HYDROXYCHLOROQUINE TREATMENT FOR PRIMARY SJOGRENS-SYNDROME - A 2-YEARDOUBLE-BLIND CROSSOVER TRIAL

Objectives-In 1985 and 1988 a positive effect of treatment of primary Sjogen's syndrome with hydroxychloroquine was reported in two small op en studies. To investigate further the clinical and laboratory effects of hydroxychloroquine in primary Sjogren's syndrome a two year study was performed. Methods-The design of the study included a prospective, placebo controlled, two year double blind crossover trial in 19 patie nts Results-A significant decrease in IgG and IgM and a tendency for a decrease in the erythrocyte sedimentation rate (ESR) during treatment with hydroxychloroquine compared with treatment with placebo were fou nd. No beneficial clinical effect of the use of hydroxychloroquine as expressed in preference for treatment with hydroxychloroquine or place bo with regard to symptoms and signs of primary Sjogren's syndrome cou ld be shown, however, nor any relevant change in tear gland activity a nd sequelae of peripheral tear function deficiency, nor salivary gland scintigraphy. Conclusions-The use of hydroxychloroquine at a dose of 400 mg daily taken over a 12 month period does not have a worthwhile c linical benefit in patients with primary Sjogren's syndrome despite an improvement of hyperglobulinaemia and slight changes in the ESR and I gM.