Treatment of Acute Otitis Media in Infants and Young Children

Currently, no consensus exists about whether young children with acute otitis media (AOM) should be treated with antibiotics. Two new double-blind, placebo-controlled, randomized trials might end the debate. In both studies, AOM was defined by acute onset and presence of middle-ear effusion, bulging tympanic membrane, and otalgia or erythema of the tympanic membrane.

Researchers in Finland randomized 319 children (age range, 6–35 months) with AOM to receive amoxicillin-clavulanate or placebo for 7 days. Treatment failure (no overall improvement by day 3, worsening condition, no improvement in otoscopic signs, perforation, severe infection requiring antimicrobial treatment, or stopping the study drug for any reason) was significantly less common in the antibiotic group than in the placebo group (18.6% vs. 44.9%; number needed to treat, 3.8). Children who received antibiotics were significantly more likely to develop diarrhea (47.8% vs. 26.6%).

Researchers in Pittsburgh randomized 291 children (age range, 6–23 months) with AOM to receive amoxicillin-clavulanate or placebo for 10 days. Children who received amoxicillin-clavulanate achieved symptom resolution more quickly than children in the placebo group (35% vs. 28% on day 2; 61% vs. 54% on day 4; 74% vs. 54% on day 7). Results were similar for sustained resolution of symptoms. Children who received antibiotics were significantly more likely to develop diarrhea (24% vs. 1%) and diaper-area dermatitis (47% vs. 4%).

A General Pediatrician's Perspective

Both studies overcome the flaws of previous studies and provide the best data to date. Jerry Klein, a leading AOM expert, believes that these studies end the debate about treatment of AOM in young children. He states, “More young children with a certain diagnosis of acute otitis media recover more quickly when they are treated with an appropriate antimicrobial agent.” Because most cases of AOM are caused by bacteria sensitive to amoxicillin-clavulanate, it's my belief that the issue isn't whether young children with AOM benefit from antibiotics, but whether the diagnosis of AOM is accurate. Both trials highlight the well-known adverse effects associated with use of antibiotics but do not address serious complications such as mastoiditis. Together, they do suggest that young children with AOM get better faster if they are treated with antibiotics, but treatment decisions must be balanced against the risk for adverse effects, particularly diarrhea.

— Howard Bauchner, MD

A Pediatric Infectious Disease Specialist's Perspective

I doubt that our readers were surprised to see additional documentation that antibiotics work for AOM. To me, the question that remains is “When do we need to treat and when can we watch and wait?” Placebo was a successful option for more than half the children in both studies. For children who look well, are old enough to easily evaluate, and can be comforted with supportive care (e.g., Tylenol and TLC), watchful waiting remains in my armamentarium. Parental wishes, history of prior infections, concerns about excess antibiotic use, and adverse effects still factor into my decision. Finally, although amoxicillin-clavulanate was used in these two studies, amoxicillin alone is still first-line therapy for many children.

— Peggy Sue Weintrub, MD