Clinical efficacy of antimicrobial drugs for acute otitis media: Metaanalysis of 5400 children from thirty-three randomized trialsā,āā,ā ,ā ā
Section snippets
Study identification
To be included in the metaanalysis, a study had to be a randomized, controlled trial of antimicrobial drugs for the initial empiric treatment of simple AOM, as defined below:
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Simple AOM new or recurrent episodes of AOM in patients without underlying disorders that might influence susceptibility to infection, such as Down syndrome, cleft palate, craniofacial anomalies, immunodeficiency, otitis media with effusion, or concurrent illness other than a viral upper respiratory tract infection.
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AOM
Literature search and trial selection
Our English-language MEDLINE search identified 303 articles. Of these, 160 remained after the initial scanning of the titles. An additional 126 articles were added after searching Current Contents and reviewing bibliographies, for a total of 286 entries in the initial data set. Reasons for excluding 256 studies are summarized in Table I. Of the remaining 30 articles, 28 had been identified from MEDLINE,29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52
DISCUSSION
Should antibiotics be part of the initial empiric therapy for AOM in children? Our metaanalysis suggests that the answer is a qualified yes. Qualifications relate to (1) the modestāthough significantāefficacy of antibiotics over placebo or no drug, (2) the limitations of a narrow treatment end point, and (3) the failure of Ī²-lactamase coverage to increase rates of primary control significantly. Six of every seven children with AOM either do not need antibiotics for primary control or will not
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From the Departments of Otolaryngology and Pediatrics, Children's National Medical Center and George Washington University School of Medicine, Washington, D.C., the Otitis Media Research Center and the Departments of Otolaryngology, Pediatrics, and Surgery, University of Minnesota School of Medicine, and the Department of Pharmacy Practice, University of Minnesota College of Pharmacy, Minneapolis
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Supported in part by National Institutes of Health grant No. P01-DC00133 from the National Institute of Deafness and Other Communicative Disorders and grant No. GM 08183-02, Public Health Service Short-Term Training Grant: Students in Health Professional Schools.
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Reprint requests: Richard M. Rosenfeld, MD, MPH, Department of Otolaryngology, Long Island College Hospital, 340 Henry St., Brooklyn, NY 11201.
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0022-3476/94 $3.00 + 0 9/20/52105