Clinical Evidence Shows Limited Effect of Antibiotics on Children With Acute Otitis Media

Almost two-thirds of children with uncomplicated acute otitis media -- a middle ear infection -- recover from pain and fever within 24 hours of diagnosis without treatment with antibiotics, and over 80% recover within 1-7 days. When treated with antibiotics, up to 93% of children will recover during the first week. These are the findings of an analysis of clinical studies conducted on children 4 weeks to 18 years of age from 1964 through 1998. The analysis was conducted by the Southern California/RAND Evidence-based Practice Center (EPC) sponsored by the Agency for Healthcare Research and Quality (AHRQ).

The EPC found no evidence to conclude that children with acute otitis media treated with amoxicillin fared any differently from those treated with more expensive antibiotics such as cefaclor, cefixime, azithromycin, or clarithromycin. Furthermore, amoxicillin caused fewer side effects. The EPC also found no evidence that short-duration (5 days or less) versus long-duration therapy (7-10 days) made a difference in the clinical outcome for children over 2 years of age.

Acute otitis media is one of the most common diagnoses in children. The EPC estimates that over 5 million episodes occur each year at a cost of approximately $3 billion. It is routine to use antibiotics for treating otitis media in the United States, whereas in other countries, such as the Netherlands, the standard practice is to use "watchful waiting" for one to two days after the onset of an ear infection in children over 2 years of age, treating only if the infection fails to improve during that time.

Although the EPC did not evaluate bacterial resistance to antibiotics, it has been reported that the rate of bacterial resistance in the Netherlands is about 1%, compared with the US average of around 25%. The report by the Evidence-Based Practice Center suggests that future research examine the efficacy of antibiotics versus "watchful waiting" and a possible link to bacterial resistance.

The EPC also pointed out other weaknesses and gaps in the clinical literature that should be addressed in future research. These include the need for standard definitions of acute otitis media and its outcomes, and standard criteria for its diagnosis. In addition, the EPC encouraged rigorous study of factors that may influence outcomes such as age and being prone to ear infections.

Each year, Medical College of Wisconsin physicians care for more than 180,000 patients, representing nearly 500,000 patient visits. Medical College physicians practice at Children's Hospital of Wisconsin, Froedtert Memorial Lutheran Hospital, the Milwaukee VA Medical Center, and many other hospitals and clinics in Milwaukee and southeastern Wisconsin.