In this study, researchers from France assessed the efficacy of ursodeoxycholic acid (UDCA) on the survival of patients with alcohol-induced cirrhosis and jaundice.
The research team included patients with histologically proven alcohol-induced cirrhosis and serum bilirubin > 50 µmol/l.
They randomly assigned 226 patients to receive either UDCA (13 to 15 mg per kg per d) or a placebo for 6 months.
- Ursodeoxycholic acid = 69%
- Placebo = 82%
The team determined that 74% of patients had associated alcohol-induced hepatitis, and 24% received corticosteroid therapy.
The 2 groups were comparable for the main clinical and biologic parameters. However, at inclusion serum bilirubin was higher in the UDCA group than in the placebo group (163 µmol/l versus 145 µmol/l).
During the course of the study, 35 patients in the UDCA group and 20 patients in the placebo group died.
The researchers found that in the intention to treat analysis, the probability of survival at 6 months was lower in the UDCA than in the placebo group (69% versus 82%).
Furthermore, after adjustment for bilirubin level at entry, the independent predictive value of the treatment group did not reach the statistical level (RR = 1.64)
Dr Gilles Pelletier’s team concluded, “UDCA administered at the dose recommended in primary biliary cirrhosis has no beneficial effect on the 6-month survival of patients with severe alcohol-induced cirrhosis”.
“An inappropriate dosage of UDCA cannot be excluded as an explanation for the lack of therapeutic benefit”.