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Posts Tagged ‘prevention’

Very Hot Tea Linked to Esophageal Cancer

Posted by medconsumers on April 1, 2009

People who drink very hot tea increase their chance of developing cancer of the esophagus, the muscular tube through which food passes from the throat to the stomach. This is the finding of a new study conducted in one province of northern Iran where people are known to drink large amounts of very hot tea because the water supply is unsafe. It is not the black tea they are drinking but its temperature that accounts for their high incidence of esophageal cancer.

The take-home message from this study: Wait four minutes or more before drinking any freshly boiled beverage.

In a recent issue of the BMJ (British Medical Journal), the lead author of this study, Resa Malekzadeh, Tehran University, and colleagues explained that their finding goes well beyond one region of one middle-eastern country. Worldwide, there are wide variations in the incidence of esophageal cancer, which suggests to cancer researchers that the disease is preventable.

Heavy alcohol and tobacco use are long known to be factors in the development of esophageal cancer and this explains why men are more likely to get esophageal cancer than women. But alcohol and tobacco are not implicated in non-Western countries with very high rates of the disease and where women are as likely as men to be diagnosed with esophageal cancer.

This made one province in northern Iran the perfect place to study another strongly suspected risk factor—drinking very hot beverages. The province has a higher rate of esophageal cancer than the rest of Iran, no gender differences in incidence, and a high intake of extremely hot tea. The investigators asked about the tea drinking habits of 300 people who were diagnosed with esophageal cancer and a control group of 571 people from the same province who were cancer-free.

To test the definitions of lukewarm, hot, and very hot, the researchers spent time measuring the actual temperature of the tea consumed by nearly 50,000 residents of the province.

The people who said that they drank their tea within two minutes after the water was boiled were five times more likely to have esophageal cancer than the people who waited four minutes or more to drink their tea.

The investigators could only guess at the reasons why. They suspect that chronic heat injury to the lining of the esophagus could cause the development of cancer. More research, they advise, should be directed to this subject.

In the editorial that accompanied this study, Australian researcher David C. Whiteman wrote that it provides “persuasive evidence” against the practice of drinking very hot tea. Whiteman also pointed out that others knew this long ago, citing the advice of Victorian cookbook writer, “Mrs Beeton, who prescribes a five to 10 minute interval between making and pouring tea, by which time the tea will be sufficiently flavorsome and unlikely to cause thermal injury.”

The first rapid response to this study (an electronic letter to the editor) came from someone in Argentina who wrote: “In Latin countries the majority of people drink black coffee, just as hot and potentially just as dangerous in terms of cancer risk. In Argentina, of course, traditionally as well as coffee, they drink maté [an herbal beverage], which is never drunk with milk and is frequently scaldingly hot.”

Maryann Napoli, Center for Medical Consumers© April 2009

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Three Weight-Loss Diets Compared

Posted by medconsumers on June 1, 2008

It’s Hard to Lose Weight, but the Mediterranean and the Atkins Diets are Best

Three weight loss diets were compared over the course of two years in a newly published clinical trial conducted in Israel. The “winners” are the Mediterranean and the Atkins diet. People on one of these two diets lost more weight than the people on the low-fat diet long recommended by the American Heart Association and many physicians.

The differences and the amounts of weight lost were not great, ranging from 6 1/2 to 11 pounds. The results, however, call into question the dire health warnings about going on the Atkins diet, which is high in fat and protein and represented in this study as the low-carbohydrate diet. Published last month in The New England Journal of Medicine, the study was partially funded by the Dr. Robert C. and Veronica Atkins Research Foundation. It was so well designed that one could reasonably come to the conclusion the trial provides yet-another example of just how hard it is to lose weight.

The Dietary Intervention Randomized Controlled Trial (DIRECT) Group was led by Iris Shai, RD, PhD, Ben-Gurion University of the Negev. The Israeli researchers have designed their trial to overcome the usual problems associated with diet studies that rely solely on the participants filling out extensive food-frequency questionnaires. (Who among us can accurately remember how many cups of broccoli were eaten in the last 12 months, much less the amount and type of fat used in the cooking?)

The best type of diet-study design would required the participants to be institutionalized for a year or two, so that the only foods available to them would be consistent with the diets under scrutiny. Such trials are too expensive, and not likely to get many willing participants.

The Israeli DIRECT study was conducted at a workplace in a country where lunch is the main meal. The 322 moderately obese, mostly male participants worked at a nuclear research center in Dimona, Israel, with a self-service cafeteria and an on-site medical clinic. The foods they were instructed to eat had been marked with stickers color-coded according to each participant’s assigned diet.

Each food item also had a label showing the number of calories and the number of grams of carbohydrates, fat, and saturated fat. Each food item was also labeled with a full circle (indicating “feel free to consume”) or a half circle (indicating “consume in moderation”). Here’s how the three diets were described in the study: “low-fat, restricted-calorie American Heart Association diet]; Mediterranean, restricted-calorie; or low-carbohydrate, non–restricted-calorie [i.e., Atkins diet].”

Food-frequency questionnaires were used in this study to validate the participants’ adherence to their assigned diets. The questionnaires had to be filled out three times during the two-year duration of the study. And lastly, the participants received telephone pep talks from dieticians six times. Even their spouses received educational support.

After all that effort, here’s what was accomplished after two years: The people on the Mediterranean diet and the people on the Atkins diet lost 9 and 11 pounds, respectively. And the people on the low-fat, restricted calories diet lost 6 1/2 pounds. The small number of women who participated in this study tended to lose more weight on the Mediterranean diet (14 pounds) than on the other diets.

Dr. Shai and colleagues concluded that the Mediterranean diet may be better for people with type 2 diabetes because it showed a more favorable effect on glucose and insulin levels, which the researchers attributed high consumption of monounsaturated fats like olive oil. The high-fat, high-protein Atkins diet had the best effect on cholesterol levels. Both diets were described as effective alternatives to the American Heart Association low-fat diet.

This study was supported by the Nuclear Research Center Negev, the Dr. Robert C. and Veronica Atkins Research Foundation, and the S. Daniel Abraham International Center for Health and Nutrition, Ben-Gurion University, Israel.

For More Information:

The DIRECT study is freely accessible at The New England Journal of Medicine’s Web site (www.nejm.org) Go to the July 17, 2008 issue to read, “Weight Loss with a Low-Carbohydrate, Mediterranean or, Low-Fat Diet.egy.

Maryann Napoli, Center for Medical Consumers ©
June 2008

Posted in Diet & Exercise | Tagged: , , | Comments Off

Avoid Drug-Related Injury

Posted by medconsumers on May 1, 2008

One Way to Avoid a Drug-Related Injury

It can take years to learn the full range of serious adverse reactions to prescription drugs. That point was driven home last month when, in one issue of the journal Archives of Internal Medicine, several studies revealed new-found harms. The popular diabetes drugs, Actos and Avandia, increase the chance of having a fracture. Fosamax and other drugs in the class known as bisphosphonates, widely prescribed for osteoporosis since 1995 to prevent fractures, can cause an irregular heartbeat called atrial fibrillation. And postmenopausal hormone drugs, once aggressively urged for all women over 50 to prevent heart attacks and strokes actually cause strokes in some women, regardless of the type of hormone regimen or when it was started.

You get the picture: the drugs taken to prevent one major health problem can often cause another. The editorial that accompanied these new studies offered the excellent suggestion that doctors should quantify the benefits and risks so their patients can fully understand what they are getting into once they are told to go on long-term drug therapy. If, say, a bone drug helps only one in 100 women avoid a hip fracture and the same drug causes a potentially fatal atrial fibrillation in one in 100, then it’s a wash.

Jerry Avorn, MD, and William H. Shrank, MD, Harvard Medical School, offered a more immediate suggestion for avoiding drug-related injuries that targets people over the age of 65 years, the group with a high prevalence of adverse drug reactions. In a recent issue of the British Medical Journal, Avorn and Shrank wrote, “When an elderly person experiences an adverse drug reaction, it may be mistakenly attributed by the patient or doctor to a new disease or (even worse) the aging process itself. Examples include the parkinsonian side effects of many antipsychotic drugs and the fatigue, confusion, or depression-like symptoms that can result from excessive use of heavily marketed psychoactive drugs.”

Avorn and Shrank go on to describe what they called an opportunity for “total cure” by stopping the offending drug or lowering its dose. “In our own practices we have often seen patients on a seemingly inexorable trajectory towards institutional care whose functional capacity was restored by thoughtful reassessment of their drug regimens. This has led to the useful if overstated recommendation that any new symptoms in an older patient should be considered a possible drug side effect until proved otherwise.”

Maryann Napoli, Center for Medical Consumers ©
May 2008

Posted in Drugs, Heart, osteoporosis, Women's Health | Tagged: , , , , | Comments Off

You Can Be Fat and Fit

Posted by medconsumers on April 1, 2008

Walk More—That’s all you have to do

For cardiovascular and other health benefits like increased longevity, you need only exercise moderately for 30 minutes at least five days a week. That has been the recommendation for nearly 15 years, and it has decades of high-quality research to back it up. In an attempt to refine things further, a team of researchers asked the questions: Can this exercise recommendation be cut back further and still produce health benefits? Will 45 minutes five days of the week provide even more?

The study designed to answer these questions drew participants from the most sedentary segment of the U.S. population—postmenopausal women. Published last year in the Journal of the American Medical Association, this study continues to produce surprise findings as researchers are still analyzing the mountains of data it has generated.

A co-author of this and many other landmark studies is exercise scientist Steven N. Blair, PED, professor in the Department of Exercise Science at the University of South Carolina. One of the world’s leading researchers on the health benefits of exercise, Dr. Blair is interviewed by Maryann Napoli.

MN: Is it fair to summarize your research as providing proof that people can be fat and fit and that they can achieve cardiovascular fitness with only a moderate degree and amount of activity?

SNB: Scientists try to stay away from using the word “proof”, but we have provided pretty compelling evidence that you can be fat and fit—just as you can be thin and unfit. And that fitness provides important protection from many chronic diseases and premature mortality even in people who are obese.

MN:
And it need not be vigorous exercise.

SNB: To attain what we’ve labeled “moderate fitness”—that is, if one follows the recommendation of 30 minutes of moderate intensity activity, such as walking on five or more days a week, you will develop a level of fitness that is protective.

MN:
Must it be done in 30 consecutive minutes?

SNB: You can do it in separate segments—in bouts of at least ten minutes or more. The evidence for that has accumulated since we first made that recommendation back in the mid-1990s. It’s clear that whether you do 30 minutes of walking in three ten-minute bouts or two 15-minute bouts or all at once, the physiologic benefits are identical.

MN: That would also cut down on injuries.

SNB:
It’s clear from our studies—and those of others—that as the amount and the intensity of the exercise goes up, the risk of injury does as well. The injury rate associated with moderate-intensity activity is incredibly low.

MN:
How fast should people walk?

SNB:
Walk purposefully as if you were going to a meeting—about 3 miles per hour, or 20 minutes a mile—but that will vary a bit depending on a person’s age, fitness, and health status. Some will need to walk a bit slower, especially when starting a program, and more fit individuals may walk at a faster rate.

MN: Why is it that those cardiac risk calculators that doctors use to determine an individual’s chance of having a heart attack in the next ten years do not include a question about physical activity? I’m referring to “risk assessment tools” like the one from the National Heart, Lung and Blood Institute that ask questions about blood pressure, cholesterol, etc. to identify who should be on drug therapy.

SNB:
That calculator is largely based on the Framingham Heart Study [initiated 60 years ago], and they have never incorporated fitness. I tell physicians if you use the Framingham risk score to characterize your patients’ risk, you’re not finished with the job, unless you also have a measure of fitness or at very least, take a careful physical activity history.

MN: Why do you think the public continues to be told that excess weight will cause premature death and heart attacks? Three years ago, researchers at the Centers for Disease Control and Prevention (CDC) published a study that showed people who are overweight or even obese do not have shortened life spans. Decreased mortality was shown only at either end of the spectrum—the morbidly obese and the very thin.

SNB:
Some people are dedicated to a concept that being overweight is hazardous to your health and they have an unwillingness to look at the actual data. When you look at the work of Katherine Flegal who headed that CDC study, you will see that she found that overweight is not the hazard for mortality as it has been made out to be, and it may even be protective. She used the best available data, such as that from the National Health and Nutrition Examination Surveys, which are broadly representative of the U.S. population. Yet there are people who have been vehement in their unrelenting criticism of Katherine and her work.

MN: Your work is focused on cardiovascular benefits, but weight loss motivates most people to exercise. I want to talk about a weight-related finding from your latest study that included 464 postmenopausal women who were sedentary, overweight or obese but basically healthy when they were randomly assigned to one of three exercise groups or the control group. This finding surprised me: After six months, “There were no differences in weight or body fat percent across the groups at follow-up but waist circumference was significantly smaller in all three exercise groups compared with the control [no exercise] group.”

SNB: That finding was not a surprise to anyone who works in this area. My colleague Bob Ross from Queen’s University in Kingston, Ontario has done more work on exercise and visceral adiposity than just about anyone. Bob said, “If you get people exercising, the visceral fat is going to go.” What we saw [in our study] was no difference in weight change across those four groups, yet all three exercising groups lost waist circumference, presumably visceral fat, compared with the control group.

MN: It should be pointed out here that one important aspect of your study is the fact that the women in the exercise groups performed their exercise routines under observation in the laboratory, thus bypassing the unreliable self-reporting that so often characterizes physical-activity studies. Your study measured what researchers call “dose response,” i.e., whether any health benefits were gained or lost by going lower or higher then the standard recommendation of 30 minutes five days a week of moderate exercise. Any other surprises?

SNB: I was a little surprised that the high-dose exercise group [225 minutes of exercise a week] did not lose more weight because they were doing three times the amount of exercise per week as the low-dose exercise group [72 minutes a week].

MN: What are you working on now?

SNB: We continue to analyze data from our study. When we looked at weights that were measured weekly in all the women, there are some fascinating findings there that I cannot talk about because we have not yet published our findings. It’s based on the notion promoted by the U.S. dietary guidelines 2005, which state, in order to prevent weight gain or promote weight loss, 60 minutes of activity a day is needed. Others have been trumpeting similar ideas. Well, if that’s the case, then the women in our high-dose exercise group should have lost a good bit more weight than the women in the lowest exercise group. We didn’t see that.

MN: Any idea why?

SNB: I’m not sure we’re ever going to know, but it is an area of research that cries out for more study—to try to understand where exercise fits in relation to weight management.

MN: The exercising study participants may not have lost weight, but regular testing of their cardiovascular/respiratory fitness during the study showed that they improved according to the amount of exercise they were assigned to perform.

SNB: Yes. As you see from our study there was a strong positive dose-response relationship for VO2 peak across the control and the three doses of exercise. Even the women in the lowest exercise group significantly improved their cardiovascular/respiratory symptoms and they only did 72 minutes of moderate intensive exercise a week. I’m coming to the conclusion that doing anything is better than nothing. I should be standing up right now while I’m talking with you.

MN: The blood pressure reductions in all three exercise groups were pitifully small.

SNB: Yes, I had expected exercise to show a dose-response gradient for blood pressure.

MN: You mean that you had expected the women doing the highest amount of exercise to have larger reductions in blood pressure.

SNB: Yes, the women were mildly hypertensive at the start of the study but all the exercise groups lowered their blood pressure only a few millimeters of mercury.

MN: There are still many proponents of vigorous-intensity exercise out there. I read that you used to be one of them until your own studies showed the health benefits of moderate-intensity exercise. I also read that you continue to enjoy running. Do you think that one day researchers will find that there are more health benefits to be gained with an intensive exercise routine?

SNB: Perhaps there might be some additional health benefits shown for vigorous exercise, but I frankly think the jury is still out on that one. I’m willing to go out on a limb here and say that doing something is better than doing nothing.

Maryann Napoli, Center for Medical Consumers ©

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Sinusitis: Saline Irrigation Works

Posted by medconsumers on September 1, 2007

An Old Sinusitis Treatment Makes a Comeback: Nasal Saline Irrigation

Sinusitis sends millions of adults and children to the doctor each year. And many receive inappropriate treatment. Though studies show that viruses are by far the most frequent cause of a sinus infection, U.S. physicians reported that they prescribed antibiotics in 82% of visits nationwide for this condition. Despite contradictory results from studies exploring the efficacy of inhaled nasal corticosteroids, these drugs are also prescribed frequently.

These are some of the alarming findings from a study reported early this year in Archives of Otolaryngology. The authors, Hadley J. Sharpe and colleagues at the University of Nebraska Medical Center in Omaha, based their study on physician-generated information from two national surveys of patient data collected during visits for ambulatory care from 1999 to 2002. The misuse of antibiotics is of particular concern because it contributes to the increase in more virulent and drug-resistant bacteria.

“Watchful waiting, lavage with saline solution, and use of decongestants or proper antimicrobial agents are the treatments of choice,” wrote the University of Nebraska research team, referring to the steps doctors should go through in treating acute sinusitis. Acute rhinosinusitis, as it is also called, usually lasts less than four weeks, and a short-term antibiotic regimen can in fact provide relief to a minority with a bacterial infection. But the effects of antibiotics on chronic sinusitis, defined as symptoms lasting 12 weeks or longer, were described by the University of Nebraska researchers as questionable.

Enter Saline Irrigation

This study exposed the poor quality of sinusitis treatment in the U.S. Does it provide an impetus for increased use of a home treatment called nasal irrigation, which involves sending a buffered salt-water solution up one nostril and out the other? “Absolutely,” agreed Otolaryngologist Donald A. Leopold, MD, a co-author of the University of Nebraska study, in a telephone interview.

“90% of my patients are rinsing their noses. It’s so easy and inexpensive, and in many ways, solves the whole problem,” said Dr. Leopold, who is professor and chair of the department of otolaryngology-head & neck surgery at the University of Nebraska Medical Center, Omaha. “It’s the every day, and sometimes twice a day, use of this stuff that makes the difference. It’s something the patients have to do on an ongoing basis, and if they do, they get better.”

Nasal saline irrigation recently received validation from a Cochrane review of all relevant clinical trials. After noting that this treatment has its foundations in yogic and homeopathic traditions, the Cochrane review concluded, “There is evidence that [saline irrigations] relieve symptoms of chronic rhinosinusitis, help as an adjunct to treatment and are well tolerated by the majority of patients.”

Allergies can also be relieved with daily nasal saline irrigation, according to two studies involving children with seasonal allergic rhinitis. Those who were randomly assigned to nasal irrigation had a decrease in symptoms and a reduced intake of antihistamines.

Range of Products Available

In the practice of yoga, nasal irrigation involves the use of a neti pot, which can be purchased at most health food stores and resembles a teapot with a narrow spout. With the head tilted sideways, the salt-water solution is poured into one nostril and, in turn, goes down the other. Today nasal irrigation can be accomplished more conveniently while leaning over the bathroom sink and using one of the over-the-counter variations on a flexible plastic squeeze bottle.

Available at most pharmacies under such brand names as NeilMed Sinus Rinse™ and SinuCleanse,TM the products are sold with packets that combine sodium chloride (salt) and sodium bicarbonate (baking soda). The latter acts as a buffer against the stinging and burning sensation caused by salt water alone. These products make saline irrigation easy for children as well as adults.

Another product called Rhinotip™ is designed to fit over the jet tip end of most dental irrigators.

No independent head-to-head comparison study of these over-the-counter nasal wash products has been conducted to determine which is best in terms of ease of use and the reduction of symptoms and use of medications.

Whatever Works

“It’s up to the individual,” said Dr. Leopold when asked which product he recommends to his patients. “I will typically introduce all the different ideas [for nasal irrigation] and if a patient says, ‘I thought it was uncomfortable pressure,’ then I will switch them from a squeeze bottle to a neti pot, for instance. And some of my patients prefer a power wash with WaterPikR which is inserted a number of inches into the nose,” Dr. Leopold continued “Whatever product makes them comfortable and lets them do it on a regular basis is the one I would like to push. Most feel better after they’ve done it, especially if you have a cold, it’s the best way to make cold go away. A small minority feel irritated by [saline irrigation], but most want to do it all the time.”

The lead author of the Cochrane review about saline irrigation, otolaryngologist Richard Harvey, MD, Royal National Throat Nose and Ear Hospital in London, U.K., was asked by e-mail whether he advises his patients to do regular nasal saline irrigations and if so, which product is recommended. “While this is an area of ongoing research, my clinical judgement and experience from working with world leaders in nose and sinus care, suggests that squeeze bottles, such as NeilMed Sinus RinseTM, and pressurised sprays which can deliver high volumes, such as Physiomer (Goëmar Laboratories, France), under positive pressure are probably the most effective.”

In a telephone interview, K.C. Mehta, MD, the California-based lung specialist who developed NeilMed Sinus RinseTM, explained the importance of “positive pressure” and “high volume” in clearing out the nasal passages. “The key to symptom relief is to physically displace and wash away excess mucous and along with it allergens, such as grass and tree pollen, dust particles, pollutants and bacteria from the nasal passages. This in turn reduces inflammation of the mucosa membrane allowing you to breathe more normally.”

Dr. Mehta says that he suffered for years with sinus infection; had all types of treatments, including surgery; and finally decided that saline irrigation worked the best in terms of controlling symptoms. He went on to develop his own products that overcome the messiness of using the traditional neti pot and introduce the high-volume, positive pressure needed to wash out the excessive mucous and allergens. A step-by-step illustration of how to use the product can be found at www.neilmed.com. [Disclosure: The writer of this article has a friend who works for the company that makes NeilMed Sinus RinseTM.]

A Trend in the Works

Saline nasal irrigation appears to be catching on, and it is the ear/nose/throat specialists who are leading the way, rather than primary care physicians. The specialists first recommended the practice as aftercare for people who have had sinus surgery. Now, saline irrigation is becoming day-to-day standard care.

And according to Dr. Leopold, word of mouth from satisfied customers is also driving the trend. “People are becoming missionaries giving saline packets to their friends with sinus problems.” Consumer satisfaction is reflected in the sales of these saline irrigation products which have doubled annually for the last few years, according to the independent market data provided by A. C. Nielsen.

Role of Antibiotics

Given the fact that the University of Nebraska study found misuse of antibiotics to be common in the treatment of rhinosinusitis, Dr. Leopold was asked how people would know when antibiotics are appropriate. “If the person has a high fever, that could be an indication for an antibiotic,” he answered. “And if they have chronic respiratory problems like asthma, I typically tell them to take antibiotics early on. I’m aggressive up front with those folks.”

But the symptoms of a cold should be gone in two or three days in people without chronic respiratory problems who rinse their noses regularly, Dr. Leopold explained, and if they are still clogged up, then an antibiotic may be appropriate. He dismissed as “unreliable” the prevailing notion that greenish-yellow mucous always signals the need for an antibiotic.

The treatment of sinus infection seems to have come full circle where it concerns saline irrigation. “Medicine rolls in trends, just like fashion,” said Dr. Leopold. “Rinsing the nose had been a huge deal around the turn of the last century. There were a lot of articles back then about rinsing solutions and rinsing devices,” he explained, but interest died out once antibiotics, “the miracle drugs,” became available.

Now nasal saline irrigation is making a comeback.

Maryann Napoli, Center for Medical Consumers ©
September 2007

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Antibiotics Prior to Dental Procedures: Big Change in Recommendations

Posted by medconsumers on July 1, 2007

For over a half century, millions of Americans with common heart valve problems, such as mitral-value prolapse, were told to start taking preventive antibiotics prior to undergoing routine dental procedures. To ignore this standard recommendation is to risk a potentially life-threatening case of bacterial endocarditis triggered by the dental procedure. Or so went a widely held belief that has been revised recently by the American Heart Association.

The AHA now restricts its preventive antibiotics advice to a much smaller group of people—those with serious heart conditions. The new guidelines were published recently in the journal, Circulation, where the AHA acknowledged its longstanding policy was based on expert opinion rather than evidence.

The AHA appointed a writing group comprised of people selected for their expertise in the prevention and treatment of endocarditis. After reviewing all relevant studies, the AHA writing group concluded that the odds of suffering a serious adverse reaction to the antibiotics are higher for most people with heart conditions than their odds of getting endocarditis due to a dental procedure. In other words, endocarditis is a rare possibility. This is similar to the conclusion of a 2004 review of all relevant studies on this topic conducted by the Cochrane Collaboration.

Central to the now-outdated AHA recommendations was the concern that even the most routine of dental procedures, such as tooth scaling, could let loose bacteria into the bloodstream. Theoretically, the bacteria would lodge on abnormal heart valves or other damaged heart tissue and cause endocarditis, an infection of the heart’s inner lining (endocardium) Ironically, the AHA guideline writers said that the chances of developing endocarditis from the more mundane everyday activities, such as tooth brushing, flossing, and use of toothpicks, are higher than getting it during a dental procedure.

On another ironic note, the AHA writing group found that studies involving the antibiotics typically prescribed before dental procedures—penicillin or amoxicillin—failed to prove that either drug is effective in reducing the release of bacteria into the bloodstream. (The studies had compared drug-treated people with untreated people who underwent the same dental procedures.) Also, there is no evidence to show that amoxicillin, the antibiotic of choice since 1990, can reduce the risk of or prevent endocarditis.

The new AHA guidelines now confine preventive antibiotics to people at the very highest risk for endocarditis, including those who have had the disease, and those with a prosthetic heart valve, congenital heart disease, hypertrophic cardiomyopathy or cardiac valvulopathy (after heart transplant). A single antibiotic dose before the dental procedure is sufficient for people in these circumstances.

Mitral Valve Prolapse

People with mitral valve prolapse (MVP), estimated to be about 18% of the population, are now freed from the need to take preventive antibiotics. The AHA writing group noted that the incidence of endocarditis is extremely low in the entire population of people with MVP. Moreover, the disease does not have the same deadly consequences in people with MVP as it does for those with the above-mentioned highest risks.

Bottom Line: A 50-year-old health policy without much supporting evidence has been revised. For most people with heart valve problems, antibiotics before a dental procedure pose more of a threat to health than the rare possibility of developing endocarditis. Furthermore, there is no evidence to show that antibiotics can reduce the risk of endocarditis. The American Dental Association endorsed the new guidelines.

Maryann Napoli, Center for Medical Consumers ©
July 2007

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Low-Dose Aspirin for Heart Protection: How Low Should a Safe Dose Be?

Posted by medconsumers on June 1, 2007

Daily aspirin protects the heart, but the dose at which this can be safely accomplished has never been established. It has long been known that the risks of aspirin—gastrointestinal or brain hemorrhage—cannot be completely eliminated even at the lowest possible doses. An international team of researchers recently determined that daily doses of aspirin as low as 30 mg are adequate for achieving the anti-clotting goal; whereas doses higher than 75 to 81 mg merely increase the risk of adverse reactions without providing any additional advantage.

The research team led by Charles L. Campbell, MD, University of Kentucky, based its conclusions on a review of 11 studies comparing people on different low doses of aspirin after a major stroke, a minor stroke (transient ischemic attack), a heart attack or a recent artery-opening procedure. It was published last month in the Journal of the American Medical Association.

The 11 studies had a combined total of about 47,000 participants (one-third were women) who were followed up to four years. The aspirin doses given in these studies, ranged from 30 mg/daily to 650 mg/ twice daily. Though millions of Americans take low-dose aspirin to prevent cardiovascular problems from occurring in the first place, no studies in this review included participants without heart disease.

Dr. Campbell, the lead author of the review was asked by e-mail how low a dose should be taken by people without heart disease, who were not addressed in this review. “The lowest dose I have seen evaluated in the primary prevention setting was 100 mg every-other-day in the Women’s Health Study,” he responded, referring to a 2005 trial that found, even at that low dose the women on aspirin had a higher rate of gastrointestinal bleeding than the women on placebos.

“I typically use 81 mg of uncoated aspirin for primary prevention in either men or women, but would not object to using lower doses among women.” (Enteric-coated products were questioned by Dr. Campbell and colleagues because they are not absorbed as well as plain aspirin.)

“I suspect the patients I recommend primary prevention for are of higher risk than the majority of women in the Women’s Health Study (more than 40% of whom had NO traditional risk factors for coronary disease),” wrote Dr. Campbell in an e-mail. “My patients are more like the over-65 population in the Women’s Health Study where low-dose aspirin was associated with a reduction in MI [heart attack]. I typically avoid alternate day dosing to keep things simple and compliance high, but don’t have a philosophical objection to that approach either.”

Aspirin is a non-steroidal anti-inflammatory drug. Though gastrointestinal bleeding is usually attributed to other drugs in this class like ibuprofen and naproxen, this adverse reaction was most often caused by aspirin in one study that looked at 18,820 hospitalized patients. Of the 1225 patients admitted as a result of adverse drug reactions, low-dose aspirin was identified as one of the most common causes, with 18% of hospitalizations and 61% of the fatal cases associated with low-dose aspirin.

Bottom line:

The conclusion of this review contradicts the typical dosage recommendation in the U.S.—between 81 mg and 325 mg. A baby aspirin (81 mg) a day is a sufficient dose for protection for people with heart disease. People without heart disease were not represented in this review, but the lead author suggests 81 mg uncoated aspirin daily, though a lower dose could be appropriate for women. No primary prevention trial has had participants taking an aspirin dose lower than 100 mg every other day.

Maryann Napoli, Center for Medical Consumers ©
June 2007

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New Cervical Cancer Vaccine Should Not Be Mandatory

Posted by medconsumers on December 1, 2006

The new cervical cancer vaccine raises concerns that did not show up in the news coverage about its approval last summer. Usually mass vaccinations are advised for diseases with a high rate of death and/or disability, but cervical cancer doesn’t come close to meeting those criteria. And most important: Is it safe to vaccinate all girls for a disease that afflicts only 9,710 American women yearly and causes 3,700 deaths? The answer might be yes, if the vaccine is risk-free. But the nation’s leading vaccine safety organization raises some serious reservations.

Those reservations were ignored last summer when the Centers for Disease Control and Prevention Advisory Committee on Immunization Practices voted to recommend that all 11- to 12-year-old girls receive the human papillomavirus (HPV) vaccine called Gardasil. This is a major step toward making the vaccine mandatory—at an age well before girls are likely to become sexually active.

Only one company, Merck, makes the HPV vaccine, which is given in three injections over six months and will cost $360. Merck says its trials proved Gardasil is “100% effective in preventing HPV infection in those who do not already have HPV with strains 16 and 18, which together cause about 70% of all cases of cervical cancer.”

These Merck-sponsored trials were submitted to the FDA, and Gardasil was approved. But Barbara Loe Fisher, an advocate for vaccine-safety studies and the president of the National Vaccine Information Center, questions the need for a cervical cancer vaccine given the availability of the Pap test, which she believes has greatly reduced the incidence of the disease. She also sees methodological flaws and major deficiencies in what has been reported to the public about HPV disease and the vaccine.

“Most people who have sex will have experience with HPV, but the majority will clear it from the body and go on to have healthy lives. Only a tiny percentage will have persistent HPV infection and will experience changes over a long period of time that will lead to cancer. On the list of cancers that kill, this is at the bottom,” she said, referring to U.S. women, as opposed to those in developing countries where cervical cancer deaths are far more common.

As a former member of the FDA Vaccines and Related Biologic Products Advisory Committee, Fisher has considerable experience analyzing the lengthy documents submitted by the vaccine companies to the FDA, as well as the agency’s own review of company-sponsored trials. Fisher’s safety concerns center on the type of placebo Merck used in the Gardasil trials. “A true placebo would be a saline solution—something that is innocuous and has no potential to cause a reaction on its own,” she said, referring to the injection given study participants who were assigned to the control group against which Gardasil was compared.

Instead, Merck used a solution that contained aluminum, Fisher explained, and neither the company nor the FDA has publicly disclosed the amount used in the solution. “Aluminum is used as an adjuvant in many vaccines to boost the potency of the vaccine,” she continued, “and though it has been in vaccines for decades, it has never been tested in clinical trials to see whether it is safe.

“We know from animal and human biological mechanism research that aluminum can cause inflammation and brain cell death. Putting it in the placebo [in a clinical trial] violates the principle of the scientific method when trying to ascertain truth,” said Fisher. “To make matters worse, aluminum is also in the Gardasil vaccine which makes it difficult to tell whether the many adverse events reported in the trials were due to the aluminum-containing placebo or the Gardasil,” she explained, referring to the well-documented fact that adverse events will show up in all clinical trial participants, even those given an inactive placebo.

Why would the FDA overlook this potential for confounding trial results? “The FDA has become partners with the vaccine manufacturers in fast-tracking these vaccines and in the process, the precautionary principle has been thrown out,” Fisher responded, adding that most health problems occurring in vaccine trials are often dismissed. “The companies tend to write them off as unassociated with the vaccine.”

Maryann Napoli, Center for Medical Consumers ©
December 2006

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Hospital Errors Still Out of Control

Posted by medconsumers on August 1, 2006

Every day patients spend in a hospital bed, they risk harm from at least one preventable medication error. This disturbing finding is cited in a recent report on medication errors undertaken by the Institute of Medicine (IOM) at the behest of Congress. While many such errors cause only minor problems, a significant number result in permanent injury or death.

The IOM estimates that a total of 1.5 million preventable injuries occur each year as a result of lapses in medication safety. Almost half of these befall residents of nursing homes or other long-term care facilities, about 400,000 afflict hospital patients, and the rest occur in outpatient settings. Injuries to hospital patients alone are said by IOM to generate $3.5 billion in extra medical costs. Given that many drug-related injuries go undetected and/or unreported, the report concedes that the estimate of 1.5 million injuries is likely too low.

While listening to the press conference announcing the report’s release last month, I was reminded of Yogi Berra’s famous line—“it’s like déjà vu all over again.” As a co-author of the 1999 IOM report on medical errors, “To Err is Human,” I found that much of what this latest report had to say was not new. In fact, I became angry at what I was hearing during the press conference—namely that preventable medication errors were still out of control, despite the urgent warnings we had sounded six years earlier.

The 1999 report concluded, “…there is reasonable agreement about useful approaches” to prevent medication errors. Six years ago we thought that our recommendations for tackling the prevention of medication related errors would be put into practice relatively quickly. In fact the 1996 report challenged the health care system to reduce all varieties of medical mistakes by 50% within five years. But while stories of individual efforts to improve medication safety may abound, the new IOM report suggests that systemwide, the risks remain serious and widespread.

The 1999 report recommended use of computers to prescribe and dispense medicines in all hospitals. The new report recommends that medication prescribing and dispensing should be done electronically by 2010 in all settings, yet, at most, one out of five hospitals and a much smaller proportion of clinics and doctor’s offices now have that capability.

The new report’s number one recommendation for safer prescribing, dispensing and use of medications is that health care providers engage consumers in “activities and behaviors that promote their health, well-being and safety.” More specifically, it recommends that patients become better informed, ask more questions about their medications and keep an up-to-date list of the drugs they take. (For more: www.iom.edu/CMS/3809/22526/35939/35945.aspx)

Similar advice has been handed out to consumers for at least several decades, but considering the continuing epidemic of medication error-related harm detailed by IOM, I question how effective this has been has been as a prevention strategy.

I don’t disagree that becoming your own first line of defense makes good common sense, given the high risk of being hurt due to the slow pace of safety improvements in prescribing and dispensing edications. But I worry that placing too much responsibility for error prevention on patients excuses providers from accountability for the safety of care they render. We don’t approach airline safety by advising passengers to inspect the airplane for air worthiness before they board or to bring a list of questions to ask pilots about their flight plan – passengers expect flying to be safe. I suggest that medication users should someday have the same expectation—that medication use is safe—and we should hold providers accountable for meeting that standard.

For now, the best advice I can give readers is to favor health care providers who demonstrate they are serious about improving medication safety. Ask if a hospital is using computerized physician order entry; ask whether an outpatient clinic or doctor’s office can electronically prescribe and transmit prescriptions; and ask whether a pharmacy can receive electronically transmitted prescriptions from your health care provider.

Arthur A. Levin, MPH, Center for Medical Consumers ©
August 2006

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Bed Bugs: One Woman’s Experience

Posted by medconsumers on June 1, 2006

You probably know that there’s an epidemic of bed bugs in the U.S., but chances are, you don’t know anyone who has been afflicted. I think I know why. For seven months, I was plagued by unseen bed bugs but never mentioned it beyond family members. I was afraid I would be treated as a pariah.

Would you want me sitting on your sofa?

I did sit on other people’s furniture. But in my defense, I was uncertain—for a long time—about whether bed bugs were the cause of the red itchy welts that first appeared on my back one afternoon at the end of the summer. In the weeks that followed, more nickel-sized itchy welts appeared, usually mid-morning. I assumed something outside was biting through my clothes—it wouldn’t have been the first time. Still, I had never experienced bites like these before.

Bed bugs were considered, but then discounted. It is impossible, several experts told us, for two people to sleep in the same bed but only one attacked. My husband, as it turns out, is not as enticing to insects. Oddly enough, he was bitten only once—three welts in a row looked just like mine. He was, however, completely unaware because they did not itch.

Initially, the welts could have been mistaken for hives, but hives don’t stick around in the same spot for a week, said the dermatologist. I had consulted him in the naïve belief that a dermatologist would know just by looking at the bites whether bedbugs were attacking me.

The nights I spent away from home on business trips, I was fine. And I was fine when I slept in our guest room, which I did most of the time in desperation and against all prevailing advice (if it’s bed bugs, the infestation will move to another room). Each time I ventured back to my own bed, there would be more bites.

I would learn that it’s impossible to diagnose bed bugs by the appearance of the bites because they can be so inconsistent. Once, when bitten on the side of an ankle, the swollen area simply looked like a sprained ankle. In other body parts like the calf, a large area would swell and stay hard for almost two weeks. More often, a dime-sized hard welt could be felt beneath the skin. And sometimes they looked like ordinary mosquito bites.

There was nothing ordinary, however, about the intense itching that lasted at least 48 hours. It was impossible to resist scratching to the point of drawing blood, though I’d read that this only intensifies the irritation and may lead to a secondary infection. By the third day after a new set of bites, the itchiness would decrease to the level of an ordinary mosquito bite.

As the months went by, I became more sensitive to the bites and no longer had to wait until mid-morning to learn that the deed had been done. Nothing relieved the extreme itchiness. In time, I became so sensitive to the bites that the itch would wake me up two hours after getting into bed. More times than I care to count, my husband and I would remove and wash all the bedding (dryer heat to 140 degrees will kill bugs) and vacuum the bedroom, only to have the attacks continue. We would jump out of bed with flashlights after a new bite but never found anything. No reputable exterminator would treat a home, we were told, until the offending insect was identified, and we had nothing to show for our efforts.

By mid-winter, I learned that, yes indeed, bed bugs will bite only one of two people sleeping in the same bed. I was listening to our local public radio station and happened on an interview with two bed bug experts, Richard Cooper and Richard Pollack (see below). When they opened the phones, a woman called in to say that her boyfriend is bitten continuously, but she isn’t. Both experts said that was not unusual!!

Though we still hadn’t captured a single insect, we got an exterminator to check out our bedroom. (The preferred term is now pest control or pest management professional, but I like the word exterminator because it holds more promise.) He searched all around the bed with a flashlight. He, too, could find nothing and assured us that we probably do not have bedbugs because there is no telltale sign of infestation, no tiny black spots (feces), no cast-off skins, etc.

Be happy it’s not bed bugs, the pest control expert said, having your apartment exterminated is costly and time-consuming. “It’s almost as bad as moving. You have to get everything out of the closets, and drawers, bag all your clothes, move everything out of your apartment except the furniture.” After hearing what we had been doing with the glue traps, white sheets (for better visibility), flashlight, etc., he told us there was one thing we hadn’t tried: turn the box spring upside down.

Amazingly, that did it. Two dark brown oval-shaped bugs about a quarter inch long were found on the wooden rim of the box spring. They were bottled and sent to the lab. The good/bad news came the next day. They were bedbugs. Of course, I was relieved to have a reason for the bites, but the prospect of bagging and moving all our stuff outside was daunting. Our duplex apartment is in an attached brick row house. No garage and a tiny backyard. It rained softly on the day of the extermination.

It cost us more than $4,700 altogether: $2,167 with no guarantee for the extermination (warning:  two bed bug experts told me that this price was excessive); $1,500 for a new mattress and box spring (see below); and the rest for rug cleaning. Because we had such a minor infestation and because all the bites had occurred only in the bedroom, we were told that the parlor floor needed only minimal treatment. We did not spread the bugs to either daughter’s apartment or to my nephew who spent several weeks in our guest room.

Remembering the end of a bed bug article I’d read in the New Yorker magazine years ago, I slashed our mattress before putting it out for the sanitation truck. The couple in that article had put their infested mattress out on the sidewalk for collection plastered with signs saying, “Bed bugs. Do not take.” They went off for a few hours, and upon return were horrified to see that someone had taken the mattress.

You might wonder how the bedbugs got to our bedroom. We do, too. We did not order a mattress from one of those companies that pick up the old mattress and put it in the back of the truck with all the new mattresses. And we did not bring any second-hand mattress, headboard or any other type of furniture into the house. Initially, I discounted the most obvious possibility—a hotel stay—but then I learned, when writing the accompanying articles (see below), that there is a long lag time (about 2-4 months) between the introduction of bedbugs and when the victim becomes aware of the bites. I had stayed at a hotel three and a half months before the initial bites.

The unsettling part of the conclusion to my story is how unsettled it is. The bed bugs have returned twice (necessitating more exterminations) in the 35 days since our apartment was initially treated. I know it only from the bites. I still haven’t seen a single bed bug beyond the two found on our box spring.

Entomologist Richard Pollack Reacts to the above article about my Bed Bug Experience

When Richard Pollack, PhD, Laboratory of Public Health Entomology at the at the Harvard School of Public Health, read about my bedbug experiences, he said it was a mistake to throw out our mattress and box spring (until he heard they were around 18 years old). “It’s a waste of money. You can treat the mattress and box spring safely. There are insecticide products for use on mattresses and their risk to people should be small.”

“I actively dissuade people from throwing out their mattresses because of the risk of spreading the bugs,” said Pollack. “Besides you can get a mattress bag that completely encases the mattress. These mattress casings are intended for reducing dust mites for people with allergies, but they may reduce the risk that the mattress you retain will foster bedbugs. When closed well, any bug or egg that may be stuck inside will be imprisoned, and the chances of anything getting through—or feeding through the fabric—are almost nil.”

Pollack was asked how consumers would know whether extermination products described as “virtually safe” are in fact, virtually safe. “I recommend that the pest control companies offer potential customers a packet of written information that includes a description of the plan for extermination; the insecticides that will be used, and where they will be used; the expected outcome; how long it will take to rid the home of pests—one month, two months—and a copy of the label that accompanies the can or gallon jug of the product to be used. The label should be like a drug label, stating what it’s for, how it works, the risks and benefits. It’s good to get everything in writing beforehand.”

After reading my story, Dr. Pollack said he thought my concern about sitting on other people’s furniture was excessive. Yes it is possible to bring bedbugs to another person’s house on your clothing, he explained. “But you said that you went for a long time suspecting bedbugs but never seeing them,” he continued. “If, however, you know you have an infestation, I believe you do have an obligation to be very careful not to bring personal possessions into someone else’s home and certainly not place them on someone’s bed.”

How Bedbug Experts Protect Themselves

Three experts were asked what they do to protect themselves from bedbugs and for advice about finding a reputable pest control company. All said they are extremely wary of hotels and conduct a thorough inspection of the room before unpacking their luggage.

“Regardless of how many stars a hotel has on its marquee or whether it has a flea bag look, I do the same thing,” said Richard Pollack, PhD, Laboratory of Public Health Entomology at the Harvard School of Public Health. “Upon entering the room, I put the luggage—still completely zipped—on the tubular luggage rack—bedbugs can’t climb smooth surfaces. And I never put luggage or clothing on the bed or chair,” he said in a telephone interview.

“First I strip the bed and pile all the bedding on one side of the mattress. Then I take a quick look around the mattress, especially the seams, and the box spring,” he continued. “I look for live bugs, cast skins, fecal spots that look like a series of black ballpoint pen dots. In a few places I’d go so far as to detach the headboard from the bed, which in many hotels is usually just resting on a bar. I also look around the framed pictures which are usually well secured to the wall in most hotels.”

Once the trip is over, Christian Borre, account executive at Systematic Pest Elimination in Hillsdale, New Jersey, does not bring the luggage into his house right away. “If it’s a 95 degree day, I keep the suitcase in the trunk of the car. Bedbugs can’t stand heat above 140 degrees” said Borre in a telephone interview. “If it’s winter, I leave it out overnight in the car trunk.” When he is ready to inspect his suitcase for bugs, he puts it on his deck, takes everything out and goes through all parts of the suitcase with a flashlight. “Then I bang the suitcase against the deck to see if anything falls out.”

According to the prevailing theory, the U.S. is experiencing a resurgence of bedbugs for the first time in 50 years because DDT was banned, but Richard Cooper, technical director for Cooper Pest Solutions in Lawrenceville, New Jersey, disagrees. He believes that bedbugs first got a foothold in the U.S. in hotels. “For many years, the baseboards of hotels and apartments would be sprayed on a monthly basis to get rid of cockroaches, and in the process, bed bugs may also have been inadvertently eliminated as they were being introduced.

“In the mid to late 90’s, the pest management industry changed the style of pest control in hotels and apartment buildings as they switched from routine sprays of organophosphate and synthetic pyrethroids to insect baits for the control of cockroaches and ants. These new methods provided excellent control for roaches and ants, but may have opened the door for bed bugs to regain a foothold, as baits have no effect on bed bugs.” Cooper said in a telephone interview, adding that international travel, especially from developing countries, also plays a role the resurgence in bed bugs.

Cooper said that people frequently have the misconception that bed bugs only hang around the bed. What’s more, “people often don’t know what they’re looking for.” Misidentification is apparently fairly common. “More than half the things submitted to our lab are not bed bugs,” said Pollack, “many are simply carpet beetles that everyone has.”

Say a lab confirms the presence of bed bugs, then what? How do you find a reputable pest control company? “Do your homework in the same way you would if a contractor told you that you need thousands of dollars worth of work on your house,” advised Pollack. “Get quotes from other companies, ask for references from satisfied customers, ask what happens if the bugs return—will you charge me more?—and check with the Bureau of Consumer Affairs.”

In some cases a single treatment will suffice; other cases are more difficult and could take months, said Pollack. “It’s a bad sign if a guy comes to your house with the equipment on his back and starts spraying; instead the person should come in with a flashlight and clipboard and first do a careful inspection.”

“Ask what the plan of attack will be,” suggested Borre, who says he gives written instructions to his customers about what his company will do, what the customers must do in terms of preparing their home in advance, and what to expect from the service. “Ask about the followup because the bugs can come back. Ask what recourse you have if the bugs come back. The price will be high because of the tediousness of the process.”

Cooper cautioned, “You don’t want someone who will just do the initial service with no follow ups. There should be a minimum of three followups. “Visit the National Pest Management Association Web site to see which companies have a Quality Pro designation, which means they meet the high standards set by the industry, but if a company isn’t listed, that doesn’t necessarily mean it’s not a good company,” he said, adding that a company with an entomologist (scientist who studies insects) on the staff is a good sign.

“Nothing you can do will guarantee that bed bugs will not be introduced into your home; however due diligence during and after travel as well as care when purchasing used items, particularly furniture will help in reducing the likelihood of introducing bed bugs” said Cooper. People who live in a single-family home with lots of distance from neighbors are less likely to get bed bugs than people living in multiple-family buildings that share walls with others, he explained, then things are out of your control.

For more information:

The following organizations have Web sites complete with pictures of bedbugs and advice:

Richard Cooper’s company www.cooperpest.com

National Pest Management Association (www.pestworld.com) explains Quality Pro standards, and lists the companies that say they meet them.

If you found this article helpful, see the list of our latest articles in “Article Archive” on our home page.

Maryann Napoli, Center for Medical Consumers ©

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