Background: Acute otitis media (AOM) is one of the most common conditions for which children take antibiotics, but the long-term effects of this practice are unclear. Although antibiotics may shorten the duration of illness, they could also contribute to resistant organisms and a greater recurrence of infection.

The Study: Bezáková and colleagues conducted a follow-up study of a prospective double-blind trial examining amoxicillin versus placebo in treating AOM in children six to 24 months of age. The authors of the original study recruited 240 children with AOM based on clinical and otoscopic findings. Three and a half years after the beginning of the initial trial, the parents of participating children were interviewed about episodes of recurrent AOM and whether referral or surgery had been needed. The primary outcome measure was the recurrence of AOM.

Results: Data were obtained on 168 (70 percent) of the original 240 participants; approximately 95 percent of the parents had remained blinded to the original treatment. During the interval three-year period, recurrent AOM was reported in 63 percent of the amoxicillin group compared with 43 percent of the placebo group (relative risk = 1.5). After adjusting for sex, allergy, and history of recurrent AOM, children in the amoxicillin-treated group were 2.5 times more likely to experience recurrent AOM (adjusted odds ratio = 2.5) compared with the placebo group. No significant difference in the need for secondary referral or surgery occurred between groups.

Conclusion: Recurrent AOM was more common among children who were initially treated with amoxicillin compared with a placebo. The authors believe their findings offer another argument for judicious use of antibiotics in children with AOM.

editor's note: A major strength of this study is that most parents remained blinded to the original treatment in their children, but several weaknesses are also present. For instance, the results were based on parental recall rather than independently confirming recurrent AOM. The authors also failed to account for follow-up data from several patients—this could have affected recurrence rates by about 1 percent, but appears unlikely to have notably changed the relative risk of AOM recurrence in the groups. Despite these limitations, this study does support the current recommendations for limiting antibiotic use in otherwise healthy children with AOM.—k.t.m.