A Cochrane review [Abstract] 1 included 7 studies (lasting 3-12 months) with a total of 842 subjects. Impact on disease activity was inconsistent. Meta-analysis was possible for two studies with mild/moderate disease (N = 148) and supported no statistically significant mean difference in systemic lupus erythematosus (SLE) disease activity index (SLEDAI) among those treated with dehydroepiandrosterone (DHEA) versus placebo (WMD -0.6, 95% CI -2.12 to 0.89). Three of the studies that could not be included in the meta-analysis reported findings in keeping with the meta-analysis result. One study reported, that if only those with 'active' disease (SLEDAI > 2) were included in the analysis, 8.3% (P = 0.04) more people remain "stable or improve" on DHEA versus placebo, measured using SLEDAI. One very small trial (n=19) in participants with severe SLE reported improvements in SLEDAI among those treated with DHEA that were of borderline statistical significance when compared with placebo.
DHEA compared to placebo had a modest but clinically significant improvement in health related quality of life measured by Patient Global Assessment, estimated as 11.5% (reduction of 11.5 mm on a 100 mm scale, 95% CI -19.08 to -3.84; 2 studies, n=148). The Physicians global score was reported in three studies; in none of the studies was a statistically significant improvement achieved. DHEA resulted in a greater number of patients experiencing adverse events (RR 2.2, 95% CI 1.65 to 2.83), particularly androgenic effects such as acne. Due to the small study size and short follow-up time it was not possible to study whether DHEA causes long term side effects such as heart problems or cancer.
Comment: The quality of evidence in downgraded by study quality (unclear allocation concealment), by inconsistency (variability in results across studies) and by imprecise results (limited study size for each comparison). Long-term outcomes and safety remain unstudied.
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