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No specific medical therapy exists for patients with nonalcoholic steatohepatitis (NASH). One therapy that previously failed in a large, randomized, controlled trial was low-dose ursodeoxycholic acid (UDCA; 13–15 mg/kg/day). Now, to evaluate the efficacy of high-dose UDCA (23–28 mg/kg/day) in this setting, investigators conducted a multicenter, randomized, placebo-controlled, double-blind study involving 185 patients with biopsy-proven NASH.
Patients were randomized to receive either high-dose UDCA or placebo in three divided daily doses for 18 months. The primary endpoint was histological improvement based on nonalcoholic fatty liver disease activity scores (NAS) and modified Brunt scores. End-of-treatment biopsies were available in 139 pat…