Efficacy of a new oral lubricant solution in the management of psychotropic drug-induced xerostomia: a randomized controlled trial.
OBJECTIVE
Xerostomia is a subjective sensation of mouth dryness often occurring as an unwanted effect of psychotropic drugs.


METHODS
The clinical efficacy and acceptability of a new oxygenated glycerol triester (OGT) oral spray (1 or 2 sprays up to 4 times daily) in the treatment of xerostomia was compared with those of a commercially available artificial saliva substitute (ASS [Saliveze]) in a 2-week, open-labeled, randomized, parallel-group study. Clinical assessment of xerostomia included evaluation of mouth dryness by means of a 10-cm-long visual analog scale, objective blinded assessment of the oral tissue condition by a dental hygienist by means of a 4-point ordinal scale, and subjective patient-based assessment of dry mouth symptoms by means of dichotomous responses to a questionnaire. [Day 14 - baseline] patient-based mouth dryness score was the primary end point.


RESULTS
Seventy-four patients (41 women and 33 men, 44 +/- 15 years) undergoing long-term psychotropic drug treatment were consecutively enrolled. At day 14, OGT resulted in better efficacy than ASS in mouth dryness score (mean difference, 1.2 +/- 0.4; P = 0.006), speech difficulties (mean difference, 1.2 +/- 0.4; P = 0.005), taste (mean difference, 1.1 +/- 0.4; P = 0.02), and overall mouth condition (mean difference, 1.4 +/- 0.9; P = 0.005). Taste of OGT was better than that of ASS (mean difference, 1.4 +/- 0.6; P = 0.04), as was OGT acceptability (mean difference, 1.4 +/- 0.9; P = 0.005).


CONCLUSIONS
Oxygenated glycerol triester lubricant oral spray was superior to a commercially available ASS in improving xerostomia and overall condition of the oral tissue.
Mouly
Stéphane J
SJ
Assistance Publique-Hôpitaux de Paris, Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital, Paris. stephane.mouly@lrb.ap-hop-paris.fr
Orler
Jean-Baptiste
JB
Tillet
Yves
Y
Coudert
Anne-Claude
AC
Oberli
Frantz
F
Preshaw
Phillip
P
Bergmann
Jean-François
JF
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003680:Deglutition Disorders / Q000139:chemically induced; D005260:Female; D005990:Glycerol / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D006801:Humans; D008153:Lubrication; D008297:Male; D008875:Middle Aged; D009061:Mouth Mucosa / Q000187:drug effects; D011619:Psychotropic Drugs / Q000009:adverse effects*; D012464:Saliva, Artificial / Q000009:adverse effects / Q000627:therapeutic use*; D012822:Silicon Dioxide / Q000009:adverse effects / Q000627:therapeutic use*; D013064:Speech Disorders / Q000139:chemically induced; D011795:Surveys and Questionnaires; D013651:Taste Disorders / Q000139:chemically induced; D014987:Xerostomia / Q000139:chemically induced / Q000188:drug therapy*
D011619:Psychotropic Drugs; D012464:Saliva, Artificial; D012822:Silicon Dioxide; D005990:Glycerol