Efficacy and safety of a new oral saliva equivalent in the management of xerostomia: a national, multicenter, randomized study.

OBJECTIVE AND STUDY DESIGN: The clinical efficacy, safety, and acceptability of a new oral saliva equivalent (Novasial) administered four times daily in the treatment of xerostomia in various medical conditions was compared with that of oxygenated glycerol triester oral spray (Aequasyal) and a moisturizing spray (Biotene) in a 2-week, multicenter, randomized, crossover study. Assessment included patient-based evaluation of mouth dryness score (primary endpoint) with a visual analog scale (VAS), blinded assessment of the oral tissue condition by a four-point ordinal scale, and patient-based assessment of tolerability and acceptability. RESULTS: At day 14, Novasial decreased oral mouth dryness by 19.5%, (12.5 ± 22.6 mm, P < .0001 versus baseline), versus 10% (6.6 ± 17.9 mm with Aequasyal, P < .0001 versus Baseline; and P < .0156 versus Novasial) and 13% (8.6 ± 18.9 mm) with Biotene (P < .0001 versus baseline). The 50% decrease in the primary endpoint was not achieved, and the overall efficacy of Novasial and Aequasyal were similar with respect to xerostomia. Novasial was preferred to Aequasyal and Biotene in alleviating taste alteration and chewing difficulty. Treatment compliance was higher with Novasial (P = .0014 versus Aequasyal). The treatments improved the oral condition with equal efficacy and were safe and well tolerated (VAS 72-77 mm). CONCLUSIONS: Novasial was a safe, well-tolerated, and acceptable treatment in patients with xerostomia induced by various treatments or pathologic conditions.

Effect of influenza vaccination of nursing home staff on mortality of residents: a cluster-randomized trial.

OBJECTIVES: To evaluate the effect of staff influenza vaccination on all-cause mortality in nursing home residents. DESIGN: Pair-matched cluster-randomized trial. SETTING: Forty nursing homes matched for size, staff vaccination coverage during the previous season, and resident disability index. PARTICIPANTS: All persons aged 60 and older residing in the nursing homes. INTERVENTION: Influenza vaccine was administered to volunteer staff after a face-to-face interview. No intervention took place in control nursing homes. MEASUREMENTS: The primary endpoint was total mortality rate in residents from 2 weeks before to 2 weeks after the influenza epidemic in the community. Secondary endpoints were rates of hospitalization and influenza-like illness (ILI) in residents and sick leave from work in staff. RESULTS: Staff influenza vaccination rates were 69.9% in the vaccination arm versus 31.8% in the control arm. Primary unadjusted analysis did not show significantly lower mortality in residents in the vaccination arm (odds ratio=0.86, P=.08), although multivariate-adjusted analysis showed 20% lower mortality (P=.02), and a strong correlation was observed between staff vaccination coverage and all-cause mortality in residents (correlation coefficient=-0.42, P=.007). In the vaccination arm, significantly lower resident hospitalization rates were not observed, but ILI in residents was 31% lower (P=.007), and sick leave from work in staff was 42% lower (P=.03). CONCLUSION: These results support influenza vaccination of staff caring for institutionalized elderly people.

Management of xerostomia in older patients : a randomised controlled trial evaluating the efficacy of a new oral lubricant solution.

BACKGROUND: Xerostomia is a subjective sensation of mouth dryness that may frequently occur in older patients. OBJECTIVE: To compare the clinical efficacy and acceptability of a new oxygenated glycerol triester (OGT) oral spray taken five times daily with that of a commercially available saliva substitute Saliveze in the treatment of xerostomia. METHODS: Forty-one institutionalised patients (28 women, 13 men; mean age 84 +/- 7 years) were randomly assigned to receive either OGT or Saliveze in a 2-week, randomised, parallel-group study. Clinical assessment of xerostomia included evaluation of mouth dryness using a self-rated, 10cm long visual analogue scale (VAS), objective assessment of oral tissue condition using a four-point ordinal scale and subjective assessment of symptoms of xerostomia using dichotomous responses to a questionnaire. The primary endpoint was the day (D) 14 patient-based mouth dryness score measured on a self-rated VAS. RESULTS: At D14, OGT resulted in significantly greater efficacy with respect to mouth dryness (mean between-treatment difference 2.1 +/- 0.1, 95% CI 1.9, 2.3; p = 0.001), swallowing difficulty (1.8 +/- 0.3, 95% CI 1.5, 2.1; p = 0.001), speech difficulty (1.1 +/- 0.2, 95% CI 1.0, 2.4; p = 0.04) and overall sensation of symptom relief (2.7 +/- 1.2, 95% CI 1.9, 3.8; p = 0.001). Objective assessment of oral tissues also showed significantly better improvement with OGT spray with respect to dryness (p = 0.01), stickiness (p = 0.005) and dullness (p = 0.001) of oral mucosa; severity of mucositis (p = 0.01); and thickening of the tongue (p = 0.03). A significant difference in taste acceptability was also noted in favour of OGT (1.4 +/- 0.6, 95% CI 1.2, 1.9; p = 0.04). CONCLUSION: OGT lubricant oral spray was superior to Saliveze in improving xerostomia and oral tissue condition in older institutionalised patients.