Most children with recurrent acute otitis media (AOM) who underwent tympanostomy tube placement fared no better than those managed with antibiotics, according to a study published Wednesday in the New England Journal of Medicine.
“We used to often recommend tubes to reduce the rate of ear infections, but in our study, episodic antibiotic treatment worked just as well for most children,” lead author Alejandro Hoberman, M.D., FAAP, said in a news release.
Pediatricians, however, should consider the study’s limitations when deciding whether to refer patients for tubes, said Steven E. Sobol, M.D., M.Sc., FAAP, chair of the AAP Section on Otolaryngology-Head and Neck Surgery Executive Committee. Dr. Sobol was not involved with the study.
AOM is among the most frequently diagnosed illnesses in U.S. children. An estimated 667,000 U.S. children received tympanostomy tubes in 2006, according to the most recent data available.
Previous studies evaluating tube placement for AOM have had mixed results, and many were published before the pneumococcal conjugate vaccine was introduced.
Researchers, therefore, conducted a study from December 2015 to March 2020 to determine whether tubes or antimicrobial treatment would lead to a greater reduction in the rate of AOM recurrence in children ages 6-35 months. They randomly assigned 250 children at three sites to tube placement or treatment with oral antibiotics if they had an episode of AOM. If medical management failed, the children could receive tubes.
During the two-year follow-up period, 10% of children in the tympanostomy tube group did not receive tubes, and 45% in the antibiotic group had tubes inserted. Therefore, researchers did an additional analysis.
Results of the intention-to-treat analysis showed no difference in the occurrence rate of AOM per child year (1.48±0.08 in the tympanostomy tube group vs. 1.56±0.08 in the antibiotic group). The episode rates in the second analysis were 1.47±0.08 and 1.72±0.11, respectively.
Researchers also found no differences between the groups in the percentage of severe illness, antibiotic resistance, quality of life measures or parents’ satisfaction with treatment.
They did find that the children treated with tubes went about two months longer than those who received antibiotics before they had an episode of AOM. However, the antibiotic group had fewer days with otorrhea.
Results also showed the rate of ear infections overall was 2.6 times higher in children younger than 1 year compared to children 2-3 years old.
“It's important to recognize that most children outgrow ear infections as they grow older,” Dr. Hoberman said. “However, we must appreciate that for the relatively few children who continue to meet criteria for recurrent ear infections — three in six months or four in one year — after having met those criteria initially, placement of tympanostomy tubes may well be beneficial.”
Dr. Sobol noted several limitations of the trial.
“In the small group of study patients randomized to receive medical management (n=121), 45% went on to undergo tympanostomy tube placement due to either failure of medical management (29%) or parental request (16%), with only 54 patients completing the study without tube placement,” he said.
“Although the study is unlikely to change current pediatric practice, it emphasizes the importance of creating an individualized approach to management, taking into account the number and severity of AOM episodes, common comorbidities such as hearing loss and speech delay and the preferences of the family,” Dr. Sobol concluded.