A preliminary trial of high-dose ursodeoxycholic acid in primary sclerosing cholangitis.

Mitchell, SA; Bansi, D; Hunt, N; Von Bergmann, K; Fleming, K; Chapman, R

Journal article

A preliminary trial of high-dose ursodeoxycholic acid in primary sclerosing cholangitis.

Abstract:: BACKGROUND and AIMS: Ursodeoxycholic acid (UDCA) is used for the treatment of cholestatic liver diseases including primary biliary cirrhosis (PBC) for which it has a positive effect on laboratory values, may delay the development of liver failure and prolong the transplant-free disease period. Standard doses of UDCA (8-15 mg/kg daily) have been shown to be ineffective in the treatment of primary sclerosing cholangitis (PSC). We report on the findings (clinical, biochemical, histological, and cholangiographic) and side effects of a 2-year double-blind placebo-controlled preliminary study of high-dose UDCA in PSC patients. METHODS: Twenty-six patients with PSC were randomized to high-dose (20 mg/kg daily) UDCA or placebo. Cholangiography and liver biopsy were performed at entry and after 2 years. Symptoms, clinical signs, and liver biochemical tests were recorded at 3 monthly intervals. RESULTS: High-dose UDCA did not influence symptoms, but there was a significant improvement in liver biochemistry (serum alkaline phosphatase, P = 0.03; gamma-glutamyl transferase, P = 0.01) and a significant reduction in progression in cholangiographic appearances (P = 0.015) and liver fibrosis as assessed by disease staging (P = 0.05). In the treatment group, a significant increase in total bile acids and saturation with UDCA >70% confirmed patient compliance. No significant side effects were reported. CONCLUSIONS: High-dose UDCA may be of clinical benefit in PSC, but trials with a larger number of participants and of longer duration are required to establish whether the effect of high-dose UDCA on liver biochemistry, histology, and cholangiography in patients with PSC is translated into improved long-term survival.

Publication status:: Published

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APA Style

Mitchell, S. A., Bansi, D., Hunt, N., Von Bergmann, K., Fleming, K., & Chapman, R. (2001). A preliminary trial of high-dose ursodeoxycholic acid in primary sclerosing cholangitis. Gastroenterology, 121(4), 900–907.

MLA Style

Mitchell, SA, et al. “A Preliminary Trial of High-Dose Ursodeoxycholic Acid in Primary Sclerosing Cholangitis.” Gastroenterology, vol. 121, no. 4, 2001, pp. 900–07.

Chicago Style

Mitchell, SA, D Bansi, N Hunt, K Von Bergmann, K Fleming, and R Chapman. 2001. “A Preliminary Trial of High-Dose Ursodeoxycholic Acid in Primary Sclerosing Cholangitis.” Gastroenterology 121 (4): 900–907.
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