ArticlesAntibiotics for acute otitis media: a meta-analysis with individual patient data
Introduction
Acute otitis media is one of the most common childhood infections, the leading cause of doctors' consultations, and the most frequent reason for children to take antibiotics.1 Evidence from systematic reviews, however, suggests that antibiotics provide only marginal benefit.2, 3 Furthermore, prescribing antibiotics is known to encourage clinic visits for subsequent episodes, intensify pressure on clinicians to prescribe, increase antibiotic use, and promote antibiotic resistance.4, 5, 6
Guidelines therefore recommend selective use of antibiotics for acute otitis media, especially in children aged 2 years or older. In children younger than 2 years, no consensus has been reached. Some guidelines recommend antibiotics for all these children,7, 8 whereas others advise antibiotics only for children under 2 years if they are severely affected or have persistent signs of disease or related comorbidity.9, 10
Reliable identification of subgroups of children who do, and do not, benefit from treatment with antibiotics has not been straightforward, because individual trials have been too small for valid and reliable subgroup analyses. A meta-analysis of the individual data from original trials enables the opportunity to identify subgroups that are most likely to benefit. We therefore aimed to identify subgroups that might benefit most from such treatment.
Section snippets
Selection of trials
We did a systematic search of the Cochrane library, PubMed database, EMBASE, and the proceedings of the international symposia on recent advances in otitis media. We selected trials that (1) used random allocation of children, (2) included children aged 0–12 years with acute otitis media, (3) compared antibiotics with placebo or no treatment, and (4) had pain and fever as an outcome. All trials were assessed for four major quality criteria: proper randomisation methods; degree of follow-up; and
Role of the funding source
This study was sponsored by the Dutch College of General Practitioners and the Netherlands Organisation for Health Research and Development (grant number 4200.0010). This sponsor had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication.
Results
Our search strategy identified nineteen trials that investigated the effectiveness of antibiotics in children with acute otitis media. After screening, nine trials were excluded, because randomisation was inadequate, the control group received another treatment, information about our selected outcomes was not available, or because they focused on special study populations, such as children with ventilation tubes.13, 14, 15, 16, 17, 18, 19, 20, 21 Of the ten eligible trials, six research groups
Discussion
Our meta-analyses of individual patient data showed that antibiotics are more beneficial in children aged less than 2 years with bilateral acute otitis media, and in those with both acute otitis media and otorrhoea—ie, in these groups three to four children have to be treated to prevent an extended course of the disease in one child. Although none of the trials included in this meta-analysis have had adequate power to produce precise effect estimates in clinically relevant subgroups, both
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