Among children aged 6 to 35 months who received the pneumococcal conjugate vaccination, tympanostomy tube placement was not found to be superior to medical management for reducing rates of acute otitis media over a 2-year period, according to study results published in The New England Journal of Medicine.
A team of US-based investigators conducted an open-label, randomized clinical trial (ClinicalTrials.gov Identifier: NCT02567825) to compare tympanostomy tube placement with nonsurgical management of acute otitis media in children over a 2-year period.
Children aged 6 to 35 months who had 3 or more episodes of acute otitis media within 6 months, or 4 or more episodes in 12 months with at least 1 episode in the preceding 6 months, were eligible for participation. Participants were randomly assigned to either tympanostomy tube placement or medical management with episodic antibiotic treatment.
The primary outcome of the analysis was the average rate of episodes of acute otitis media during a 2-year period (measured in child-years). Secondary outcomes included the number of children with treatment failure, time to first episode of acute otitis media, episodic frequency distribution, the percentage of severe episodes, cumulative days per year of tube otorrhea and other related symptoms, occurrence of diarrhea or diaper dermatitis, and nasopharyngeal antimicrobial resistance.
A total of 13 children in the tympanostomy tube cohort did not undergo treatment, and 54 children originally assigned to medical management underwent tympanostomy tube placement. In the main intention-to-treat analysis, the rates of episodes of acute otitis media per child-year (±SE) in 2 years in the tympanostomy tube and medical management groups were 1.48±0.08 and 1.56±0.08, respectively (risk ratio, 0.97; P =.66). Due to the changes in assignment groups, the investigators conducted an additional per-protocol analysis in which the rates in the tympanostomy tube and medical management groups were 1.47±0.08 and 1.72±0.11, respectively (risk ratio, 0.82).
Of the 1329 children screened for participation, 250 children were enrolled in the study, all of whom had received the pneumococcal conjugate vaccine; 129 children were assigned to the tympanostomy tube group and 121 were assigned to the medical management group. Of the overall cohort, 229 children completed 1-year follow-up and 208 children completed 2-year follow-up.
The occurrence rate of acute otitis media in the first year was nearly 2 times the rate in the second year of follow-up for both cohorts.
The occurrence of otorrhea, protocol-defined diarrhea, and medication-related diaper dermatitis were considered adverse events; however, these adverse events and the frequency distribution of acute otitis media episodes, the frequency of severe episodes, and antimicrobial resistance were not significantly different between treatment groups.
Secondary outcomes in favor of the tympanostomy-tube group were time to first episode of acute otitis media, various episode-related clinical findings, and the percentage of children meeting criteria for treatment failure. However, there were fewer cumulative days with otorrhea in the medical management cohort.
“A trial limitation stems from receipt of tympanostomy tubes, for differing reasons and at differing times, by certain children in the medical-management group, thereby complicating the task of analysis,” the authors noted.
Disclosure: Some authors declared affiliations with biotech, pharmaceutical, and/or device companies or other conflicts. Please refer to the original article for a full list of authors’ disclosures.
Hoberman A, Preciado D, Paradise JL, et al. Tympanostomy tubes or medical management for recurrent acute otitis media. N Engl J Med. 2021;384(19):1789-1799. doi:10.1056/NEJMoa2027278