Antibiotics are effective in acute otitis media in children younger than 2 years with bilateral disease and in children with both otorrhea and acute otitis media
Article Outline
- Rovers MM, Glasziou P, Appelman CL, Burke P, McCormick DP, Damoiseaux RA, et al. Antibiotics for acute otitis media: a meta-analysis with individual patient data. Lancet 2006;368:1429-35
- References
- Copyright
Rovers MM, Glasziou P, Appelman CL, Burke P, McCormick DP, Damoiseaux RA, et al. Antibiotics for acute otitis media: a meta-analysis with individual patient data. Lancet 2006;368:1429-35
Question Are there subgroups of children who would or would not benefit more than others from treatment with antibiotics?
Design Meta-analysis of data from six randomized trials of the effects of antibiotics in acute otitis media.
Study Selection and Assessment Following a systematic search of the Cochrane library, PubMed database, EMBASE, and the proceedings of the international symposia on recent advances in otitis media, six trials were identified. All trials were assessed rigorously for quality.
Outcomes The primary outcome was an extended course of acute otitis media, which was defined as pain, fever, or both at 3 to 7 days.
Results Individual patient data from 1643 children from 6 months to 12 years of age were validated and reanalyzed. Significant effect modifications were noted for otorrhea, and for age and bilateral acute otitis media. In children <2 years of age with bilateral acute otitis media, 55% of controls and 30% on antibiotics still had pain, fever, or both at 3 to 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 otorrhea, the rate difference and NNT, respectively, were −36% (−53% to −19%) and three, whereas in children without otorrhea, the equivalent values were −14% (−23% to −5%) and eight.
Conclusions Antibiotics seem to be most beneficial in children <2 years of age with bilateral acute otitis media, and in children with both acute otitis media and otorrhea. For most other children with mild disease, an observational policy seems justified.
Comment Acute otitis media is usually a bacterial infection that is preceded by a viral upper respiratory tract infection. Evidence from systematic reviews, however, suggests that antibiotics provide only marginal benefit.1 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. This study is so far the best attempt to identify such subgroups of children by pooling the original data from several randomized trials and performing a meta-analysis of the individual patient data. Despite the large number of patients in the meta-analysis, only a limited number of subgroups were analyzed: age (<2 vs ≥2 years), bilateral acute otitis media (yes vs no), and concurrent ottorhea (yes vs no). Data were not provided for subgroups dichotomized on the basis of pain severity, amount of nasal discharge, cough, or fever. Indeed, the original trials included studies that had excluded children on the basis of severe symptoms, the child being too unwell, or recurrent acute otitis media. Thus, treatment of children without antibiotics should presumably be reserved for those with a mild general illness.2 This study shows that antibiotics are effective in acute otitis media in children <2 years of age with bilateral disease and in children with both otorrhea and acute otitis media.
References
PII: S0022-3476(07)00188-6
doi:10.1016/j.jpeds.2007.02.049
© 2007 Mosby, Inc. All rights reserved.
