Observation Advised for Most Children with Acute Otitis Media

UTRECHT, The Netherlands, Oct. 20 -- Antibiotics for acute otitis media are most beneficial for children younger than age two with bilateral infections and for any child with otorrhea, according to researchers here.

For most other children a policy of watchful waiting seems justified, Maroeska Rovers, M.D., of the University Medical Centre Utrecht, and colleagues, reported in the Oct. 20 issue of The Lancet on the basis of a meta-analysis.

Reliable identification of subgroups of children who benefit from antibiotic treatment has not been straightforward because individual trials have been too small for valid analyses, Dr. Maroeska said.

To identify subgroups likely to benefit, the researchers did a meta-analysis of data from six randomized trials, with individual patient data from 1,643 children, ages six months to 12 years.

Trials came from the Cochrane library, PubMed database, Embase, and the proceedings of international symposia on recent advances in otitis media.

The effect of antibiotics on pain and fever was modified by age and bilateral infection and by otorrhea, the researchers reported. Relative to placebo, the overall relative risk (RR) for an extended course of acute otitis media at three-to-seven days with antibiotics was 0.83 (95% CI 0.78-0.89).

The overall rate difference (RD) between the control group and the antibiotic group was 13% (RD -13%, CI, 9%-17%), meaning that eight children would require treatment to prevent an extended course of the disease in one child, the researchers said.

Among children younger than two years with bilateral acute otitis media, 55% of controls and 30% on antibiotics still had pain, fever, or both, at three-to-seven days, with a rate difference between these groups of about 25% (RD?25%, CI ?36% to ?14%). Thus four children would have to be treated to prevent an extended disease in one child, according to the researchers.

Among children two years or older with bilateral disease, the rate difference was about 12% (RD -12%, CI, -25% to 1%), meaning nine children would have to be treated for one child helped.

For children younger than two years but with unilateral infection, 20 children would have to be treated to help one child (RD-5%, CI -17% to 7%).

However, there was no significant difference for age alone, the researchers reported.

About 60% of children with otorrhea in the control group had pain, fever, or both, at three-to-seven days, whereas only about 25% of those given antibiotics had protracted illness, the researchers reported.

In children with otorrhea the rate difference of about 36% (?36%, CI, ?53% to ?19%), with three children requiring treatment, was much greater than that of the 14% for children without otorrhea (?14%, CI ?23% to ?5%), with eight requiring treatment to prevent one case.

The investigators postulated that in children younger than two years with both ears affected and in those with otorrhea, the infection is more often bacterial than viral, thus warranting antibiotic treatment.

In a lengthy review of the study's limitations, the researchers cited the fact that the severity of the pain was estimated by parents, which might have resulted in incorrect estimation of actual pain. However, fever analysis showed much the same trend, they said.

The children may not have been representative of those seeing general practitioners so that the most severely affected children might be under-represented, and since not all the trials used the most objective diagnostic methods, some children might not have had ear infections.

Finally, the investigators said, they did not study all possible subgroups and so might have missed a subgroup, such as those with cleft palate or Down's syndrome.

Still, they emphasized, a major strength of the study was that its large size made it possible to identify subgroups that could benefit from antibiotic treatment.

In conclusion, the researchers said that the effects of antibiotic treatment were not significantly modified by either age or bilateral disease alone. However, the number of children who would require treatment to be effective was lower for the combined model than for the individual components, indicating that targeting both age and bilaterality would increase the benefits of antibiotic therapy.

In a commentary in the same issue, Petri Mattila, M.D, of Helsinki University Central Hospital in Finland wrote that the results of the Rovers study seem straightforward. The reduction in the use of antibiotics for these children would have vast financial implications and would considerably reduce the adverse effects of antibiotic use, such as diarrhea and antibiotic resistance.

Reducing antibiotic use has raised concerns about increasing the risk of mastoiditis, Dr. Mattila noted. However, among 1,643 children in the Dutch study, none developed mastoiditis.

Nevertheless, it is extremely important to remember that a diagnosis of acute otitis media in a febrile child does not exclude other bacterial diseases, such as pneumonia, sepsis, or meningitis, Dr. Mattila said. "Watchful waiting with pain relief must include the exclusion of other bacterial infections, with proper parental education and easy access to follow-up care."