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Journal Article

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Sanders S, Glasziou P. P., Del Mar C., Rovers M. M. Antibiotics for acute otitis media in children. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD000219. DOI: 10.1002/14651858.CD000219.pub2.

This review is published as a Cochrane Review in The Cochrane Library 2009, Issue 2.
This version first published online: 26 January 2004 in Issue 1, 2004.
Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and The Cochrane Library should be consulted for the most recent version of the Review.
Access online at the Cochrane Library

2009 HERDC submission. FoR code: 1114

Copyright © 2009 The Cochrane Collaboration.


Background: Acute otitis media (AOM) is one of the most common diseases in early infancy and childhood. Antibiotic use for AOM varies from 56% in the Netherlands to 95% in the USA and Australia.

Objectives: To assess the effects of antibiotics for children with AOM.

Search strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2008, issue 2) which contains the Acute Respiratory Infections (ARI) Group's Specialized Register; MEDLINE (1966 to June week 4 2008); OLDMEDLINE (1958 to 1965); EMBASE (January 1990 to July 2008); and Current Contents (1966 to July 2008).

Selection criteria: Randomised controlled trials comparing 1) antimicrobial drugs with placebo 2) immediate antibiotic treatment with observational treatment approaches in children with AOM.

Data collection and analysis: Three review authors independently assessed trial quality and extracted data.

Main results: We found 10 trials (2928 children) from high income countries with low risk of bias. Pain was not reduced by antibiotics at 24 hours, but was at two to seven days, (relative risk (RR) 0.72; 95% confidence interval 0.62 to 0.83). However four trials (1271 children) comparing antibiotics prescribed immediately rather than initial observation found no difference at three to seven days. Antibiotics did not reduce tympanometry, perforation or recurrence. The only case of mastoiditis was in an antibiotic treated child. Vomiting, diarrhoea or rash was higher in children taking antibiotics (RR 1.37; 95% CI 1.09 to 1.76). Individual patient data meta-analysis of a subset of the included trials found antibiotics to be most beneficial in children: aged less than two; with bilateral AOM and with both AOM and otorrhoea.

Authors' conclusions: Antibiotics slightly reduce the number of children with acute middle ear infection experiencing pain after a few days. However, most (78%) settle spontaneously in this time, meaning 16 children must be treated to prevent one suffering ear pain. This benefit must be weighed against the possible harms: 1 in 24 children experience symptoms caused by antibiotics. Antibiotics are most useful in children under two years of age, with bilateral AOM, and with both AOM and discharging ears. For most other children with mild disease, an expectant observational approach seems justified. We have no data on populations with higher risks of complications. Plain language summary: Antibiotics for reducing the pain of middle ear infection (acute otitis media) in children. Acute otitis media (AOM) is common in children, causing pain and deafness. Though AOM usually resolves without treatment, it is often treated with antibiotics. This review found that antibiotics are not very useful for most children with AOM. Antibiotics marginally decreased the number of children with pain at 24 hours (when most children were better), only slightly reduced the number of children with pain in the few days following and did not reduce the number of children with hearing loss (that can last several weeks). However, antibiotics seem to be most beneficial in children younger than two years of age with bilateral AOM (infection in both ears), and in children with both AOM and otorrhoea (discharge from the ear). There was not enough information to know if antibiotics reduced rare complications such as mastoiditis (an infection of the bones around the ear). Some guidelines have recommended a management approach in which certain children are observed and antibiotics taken only if symptoms remain or have worsened after a few days. This review found no difference between immediate antibiotics and observational treatment approaches in the number of children with pain three to seven days after assessment. All of the studies included in this review were from high-income countries. Data from populations in which the incidence of AOM and risk of progression to mastoiditis is much higher are lacking. Antibiotics caused unwanted effects such as diarrhoea, stomach pain and rash, and may also increase resistance to antibiotics in the community. It is difficult to balance the small benefits against the small harms of antibiotics for most children.



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