Primary biliary cirrhosis is an uncommon and slowly progressive autoimmune disease of the liver that primarily attacks middle-aged women. The cause of the disease is unknown. Over the last 30 years, substantial increases in the prevalence of primary biliary cirrhosis have been observed. Primary biliary cirrhosis is now a frequent cause of liver morbidity, and the patients are significant users of health resources, including liver transplantation.
Ursodeoxycholic acid (UDCA) is the only FDA approved drug to treat primary biliary cirrhosis, but the effects remain controversial. This review evaluates if UDCA has any beneficial role to play in relation to primary biliary cirrhosis patients. It includes 16 randomised clinical trials with a total of 1447 patients. The primary outcome measures were mortality and mortality or liver transplantation. Although UDCA showed a reduction in liver biochemistry, jaundice, and ascites, this review did not demonstrate any benefit of ursodeoxycholic acid on mortality and mortality or liver transplantation.The use of UDCA is associated with weight gain and costs. A number of the trials had risk of bias and the topic seems to have selective reporting of outcomes.