No direct comparison of
tauroursodeoxycholic acid (
TUDCA) and
ursodeoxycholic acid (UDCA) has yet been carried out in the treatment of
liver cirrhosis in China. We designed a double-blind randomized trial to evaluate the potential therapeutic efficacy of
TUDCA in
liver cirrhosis, using UDCA as parallel control. The enrolled 23 patients with
liver cirrhosis were randomly divided into
TUDCA group (n=12) and UDCA group (n=11), and given
TUDCA and UDCA respectively at the daily dose of 750 mg, in a randomly assigned sequence for a 6-month period. Clinical, biochemical and histological features, and liver ultrasonographic findings were evaluated before and after the study. According to the inclusion criteria, 18 patients were included in the final analysis, including 9 cases in both two groups. Serum ALT, AST and ALP levels in
TUDCA group and AST levels in UDCA group were significantly reduced as compared with baseline (P<0.05).
Serum albumin levels were significantly increased in both
TUDCA and UDCA groups (P<0.05).
Serum markers for
liver fibrosis were slightly decreased with the difference being not significant in either group. Only one patient in
TUDCA group had significantly histological relief. Both treatments were well tolerated and no patient complained of side effects. It is suggested that
TUDCA therapy is safe and appears to be more effective than UDCA in the treatment of
liver cirrhosis, particularly in the improvement of the biochemical expression. However, both drugs exert no effect on the
serum markers for
liver fibrosis during 6-month treatment.