LETTER TO THE EDITORS Federico Marchetti Æ Luca Ronfani Æ Sergio Conti Nibali Maurizio Bonati Æ Giorgio Tamburlini Æ for the Italian Study Group on Acute Otitis Media Restricted indications for the use of antibiotics in acute otitis media Received: 28 March 2004 / Accepted: 2 April 2004 / Published online: 14 May 2004 Ó Springer-Verlag 2004 Keywords Otitis Æ Antibiotic Æ Practice guidelines Sir, Sanz et al. [1] reported significant variations in the proportion of children diagnosed with acute otitis media (AOM) who were treated with antibiotics in different countries: antibiotic use was highest in Barcelona, Spain (93% of children) and lowest in Smolensk, Russia (56.4% of children were treated without antibiotics). The type of antibiotics used varied widely. Because the Drug Utilization Research Group in Children, the international collaborative group that performed the study, is planning to investigate these country differences, a brief comment based on a recent Italian initiative can be a useful contribution. Evidence from systematic reviews suggests that anti- biotic treatment of AOM provides only marginal bene- fits [2]. Approximately 80% of children with AOM improve without antibiotics, and those not immediately treated with antibiotics are unlikely to develop serious complications [3]. To minimise the development of antibiotic resistance and reduce the annual number of antibiotic prescriptions, parents and physicians may, therefore, decide to administer only symptomatic treatment for the first 48–72 h in AOM patients with non-severe symptoms and treat with antibiotics those children who show no improvement [3, 4, 5]. In Italy, the Associazione Culturale Pediatri, a professional association whose 3000 members are mainly primary care paediatricians, developed practice guidelines (PGs) for the treatment of AOM, which are similar to the PGs developed by the Dutch College of General Practitioners [6] in that they substantially restrict the indications for using antibiotics. However, implementation of PGs based on their dissemination alone is usually not effective. Ample evidence exists to support the argument that the simplest, most cost- effective intervention to increase the implementation of PGs is an analysis of the antecedents and consequences controlling behaviours of both physicians and patients [7]. However, it is essential to have the direct involve- ment of the prescribers in evaluating of the guidelines in their own practice [8, 9]. We, therefore, designed and carried out a large prospective study aimed at assessing acceptability and effectiveness of a case-management algorithm based on symptomatic treatment only for 48–72 h. The study protocol envisaged immediate prescription of the antibiotic amoxicillin (75–90 mg/kg per day in three doses for no less than 5 days) only in the presence of otorrhaea, a history of recurrent otitis media (defined as three or more attacks in 6 months, or four or more in 12 months) and in children who appear very sick. In all other cases, children were given paracetamol (10–15 mg/ kg per dose) and nose washes with saline solution. Children under 1 year of age, those already receiving antibiotics, those with serious concomitant illness (asthma, bronchitis, bronchopneumonia) or chronic disease (Down’s Syndrome, cystic fibrosis, immunode- ficiency and cranio-facial malformations) were excluded from the study. The study was carried out by a network of 169 paediatric practitioners and enrolled 1277 chil- dren with AOM aged 12 months to 14 years. Of 1099 F. Marchetti (&) Department of Paediatrics, Institute of Child Health, IRCCS Burlo Garofolo, Via dell’Istria 65/1, 34100 Trieste, Italy E-mail: fedemarche@tin.it Tel.: +39-040-3785454 Fax: +39-040-3785362 L. Ronfani Centro per la Salute del Bambino-ONLUS, Trieste, Italy S. Conti Nibali Messina, Italy M. Bonati Laboratory for Mother and Child Health, Mario Negri Institute for Pharmacological Research, Milan, Italy G. Tamburlini Unit for Health Service Search, Department of Paediatrics, Institute of Child Health, IRCCS Burlo Garofolo, Trieste, Italy Eur J Clin Pharmacol (2004) 60: 293–294 DOI 10.1007/s00228-004-0771-y