Antibiotics for acute otitis media in children

Venekamp, Roderick P., Sanders, Sharon, Glasziou, Paul P., Del Mar, Chris B. and Rovers, Maroeska M. (2013) Antibiotics for acute otitis media in children. Cochrane Database of Systematic Reviews, 1: . doi:10.1002/14651858.CD000219.pub3

Author Venekamp, Roderick P.
Sanders, Sharon
Glasziou, Paul P.
Del Mar, Chris B.
Rovers, Maroeska M.
Title Antibiotics for acute otitis media in children
Journal name Cochrane Database of Systematic Reviews   Check publisher's open access policy
ISSN 1469-493X
Publication date 2013-01-31
Year available 2013
Sub-type Critical review of research, literature review, critical commentary
DOI 10.1002/14651858.CD000219.pub3
Open Access Status
Issue 1
Total pages 59
Place of publication Oxford, United Kingdom
Publisher John Wiley & Sons
Collection year 2014
Language eng
Formatted abstract
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, Canada and Australia.

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

Search methods: We searched CENTRAL (2012, Issue 10), MEDLINE (1966 to October week 4, 2012), OLDMEDLINE (1958 to 1965), EMBASE (January 1990 to November 2012), Current Contents (1966 to November 2012), CINAHL (2008 to November 2012) and LILACS (2008 to November 2012).

Selection criteria: Randomised controlled trials (RCTs) comparing 1) antimicrobial drugs with placebo and 2) immediate antibiotic treatment with expectant observation (including delayed antibiotic prescribing) in children with AOM.

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

Main results: For the review of antibiotics against placebo, 12 RCTs (3317 children and 3854 AOM episodes) from high-income countries were eligible. However, one trial did not report patient-relevant outcomes, leaving 11 trials with generally low risk of bias. Pain was not reduced by antibiotics at 24 hours (risk ratio (RR) 0.89; 95%confidence interval (CI) 0.78 to 1.01) but almost a third fewer had residual pain at two to three days (RR 0.70; 95% CI 0.57 to 0.86; number needed to treat for an additional beneficial outcome (NNTB) 20) and fewer had pain at four to seven days (RR 0.79; 95% CI 0.66 to 0.95; NNTB 20). When compared with placebo, antibiotics did not alter the number of abnormal tympanometry findings at either four to six weeks (RR 0.92; 95%CI 0.83 to 1.01) or at threemonths (RR 0.97; 95% CI 0.76 to 1.24), or the number of AOMrecurrences (RR 0.93; 95% CI 0.78 to 1.10). However, antibiotic treatment did lead to a statistically significant reduction of tympanic membrane perforations (RR 0.37; 95% CI 0.18 to 0.76; NNTB 33) and halved contralateral AOMepisodes (RR 0.49; 95% CI 0.25 to 0.95; NNTB 11) as compared with placebo. Severe complications were rare and did not differ between children treated with antibiotics and those treated with placebo. Adverse events (such as vomiting, diarrhoea or rash) occurred more often in children taking antibiotics (RR 1.34; 95% CI 1.16 to 1.55; number needed to treat for an additional harmful outcome (NNTH) 14). Funnel plots do not suggest publication bias. Individual patient data meta-analysis of a
subset of included trials found antibiotics to be most beneficial in children aged less than two with bilateral AOM, or with both AOM and otorrhoea.

For the review of immediate antibiotics against expectant observation, five trials (1149 children) were eligible. Four trials (1007 children) reported outcome data that could be used for this review. From these trials, data from 959 children could be extracted for the metaanalysis on pain at days three to seven. No difference in pain was detectable at three to seven days (RR 0.75; 95% CI 0.50 to 1.12). No serious complications occurred in either the antibiotic group or the expectant observation group. Additionally, no difference in tympanicmembrane perforations and AOMrecurrence was observed. Immediate antibiotic prescribing was associated with a substantial increased risk of vomiting, diarrhoea or rash as compared with expectant observation (RR 1.71; 95% CI 1.24 to 2.36).

Authors’ conclusions: Antibiotic treatment led to a statistically significant reduction of children with AOMexperiencing pain at two to seven days compared with placebo but since most children (82%) settle spontaneously, about 20 children must be treated to prevent one suffering from ear pain at two to seven days. Additionally, antibiotic treatment led to a statistically significant reduction of tympanic membrane perforations (NNTB 33) and contralateral AOMepisodes (NNTB 11). These benefits must be weighed against the possible harms: for every 14 children treated with antibiotics, one child experienced an adverse event (such as vomiting, diarrhoea or rash) that would not have occurred if antibiotics had been withheld. Antibiotics appear to be most useful in children under two years of age with bilateral AOM, or with both AOM and otorrhoea. For most other children with mild disease, an expectant observational approach seems justified. We have no trials in populations with higher risks of complications.
Keyword Acute disease
Age factors
Anti-bacterial agents [therapeutic use]
Otitis media [drug therapy]
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ
Additional Notes Article number CD000219.

Document type: Journal Article
Sub-type: Critical review of research, literature review, critical commentary
Collections: Official 2014 Collection
School of Medicine Publications
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