Adding new evidence to the debate on the best treatment for middle-ear infections, or acute otitis media, in young children, clinical researchers at the Children's Hospital of Pittsburgh of the University of Pittsburgh Medical Center have found antibiotics to be more effective than a placebo in relieving symptoms. These findings appear in the January 13th issue of the New England Journal of Medicine. The study was funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health.
Most American children with middle-ear infections are treated with antibiotics. But for children with mild symptoms, US clinical practice guidelines generally recommend watchful waiting, reserving antibiotics for children whose symptoms do not improve with time. In contrast, responding to concerns about the overuse of antibiotics, doctors in many European countries follow a strategy of watchful waiting for nearly all cases of middle-ear infections in children. Previous trials comparing the two strategies yielded conflicting results, chiefly, say the authors of the current study, because of differences among the trials in the definition of middle-ear infections.
In the NEJM study, the investigators randomly assigned 291 children between 6 and 23 months of age with acute middle ear infections, diagnosed by stringent criteria, to receive either amoxicillin-clavulanate or a placebo for 10 days. They found that those children in the treatment group had a significant reduction in both the severity and duration of their symptoms compared with those in the placebo group. The study authors caution that these results must be weighed against concerns about the side effects of antibiotics and the potential emergence of antimicrobial resistance.
A Hoberman et al. Treatment of acute otitis media in children under 2 years of age. New England Journal of Medicine. DOI:10.1056/NEJMoa0912254 (2011).