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Researchers examine the available evidence on effective management of otitis media in children

Acute otitis media (AOM)—or inflammation of the middle ear—is common among children, with over 5 million episodes of AOM occurring in 1995 at a cost of nearly $3 billion. Unfortunately, AOM incidence is increasing, with doctors' visits for the problem doubling from 1975 to 1990. Antibiotics have been used routinely to treat uncomplicated AOM, but this approach is controversial, especially in children older than 6 months, due in part to concern about antibiotic resistance of bacteria associated with AOM.

Researchers at the Southern California Evidence-based Practice Center (EPC), which is supported by the Agency for Healthcare Research and Quality (contract 290-97-0001), reviewed the available scientific evidence on management of acute and persistent otitis media in children. Their findings are reported in the following two articles.

Takata, G.S., Chan, L.S., Shekelle, P., and others. (2001, August). "Evidence assessment of management of acute otitis media: I. The role of antibiotics in treatment of uncomplicated acute otitis media." Pediatrics 108(2), pp. 239-247.

Most children with uncomplicated AOM not initially treated with antibiotics (78 percent) no longer had pain or fever within 4 to 7 days and suffered no complications. Antibiotics offered them only a modest benefit, according to this review of the evidence. About 19 percent of children with AOM not treated with antibiotics experienced a 1- to 7-day clinical failure rate (pain, fever, or middle ear fluid) and few complications. When treated with amoxicillin, the clinical failure rate was reduced to 7 percent. In clinical terms, 8 children with AOM would have to be treated with ampicillin or amoxicillin to avoid one case of clinical failure during this time frame.

There was no evidence to support the superior efficacy of any particular antibiotic or dosing regimen. Adverse effects, primarily gastrointestinal, were more common among children on cefixime than among those on ampicillin or amoxicillin. They also were more common among children on amoxicillin-clavulanate than among those on azithromycin. However, the data were insufficient to draw conclusions about any particular age group, especially those younger than 2 years of age.

The EPC investigators synthesized the literature of seven electronic databases of articles published between 1966 and March 1999 on the natural history and antibiotic treatment of uncomplicated AOM. A panel of 11 multidisciplinary experts guided the systematic review of the literature. The authors were unable to generalize their results, since many studies failed to identify patient age and otitis-prone status.

Chan, L.S., Takata, G.S., Shekelle, P., and others. (2001, August). "Evidence assessment of management of acute otitis media: II. Research gaps and priorities for future research." Pediatrics 108(2), pp. 248-254.

A panel of experts screened a total of 3,461 abstracts and titles of AOM studies from 1966 to March 1999, reviewed 760 full-length articles, and used a total of 80 studies in 85 articles. The panel concluded that although there is a large body of research literature on AOM, its quality is uneven and its findings are not generalizable. For example, although AOM is readily recognized as a clinical condition, clinicians and researchers do not agree on a standard definition of AOM, even among often-cited sources. Only half of the studies approximated the diagnostic criteria for middle ear effusion (MEE), almost none met the criteria for rapid onset, and only one-third met the criteria for signs and symptoms as defined by expert definition of AOM.

Also, disagreement exists about the relative importance of factors influencing the possible outcome of AOM treatment. In the description of the study population, only 36 percent of the 80 studies mentioned the two top ranking risk factors (age of child and otitis-prone status), 59 percent mentioned only age but not otitis-prone status, and 5 percent mentioned neither factor. In general, the type of outcome measure varied between studies, and the definitions of common outcomes, such as clinical failure, were not uniform. Only five studies reported the clinical failure rate between 1 and 7 days. Few studies reported on clinical failure, pain, fever, and MEE by age, and none reported these outcomes by otitis-prone status.

Explicitly defined AOM outcomes are needed to aid in comparing and synthesizing study results. Also, explicit descriptions of the populations studied, including age and whether or not the subjects are otitis-prone, are needed to assess the generalizability of study findings, according to the authors. Of the 74 randomized controlled trials studied, only 53 percent were of acceptable quality. Only 41 percent of these studies mentioned double-blinding, 70 percent described the characteristics of study dropouts, 38 percent used appropriate randomization methods, and 23 percent used appropriate blinding strategies.

Editor's Note: Copies of the report from which these findings are drawn, Management of Acute Otitis Media, Evidence Report/Technology Assessment No. 15 (AHRQ Publication No. 00-E010), as well as a 4-page summary of the report (AHRQ Publication No. 00-E008), are available from the AHRQ Publications Clearinghouse.

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