title: Xylitol syrup for the prevention of acute otitis media.
abstract: BACKGROUND
  Acute otitis media (AOM) is a common childhood illness and the leading indication for antibiotic prescriptions for US children. Xylitol, a naturally occurring sugar alcohol, can reduce AOM when given 5 times per day as a gum or syrup, but a more convenient dosing regimen is needed for widespread adoption.
  
  
  METHODS
  We designed a pragmatic practice-based randomized controlled trial to determine if viscous xylitol solution at a dose of 5 g 3 times per day could reduce the occurrence of clinically diagnosed AOM among otitis-prone children 6 months through 5 years of age.
  
  
  RESULTS
  A total of 326 subjects were enrolled, with 160 allocated to xylitol and 166 to placebo. In the primary analysis of time to first clinically diagnosed AOM episode, the hazard ratio for xylitol versus placebo recipients was 0.88 (95% confidence interval [CI] 0.61 to 1.3). In secondary analyses, the incidence of AOM was 0.53 episodes per 90 days in the xylitol group versus 0.59 in the placebo group (difference 0.06; 95% CI -0.25 to 0.13); total antibiotic use was 6.8 days per 90 days in the xylitol group versus 6.4 in the placebo group (difference 0.4; 95% CI -1.8 to 2.7). The lack of effectiveness was not explained by nonadherence to treatment, as the hazard ratio for those taking nearly all assigned xylitol compared with those taking none was 0.93 (95% CI 0.56 to 1.57).
  
  
  CONCLUSIONS
  Viscous xylitol solution in a dose of 5 g 3 times per day was ineffective in reducing clinically diagnosed AOM among otitis-prone children.
authors.affiliation: Pediatric Physician's Organization at Children's, Brookline, Massachusetts;
authors.forename: Louis
authors.initials: L
authors.lastname: Vernacchio
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Corwin
authors.forename: Richard M
authors.initials: RM
authors.lastname: Vezina
authors.forename: Steven I
authors.initials: SI
authors.lastname: Pelton
authors.forename: Henry A
authors.initials: HA
authors.lastname: Feldman
authors.forename: Tamera
authors.initials: T
authors.lastname: Coyne-Beasley
authors.forename: Allen A
authors.initials: AA
authors.lastname: Mitchell
mesh_terms: D000208:Acute Disease; D000284:Administration, Oral; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D010033:Otitis Media / Q000517:prevention & control*; D016037:Single-Blind Method; D013549:Sweetening Agents / Q000008:administration & dosage*; D014993:Xylitol / Q000008:administration & dosage*
chemical_list: D013549:Sweetening Agents; D014993:Xylitol
keywords: otitis media