This study will evaluate the effectiveness of the male hormone dehydroepiandrosterone (DHEA)
in treating Sjogren's syndrome. This autoimmune disorder, in which the immune system
attacks the salivary glands and tear glands, affects primarily women. Patients' eyes and
mouth become drier over time, and can lead to problems such as serious tooth decay and eye
irritations. Sex hormones seem to influence the immune response and may help decrease
disease severity. DHEA has benefited some patients with two other autoimmune diseases,
rheumatoid arthritis and systemic lupus erythematosus.
Women 18 to 75 years of age with Sjogren's syndrome may be eligible for this 7-month study.
At the initial visit, candidates will have a physical examination, routine blood and urine
tests and eye and dental examinations, including a test to measure saliva production for
screening purposes and to establish baseline values for participants.
Those enrolled in the study will be randomly assigned to take either DHEA or placebo
(look-alike tablet with no active ingredient) once a day for 6 months and will be monitored
with follow-up visits at months 1, 3, 6 and 7. Physical examination, blood tests and
urinalysis will be repeated at months 1, 3, 6 and 7; saliva will be collected at months 3, 6
and 7; and eyes will be examined at 3 and 6 months. Because hormone changes may have both
physical and emotional effects, patients will be asked questions about their mood, symptoms
and side effects of treatment.
It is not known if Sjogren's syndrome is associated with osteoporosis (bone thinning), but
since this condition occurs in other autoimmune disorders, patient's bone density will be
measured at the first visit, and blood drawn at 3 and 6 months will be tested for various
substances associated with changes in bone density. A 24-hour urine collection at the first
visit and later urine tests will also be tested for substances associated with bone
Primary Sjogren's syndrome (SS) is an autoimmune disease chiefly affecting the exocrine
glands. One of the most troublesome manifestations of SS is severe salivary gland
dysfunction. There is no accepted treatment for the underlying autoimmune reactivity or the
salivary gland dysfunction in SS. SS, as well as many other autoimmune diseases,
predominantly affects women. Although sex hormones do not cause SS or other autoimmune
disease, they appear to influence immunological responses and ultimately the severity of
disease. We propose to test the effects of dehydroepiandrosterone (DHEA), a mildly
androgenic adrenal hormone, on lacrimal and salivary gland function in SS. In a randomized,
double-masked, outpatient protocol, patients will receive DHEA for 6 months. Efficacy of
treatment will be assessed by monitoring salivary and lacrimal function, serological markers
of autoimmune activity, and subjective reports of local and systemic symptoms.
Females with a diagnosis of Primary Sjogren's Syndrome.
No history of breast cancer.