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Cover of Management of Acute Otitis Media

Management of Acute Otitis Media

Evidence Reports/Technology Assessments, No. 15

Investigators: , MD, Principal Investigator, , MD, MS, , MD, PhD, , PhD, , MD, MPH, , MD, , PhD, , PhD, , MSLS, , MS, , MS, and , MS.

Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 01-E010ISBN-10: 1-58763-027-3

Structured Abstract


Our objective with this report was to analyze the evidence on the initial management of uncomplicated acute otitis media (AOM) in children. We assessed three questions: What is the natural history of AOM without antibiotic treatment? Are antibiotics effective in preventing clinical failure? and What is the relative effectiveness of specific antibiotic regimens such as: (1) amoxicillin or trimethoprim-sulfamethoxazole vs. other antibiotics, (2) oral fluoroquinolones, (3) >60 mg/kg/day amoxicillin or amoxicillin-clavulanate vs. 40 mg/kg/day, (4) high-dose amoxicillin therapy twice a day vs. three times a day, and (5) short-term vs. long-term antibiotic therapy?

Search Strategy:

The technical experts and project staff developed a literature search strategy that used MEDLINE, the Cochrane Library, HealthSTAR, International Pharmaceutical Abstracts, Cumulative Index to Nursing & Allied Health Literature, BIOSIS, and EMBASE. Headings included "om" (otitis media), "mastoiditis," "om w/effusion," "om, suppurative" with the subheading "drug therapy," and "anti-infective agents," including "antibiotics" and "other drugs." Text words included otitis media, antibiotic, antimicrobial, antibacterial, specific antibiotic names and natural history, natural course, untreated, spontaneous, and self-limited for the natural history search. Additional articles were identified by review of reference lists in proceedings, published articles, reports, and guidelines.

Selection Criteria:

The selection criteria included human studies addressing AOM in children age 4 weeks to 18 years. Excluded were studies on patients with immunodeficiencies or craniofacial deficiencies, including cleft palate. Randomized clinical trials and cohort studies were included for the question on natural history. Randomized controlled trials were used to address the questions on antibiotic effectiveness.

Data Collection and Analysis:

Two physician reviewers independently evaluated articles and abstracted data. They excluded articles that did not address any of the key questions or that had unabstractable data. They assessed the quality of the studies. Project staff developed evidence tables using the abstracted data. Meta-analyses were performed as appropriate. Twenty-four experts and consumers critiqued the draft of this evidence report.

Main Results:

Clinical failure was defined generally as the failure to resolve or improve clinical signs and symptoms at specific time intervals. In children with AOM not initially treated with antibiotics, the reported rate of clinical failure at 24-48 hours was 7.7 percent in one study and at 24-72 hours was 26 percent in another study. The pooled estimated failure rate at 1-7 days was 18.9 percent and was 22.2 percent at 4-7 days. Compared with this failure rate, children treated with ampicillin or amoxicillin showed a reduction in clinical failure at 2-7 days of 12.3 percent. This result generally was robust to sensitivity analysis. Eight children with AOM would need to be treated with ampicillin or amoxicillin rather than no antibiotic treatment to avoid a case failure. The pooled comparisons of specific antibiotic regimens showed no difference in clinical failure rates. Adverse effects, primarily gastrointestinal, were more common in children on cefixime than those on ampicillin or amoxicillin and more common in children on amoxicillin-clavulanate (original formulation) than those on azithromycin.


There is a wide range of reported clinical failure rates in the first week in children with AOM who are not treated with antibiotics. The pooled estimates indicate that a majority of these children have clinical resolution within the first week after presentation. These studies, which generally are of small sample size, report few episodes of suppurative complications, regardless of antibiotic treatment. In general, the children in the natural history studies had close followup. Antibiotic treatment with ampicillin or amoxicillin produces a statistically significant improvement in failure rates compared with no antibiotic treatment of AOM. We found no difference in clinical failure rates in the antibiotic regimens assessed. Since we were unable to do subgroup analysis in the meta-analytic comparisons, we cannot generalize those findings to children in specific age groups, such as younger than or older than 2 years of age, or by otitis-prone status. Several studies suggest greater caution be taken with children younger than 2 years old.

Future Research:

Randomized controlled studies still are needed to address definitively the initial key questions. Future research should focus on: (1) establishing uniform definitions of AOM and relevant outcomes, (2) establishing uniform diagnostic criteria, (3) strengthening internal and external validity, (4) addressing relevant influencing factors such as age and otitis-prone state, and (5) measuring long-term as well as short-term outcomes. Studies also should be of sufficient power to establish differences in antibiotic efficacy. In addition, future studies should address the bacterial resistance issue.


Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No. 290-97-0001. Prepared by: Southern California Evidence-based Practice Center.

Suggested citation:

Marcy M, Takata G, Shekelle P, et al. Management of Acute Otitis Media. Evidence Report/Technology Assessment No. 15 (Prepared by the Southern California Evidence-based Practice Center under Contract No. 290-97-0001). AHRQ Publication No. 01-E010. Rockville, MD: Agency for Healthcare Research and Quality. May 2001.

On December 6, 1999, under Public Law 106-129, the Agency for Health Care Policy and Research (AHCPR) was reauthorized and renamed the Agency for Healthcare Research and Quality (AHRQ). The law authorizes AHRQ to continue its research on the cost, quality, and outcomes of health care and expands its role to improve patient safety and address medical errors.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service.


2101 East Jefferson Street, Rockville, MD 20852. www​

Bookshelf ID: NBK33163


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