Protecting Little Pitchers' Ears by Rebecca D. Williams Eavesdrop among parents at any playground and you'll hear them swapping tales about one of the most common maladies of toddlerhood--ear infections. The sleepless nights, endless trips to the pediatrician, and repeated rounds of expensive antibiotics are so common they're something of a preschool rite of passage. Ninety percent of American children will have had at least one ear infection before age 6. Collectively called otitis media (inflammation of the middle ear), ear infections and middle ear fluid accounted for 24.5 million doctors visits in 1990, a 150 percent increase since 1975, according to the national Centers for Disease Control and Prevention. Americans spend $3.5 billion each year to treat them. Physicians have traditionally taken an aggressive approach to fight various types of otitis media, maintaining that a young child's hearing needs to be at its best during language development. Yet recently, doctors and researchers have begun to debate traditional approaches to treating otitis media, especially otitis media with effusion (OME), which is chronic and can cause mild hearing loss. Although FDA doesn't have authority over how doctors treat ear infections, the agency does regulate all drugs and devices used in the process and is interested in the outcome of recent OME research. OME occurs when the middle ear doesn't drain properly and fills with a sticky fluid, but causes no symptoms of infection such as pain or fever. Sometimes called "glue ear," OME often appears after a cold or acute ear infection. Children are more prone to the condition than adults because their eustachian tubes, which drain fluid from the ear to the nose, are short and horizontal and often don't function properly. An acute ear infection, called acute otitis media (AOM), is caused by bacteria or viruses. This condition is very painful and makes a child feverish and fretful (often in the middle of the night). While most American doctors agree about how to treat acute otitis media, much debate has risen recently in the United States about the best remedy for otitis media with effusion. Ironically perhaps, the latest consensus among researchers reveals that the best treatment is an easy one--"watch and wait." A Frustrating Earful As parents and doctors can attest, getting rid of middle ear fluid is tricky. Antibiotics don't always work, while surgical remedies are costly, often frightening, and may not solve the problem once and for all. Last July, the Agency for Health Care Policy and Research (AHCPR), a component of the Public Health Service, issued new guidelines for treating otitis media with effusion. A panel of independent experts recommended changing the traditional approach for treating OME in children ages 1 to 3, which has involved initially prescribing antibiotics. If that didn't clear it up, doctors inserted tympanostomy tubes, small tubes in the eardrum to drain the fluid behind it. The panel found, however, that rushing into either treatment is not necessary. Middle ear fluid goes away on its own within three months in about 60 percent of cases and within six months in 85 percent of cases. The panel recommended that when a child has ear fluid and no signs of infection, physicians should take a "watch and wait" attitude for three months. After that, if the fluid is still present, the child's hearing should be tested. If hearing is normal, the doctor should either continue watchful waiting or begin antibiotic treatment. In the event of hearing loss, however, the physician should begin antibiotic treatment or try tympanostomy tubes. FDA has approved a number of tubes for the procedure. The panel recommends them only if the OME lasts four to six months and there's hearing loss in both ears. Procedures such as taking out the child's adenoids or tonsils, or administering steroids, decongestants and antihistamines, are ineffective and should not be done, the panel said. "If all doctors followed these guidelines, there would be fewer antibiotics prescribed and fewer surgeries as well," says Alfred Berg, M.D., co-chairman of the panel and professor of family medicine at the University of Washington School of Medicine in Seattle. Although the panel limited its recommendations to OME, some researchers have begun to question the way American doctors use antibiotics for acute otitis media as well. AOM is treated with a 7- to 10-day round of antibiotics in more than 90 percent of cases. For children with recurrent infections, physicians sometimes prescribe a daily low dose of antibiotics for weeks as a preventative measure. While this approach can be effective, it may also encourage resistant strains of bacteria to develop. Physicians aware of this possibility can adjust medications if necessary. "Treatment of acute otitis media is basically by tradition, a tradition that has not been adequately investigated," says Larry Culpepper, M.D., a professor of family medicine at Brown University and member of the AHCPR panel. "I think the real answer is that we don't know for sure if there's a significant benefit for treating kids with antibiotics [for acute otitis media]," he says. European doctors don't treat AOM the way American doctors do, Culpepper says. Overseas, doctors commonly take a "watch and wait" attitude. When they do order antibiotics, it's for a shorter period and at lower doses. Culpepper is conducting a study comparing treatment of AOM in the Netherlands, the United Kingdom, and the United States. By examining the results of treating 4,500 children, he hopes to see which country's approach produces the best results. Two Treatments For now in the United States, antibiotics and tympanostomy tubes remain the most common and accepted tools for treating acute otitis media and otitis media with effusion. Both approaches have benefits. Many oral antibiotics are inexpensive and can relieve a child's pain and fever from an acute ear infection in a few hours. For chronic fluid, tympanostomy tubes instantly drain the middle ear and restore hearing. According to the National Center for Health Statistics, there were about 670,000 surgeries in 1988 to insert ear tubes, making it the most common surgical procedure for children. But there are drawbacks to both approaches as well. Antibiotics don't always work completely, leaving some infected fluid. Other times, the bacteria are resistant to the drug. Some researchers believe resistant bacteria are on the rise because our country overuses many antibiotics. Antibiotics have side effects, too--the most troubling one being diarrhea. Others include thrush (an oral yeast infection) and vaginal yeast infections in girls. If antibiotics are used, parents must be vigilant in giving each dose on time. Skipping or getting off schedule with doses will only make the infection worse, allowing bacteria that are resistant to the drug to grow. "The child gets better, and the parents get lax," says Michael Blum, M.D, a medical officer at FDA. "If you skip a day here or there, there's more potential for resistant bacteria to develop." When antibiotics fail, surgery is the next option. Most tympanostomies are done by ear, nose and throat specialists in an outpatient setting at a hospital. A general anesthesia is used for most children, not because it's very painful, but because the child needs to lie perfectly still. During surgery, the physician cleans the ear canal, makes a small incision in the eardrum, suctions out the fluid behind it (a procedure called myringotomy), and places a tiny tube in the incision. The procedure is done under a microscope with an instrument that resembles a small pair of tweezers. It lasts about 15 to 30 minutes. The AHCPR panel estimated the cost of tubes at about $2,174 (including a parent's lost time in work). Unfortunately, the tubes can easily fall out within weeks or months, and must be replaced. One-third of children with tubes have them replaced within five years of the first operation. Other drawbacks of tubes include the risk of complications from anesthesia and the need for children to protect their ears with earplugs while swimming or bathing. It's a good idea to wait until autumn to put in tubes so that they won't interfere with beach and pool trips. A child's hearing should always be tested before inserting tubes, the panel said. A loss of 20 decibels in each ear (as loud as a humming refrigerator) warrants treatment, the panel said. Although that's not a large hearing loss, experts are quick to point out that no one knows just how much loss might impede a child's language development. Accurate Diagnosis Before a child undergoes any treatment, it's crucial to get an accurate diagnosis, the panel advised. A magnifying instrument called a pneumatic otoscope enables the doctor to see the eardrum while pumping a puff of air against it. If the eardrum is red and inflamed, it's probably infected. If it's not inflamed, but still doesn't move properly when the air hits it, it probably has uninfected fluid behind it. "Many doctors do not use the pneumatic otoscope," says Cynthia Carney, a journalist and consumer representative on the AHCPR panel. "We say very clearly in the guidelines that that's the only way to be sure." Many doctors either don't know how to use the pneumatic otoscope properly, or they can't get an accurate reading on a squirming, screaming 2-year-old. But experts say the results with a pneumatic otoscope are worth the extra time and effort. The diagnosis can be confirmed by a specialist with another test called a tympanogram. Using a soft plug fitted snugly into the ear canal, the tympanometer emits a low noise and records how the eardrum reacts. If it doesn't move well, that's an indication that there's fluid behind the drum. Prevention Although the causes of otitis media aren't fully known, several factors increase a child's risk for developing ear infections: Bottle-feeding. Bottle-fed babies are two to three times more likely to develop otitis media in the first year of life than are breast-fed babies. Breast milk may have antibodies that ward off the infections. Also, when a child sucks a bottle while going to sleep, the milk can be forced into the middle ear, perhaps leading to infection. Second-hand smoke. Studies have shown that children whose parents smoke are nearly three times more likely to develop middle ear fluid than children whose parents don't smoke. They also take longer to recover. Group childcare. Because they're exposed to a wide variety of cold viruses, children in group child-care facilities have a greater chance of developing ear infections than children cared for at home. Allergies. Allergies can increase a child's likelihood of ear infections because watery mucus from the nose can clog the eustachian tube and prevent it from draining properly. That's why doctors sometimes prescribe antihistamines to help clear up middle ear fluid. The AHCPR panel did not find enough scientific evidence to support that treatment, however, and did not recommend it. Birth defects. Certain conditions such as cleft palate, Down syndrome, and nervous system abnormalities can increase a child's chances of developing ear infections. The panel's recommendations don't apply to these children, who should be evaluated individually by their doctors. n Rebecca D. Williams is a writer in Oak Ridge, Tenn. Panel Recommendations The AHCPR panel recommendations are summarized in a consumer booklet called "Middle Ear Fluid in Young Children." Free copies are available through the AHCPR Publications Clearinghouse, P.O. Box 8547, Silver Spring, MD 20907; telephone (1-800) 358-9295. Free fax copies are available by faxing to (301) 594-2800; after dialing, push "1." n Common Antibiotics for Ear Infections Many antibiotics are approved by FDA to fight otitis media, although most doctors rely on a few favorites. Drug manufacturers have made a number of the drugs in liquid fruity flavors palatable to kids. Most antibiotics fall under four families: penicillins, cephalosporins, sulfonamides, and erythromycins. Here are some common brand names. Amoxicillin: A generic name for the most common antibiotic used to treat ear infections. This is a synthetic penicillin. Physicians like it because it causes less diarrhea than some other antibiotics, it's absorbed well, and it's only given three times a day. It's also inexpensive. Side effects may include mild diarrhea and rashes. If the rash itches, the child might be allergic to the drug. Pediazole: A brand-name combination of erythromycin and sulfisoxazole. Can be used if a child is allergic to penicillin. Side effects may include some abdominal cramping and discomfort and, infrequently, nausea, vomiting and diarrhea. If any rash develops, the drug should be discontinued. Bactrim and Septra: Two brand names of a sulfonamide drug combined with trimethoprim. They can be used in children who are allergic to penicillin. Side effects may include mild nausea, vomiting, diarrhea, rashes, an increased sensitivity to sunlight, and a reduction in white blood cells. Ceclor: A brand name of a cephalosporin antibiotic that is effective, but expensive. Side effects may include diarrhea and a rash. Children may be allergic to cephalosporins if they're allergic to penicillin. Some newer cephalosporins include Ceftin, Cefzil, Vantin, Suprax, and Lorabid. Gantrisin: In its liquid forms, Gantrisin is a brand name for acetyl sulfisoxazole and is often used as a preventative drug for children with recurrent infections, because it's given only once a day. It's approved for acute otitis media when used in combination with penicillin or erythromycin. Augmentin: An amoxicillin drug with extra ingredients to inhibit bacterial resistance. May clear up infections when other drugs have failed. Despite the number of antibiotics available to treat ear infections, FDA is concerned about the growth of increasing numbers of bacteria resistant to antibiotics. "The agency is actively pursuing the establishment of a surveillance program for all antimicrobial products," says Albert Sheldon, Ph.D., a microbiologist in FDA's division of anti- infective drug products. Last year, FDA asked manufacturers of new drugs seeking FDA approval to track their effect on certain strains of bacteria. FDA officials also participate in professional organizations that track bacterial resistance both in this country and around the world. One way for parents to combat bacterial resistance is to be vigilant in giving each dose on schedule. Skipping or delaying doses can encourage resistant bacteria to develop. n -- R.D.W