Intervention Review

Anabolic steroids for the treatment of weight loss in HIV-infected individuals

  1. Karen KJ Johns1,*,
  2. MJ Beddall2,
  3. RC Corrin3

Editorial Group: Cochrane HIV/AIDS Group

Published Online: 19 OCT 2005

Assessed as up-to-date: 15 AUG 2005

DOI: 10.1002/14651858.CD005483


How to Cite

Johns KKJ, Beddall MJ, Corrin RC. Anabolic steroids for the treatment of weight loss in HIV-infected individuals. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD005483. DOI: 10.1002/14651858.CD005483.

Author Information

  1. 1

    Health Canada, Bureau of Metabolism, Oncology, and Reproductive Sciences of the Therapeutic Products Directorate, Ottawa, Ontario, Canada

  2. 2

    Ottawa, Ontario, Canada

  3. 3

    Therapuetic Products Directorate, Health Canada, Bureau of Gastroenterology, Infection and Viral Diseases, Ottawa, Ontario, Canada

*Karen KJ Johns, Bureau of Metabolism, Oncology, and Reproductive Sciences of the Therapeutic Products Directorate, Health Canada, Finance Building, Tunney's Pasture, Ottawa, Ontario, K1H 5T1, Canada. karen_johns@hc-sc.gc.ca.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 19 OCT 2005

SEARCH

 

Abstract

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

Background

Individuals with HIV infection often lose weight during the course of their disease. Furthermore, low serum concentrations of testosterone are common in individuals with HIV infection, particularly those with weight loss. Treatment of weight loss with anabolic steroids in HIV-infected individuals may be beneficial.

Objectives

Our objectives were to assess the efficacy and safety of anabolic steroids for the treatment of weight loss in adults with HIV infection.

Search methods

We searched the following databases: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, AIDSLINE, AIDSearch, EMBASE, CINAHL, Current Contents, and the National Library of Medicine Gateway Abstracts for controlled trials up to April 2005. We also searched the bibliographies of the identified studies and review the articles. In addition, pharmaceutical manufacturers of anabolic steroids were contacted.

Selection criteria

Randomized controlled trials that compared the use of an anabolic steroid to placebo to treat weight loss in adults with HIV were included. Randomized controlled trials that compared the use of anabolic steroids to placebo for the treatment of weight loss in adults with HIV were selected. Change from baseline in lean body mass or in body weight was reported as on outcome measure.

Data collection and analysis

Two reviewers independently assessed the trials for quality of randomization, blinding, withdrawals, and adequacy of allocation concealment. For continuous data, weighted mean differences (WMD) were calculated. For dichotomous outcomes, risk differences, were calculated. Because of uncertainty as to whether consistent true effects exist in such different populations and treatments, the authors decided a priori to use random effects models for all outcomes.

Main results

Thirteen trials met the inclusion criteria. Two hundred ninety-four individuals randomized to anabolic steroid therapy and 238 individuals randomized to placebo were included in the analysis of efficacy for change from baseline in lean body mass. Three hundred forty-three individuals randomized to anabolic steroid and 286 randomized to placebo were included in the analysis of efficacy for change from baseline in body weight. The mean methodologic quality of the included studies was 4.1, of a maximum 5 points. Although significant heterogeneity was present for both outcomes, the average change in lean body mass was 1.3 kg (95% CI: 0.6, 2.0), while the average change in total body weight was 1.1 kg (95% CI: 0.3, 2.0). A total of eight deaths occurred during the treatment period; four in the anabolic steroid treatment groups and four in the placebo-treatment groups (risk difference 0.00, 95% CI -0.03, 0.03). The risk difference for withdrawals or discontinuations of study medication due to adverse events was 0.00 (95% CI: -0.02, 0.03).

Authors' conclusions

Although the results of the trials were heterogeneous, on average, the administration of anabolic steroids appeared to result in a small increase in both lean body mass and body weight as compared with placebo. While these results suggest that anabolic steroids may be useful in the treatment of weight loss in HIV infected individuals, due to limitations, treatment recommendations cannot be made. Further information is required regarding the long-term benefit and adverse effects of anabolic steroid use, the specific populations for which anabolic steroid therapy may be most beneficial, and the optimal regime. In addition, the correlation of improvement in lean body mass with more clinically relevant endpoints, such as physical functioning and survival, needs to be determined.

 

Plain language summary

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

Anabolic steroids for the treatment of weight loss in HIV-infected individuals

Anabolic steroids may be beneficial in the treatment of weight loss in HIV-infected individuals. Anabolic steroids include testosterone and its derivatives. One of the functions of testosterone is to help build muscle. Testosterone has been demonstrated to increase muscle mass and lean body mass in testosterone-deficient but otherwise healthy men. Individuals with HIV infection often lose weight and have low blood levels of testosterone; thus, the use of anabolic steroids in the treatment of weight loss in individuals with HIV infection may be beneficial. The purpose of this review was to evaluate anabolic steroids as a means of treatment of weight loss in individuals with HIV infection. The review includes 13 randomized clinical trials in the primary analysis. The results suggested that anabolic steroids increased both lean body mass and body weight. However, the results were not consistent among individual trials and the average increase was small and may not be clinically relevant. Furthermore, the results need to be interpreted with caution as this meta-analysis was limited due to small sample sizes; short duration of treatment and of follow-up; and heterogeneity of the study populations, the anabolic interventions, and concomitant therapies.

 

摘要

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

背景

使用合成類固醇(anabolic steroids)以治療HIV感染者之體重減輕

HIV感染者在罹病期間經常會體重減輕。此外,這些HIV感染者,特別是有體重減輕的,睪固酮的血清濃度偏低是非常常見的。所以用合成類固醇治療HIV感染者的體重減輕可能是有助益的。

目標

我們的目的是評估使用同化作用類固醇在治療HIV感染的成年人併有體重減輕時的效力和安全性

搜尋策略

我們搜尋以下的資料庫:Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, AIDSLINE, AIDSearch, EMBASE, CINAHL, Current Contents和the National Library of Medicine Gateway Abstracts 中有控制組的臨床試驗,直到西元2005年4月為止。針對找到的研究,也搜尋其參考書目並回顧文章。此外,也與合成類固醇的製造藥廠取得聯繫。

選擇標準

選擇試驗的標準是:比較使用合成類固醇與安慰劑以治療HIV感染成人體重減輕情形的隨機、有控制組的臨床試驗。成效是以體重或精瘦身體質量(lean body mass)的改變來衡量。

資料收集與分析

二個評論者獨立地評估這些臨床試驗中關於隨機分配、隱瞞方式(blinding)、退出及隱瞞分配過程的適當性等的品質。針對連續性的資料,計算其加權平均差異(weighted mean differences);針對使用二分法的試驗結果,則計算其危險性差異。由於在這樣不同的族群和治療中,並不確定是否真有一致性的效果存在,作者以邏輯猜測決定對所有結果使用隨機效果模型(random effects models)。

主要結論

十三個試驗符合選擇標準。在改變精瘦身體質量的效果分析中,有294位被隨機分配到合成類固醇療法,238位被隨機分配到安慰劑。在改變體重的效果分析中,有343位被隨機分配到合成類固醇療法,286位被隨機分配到安慰劑。關於這些選擇的研究,其方法學的品質平均分數是4.1,滿分為5分。雖然兩種結果均存在有顯著的異質性,精瘦身體質量上的平均變化是1.3公斤(95%的信心區間是0.6,2.0),體重的平均變化則是1.1公斤(95%的信心區間是0.3,2.0)。在治療期間,總共有八位死亡,四位在合成類固醇治療組,四位在安慰劑治療組 (危險差異為0.00, 95%信心區間−0.03, 0.03)。因副作用而退出或中斷試驗用藥的風險差異是0.00(95%信心區間為−0.02,0.03)。

作者結論

雖然試驗的結果是不一致的,平均而言,給予合成類固醇和安慰劑相比似乎可使精瘦身體質量和體重小幅增加。雖然這些結果暗示,以合成類固醇治療HIV感染者的體重減輕可能是有用的,但是由於試驗的諸多限制,無法確立治療的建議。關於長期使用合成類固醇的好處和不良反應、哪些特定族群的患者使用合成類固醇治療是最有好處的和理想的處方劑量等議題則仍需更多的資料。此外,改善精瘦身體質量和其它與臨床較為相關的指標(例如身體功能和存活)之間的關連,也需要被確立。

翻譯人

本摘要由臺北榮民總醫院李慶威翻譯。

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

總結

合成類固醇在治療成人HIV感染併體重減輕時可能是有益的。合成類固醇包括睪固酮和它的衍生物。 其中一個睪固酮的作用是幫助建造肌肉。睪固酮在睪固酮缺少的人可以增加肌肉質量和精瘦身體質量,但是在一般健康的人則沒有此現象。HIV感染的病人經常會有體重減輕以及低血清濃度的睪固酮。本篇回顧性文章的目的主要是評估合成類固醇用來治療HIV感染的病人的體重減輕。本篇回顧文章主要分析包括13個隨機分配的臨床試驗。 結果顯示合成類固醇增加了精瘦身體質量和體重。但是,試驗結果在個別試驗不具有一致性,而且少量的平均增加值可能不具臨床意義的。此外,因為這整合分析受限於樣本小,治療期間和後續追蹤時間短,而且研究對象、合成作用干預和伴隨療法的不一致性,因為上述原因,這結果需要小心地被解釋。