Pilot clinical trial concludes Dehydroepiandrosterone (DHEA) not effective for treating Sjögren’s syndrome

Researchers studied the effect of the non-prescription hormone DHEA on 28 Sjögren’s patients. A positive response was considered to be a 20% improvement in at least two of three domains: ocular, oral and laboratory.

Fourteen subjects received DHEA and 14 a placebo. Only two subjects met response criteria in the DHEA group, and three met the criteria in the placebo group. No significant differences were noted between the DHEA and placebo groups for: changes in dry mouth or dry eye symptoms; ocular dryness (Schirmer I test; van Bijsterveld scores); stimulated salivary flow; IgG or ESR. Four DHEA and one placebo group patient dropped out of the study because of adverse effects. In conclusion, DHEA showed no evidence of efficacy as a treatment for Sjögren’s syndrome. Without evidence for efficacy, Sjögren’s syndrome patients should be discouraged from using unregulated DHEA supplements, since long-term adverse consequences of exposure to this hormone are unknown.

Study conducted by: Stanley R. Pillemer, National Institutes of Health (NIH), Bethesda, MD; Michael Brennan, Carolinas Medical Center, Charlotte, NC; Vidya Sankar, NIH; Rose Anne Leakan, NIH; Margaret Grisius, NIH; Sophie Ligier, Hôpital Maisonneuve-Rosemont, Montreal, PQ, Canada; Marc R. Kok, NIH; Bruce J. Baum, NIH; Philip C. Fox, NIH.

Return to Main Listing