BACKGROUND: Antibiotics are of limited effectiveness in treating acute otitis media in children aged older than 2 years. Antibiotic treatment, however, is widely prescribed in children younger than 2 years because they are thought to be at greater risk for complications. Widespread use of antibiotics is not benign, as side effects are common, and antibiotic resistance is a concern. Moreover, the benefit of antibiotics in children younger than 2 years has not been demonstrated in clinical studies.
POPULATION STUDIED: Children with acute otitis media were included if they were aged between 6 months and 2 years. They were selected from general practices in the Netherlands. Children were excluded if they had taken antibiotics in the preceding 4 weeks; had documented penicillin allergy, compromised immunity, craniofacial abnormalities, or Down syndrome; or had been entered in the study before.
STUDY DESIGN AND VALIDITY: This is a practice-based double-blind randomized controlled trial. Patients received either placebo or amoxicillin 40 mg per kg daily for 10 days. In addition, all patients used decongestant nasal drops and analgesics, as needed. Parents of patients kept a 10-day diary documenting symptoms and medication use. Assessment of response to therapy occurred at 4 and 11 days after the start of therapy, with a home visit after 6 weeks. This is a well-designed randomized controlled trial. To standardize the diagnosis of acute otitis media, participating physicians received special training. The authors did not describe the methods used to prevent researchers from knowing to which group the patient would be assigned (concealed allocation). This lack of concealment could introduce selective enrollment of patients. Follow-up was frequent and nearly complete. One concern: Otitis media resolves within 2 days in 90% of children older than 2 years.1 The later assessment time used in this study (4 days) may be less clinically relevant and may favor the placebo. The authors of this study focused on short-term outcomes and did not report on the incidence of chronic otitis media, hearing loss, and any unpleasant effects from antibiotics.
OUTCOMES MEASURED: The primary outcome was the presence of symptoms after 4 days of therapy, including earache, fever (>38 °C), crying, irritability, or the prescription of another antibiotic because of worsening symptoms. Secondary outcome measures included clinical treatment failure at day 11.
RESULTS: Persistent symptoms at day 4 were present in 59% of the children in the amoxicillin group and 72% in the placebo group (P=.03) . Between 7 and 8 children aged 6 to 24 months with acute otitis media need to be treated to improve symptoms in 1 child on day 4 (number needed to treat=7.7; 95% confidence interval, 4-100). There was a high rate of treatment failure in both groups after therapy was completed: 64% in the treated group and 70% in the placebo group.
Between 7 and 8 children aged younger than 2 years have to be treated with an antibiotic for 1 of them to receive a symptomatic benefit at 4 days compared with placebo. However, only a small percentage (30% to 36%) will be completely symptom free 11 days after presentation, regardless of antibiotic treatment. Since antibiotic treatment is not completely benign and its benefits are minimal for most children, most children between the ages of 6 months and 2 years need not be treated with antibiotics.