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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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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.

View this table:
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.

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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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