In recent years, physicians have been moving toward using evidence-based, patient-oriented outcomes data to guide the management of a variety of medical conditions. Because of this evidence-based medicine approach, the treatment of acute otitis media has become controversial in the United States. Discussion in the medical literature has centered on inappropriate use of antibiotics in the treatment of acute otitis media and upper respiratory tract infections.^1,2 Current antibiotic usage patterns are thought to contribute to the increasing patterns of antimicrobial resistance in common pathogens of the middle ear.³ In response, the Centers for Disease Control and Prevention instituted a nationwide effort to address the problem of emerging infectious diseases and define patterns of antimicrobial resistance.⁴ More specifically, the Drug-Resistant Streptococcus pneumoniae (DRSP) Therapeutic Working Group has recommended doubling the dosage of amoxicillin to 80 to 90 mg per kg per day in the empiric treatment of acute otitis media, along with recommending earlier use of broader spectrum antibiotics for treatment “failures” after three days.⁵ These recommendations are of concern because they are not based on any patient-oriented outcomes evidence.

A brief review of the evidence in the approach to otitis media would be helpful. Three essential questions must be answered: Does acute otitis media need to be treated with antibiotics? If so, which antibiotic should be used? How long should treatment be continued? Four systematic reviews analyze the literature on these topics.^6–9 These reviews provided the following conclusions:

• More than 80 percent of cases of acute otitis media resolve spontaneously.^6–8

• The only short-term advantage of using antibiotics to treat otitis media is a modest decrease in the number of children with continued pain at two to seven days from diagnosis. Use of antibiotics has not affected the long-term outcomes.^6,7

• Narrow-spectrum antibiotics are still the recommended and effective treatment for acute otitis media⁸ and, in most children, a shortened course (five days) is adequate treatment with no negative impact on clinical outcomes.⁹

These conclusions are based on patient-oriented evidence, but the CDC guidelines are based on laboratory data (disease-oriented evidence) and consensus opinion. Guidelines developed using a nonsystematic approach can be misleading and, in this case, imply that all children with garden-variety otitis media require increased dosages of antibiotics. Whether intended or not, the implications of the CDC guidelines are already widely communicated by editorials, newsletters and the pharmaceutical industry. Despite the large amount of in vitro data cited, there is little correlation between the Petri dish and how a child responds to antibiotic treatment.

What are the costs of the recommended antibiotic regimens to the health care system and to patients and their families? Combinations of amoxicillin and amoxicillin-clavulanate will likely challenge patient adherence. Three daily doses of intramuscular ceftriaxone are expensive and are not likely to be an acceptable regimen for infants and children. The authors state that “…[in] the absence of any significant dose-related toxicity, it seems reasonable to use amoxicillin at 80 to 90 mg per kg per day….”⁵ However, antibiotic treatment of acute otitis media is associated with a doubling of the risk of rashes, vomiting and diarrhea.^6,7 Will doubling the antibiotic dose further increase the risk for drug reactions? If so, this will translate into more physician office visits, more time off from work for parents, and more missed days of school for children. Are these acceptable risks in a condition that resolves spontaneously 80 percent of the time without antibiotics?

The focus of the DRSP Therapeutic Working Group is to address increasing antibiotic resistance with increased doses of amoxicillin and the earlier use of broad-spectrum antibiotics. In the Netherlands and Iceland, however, the rate of antibiotic use for acute otitis media is one-third of that in the United States, and the rate of antibiotic resistance is much lower.^3,10 No clinical evidence shows that increasing the dosage of amoxicillin or using broad-spectrum antibiotics will overcome antibiotic resistance—and it may make it worse.

These recommendations by the CDC and the DRSP Therapeutic Working Group may be useful in some patient subpopulations, but we believe that they should not be generalized to primary care and family practice populations without solid, clinical, patient-oriented outcomes data to support them. Rather than throwing more antibiotics at ear infections, we should be focusing efforts on reducing their indiscriminate use and identifying subsets of children who truly need antibiotics.