Published 30 June 2009, doi:10.1136/bmj.b2525
Cite this as: BMJ 2009;338:b2525

Research

Recurrence up to 3.5 years after antibiotic treatment of acute otitis media in very young Dutch children: survey of trial participants

¹ Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, PO Box 85060, 3508 AB Utrecht, Netherlands, ² General Practice de Hof van Blom, 8051 JT Hattem, Netherlands, ³ Department of Otorhinolaryngology, Wilhelmina Children’s Hospital, University Medical Center Utrecht

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.

© Bezáková et al 2009
This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
http://creativecommons.org/licenses/by-nc/2.0/

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