Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome

Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration

The purpose of the study is to examine whether dehydroepiandrosterone (DHEA) administration improves fatigue and general well-being in patients with systemic lupus erythematosus or primary Sjögren's syndrome

Fatigue and reduced general well-being are frequent complaints in patients with the chronic autoimmune disorder systemic lupus erythematosus (SLE) or primary Sjögren's syndrome (pSS). Uncontrolled studies suggested that the administration of dehydroepiandrosterone (DHEA) may improve such complaints. The aim of our randomized double-blind placebo-controlled study is to examine the effect of daily oral 200 mg DHEA on fatigue, well-being, and functioning in women with SLE or pSS.

Inclusion Criteria:

• pSS with a focus score >= 1 on minor salivary gland biopsy and fulfilling European classification criteria (Ann Rheum Dis 1996;55:116-21)
• SLE according to ACR classification criteria (Arthritis Rheum 1982;25:1271-7)
• Willingness to apply effective contraception (premenopausal women)
• Written informed consent.

Exclusion Criteria:

• Pregnancy
• Pregnancy wish
• Serum creatinine > 150 µmol/L
• Glucocorticoid use at a daily dose > 10 mg prednisone (or equivalent)
• Cyclophosphamide treatment in the preceding year
• Hyper- or hypothyroidism
• History of malignancy within the previous 5 years with exception of squamous or basal cell carcinoma of the skin