March/April 2012

Physicians as Supplement Supervisors

By Maura Keller
Aging Well
Vol. 5 No. 2 P. 22

Physicians must thoroughly evaluate the supplements an older patient may be taking for the supplements’ role in nutritional adequacy and in conjunction with the patient’s prescribed medications.

Interest in vitamin supplements is at an all-time high. According to the Council for Responsible Nutrition, more than 150 million Americans use dietary supplements. Worldwide, millions more take multivitamin and mineral supplements, hoping to promote health and enhance their dietary intake. And although physiological and functional needs alter the dietary requirements of older adults, patients’ supplement needs should be evaluated and their use monitored by their physicians.

Physician Vigilance Necessary
David Jacobs, PhD, a professor of epidemiology at the University of Minnesota School of Public Health, suggests doctors need to know as much about supplements as they do about drugs.

“The field of supplements is as complex as the field of drugs but for the most part without benefit of the randomized studies that have been produced in response to drug regulation,” Jacobs says. “Doctors should be aware that the several clinical trials of isolated supplements have often had null or even adverse outcomes. [Patients] should be suspicious of taking supplemental isolated compounds without good cause. Nutrient-rich food is by far the best solution to adequate nutrition in the elderly.”

This means physicians should be concerned with issues related to a patient’s ability to eat (locomotion, cognition, social isolation, and chewing capability). “For the most part, physicians for the elderly are treating only ailments, whereas good nutrition should help to maintain health in the elderly,” Jacobs says.

Older adults can also experience a reduced ability to cook and prepare food, difficulty chewing because of bad teeth, digestion issues ranging from intestinal problems to incontinence, social isolation, and declining cognitive skills. These issues can play a role in older adults’ consumption of proper foods and the subsequent deficiencies that may result from their inability to do so.

“Dietary supplements should preferably be used with good medically based cause, such as symptomatic nutrient deficiency disorder,” Mursu says. “Deficiencies of iron, folic acid, and B12 are the most common ones, but if the diet is poor, older patients may be deficient in several other nutrients. Correcting these conditions with supplementation is clearly justified.”

Older adults can also experience a reduced ability to cook and prepare food, difficulty chewing because of bad teeth, digestion issues ranging from intestinal problems to incontinence, social isolation, and declining cognitive skills. These issues can play a role in older adults’ consumption of proper foods and the subsequent deficiencies that may result from their inability to do so.

“Dietary supplements should preferably be used with good medically based cause, such as symptomatic nutrient deficiency disorder,” says Jaakko Mursu, a nutritional epidemiologist in the School of Public Health at the University of Minnesota. “Deficiencies of iron, folic acid, and B12 are the most common ones, but if the diet is poor, older patients may be deficient in several other nutrients. Correcting these conditions with supplementation is clearly justified.”

Currently, most experts consider commonly used dietary supplements to be safe if the doses are conservative.

Mursu points to recent studies that have assessed the role of vitamin D in chronic diseases. “There is a lot of evidence that vitamin D deficiency is common, especially among the elderly and in the northern hemisphere where the sun exposure is limited,” he says. “In several countries, the recommendations regarding vitamin D have been increased and, in most cases, recommended levels are impossible to attain without supplementation.” Further studies, especially large-scale randomized trials, are still needed to verify that correcting this deficiency yields improvements in health as hypothesized.

Key Considerations
As Melina Jampolis, MD, an internist and board certified physician nutrition specialist, explains, older patients often self-medicate with dietary supplements, intending to prevent, maintain, or improve health.

“Supplements, when used correctly, may be particularly beneficial to older patients whose diet may be inadequate due to decreased appetite, limited income, limited outdoor exposure, or decreased mobility and ability to shop and prepare balanced meals,” Jampolis says. “Older patients may have decreased nutrient absorption due to aging and gastric hypochlorydia—B12 especially. Doctors need to know the cases in which supplements may be useful and are clinically validated and when they are not appropriate, a waste of money, or worse, dangerous. And [they should] also be aware of supplement/drug interactions, particularly herbal supplements.”

As Jampolis notes, this is of particular concern if a patient is taking warfarin, as several supplements, including garlic, Coenzyme Q10, ginseng, and ginkgo, could interact with this blood-thinning medication. Ginkgo can also increase the sedative effects of certain antidepressants and the blood levels of certain blood pressure medications, both of which could be of particular concern in the aging population. St John’s Wort, a commonly used supplement that may be effective for addressing mild to moderate depression, can interfere with warfarin, digoxin, and statins.

Potential Benefits
“Most of the commonly used vitamin and mineral supplements, including antioxidants, however, have not been found to prevent major chronic diseases such as cardiovascular diseases, cancer, or type 2 diabetes,” Mursu says. “However, dietary supplements are a very large group of various products and used for multiple reasons, and for many products and outcomes, the long-term effects on health are not known. For some of the supplements and for some conditions, the evidence is promising and thus the use might be beneficial.”

For example, Mursu explains, fish oil has been found to prevent secondary cardiovascular events although the evidence is not conclusive and regular consumption of fish may provide the same benefits. “Also, many elderly are deficient in vitamin D, and correcting this deficiency with supplementation might improve health, especially when obtaining sufficient amounts of vitamin D from the diet is challenging,” Mursu says.

And when it comes to iron supplements, it appears that older adults may have too much iron in their bodies, which negates the need for supplements. Researchers at Tufts University analyzed blood samples from more than 1,000 white men and women aged 67 to 96 and found about 3% of the study group had too little iron and 13% had too much iron in their bodies.

While the use of dietary supplements in the aging population is a topic that prompts opposing views, experts all agree that high doses of any compound may be toxic, especially when used for extended periods of time.

“Supplement-related toxicity is generally rare but out of the most commonly used supplements, vitamin A can be toxic in relatively low doses and can lead to liver problems in a very short period of time,” Mursu says. “Water soluble vitamins such as vitamins C and B are considered to be safe as extra amounts can be effectively excreted.” The effects of some supplements, such as herbs, are unknown and may contain contaminants, interfering with the metabolism of certain drugs, and therefore should be used with caution.”

While there is no single group of patients who should never use supplements, in some cases there is a concern about safety. One example would be that patients with hypertension should avoid stimulants because they increase blood pressure.

“Some dietary supplements may also interact with other supplements or prescription and over-the-counter medicines,” Mursu says. “For example St John’s Wort is known to adversely affect selective serotonin reuptake inhibitor drugs and birth control pills. Calcium can interact with heart medicine, certain diuretics, and aluminum- and magnesium-containing antacids.”

Finding What Works
Is a diet without supplements adequate for proper nutrition in older adults?

It depends on whom you ask, but experts agree that physicians need to work with older patients on an individual basis to determine whether dietary supplements are appropriate for them. Vitamin D supplements appear to receive widespread acceptance within the medical community.

“People over the age of 60 probably need a vitamin D supplement, particularly if they live in northern latitudes, during the winter, have dark skin, or are obese, as fat sequesters vitamin D, reducing blood levels,” Jampolis says. “As people age, the ability of the skin to produce vitamin D decreases. However, if they eat a very balanced diet that limits processed food and includes regular fish consumption—for omega-3s—whole grains, healthy fats, lean protein, low-fat or fat-free dairy, and a variety of fruits and vegetables, they spend time outdoors, and their vitamin D levels are normal, I don’t think any other supplements are essential.”

Jacobs believes dietary supplements in healthy people are not usually helpful and can be skipped. “The most debilitated elderly may benefit from well-chosen supplements in exactly the same way as they would benefit from other drugs,” Jacobs says. “The big problem in geriatric nutrition is to get enough food intake. It is not clear what supplements might be helpful in the long term in relatively debilitated elderly; this is an area for research.”

Jacobs stresses that taking isolated compounds as supplements does not fix a nutrient-poor diet. For example, eating enriched white bread—adding a dozen isolated compounds that were removed from among the thousands of compounds that were lost in refining of whole grain—is not as healthful as eating whole cereal grain bread.

“Considering diet solely from the perspective of its parts—nutrients, particular foods—has not been productive in disease prevention,” Jacobs says. “It has led to fad diets such as low carbohydrate, low fat, high protein, etc. There is inadequate long-term research on these types of patterns.”

In the Know
Doctors need to thoroughly evaluate what supplements older patients may be using in conjunction with their prescribed medications. Peter Rugg, MD, a partner at Wachusett Emergency Physicians in Boston, an assistant professor at the University of Massachusetts Medical School, and chair of the Scientific Advisory Council at USANA Health Sciences, says any patient with an interest in taking vitamins needs to do his or her research and invest only in high-quality supplements.

This includes products from supplement companies that have acquired drug establishment registration with the FDA and operate an FDA-registered facility, following the FDA’s highest possible standard for manufacturers. It is important that patients buy from reputable companies to ensure good quality-control standards and that the labeled dose is accurate and the product is free from contaminants.

Rugg recommends physicians find supplements that have been tested by competent third parties such as NSF International, an independent not-for-profit organization that helps protect consumers by certifying products and writing standards for food, water, and consumer goods. The NSF certification guarantees that the ingredients on the product’s label are actually in the product at the labeled amounts.

As Jampolis points out, ConsumerLab.com is an independent organization that tests supplement quality. “US Pharmacopeia verification is also useful in identifying reliable products, but they charge for testing so not all companies use their service,” she says. “It is also critical that physicians tell patients that supplements should be used in addition to, not in place of, a healthy diet as nutrients from food are almost always better.”

What the Future Holds
While key researchers may disagree on the benefits of supplements for older and younger patients alike, during the past 20 years, there has been an explosion of research in the science of supplements that will hopefully result in a better understanding on the part of patients and doctors.

“This [research] has been coupled with a burgeoning interest on the part of the public on the benefits of supplementation,” Rugg says. “Currently we are following the increase in importance of vitamin D as a vitamin and hormone. Its impact on enzymatic reactions throughout the body, immune health, cardiovascular health, and bone health deserves our attention over the next few years.”

Mursu agrees: “Research findings for vitamin D are promising and hopefully in the near future, within a few years, large-scale randomized trials will provide answers whether supplementation will provide health benefits. Most of the studies done regarding dietary supplements have concentrated on selected compounds and outcomes, most commonly vitamins and minerals, and cardiovascular and cancer prevention. Very little research is done to assess the effects on other chronic diseases. Future studies will hopefully bring more insight in to these.”

— Maura Keller is a Minneapolis-based writer and editor.

Supplements Treat Dangerous Vitamin D Deficiency
A new study indicates vitamin D deficiency is common among women in nursing homes and is associated with an increased risk of death. The findings highlight the need to prevent and treat vitamin D deficiency, according to lead author Stefan Pilz, MD, of the Medical University of Graz in Austria, and his colleagues.

The study will appear in the April issue of The Journal of Clinical Endocrinology and Metabolism.

The study in Austria of nearly 1,000 female nursing home residents with an average age of almost 84 found that 284 (30%) of the patients died after an average follow-up time of 27 months. The researchers also found that almost 93% had lower-than-recommended vitamin D levels.

“Our findings show that the vast majority of nursing home residents are severely vitamin D deficient, and those with the lowest vitamin D levels are at high risk of mortality,” Pilz said in a news release from the Endocrine Society. “This situation warrants immediate action to prevent and treat vitamin D deficiency.”

Vitamin D deficiency is a risk factor for bone deterioration. Treatment involves taking up to 800 IU of vitamin D per day.

“Vitamin D supplementation in these patients can exert significant benefits on clinically relevant outcomes such as fractures,” Pilz said. “In light of our findings and the existing literature on adverse effects of vitamin D deficiency, there exists now an urgent need for effective strategies to improve vitamin D status in older institutionalized patients.”

While the study uncovered an association between vitamin D deficiency and mortality among women in nursing homes, it did not prove a cause-and-effect relationship.

— Source: Endocrine Society

Supplements Are Subject to Looser Regulation
While drugs in the United States must undergo extensive testing and monitoring to ensure their safety and efficacy, supplements come under much weaker regulation. In a perspective article published in The New England Journal of Medicine, Pieter A. Cohen, MD, criticizes the current deficiencies in the regulation of the supplement industry. He argues that a new guidance proposal by the FDA makes important steps toward enhancing supplement safety but still doesn’t go far enough.

According to the Dietary Supplement Health and Education Act of 1994 (DSHEA), companies can market dietary supplements that contain established ingredients (meaning the ingredients were sold in the United States before 1994) without providing any evidence of safety or efficacy. For newer ingredients, however, the law mandates that producers provide data demonstrating their safety. But the law is not being enforced.

Since 1994, the number of dietary supplements sold in the United States has jumped from about 4,000 to 55,000. And while it isn’t clear how many of these supplements actually contain new substances, the FDA has received safety evidence for only 170 new ingredients over this period.

According to new guidelines proposed by the FDA in July, supplements will be evaluated based on their history of safe use, their daily dosage and formulation, and the length of time they are meant to be used. If a new supplement contains doses greater than what was historically used, a variety of tests would be mandated. Different formulations of ingredients would be considered as new ingredients, also requiring safety data.

While Cohen believes these measures will certainly improve the safety of supplements, he says they are still insufficient. He points out that even a history of widespread use cannot ensure a particular ingredient is safe for consumers, and certain ingredients will still not require testing in humans under the new proposal. Additionally, the guidance does not compel producers to send all of their data to the FDA.

Josh Bloom, PhD, director of chemical and pharmaceutical sciences for the American Council on Science and Health, points out that the new guidelines are nowhere close to being as strict as the testing process required for drugs. “People are not aware that most of these supplements are drugs or unknown mixtures of several drugs,” he says.

With 100 million Americans spending $28 billion annually on some type of vitamins, minerals, herbal remedies, or other dietary supplements, it is clear that many people are under the impression that supplements are both safe and effective.

— Source: American Council on Science and Health