SINGLE-BLINDED CONTROLLED TRIAL OF LOW-DOSE ORAL IFN-ALPHA FOR THE TREATMENT OF XEROSTOMIA IN PATIENTS WITH SJOGRENS-SYNDROME

A single-blinded controlled trial was conducted to test the efficacy o f low-dose oral human interferon-alpha (IFN-alpha) to improve salivary function in patients with Sjogren's syndrome, Fifty-six outpatients w ith primary and 4 patients with secondary Sjogren's syndrome were assi gned randomly into treatment groups of either IFN-alpha or sucralfate (control). The IFN-alpha (150 IU) or sucralfate (250 mg) was given ora lly three times a day for 6 months, Saliva was quantitated monthly by the Saxon test, After 6 months of treatment, 15 of 30 (50%) IFN-alpha- treated patients had saliva production increases at least 100% above b aseline, whereas only 1 of 30 (3.3%) sucralfate patients had a compara ble increase (p < 0.001), The increase in saliva production, by treatm ent group, was significantly greater (p < 0.01) in the IFN-alpha treat ed group at every month after treatment. Serial labial salivary gland biopsies of 9 IFN-alpha responder patients showed that lymphocytic inf iltration was significantly decreased (p < 0.02) and the proportion of intact salivary gland tissue was significantly increased (p 0.004) af ter the IFN-alpha treatment. In this study, IFN-alpha therapy signific antly improved Sjogren's syndrome salivary gland dysfunction.