The clinical effects of electrostimulation on salivary function of Sjögren's syndrome patients. A placebo controlled study.

A multi-center double-blind study of an electro-stimulator device was conducted to evaluate its ability to increase the production of saliva and reduce clinical symptomatology. A total of 77 Sjögren's syndrome patients at three centers were assigned to active devices (n = 40) or to placebo devices (n = 37). There were 2 male and 32 female patients assigned to active devices, and 1 male and 36 female patients assigned to placebo devices. The age range with the greatest number of patients was 60-69 years making up more than 31% of the study population. The selection criteria required the patients to have no greater than 0.2 g/min of whole salivary production (approximately 19% of normal salivary production). At the start of the study, the patients assigned the active device had a mean salivary production of 0.06 ml per min (6% of normal) and patients assigned placebo devices had a mean salivary production of 0.07 ml per min (7% of normal). There were three scheduled visits, 2 weeks apart, over a treatment period of 4 weeks. At all visits, the patients using active devices showed a statistically greater (P = 0.005 to 0.02) increase in the production of saliva than placebo patients. The study also evaluated the reduction of patients symptoms associated with xerostomia. Patients showed significant improvement in (1) difficulty in swallowing and (2) burning tongue (P = 0.008). Some patients on their initial visit had no response to the active device and did not show a significant response at subsequent visits.(ABSTRACT TRUNCATED AT 250 WORDS)

RCT Entities:   Population Interventions Outcomes