Game Changers in Pediatrics 2011

Laurie Scudder, DNP, PNP


November 23, 2011

In This Article

Otitis Media: The Saga Continues

Two important studies were published in the New England Journal of Medicine in January 2011 that called into question the current recommendations for watchful waiting for acute otitis media (AOM) particularly in younger children. The first study, a randomized controlled trial conducted in Finland, compared amoxicillin-clavulanate to placebo in children between the ages of 6 and 35 months of age.[18] Treatment failure was much higher in the placebo group (44.9%) than in the intervention group (18.6%, P < .001), a difference that was apparent by day 3. The second study, also a randomized controlled trial, was conducted at 2 centers in the United States and included just under 300 children between the ages of 6 and 23 months.[19] This trial, too, compared amoxicillin-clavulanate to placebo for treatment of children who met stringent diagnostic criteria for AOM. As was noted in the Finnish study, clinical failure was markedly reduced with treatment. Treatment failure had occurred by day 4-5 in 23% of the placebo group but in only 4% of treated children. At the end of the 10-day course of medication, treatment failure had occurred in 16% of treated children and 51% of children on placebo. Treatment was also associated with more rapid resolution of middle ear effusion and a lower likelihood of persistent infection.

Other key points:

  • Failure rates were much higher in these studies than in earlier studies, including those considered in the development of the 2004 AAP guideline for diagnosis and management of AOM.[20] This difference may be attributed to the use of stringent diagnostic criteria in these trials.

  • Adverse events, most notably diarrhea and diaper dermatitis, were higher in the treatment groups and the majority resolved without intervention. In the US study, one child in the placebo group developed mastoiditis.

  • The resolution of symptoms such as fever occurred more quickly in the treatment groups in both studies.

Why Is This a Game Changer?

In commenting on these studies, William T. Basco, Jr., MD, Director, Division of General Pediatrics at Children's Hospital of Medical University of South Carolina noted that the results of both must be seriously considered as they provide some of the best data yet on what to expect with either observation or active treatment of AOM in young children. He emphasizes a point noted by the Finnish researchers: while the failure rate in their placebo group was much higher than in previous studies, this may be because earlier trials used less stringent diagnostic criteria at entry. Use of less stringent criteria for diagnosis means fewer of those children would have experienced clinical failure given that they might not have had AOM in the first place. That was not the case in these trials -- these children met very clear diagnostic criteria and definitely had AOM. As noted by Jerome O. Klein, MD, a Professor of Pediatrics at Boston University School of Medicine, in an accompanying editorial, the issue of watchful waiting vs antibiotics for AOM has been controversial since the guidelines were issued and a well-designed study was needed to definitively answer the question as to whether AOM is a treatable illness.[21] These 2 studies appear to answer that question with a very clear "yes."


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