BOSTON, Jan. 17 (UPI) -- Doctors reported Wednesday that insertion of tubes in children to relieve middle ear fluid doesn't appear to provide any advantage over waiting to see if the problem clears up by itself.
The surgical procedure, known as tympanostomy, is performed as many as 400,000 times a year in the United States, but researchers suggested that perhaps 70 percent of those procedures may not provide any long-term benefit -- and might cause long-term harm.
"We think the studies show that the best advice is not 'to just do something' but to 'sit still and wait' to see if the tubes are necessary, said Jack Paradise, professor of pediatrics and otolaryngology at the University of Pittsburgh and lead author of the study that will appear in Thursday's editions of the New England Journal of Medicine.
Stephen Berman, professor of pediatrics at the University of Colorado Health Sciences Center in Denver, who wrote an editorial in the journal, told UPI, "This study should reassure parents that it is not necessary to put tubes in kids so they can keep up with others later in life."
He said that primary care physicians, otolaryngologists and parents need to understand that, for children who only have fluid in the ears, the operation is probably not necessary.
He said that in about 1 percent to 5 percent of the cases the insertion of the ventilating tubes would be helpful. He said that use of the tubes in children prone to ear infections may be useful in reducing pain in the children but the procedure only prevents about one infection a year.
He estimated that 30 percent of the operations are performed in children with recurrent infections.
Paradise and colleagues enrolled 6,350 newborns in the study, assessing them regularly for middle ear fluid. They identified 429 children under the age of 3 with persistent effusion -- fluid in the ear for at least three months -- and assigned them to having the tubes implanted immediately or to wait six to nine months longer before having the tubes inserted to see if the condition resolved.
He reported on 195 children with early treatment and 196 children who had delayed treatment, using tests to assess development by ages 9 to 11. The children were tested using validated measurements of intelligence and other developmental studies.
A third group of 241 children with a variety of ear ailments -- but not sick enough to be considered for tubes -- were observed and took similar developmental tests at ages 3, 4, 6 and then between 9 and 11.
A fourth group of 159 children were eligible for tube insertion. However, their parents would not let them be randomized. Sixty of those children eventually had tubes inserted. They also took the developmental tests.
"We found no developmental differences when we compared any of the groups of children," Paradise told UPI.
Previously, the researchers have found no development problems between the groups at earlier ages, and they continued to see no differences in later years. "The consistency of the results in different age periods not only affirms the validity of our findings, but also suggests that developmental differences between the treatment groups will not emerge at later ages," Paradise reported.
Tympanostomy, the second-most-performed pediatric surgical procedure -- only neonatal circumcision is performed more often -- gained traction in the 1950s, 1960s and 1970s as a method of treating children with persistent middle ear effusion because of a perceived association between the effusion and subsequent developmental impairments.
Even though the reports suggest the tubes may not be necessary, some doctors recommend that, in cases of frequent infection, implanting the tubes may save a child from having to undergo course after course of antibiotic therapy.
"It may be simpler to insert the tubes than to subject children and their parents from trip after trip to the doctor for relief of these infections. In addition the use of multiple courses of antibiotics increases the risk of development of resistant bacteria," suggested Jordan Josephson, director of the New York Nasal and Sinus Center at Lenox Hill Hospital and author of the new book, "Sinus Relief Now."
Josephson told UPI that the tubes pop out on their own and the eardrum heals with very little scarring, so there appears to be little downside problems with the treatment. He noted that the studies did not address questions about treating children who have profound hearing loss or who have long periods in which fluid exists in the ears.
Paradise said children with repeated middle ear infections would be eligible for tube insertions if they were having three infections within a six-month period or four or more infections within a year. However, he said that even among these children a watch-and-wait approach is reasonable.
Berman, however, said that there may be long-term problems with tube operations. "There is more scarring among those who undergo the operations than among children who don't have the procedures done, and we really don't know how that will affect hearing when that person is in his 50s or 60s or 70s," he told UPI.
"There is no one in their 60s yet who underwent these treatments when they first started in the 1950s," Paradise noted. "No one knows how these patients will do in their older age."