title: Antibiotics versus placebo or watchful waiting for acute otitis media: a meta-analysis of randomized controlled trials.
abstract: BACKGROUND
  Recommendations on withholding antibiotics in children with acute otitis media (AOM) have been inadequately implemented in clinical practice.
  
  
  OBJECTIVE
  We evaluated the role of prescribing antibiotics for AOM.
  
  
  METHODS
  We performed a meta-analysis of randomized controlled trials (RCTs) that were retrieved from searches performed in the PubMed and Cochrane databases, and compared antibiotic treatment with placebo or watchful waiting (delayed antibiotic treatment if clinically indicated) for patients with AOM.
  
  
  RESULTS
  We identified seven trials comparing antibiotic treatment with placebo (all double-blinded) and four trials comparing antibiotic treatment with watchful waiting (two investigator-blinded and two open-label) trials, all of which involved children (6 months to 12 years). Clinical success was more likely with antibiotics than comparator treatment in: placebo-controlled trials [seven RCTs, 1405 patients, risk ratio (RR) = 1.11, 95% confidence interval (CI) = 1.05-1.18]; watchful waiting trials (four RCTs, 915 patients, RR = 1.18, 95% CI = 1.07-1.32); and all trials combined (11 RCTs, 2320 patients, RR = 1.13, 95% CI = 1.08-1.19). Similarly, persistence of symptoms 2-4 days after treatment initiation was less likely with antibiotics in: placebo-controlled trials (four RCTs, 1014 patients, RR = 0.75, 95% CI = 0.64-0.88) and all trials combined (five RCTs, 1299 patients, RR = 0.68, 95% CI = 0.54-0.85). Diarrhoea was more likely with antibiotics (seven RCTs, 1807 patients, RR = 1.50, 95% CI = 1.16-1.95). No differences between the compared treatments were found regarding other effectiveness and safety outcomes.
  
  
  CONCLUSIONS
  Antibiotic treatment is associated with a more favourable clinical course in children with AOM, compared with placebo, and also compared with watchful waiting. However, safety issues and the rather small treatment effect difference render the consideration of additional factors necessary in relevant clinical decision making.
authors.affiliation: Alfa Institute of Biomedical Sciences, Athens, Greece.
authors.forename: Evridiki K
authors.initials: EK
authors.lastname: Vouloumanou
authors.forename: Drosos E
authors.initials: DE
authors.lastname: Karageorgopoulos
authors.forename: Maria S
authors.initials: MS
authors.lastname: Kazantzi
authors.forename: Anastasios M
authors.initials: AM
authors.lastname: Kapaskelis
authors.forename: Matthew E
authors.initials: ME
authors.lastname: Falagas
mesh_terms: D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D006801:Humans; D007223:Infant; D010033:Otitis Media / Q000188:drug therapy*; D010919:Placebos / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D010919:Placebos