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Ursodeoxycholic acid for primary biliary cirrhosisGong Y, Huang ZB, Christensen E, Gluud C
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SummaryUrsodeoxycholic acid is not likely to yield a benefit on survival of patients with primary biliary cirrhosisPrimary 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.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2008 Issue 3, Copyright © 2008 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This version first published online:
January 21. 2002 AbstractBackgroundPrimary biliary cirrhosis is an uncommon autoimmune liver disease with unknown aetiology. Ursodeoxycholic acid (UDCA) has been used for primary biliary cirrhosis, but the effects remain controversial. ObjectivesTo evaluate the benefits and harms of UDCA on patients with primary biliary cirrhosis against placebo or no intervention. Search strategyWe searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Central Register of Controlled Trials on The Cochrane Library, MEDLINE, EMBASE, SCI-EXPANDED, The Chinese Biomedical CD Database, LILACS, and the references of identified studies. The last search was performed in January 2007. Selection criteriaRandomised clinical trials evaluating UDCA versus placebo or no intervention in patients with primary biliary cirrhosis. Data collection and analysisThe primary outcomes were mortality and mortality or liver transplantation. Binary outcomes were reported as odds ratio (OR) or relative risk (RR) and continuous outcomes as weighted mean difference, all with 95% confidence intervals (CI). Meta-regression was used to investigate the associations between UDCA effects and quality of the trial, UDCA dose, trial duration, and patient's severity of primary biliary cirrhosis. We also used Bayesian meta-analytic approach to estimate the UDCA effect as sensitivity analysis. Main resultsSixteen randomised clinical trials evaluating UDCA against placebo or no intervention were identified. Data from three trials have been updated. Nearly half of the trials had high risk of bias. The combined results demonstrated no significant effects favouring UDCA on mortality (OR 0.97, 95% CI 0.67 to 1.42) and mortality or liver transplantation (RR 0.92, 95% CI 0.71 to 1.21). The findings were supported by the Bayesian meta-analyses. UDCA did not improve pruritus, fatigue, autoimmune conditions, liver histology, or portal pressure. UDCA seemed to improve biochemical variables, like serum bilirubin, ascites, and jaundice, but the findings were based on few trials with sparse data. The use of UDCA is significantly associated with adverse events, mainly weight gain. Authors' conclusionsThis systematic review did not demonstrate any benefit of UDCA on mortality and mortality or liver transplantation of patients with primary biliary cirrhosis. The few beneficial effects could not be due to random errors or outcome reporting bias. |