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No effective treatment has been identified for patients who have primary sclerosing cholangitis (PSC). Pilot studies have suggested that outcomes might be improved by administration of high-dose ursodeoxycholic acid (UDCA). To further assess this agent, investigators conducted a multicenter, blinded, placebo-controlled trial involving 150 patients who fulfilled predefined PSC diagnostic criteria, including presence of disease-compatible liver biopsy features. Patients were randomized to receive either high-dose UDCA (28–30 mg/kg/day) or placebo and were stratified by histological stage (I/II or III/IV), presence or absence of varices, and Mayo risk score (greater or less than 1.5). At baseline, both treatment groups were similar with respec…