Clinical trial of a mucin-containing oral spray for treatment of xerostomia in hospice patients.

Thirty-five hospice patients complaining of dry mouth entered a double-blind, single-phase placebo-controlled trial of a mucin-containing oral spray (Saliva Orthana) for the relief of xerostomia. The sprays were administered ad libitum for two weeks by the patients themselves, with nursing help as necessary. A detailed history and examination were undertaken, together with collection of microbiological specimens, at entry and after seven and 14 days of spray usage, respectively. Thirty-one patients were available for follow-up at seven days and 26 patients after 14 days. Relief of oral dryness during the day was reported by 9/15 patients on Saliva Orthana and 10/16 patients on placebo by day 7, with a similar degree of improvement maintained to day 14. The corresponding figures by day 7 for relief of dryness at night were 8/15 for Saliva Orthana and 8/16 for placebo. There were no statistically significant differences between those on active and those on placebo spray for any of the oral symptoms recorded. Neither spray had any major impact on the oral microflora. However, the majority of patients in both treatment groups wished to continue using a mouth spray at the end of their involvement in the trial. Whilst the data from this study provide no evidence for increased benefit of a mucin-containing spray over a mucin-free placebo among xerostomic hospice patients, it is clear that both sprays provided worthwhile symptomatic relief of oral dryness for many of the participants.

RCT Entities:   Population Interventions Outcomes