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Posts Tagged ‘Alternative Medicine’

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Mediterranean Diet: What Accounts for the Health Benefit?

Posted by medconsumers on July 1, 2009

The Mediterranean diet is not only wildly popular around the world but also considered to be one of the most healthful diets of all that have received in-depth research attention. Yet it is unclear whether it is the wine, olive oil or some other component of the diet that largely accounts for the health benefits, chief among them is longevity.

An international team of researchers led by Dr. Antonia Trichopoulous produced the first study to assess the relative importance of the individual components of the Mediterranean diet. It was published last month in the online version of the British Medical Journal.

The 23,349 participants in the study were Greek adults who were free of heart disease, cancer, and diabetes at the start of the study. After 8 ½ years of follow-up, those who reported the strictest adherence to a Mediterranean diet showed a lower mortality rate than those who did not.

The researchers teased out the contribution of the nine dominant components of the traditional Mediterranean diet that account for the lower mortality. In descending order of importance, the components are: moderate consumption of alcohol (primarily wine), low consumption of meat and meat products, high consumption of vegetables, high consumption of fruits and nuts, high consumption of oil (mostly olive oil) and high consumption of legumes (e.g., beans, lentils).

There were some surprises in this study. The researchers found that high consumption of fish and seafood, cereals, and low consumption of dairy products had no effect on reduced mortality. The study was funded by the Europe against Cancer Program of the European Commission and the Greek Ministries of Health and Education.

An international team of researchers led by Dr. Antonia Trichopoulous produced the first study to assess the relative importance of the individual components of the Mediterranean diet. It was published last month in the online version of the British Medical Journal.

The 23,349 participants in the study were Greek adults who were free of heart disease, cancer, and diabetes at the start of the study. After 8 ½ years of follow-up, those who reported the strictest adherence to a Mediterranean diet showed a lower mortality rate than those who did not.

The researchers teased out the contribution of the nine dominant components of the traditional Mediterranean diet that account for the lower mortality. In descending order of importance, the components are: moderate consumption of alcohol (primarily wine), low consumption of meat and meat products, high consumption of vegetables, high consumption of fruits and nuts, high consumption of oil (mostly olive oil) and high consumption of legumes (e.g., beans, lentils).

There were some surprises in this study. The researchers found that high consumption of fish and seafood, cereals, and low consumption of dairy products had no effect on reduced mortality. The study was funded by the Europe against Cancer Program of the European Commission and the Greek Ministries of Health and Education.

Maryann Napoli, Center for Medical Consumers(c)

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Red Yeast Rice Supplements: Not a Safe Alternative to Statins

Posted by medconsumers on July 1, 2009

Many people who cannot tolerate any of the cholesterol-lowering drugs called statins (e.g., Lipitor, Pravachol, Zocor) turn to an herbal supplement called red yeast rice, which lowers the low-density lipoprotein (LDL) cholesterol. Statin intolerance is most often chalked up to muscle pain (myalgia). A rare side effect of all statins is the potentially fatal disease called rhabdomyolysis, which causes destruction of the skeletal muscles.

A new trial, with only 62 statin-intolerant participants, randomly assigned them to take either red yeast rice supplements (1800 mg) or a placebo twice daily for six months. All took part in a 12-week program of education, diet, exercise, and relaxation sponsored by a local cardiology practice.

Both groups lost weight but the people taking the supplements showed greater reductions in LDL than the people on placebos. And the supplement group did not suffer more muscle pain. Yet despite these promising findings, the editorial that accompanied this study, published recently in Annals of Internal Medicine, advised doctors not to recommend the red yeast rice supplement. Reason: it is “an unapproved, unstandardized form of lovastatin labeled as a nutraceutical.”

The basis for this charge is a 2008 test of ten different brands of red yeast rice supplements by ConsumerLab.com. This independent testing group revealed that all ten supplements contained naturally occurring statin compounds in varying doses—some as high as that of prescription statins. This explains why the supplement used in the new study contained lovastatin (sold under the brand name: Mevacor).

There are other reasons why the new trial failed to show that supplements are better than statins. It lasted only six months and thus could not rule out the possibility that red yeast supplements taken longer would cause muscle pain. Unlike statins, the supplements have not been proven to reduce the risk of heart attack and stroke. The new study was primarily funded by the Commonwealth of Pennsylvania.

For information on the risks and small benefits of statin drugs, read this. And if you are taking Zetia or Vytorin, read this. And if you want to know more about statin drugs vs. the Mediterranean diet, read this.

Maryann Napoli, Center for Medical Consumers©

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Wrist Splints Work For Thumb Arthritis

Posted by medconsumers on June 1, 2009

People with osteoarthritis at the base of the thumb are often told to wear a thumb splint to ease symptoms. The first study to test this advice found it to be effective for many people. It was published recently in Annals of Internal Medicine by a French team of researchers led by Francois Rannou, MD.

The 112 participants were mostly women, who were randomly assigned to wear custom-made splints at night or to continue with their usual care, which could include anti-inflammatory drugs and steroid injections but no splints. Dr. Rannou and colleagues found that nighttime splinting had no effect at one month, when all the participants were asked about their pain levels and hand function.

At 12 months, however, larger improvements in pain scores and hand function were reported for a greater proportion of the people wearing nighttime splints, compared to those who continued their usual care. At 12 months, 86% of the people assigned to wear a splint reported wearing it more than 5 nights a week.


Maryann Napoli, Center for Medical Consumers(c) June2009

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Posted in Alternative Medicine, Chronic Conditions, Pain, Women's Health | Tagged: , , | Comments Off

Home Remedy and Antibiotics for Eczema

Posted by medconsumers on May 11, 2009

A small, preliminary study published in the journal Pediatrics showed a combination treatment can alleviate symptoms of the painful itchy skin disease called atopic dermatitis, which is the most common of the many forms of eczema. It combines a home remedy—soaking in bath water diluted with laundry bleach—and antibiotics.

Jennifer T. Huang, MD, and colleagues at the Northwestern University, Feinberg School of Medicine, Chicago, acknowledged that, along with other pediatricians, they had been advising the diluted bleach baths for some time because they appear to alleviate symptoms and cut down on infections. Their study is the first to include this home remedy.

In an effort to reduce the most troubling complication of atopic dermatitis, all 31 children with eczema who participated were given oral antibiotics for 14 days prior the start of the study. This was to combat the bacterial infection, most often staphylococcus, which can occur when children scratch themselves hard enough to draw blood.

The participants, ages 6 months to 17 years, were then randomly assigned to sit submerged in a bathtub full of water mixed with 1/2 cup of bleach for 5 to 10 minutes twice a week over three months, or a bathtub full of plain water. Only the children in the bleach-bath group were given an antibiotic ointment (mupirocin), which was applied intranasally.

At three months, the children in the bleach-bath group showed greater decrease in the severity in their symptoms and in symptoms of bacterial infections. Huang and colleagues wrote that the next research step should be more studies that assess the efficacy and long-term safety of diluted bleach baths without the addition of antibiotics.

Maryann Napoli, Center for Medical Consumers© May 2009

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Posted in Alternative Medicine, Children's Health, SKIN | Tagged: , , , , | Comments Off

Peppermint Oil, Fiber and Antispasmodic Drugs for IBS

Posted by medconsumers on January 1, 2009

Three inexpensive treatments work well for many people with irritable bowel syndrome, according to a new review published in the British Medical Journal. While peppermint oil, fiber and antispasmodic drugs have long been known to be helpful, uncertainties surround the supporting evidence. After evaluating 30 years of published research, the reviewers verified the effectiveness of these three treatments in comparison to placebo and found that peppermint oil may provide the strongest benefit.

These findings are of special interest due to the serious harms caused by two widely advertised prescription drugs for irritable bowel syndrome—Lotronex (ischemic colitis, transfusions, surgery, death) and Zelnorm (heart attacks, strokes).

The Fiber Trials
The symptoms of irritable bowel syndrome can be chronic and varied, including diarrhea, bloating, constipation and abdominal pain. And the condition is difficult to treat. Starting with the old, stand-by—fiber—the international review team led by Alexander C. Ford, McMaster University, Hamilton, Ontario, Canada, found 12 trials that explored this treatment. Virtually all those that involved the insoluble fiber in wheat bran found that it was no better at easing symptoms than a low-fiber diet or placebo.

Soluble fiber is best, but the reviewers were careful to note that the beneficial effects seemed to be limited to ispaghula husk, also known as psyllium, which contains a high level of soluble dietary fiber. (This is the chief ingredient in many commonly used laxatives, such as Metamucil® and Serutan®.) Based on the six soluble fiber trials in this review, the reviewers estimated how many people experienced relief. For every six people on a diet high in ispaghula husk, one experienced symptom relief. Adverse effects were not mentioned by the authors of most of the 12 trials.

Peppermint Oil Trials
Peppermint oil was better than placebo at alleviating symptoms, though the trials did not use the same doses. (They ranged from 200 mg to 225 mg capsules of peppermint oil, taken two or three times daily.) While peppermint oil was the most effective of the three treatments, it had the least amount of supporting research. There were only four trials with 392 participants, altogether. Efficacy was high, though. For every two people who took peppermint oil, one experienced symptom relief. Adverse effects occurred in five people taking peppermint oil, compared to none for those taking placebo. The trial authors, however, did not elaborate on the nature of the adverse effects.

Anti-Spasmodic Trials
Antispasmodic drugs are generally seen as the first-line treatment, especially when pain and bloating are the predominant symptoms. The highest number of trials, 22 in all, compared antispasmodic drugs with placebo in 1,778 participants, altogether. Most followed participants for less than four months. Adverse effects were described as, “significantly more frequent in those taking antispasmodic drugs than in people taking placebo, but none was serious.” For every three or four people who took an antispasmodic drug, one experienced symptom relief. Of the five different antispasmodic drugs studied, only one drug, hyoscine, showed consistent evidence of efficacy. It is an inexpensive prescription drug that is available generically. This review of trials was funded by the American College of Gastroenterology.

Maryann Napoli, Center for Medical Consumers© January 2009

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Vitamins: Research Shows No Benefit and Some Risks

Posted by medconsumers on December 1, 2008

Vitamins Don’t Work: Research Continues to Find No Benefit and Some Risks

Looking for ways to save money? Stop taking vitamins. The scientific case against them has been building over the last few years, starting with the report from the 2006 U.S. National Institutes of Health State-of-the Science Conference on Multivitamins/Mineral Supplements. The next year, a Cochrane review of all antioxidant trials caused an uproar because it found no preventive benefit to taking these supplements and a slight increase in mortality. And just in the last month alone, one new trial found no cancer preventive benefit to taking B vitamins; and another trial found no cardiovascular preventive effects for vitamins C and E. Both were published in the Journal of the American Medical Association.

B Vitamins
The B vitamins trial was led by Shumin M. Zhang, MD, and colleagues at Brigham and Women’s Hospital in Boston and Harvard Medical School. The impetus for this trial, explained the researchers, was the prevailing idea that folate, vitamin B6 and vitamin B12 might play an important role in cancer prevention. Yet the researchers also noted that information from earlier trials of folic acid alone or in combination with B vitamins have produced mixed results, and one trial “even raised concerns about deleterious effects.” What’s more, women were underrepresented in these trials.

Zhang and colleagues recruited 5,442 female health professionals, aged 42 years or older with cardiovascular disease or three or more risk factors for heart disease. All were randomly assigned to take a placebo or a daily supplement that combined 2.5 mg of folic acid, 50 mg of vitamin B6 and 1 mg of vitamin B12.

After seven years, the women taking the combination supplement had the same rate of cancer as those taking a placebo. This trial was funded by a grant from the U.S. National Institutes of Health.

Vitamins E and C
The other new trial found that vitamins E and C did not prevent cardiovascular disease in healthy men, aged 50 and older. The Physicians’ Health Study II involved 14,641 male physicians, 5% of whom had cardiovascular disease at the start of the trial. The men were randomly assigned to take 400 IU of vitamin E every other day and 500 mg of vitamin C daily or a placebo.

After a mean follow-up of eight years, the supplements had not reduced the risk for heart attack, stroke, death, heart failure, angina or the need for a coronary artery-opening procedure. Worse, vitamin E was associated with an increased risk for hemorrhagic stroke, or bleeding in brain (39 hemorrhagic strokes in the men taking vitamin E, compared with 23 in those taking a placebo). The negative results shown for vitamin E confirm those from earlier studies that involved men and women with preexisting cardiovascular disease.

This trial was led by Howard D. Sesso, ScD, Harvard School of Public Health, and funded by grants from the National Institutes of Health, the BASF Corporation, Wyeth Pharmaceuticals, and DSM Nutritional Products Inc (formerly Roche Vitamins).

Earlier Vitamin Research:
These two new trials are but a small part of the research that has found vitamins do not prevent illness or prolong life. Far more extensive is the following government report about multivitamins and the Cochrane review of antioxidant trials mentioned at the beginning of this article.

The report from the 2006 NIH State of the Science Conference on Multivitamins/Minerals for the Prevention of Chronic Conditions. A panel of experts was charged with the task of reviewing all placebo-controlled trials designed to see whether multivitamins and/or minerals can prevent cancer; age-related sensory loss; and cardiovascular, endocrine, neurologic, musculoskeletal, gastroenterologic, renal and pulmonary diseases. This is the report’s conclusion:

In systematically evaluating the effectiveness and safety of multivitamins and/or minerals in relation to chronic disease prevention, we found few rigorous studies on which to base clear conclusions and recommendations. Most of the studies we examined do not provide strong evidence for beneficial health-related effects of supplements taken singly, in pairs, or in combinations of 3 or more.

Within some studies or subgroups of the study populations, there is encouraging evidence of health benefits, such as increased bone mineral density and decreased fractures in postmenopausal women who use calcium and vitamin D supplements. However, several other studies also provide disturbing evidence of risk, such as increased lung cancer risk with beta-carotene use among smokers.”

The updated 2008 Cochrane review: “Antioxidant supplements for prevention of mortality in healthy participants and patients with various diseases.” The 68 placebo-controlled trials included in this review attempted to answer these questions: Can antioxidants prevent disease in healthy people? Can they prevent recurrences in people with cancer, heart disease or other illnesses?

This is the Cochrane review’s conclusion:

We found no evidence to support antioxidant supplements for primary or secondary prevention. Vitamin A, beta-carotene, and vitamin E may increase mortality. Future randomized trials could evaluate the potential effects of vitamin C and selenium for primary and secondary prevention. Such trials should be closely monitored for potential harmful effects. Antioxidant supplements need to be considered medicinal products and should undergo sufficient evaluation before marketing.

Funding Questioned: When this Cochrane Review was first published in 2007, we reported its findings and addressed one of the strongest criticisms leveled against it. Many suspected that the review was funded by the pharmaceutical industry to counteract public enthusiasm for vitamins. In our 2007 article on this topic, one of the review’s co-authors was asked about the funding: Christian Gluud, MD, of the Cochrane Hepato-Biliary Group, Rigshospitalet, Copenhagen University Hospital, responded, “The sole sponsor of this review is the Copenhagen University Trial Unit, a publicly funded, not-for-profit clinical research center, and about 90% of the trials in this review were funded by companies that make vitamins.”

Maryann Napoli, Center for Medical Consumers©

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On Exposure to Light at Night

Posted by medconsumers on September 1, 2008

On Exposure to Light at Night, Cancer…and Rethinking Normal Sleep

There is no scientific consensus about the cause of breast cancer, according to Richard G. Stevens, PhD, Professor and Cancer Epidemiologist at the University of Connecticut Health Center, Farmington. That’s as true today as it was in 1987 when Dr. Stevens began to publish a new theory about exposure to electric light at night and how it may trigger disruptions in the body’s circadian rhythm—that is, the cyclical changes that recur regularly over a 24-hour period.

These disruptions, in turn, can cause hormonal disturbances implicated in the development of breast cancer. Central to this theory is melatonin, a hormone that helps regulate the sleeping/waking cycles. Melatonin is primarily produced by the pineal gland at night and is suppressed by exposure to light.
Since his theory was first proposed, Dr. Stevens has co-authored studies showing an increased risk of breast cancer among women who work the graveyard shift. And he has co-authored another study showing a decreased risk among women who sleep nine hours or more each night. He also challenges the prevailing medical wisdom about normal sleep in the following interview conducted by Maryann Napoli, Center for Medical Consumers.

MN: In just 20 years, you went from proposing what might have seemed like a crackpot idea at the time to having it validated by the International Agency for Research on Cancer, based in Lyon, France. In 2007, that agency, which is part of the World Health Organization, declared shift work to be a “probable human carcinogen.” What made you initially suspect the link between breast cancer and exposure to electric lighting at night?

RGS: I’ve been interested in breast cancer for a very long time. It’s a mystery why it is so common in industrialized countries and why it becomes common as countries become industrialized. Up until the mid-1980s, we [researchers] thought it had to be due to the Western diet that is high in fat, but the really good, big cohort studies of diet that followed hundreds of thousands of women for 10-30 years – all came up negative. There is no relationship between fat consumption in adulthood and the risk of breast cancer.

MN: So you began thinking of other possible causes.

RGS: Yes, I was lying in bed awake in the middle of the night with the light from the street lamp coming into my room—and I’m not suggesting that streetlights alone are the problem. [It was so bright] I could almost read in my bedroom, and I thought this is something that has changed since society has become industrialized. I wondered if that had anything to do with cancer. Then I found out about what light can do and the hormones and the melatonin connection. Then I started publishing on the topic.

MN: You took off from the idea that we humans have evolved over the course of three billion years, but we have dramatically changed the environment only in the last 130 years with the introduction of electricity. How did you start to prove your theory?

RGS: The way we gather evidence is to make predictions. For example, if shift workers get lots of light at night and their circadian rhythms are disrupted, then, according to the theory, they should be at higher risk of breast cancer. Another prediction was that blind women would be at a lower risk [because their melatonin is not suppressed by exposure to light]. Another is the association between long sleep duration and a lower risk of breast cancer.

MN: You co-authored a study of shift workers that was published in the Journal of the National Cancer Institute in 2001. It showed an increased risk of breast cancer among women who worked long hours and many years in the graveyard shift, compared with those who didn’t do shift work. But it was only a modest increase in risk, wasn’t it?

RGS: That’s correct. But keep in mind that the comparison group, though it was comprised of women who didn’t do shift work, was getting plenty of the usual exposure to electric light at night. The strongest evidence is for the shift workers, but we don’t have a lock on it yet. There are also the four or five studies of breast cancer in blind women, and they all reported a lower risk of breast cancer as predicted. There are three good studies of sleep duration, two of which found that women who sleep a long time have a lower risk of breast cancer. So you get the idea—it looks as though the more time you spend in darkness, the lower the risk of breast cancer, although there is no scientific consensus on this. We need more studies consistent with those we have if we are to get to that point.

MN: What other ill effects might be associated with circadian disruption?

RGS: Three studies about prostate cancer were published in the last few years. Two showed that shift-working men were at a higher risk of prostate cancer. And another, just published in the British Journal of Cancer, was about sleep duration—the longer the sleep, the lower the risk of prostate cancer.

MN: What about interrupted sleep? People who wake up in the middle of the night will read or watch TV. Or they turn on the light briefly just to go to the bathroom.

RGS: There is evidence that those vanity lights in the bathroom [with light bulbs all around the mirror] are bright enough to start lowering the melatonin almost immediately.

MN: Is it OK to keep a night light in the bathroom?

RGS: We don’t know yet whether this is relevant to breast cancer, but just in terms of circadian health, the best thing to install in the bathroom is a night light with a red bulb.

MN: Why red?

RGS: The wavelength with the maximum ability to affect melatonin is blue. Red is much less efficient. You need a lot of red light to affect melatonin. So a dim red bulb will almost surely have no effect on your melatonin.

MN: My husband has a very bright digital alarm clock on his side of the bed. It’s irritating to me when he’s not in the bed to block the light.

RGS: What color is it?

MN: Green.

RGS: Throw it away and get a red one. We don’t know whether that green light is bright enough [to cause a problem], but if it irritates you, throw it away.

MN: So the point is to keep the bedroom as dark as possible.

RGS: You don’t have to be asleep for melatonin rhythm to be fine, but you do have to be in the dark.

MN: So, if you can’t sleep, you’re better off just staying in bed in the dark, perhaps listening to your radio or iPod?

RGS: I don’t think there are experts on this anymore. What we have been told by the sleep doctors for some time now is that you’re supposed to be getting eight straight hours of sleep. And if you wake up in the middle of the night, you should leave the bedroom and read or watch television. But that view runs counter to our evolution and is being seriously questioned by many sleep researchers.

MN: Why?

RGS: We have evolved in 12 hours of dark—a biphasic sleep—a first sleep and a second sleep. There’s an historian who points out that there are many references to the first sleep and the second sleep in medieval literature, in Shakespeare and in Chaucer. What it means is that it was normal—up to the invention of electricity—to go to sleep fairly close after the sunset, sleep for a few hours and then wake up and be awake for maybe an hour or two in the dark. (See Recommended Reading).

MN: But isn’t this is a form of insomnia?

RGS: There is a growing group of sleep researchers who are challenging that idea. I think it’s fine to be awake in the middle of the night. Enjoy the period of quiet wakefulness. But if you do get up and turn on the lights, you are suppressing melatonin, you are disrupting circadian rhythms and that, to me, may be increasing your risk of breast cancer and perhaps other maladies.

MN: What about taking melatonin supplements?

RGS: People often say to me, “Melatonin is good for you because it fights cancer, so I’m going to take a melatonin tablet every day.” I would certainly not do that. It has become clear with experiments in people taking melatonin tablets in the evening that this will actually change circadian rhythm and that can’t be good.

MN: So in summary: If you have insomnia, you shouldn’t take melatonin supplements or get up to watch TV or read. You should just lie there in your bedroom that is as dark as possible. How do you think that advice will go over with the millions of pill-popping insomniacs out there?

RGS: Change your attitude. That period of quiet wakefulness in the middle of the night is a time to wander peacefully in your mind and spirit.

Recommended Reading:

“Acknowledging Preindustrial Pattern of Sleep May Revolutionize Approach to Sleep Dysfunction” by Walter A. Brown, MD, May 26, 2006, Applied Neurology. This article is accessible at www.psychiatrictimes.com/display/article/10168/56881

Maryann Napoli, Center for Medical Consumers ©
September 2008

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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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Yogurt Drink Prevents Antibiotic-Induced Diarrhea

Posted by medconsumers on July 8, 2007

A yogurt drink sold in many supermarkets has been shown to reduce the risk of severe diarrhea that can occur after taking antibiotics. The study, published last month in the British Medical Journal Online First, was conducted at several hospitals, a setting where people are most likely to be exposed to drug-resistant strains of bacteria.

Of particular concern in most industrialized countries is the emergence of Clostridium difficile, an increasingly common, sometimes fatal, complication of antibiotic treatment, which occurs in about 5-25% of all hospitalized patients, usually two or three weeks after finishing antibiotic treatment.

Eating yogurt is now a standard way for people to protect themselves while on antibiotics. And to serve this expanding market, more and more yogurt products now feature the word probiotics on the label, claiming that they contain live cultures. Probiotics are defined as “live micro-organisms which when administered in adequate amounts confer a health benefit on the host.” Most probiotic products contain bacteria that help to balance the hundreds of different species of bacteria found in the human body.

Probiotics are gaining some research attention because of the overuse of antibiotics and the resulting increase in drug resistance. Probiotic-containing foods and capsules are consumed to overcome the tendency of antibiotics to kill the normal as well as the harmful bacteria. The problem with products claiming to contain probiotics or “live active cultures” is that they are unregulated, so it’s impossible to know whether they actually contain adequate amounts of live bacteria and the right strains of live bacteria.

British Hospital Study

The probiotic drink used in the newly published British hospital study was Actimel, sold as DanActive in the U.S. This study was partly funded by Danone, a French company that makes both products, which contain Lactobacillus casei, L bulgaricus and Streptococcus thermophilus. All three strains had already been evaluated for the prevention or treatment of diarrhea associated with antibiotic use and found to be safe, according to the British researchers led by Mary Hickson, Imperial College, London, England.

The researchers recruited patients from three London hospitals. All were asked to participate within 48 hours of taking their first dose of antibiotics prescribed for a variety of infections unrelated to any gastrointestinal ailments. The 113 patients (mean age, 74 years) who decided to participate were randomly assigned to drink either four ounces of Actimel or a placebo drink (milkshake).

All agreed beforehand to take the assigned drink twice a day during the course of antibiotics and for one week after completing the regimen. Neither the patients nor the hospital staff knew who was in the probiotics group and who was in the placebo (milkshake) group. When participants developed diarrhea, stool samples were analyzed for the potentially fatal Clostridium difficile toxin.

The hospital patients in the probiotics group fared much better than those in the placebo group. Hickson and colleagues concluded, “Consumption of a probiotic drink containing L casei, L bulgaricus and S thermophilus can reduce the incidence of antibiotic-associated diarrhea and C difficile-associated diarrhea. This has the potential to decrease morbidity, heath care costs, and mortality if used routinely in patients over age 50.”

Here are the results of the study: 12% of the hospital patients in the probiotic group developed diarrhea associated with antibiotic use, compared with 34% of the patients in the placebo group. No one in the probiotics group developed C difficile, but 9% of the patients in the placebo group developed this serious complication.

Cost Effective, Too

Hickson and colleagues provided this estimate of the cost savings in U.S. dollars. The average cost of the probiotics regimen in this study was $20 per patient. The cost of preventing one case of C difficile-associated diarrhea with probiotics was estimated to be $120, excluding dispensing and nursing costs. This is due to that fact that six patients were treated with probiotics for each case of C difficile prevented.

The $120 was then compared with the $3,669 it would cost in the U.S. to provide the standard medical treatment for one person with C difficile. The high cost is mainly due to the increased length of hospital stay required for people with C difficile and the use of a costly intravenous antibiotic called vancomycin, according to Hickson and colleagues.

Vaginal Infections

Something important to women was not addressed in the British study. Many eat yogurt while on antibiotics in order to avert another nasty side effect—vaginal infections. Will the yogurt drink used in this study have any preventive benefit for this infection? The answer is no, according to a leading probiotics expert not associated with the British study: Gregor Reid, PhD, Canadian Research and Development Centre for Probiotics in London, Ontario. “The product [Actimel/DanActive] is designed for intestinal benefits and not for the type of bacteria strains needed to promotevaginal health.”

There is, however, another product proven to reduce the risk of vaginal infections, called Fem-Dophilus (www.jarrowprobiotics.com), said Dr. Reid, who owns patents to the strains present in these capsules. As for the probiotic claims on numerous products sold in supermarkets and pharmacies: “It’s only a probiotic if the product formulation has been clinically tested. Many of them have not. At least, if they have the strains of probiotic in a suitable viable count as found in studies with other formulations, it is promising, but the real test is a human study with the formulation.”

Maryann Napoli, Center for Medical Consumers ©
July 2007

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