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COMMENTARY |
Department of Otolaryngology, State University of New York Downstate Medical Center and the Long Island College Hospital, Brooklyn, NY 11201
Abbreviations: AOM, acute otitis media
A major paradigm shift lies at the core of the new clinical practice guideline for acute otitis media (AOM),1 ie, the option of allowing selected children to fight an ear infection on their own before the initiation of antibiotic treatment. These children initially receive analgesics, with antibiotics being reserved for those whose conditions worsen or fail to improve within 48 to 72 hours. Although new to many US physicians, the observation option for AOM is an official policy in the Netherlands, Sweden, and now New York State.2 By offering the observation option, the new guideline changes the central AOM management decision from which antibiotic should be given3 to whether an antibiotic should be given at all.4
The paradigm shift is needed because 5.2 million AOM episodes each year5 are treated with antibiotics in the United States, although most would resolve spontaneously. Stated simply, this volume of antibiotic use for largely self-limiting infections does not serve the greater good. Antibiotics are therapeutic agents that affect society, not just individuals.6 Each course of therapy creates selective pressure for resistant bacteria in the child's nasopharynx, which spread readily among families, schools, and child care centers. These organisms, and those they create with resistance genes in transferrable plasmids, may cause fatal infections among healthy or immunocompromised individuals.7 The number of resistant bacterial pathogens throughout the world continues to increase each year.8,9
More than 100 antibiotics have been introduced in the past 60 years, increasing the annual production of broad-spectrum antibiotics in the United States from 0.5 to 50.0 million pounds.6 Unfortunately, bacteria have a staggering evolutionary advantage over antibiotics and the human beings who produce them; as the oldest known inhabitants of the planet, bacteria have been present for 3.5 billion years of the earth's 4.5 billion-year history, compared with 200 000 years for human beings and 60 years for antibiotics.7 Moreover, bacteria are ubiquitous, saturating every square millimeter of soil and representing 5% of our body weights (
100 000 billion bacteria per person).6,7 Antibiotics have stimulated unparalleled evolutionary changes in bacteria, which until recently were not evolving faster than other living beings.
The societal consequences of antibiotic use must be balanced against the natural history of untreated AOM and the effects of therapy on individual outcomes. Placebo treatment of AOM relieved pain, fever, or both within 24 hours for 61% of children with AOM (95% confidence interval: 50–72%) in randomized trials, which increased to 80% (95% confidence interval: 69–90%) after 2 to 3 days.10 Initial antibiotic therapy for uncomplicated AOM has no effect on outcomes within 24 hours but increases absolute rates of clinical resolution by at most 12% at 2 to 7 days.5,11 Therefore, 8 children must receive antibiotics to improve the condition for 1 additional child at 7 days, compared with results from the natural history alone. The effects of antibiotics on bacteriologic end points are greater,12 but the clinical relevance is unclear, because 60% to 80% of children with persistent bacteria in their middle ears after 4 to 6 days exhibit clinical improvement or resolution.13
The resolution rates noted above were based on high-quality, albeit imperfect, evidence. Nine randomized, controlled trials14–22 between 1968 and 2000 assessed the clinical efficacy of antimicrobial treatment of AOM. All except 1 study15 were placebo-controlled and blinded. Diagnoses of AOM were based on otoscopic plus clinical findings in 4 trials,14,15,20,22 and 5 studies confirmed diagnoses with tympanometry21 or otolaryngology referrals.16–19 Children <2 years of age were explicitly excluded from 3 trials,17,18,20 and 1 trial20 excluded cases of AOM with severe associated symptoms. Because of the limitations noted, recommendations regarding child suitability for the observation option are based on child age, illness severity, diagnostic certainty, and certainty of follow-up monitoring.4
Initially withholding antibiotics from (mostly older) children with AOM did not increase suppurative complications in randomized trials.5,11 Whether restrictive antibiotic use increases acute mastoiditis at the population level is unresolved, but the potential increase is only 2 cases per 100 000 children per year and must be weighed against the potential adverse effects.23 Risks of antibiotic use include allergic reactions, gastrointestinal upset, accelerated bacterial resistance, and unfavorable changes in nasopharyngeal bacterial flora.24–27 Antibiotics not only may fail to eradicate the organisms but also may induce middle-ear effusion superinfection with resistant pneumococci from the nasopharynx.28 Moreover, antibiotic prescribing has a "medicalizing" effect, increasing revisit rates and the likelihood of seeking medical care for future illness.29
Optimal antibiotic prescribing for AOM, regardless of whether observation is used, mandates efforts to improve diagnostic certainty. Even the most well-trained diagnosticians find no pathogens with tympanocentesis for 30% of children with suspected bacterial AOM.30,31 The prevalence of bacterial AOM is likely lower in the 9 trials cited above and in daily clinical practice, because of uncertainties introduced by viral pathogens, difficulties in diagnosing middle-ear effusion, and vague otalgia symptoms among very young children. Uncertainty can be reduced but not eliminated with pneumatic otoscopy for primary diagnosis, with tympanometry as an adjunctive measure. By including diagnostic uncertainty in the management paradigm, the observation option allows clinicians to prioritize their antibiotic prescribing.32 This in no way is meant to encourage or condone sloppy diagnosis.
Initial observation of AOM without antibiotics is presented as an option, and not a recommendation, primarily for children 
2 years of age with nonsevere symptoms or an uncertain AOM diagnosis. Clinicians who are uncomfortable with this approach are free to follow the old paradigm. The new paradigm, however, could reduce antibiotic use among eligible children by 65%.33–35 Families benefit from less antibiotic-related diarrhea, vomiting, skin rashes, and allergic reactions, including anaphylaxis.36 Society benefits from the greater good of reduced antibiotic resistance and sustained drug efficacy for children with serious bacterial illnesses. The disadvantage would be slightly longer mean symptom durations (3 vs 2 days)20,22,34 for some children who are initially observed, which could be managed successfully with analgesics or initiation of antibiotics when needed.
Greater use of the observation option for AOM was highlighted as the next major frontier in appropriate antibiotic prescribing at a recent conference sponsored by the Centers for Disease Control and Prevention.37 Earlier efforts focused on avoiding antibiotics in primarily viral illnesses, such as rhinitis, bronchitis, and the common cold. The rationale for observation stems from the favorable natural history of untreated AOM10 and the unfavorable harm/benefit ratio of universal antibiotic therapy.6,7 Perhaps we should offer the words of British biologist Hans Krebs to children with AOM, "You and your family must clearly understand that the great ultimate healer is always nature itself and that the drug, the physician, and the patient can do no more than assist nature, by providing the very best conditions for your body to defend and heal itself."38 What a marvelous campaign slogan for the greater good.
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FOOTNOTES |
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Address correspondence to Richard M. Rosenfeld, MD, MPH, Department of Otolaryngology, State University of New York Downstate Medical Center and the Long Island College Hospital, 339 Hicks St, Brooklyn, NY 11201. E-mail: richrosenfeld{at}msn.com
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REFERENCES |
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 TOP REFERENCES |
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-hemolytic streptococci, and Staphylococcus aureus in children with acute otitis media.
Clin Infect Dis. 2002;34
:1301
–1309[CrossRef][ISI][Medline]This article has been cited by other articles:
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  E. R. Wald To Treat or Not to Treat Pediatrics, April 1, 2005; 115(4): 1087 - 1089. [Full Text] [PDF]
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