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  • Antibiotics reduced the time to resolution of symptoms in otitis mediaChildren diagnosed with otitis media by an otoscopist benefited from antibiotics but suffered more side effects

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Antibiotics reduced the time to resolution of symptoms in otitis media

https://doi.org/10.1136/archdischild-2011-300825

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    Study design

    Design

    Randomised placebo-controlled trial.

    Allocation

    Patients were stratified for history of recurrent otitis media and exposure to other children and randomised in blocks of four. The method of allocation concealment was not stated.

    Blinding

    Blinding of researchers, parents and caregivers.

    Study question

    Setting

    Large tertiary hospital in Pittsburgh, USA and associated private clinic.

    Patients

    291 children aged 6–23 months, who had received pneumococcal conjugate vaccine, and scored 3 or more on the Acute Otitis Media Severity of Symptoms scale.

    Intervention

    144 infants were assigned to amoxicillin–clavulanate (Augmentin ES), amoxicillin 90 mg/kg (clavulanate 6.4 mg/kg) divided in two daily doses for 10 days and 147 were assigned to placebo.

    Outcomes

    Primary outcome was time to resolution of symptoms; secondary outcomes were overall efficacy, use of paracetamol and adverse events.

    Follow-up period

    Until days 21–25.

    Patient follow-up

    137/144 in treatment versus 145/147 in placebo (compliance achieved in 85%).

    Main results

    Intention-to-treat analysis.

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    Table 1

    Conclusion

    Children treated with antibiotics for acute otitis media diagnosed by strict criteria benefited with reduced time to resolution of symptoms; however, treatment resulted in more diarrhoea and rash.

    Abstracted from

    Hoberman A, Paradise JL, Rockette HE, et … OpenUrlCrossRefPubMedWeb of Science

    Correspondence to Martin Burton, Consultant Otolaryngologist, Oxford Radcliffe NHS Trust, The West Wing, John Radcliffe Hospital, Oxford OX3 9DU, UK; mburton{at}cochrane-ent.org

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    Footnotes

    • Sources of funding Supported by grant 3U01AI066007-02S1 from the National Institute of Allergy and Infectious Diseases.

    Footnotes

    • Sources of funding Supported by the Fellowship Award of the European Society for Paediatric Infectious Diseases (to Dr Ruohola), grants from the Foundation for Paediatric Research and others.

    Footnotes

    • Competing interests None.

    • Provenance and peer review Commissioned; internally peer reviewed.

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