Objective.— To conduct a meta-analysis of randomized controlled trials of antibiotic
treatment of acute otitis media in children to determine whether outcomes
were comparable in children treated with antibiotics for less than 7 days
or at least 7 days or more.
Data Sources.— MEDLINE (1966-1997), EMBASE (1974-1997), Current Contents, and Science
Citation Index searches were conducted to identify randomized controlled trials
of the treatment of acute otitis media in children with antibiotics of different
Study Selection.— Studies were included if they met the following criteria: subjects aged
4 weeks to 18 years, clinical diagnosis of acute otitis media, no antimicrobial
therapy at time of diagnosis, and randomization to less than 7 days of antibiotic
treatment vs 7 days or more of antibiotic treatment.
Data Extraction.— Trial methodological quality was assessed independently by 7 reviewers;
outcomes were extracted as the number of treatment failures, relapses, or
Data Synthesis.— Included trials were grouped by antibiotic used in the short course:
(1) 15 short-acting oral antibiotic trials (penicillin V potassium, amoxicillin
[-clavulanate], cefaclor, cefixime, cefuroxime, cefpodoxime proxetil, cefprozil),
(2) 4 intramuscular ceftriaxone sodium trials, and (3) 11 oral azithromycin
trials. The summary odds ratio for treatment outcomes at 8 to 19 days in children
treated with short-acting antibiotics for 5 days vs 8 to 10 days was 1.52
(95% confidence interval [CI], 1.17-1.98) but by 20 to 30 days outcomes between
treatment groups were comparable (odds ratio, 1.22; 95% CI, 0.98 to 1.54).
The risk difference (2.3%; 95% CI,−0.2% to 4.9%) at 20 to 30 days suggests
that 44 children would need to be treated with the long course of short-acting
antibiotics to avoid 1 treatment failure. This similarity in later outcomes
was observed for up to 3 months following therapy (odds ratio, 1.16; 95% CI,
0.90-1.50). Comparable outcomes were shown between treatment with ceftriaxone
or azithromycin, and at least 7 days of other antibiotics.
Conclusion.— This meta-analysis suggests that 5 days of short-acting antibiotic use
is effective treatment for uncomplicated acute otitis media in children.