Evaluation of the efficacy of a topical sialogogue spray containing malic acid 1% in elderly people with xerostomia: a double-blind, randomized clinical trial

Gerodontology. 2014 Dec;31(4):274-80. doi: 10.1111/ger.12034. Epub 2013 Jan 7.

Abstract

Objective: The aim of this study was to evaluate the clinical efficacy of a topical sialogogue spray containing 1% malic acid for elderly people affected by xerostomia.

Material and methods: This research took the form of a double-blind, randomized clinical trial. Forty-one individuals (mean age: 78.7 years) with xerostomia were divided into two groups: for the first 'intervention group' (21 subjects) a topical sialogogue spray (1% malic acid) was applied, while for the second 'control group' (20 subjects), a placebo spray was applied; for both groups, the sprays were applied on demand during 2 weeks. The Xerostomia Inventory (XI) was used to evaluate xerostomia levels before and after product/placebo application. Unstimulated and stimulated salivary flows rates, before and after spray application, were measured.

Results: XI scores decreased significantly (clinically meaningful) from 36.4 ± 7.3 points to 29.1 ± 7.1 (p < 0.05) with an XI difference of 7.2 ± 6.1, after the combination among 1% malic acid with xylitol and fluoride application. After 2 weeks of 1% malic acid application, unstimulated and stimulated salivary flows rates increased significantly (p < 0.05).

Conclusion: A topical sialogogue spray containing 1% malic acid improved xerostomia in an elderly population and increased unstimulated and stimulated salivary flows rates.

Keywords: drug; elderly; hyposialia; malic acid; xerostomia.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Aerosols
  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Female
  • Fluorides / administration & dosage
  • Fluorides / therapeutic use
  • Humans
  • Malates / administration & dosage
  • Malates / therapeutic use*
  • Male
  • Placebos
  • Saliva / drug effects
  • Saliva / metabolism
  • Saliva, Artificial / administration & dosage
  • Saliva, Artificial / therapeutic use*
  • Secretory Rate / drug effects
  • Treatment Outcome
  • Xerostomia / classification
  • Xerostomia / drug therapy*
  • Xylitol / administration & dosage
  • Xylitol / therapeutic use

Substances

  • Aerosols
  • Malates
  • Placebos
  • Saliva, Artificial
  • malic acid
  • Fluorides
  • Xylitol