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

doi:10.1136/bmj.320.7231.350

BMJ 2000;320:350-354 ( 5 February )

General Practice

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

Roger A M J Damoiseaux, general practitioner, ^a Frank A M van Balen, general practitioner, ^a Arno W Hoes, professor of clinical epidemiology, ^b Theo J M Verheij, professor of general practice, ^a Ruut A de Melker, professor of general practice. ^a

^a Department of General Practice, University Medical Centre, Universiteitsweg 100, 3584 CG Utrecht, Netherlands, ^b Department of General Practice and Julius Centre for Patient Oriented Research, University Medical Centre

Correspondence to: R A M J Damoiseaux R.A.M.J.Damoiseaux{at}med.uu.nl

Objective: To determine the effect of antibiotic treatmentfor acute otitis media in children between 6 months and 2 yearsofage.
Design: Practice based, double blind, randomised,placebo controlledtrial.
Setting: 53 general practices in theNetherlands.
Subjects: 240 children aged 6 months to 2 years withthe diagnosis of acute otitismedia.
Intervention: Amoxicillin 40 mg/kg/day in threedoses.
Main outcome measures: Persistent symptoms at day four and durationof fever and pain or crying, or both. Otoscopy at days four and11, tympanometry at six weeks, and use ofanalgesic.
Results: Persistent symptoms at day four were lesscommon in the amoxicillin group (risk difference 13%; 95% confidenceinterval 1% to 25%). The median duration of fever was two daysin the amoxicillin group versus three in the placebo group (P=0.004).No significant difference was observed in duration of pain orcrying, but analgesic consumption was higher in the placebo groupduring 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, andtympanometric findings at six weeks were similar in bothgroups.
Conclusions: Seven to eight children aged 6 to 24 monthswith acute otitis media needed to be treated with antibioticsto improve symptomatic outcome at day four in one child. Thismodest effect does not justify prescription of antibiotics atthe first visit, provided close surveillance can beguaranteed.

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Rapid Responses:

Read all Rapid Responses

Meeting parental expectations: Andrew Thornett
bmj.com, 5 Feb 2000 [Full text]
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