Antibiotic Treatment for Pediatric Acute Otitis Media and the Prevention of Serious Complications: A Meta-analysis

Background: Systemic antibiotics have been central to the treatment of acute otitis media (AOM) in children. The American Academy of Pediatrics in its guidelines on the management of AOM, encourages in specific pediatric groups expectant observation (i.e., deferring antibiotics) as an option. These guidelines are supported by a high rate of spontaneous resolution of AOM in children and by placebo-controlled trials showing limited sequelae in children managed without antibiotics. Our research suggests that 80% of AOM episodes in the U.S. children are still promptly treated with antibiotics. Concern for intratemporal and intracranial suppurative complications is one of the main drivers for routine antibiotic prescribing for pediatric AOM. However, published meta-analyses on antibiotic treatment of AOM, relying on randomized controlled trials (RCTs) with small sample sizes, have not been able to quantify the benefit of antibiotic treatment in preventing serious suppurative complications. We sought to integrate observational studies to achieve the power needed to compare the rate of serious suppurative AOM complications in patients treated with systemic antibiotics against those treated expectantly.

Methods: We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline. Included studies were RCTs or observational studies that compared antibiotics and a control group (i.e., placebo, watchful waiting, or no antibiotic treatment) in children with AOM. We required at least one of our outcomes to be evaluated for inclusion: acute mastoiditis, brain abscess, or meningitis. Databases searched included PubMed/MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Web of Science (search date: June 8, 2021). Three authors independently assessed trial quality and extracted data, with each study reviewed by two authors. Publication bias was assessed with a funnel plot and effect estimates were summarized with random effects models where appropriate.

Results: Six studies were included (Table 1). Antibiotics showed a protective effect for acute mastoiditis (pooled OR 0.48, 95% CI 0.39-0.58), with a number needed to treat (NNT) of 5,368 (Figure 1). Several studies aimed to assess intracranial complications, but only two observed these outcomes. Cars 2017 identified one case of meningitis in 331,897 treated AOM episodes and three in the untreated group (n=67,038). Cushen 2020 identified one brain abscess though the study included children and adults and did not provide stratified results.

Conclusion: Antibiotics showed a protective effect against the development of acute mastoiditis in the treatment of pediatric AOM, but the number needed to treat is very large. Studies assessing intracranial complications were scarce with insufficient power for conclusive evidence on the benefit of antibiotics but expected NNT are large due to small incidence rates. The limited protective value of systemic antibiotics against suppurative AOM complications should be considered prior to initiating antibiotic therapy for uncomplicated AOM in children.