-6305.
Email address: firstname.lastname@example.org (Douglas L. Seidner)
Copyright © 2005 by American Gastroenterological Association
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