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General Practice

Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years

BMJ 2000; 320 doi: (Published 05 February 2000) Cite this as: BMJ 2000;320:350
  1. Roger A M J Damoiseaux (R.A.M.J.Damoiseaux{at}, general practitionera,
  2. Frank A M van Balen, general practitionera,
  3. Arno W Hoes, professor of clinical epidemiologyb,
  4. Theo J M Verheij, professor of general practicea,
  5. Ruut A de Melker, professor of general practicea
  1. a Department of General Practice, University Medical Centre, Universiteitsweg 100, 3584 CG Utrecht, Netherlands
  2. b Department of General Practice and Julius Centre for Patient Oriented Research, University Medical Centre
  1. Correspondence to: R A M J Damoiseaux
  • Accepted 11 November 1999


Objective: To determine the effect of antibiotic treatment for acute otitis media in children between 6 months and 2 years of age.

Design: Practice based, double blind, randomised, placebo controlled trial.

Setting: 53 general practices in the Netherlands.

Subjects: 240 children aged 6 months to 2 years with the diagnosis of acute otitis media.

Intervention: Amoxicillin 40 mg/kg/day in three doses.

Main outcome measures: Persistent symptoms at day four and duration of fever and pain or crying, or both. Otoscopy at days four and 11, tympanometry at six weeks, and use of analgesic.

Results: Persistent symptoms at day four were less common in the amoxicillin group (risk difference 13%; 95% confidence interval 1% to 25%). The median duration of fever was two days in the amoxicillin group versus three in the placebo group (P=0.004). No significant difference was observed in duration of pain or crying, but analgesic consumption was higher in the placebo group during the first 10 days (4.1 v 2.3 doses, P=0.004). In addition, no otoscopic differences were observed at days four and 11, and tympanometric findings at six weeks were similar in both groups.

Conclusions: Seven to eight children aged 6 to 24 months with acute otitis media needed to be treated with antibiotics to improve symptomatic outcome at day four in one child. This modest effect does not justify prescription of antibiotics at the first visit, provided close surveillance can be guaranteed.


  • Funding Netherlands Organisation for Scientific Research (grant no 904-58-074).

  • Competing interests Nasivin nose drops for this study were donated by E Merck Nederland BV.

  • Accepted 11 November 1999
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