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A new study claiming that multivitamin use by postmenopausal women does little to improve their risk of mortality fails to take into account important dietary factors or accurately grasp how dietary supplements and health claims are regulated by the U.S. Food and Drug Administration (FDA). According to the study, which was published in the February 9 issue of Archives of Internal Medicine, postmenopausal women who take multivitamins have the same risk of dying from “most common cancers, cardiovascular disease or of any cause as women who do not take multivitamin supplements.”

“While cohort and observational studies like these can be important, they in no way constitute convincing or conclusive evidence,” said Daniel Fabricant, Ph.D., vice president of scientific and regulatory affairs for the Natural Products Association. “This study fails to tell the whole story about the positive effect that vitamins and minerals can have on health. It also does not take into account important factors such as nutrients gained through diet.”

Fabricant said it is “unprincipled” that the authors arbitrarily lumped supplement types into generalized categories that do not represent nutrient intake accurately. And when coupled with the fact that nutrient intake through the diet was not accounted for, Fabricant explained, the study has no means of establishing a baseline for which to draw any comparisons or eliminate bias.

Also troubling was the author’s apparent lack of understanding about how dietary supplements are regulated.

“The authors seem to be confused or unaware of how supplements are regulated and exactly what constitutes a health claim authorized by the FDA,” Fabricant said. “For example, they cite that there is only one supplement, folic acid, worthy of a public health recommendation by way of a health claim. However, even a cursory visit to the FDA’s Web site would have revealed that other nutrients and dietary ingredients, including the very calcium and vitamin D that they studied, also have FDA-authorized health claims.” The FDA was granted the ability to approved or authorize claims explaining a nutrient’s positive health benefits when supported by research as a result of the 1994 regulating dietary supplements.

Taken as whole, the research on dietary supplements in the prevention of chronic diseases, is strong and consistent,” said Fabricant. “To suggest that taking vitamins and minerals with a demonstrated health benefit is unnecessary sends the wrong public health message."

The Natural Products Association and the Natural Products Foundation issued the following statements in response to a study published today in the Archives of Pediatrics and Adolescent Medicine titled "Vitamin and Mineral Supplement Use by Children and Adolescents in the 1999-2004 National Health and Nutrition Examination Survey."

Comments are from the association's vice president of scientific and regulatory affairs, Daniel Fabricant, Ph.D., and the foundation's Tracy Taylor, its executive director.

"The study is important, especially in a time where health care cost savings have moved into the center of our stream of consciousness, because it supports previous NHANES data not only on adults, but more importantly the data sets on children and adolescents that demonstrate that those with less healthy nutritional, activity and other socioeconomic factors, use vitamin and mineral supplements the least, thus may be at even greater risk for nutritional insufficiency and the health hazards associated with it," said Fabricant.

"The authors of the study are incorrect in their assertion that the industry is unregulated; nothing could be further from the truth. The industry is strongly and fairly regulated with mandatory adverse event reporting and cGMPs [current good manufacturing practices] at the front line of those regulations, in the same manner and magnitude as they are present in other industries also regulated by the Food and Drug Administration (FDA). However, the authors' mistake is not surprising considering that studies have demonstrated time and again that the majority of medical schools do not even meet the 1985 National Academy of Sciences (NAS) recommendations for hours of nutritional education and coursework.

"This is why we are a part of developing quality research tools like the National Institutes' of Health Dietary Supplement Label Database. Scientific decisions and national health care policy should be based on accurate information in understanding the universe of dietary supplements, including, but not limited to how dietary supplements are regulated, so that researchers and health care providers have the ability to factually evaluate the contributions of supplements to the diet, and do not make uninformed statements regarding supplements."

Taylor agreed with Fabricant about the importance of the research, but expressed concern that Americans historically do not get their nutritional needs met through diet alone, as the study's authors recommend.

"At a time when families are struggling to eat balanced and nutritious meals, this study could be seen as discouraging the use of the very vitamins and minerals that could bridge any nutritional gaps," said Taylor. "History has demonstrated that Americans will often forgo purchasing nutrient rich foods in favor of inexpensive fast foods in an economic crunch. And given the fact that more than two-thirds of Americans already fail to get the essential nutrients they need even in the best of times, we hope the take away from this study is not to cancel the nutrition insurance vitamins and minerals provide for many."

The Natural Products Association is the nation's largest and oldest non-profit organization dedicated to the natural products industry. The association represents more than 10,000 retailers, manufacturers, wholesalers and distributors of natural products, including foods, dietary supplements, and health/beauty aids. Association members meet annually each July in Las Vegas at the association's official tradeshow, Natural MarketPlace.

A study released in late January warns that individuals who have purchased diet pills from South America may be unintentionally compromising their health. Due to the unprecedented international purchasing possibilities of the Internet, it appears that many US residents who are looking for new dietary solutions may fall prey to unscrupulous sales -- and may even be taking amphetamines without even knowing it!

A study recently been published online in Springer's Journal of General Internal Medicine which was carried out by Dr Pieter Cohen of the Department of Internal Medicine at the Cambridge Health Alliance and Harvard Medical School, brings attention to this unfortunate abuse. In the US, the FDA has already banned amphetamine-based appetite suppressants, but they are still prevalent internationally.

Fenproporex is one of the most widely used of these appetite suppressants. It is quickly converted into amphetamine, and addictive. But due to its international availability in locales like Brazil, this drug has found its way to the US through Internet sales despite the FDA's appropriate ban on the substance. It appears that many are unaware that these diet pills combine fenproporex and benzodiazepines, selective serotonin reuptake inhibitors, diuretics, laxatives, thyroid hormones and other substances.

"To illustrate the risks posed by taking these diet pills, Dr Cohen reviews two case reports of patients taking appetite suppressants containing fenproporex, illegally imported from Brazil. In the first case, a 26-year-old woman suffered from intermittent chest pains, palpitations, headaches and insomnia for two years. She consulted her doctor numerous times over the two-year period for these unexplained symptoms. Her urine tested positive for amphetamines and benzodiazepines, and both fenproporex and chlordiazepoxide were present in her pills. Her symptoms disappeared after she stopped taking the imported pills.

"In the second case, a 38-year-old man tested positive for amphetamines after an occupational urine screening test and was suspended from work. Both fenproporex and fluoxetine were detected in his imported pills. While he was taking the pills he also experienced insomnia and palpitations, symptoms which disappeared after he stopped taking the pills. In both cases, not all the substances detected in the pills matched the ingredients on the vial labels."

"Given the wide variety of potential adverse effects from the medications included in these diet pills, patients attempting to lose weight who experience unexplained symptoms should be specifically questioned [by their physicians] regarding the use of imported diet pills," said Dr. Cohen.

We might add that before taking any form of dieting pills, it is always prudent to make sure that it has approved by the FDA and is sold legally in the US. In all cases, it is always best to consult one's doctor first before any dietary alterations of this type.

SpringerLink: Imported Fenproporex-based Diet Pills from Brazil: A Report of Two Cases
Science Daily: Hidden Amphetamines In Some Diet Pills Pose Health and Employment Risks
MSNBC: Diet pills from Brazil pose big health risks
Examiner: Amphetamine Based Diet Pills Ensure You'll Lose More than Just Weight
Fox News: Report Warns of Dangerous Amphetamines Found in Online Diet Pills

A new study from the January issue of Archives of Internal Medicine suggests an additional or alternative path to lowering high blood pressure: balancing sodium and potassium intake. Potassium acts as a counter to sodium, helping to balance or minimize the detrimental effects of sodium in diets that need to be wary of salt. The ratio of sodium-to-potassium was found to be a much stronger predictor of cardiovascular disease than independent measures of either sodium or potassium by themselves.

"There isn't as much focus on potassium, but potassium seems to be effective in lowering blood pressure and the combination of a higher intake of potassium and lower consumption of sodium seems to be more effective than either on its own in reducing the risk of cardiovascular disease," said Dr. Paul Whelton, principle author of the study and the president and CEO of Loyola University Health System.

The study's trials, which followed a middle age population for 15 years, found that participants with the highest sodium-to-potassium ratios were 50% more likely to experience cardiovascular disease than those with the lowest sodium-to-potassium ratios. This study is a vast improvement over previous investigations of the relationship between sodium, potassium and cardiovascular disease because it had such a long duration, high participant population, and physical data collection (urine samples) compared with previous trials. Many earlier studies relied on participant recall of what they had eaten, or what they ate, and many of those previous efforts had been cross-sectional rather than follow-up studies.

Whelton was a member of the recent Institute of Medicine panel which has laid out new recommendations for salt and potassium intake. For 19-to-50 year-old adults, in order to prevent the onset of heart disease, it isrecommended that you should consume no more than 2,300 milligrams of sodium per day -- equivalent to one teaspoon of table salt. Presently, 95% of men and 75% percent of women in the US exceed this amount, while only half of US population receives the recommended amount of potassium. In order to lower blood pressure and minimize the effects of sodium intake, adults should have 4.7 grams of potassium in their diet on a daily basis. (There are exceptions of course -- those who have a clinical condition or medication should consult their doctor before increasing potassium in their diet.)

For more info about potassium and the Loyola Study, please click on the links below:

DSIB: Potassium
Loyola Medicine: Reducing Salt Intake Isn't The Only Way To Reduce Blood Pressure

Green tea has been shown to mildly lower total cholesterol levels and improve the cholesterol profile (decreasing LDL “bad” cholesterol and increasing HDL “good” cholesterol) in most, but not all, studies. Green tea may also promote cardiovascular health by making platelets in the blood less sticky.

Green tea has also been shown to protect against damage to LDL (“bad”) cholesterol caused by oxygen. Consumption of green tea increases antioxidant activity in the blood. Oxidative damage to LDL can promote atherosclerosis. While population studies have suggested that consumption of green tea is associated with protection against atherosclerosis,9 the evidence is still preliminary.

Several animal and test tube studies have demonstrated an anticancer effect of polyphenols from green tea. In one of these studies, a polyphenol called catechin from green tea effectively inhibited metastasis (uncontrolled spread) of melanoma (skin cancer) cells.13 The polyphenols in green tea have also been associated with reduced risk of several types of cancer in humans. However, some human studies have found no association between green tea consumption and decreased cancer risk.

In a double-blind trial, people with leukoplakia (a pre-cancerous oral condition) took 3 grams orally per day of a mixture of whole green tea, green tea polyphenols, and green tea pigments orally, and also painted a mixture of the tea on their lesions three times daily for six months. As compared to the placebo group, those in the green tea group had significant decreases in the pre-cancerous condition.

Compounds in green tea, as well as black tea, may reduce the risk of dental caries. Human volunteers rinsing with an alcohol extract of oolong tea leaves before bed each night for four days had significantly less plaque formation, but similar amounts of plaque-causing bacteria, compared to those with no treatment.

Green tea polyphenols have been shown to stimulate the production of several immune system cells, and have topical antibacterial properties—even against the bacteria that cause dental plaque.

One study found that intake of 10 cups or more of green tea per day improved blood test results, indicating protection against liver damage. Further studies are needed to determine if taking green tea helps those with liver diseases.

Tea flavonoids given by capsule reduced fecal odor and favorably altered the gut bacteria in elderly Japanese with feeding tubes living in nursing homes. The study was repeated in bedridden elderly not on feeding tubes, and green tea was again shown to improve their gut bacteria. These studies raise the possibility of using green tea in other settings where gut bacteria are disturbed, such as after taking antibiotics. Further studies are needed to clarify the role of green tea in this respect, however.

High-tannin tea has been shown to reduce the need for blood removal from people with iron overload, or hemochromatosis, in an open study. The tea had to be taken with meals and without lemon or milk to be effective. Tea is believed to help in hemochromatosis by preventing iron absorption. In a double-blind trial, men with precancerous changes in the prostate received a green tea extract providing 600 mg of catechins per day or a placebo for one year. After one year, prostate cancer had developed in 3.3% of the men receiving the green tea extract and in 30% of those given the placebo, a statistically significant difference. These results suggest that drinking green tea or taking green tea catechins may help prevent prostate cancer in men at high risk of developing the disease.

There are four case reports in which certain types of leukemia or lymphoma (low grade B-cell malignancies) improved after the patients began taking green tea extracts.