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Bile acids for viral hepatitis

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Abstract

Background

The viral hepatitides are common causes of liver diseases globally. Trials have assessed bile acids for patients with viral hepatitis, but no consensus was reached regarding their usefulness.

Objectives

To assess the beneficial and harmful effects of bile acids for viral hepatitis.

Search methods

Searches were performed of The Cochrane Hepato‐Biliary Group Controlled Trials Register (September 2002), The Cochrane Library (Issue 2, 2002), MEDLINE (September 2002), EMBASE (September 2002), and The Chinese Biomedical Database (April 2001).

Selection criteria

Randomised clinical trials comparing any dose or duration of bile acids versus placebo or no intervention for viral hepatitis were included, irrespective of language, publication status, or blinding.

Data collection and analysis

Two reviewers extracted the data independently. The methodological quality of the trials was evaluated with respect to generation of the allocation sequence, allocation concealment, double blinding, and follow‐up. The outcomes were presented as relative risks (RR) or weighted mean differences (WMD) with 95% confidence intervals (CI).

Main results

We identified 29 randomised trials of bile acids for hepatitis B or C; none were of high methodological quality. In one trial, ursodeoxycholic acid (UDCA) versus placebo for acute hepatitis B significantly reduced the risk of hepatitis B surface antigen positivity at the end of treatment and serum HBV DNA level at the end of follow‐up. In another trial, UDCA versus no intervention for chronic hepatitis B significantly reduced the risk of having abnormal serum transaminase activities at the end of treatment. Twenty‐five trials compared bile acids (21 trials UDCA; four trials tauro‐UDCA) versus placebo or no intervention with or without co‐interventions for chronic hepatitis C. Bile acids did not significantly reduce the risk of having detectable serum HCV RNA (RR 0.99, 95% CI 0.91 to 1.07), cirrhosis, or portal and periportal inflammation score at the end of treatment. Bile acids significantly decreased the risk of having abnormal serum alanine aminotransferase activity at the end of treatment (RR 0.82, 95% CI 0.76 to 0.90) and follow‐up (RR 0.91, 95% CI 0.85 to 0.98). Bile acids significantly increased the Knodell score (WMD 0.20, 95% CI 0.08 to 0.31) at the end of treatment. No severe adverse events were reported. We did not identify trials including patients with hepatitis A, acute C, D, or E.

Authors' conclusions

Bile acids lead to a significant improvement in serum transaminase activities in hepatitis B and C. There is insufficient evidence either to support or to refute effects on viral markers, mortality, incidence of cirrhosis, or liver histology. Trials with high methodological quality are required.

Plain language summary

Bile acids may improve liver biochemistry of patients with hepatitis B or C, but there is insufficient evidence about other beneficial effects

Viral hepatitides are common infectious liver diseases associated with significant morbidity and mortality. Based on this systematic Review, bile acids may decrease serum transaminase activities in patients with acute hepatitis B, chronic hepatitis B, or chronic hepatitis C. There is insufficient evidence either to support or to refute effects on mortality, incidence of cirrhosis, liver histology, or viral markers. No clinical trials have evaluated bile acids for hepatitis A, acute hepatitis C, hepatitis D, or hepatitis E.