Evidence That Antimicrobial Agents Are Indicated for Treatment of Acute Otitis Media

Compared with placebo (or no drug), antimicrobials:

1. Sterilize the middle ear effusion7

2. Result in earlier resolution of symptoms of acute infection8

3. Shorten time with middle ear effusion (hearing loss)9

4. Dramatically decrease suppurative complications10,11

Microbiologic Outcome Howie et al.7 evaluated the microbiologic efficacy with various therapeutic regimens, including a placebo. Although these studies suggest that many cases of infection of the middle ear resolve spontaneously or with the assistance of spontaneous drainage, the data indicate that the most important bacterial pathogens responsible for otitis media will not resolve clinically or microbiologically without medical intervention. A proportion of middle ear effusions that have a positive culture clear the organism without drug intervention (spontaneous clearance). However, in about 20% of infections due to S. pneumoniae, and in 50% of infections due to H. influenzae, administration of an antimicrobial agent to which these organisms are susceptible results in sterilization of the effusion in almost all the ears.

Symptomatic Outcome Rosenfeld et al.8 conducted a metaanalysis of 5400 children from 33 randomized trials that addressed the question of efficacy of antimicrobial therapy. These investigators found the spontaneous (without antibiotics or tympanocentesis) rate of primary control to be 81%. However, the rate was 95% when antimicrobial agents were administered. They concluded that "antibiotics have a modest but significant impact on the primary control of acute otitis media."

Middle Ear Effusion Outcome Kaleida and colleagues9 evaluated amoxicillin or placebo for management of nonsevere acute otitis media. (The distinction between severe and nonsevere disease was based on an otalgia scoring system and the child's temperature; subjects in the severe category were not randomized to receive only placebo.) At the completion of the 2-week amoxicillin treatment, there were statistically fewer children with middle ear effusion (47%) when compared to those who received placebo (63%). Since presence of middle ear effusion is associated with a conductive hearing loss, the administration of an antimicrobial agent reduces the time with hearing loss, which may have implications for child development.

Suppurative Complications Outcome Two important, large clinical trials conducted in Scandinavia during the 1950s, in which patients either were treated with an antibiotic or the agents were withheld, demonstrated that the suppurative complications of otitis media, such as mastoiditis and meningitis, almost exclusively occurred in those children who did not receive antimicrobial agents.10'11 The rate of suppurative complications of acute otitis media has dramatically fallen with the advent of the widespread use of antimicrobial agents for this infection. Withholding antimicrobial therapy today will most likely result in an increase in complications.

Indeed, the Centers for Disease Control and Prevention and the American Academy of Pediatrics have recently reaffirmed the recommendation to treat all documented cases of acute otitis media with an antimicrobial agent, but stressed the need to make a distinction between acute otitis media and otitis media with effusion, as the latter disease does necessarily require medical treatment.12

Selection of an Antimicrobial Agent

Of the 15 antimicrobial agents currently approved for treatment of acute otitis media, amoxicillin is still recommended for initial empiric therapy, as it is relatively safe, effective for most strains of S. pneumoniae and H. influenzae, and available in a variety of formulations (Table 78-3). The traditional dose of amoxicillin is 40 mg/kg in three divided doses per day, but in communities in which there is a high prevalence of resistant pneumococcus, 80 mg/kg in two doses is now advocated. If the patient is allergic to the penicillins, a combination of ery-thromycin and sulfisoxazole, or one of the new macrolides,

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