Xylitol Syrup for the Prevention of Acute Otitis Media

Abstract

WHAT'S KNOWN ON THIS SUBJECT: Xylitol given as a gum or syrup 5 times daily has been shown to reduce the incidence of acute otitis media in children, but this dosing schedule is unlikely to be feasible for many families. WHAT THIS STUDY ADDS:A regimen of viscous xylitol syrup in a dose of 5 g 3 times daily was ineffective in preventing recurrences of acute otitis media in otitis-prone children. 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 otitisprone children. Dr Vernacchio conceptualized and designed the study, supervised all aspects of the study implementation, performed the original analysis, reviewed and revised the analysis, and drafted the original manuscript; Drs Corwin and Mitchell conceptualized and designed the study, supervised all aspects of the study implementation, and reviewed and revised the analysis; Mr Vezina conceptualized and designed the study, monitored the randomization procedures, and reviewed and revised the analysis; Dr Pelton conceptualized and designed the study and reviewed and revised the analysis; Dr Feldman conceptualized and designed the study, created the randomization procedures, performed the original analysis, and reviewed and revised the analysis; Dr Coyne-Beasley supervised all aspects of the study implementation at the UNC site; and all authors reviewed and revised the manuscript and approved the final manuscript as submitted.This trial has been registered at www.clinicaltrials.gov (identifier NCT1044030).www.pediatrics.org/cgi

Complementary and Alternative Medicine Treatment Options for Otitis Media

“…A recent National Institute of Health-funded study examined 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. 32 Unfortunately, the results were discouraging, as there were no significant differences in the occurrence of AOM and total antibiotic use between the xylitol group versus the placebo group. Therefore, the use of xylitol was not opted by many national guidelines as a means to prevent OM.…”

Otitis media

“…Echinacea, an immune modulator and mild antiviral that is often used as a home remedy, has been reported to reduce the risk of recurrent respiratory infections, including virologically confirmed cases, and OM 150 . Xylitol, a five-carbon naturally occurring sugar alcohol with antibacterial properties, has been shown to prevent recurrent AOM with some success [151][152][153] . However, the successful dose regimens (that is, chewing gum or syrup given five times per day continuously for 2-3 months) are not practical.…”

Acute Otitis Media in Children—Current Treatment and Prevention

“…The authors did not find sufficient evidence that xylitol administered during a respiratory infection could prevent AOM. An even more recent randomized controlled trial comparing xylitol syrup to placebo found no effect on the number of AOM recurrences in otitis-prone children [38].…”