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.
To assess the effects of antibiotics for children with AOM.
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).
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.
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.
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.