Ursodeoxycholic acid for primary biliary cirrhosis.

Area of Science:

• Hepatology and Gastroenterology
• Clinical Pharmacology
• Autoimmune Liver Diseases

Background:

• Primary biliary cirrhosis (PBC) is a chronic, progressive, autoimmune liver disease of unknown cause.
• Ursodeoxycholic acid (UDCA) is FDA-approved for PBC, but its efficacy remains debated.

Purpose of the Study:

• To systematically evaluate the beneficial and harmful effects of ursodeoxycholic acid (UDCA) in patients with primary biliary cirrhosis (PBC).
• To assess UDCA's impact on mortality, liver transplantation, adverse events, symptoms, and biochemical markers.

Main Methods:

• Conducted a systematic review and meta-analysis of randomized clinical trials comparing UDCA with placebo or no intervention in PBC patients.
• Searched multiple databases up to January 2012, including Cochrane Hepato-Biliary Group Register, CENTRAL, MEDLINE, and EMBASE.
• Assessed risk of bias, performed meta-analyses using random and fixed-effect models, and employed trial sequential analysis.

Main Results:

• No significant differences were found for UDCA versus placebo/no intervention regarding all-cause mortality, liver transplantation, or serious/non-serious adverse events.
• UDCA did not significantly impact pruritus or fatigue but showed a potential benefit in reducing jaundice in a fixed-effect analysis.
• Significant improvements were observed in serum bilirubin and alkaline phosphatase levels, with potential benefits in other liver biochemistry markers and histological progression.

Conclusions:

• This review found no significant benefits of UDCA on mortality, liver transplantation, pruritus, or fatigue in PBC patients.
• UDCA demonstrated beneficial effects on liver biochemistry and histological progression.
• High risk of bias in most trials and potential for random errors necessitate high-quality, low-bias randomized trials for definitive conclusions.