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Primary sclerosing cholangitis (PSC) is an uncommon cause of chronic liver disease; however, it can be associated with liver failure and cholangiocarcinoma. No effective medical therapy for PSC is known. Results from small pilot studies have suggested that ursodeoxycholic acid (UDCA) is effective in PSC. In this large, randomized, double-blind, multicenter Scandinavian study, researchers evaluated the effectiveness of high-dose UDCA in patients with radiographically proven PSC.
Enrolled subjects received either daily UDCA (17–23 mg/kg) or placebo for 5 years. The investigators planned to enroll 346 patients. Initially, 219 subjects were recruited; however, 21 patients were excluded because they did not receive any medication or did not retur…