Objectives: To examine the safety and efficacy of anhydrous crystalline maltose for treatment of dry mouth and other symptoms of dryness in patients with primary Sjögren's syndrome.
Design: Anhydrous crystalline maltose was delivered orally as a 200-mg lozenge given three times daily over a 24-week period to a total of 100 subjects. All participants had prominent complaints of persistent dry mouth associated with primary Sjögren's syndrome. Patients were examined at baseline and every 6 weeks of treatment.
Settings: Patients were seen in outpatient clinics at a total of 27 sites within the United States.
Outcome measures: Unstimulated whole saliva output, a measure of basal salivary gland function, was determined at each visit. Symptoms associated with oral and ocular dryness were assessed at the same time with the use of 100-mm visual analogue scales. Safety was assessed by physical examination and laboratory studies.
Results: During this clinical trial, a majority of evaluable subjects (39/76) demonstrated an increase in unstimulated whole saliva output, and the treatment exhibited an excellent safety profile. The anhydrous crystalline maltose treatment led to significant improvement in several subjective measures of oral and ocular comfort.
Conclusions: In this study, anhydrous crystalline maltose lozenges administered three times daily for 24 weeks improved salivary output and decreased complaints of dry mouth and eyes in patients with primary Sjögren's syndrome. Side-effects were minimal, and treatment was without significant adverse events. These results are similar to the benefits observed in two prior studies reported by the authors. This safe and simple intervention appears to provide clinical benefit to primary Sjögren's syndrome patients with distressing dry mouth symptoms.