Role and Dose of UDCA in Fatty Liver Disease
UDCA is NOT recommended for the treatment of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), as the treatment effects have not been proven and there is insufficient evidence supporting its efficacy. 1, 2
Evidence Against UDCA Use in Fatty Liver
The Korean Association for the Study of the Liver conducted studies showing that the usual dose of UDCA (13-15 mg/kg/day) was not significantly better than placebo in improving liver function or liver histology in NASH patients. 1 This finding is reinforced by the American College of Gastroenterology, which explicitly states that UDCA is not recommended for NAFLD or NASH due to lack of evidence supporting its efficacy. 2
High-Dose UDCA Studies
While some investigators explored high-dose UDCA (25-35 mg/kg/day) in NASH, the results were inconsistent:
- One study showed improvement only in liver function tests but lacked paired biopsies to confirm histological benefit 1
- A multi-arm comparative study found that UDCA monotherapy failed to show any differences versus placebo 1
- The combination of UDCA with vitamin E showed some promise with normalization of AST/ALT and histological improvement, but the sample size was too small to draw firm conclusions 1
Experimental Data
Animal studies using methionine- and choline-deficient diet models showed dose-dependent improvements with very high doses (40-80 mg/kg), but these findings have not translated to proven clinical benefit in humans. 3 A small human study in overweight patients showed decreased ALT and miR-122 levels with UDCA 300 mg twice daily, but this does not constitute sufficient evidence for routine clinical use. 4
Clinical Bottom Line
Based on current guideline-level evidence, UDCA should not be prescribed for fatty liver disease. 1, 2 The treatment effects remain unproven, and further large-scale studies are needed before any recommendation can be made. 1
Alternative Approaches
For patients with NAFLD/NASH, focus should be on:
- Weight loss and lifestyle modification as first-line therapy 1
- Vitamin E (800 IU/day) may be considered for biopsy-proven NASH in non-diabetic patients 1
- Management of metabolic comorbidities (diabetes, dyslipidemia, hypertension) 1
Important Caveat
UDCA remains the established treatment for cholestatic liver diseases like primary biliary cholangitis (13-15 mg/kg/day) but has no proven role in fatty liver disease. 1, 5, 2 Do not confuse these distinct clinical entities when making treatment decisions.