Background Xerostomia is a major distressing symptom in Sjögren’s syndrome (SS). Persistent dryness of the mouth causes oral pain, discomfort and significantly interferes with the quality of life. Rebamipide, in addition to its gastro-protective effect has displayed various anti-inflammatory actions including inhibition of neutrophilic leukocyte activation. Preclinical and clinical studies have demonstrated an increase in saliva volume following rebamipide administration.

Objectives To assess efficacy of rebamipide in the treatment of dry mouth symptoms related to Sjögren’s syndrome.

Methods Fifty-five patients (9 men, 46 women; of mean age 52.1 years) with American European Consensus Criteria Group (AECG)-based diagnosis of SS participated in this randomized double-blind placebo-controlled trial. Inclusion criteria included SS patients with dry mouth symptoms. Patients with dry mouth due to other conditions were excluded. Patients were randomized 1:1 to receive either 300mg/d (100mg ×3/day) of rebamipide or placebo for 12 weeks together with their usual therapy. Outcome measures included patient-assessed improvement of dry mouth symptoms and increase in salivary secretion (evaluation of unstimulated saliva; questionnaires including the visual analogue scale (VAS) for Sicca-syndrome VAS 0-100mm). Subjective and objective findings of dry mouth were recorded at baseline, two, four, six, eight, ten and twelve weeks. Safety and efficacy was assessed at each visit.

Results A statistically significant improvement in dry mouth symptoms in the rebamipide-treated group compared to the placebo-treated group was observed. At two, four, eight, ten and twelve weeks, dry mouth improvement rates were respectively, 24.5, 46.3, and 49.9, 51.8 and 52.3% for rebamipide and 21.2, 25.1, 28,3, 29.0 and 33.6% for placebo.There was a statistically significant mean increase in salivary secreted volume at all time points in the rebamipide group compared to the control group.

Conclusions The findings of the present study indicate that rebamipide had a salivary secretion increasing effect and improved symptoms of dry mouth. Rebamipide, may thus prove to be a useful adjunctive in the treatment of dry mouth symptoms in SS patients. Further large-scale longitudinal studies are however needed to clarify the efficacy of rebamipide.

Disclosure of Interest None Declared