A child aged up to 24 months will probably recover from otitis media (middle ear infection) more rapidly if given antibiotics, compared to “watchful waiting”, irrespective of symptom severity, US researchers revealed in an article published in NEJM (New England Journal of Medicine). These findings clash with most guidelines in North America and Europe, which recommend watchful waiting for children with mild symptoms.

Alejandro Hoberman, M.D., chief of the Division of General Academic Pediatrics and vice chair of Clinical Research at Children’s Hospital of Pittsburgh of UPMC, and team found that treating acute otitis media (AOM) with a 10-day course of antibiotics was more effective in reducing treatment duration and severity of symptoms compared to a placebo.

Dr. Hoberman added that those on antibiotic treatment were much less likely to have evidence of persistent signs of acute infection (clinical failure) that required subsequent treatment, compared to the watchful waiting patients.

Dr. Hoberman said:

Based on these findings, there is strong evidence in favor of treating children younger than 2 years of age with antibiotics, irrespective of the severity of the ear infection. To some degree, this is contrary to current clinical guidelines, which include an option for watchful waiting rather than prompt treatment for young children with apparently mild symptoms. We expect our study to have an impact on treatment guidelines for the United States that currently are being revised.”

Current guidelines issued by the AAP (American Academy of Pediatrics) and AAFP (American Academy of Family Physicians) recommend watchful waiting for children with mild symptoms and whose diagnosis of acute otitis media is uncertain. Canada and several European countries have similar guidelines.

The authors wrote:

“However, these recommendations are based on studies with many important limitations, most notably, a lack of strict diagnostic criteria. In other words, many of the children studied merely may have had fluid in the middle ear instead of an actual ear infection. Other limitations were the inclusion of few very young children, in whom the infection tends to be more stubborn, and the use of antibiotics that had a limited effectiveness or were given in doses that were ineffective.”

Hoberman and team randomly selected 291 children aged 6 to 24 months into two groups – a placebo or antibiotic (amoxicillin-clavulanate) group. They were treated for 10 days.

They found that:

  • Those in the antibiotic group experienced improved symptoms earlier
  • Those in the antibiotic group had lower mean symptom scores over the first seven days
  • Clinical failure rates during days 4 and 5 were 23% in the placebo group and 4% in the antibiotic group
  • Clinical failure rates during days 10 to 12 were 51% in the placebo group and 16% in the antibiotic group

Accurate diagnosis is still the key to optimal management of acute otitis media, Dr. Hoberman stressed.

Hoberman added:

“Young children with a certain diagnosis of AOM are more likely to recover when treated with an appropriate antibiotic, and their symptoms will subside more quickly. Provided the diagnosis of AOM in children younger than 2 years of age is certain, we favor treatment with antibiotics.”

“Treatment of Acute Otitis Media in Children under 2 Years of Age”
Alejandro Hoberman, M.D., Jack L. Paradise, M.D., Howard E. Rockette, Ph.D., Nader Shaikh, M.D., M.P.H., Ellen R. Wald, M.D., Diana H. Kearney, R.N., C.C.R.C., D. Kathleen Colborn, B.S., Marcia Kurs-Lasky, M.S., Sonika Bhatnagar, M.D., M.P.H., Mary Ann Haralam, C.R.N.P., Lisa M. Zoffel, C.R.N.P., Carly Jenkins, R.N., Marcia A. Pope, R.N., Tracy L. Balentine, R.N., and Karen A. Barbadora, M.T.
N Engl J Med 2011; 364:105-115January 13, 2011

Written by Christian Nordqvist