Abstract

Objective: Dehydroepiandrosterone (DHEA) administration has been reported to improve fatigue, psychological distress, and physical disability. These are common features of primary Sjögren’s syndrome (pSS). We investigated the effects of DHEA administration on fatigue, well-being, and functioning in women with pSS.

Methods: In a double-blind, randomized placebo-controlled clinical trial, 60 female patients with pSS received 200 mg oral DHEA or placebo. Primary outcome measures were general fatigue, depressive mood, mental well-being, and physical functioning. Also pain, sicca complaints and disease activity parameters were measured. Patients were assessed before treatment, after 3, 6, and 12 months on study medication, and 6 months after cessation of treatment.

Results: Patients from both the DHEA- and placebo-treated group improved on general fatigue (p < .001), mental well-being (p = .04), and depressive mood (p = .008). Physical functioning did not change (p = .44). Of the secondary outcome variables, complaints of a dry mouth diminished during treatment in both groups (p = .006), the erythrocyte sedimentation rate showed a decrease for the DHEA group (p = .02), and complaints of dry eyes improved in the placebo group (p = .01). The belief to have used DHEA was a stronger predictor for improvement of fatigue and well-being than the actual use of DHEA.

Conclusions: Our study does not support a superior effect of DHEA over placebo in female patients with pSS. Both DHEA and placebo induce improvement of fatigue and well-being. This may suggest possibilities for cognitive-behavioral interventions. Cinicaltrials.gov registration: NCT00391924