This phase IV randomized controlled trial tested whether ursodeoxycholic acid (UDCA) could improve liver health in people with chronic liver disease who had abnormal ALT levels for at least 6 months. The study included 262 patients from multiple academic hospitals in South Korea.
Participants were randomly assigned to take either UDCA (100 mg three times daily) or a placebo for 8 weeks. The main goal was to see how much ALT levels changed from the start of the study. ALT is a liver enzyme that can indicate liver damage.
Results showed that the UDCA group had a greater drop in ALT levels (average decrease of 14.70 U/L) compared to the placebo group (5.51 U/L). More people in the UDCA group also had their ALT levels return to normal (26.52% vs. 13.08%). Additionally, UDCA led to a small but significant improvement in a fibrosis score (FibroTest), suggesting less liver scarring.
Side effects were similar between the two groups, and no serious side effects occurred in the UDCA group. The study was short-term (8 weeks) and used a blood test for fibrosis rather than a liver biopsy, which is more accurate. Overall, UDCA appears to be a safe and effective short-term treatment for improving liver enzymes and fibrosis in chronic liver disease.