Dry Mouth Relief: Evaluation of Two Preparations in Sjogren's Syndrome

Objectives: To compare the duration of dry mouth relief after 8 weeks use of two dry mouth sprays; OasisTM and Glandosane®, in Sjogren's Syndrome. The oral soft tissue acceptability and the efficacy of the two study products were also evaluated. Methods: A double-blind, randomised, two-way crossover, single-centre, clinical trial was performed on a moderate to severe dry mouth Sjogren's Syndrome patients. Fifty patients completed the two arms of the study. Both study arms consisted of a baseline visit, a Day-7, and a follow-up visit after 8 weeks. There was a 7-14 day washout period between each study arm. Patients completed questionnaires at the screening, Day-7 and follow-up visits, and a diary card at the end of 1, 4 and 8 weeks of each product use. A clinical oral examination was performed at baseline, Day-7 and follow-up visit by the same dental examiner for each patient. Results: OasisTM had a statistically significantly longer duration of dry mouth relief than Glandosane® (Mean/minutes ±SD; Oasis 89.2 ±73.0, Glandosane® 47.8 ±53.5, OasisTM vs. Glandosane® 41.31, p<0.0001). Compared with patients' usual remedies, OasisTM had a longer duration of dry mouth relief (21.06, p=0.067) whereas Glandosane had a shorter duration of dry mouth relief (-15.30, p=0.109). Subjective ratings of product performance and acceptability showed similar trends to those reported for duration of dry mouth. Ratings for OasisTM and patients' usual dry mouth remedies were comparable and were both numerically greater than ratings for Glandosane®. Adverse events were reported with both products but none were serious. Conclusions: Both study products were well tolerated but OasisTM spray provided a statistically significant longer dry mouth relief compared with Glandosane® spray. OasisTM and patients' usual remedies had similar subjective ratings for performance and acceptability and both these were greater than Glandosane®. This research was supported by a grant from GlaxoSmithKline