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).


CONCLUSIONS
OGT lubricant oral spray was superior to Saliveze in improving xerostomia and oral tissue condition in older institutionalised patients.
Mouly
Stéphane
S
Department of Internal Medicine, Lariboisière Hospital, Paris, France. stephane.mouly@lrb.aphp.fr
Salom
Michel
M
Tillet
Yves
Y
Coudert
Anne-Claude
AC
Oberli
Frantz
F
Preshaw
Philip M
PM
Desjonquères
Stéphane
S
Bergmann
Jean-François
JF
D000284:Administration, Oral; D000336:Aerosols; D000368:Aged / Q000502:physiology*; D000369:Aged, 80 and over; D004311:Double-Blind Method; D023381:Endpoint Determination; D005260:Female; D005990:Glycerol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006760:Hospitalization; D006801:Humans; D008134:Long-Term Care; D054327:Lubricants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D009055:Mouth / Q000473:pathology; D019999:Pharmaceutical Solutions; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014987:Xerostomia / Q000188:drug therapy* / Q000473:pathology
D000336:Aerosols; D054327:Lubricants; D019999:Pharmaceutical Solutions; D005990:Glycerol