Ears, Nose, and Throat
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The Benefits of Surgery for Ear Infection
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 (see the Family Health Guide online update on phenylpropanolamine),
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 4-Hour Liqui-Gels
Dimetapp 4-Hour Tablets
Dimetapp 12-Hour Extentabs Tablets
Naldecon DX Pediatric Drops
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
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
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
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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 reports 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 hadnt 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 Parkinsons 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
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