The efficacy and toxicity of cyclosporin A (CyA) were studied in a blind fashion in 20 patients with primary Sjögren's syndrome (pSS). The dose of CyA or placebo was 5 mg/kg of body weight daily. Among the 20 patients, 10 received CyA and 10 placebo. The two groups were matched for age, sex, and disease duration. Patients treated with CyA improved in subjective xerostomia in comparison with patients treated with placebo. Subjective xerophthalmia and recurrent parotid gland enlargement did not differ in the two groups. No change in Schirmer's test and stimulated parotid flow rate was observed in either group. In contrast, the histopathological lesion of patients treated with CyA remained unchanged in most of the patients, while in the placebo treated group the lesion deteriorated. Laboratory parameters did not change before or after treatment in either group. The only clinical side effect observed in the CyA treated group was hypertrichosis.
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