Use of orally administered anhydrous crystalline maltose for relief of drymouth

Objectives: To examine the safety and efficacy of anhydrous crystalline mal tose (ACM) for treatment of dry mouth. Design: ACM was delivered orally as a 200-mg lozenge given three times dail y over a 12-week (study Alpha) or 24-week (study Omega) period to a total o f 22 and 97 subjects, respectively. All participants had prominent complain ts of persistent dry mouth associated with primary Sjogren's syndrome. Pati ents were examined every 4 weeks in study Alpha and every 6 weeks in study Omega. Settings: Patients were seen in outpatient clinics at a total of 33 sites w ithin the United States. Outcome measures: Unstimulated whole saliva output, a measure of basal sali vary 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 analog scales. Safety was assessed by physical examination and l aboratory studies. Results: During these clinical trials, a majority of subjects demonstrated an increase in unstimulated whole saliva output and the treatment exhibited an excellent safety profile. The ACM treatment in study Omega Zed to signi ficant improvement in several subjective measures of oral and ocular comfor t. Conclusions: In these two studies, ACM lozenges administered three times da ily for 12 or 24 weeks improved salivary output and decreased complaints of dry mouth and eyes. Side effects were minimal, and treatment was without s ignificant adverse events. This safe and simple intervention may provide cl inical benefit to individuals with distressing dry mouth symptoms.