Elsevier

The Lancet

Volume 368, Issue 9545, 21–27 October 2006, Pages 1429-1435
The Lancet

Articles
Antibiotics for acute otitis media: a meta-analysis with individual patient data

https://doi.org/10.1016/S0140-6736(06)69606-2Get rights and content

Summary

Background

Individual trials to test effectiveness of antibiotics in children with acute otitis media have been too small for valid subgroup analyses. We aimed to identify subgroups of children who would and would not benefit more than others from treatment with antibiotics.

Methods

We did a meta-analysis of data from six randomised trials of the effects of antibiotics in children with acute otitis media. Individual patient data from 1643 children aged from 6 months to 12 years were validated and re-analysed. We defined the primary outcome as an extended course of acute otitis media, consisting of pain, fever, or both at 3–7 days.

Findings

Significant effect modifications were noted for otorrhoea, and for age and bilateral acute otitis media. In children younger than 2 years of age with bilateral acute otitis media, 55% of controls and 30% on antibiotics still had pain, fever, or both at 3–7 days, with a rate difference between these groups of −25% (95% CI −36% to −14%), resulting in a number-needed-to-treat (NNT) of four children. We identified no significant differences for age alone. In children with otorrhoea the rate difference and NNT, respectively, were −36% (−53% to −19%) and three, whereas in children without otorrhoea the equivalent values were −14% (−23% to −5%) and eight.

Interpretation

Antibiotics seem to be most beneficial in children younger than 2 years of age with bilateral acute otitis media, and in children with both acute otitis media and otorrhoea. For most other children with mild disease an observational policy seems justified.

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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