A randomized controlled trial of high-dose ursodesoxycholic acid for nonalcoholic steatohepatitis
Abstract
en anglais morbidity and may have antioxidant, anti-inflammatory, and antifibrotic properties and may reduce liver injury in NASH. To date, no studies have assessed the efficacy and safety of high-dose UDCA (HD-UDCA) in patients with NASH. Methods We conducted a 12-month, randomized, double-blind, placebo-controlled multicenter trial to evaluate the efficacy and safety of HD-UDCA (28–35 mg/kg per day) in 126 patients with biopsy-proven NASH and elevated alanine aminotransferase (ALT) levels. The primary study end point was reduction in ALT levels from baseline in patients treated with HD-UDCA compared with placebo. Secondary study end points were the proportion of patients with ALT normalization, relative reduction in the scores of serum markers of fibrosis and hepatic inflammation, and safety and tolerability. Results HD-UDCA significantly reduced mean ALT levels −28.3% from baseline after 12 months compared with −1.6% with placebo (p <0.001). At the end of the trial, ALT levels normalized (⩽35 IU/L) in 24.5% of patients treated with HD-UDCA and in 4.8% of patients who received placebo (p = 0.003). Both results were not accounted for by changes in weight during the trial. HD-UDCA significantly reduced the FibroTest® serum fibrosis marker (p <0.001) compared with placebo. HD-UDCA also significantly improved markers of glycemic control and insulin resistance. There were no safety issues in this population. Conclusions Treatment with HD-UDCA was safe, improved aminotransferase…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 126 participants or records.
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