Efficacy and safety of tauroursodeoxycholic acid in the treatment of liver cirrhosis: a double-blind randomized controlled trial.
Level 2 - randomized trial
Individual randomized controlled trial
PubMed 23592128 · doi:10.1007/s11596-013-1095-x
What was done
Twenty-three Chinese patients with liver cirrhosis were enrolled in a double-blind, randomized trial comparing tauroursodeoxycholic acid (TUDCA; n = 12) against ursodeoxycholic acid (UDCA; n = 11) at a daily dose of 750 mg for 6 months. Eighteen patients (9 per group) completed the study and were analyzed. Clinical, biochemical, histological, and ultrasonographic parameters were evaluated before and after treatment.
What was found
The abstract reports p-values and directional changes without raw numerical values, effect sizes, or confidence intervals: - Serum ALT, AST, and ALP levels significantly decreased from baseline in the TUDCA group (P < 0.05). - In the UDCA group, only AST levels decreased significantly from baseline (P < 0.05). - Serum albumin levels increased significantly from baseline in both groups (P < 0.05). - Serum markers for liver fibrosis showed non-significant decreases in both groups. - Histological improvement was observed in only one patient in the TUDCA group. - No adverse events or side effects were reported in either group.
Why it matters
This provides preliminary comparative evidence that TUDCA is well-tolerated and may produce broader liver enzyme reductions than UDCA in cirrhotic patients, though neither agent demonstrated clear short-term anti-fibrotic efficacy.
Limits
The sample size is extremely small (n = 18 analyzed, 5 dropouts), severely limiting statistical power. The abstract reports within-group baseline comparisons rather than direct between-group statistical testing. Underlying etiologies of cirrhosis, blinding details, and exact numerical values with error estimates are omitted from the abstract. Histological response was essentially absent over the 6-month duration.
Cited by
- partial TUDCA thins biliary sludge in the bile ducts and reduces liver fibrosis.