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The debate about whether to treat acute otitis media (AOM) with antibiotics affects nearly all practicing paediatricians. In 2004, the American Academy of Pediatrics (AAP) recommended watchful waiting, long practiced in European countries, as an option in children 6–23 months old with ‘non-severe’ illness and an ‘uncertain’ diagnosis.1 This recommendation was based on clinical trials showing high rates of spontaneous resolution of symptoms, so that an estimated 7–17 children would need to be treated with antibiotics to improve one child's clinical outcomes. However, limitations of previous trials, including variability in diagnostic criteria, participants' ages and antimicrobial and supportive treatments used, have kept the debate alive.2,–,4 Two recent randomised trials by Hoberman and colleagues and Tahtinen and colleagues have addressed the benefit of antibiotics in young children with AOM diagnosed by strict criteria.
Both studies were randomised, double-blind trials that compared amoxicillin-clavulanate (amox/clav) with a taste-matched placebo in children with carefully diagnosed AOM. Participants, inclusion criteria and main outcomes were similar (table 1). Both studies had high completion rates (96% and 98%). The trials differed mainly in the dose and duration of antibiotic used, and how outcomes were measured.
Both studies showed a statistically significant benefit of antibiotics on primary outcomes and some secondary outcomes …
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