It increases the proportion of non-toxic hydrophilic bile acids and, consequently, reduces the proportion of hepatotoxic toxic hydrophobic bile acids in the bile acid pool. A substantial body of evidence suggests that PBC is an autoimmune disease, in which an autoimmune process is responsible for a chronic nonsuppurative destructive cholangitis, which leads to injury and destruction of small intrahepatic bile ducts and hence progressive intrahepatic cholestatic liver disease. Thus, there is a rationale for treating PBC with an immunosuppressive drug. Those that have been tried have tended to be too toxic in the doses necessary to achieve effective immunosuppression.
Inclusion criteria Patients with precirrhotic PBC .
0.5 g twice daily alone. Initially, the duration of the trial will be 2 years. Routine blood counts and biochemical liver tests will be monitored at 3 monthly intervals. Quantitative tests of hepatocellular function, including the galactose elimination capacity, will be monitored at 6 monthly intervals. Needle biopsies of the liver will be obtained before randomisation and after 2 years of trial medication.