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Vitamin E: Popular with Seniors But Mired in Controversy

Harvard Medical Pulls Back Support, Supporters Going Full Blast include Industry Group, National Eye Institute

By Tucker Sutherland, editor

Feb. 20, 2005 - Vitamin E is one of the most widely used supplements, taken regularly by nearly a quarter of senior adults ages 55 and over. But recent research suggests that it may not do as much good in preventing cancer and other diseases as once thought, and it might actually cause harm. But this popular vitamin still has plenty of supporters. (See links to related stories.)

Until two years ago students in Harvard Medical School’s “Preventive Medicine and Nutrition” course were assigned to argue the wisdom of recommending vitamin E to patients. “But we have now dropped vitamin E as a debate topic,” says Harvard Women’s Health Watch advisory board member Dr. Helen Delichatsios, because recent data overwhelmingly show that vitamin E is not useful.

On the other hand, the Council for Responsible Nutrition, has aggressively furnished the media with research reports that Vitamin eye is beneficial for age-related cataracts, Alzheimer’s disease, certain cancers, heart disease, stroke and more. These reports came from presentations at the New York Academy of Sciences in January.

The Council for Responsible Nutrition (CRN), founded in 1973, is a Washington, D.C.-based trade association representing dietary supplement industry ingredient suppliers and manufacturers. They say, “CRN members adhere to a strong code of ethics, comply with dosage limits and manufacture dietary supplements to high quality standards under good manufacturing practices.” For more information on CRN: http://www.crnusa.org.

How did vitamin E fall from grace? Basically, although observational studies had linked the vitamin with decreased risk of heart disease and cancer, these expected benefits didn’t always pan out in placebo-controlled trials, which put vitamin E to the test against a dummy pill.

In addition, a recently published analysis of clinical trials involving nearly 136,000 people who took vitamin E for one reason or another found that the overall risk of dying was greater in those who took higher doses, compared to those who took lower doses.

"Our study results do not support the use of high-dose vitamin E supplements. If people are taking a multivitamin, they should make sure it contains no more than a low dose of vitamin E," said study lead author and internist Edgar R. Miller III, M.D., Ph.D., associate professor of medicine at The Johns Hopkins University School of Medicine.

"A lot of people take vitamins because they believe it will benefit their health in the long term and prolong life. But our study shows that use of high-dose vitamin E supplements certainly did not prolong life, but was associated with a higher risk of death," added Miller in releasing the study that started the controversy.

While we await the results of some ongoing trials that might clarify the role of lower doses of vitamin’s E role in preventing disease, Dr. Celeste Robb-Nicholson, editor in chief of Harvard Women’s Health Watch, says, “Try to get most of your vitamin E from food. There’s strong evidence that diets containing large amounts of vitamin E-rich foods are good for you. If you’re uncertain about how much you’re getting from your diet, consider taking a supplement containing no more than 150–200 IU per day. At that level, taking vitamin E still falls under the rubric of ‘shouldn’t hurt and might help.’”

There has already been some additional testing. About 40 percent of diabetic patients can reduce their risk of heart attacks and of dying from heart disease by taking vitamin E supplements, according to a study published in the November 2004 Diabetes Care.

Following the John Hopkins study concerning the danger of high dosages of vitamin E, the National Eye Institute reviewed the 2001 findings of the Age-Related Eye Disease Study (AREDS), a study of nearly 5,000 patients with varying stages of age-related macular degeneration (AMD) a leading cause of vision loss in senior citizens. The study concluded that NEI still recommends 400 international units (IU) for those at high risk of AMD.

The best practice, as always when considering medicines and supplements, is to consult with your personal physician. Clearly, your personal health situation is a key factor in the decision concerning taking Vitamin E, and in what dosage.

A safety valve, for the moment, for those who value their Vitamin E, might be to limit daily intake to no more than 400 international units (IU). The danger level in most of the research seems to be at the 500 IU level

Due to the high interest in Vitamin E, we are presenting below all the reports on Vitamin E provided by the Council for Responsible Nutrition. We make no judgment on their value and do caution this is an industry-related organization.

Vitamin E May Protect Against Age-Related Cataract

NEW YORK, January 27, 2005 — There is “substantial evidence” that vitamin E may have a beneficial effect on the development of age-related cataracts in people who take the vitamin, says a leading expert on nutrition and aging, Dr. Paul F. Jacques.

Dr. Jacques spoke at a health and science writers’ workshop on vitamin E and health at the New York Academy of Sciences sponsored by the Council for Responsible Nutrition. He is Director of the Nutritional Epidemiology Program and Senior Scientist at the Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University, where he is also Professor at the Gerald J. and Dorothy R. Friedman School of Nutrition Science and Policy.

“Almost half of all Americans experience visual disability from cataracts,” the epidemiologist told the group. He explained that a cataract is a clouding of the lens, or opacification, characterized by an accumulation of damaged lens proteins. The protein accumulation disrupts the normally uniform density within the fiber cells of the lens, causing light refraction. This then interferes with the transmission of light to the retina.

Dr. Jacques said, “We have evidence that a cataract is the result of oxidation of constituents of the lens fiber cells.” That process of oxidation might explain why vitamin E, an antioxidant, would have a beneficial effect on cataract.

“The results of my past and ongoing studies, as well as studies by other investigators, show that individuals who consume vitamin E supplements or who have higher plasma concentrations of vitamin E have a lower risk of cataract, particularly cataract in the lens nucleus,” the researcher told the group today.

There are a number of risk factors for age-related cataracts: age, gender, diabetes, sunlight and ultraviolet radiation, and smoking. Cataracts are the leading cause of blindness worldwide, with 15-25 million cases of blindness resulting from cataracts that have not been operated on (the procedure is called surgical extraction). In the U.S. and other developed countries, this type of cataract is responsible for 40-60% of adult visual disability.

Dr. Jacques cautioned, “Forty-five percent of Americans develop cataracts with visual impairment by age 85, creating a large economic burden.” He said that cataract extraction is the most frequently performed surgery among elderly Americans, totaling 3.5 billion dollars annually, the single largest Medicare expenditure.

Dr. Jacques called for more studies to look at nutrition and cataracts now, adding that “there’s substantial evidence that vitamin E may have a beneficial effect on age-related cataract.”

Vitamin E May Prove Beneficial in Alzheimer’s Disease

NEW YORK, January 27, 2005 — “There remains some legitimate evidence of benefit for the use of vitamin E in populations having Alzheimer’s disease, and studies with other neurological diseases including Down syndrome is warranted,” according to a prominent researcher in the field. Mary Sano, Ph.D., is Director of the Alzheimer’s Disease Research Center at New York’s Mount Sinai School of Medicine. She said the evidence of vitamin E’s benefit is elusive and “what we know from clinical trials suggests benefit in selected populations.”

Dr. Sano spoke at a health and science writers’ workshop on vitamin E and health at the New York Academy of Sciences sponsored by the Council for Responsible Nutrition. In addition to her position at the Mount Sinai School of Medicine, Dr. Sano is also Director of Research and Development at the Bronx Veterans Administration Hospital in New York.

Cases of Alzheimer’s disease are increasing because the population in whom it occurs is increasing. Individuals aged 65 and over comprise the fastest growing population of this country. The more seniors we have, the greater the incidence and prevalence of Alzheimer’s disease. Furthermore, Dr. Sano said, people are living longer with the disease.

The researcher told the group, “The diagnosis of Alzheimer’s disease is preceded by a 3-5 year period of mild but significant cognitive impairment.” She added that an interesting component of the problem is that “the changing technology required for routine activities carries a high cognitive demand.”

Dr. Sano described a recent study comparing vitamin E and selegiline in Alzheimer’s disease patients. Selegiline is a medication used in Parkinson’s disease, and because it may have a neuroprotective component, it is now being studied in Alzheimer’s. The researcher and her group mounted a two-year double-blind study among 341 moderately impaired patients. There were three treatment groups: selegiline (10 mg per day), vitamin E (2000 IU per day), and a combination of the two, as well as a placebo group. Patients were followed until they experienced a loss of basic activities of daily living (ADL), were institutionalized, developed severe dementia, or they died.

There was no effect on cognition in those patients on vitamin E, however their group showed the most improvement in the other criteria. They were able to remain out of institutions longer, and they experienced 25% less deterioration in their activities of daily living than did the other patients.

Antioxidant vitamin E holds promise because of the oxidative damage inherent in Alzheimer’s disease. The scientist explained that the disease process causes damage to lipids, proteins, and DNA and RNA. It causes significant changes in the brain, resulting in loss of synapses, neuronal dysfunction, and death. Since Vitamin E is an antioxidant, it acts to scavenge up damaging free radicals. Laboratory experiments show that the vitamin limits the oxidation of lipids in cell membranes, enhances blood flow within brain cell cultures and also reduces cell death in cell cultures.

Dr. Sano doesn’t recommend such high doses of vitamin E for the general population, and said that there is no strong evidence that it can prevent Alzheimer’s in healthy individuals, only in those who have the disease. Her group is now studying patients with Down syndrome. These persons get Alzheimer’s disease early, often before the age of 50. She’s hoping her research with these patients will determine if vitamin E can be of benefit, and provide clues for preventing the disease in a healthy population.

Vitamin E Has Potential To Prevent Certain Cancers

NEW YORK, January 27, 2005 — “Vitamin E supplementation may have a profound effect on reducing the burden of several major cancers,” said Mark Moyad, M.D., M.P.H. He told a group of reporters here today that not only may vitamin E reduce an individual’s risk of getting certain cancers, but it may also reduce the risk of dying from those diseases.

The prostate cancer expert spoke at a health and science writers’ workshop on vitamin E and health at the New York Academy of Sciences sponsored by the Council for Responsible Nutrition. Dr. Moyad is the Phil F. Jenkins Director of Preventive & Alternative Medicine at the University of Michigan Medical Center (Department of Urology) .

He told the writers, “Cancer has now surpassed heart disease as the number one cause of mortality. Therefore, it is imperative that more basic science and clinical research is not only funded but also initiated on potential cancer prevention agents, or on agents that slow the progression of existing cancer. The National Cancer Institute and the American Cancer Society estimate that there will be over 63,000 new cases of bladder cancer (the fourth most common cancer), and that over 13,000 individuals will die from this disease in 2005. Interestingly, several large epidemiologic studies have demonstrated that long-term use of vitamin E supplements may reduce the risk of bladder cancer.”

Dr. Moyad said that many researchers were surprised in 1998 when the results of the ATBC trial, or Alpha-Tocopherol (vitamin E) Beta-Carotene Trial, were published.  This trial, completed in Finland with over 29,000 men, found that vitamin E reduced the risk of prostate cancer by 32% and deaths from prostate cancer by 41% compared to placebo.  Because of that and several other studies, the National Cancer Institute decided to fund the SELECT Trial, which includes approximately 32,000 men on vitamin E (400 IU), selenium (200 mcg), the combination, or placebo for 7-12 years. Although this trial began only a few years ago, recruitment has actually completed several years early, making it one of the fastest trials filled to capacity in the history of this country.

“The potential for vitamin E, or vitamin E in combination with other agents, to reduce the risk of several of leading cancer killers is indeed interesting,” Dr. Moyad told the group. “In fact, the results of the SUVIMAX French randomized study were published in the past several weeks. In healthy men taking a combination supplement that included vitamin E versus others who took placebo, the seven and a half year study showed not only a reduction in total cancer risk, but also a reduction in overall mortality.”

Dr. Moyad concluded, “Because of its low cost and the ease with which it can be purchased, vitamin E has to be one of the most potentially effective cancer prevention agents studied to date.” 

Vitamin E Helps Male Ultra-Marathoners Avoid Cell Damage:
Female Athletes Can Recover From Race Stress Without It

NEW YORK, January 27, 2005­ — Are you thinking of running an ultra-marathon? If so, you might want to include vitamin E in your pre-race prep. According to researchers at the Linus Pauling Institute of Oregon State University, taking vitamin E before such a grueling race may lessen or avert some of the cellular damage it can cause.

As one would expect, an ultra-marathon is a marathon and then some. In Corvallis, Oregon, contestants run up and down 32 miles of steep hills, with an elevation gain and loss of 12,000 feet. Dr. Maret Traber and her group have been working with these runners, investigating the antioxidant effects of vitamin E and whether it can protect the body from oxidative stress caused by such extreme athletics. Dr. Traber is Principal Investigator in the Linus Pauling Institute and Professor in the Department of Nutrition & Exercise Sciences at Oregon State University.

She explains, “The body converts food energy into energy it can use, producing carbon dioxide and water. The process is similar to that of a log burning in a fireplace, you’re burning energy in order to have enough energy to run your body. Energy conversion on the cellular-level is not perfect but it is efficient. But because it’s not perfect, about one percent of energy escapes as free radicals like superoxide; a very toxic free radical that contains oxygen and that can initiate all kinds of damage. That’s where you get into the damage caused by oxidative stress. We study this on the membrane level.”

The researcher spoke today at a health and science writers’ workshop on vitamin E and health, held at the New York Academy of Sciences and sponsored by the Council for Responsible Nutrition. In Dr. Traber’s double-blind study, ultra-marathoners took either antioxidant vitamins C and E or placebo daily for 6 weeks, and then were evaluated for oxidative stress on the race morning and every morning for the week after the race. The nutritionist found no increase in cell membrane damage caused by oxidative stress in those runners who took vitamin E, although there was membrane damage in those taking placebo.

What the researchers found most interesting, however, was that although the oxidative stress markers for women on placebo went back to normal two days after the race, men on placebo had elevated oxidative stress markers for a week after the event.

The role that gender played in this study was unexpected. According to Dr. Traber, “Women are better protected from oxidative stress than are men. This was surprising. I wouldn’t have guessed that there was a gender difference.” .

The nutritionist suggested that men who decide spontaneously to run a marathon and who haven’t been training or planning ahead, can really can do some serious injury to their muscles and experience oxidative stress. This is especially true if they haven’t had proper nutrition. Taking vitamin E, however, may help them recover sooner.

Vitamin E Called Essential Nutrient Worthy Of Further Research At High Doses

NEW YORK, January 27, 2005 — During her opening presentation today at Vitamin E Impact on Health and Disease, a health and science writers’ workshop held at the New York Academy of Sciences and sponsored by the Council for Responsible Nutrition (CRN), Annette Dickinson, Ph.D., president, CRN, told reporters that vitamin E is  “an essential nutrient worthy of on-going clinical research studying its benefit at high doses.”

According to Dr. Dickinson, in addition to numerous completed research studies which have shown vitamin E to have protective benefit at a wide range of doses in a number of different areas, such as immune function, eye health, specific cancers, Alzheimer’s, and heart health, a number of on-going clinical trials have potential to show further promise in these areas and demonstrate the researchers’ confidence in the safety of vitamin E at intake levels of 400 IU and above.

For example, The Physicians’ Health Study being conducted by researchers at Harvard University involves more than 14,000 U.S. doctors, examining the effect of 400 IU of vitamin E, taken on alternate days, for preventing cardiovascular disease, prostate and colon cancer, eye disease and cognitive decline.

Researchers from Harvard Medical School at Brigham and Women’s Hospital are analyzing the results of 600 IU of vitamin E given on alternate days, for protection against cardiovascular disease, eye disease, and cognitive decline.  The study, involving over 39,000 women has recently been completed and the results are currently being analyzed.

Another large clinical trial, funded by the National Cancer Institute, is being conducted in research centers nationwide involving more than 30,000 men, investigating the role of 400 IU of vitamin E (and selenium at 200 mcg) in helping prevent prostate cancer.  Treatment of subjects in this long-term trial will be continued through 2013. In a subset of 10,000 men age 60 years and older in this same trial, the effect of vitamin E and selenium in protecting against Alzheimer’s Disease will also be evaluated.

Dr. Dickinson stated, “The fact that these studies and others continue to be conducted demonstrates the confidence these prominent researchers have in not only the potential benefit of vitamin E, but also in the nutrient’s safety at high levels.”  She further pointed out that the Institute of Medicine (IOM), a scientific advisory body, has concluded that vitamin E is safe for chronic use in the general population at levels up to 1,000 mg (1,000 IU synthetic vitamin E or 1,500 IU natural vitamin E).

CRN believes that supplements provide their greatest benefit when they are used in conjunction with other healthy lifestyle choices, such as eating a balanced diet, exercising regularly, and getting enough sleep.  However, Dr. Dickinson said, “Diet alone does not always provide enough essential nutrients, and supplements can fill the gaps where there are nutrient shortfalls.”  She pointed out this is the case for vitamin E, noting the Recommended Dietary Allowance (RDA) is 15 mg, an amount that even those with the best food intentions don’t always meet.  “For example, in order to meet the RDA, you would need to eat 25 cups of raw spinach (4 cups cooked).  If you’re not a spinach lover, almonds offer another choice for food rich in vitamin E.  If you wanted to get 200 IU of vitamin E, an amount that has been shown in some trials to have health benefits, you would need to eat approximately 650 almonds.  Unfortunately, the 4,500 calories and 390 grams of fat that you’d be getting in that scenario would likely cancel out any potential benefit.”

Dr. Dickinson’s best advice when incorporating vitamin E supplements into a nutrition program is to buy from a company or source you know and trust, follow label directions, and share information on the supplements you are taking with your healthcare professional.

Vitamin E Reduces Inflammation:
Key To Reducing Heart Disease, Stroke And Other Health Problems

NEW YORK, January 27, 2005 — Vitamin E plays a significant role in both reducing inflammation and cleansing the body of damaging free radicals, according to a prominent cardiovascular surgeon speaking today at a health and science writers’ workshop on vitamin E and health, held at the New York Academy of Sciences and sponsored by the Council for Responsible Nutrition. However, Americans don’t consume enough vitamins and minerals in their diets because of modern methods of food production, so they should consider using supplements to replace the missing nutrients.

“Inflammation is the heart of the matter. It’s becoming clear that inflammation plays an important causative role in heart disease,” Gerald M. Lemole, M.D., told the group. He is W. Samuel Carpenter III Distinguished Chair of Cardiovascular Surgery, Chief of Cardiac Surgery at Christiana Care Health Services, and Professor of Surgery at Thomas Jefferson University. The cardiac surgeon explained that normal inflammation is the body’s protective response to toxins, pathogens, irritants, trauma, free radicals, and unrecognized molecules. However, things can go wrong, and groups of inflamed white blood cells may build up, rupture, and trigger a heart attack. The body’s response to this is an elevated C-reactive protein (CRP) level, homocysteine level, and fibrinogen—all implicated in worsening heart disease. In fact, cardiologists now consider an elevated CRP level to be an increasingly important marker for heart disease. He told the group that other risk factors for inflammation are obesity, smoking, genetic predisposition, high stress, and diets rich in highly processed and carbohydrate-rich foods. Chronic inflammation, he said, is linked to periodontal disease, diabetes, Alzheimer’s disease, and cancer as well as heart disease. Antioxidants such as vitamin E can ameliorate that risk.

In discussing why nutritional supplementation may be necessary, Dr. Lemole listed several reasons such as environmental stress, nutritional deficiencies in our food supply, inadequacy of the recommended requirements, constitutional variations, and medically induced deficiencies. He said, “We’ve industrialized farm production, and that’s led to serious problems in the micronutritional composition of foods. Growth hormones and antibiotics, which deplete vitamins A and B, are used in over half of commercial livestock. Refinement of sugars, grains, flours, and other food has deprived us of consuming many essential and nutritional ingredients.”

Dr. Lemole told the group that the situation is worsening. There are fewer and fewer naturally occurring antioxidants in our food supply. He cautioned, “We know that an inflammatory process can trigger certain diseases. We’re aware that age-related immune deficiency is caused by free radicals and that it can be reversed by antioxidants. And unfortunately, we’re all too familiar now with the realization that wall of the artery is a living, reactive tissue capable of mounting an inflammatory response. That inflammatory response is heart disease.”

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