Childhood ear infections: Treatments worse than disease

Should your child be given antibiotics for a middle ear infection (otitis media)? "There is no evidence that antibiotics are effective in treating acute otitis media or chronic otitis media with effusion [fluid in the ear]," answered Erdem I. Cantekin, Ph.D., professor of otolaryngology, University of Pittsburgh School of Medicine, in a telephone interview. "And there is clear evidence that antibiotics are harmful."

Dr. Cantekin is unequivocal about the reason for the rising incidence of ear infection among American children, which now afflicts two-thirds of those who are under the age of two. "It's because of the overuse of antibiotics," he said. "Like sinusitis, chronic ear infection with effusion is a totally man-made disease caused by inappropriate use of antibiotics. Both sinusitis and ear infection are self-limiting diseases," he said, referring to the body's ability to rid itself of benign infections without treatment. This includes the minority of cases where some bacteria can be found in the ear fluid.

In most children, the acute ear infection is merely part of having a cold. "If you want to make your child comfortable, give the treatment given to children in Switzerland, Holland, the United Kingdom, and Scandinavian countries. Buy an eardrop solution at the drug store which is 20% benzocaine [a local anesthetic], and give the child NyQuil, which contains acetaminophen and a decongestant, to alleviate pain and congestion.

"Granted, you'll probably have to beg the pharmacist and pediatrician for the eardrops--antibiotic prescriptions and doctor visits are a $2 billion a year business--but you can get it. If you do this instead of antibiotics, your child will not get a second infection and will not go from one drug to another. There is clear evidence that prophylactic use doesn't work." He explained typical prophylacic use in this way: The baby has a cold and the doctor judges him or her to be prone to otitis media merely on the basis of finding that the eardrum is red. "The common practice of giving antibiotics in the first three years of life, he says, will impair a child's immunity."

A Whistle-Blower
In the early 1980s, Dr. Cantekin was a member of a research team at the Children's Hospital of Pittsburgh which conducted a placebo-controlled study of the standard treatments for middle ear infection with effusion: the antibiotic amoxicillin, either with or without the decongestant/antihistamine combination. When the study was published in The New England Journal of Medicine in 1987, results favored amoxicillin alone. The reduced rate of reccurrent ear fluid among the amoxicillin-treated children, however, was modest enough for the investigators to write, "...amoxicillin treatment increases to some extent [emphasis ours] the likelihood of resolution." But Dr. Cantekin's analysis showed that amoxicillin wasn't even modestly effective. In fact, he found a far different conclusion and submitted his own analysis to several medical journals. Four years later, the Journal of the American Medical Association published his manuscript with a lengthy editorial explaining why it did so (JAMA, 18 December 1991).

Using the same data, Dr. Cantekin and colleagues showed that the recurrence rate was actually two to six times higher than among the amoxicillin-treated children, compared to those given a placebo. They concluded that "amoxicillin with and without decongestant-antihistamine combination is not effective for the treatment of persistent asymptomatic middle-ear effusions in infants and children." As with all whistle blowers, Dr. Cantekin was dismissed from his position at the Otitis Media Research Center at Children's Hospital of Pittsburgh (see HealthFacts, January 1992).

A team of investigators with such a sharp disagreement over its own study results raised disturbing questions about the objectivity of scientific research, particularly as it concerns one of the principal investigators, Charles D. Bluestone, M.D., who failed to disclose that he had received $260,000 in honoraria and $3.5 million in grants from drug companies. That interpretation of clinical data could be skewed by investigators biased toward drug therapy became the subject of two congressional hearings.

Surgery Guidelines
The controversy, which spilled into the general media in 1991, was revived recently by a series of letters to the editor of JAMA (1 March 1995). Among them are letters from Drs. Bluestone and Cantekin, written in reaction to new practice guidelines aimed at the use of another common treatment for otitis media with effusion: ear tube placement surgery (tympanostomy).

When antibiotics fail to stop recurrent ear infection, pediatricians typically advise this operation, which involves insertion of tiny tubes to drain the fluid accumulation that results from repeated ear infections. The fluid buildup is symptomless, but it can cause a temporary hearing loss, which is thought to impair speech development and learning ability. Though there is no hard evidence on the actual impact of this temporary hearing loss, more than one million ear tube placement operations are now performed yearly in the U.S.

It was only a matter of time before the nationwide effort to cut excessive medical costs centered attention on tympanostomy. Nearly 60% of these operations were judged inappropriate by the panel of experts which published the new practice guidelines. (One quarter are unnecessary and another one third are equivocal, that is, presenting as many risks as benefits.) The panel also noted that the operation has received widespread acceptance, despite frequent complications and contradictory evidence of its efficacy. Given the inadequacy of the published studies, the panel relied on several methods to determine appropriate indications for surgery, among them interviews with practicing physicians and a consensus of expert opinion.

Dr. Cantekin expressed strong disagreement with these practice guidelines and others published last year by the Agency for Health Care Policy Research (see HealthFacts, September 1994). Both panels, he says, "are dominated by physicians like Dr. Bluestone and organizations like the American Academy of Pediatrics and the American Academy of Family physicians with well-established financial ties with pharmaceutical companies and a bias toward antibiotic therapy." The American Academy of Otolaryngology, also with members on the panel, represents the surgical specialty that made tympanostomy a $2 billion a year business.

Only about 5% of tympanostomies are appropriate, estimates Dr. Cantekin, and the recurrences that produce chronic ear fluid are the direct result of antibiotic abuse. The new practice guidelines encourage aggressive treatment with antibiotics before a child should be considered a candidate for surgery. Advice such as this has led to the current crisis identified by public health officials.

A Public Health Hazard
A report published early this year in JAMA (18 January 1995) found that the increase in these drug-resistant organisms clearly parallels the increase in antimicrobial drug prescriptions by office-based physicians within the last decade. "Each year, at least 150 million courses of antibiotics are prescribed in the U.S." In the last decade, otitis media has become the leading reason for antibiotic prescriptions by an office-based physician; there has been a 74% increase in prescriptions for this diagnosis since 1980.

As the older antimicrobials, such as the penicillins (including ampicillin) fail to stop a bacterial infection, says the report, doctors are increasingly turning to more powerful and more expensive versions, such as cephalosporins. "The indiscriminate use of antibiotics for treatment of otitis media is one of the factors in the emergence of antibiotic-resistant 'superbugs,' a significant hazard to the public," according to Dr. Cantekin.

Designer Drugs
"The drug companies spend large sums of money to promote the use of 'me too' or 'designer' antibiotics with a cost many times greater than amoxicillin. There is no scientific evidence whatever that any of these designer drugs is more effective than placebo in the treatment of otitis media."

Many pediatricians justify antibiotics for middle ear effusion as a preventive against serious complications, such as mastoiditis and meningitis. "There is a pretty healthy debate within the medical profession over this practice," said Bob Howard, spokesperson for the CDC's National Center for Infectious Diseases. "Some northern European countries have done studies in which they have significantly reduced usage or not used antibiotics at all for otitis media. They let the infection run its course using just analgesics like acetaminophen, and these countries have not seen a significant rise in complications like mastoiditis and meningitis."

Incredibly, "the rapid emergence of resistant bacteria such as penicillin-resistant Streptococcus pneumoniae [the most frequent bacterium causing otitis media] during the past few years" was cited as justification for sending more American children to the operating room. In their letter to the editor of JAMA responding to the new practice guidelines, Drs. Charles D. Bluestone and Jerome O. Klein, an otolaryngologist and pediatrician, respectively, went on to describe tube placement surgery as an "important alternative to antimicrobial treatment and prophylaxis."

In his letter to JAMA, Dr. Cantekin wrote:

"Dr. Kleinman and colleagues [panel members who set the new guidelines] report that 41% of tympanostomy tube insertions are appropriate. This astonishing conclusion translates in 1994 into some 600,000 unnecessary pediatric surgical procedures in the U.S. at a cost of $1.2 billion. Kleinman et al, without any scientific evidence, recommend that surgery not be performed 'until a perfusion persists though a course of antibiotics and at least 90 days of watchful waiting' and that antibiotic prophylaxis be used for recurrent otitis media.

"They do not cite their own abstract, which reported that of 3,970 children proposed for tympanostomy tube surgery, each child was treated unsuccessfully with an average 4.3 courses of antibiotics. The data collected by Kleinman et al indicate the ineffectiveness of ubiquitous antibiotic treatment. The argument of Kleinman et al, reduced to a nutshell, is that the other 59% of children should also be aggressively and unsuccessfully treated with 4.3 courses prior to surgery. Why?"

Antibiotic use may have interfered with the homeopathic medicine given in a recent study of European children with upper respiratory infections. Two letters in response to the February HealthFacts report on this study pointed out that all 170 children who took part had prior use of antibiotics. The letters suggest that this could account for why homeopathic medicine showed only minimal benefit. The children, aged 1 1/2 to ten years, had been given at least two courses of antibiotics before entering the clinical trial, which took place at medical centers in Holland and Belgium. The study was published in the British Medical journal (BMJ, 19 November 1994).

The National Center for Homeopathy's letter states, "Antibiotics are known to interfere with the action of homeopathic remedies." It went on to note how negatively the BMJ chose to present the benefit ("at most a small effect") shown among the homeopathically treated children. But the National Center for Homeopathy points out the greater reduction in antibiotic use among the children treated homeopathically. "This study found a 54.8% reduction in the use of antibiotics in those children given homeopathic medicines, while those children who received a placebo experienced a 37.7% reduction in antibiotic use."

HealthFacts subscriber, Suzanne Antisdel of Detroit, had this reaction to e European study: "We must learn to grab any chance that comes our way to avoid antibiotics. And homeopathy is one of the most effective and least harmful alternative methods yet to be found."

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