Aim: Tauroursodeoxycholic acid (TUDCA) is a taurine conjugated form of ursodeoxycholic acid (UDCA) with higher hydrophility. To\nfurther evaluate the efficacy and safety of TUDCA for primary biliary cholangitis (PBC), we performed this study on Chinese patients.\nMethods: 199 PBC patients were randomly assigned to either 250mg TUDCA plus UDCA placebo or 250mg UDCA plus TUDCA\nplacebo, 3 times per day for 24 weeks. The primary endpoint was defined as percentage of patients achieving serum alkaline\nphosphatase (ALP) reduction of more than 25% from baseline.\nResults: At week 24, 75.97% of patients in the TUDCA group and 80.88% of patients in the UDCA group achieved a serum ALP\nreduction of more than 25% from baseline (P=0.453). The percentage of patients with serum ALP levels declined more than 40%\nfollowing 24 weeks of treatment was 55.81% in the TUDCA group and 52.94% in the UDCA group (P=0.699). Both groups showed\nsimilar improvement in serum levels of ALP, aspartate aminotransferase, and total bilirubin (P>0.05). The proportion of patients with\npruritus/scratch increased from 1.43% to 10.00% in UDCA group, while there�s no change in TUDCA group (P=0.023). Both drugs\nwere well tolerated, with comparable adverse event rates between the 2 groups.\nConclusions: TUDCA is safe and as efficacious as UDCA for the treatment of PBC, and may be better to relieve symptoms than\nUDCA.
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