Skip Navigation Archive: U.S. Department of Health and Human Services
Archive: Agency for Healthcare Research Quality
Archive print banner

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

This information is for reference purposes only. It was current when produced and may now be outdated. Archive material is no longer maintained, and some links may not work. Persons with disabilities having difficulty accessing this information should contact us at: Let us know the nature of the problem, the Web address of what you want, and your contact information.

Please go to for current information.

Press Release Date: August 9, 2000

Almost two-thirds of children with uncomplicated acute otitis media (AOM)—a middle ear infection—recover from pain and fever within 24 hours of diagnosis without treatment with antibiotics, and over 80 percent recover within 1-7 days. When treated with antibiotics, up to 93 percent 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 AOM 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 was chosen as an EPC topic because the lack of a standard definition and diagnosis criteria has created a great deal of uncertainty about whether, and which, antibiotics are an effective treatment," said Lisa Simpson, M.B., B.Ch., M.P.H., AHRQ deputy director. "This EPC report gives clinicians and policy makers information to address the controversy over the use of antibiotics in treating children with acute otitis media."

AOM is one of the most common diagnoses in children. The EPC estimates that over 5 million episodes of AOM occur each year at a cost of approximately $3 billion. It is routine to use antibiotics for AOM 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 percent, compared with the U.S. average of around 25 percent. The EPC 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 literature that should be addressed in future research. These include the need for standard definitions of AOM and its outcomes and standard criteria for its diagnosis. In addition, the EPC encouraged rigorous study of factors that may influence AOM outcomes such as age and being prone to AOM.

Select to access the summary of the EPC findings, Management of Acute Otitis Media Summary, Evidence Report/Technology Assessment 15. The summary is also available by calling the AHRQ Publications Clearinghouse at 1-800-358-9295. The full evidence report will be available later this year.

For additional information contact AHRQ Public Affairs at (301) 427-1364: Karen Carp, (301) 427-1858 (; or, Karen Migdail, (301) 427-1855 ( For an interview with S. Michael Marcy, M.D., principal investigator for the EPC report on Management of Acute Otitis Media and staff pediatrician for the Southern California Kaiser Permanente Medical Group, or to speak to Glenn Takata, M.D., first author of the report, please call Karen Carp or Karen Migdail.

The information on this page is archived and provided for reference purposes only.


AHRQ Advancing Excellence in Health Care