title: Antibiotic treatment of acute otitis media in children under two years of age: evidence based?
abstract: BACKGROUND
  Appropriate use of antibiotics is one of the major issues in medicine today. In most countries, acute otitis media in children is treated with antibiotics; however, the efficacy of antibiotic use in every acute otitis media is a controversial issue. It may be worthwhile looking for special risk groups that benefit more from antibiotic treatment for acute otitis media. Children under two years of age with acute otitis media are at risk of poor outcome.
  
  
  OBJECTIVE
  To assess whether the current high prescription rates of antibiotics for acute otitis media in children under two years of age (being a risk group for poor outcome) are based on an established increased efficacy.
  
  
  METHODS
  Systematic literature review and a quantitative analysis with an assessment of the methodological quality of published trials, comparing antibiotic treatment with non-antibiotic treatment in acute otitis media in children aged under two years.
  
  
  RESULTS
  Six trials were included. Trials from before 1981 had a poor methodological quality. Four were suitable for the quantitative analysis. Only two of them were truly placebo-controlled. Of these two, one included only recurrent acute otitis media and the other included only non-severe episodes. With these restricted data, no statistically significant difference was found between antibiotic-treated children and controls under two years of age with acute otitis media, judged on the basis of clinical improvement within seven days (common odds ratio = 1.31; 95% CI = 0.83-2.08).
  
  
  CONCLUSIONS
  The current high prescription rates of antibiotics among children under two years of age with acute otitis media are not sufficiently supported by evidence from published trials. New randomized placebo-controlled trials using reliable methodology are needed in this young age group.
authors: Department of General Practice, Utrecht University, The Netherlands.
authors: R A
authors: RA
authors: Damoiseaux
authors: F A
authors: FA
authors: van Balen
authors: A W
authors: AW
authors: Hoes
authors: R A
authors: RA
authors: de Melker
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D019317:Evidence-Based Medicine; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D010033:Otitis Media / Q000188:drug therapy*; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents