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Dehydroepiandrosterone for systemic lupus erythematosus

Crosbie D, Black C, McIntyre L, Royle PL, Thomas S

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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.

This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2008 Issue 3, Copyright © 2008 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This record should be cited as: Crosbie D, Black C, McIntyre L, Royle PL, Thomas S. Dehydroepiandrosterone for systemic lupus erythematosus. Cochrane Database of Systematic Reviews 2007, Issue 4. Art. No.: CD005114. DOI: 10.1002/14651858.CD005114.pub2.

This version first published online: October 17. 2007

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 strategy

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.

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