A review of 2 recent studies finds statistically significant advantages of antibiotics in terms of initial resolution of symptoms and clinical failure rate.
Antibiotics provide a modest benefit for young children with acute otitis media (AOM), concludes a review of recent studies
published online on September 26, 2012, in Current Allergy and Asthma Reports
. The review cautions, however, that a clinician’s decision whether to treat such patients with antibiotics should be determined on a case-by-case basis.
The review authors outline the results of 2 studies published on January 13, 2011, in the New England Journal of Medicine
. In the first study
, 291 children aged 6 to 23 months with AOM were randomly assigned to receive either amoxicillin-clavulanate (90 mg/kg/day amoxicillin and 6.4 mg/kg/day clavulanate) or placebo for 10 days. The researchers found initial resolution of symptoms for 35%, 61%, and 80% of the antibiotic group and 28%, 54%, and 74% of the placebo group by day 2, 4, and 7 of treatment, respectively. They also found that clinical failure by day 10 to 12 occurred in 16% of the antibiotic group, compared with 51% of the placebo group.
In the second study
, 319 children aged 6 to 35 months with AOM were randomly assigned to receive either amoxicillin-clavulanate (40 mg/kg/day amoxicillin and 5.7 mg/kg/day clavulanate) or placebo for 7 days. The researchers found that by day 8, 18.6% of the antibiotic group was classified as treatment failures, compared with 44.9% of the placebo group. In addition, a change of treatment was required for 6.8% of the antibiotic group and 33.5% of the placebo group.
The review authors note that prior to 2004, antibiotics were the standard of care for children with AOM. In 2004, however, a guideline from the American Academy of Pediatrics and the American Academy of Family Physicians indicated that observation without antibiotics was an option for children aged 6 to 24 months whose diagnosis was uncertain and who had non-severe illness.
The 2 studies described above found statistically significant positive effects of antibiotic treatment for AOM in young children. However, the review authors note that these studies have inspired a great deal of debate in the literature. Critics have pointed out that their criteria for AOM were far stricter than could be used in clinical practice and that the benefits of antibiotics seemed greater in these sicker patients. In addition, they have pointed out that a significant increase in side effects, particularly diarrhea, were associated with antibiotics.
In all, the review authors note, the studies’ results suggest that clinicians should determine on a case-by-case basis whether to treat AOM in young children with antibiotics immediately or to take a wait-and-see approach, treating with antibiotics if symptoms do not resolve on their own. They conclude that a better means of predicting which patients with AOM will benefit from antibiotics is key to improving treatment of AOM in young children.