Ears, Nose, and Throat

Published: September, 2005

The Benefits of Surgery for Ear Infection are Unclear
Every year thousands of young children undergo surgery to alleviate chronic middle ear infections (otitis media). The demand for these procedures is driven by the concern that persistent bouts of ear infection will cause hearing loss and long-term effects on their child's speech and language development. However, the benefits of surgery are unclear — even after two recent new studies.

The most common operation involves inserting tubes through the eardrums to drain fluid that collects in the middle ear. Whether or not prompt implementation of this surgery actually protects against the development of infection was the subject of the first study in which 6,350 children were checked regularly for ear infections. By the age of 3, 429 of them were diagnosed with chronic ear infections. About half received the surgery as soon as possible, while the others waited up to nine months. The researchers found the children who had the surgery promptly had fewer subsequent ear problems than those who waited. But there was no significant difference in their speech, language, cognition or psychosocial development as measured by standardized tests and parental assessments. In fact the mean scores for all of the children fell with the average range for that age.

The second study examined hospital discharge records for children in Ontario to determine whether removing adenoids and/or tonsils at the same time as the insertion of tubes helped reduce the likelihood of subsequent ear problems. Of the 37,316 cases who received tubes, 28% also involved the removal of adenoids and/or tonsils. About one quarter of those who didn't undergo adjuvant surgery were re- hospitalized within two years after their initial surgery for subsequent ear problems. But those who did nearly halved their risk of re-hospitalization. Having both adenoids and tonsils out provided additional benefit.

So should children with chronic ear infections have tubes inserted, and should they also have their adenoids and tonsils taken out? Because of limitations in these and previous studies, we still don't know. More research is needed to weigh the long-term risks of hypothetical development impairment verses the not fully understood risk of the different surgeries.
August 2001 Update

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Products Containing Phenylpropanolamine (PPA) Pulled From Shelves
Responding to concerns that phenylpropanolamine (PPA), an ingredient found in many over-the-counter medications, may increase risk of hemorrhagic stroke, the U.S. Food and Drug Administration has asked manufacturers to remove drugs containing PPA from the market. The following list may not be complete and does not include drug store and supermarket brands, so please check the label or ask your pharmacist. You should also discard any items in your medicine cabinet that contain PPA.

Drugs Pulled From the Market:
Acutrim Diet Gum Appetite Suppressant Plus Dietary Supplements
Acutrim Maximum Strength Appetite Control
Alka-Seltzer Plus Children's Cold Medicine Effervescent
Alka-Seltzer Plus Cold Medicine (cherry or orange flavor)
Alka-Seltzer Plus Cold Medicine Original
Alka-Seltzer Plus Cold & Cough Medicine Effervescent
Alka-Seltzer Plus Cold & Flu Medicine Effervescent
Alka-Seltzer Plus Cold & Sinus Effervescent
Alka-Seltzer Plus Night Time Cold Medicine Effervescent
BC Allergy Sinus Cold Powder
BC Sinus Cold Powder
Comtrex Deep Chest Cold & Congestion Relief
Comtrex Flu Therapy & Fever Relief Day & Night
Contac 12 Hour Cold Capsules
Contac 12 Hour Cold Caplets
Coricidin D Cold, Flu & Sinus
Dexatrim Caffeine Free
Dexatrim Extended Duration
Dexatrim Gelcaps, Dexatrim Vitamin C / Caffeine Free
Dimetapp Cold & Allergy Chewable Tablets
Dimetapp Cold & Cough Liqui-Gels
Dimetapp DM Cold & Cough Elixir
Dimetapp Elixir
Dimetapp 4-Hour Liqui-Gels
Dimetapp 4-Hour Tablets
Dimetapp 12-Hour Extentabs Tablets
Naldecon DX Pediatric Drops
Permathene Mega-16
Robitussin CF
Tavist-D 12 Hour Relief of Sinus & Nasal Congestion
Triaminic DM Cough Relief
Triaminic Expectorant Chest & Head Congestion
Triaminic Syrup Cold & Allergy
Triaminic Triaminicol Cold & Cough
January 2001 Update

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Zinc Lozenges Have No Beneficial Effect on the Common Cold
Over the past few years, more and more people have begun to reach for zinc lozenges at the first sign of a cold. But a study published in the journal Clinical Infectious Diseases suggests that there is little scientific evidence of zinc's effectiveness to support the treatment's popularity.

In a study funded by Warner Lambert Consumer Healthcare, a company that manufactures zinc lozenges, researchers conducted two clinical trials to test zinc's efficacy. One trial involved 273 people who were exposed to a specific cold virus, called rhinovirus, to induce a cold. The other trial involved 281 subjects with natural colds. Both groups were broken up into four subgroups that received one of the following treatments: 13.3 milligrams (mg) of zinc gluconate, 11.5 mg of zinc acetate, 5 mg of zinc acetate, or a placebo. Zinc gluconate and zinc acetate are different formulations of zinc; zinc gluconate is more commonly found in lozenges. Treatment was started within a day of the onset of cold symptoms and continued every 2-3 hours (up to 6 lozenges per day) until the cold symptoms disappeared, or up to 14 days.

The researchers measured the effects of the treatments on both the duration and severity of the colds. Patients self-scored the severity of seven cold symptoms: sneezing, runny nose, nasal obstruction, sore throat, cough, headache, and hoarseness.

At the end of the study, researchers found that zinc gluconate had a small but significant effect on the duration of induced cold symptoms. People who had taken zinc gluconate had cold symptoms for about 2.5 days as opposed to 3.25 for high-dose zinc acetate and 3.5 days for low-dose zinc acetate and placebo. None of the treatments, including zinc gluconate, reduced the severity of cold symptoms for the first three days of the cold. And none of the zinc preparations or placebo had a significant effect on the duration or severity of symptoms in people with natural colds.

Overall, the study suggests that zinc lozenges have little, if any, beneficial effect on the treatment of the common cold.
January 2001 update

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New Relief for Allergy Sufferers
Too many people are familiar with the signs and symptoms of hay fever (allergic rhinitis). An itchy, runny, or stuffy nose; sneezing; and red irritated eyes can easily ruin the pleasures of a spring or fall day outside. One approach to treating these symptoms is to take an antihistamine (allergy) pill, either in an over-the-counter form or one that requires a doctor's prescription.

A recent report from Australia suggests that this may not be the best way to relieve nasal allergy symptoms. Researchers at Monash University in Melbourne analyzed the results of 16 studies and learned that using a nasal spray that contains steroid medication provides significantly greater relief of nasal symptoms (stuffiness, itchiness, runniness, and postnasal drip) than do oral antihistamines. Most of the studies analyzed indicated that these sprays were generally better at reducing sneezing as well. Both allergy pills and nasal sprays appear to be about equally effective in relieving eye problems caused by allergies.

Nonprescription antihistamines are safe too, but may cause drowsiness. Newer prescription allergy medicines are effective as well, but some people with heart or liver problems cannot take these medications safely. Experts agree that inhaled steroid sprays for the treatment of allergy symptoms are safe and cause few side effects. These sprays are also proving to be more cost-effective. If you suffer from allergies, talk with your doctor about taking a new look at this treatment option. For more information on nasal allergies, see page 462 in the Family Health Guide.

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Phenylpropanolamine Safety Concerns
A recently released study reports that use of phenylpropanolamine (PPA) — an ingredient in many over-the-counter medications — is associated with an increased risk of hemorrhagic stroke (stroke caused by bleeding into the brain). Phenylpropanolamine causes blood vessels to contract, which can help relieve nasal congestion. It also stimulates the central nervous system, thereby acting as an appetite suppressant. Many cold and allergy products (for example, Contac, Sudafed, and Robitussin-CF) and diet aids (Acutrim, Dexatrim) contain PPA.

Over the past 20 years, more than 30 published case reports have linked PPA intake with bleeding in the brain. One of the earliest reports concerned a diet pill (which is no longer available) that contained both PPA and caffeine. The report’s authors concluded that PPA might cause brain bleeding more often than believed and may trigger episodes of high blood pressure. Later reports implicated products that contained only PPA. Most of these were related to PPA in diet pills, although at least five involved PPA found in cold remedies.

An epidemiological study of PPA and stroke was published in 1984. This research looked at the number of cerebral hemorrhages that occurred among HMO patients who had filled a prescription for phenylpropanolamine between 1977 and 1981. This analysis concluded that PPA users were no more likely to experience bleeding in the brain than people who hadn’t used PPA. Yet, the FDA and the manufacturers of products containing PPA agreed that more study was needed. In 1992, they commissioned the Hemorrhagic Stroke Project (HSP) in which investigators compared 702 individuals who had experienced a brain hemorrhage with 1,376 control subjects. The study volunteers included men and women ages 18-49 years old.

After researchers adjusted for the impact of race, history of high blood pressure, cigarette smoking, and educational level, they found users of cold-remedies or diet pills containing PPA were 49% more likely to have a hemorrhagic stroke when compared to individuals who had not taken PPA. Users of PPA in cold medicines (but not diet pills) had a 23% higher risk of hemorrhagic stroke when compared to non-users.

PPA consumed in diet pills increased that risk substantially, however, being 15 times greater for users than nonusers — even after statistical adjustments. For women, the association between PPA in appetite suppressants and hemorrhagic stroke was 17 times higher (after statistical adjustment) for users versus nonusers. For first dose PPA users, the statistically adjusted risk for brain bleeding was three times greater than for controls.

Study investigators also observed that bleeding in the brain was more likely to occur in people who took greater than the median dose (75 mg). Interestingly, when compared to control subjects, case subjects were significantly more likely to have other risk factors for hemorrhagic stroke. For example, they were nearly twice as likely to have a history of high blood pressure, a family history of hemorrhagic stroke, heavy alcohol use, and were also more likely to report cocaine use. The PPA users were more likely to have taken aspirin (which may raise hemorrhagic stroke risk) and more than twice as likely than controls to have consumed caffeine and more than 10 times as likely to have had recent nicotine exposure. Like PPA, caffeine and nicotine also constrict blood vessels, perhaps exaggerating this effect and contributing to bleeding risk.

Certainly, this research strongly suggests that taking PPA in diet pills might increase hemorrhagic stroke risk. Because weight loss achieved through the use of these drugs is not apt to be healthy or long lasting, there is little to justify the apparent increased risk of using PPA-containing diet pills. The associated risk for stroke with PPA use in cold medicines is not as dramatic, yet these data are a sobering reminder to take seriously the directions and warnings on products containing PPA. Specifically, people with heart disease and high blood pressure should not take PPA without consulting their doctors. Individuals who take monoamine oxidase inhibitors (used for depression, psychiatric or emotional conditions, and Parkinson’s disease) — or who have stopped taking them only within the last two weeks — also should not take products containing PPA until they clear it with their physicians. Finally, these data bring home the message that over-the-counter drugs are drugs, and like prescription medications, they come with potential risks and side effects.

Right now it is uncertain whether the FDA will vote to restrict medications with PPA to prescription-only status, but it is taking these results under advisement.

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