PEDIATRICS Vol. 108 No. 2 August 2001, pp. 239-247
Evidence Assessment of Management of Acute Otitis Media: I. The Role of Antibiotics in Treatment of Uncomplicated Acute Otitis Media
Received Aug 22, 2000; accepted Nov 21, 2000.
, §,
, #,
From the * Division of General Pediatrics, Childrens Hospital,
Los Angeles, California; Context. In 1995, >5 million
episodes of acute otitis media (AOM) accounted for $3 billion in health
care expenditures.
Objectives. To synthesize the literature on the natural
history of AOM, the effectiveness of antibiotic treatment in
uncomplicated AOM, and the relative effectiveness of specific
antibiotic regimens.
Data Sources. Seven electronic databases for articles
published between 1966 and March 1999 and reference lists in
proceedings, published articles, reports, and guidelines.
Study Selection. Two physicians independently assessed
each article. Studies addressing AOM in children 4 weeks to 18 years
old were included; those addressing children with immunodeficiencies or
craniofacial abnormalities were excluded. Randomized, controlled trials
(RCTs) were used to assess antibiotic effectiveness, and RCTs and
cohort studies were used to assess the natural history of AOM. Among the 3491 citations identified, 80 (2.3%) met our inclusion criteria.
Data Extraction. Two physicians independently abstracted
data and assessed the quality of studies using a validated scale for
RCTs and 8 quality components for cohort studies.
Data Synthesis. Random-effects estimates of pooled
absolute rate differences of outcomes were derived, and heterogeneity
of both the rates and rate differences was assessed. Children with AOM
not treated with antibiotics experienced a 1- to 7-day clinical failure
rate of 19% (95% confidence interval: 0.10-0.28) and few suppurative complications. When patients were treated with
amoxicillin, the 2- to 7-day clinical failure rate was
reduced to 7%, a 12% (95% confidence interval: 0.04-0.20)
reduction. Adverse effects, primarily gastrointestinal, were more
common among children on cefixime than among those on
ampicillin or amoxicillin. They were also more common among children on amoxicillin-clavulanate than
among those on azithromycin.
Conclusions. The majority of uncomplicated cases of AOM
resolve spontaneously without apparent suppurative complications.
Ampicillin or amoxicillin confers a limited
therapeutic benefit. There is no evidence to support any particular
antibiotic regimens as more effective at relieving symptoms. Certain
antibiotics are more likely than others to cause diarrhea and other
adverse events.
Division of Biostatistics & Outcomes
Assessment, Los Angeles County and University of Southern California
Medical Center, Los Angeles, California; § Center for Pediatric Health
Outcomes Research, Department of Pediatrics, University of Southern
California, Los Angeles, California; Health Services Research and
Development Service, Greater Los Angeles Veterans' Affairs Healthcare
System, Los Angeles, California; ¶ Statistics Group, RAND, Santa
Monica, California; # Southern California Evidence-Based Practice
Center, RAND, Santa Monica, California; ** Division of Infectious
Diseases, Childrens Hospital, Los Angeles, California; Department
of Pediatrics, Southern California Kaiser-Permanente Health Care
Program, Panorama City, California.
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