Intervention Review

Anabolic-androgenic steroids for alcoholic liver disease

  1. Andrea Rambaldi*,
  2. Christian Gluud

Editorial Group: Cochrane Hepato-Biliary Group

Published Online: 18 OCT 2006

Assessed as up-to-date: 20 AUG 2006

DOI: 10.1002/14651858.CD003045.pub2


How to Cite

Rambaldi A, Gluud C. Anabolic-androgenic steroids for alcoholic liver disease. Cochrane Database of Systematic Reviews 2006, Issue 4. Art. No.: CD003045. DOI: 10.1002/14651858.CD003045.pub2.

Author Information

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

*Andrea Rambaldi, Cochrane Hepato-Biliary Group, Copenhagen Trial Unit, Centre for Clinical Intervention Research, Department 3344, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, Copenhagen, DK-2100, Denmark. arambaldi@hotmail.com. rambaldi.andrea@libero.it.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 18 OCT 2006

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Abstract

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

Background

Alcohol is one of the most common causes of liver disease in the Western World. Randomised clinical trials have examined the effects of anabolic-androgenic steroids for alcoholic liver disease.

Objectives

To assess the beneficial and harmful effects of anabolic-androgenic steroids for patients with alcoholic liver disease based on the results of randomised clinical trials.

Search methods

We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Controlled Trials Register in The Cochrane Library, MEDLINE, EMBASE, LILACS, and Science Citation Index Expanded until June 2006. Electronic searches were combined with full text searches. Manufacturers and researchers in the field were also contacted.

Selection criteria

Randomised clinical trials studying patients with alcoholic steatosis, alcoholic fibrosis, alcoholic hepatitis, and/or alcoholic cirrhosis were included. Interventions encompassed anabolic-androgenic steroids at any dose or duration versus placebo or no intervention. The trials could be double blind, single blind, or unblinded. The trials could be unpublished or published, and no language limitations were applied.

Data collection and analysis

Outcomes are assessed at maximal follow-up. All analyses were performed according to the intention-to-treat method. The statistical package RevMan Analyses was used. The methodological quality of the randomised clinical trials was assessed.

Main results

Combining the results of five randomised clinical trials randomising 499 patients with alcoholic hepatitis and/or cirrhosis demonstrated no significant effects of anabolic-androgenic steroids on mortality (relative risk (RR) 1.01, 95% confidence interval (CI) 0.79 to 1.29), liver-related mortality (RR 0.83, 95% CI 0.60 to 1.15), complications of liver disease (RR 1.25, 95% CI 0.74 to 2.10), and liver histology. Anabolic-androgenic steroids did not significantly affect a number of other outcome measures, including sexual function and liver biochemistry. Anabolic-androgenic steroids were not associated with a significantly increased risk of non-serious adverse events (RR 1.14, 95% CI 0.50 to 2.59) or with serious adverse events (RR 4.54, 95% CI 0.57 to 36.30).

Authors' conclusions

This systematic review could not demonstrate any significant beneficial effects of anabolic-androgenic steroids on any clinically important outcomes (mortality, liver-related mortality, liver complications, and histology) of patients with alcoholic liver disease.

 

Plain language summary

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

No evidence to support anabolic-androgenic steroids for alcoholic liver disease

Alcohol causes a major part of the liver diseases in the Western World. Several trials have addressed the effects of anabolic-androgenic steroids for alcoholic liver disease. This systematic review could not demonstrate any significant effects of anabolic-androgenic steroids on mortality, liver-related mortality, liver complications, and histology of patients with alcoholic liver disease. Anabolic-androgenic steroid intervention is not associated with a significant increase in non-serious adverse events, but with the seldom occurrence of serious adverse events. Accordingly, there is no evidence supporting the use of anabolic-androgenic steroids for alcoholic liver disease, but further randomised clinical trials may be needed to settle the question.

 

摘要

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

背景

合成男性荷爾蒙在酒精性肝病之應用

在西方世界酒精是引起肝病最常見的原因之一。許多臨床隨機性試驗檢驗了合成男性荷爾蒙對酒精性肝病的影響。

目標

基於臨床隨機性試驗的結果來讓我們評估合成男性荷爾蒙對酒精性肝病的利與弊。

搜尋策略

我們從考科藍實證資料庫、醫學文獻資料庫、EMBASE醫藥學文獻資料庫、拉丁美洲及加勒比文獻健康科學資料庫及科學引用文獻索引資料庫中,搜尋了自西元2006年6月以來,從考科藍肝膽群組控制試驗註冊者、考科藍控制試驗註冊者。我們採用電子與全文搜尋同時進行,也接觸了此領域的廠商與研究者。

選擇標準

隨機性臨床試驗蒐集了病人包括:酒精性肝臟脂肪變性、酒精性肝纖維化、酒精性肝炎或/及酒精性肝硬化。介入性治療乃是在任何劑量或任何使用持續時間下使用合成男性荷爾蒙,並與安慰劑或無介入性治療來比較。此試驗可以是雙盲、單盲或無盲。此試驗應用上可以是未發表或已發表及無語言限制性的。

資料收集與分析

結果的分析仍是在最長的追蹤下評估。所有分析的執行乃是根據治療意向法。統計使用套裝Rev Man軟體分析。方法學中隨機臨床性試驗的品質也被評估。

主要結論

結合了五個隨機臨床性試驗的結果,隨機分配499位有酒精性肝炎及/或肝硬化病人,顯示合成男性荷爾蒙對死亡率沒有顯著影響(相對危險比:1.01,95%信賴區間0.79至1.29),肝臟相關死亡率(相對危險比:0.83,95%信賴區間0.60至1.15),肝併發症死亡率(相對危險比:1.25,95%信賴區間0.79至2.10)及肝臟組織學。合成男性荷爾蒙並沒有顯著影響其他方面預後測量,包括性功能及肝生物化學。合成男性荷爾蒙也並不會顯著提高非嚴重副作用(相對危險比:1.14,95%信賴區間0.50至2.59)或嚴重副作用(相對危險比:4.54,95%信賴區間0.57至36.30)。

作者結論

此系統性回顧並無法顯示合成男性荷爾蒙應用在酒精性肝病上面,對臨床上重要的預後(肝臟相關死亡率、肝併發症死亡率及組織學上)有任何顯著性幫助。

翻譯人

本摘要由臺中榮民總醫院翁碩駿翻譯。

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

總結

目前並沒有證據說合成男性荷爾蒙可應用在酒精性肝病上。酒精是最主要造成西方國家肝病的原因。一些臨床試驗已強調合成男性荷爾蒙應用在酒精性肝病。但此篇系統性回顧說明合成男性荷爾蒙不能展現任何有意義之差異針對死亡率、肝臟疾病相關死亡率和酒精性肝病的病理組織。合成男性荷爾蒙介入性治療並不會導致嚴重之副作用。因此,目前並沒有證據顯示在酒精性肝病病人能使用合成男性荷爾蒙,反而是更多的隨機性臨床試驗才能回答此問題。