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Dehydroepiandrosterone for systemic lupus erythematosus

  • Review
  • Intervention

Authors


Abstract

Background

Systemic lupus erythematosus (SLE) is a chronic inflammatory, multisystem autoimmune condition. Dehydroepiandrosterone (DHEA) is a naturally occurring inactive steroid which may possess disease activity modifying properties as well as the ability to reduce flares and steroid requirements.

Objectives

To assess the effectiveness and safety of dehydroepiandrosterone compared to placebo in the treatment of people with systemic lupus erythematosus.

Search methods

We searched The Cochrane Library (Issue 2, 2006), MEDLINE, Pub Med, EMBASE, Science Citation Index and ISI Proceedings as well as searching web sites of Genelabs, FDA and EMEA. (Searches undertaken in June 2006 unless otherwise specified).

Selection criteria

We included randomised controlled trials of at least three months duration comparing DHEA to a placebo in people with SLE.

Data collection and analysis

Two review authors assessed quality and extracted data.

Main results

From the seven RCTs identified (842 participants) to date there is 'gold' ranking evidence (www.cochranemsk.org) that DHEA:

had little clinical effect on disease activity in those with mild/moderate disease (measured by SLEDAI or SLAM) but one study demonstrated evidence of stabilisation or improvement in 8.3% more patients than those treated with placebo;
had a modest but clinically significant improvement in health related quality of life measured by Patient Global Assessment, estimated as 11.5% (11.5 mm on a 100 mm scale) by meta-analysis;
resulted in a greater number of patients experiencing adverse events, particularly androgenic effects such as acne where patients risk was doubled when compared to placebo (RR 2.2; 95% CI 1.65 to 2.83)

Authors' conclusions

Studying effectiveness of DHEA for SLE is difficult, reflecting the problems of studying any treatment for a disease as complex as SLE. From the seven RCTs to date, there was evidence that DHEA had a modest but clinically significant impact on health related quality of life in the short term. Impact on disease activity was inconsistent, with DHEA showing no benefit over placebo in terms of change in SLEDAI in all but one of the 6 studies reporting this outcome. Long term outcomes and safety remain unstudied.

摘要

背景

Dehydroepiandrosterone (DHEA) 治療紅斑性狼瘡

紅斑性狼瘡是一種慢性發炎多系統自體免疫疾病。Dehydroepiandrosterone (DHEA)是內生性無活性類固醇,有治療紅斑性狼瘡修飾疾病活性及減少類固醇用量及減少疾病發作潛力。

目標

評估Dehydroepiandrosterone (DHEA)與安慰劑治療紅斑性狼瘡之效果及安全性。

搜尋策略

搜尋包括Cochrane Library (Issue 2, 2006), MEDLINE, Pub Med, EMBASE, Science Citation Index and ISI Proceedings as well as searching web sites of Genelabs, FDA and EMEA. (Searches undertaken in June 2006 unless otherwise specified)。

選擇標準

隨機對照試驗研究評估Dehydroepiandrosterone與安慰劑治療紅斑性狼瘡至少3個月之效果

資料收集與分析

兩位作者獨立進行資料摘錄,並對研究的品質進行評估。

主要結論

7個研究包含842例病患於分析中。Dehydroepiandrosterone治療輕中度紅斑性狼瘡﹝以SLEDAI或SLAM為指標﹞,在疾病活性方面有少量臨床效果,但一篇研究顯示DHEA比安慰劑,多8.3% 患者穩定或進步。在病患整體評估健康相關生活品質測量,有中等臨床進步,統合分析差異11.5% (11.5 mm on a 100 mm scale)。在副作用較多,尤其雄性激素作用長青春痘為兩倍,相對風險2.2 (95% CI 1.65 to 2.83)。

作者結論

研究評估Dehydroepiandrosterone治療像紅斑性狼瘡般複雜疾病是困難的。7個研究顯示DHEA短期在病患整體評估健康相關生活品質有中等臨床效果,在疾病活性方面結果不一致,僅6篇中之1篇顯示SLEDAI有改善。長期效果及副作用需進一步研究。

翻譯人

本摘要由林口長庚醫院余光輝翻譯。

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

總結

DHEA可降低狼瘡對器官的損害或本研究沒有測量的危害。可能的副作用可能包括痤瘡,過度頭髮生長,月經的變化。但我們沒有確切關於副作用和併發症的資訊。現在還不知道是否DHEA會導致長期的副作用,如心臟病或癌症。這是因為還沒有多少人被加入研究且最長的研究時間只有1年。什麼是系統性紅斑狼瘡(SLE)和DHEA?系統性紅斑狼瘡(SLE),或單純狼瘡'是一群疾病,會造成人體的免疫系統攻擊身體。它可以影響任何器官系統包括結締組織,包括皮膚,腎臟,眼睛,肺部,心臟,肌肉,骨骼,神經系統,胃腸系統。這些症狀可從輕微到危及生命。狼瘡主要發生在年輕女性,但男性和小孩也會發生。DHEA(dehydroepiandrosterone)是一種人體內的激素。狼瘡的患者往往體內DHEA濃度較低,所以給予DHEA藥片補充可能可以幫助控制免疫系統。DHEA可能還可削減皮質類固醇治療的需要,這意味著減少皮質類固醇的副作用。什麼是DHEA的效用?疾病活動(症狀活躍或症狀的改變):我們不能肯定,但在使用DHEA後疾病活動的確存在差異。這樣結果很可能只是機率造成。整體健康:增加超過12分(其量表為 0至100)。較少器官損害:我們不知道是否服用DHEA能夠減少器官損害,因為在任何研究中都沒有測量。副作用及併發症:比起沒有治療,使用DHEA中,每 00多個輕度至中度狼瘡患者會多出20人有痤瘡問題。

Plain language summary

Dehydroepiandrosterone (DHEA) for lupus erythematosus

This summary of a Cochrane review presents what we know from research about the effect of dehydroepiandrosterone (DHEA) for lupus. The review shows that:

DHEA probably leads to little or no difference in disease activity in people with mild to moderate disease, but probably slightly improves overall well-being. These results are based on moderate quality evidence.
DHEA may improve disease activity in people with severe or active lupus, but this result is based on low quality evidence so there is not enough evidence to be certain.
It is not known whether DHEA reduces the damage that lupus causes to organs as damage was not measured in the studies.
Possible side effects may include acne, excessive hair growth, and menstrual changes. But we often do not have precise information about side effects and complications.
It is not known whether DHEA causes long term side effects such as heart problems or cancer. This is because there were not many people in the studies and the longest study was only 1 year long.

What is Systemic lupus erythematosus (SLE) and DHEA (dehydroepiandrosterone)?

Systemic lupus erythematosus (SLE) or simply 'lupus' is a group of diseases in which the body's immune system attacks the body. It can affect any organ system involving connective tissue, including the skin, kidneys, eyes, lungs, heart, muscles and bones, nervous system, and gastrointestinal system. The symptoms can range from mild to life-threatening. Lupus occurs mainly in young women, but also in men and children.
DHEA (dehydroepiandrosterone) is a hormone in the body. People with lupus tend to have lower levels of DHEA, so taking DHEA supplements in pill form may help control the immune system. DHEA might also cut the need for corticosteroid treatment which means less side effects from corticosteroids.

What are the effects of DHEA (dehydroepiandrosterone)?

Disease activity (flares or changes in symptoms): We can not be sure that there is actually a difference in disease activity when taking DHEA. It is possible that these results are by chance.
Overall well-being: Improves by 12 more points on a scale of 0 to 100
Less organ damage: We are not sure whether taking DHEA could reduce organ damage because it was not measured in any of the studies.
Side effects and complications: 20 out of 100 more people with mild to moderate lupus will have acne with DHEA than with no treatment.

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