Effect of dehydroepiandrosterone administration on fatigue, well-being, and functioning in women with primary Sjögren syndrome: a randomised controlled trial
- 1 Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands
- 2 Department of Clinical & Health Psychology, Utrecht University, Utrecht, The Netherlands
- 3 Department of Internal Medicine, Division of Clinical Immunology, University Medical Center Groningen, Groningen, The Netherlands
- Rinie Geenen, Utrecht University, Department of Clinical and Health Psychology, PO Box 80140, 3508TC Utrecht, The Netherlands;
- Accepted 22 May 2007
- Published Online First 1 June 2007
Objective: Dehydroepiandrosterone (DHEA) administration has been reported to improve fatigue, psychological distress, and physical disability. These are common features of primary Sjögren syndrome (pSS). We investigated the effects of DHEA administration on fatigue, well-being, and functioning in women with pSS.
Methods: In a double-blind, randomised 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. In addition, 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<0.001), mental well-being (p = 0.04), and depressive mood (p = 0.008). Physical functioning did not change (p = 0.44). Of the secondary outcome variables, complaints of a dry mouth diminished during treatment in both groups (p = 0.006), the erythrocyte sedimentation rate showed a decrease for the DHEA group (p = 0.02), and complaints of dry eyes improved in the placebo group (p = 0.01). 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 behavioural interventions.
Funding: This study was financially supported by the Dutch Arthritis Association (NR 98-2-301). The study sponsor was not involved in study design, in the collection, analysis, and interpretation of data, in the writing of the report and in the decision to submit the paper for publication.
Competing interests: None declared