The debate over tympanostomy tubes vs. recurrent antibiotics acute otitis media (AOM) in young children is long-standing. Now, the results of a randomized controlled trial show that the tubes do not significantly reduce the rate of episodes compared to antibiotics, and that medical management does not increase antibiotic resistance.
“We found no evidence of microbial resistance through antibiotic treatment. If there is no impact on resistance, why unnecessarily risk the complications of surgery?” said lead author Alexander Hoberman, MD, of Pittsburgh Children’s Hospital, Pittsburgh, Pennsylvania Medscape Medical News.
The study of Hoberman and colleagues was published today a The New England Journal of Medicine.
OMA is the most common disease diagnosed in children in the United States after the common cold, affecting 5 out of 6 children under 3 years of age. It is the main indication for antimicrobial treatment and insertion of the tympanostomy tube is the most frequent pediatric operation after the newborn period.
Randomized controlled clinical trials were conducted in the 1980s, but overuse issues arose in the 1990s. The American Academy of Otolaryngology – Head and Neck Surgery Foundation published the first clinical practice guidelines in 2013.
Parents need to weigh the pros and cons. The use of tubes may prevent or delay the next round of medication, but the tubes cost more and present small risks (anesthesia, refractory otorrhea, tube blockage, dislocation or premature extrusion, and mild conductive hearing loss).
“We addressed issues that affected older studies: a two-year long-term follow-up, validated infection diagnoses to determine eligibility, and used rating scales to measure quality of life,” Hoberman said.
The researchers randomly assigned children to receive antibiotics or tubes. To be eligible, children had to be between 6 and 35 months old and have had at least three episodes of OMA within 6 months or at least four episodes in a 12-month period, including at least one during the previous 6 months.
The main outcome was the average number of AOM episodes per child-year. Children were evaluated at eight-week intervals and within 48 hours of developing symptoms of ear infection. Medically treated children received oral amoxicillin or, if ineffective, intramuscular ceftriaxone.
Criteria for determining treatment failure included persistent otorrhea, perforation of the tympanic membrane, associated with antibiotics. diarrhea, reaction to anesthesia, and recurrence of AOM at a frequency equal to the frequency prior to antibiotic treatment.
Comparing tympanostomy tubes with antibiotics, Hoberman said, “We were unable to show benefits in the rate of ear infections per child and year for a period of two years.” As expected, the infection rate fell by about half from the first year to the second in all children.
In general, the researchers found no “substantial differences between treatment groups” in terms of the frequency of AOM, the percentage of serious episodes, the extent of antimicrobial resistance, the quality of life of children, and parental stress.
In an intention-to-treat analysis, the rate of OMA episodes per year-child during the study was 1.48 ± 0.08 for tubes and 1.56 ± 0.08 for antibiotics (Pg = .66).
However, chance was not maintained in the arm with intent to try. Ten percent (13 of 129) of children expected to receive tubes did not get them because of the parent’s request. In contrast, 16% (54 of 121) of the children in the antibiotic group received tubes, 35 (29%) of them according to the trial protocol due to frequent recurrences, and 19 (16%) ) at the request of the parents.
In a protocol analysis, the OMA episode rates per child-year were 1.47 ± 0.08 for the tubes and 1.72 ± 0.11 for the antibiotics.
Tubes were associated with a longer time to first ear infection after placement, with an average of 4.34 months compared to 2.33 months for children who received antibiotics. A smaller percentage of children in the tube group experienced treatment failure than in the antibiotic group (45% vs. 62%). Children who received tubes also had fewer days a year with symptoms compared with children in the antibiotic group (mean, 2.00 ± 0.29 days vs. 8.33 ± 0.59 days).
The frequency distribution of OMA episodes, the percentage of severe episodes, and the antimicrobial resistance detected in the respiratory specimens were the same for both groups.
Hoberman and colleagues add to our knowledge of managing children with recurrent ear infections with a comprehensive and rigorous clinical trial showing comparable efficacy of tympanostomy tube insertion, with antibiotics for new infections compared to a vigilant wait, with intermittent oral antibiotics, if new ear infections occur. “said Richard M. Rosenfeld, MD, MPH, MBA, Distinguished Professor and Chair of the Department of Otorhinolaryngology at SUNY Downstate Medical Center, New York.
However, in a accompanying editorial, Ellen R. Wald, MD, of the University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin, noted that the sample size was smaller than desired, as participants changed groups.
In addition, Rosenfeld, who was the lead author of the 2013 guidelines, said the study probably underestimates the impact of the tubes “because about two-thirds of the children who received them had no fluid in the middle ear. persistent at baseline and would not have been candidates for tubes based on the current national guideline to the indications of the tube. “
“Both tubing and intermittent antibiotic therapy are effective in managing recurrent MAO, and parents of children with persistent middle ear spillage should be involved in sharing decisions with their doctor to decide the best management option. said Rosenfeld. “When in doubt, it is appropriate to wait carefully, because many children with recurrent AOMs work better over time.”
Hoberman owns shares in Kaizen Bioscience and holds patents on devices to diagnose and treat OMA. A co-author consults Merck. Wald and Rosenfeld report irrelevant financial relationships.