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A Meta-analysis of Individual Patient Data

Laura Koopman, MSc; Arno W. Hoes, MD, PhD; Paul P. Glasziou, MD, PhD; Cees L. Appelman, MD, PhD; Peter Burke, FRCGP, MRCP(Ire); David P. McCormick, MD; Roger A. Damoiseaux, MD, PhD; Nicole Le Saux, MD, PhD; Maroeska M. Rovers, PhD

Arch Otolaryngol Head Neck Surg. 2008;134(2):128-132.

Objectives  To determine predictors of the development of asymptomatic middle ear effusion (MEE) in children with acute otitis media (AOM) and to assess the effect of antibiotic therapy in preventing the development of MEE in these children.

Data Sources  A systematic literature search was performed using PubMed, EMBASE, the Cochrane databases, and the proceedings of international otitis media symposia.

Study Selection  A trial was selected if the allocation of participants to treatment was randomized, children aged 0 to 12 years with AOM were included, the comparison was between antibiotic therapy and placebo or no (antibiotic) treatment, and MEE at 1 month was measured.

Data Extraction  Data from 5 randomized controlled trials were included in the meta-analysis of individual patient data (1328 children aged 6 months to 12 years). We identified independent predictors of the development of asymptomatic MEE and studied whether these children benefited more from antibiotic therapy than children with a lower risk. The primary outcome was MEE (defined as a type B tympanogram) at 1 month.

Data Synthesis  The overall relative risk of antibiotic therapy in preventing the development of asymptomatic MEE after 1 month was 0.9 (95% confidence interval, 0.8-1.0; P =.19). Independent predictors of the development of asymptomatic MEE were age younger than 2 years and recurrent AOM. No statistically significant interaction effects with treatment were found.

Conclusion  Because of a marginal effect of antibiotic therapy on the development of asymptomatic MEE and the known negative effects of prescribing antibiotics, including the development of antibiotic resistance and adverse effects, we do not recommend prescribing antibiotics to prevent MEE.

Author Affiliations: Julius Center for Health Sciences and Primary Care (Ms Koopman and Drs Hoes, Appelman, Damoiseaux, and Rovers) and Departments of Pediatrics and Otolaryngology, Wilhelmina Children's Hospital (Dr Rovers), University Medical Center Utrecht, Utrecht, the Netherlands; Department of Primary Health Care, Institute of Health Sciences, University of Oxford, Oxford (Dr Glasziou), and Community Clinical Sciences Division, Department of Primary Medical Care, Southampton University, and Aldermoor Health Centre, Southampton (Dr Burke), England; Department of Pediatrics, University of Texas Medical Branch at Galveston (Dr McCormick); and Division of Infectious Diseases, Department of Pediatrics, Children's Hospital of Eastern Ontario, Ottawa, Canada (Dr Le Saux).