However, for most children with mild disease in high-income countries, an expectant observational approach seems justified. It is difficult to balance the small benefits against the small harms of antibiotics in children with AOM. Data are lacking from populations in which the AOM incidence and risk of progression to mastoiditis is higher.Īntibiotics caused unwanted effects such as diarrhoea, vomiting and rash and may also increase resistance to antibiotics in the community. All of the studies included in this review were from high-income countries. There was not enough information to know if antibiotics reduced rare complications such as mastoiditis (infection of the bones around the ear). Furthermore, no differences in the number of children with hearing loss at four weeks, perforations of the eardrum and late AOM recurrences were observed between groups. We found no difference between immediate antibiotics and expectant observational approaches in the number of children with pain three to seven days and 11 to 14 days after assessment. Results from an individual patient data meta-analysis including data from six high-quality trials (1643 children), which were also included as individual trials in our review, showed that antibiotics seem to be most beneficial in children younger than two years of age with infection in both ears and in children with both AOM and a discharging ear. However, antibiotics did slightly reduce the number of children with perforations of the eardrum and AOM episodes in the initially unaffected ear compared with placebo. We found that antibiotics were not very useful for most children with AOM antibiotics did not decrease the number of children with pain at 24 hours (when 60% of children were better anyway), only slightly reduced the number of children with pain in the days following and did not reduce the number of children with late AOM recurrences and hearing loss (that can last several weeks) at three months compared with placebo. Four trials (1007 children) reported outcome data that could be used for this review. Two trials were performed in a GP setting and three in an outpatient hospital setting. Three trials were performed in a general practice (GP) setting, six in an outpatient hospital setting and four in both settings.įor the review of antibiotics against expectant observation, five trials (1149 children) from high-income countries were eligible with low to moderate risk of bias. The evidence in this review is current to 26 April 2015.įor the review of antibiotics against placebo we included 13 trials (3401 children aged between two months and 15 years) from high-income countries with generally low risk of bias. Though AOM usually resolves without treatment, it is often treated with antibiotics. By three years of age, most children have had at least one AOM episode. This review compared 1) the clinical effectiveness and safety of antibiotics against placebo in children with an acute middle ear infection (acute otitis media (AOM)) and 2) the clinical effectiveness and safety of antibiotics against expectant observation (observational approaches in which prescriptions may or may not be provided) in children with AOM.ĪOM is one of the most common infections in early infancy and childhood, causing pain and general symptoms of illness such as fever, irritability and problems feeding and sleeping.
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