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Randomised controlled trial
Amoxicillin-clavulanate improves symptoms, reduces treatment failure in select children with acute otitis media and increases risk of diarrhoea
  1. Andrea Marmor1,
  2. Thomas B Newman1
  1. 1Departments of Pediatrics (Marmor and Newman) and Epidemiology (Newman) University of California, San Francisco, California, USA
  1. Correspondence to Andrea Marmor
    MS-6E, Pediatrics, San Francisco General Hospital, 1001 Potrero Avenue, San Francisco, CA 94110, USA; amarmor{at}

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Commentary on: OpenUrlCrossRefPubMedWeb of Science

Commentary on: OpenUrlCrossRefPubMedWeb of Science


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.

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Table 1

Methodologic features


Both studies showed a statistically significant benefit of antibiotics on primary outcomes and some secondary outcomes …

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  • Competing interests None.