Effect of dehydroepiandrosterone administration on fatigue, well-being, and functioning in women with primary Sjögren syndrome: a randomised controlled trial.
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.
Hartkamp
A
A
Department of Rheumatology & Clinical Immunology, University Medical Center Utrecht, Utrecht, The Netherlands.
Geenen
R
R
Godaert
G L R
GL
Bootsma
H
H
Kruize
A A
AA
Bijlsma
J W J
JW
Derksen
R H W M
RH
D000328:Adult; D000339:Affect; D000368:Aged; D001799:Blood Sedimentation; D016009:Chi-Square Distribution; D003687:Dehydroepiandrosterone / Q000627:therapeutic use*; D019314:Dehydroepiandrosterone Sulfate / Q000097:blood; D004311:Double-Blind Method; D005221:Fatigue / Q000188:drug therapy* / Q000523:psychology; D005260:Female; D006801:Humans; D008875:Middle Aged; D010147:Pain Measurement; D011569:Psychiatric Status Rating Scales; D011788:Quality of Life; D012859:Sjogren's Syndrome / Q000097:blood / Q000188:drug therapy* / Q000523:psychology*; D013739:Testosterone / Q000097:blood; D017211:Treatment Failure
D013739:Testosterone; D003687:Dehydroepiandrosterone; D019314:Dehydroepiandrosterone Sulfate