Intervention Review

Bile acids for viral hepatitis

  1. Wendong Chen1,*,
  2. Jian Ping Liu2,
  3. Christian Gluud3

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 17 OCT 2007

Assessed as up-to-date: 21 AUG 2007

DOI: 10.1002/14651858.CD003181.pub2


How to Cite

Chen W, Liu JP, Gluud C. Bile acids for viral hepatitis. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD003181. DOI: 10.1002/14651858.CD003181.pub2.

Author Information

  1. 1

    Toronto Health Economics and Technology Assessment Collaborative (THETA), University of Toronto, Departments of Health Policy Management and Evaluation, and Pharmacy, Toronto, Ontario, Canada

  2. 2

    Beijing University of Chinese Medicine, Centre for Evidence-Based Chinese Medicine, Beijing, China

  3. 3

    Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Cochrane Hepato-Biliary Group, Copenhagen, Denmark

*Wendong Chen, Departments of Health Policy Management and Evaluation, and Pharmacy, Toronto Health Economics and Technology Assessment Collaborative (THETA), University of Toronto, Room 679, 6th floor, Leslie L. Dan Pharmacy Building, 144 College Street, Toronto, Ontario, M5S 3M2, Canada. wdchen@uhnres.utoronto.ca.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 17 OCT 2007

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Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Trials have assessed bile acids for patients with viral hepatitis, but no consensus has been reached regarding their usefulness.

Objectives

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

Search methods

Searches were performed in The Cochrane Hepato-Biliary Group Controlled Trials Register (July 2007), The Cochrane Library (Issue 1, 2007), MEDLINE (July 2007), EMBASE (July 2007), Science Citation Index Expanded (July 2007), and Chinese Biomedical Database (July 2007).

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. Co-interventions were allowed in the included randomised clinical trials.

Data collection and analysis

Two authors 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. We were unable to extract data from two trials. 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 hepatitis C, hepatitis D, or hepatitis E.

Authors' conclusions

Bile acids lead to a significant improvement in serum transaminase activities in hepatitis B and C but have no effects on the clearance of virus. There is insufficient evidence either to support or to refute effects on long-term outcomes including hepatocellular carcinoma, hepatic decompensation, and liver related mortality. Randomised trials with high methodological quality are required before clinical use is considered.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

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

Viral hepatitis causes significant morbidity and mortality. Based on this Cochrane systematic review, bile acids may decrease serum transaminase activities in patients with acute hepatitis B, chronic hepatitis B, or chronic hepatitis C. However, bile acids have no effects in eradicating viral markers. There is insufficient evidence either to support or to refute effects on the long-term outcomes that include hepatocellular carcinoma, decompensated cirrhosis, and/or liver related mortality.

No clinical trials have evaluated bile acids for patients with hepatitis A, acute hepatitis C, hepatitis D, or hepatitis E. Accordingly, bile acids should first be evaluated in adequately sized and adequately conducted randomised trials before clinical use is considered.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

膽酸於病毒性肝炎之應用

已經有試驗評估膽酸於病毒性肝炎病患的運用,但是它們的效用尚未達成共識。

目標

評估膽酸對於病毒性肝炎的利弊

搜尋策略

搜尋2007年7月Cochrane HepatoBiliary Group Controlled Trials Register,Cochrane Library(2007年第1期),EMBASE (2007年7月),MEDLINE(2007年7月),Science Citation Index Expanded (2007年7月), 以及Chinese Biomedical Database (2007年7月) 。

選擇標準

包括的隨機臨床試驗為比較任何劑量或者治療時間的膽酸與安慰劑或者沒有進行治療在病毒性肝炎的情形。 在被包括的隨機臨床試驗共同性治療是被容許的。“ – (補譯調整)>”收納病毒性肝炎治療隨機臨床試驗比較任何劑量或治療時間的膽汁酸與安慰劑或沒有治療,而不限語言,出版狀況,或盲法。在被收納的隨機臨床試驗共同性治療是被容許的。

資料收集與分析

兩位作者獨立地選出資料。試驗的方法學的品質是評估其分配順序的形成,分配隱藏,雙盲和追蹤的情形。結果是以相對風險(RR)或者加重平均差別(WMD)合併95% 信賴區間(CI)來呈現。

主要結論

我們找到29個試驗膽酸於B型或C型肝炎的隨機試驗;沒有一個具高品質的方法學。有二個試驗我們找不出資料。其中一個試驗,ursodeoxycholic acid (UDCA)相較於安慰劑對急性B型肝炎在治療結束時有意義地的降低B型肝炎表面抗原陽性現象的風險和在追蹤結束時血清中B型肝炎病毒DNA的高度。另一個試驗,對於慢性B型肝炎UDCA與沒有治療的試驗相較在治療結束時顯著降低有異常的血清轉胺基 活性的風險。25個試驗(21個試驗UDCA; 4 個試驗 tauroUDCA)針對慢性肝炎C比較膽酸與安慰劑或沒有治療合併或沒有合併共同性治療的情形。 在治療結束時 膽酸沒有顯著降低可以偵測到血清中C型肝炎病毒RNA的風險 (RR 0.99,95% CI 0.91 to 1.07), 肝硬化或門靜脈和門靜脈周圍發炎的評分。 膽酸顯著減少異常的血清丙氨酸轉氨?活性的風險,在治療結束時 (RR 0.82,95% CI 0.76 to 0.90),在追蹤結束時 (RR 0.91,95% CI 0.85 to 0.98)。在治療結束時膽酸顯著增加Knodell score (WMD 0.20,95% CI 0.08 to 0.31)。 沒有嚴重的不利事件被報告。 我們沒有找到包括有A型肝炎,急性C型肝炎,D型肝炎或E肝炎病人的試驗。

作者結論

膽酸導致有意義性的改善B型和C型肝炎血清中轉氨?活性,但是對病毒的清除無效。沒有足夠的證據支持或者反駁長期的結果包括肝癌,肝臟的去代償和與肝臟相關的死亡率。 在考慮臨床使用之前,高品質方法學的隨機試驗是須要的

翻譯人

本摘要由臺中榮民總醫院王建得翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

膽酸可能可以改善B型和C型肝炎病人肝生化指標,但是沒有足夠的證據支持或者反駁長期的有益效應。病毒性肝炎導致重大的罹病率和死亡率。依據這個考科藍系統性的回顧,膽酸可降低急性B型肝炎,慢性B型肝炎,慢性C型肝炎病人血清丙氨酸轉氨?活性。然而,膽酸沒有清除病毒指標的效應。。沒有足夠的證據支持或者反駁長期的結果包括肝癌,肝臟的去代償和與肝臟相關的死亡率。沒有臨床試驗評估膽酸於A型肝炎,急性C型肝炎,D型肝炎或E肝炎的效應。因此,在考慮臨床使用之前,膽酸應首要以合適的樣本數量和適當管理的隨機試驗來評估。