Abstract | BACKGROUND: 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:
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Authors | Stéphane Mouly, Michel Salom, Yves Tillet, Anne-Claude Coudert, Frantz Oberli, Philip M Preshaw, Stéphane Desjonquères, Jean-François Bergmann |
Journal | Drugs & aging
(Drugs Aging)
Vol. 24
Issue 11
Pg. 957-65
( 2007)
ISSN: 1170-229X [Print] New Zealand |
PMID | 17953462
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Aerosols
- Lubricants
- Pharmaceutical Solutions
- Glycerol
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Topics |
- Administration, Oral
- Aerosols
- Aged
(physiology)
- Aged, 80 and over
- Double-Blind Method
- Endpoint Determination
- Female
- Glycerol
(administration & dosage, adverse effects, therapeutic use)
- Hospitalization
- Humans
- Long-Term Care
- Lubricants
(administration & dosage, adverse effects, therapeutic use)
- Male
- Mouth
(pathology)
- Pharmaceutical Solutions
- Surveys and Questionnaires
- Treatment Outcome
- Xerostomia
(drug therapy, pathology)
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