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Investigators compared the safety, efficacy, acceptability, and cost of watchful waiting and of antibiotics for treating nonsevere acute otitis media (AOM) in 223 children, more than half of whom were younger than 2 years. Investigators were blinded to each child's treatment group but parents were not.
Patients in the immediate antibiotic treatment group received oral amoxicillin for 10 days at a dosage of 90 mg/kg/day in two doses to a maximum of 1,500 mg/day. Patients in the watchful waiting group received amoxicillin 90 mg/kg/day only when AOM failed to resolve or recurred. Both groups were evaluated at day 12 and day 30.
Parents of children in both groups were given a brief educational intervention about middle ear infection and the cost and possible adverse effects of antibiotics and how resistance to these drugs can develop. They also received saline nose drops, cerumen-removal drops, ibuprofen, and a decongestant-antihistamine preparation to administer as needed.
The treatment failure rate was 5% in the antibiotic group and 21% in the watchful waiting group. Regardless of intervention group, failure or recurrence was more common in children who had received an antibiotic within 30 days before the trial began. As for cure, immediate antibiotic treatment was superior early on but, because of later recurrences, both groups had nearly identical outcomes by day 30.
Streptococcus pneumoniae was eradicated in most children in the immediate antibiotic group, but S pneumoniae strains cultured from children in this group on day 12 were more likely to be multidrug-resistant than strains from children in the watchful waiting group were likely to be.
Although the antibiotic group had more adverse events, neither group experienced any serious adverse events.
The two groups had similar rates of office and emergency department visits, telephone calls to the physician's office, and days of missed school or work. Because of a lower prescription rate in the watchful waiting group, antibiotic costs averaged $11.43 for these children-compared with $47.41 for children in the antibiotic group (McCormick DP et al: Pediatrics 2005;115:1455).
According to these data, treating five or six patients with antibiotics would result in one additional normal tympanic membrane examination at day 12 follow-up.
These investigators do not offer a ringing endorsement of watchful waiting but, instead, a careful, measured recommendation with some caveats. They propose that watchful waiting requires having a way to grade the severity of otitis (using watchful waiting only in cases that are not severe); thorough parent education; symptom management; good access to follow-up care; and effective antibiotics and dosing when one of these drugs is needed.