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A Response From Pittsburgh

Ellen M. Mandel, MD; Howard E. Rockette, PhD; Charles D. Bluestone, MD; Jack L. Paradise, MD; Robert J. Nozza, PhD

JAMA. 1993;269(4):516-517.

	Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings.

CANTEKIN et al¹ have recently challenged our 1987 New England Journal of Medicine report² that in infants and children with otitis media with effusion (secretory otitis media), amoxicillin treatment modestly increased the likelihood of resolution. From reanalyses of our clinical trial data, Cantekin et al concluded instead that amoxicillin had been no more efficacious than placebo, and that otoscopic diagnoses in our trial had been biased. Further, they cited reports "indicat[ing] that antimicrobial treatment is not effective even for acute otitis media."

To arrive at these positions, Cantekin et al committed a series of methodological improprieties, invoked fallacious concepts and invalid assumptions, and inadequately represented the findings of cited studies. Space constraints preclude our discussing these fully, but the most important were the following:

Post Hoc Use of an Altered and Invalid Method for Determining Outcome.

—Our amoxicillin trial was conducted from 1981 through 1984. Its original protocol . . . [Full Text PDF of this Article]

Author Affiliations
From the Otitis Media Research Center (Drs Mandel, Rockette, Paradise, Bluestone, and Nozza) and the Departments of Pediatric Otolaryngology (Dr Bluestone), Audiology and Communication Disorders (Dr Nozza), and Pediatrics (Drs Mandel and Paradise), Children's Hospital of Pittsburgh (Pa); the Departments of Otolaryngology (Drs Bluestone and Nozza), Pediatrics (Drs Mandel and Paradise), and Clinical Epidemiology and Preventive Medicine (Dr Paradise), University of Pittsburgh School of Medicine; and the Department of Biostatistics, University of Pittsburgh Graduate School of Public Health (Dr Rockette). Dr Nozza is now with the Department of Communication Sciences and Disorders, University of Georgia, Athens.

Footnotes
Reprint requests to ENT Department, Children's Hospital of Pittsburgh, 3705 Fifth Ave at DeSoto Street, Pittsburgh, PA 15213 (Dr Mandel).

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