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Title: Nutritional Supplement Reduces Need For Traditional Ulcerative Colitis Treatment

"Nutritional Supplement Reduces Need For Traditional Ulcerative Colitis Treatment"

BETHESDA, MD -- April 6, 2005 -- According to a study published in the American Gastroenterological Association (AGA) journal Clinical Gastroenterology and Hepatology, a nutritionally complete oral supplement enriched with fish oil, soluble fiber and antioxidants reduces reliance on traditional therapies for people with ulcerative colitis. Moreover, people who took the oral supplement were less likely to start corticosteroid drug therapy, which has many long-term side effects. "Our study proves that an oral supplement which combines fish oil, soluble fiber and antioxidants is safer and causes fewer side effects than many of the medications currently available to treat ulcerative colitis," said Douglas Seidner, MD, lead study author with The Cleveland Clinic, Cleveland, Ohio. "This supplement will provide yet another treatment option to alleviate symptoms for patients suffering from this debilitating disease." Researchers at The Cleveland Clinic conducted a randomized controlled clinical trial of patients 18 and older with mild to moderate active ulcerative colitis to assess the benefits of adding this oral supplement to standard medical therapy for the disease. This study shows that patients on corticosteroid therapy who were given the oral supplement vs. a placebo had a significant reduction in the dose of corticosteroids needed to control clinical symptoms of ulcerative colitis. Ulcerative colitis is an inflammatory bowel disease in which the lining of the large intestine becomes inflamed and ulcerated, and most commonly affects people between 15 and 40 years of age. Ulcerative colitis can be attributed to an immune disorder or heredity, among other things, and is characterized by abdominal cramps, bloody diarrhea and fever. Treatments for the disease, including corticosteroids and mesalamine are intended to control inflammation. While corticosteroids are highly effective in the treatment of ulcerative colitis, prolonged use often leads to insomnia, mood alterations, increased appetite, hypertension, osteoporosis and other adverse events. Adverse effects of corticosteroid use are a concern to physicians and lead to discontinuation of the therapy by many patients. However, more than 25 percent of patients who discontinue the therapy have a relapse of symptoms. Previous smaller studies have shown that fish oil is effective in reducing the need for corticosteroids in ulcerative colitis patients. The current study combines fish oil with soluble fiber to diminish the inflammation associated with ulcerative colitis symptoms and positively affect nutrition. "The need to find new treatments that are safe, effective and inexpensive remains and physicians should consider adding this combination of active ingredients as an adjuvant therapy for ulcerative colitis," said Seidner. Researchers at The Cleveland Clinic conducted a randomized controlled study on adult patients over the age of 18 who had ulcerative colitis for at least 6 months, had active inflammation according to endoscopic exam results and had symptoms of mild to moderate activity of the disease. During the study, patients were either given a ready-to-feed carbohydrate-based drink as a placebo or the Ulcerative Colitis Nutritional Supplement (UCNS) which contains fish oil, soluble fiber and a combination of vitamins and antioxidants. The UCNS was found to reduce reliance on traditional corticosteroid therapy for ulcerative colitis in the study population. The oral supplement is manufactured by Ross Products and Abbott Laboratories and is currently being evaluated for commercial introduction. SOURCE: American Gastroenterological Association

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