Xylitol sugar supplement for preventing middle ear infection in children up to 12 years of age 

Review question
We reviewed the evidence about the effectiveness and safety of xylitol to prevent acute middle ear infection (acute otitis media; AOM) in children up to 12 years old.

AOM is the most common bacterial infection among young children in the United States. Although serious complications are rare, this common childhood ailment imposes a huge impact on the healthcare system. In the United States, it accounted for almost 20 million office visits. Antibiotic treatment of AOM is costly and raises concerns about the development of antibiotic-resistant strains of bacteria. Surgery is invasive and costly, and because of these factors, effective measures for preventing AOM are sought. An alternative treatment is xylitol or birch sugar. Xylitol has been used for decades as a natural non-sugar sweetener principally in chewing gums, confectionery, toothpaste and medicines, and can reduce the risk of tooth decay.

Search date

We searched the literature up to January 2016. This is an update of a review that was last published in 2011.

Study characteristics
We identified five clinical trials that involved 3405 children, mostly from the same research group. Four trials were conducted in Finland and enrolled healthy children (three trials) or children with an acute respiratory infection (one trial). The fifth trial was conducted in the USA and enrolled otitis-prone children who were recruited from attendance at general medical practices.

Study funding sources

All five trials received governmental funding; and the Finnish study investigators have a US patent for the use of xylitol to treat respiratory infections.

Key results

Xylitol, administered in chewing gum, lozenges or syrup, can reduce the occurrence of AOM among healthy children with no acute upper respiratory infection from 30% to 22%. There is no difference in side effects (namely, abdominal discomfort and rash). Based on these results we would expect that out of 1000 children up to 12 years of age, 299 would experience an AOM compared with between 194 and 263 children who would experience an AOM if they are provided with xylitol chewing gum. The preventive effect among healthy children with respiratory infection or among otitis-prone children is inconclusive.

Quality of the evidence
The quality of evidence was moderate for healthy children and children with respiratory infections but low for otitis-prone children.

Authors' conclusions: 

There is moderate quality evidence showing that the prophylactic administration of xylitol among healthy children attending daycare centres can reduce the occurrence of AOM. There is inconclusive evidence with regard to the efficacy of xylitol in preventing AOM among children with respiratory infection, or among otitis-prone children. The meta-analysis was limited because data came from a small number of studies, and most were from the same research group.

Read the full abstract...

Acute otitis media (AOM) is the most common bacterial infection among young children in the United States. There are limitations and concerns over its treatment with antibiotics and surgery and so effective preventative measures are attractive. A potential preventative measure is xylitol, a natural sugar substitute that reduces the risk of dental decay. Xylitol can reduce the adherence of Streptococcus pneumoniae (S pneumoniae) and Haemophilus influenzae (H influenzae) to nasopharyngeal cells in vitro. This is an update of a review first published in 2011.


To assess the efficacy and safety of xylitol to prevent AOM in children aged up to 12 years.

Search strategy: 

We searched CENTRAL (to Issue 12, 2015), MEDLINE (1950 to January 2016), Embase (1974 to January 2016), CINAHL (1981 to January 2016), LILACS (1982 to January 2016), Web of Science (2011 to January 2016) and International Pharmaceutical Abstracts (2000 to January 2016).

Selection criteria: 

Randomised controlled trials (RCTs) or quasi-RCTs of children aged 12 years or younger where xylitol supplementation was compared with placebo or no treatment to prevent AOM.

Data collection and analysis: 

Two review authors independently selected trials from search results, assessed and rated study quality and extracted relevant data for inclusion in the review. We contacted trial authors to request missing data. We noted data on any adverse events of xylitol. We extracted data on relevant outcomes and estimated the effect size by calculating risk ratio (RR), risk difference (RD) and associated 95% confidence intervals (CI).

Main results: 

We identified five clinical trials that involved 3405 children for inclusion. For this 2016 update, we identified one new trial for inclusion. This trial was systematically reviewed but due to several sources of heterogeneity, was not included in the meta-analysis. The remaining four trials were of adequate methodological quality. In three RCTs that involved a total of 1826 healthy Finnish children attending daycare, there is moderate quality evidence that xylitol (in any form) can reduce the risk of AOM from 30% to around 22% compared with the control group (RR 0.75, 95% CI 0.65 to 0.88). Among the reasons for dropouts, there were no significant differences in abdominal discomfort and rash between the xylitol and the control groups. Xylitol was not effective in reducing AOM among healthy children during a respiratory infection (RR 1.13, 95% CI 0.83 to 1.53; moderate quality evidence) or among otitis-prone healthy children (RR 0.90, 95% CI 0.67 to 1.21; low-quality evidence).