URSODEOXYCHOLIC THERAPY IN CHRONIC LIVER-DISEASE - A METAANALYSIS IN PRIMARY BILLIARY CIRRHOSIS AND IN CHRONIC HEPATITIS

Objectives: to determine whether ursodeoxycholic acid (UDCA) is effect ive in improving primary biliary cirrhosis (PBC) or chronic hepatitis (CH). Methods: Meta-analysis (MA) was performed on nine papers and thr ee abstracts describing PBC and on nine papers and two abstracts with CH that were published between 1985 and 1992 and were identified throu gh MEDLINE. Studies were included if they fulfilled established qualit y criteria and the patients had at least liver histology at the start and two to three relevant laboratory tests repeated after UDCA. A tota l of 800 patients with PBC were treated for 6-48 months. In CH, 285 pa tients were treated for 1-21 months. Results: In PBC, an average daily UDCA of 13 mg/kg day improved the liver tests AST, ALT, ALP, and GGT (all p < 0.001). The effect on serum bilirubin was too heterogeneous t o evaluate. When evaluated individually, the studies showed an indeter minate effect on histologic progression and treatment failure. When po oled in MA, UDCA improved the liver histology (p < 0.001) and prevente d treatment failure (p < 0.04). In CH, UDCA at an average of 11 mg/kg day improved AST, ALT, GGT, and total bilirubin (all p < 0.001) and al so ALP (p = 0.014). There was no effect on histology of CH and no data on treatment failure. Conclusions: MA confirmed a beneficial effect o f UDCA in PBC on liver tests, histology, and treatment failure. In CH, there was an improvement in liver tests, but the evidence for histolo gic effect was sparse and insignificant. Future studies in PBC must ex plore the disease after UDCA is discontinued. Trials in CH should dist inguish between the diagnostic subgroups, document patient compliance with UDCA, and include histology and treatment failure as end points.