Antibiotics for the prevention of acute and chronic suppurative otitis media in children

Cochrane Database Syst Rev. 2006 Oct 18:(4):CD004401. doi: 10.1002/14651858.CD004401.pub2.


Background: Acute otitis media (AOM) is a common childhood illness. These middle ear infections may be frequent and painful. AOM may be associated with perforation of the tympanic membrane and can progress to chronic suppurative otitis media (CSOM).

Objectives: To determine the effectiveness of long-term antibiotics (for longer than six weeks) in preventing any AOM, AOM with perforation and CSOM.

Search strategy: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2006), MEDLINE (January 1966 to March Week 3 2006), OLD MEDLINE (1950 to 1965), EMBASE (1990 to December 2005) and the references of relevant studies.

Selection criteria: All randomised controlled trials of long-term (longer than six weeks) antibiotics versus placebo or no treatment for the prevention of AOM, AOM with perforation, or CSOM were eligible.

Data collection and analysis: Two authors independently extracted the data for: any AOM; episodes of AOM; any recurrent AOM; episodes of illness; any side effects; any antibiotic resistance, as well as outcomes at end of intervention (any AOM); and following cessation of intervention (any AOM). For dichotomous outcomes, the summary risk ratio (fixed and random-effects models) was calculated. For rate outcomes, the summary incidence rate ratio was calculated.

Main results: Sixteen studies involving 1483 children met our inclusion criteria. All studies enrolled children at increased risk of AOM, and in seven studies the children were prone to otitis media. The majority of studies were high quality and most (15 studies) reported data for our primary outcomes. None reported AOM with perforation or CSOM. Long-term antibiotics reduced any episode of AOM (13 studies, 1358 children, risk ratio (RR) 0.62, 95% CI 0.52 to 0.75; random-effects model) and number of episodes of AOM (12 studies, 1112 children, incidence rate ratio (IRR) 0.48, 95% CI 0.37 to 0.62; random-effects model). Approximately five children would need to be treated long term to prevent one child experiencing AOM whilst on treatment. Antibiotics prevented 1.5 episodes of AOM for every 12 months of treatment per child. Statistical heterogeneity was explored. Long-term antibiotics were not associated with a significant increase in adverse events (11 studies, 714 children, RR 1.99, 95% CI 0.25 to 15.89; random-effects model).

Authors' conclusions: For children at risk, antibiotics given once or twice daily will reduce the probability of AOM while the child is on treatment. Antibiotics will reduce the number of episodes of AOM per year from around three to around 1.5. We believe that larger absolute benefits are likely in high-risk children. These conclusions were not affected by sensitivity analyses.

Publication types

  • Meta-Analysis
  • Review
  • Systematic Review

MeSH terms

  • Acute Disease
  • Adolescent
  • Anti-Bacterial Agents / therapeutic use*
  • Child
  • Child, Preschool
  • Chronic Disease
  • Humans
  • Infant
  • Infant, Newborn
  • Otitis Media / drug therapy
  • Otitis Media, Suppurative / prevention & control*
  • Randomized Controlled Trials as Topic
  • Secondary Prevention
  • Tympanic Membrane Perforation / prevention & control


  • Anti-Bacterial Agents