Recurrence up to 3.5 years after antibiotic treatment of acute otitis media in very young Dutch children: survey of trial participantsBMJ 2009; 338 doi: https://doi.org/10.1136/bmj.b2525 (Published 30 June 2009) Cite this as: BMJ 2009;338:b2525
- Natália Bezáková, medical student1,
- Roger A M J Damoiseaux, general practitioner2,
- Arno W Hoes, professor of clinical epidemiology and general practice1,
- Anne G M Schilder, otorhinolaryngologist and clinical epidemiologist3,
- Maroeska M Rovers, clinical epidemiologist1
- 1Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85060, 3508 AB Utrecht, Netherlands
- 2General Practice de Hof van Blom, 8051 JT Hattem, Netherlands
- 3Department of Otorhinolaryngology, Wilhelmina Children’s Hospital, University Medical Center Utrecht
- Correspondence to: M M Rovers
- Accepted 17 February 2009
Objective To determine the long term effects of antibiotic treatment for acute otitis media in young children.
Design Prospective three year follow-up study within the framework of a primary care based, double blind, randomised, placebo controlled trial.
Setting 53 general practices in the Netherlands.
Participants 168 children aged 6 months to 2 years with acute otitis media.
Interventions Amoxicillin 40 mg/kg/day in three doses compared with placebo.
Main outcome measures Recurrence of acute otitis media; referral to secondary care; ear, nose, and throat surgery.
Results Acute otitis media recurred in 63% (47/75) of children in the amoxicillin group and in 43% (37/86) of the placebo group (risk difference 20%, 95% confidence interval 5% to 35%); 30% (24/78 amoxicillin; 27/89 placebo) of children in both groups were referred to secondary care, and 21% (16/78) of the amoxicillin group compared with 30% (27/90) of the placebo group had ear, nose, and throat surgery (risk difference −9%, −23% to 4%).
Conclusion Recurrent acute otitis media occurred more often in the children originally treated with amoxicillin. This is another argument for judicious use of antibiotics in children with acute otitis media.
Trial registration Netherlands Trial Register NTR1426.
We thank the participating children and all the general practitioners who included patients in this trial.
Contributors: NB analysed and interpreted the data. RAMJD was responsible for the design, planning, and data collection of the original trial and contributed to the initial concept and data interpretation of the study. MMR supervised the study and interpreted the data. AWH and AGMS contributed to the data interpretation. NB and MMR prepared the manuscript, and all authors commented on it. MMR is the guarantor.
Funding: Netherlands Organisation for Scientific Research (grant No 90458074) funded the original trial.
Competing interest: MMR has participated in a CME accredited symposium on the burden of otitis media, which was supported by an unrestricted grant from GlaxoSmithKline.
Ethical approval: The ethics committee of the University Medical Center Utrecht approved the protocol.
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