Vitamin D Supplements Do Not Reduce Falls, Fractures or Improve Bone Density

Much has been written about the benefits of supplementing Vitamin D in patients. The World Health Organization sets its normal blood level at 20 while in North America it is listed at over 30. Under normal circumstances when your skin is exposed to sunlight your kidneys produce adequate amounts of Vitamin D.

Over the last few years low vitamin D levels have been associated with acute illness and flare-ups of chronic illness. The Vitamin D level is now the most ordered test in the Medicare system and at extraordinary expense. Supplementing Vitamin D has become a major industry unto itself.

The October 4th edition of the Lancet Diabetes and Endocrinology contained an article written by New Zealand researchers that looked at 81 randomized research trials containing almost 54 thousand participants. “In the pooled analyses, researchers found that Vitamin D Supplementation did not reduce total fracture, hip fracture, or falls – even in trials in which participants took doses greater than 800 IU per day.” Vitamin D supplementation did not improve bone mineral density at any site studied (lumbar spine, hip, femoral neck, forearm or total body).

They concluded that there is little justification for the use of Vitamin D Supplements to maintain or improve musculoskeletal health, and clinical guidelines should reflect these findings.

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What Is In Those Supplements?

VitaminsThe Attorney General of the State of New York charged four national retailers on Monday, February 2nd  of selling dietary supplements that were “ fraudulent and in many cases contaminated with unlisted ingredients.” His office said they had run tests on popular store brands of herbal supplements at the retailers – Walgreens, Walmart, Target and GNC and found that out of five products tested, four contained none of supplements listed on the label. At GNC they found that five of six samples from its “Herbal Plus “brand were either “unrecognizable or a substance other than what they claimed to be.” They analyzed Ginkgo Biloba, St. John’s Wort, Ginseng, Echinacea, Saw Palmetto, Garlic and Valerian Root.

For many years now health care advocates have encouraged the Federal government to establish a safety monitoring system for the multibillion dollar vitamin, mineral, herb and supplement product market. Many health care providers question the safety and efficacy of these products to begin with since there are few if any well designed double blinded controlled studies which look at their overall risks and benefits. To now find out that the bottles do not even contain product raises further questions about their efficacy and safety. The American College of Nephrology has been trying to educate the public to the harmful contaminants they have found in many over the counter supplements leading to renal failure and problems in children. Most of these poisons and heavy metal contaminants however, came from products produced overseas.

The time to set up a Federal watchdog on these products is long overdue. The National Institute of Health Division of Alternative and Complimentary Medicine has always taken the position that if products results are positive and reproducible in legitimate studies then the product is not an alternative treatment. That feeling is still shared by me but it does require the product to be in the container you purchase free of harmful contaminants.

Glucosamine Study: “It Doesn’t Work”

C. Kent Kwoh, M.D., of the University of Arizona in Tucson reported results of a study to examine whether individuals who take glucosamine showed evidence of structural benefits in the treatment of their knee arthritis on MRI scans and in biochemical markers of cartilage deterioration. The study appeared in the online version of Arthritis & Rheumatology.

GlucosamineThere is a big retail market for glucosamine with more than one in ten U.S. adults using it for relief of arthritic pain. Many studies have been done but most were sponsored by manufacturers of glucosamine so the results are felt to be reliable. Worldwide sales of glucosamine top $2 billion dollars per year.

To evaluate the substance, Dr. Kwoh found 201 volunteers from his community with chronic knee pain. The patient’s mean age was 52 years old. More than 50% were women. Their body mass index averaged 29kg/m2 indicating they were not grossly overweight. They were randomized and blinded into two groups one receiving 1500mg of glucosamine hydrochloride (Reganasure) or a placebo in a 16 ounce bottle of a diet beverage. They then followed the patients for six months recording their pain evaluations, their changes on MRI images of their knees and noting any difference in the levels of C-terminal telopeptide of type II collagen – a marker of collagen deterioration. The results showed no differences between the glucosamine and placebo group.

Joanne Jordan, M.D., Chief of Rheumatology University of North Carolina noted that the study showed that glucosamine at this dose and for this length of time does not alter or help arthritis sufferers. “Nobody wishes it worked more than me.” said Nancy E Lane, M.D., director of the Center for Musculoskeletal Health at the University of California Davis in Sacramento. “It doesn’t work. There’s a group of patients who get a reduction in pain when they take glucosamine because glucosamine is a sugar and sugars can be analgesic to some people.”

No one has shown that glucosamine is harmful to anyone. It would be helpful if the study ran for more than six months since arthritis is a long term episodic disease. The investigation of supplements and alternative treatments is long overdue so this scientific study is welcome. It just needs to be continued for a longer period of time to satisfy those who use the product and have gotten relief.

Supplement Toxicity on the Rise

VitaminsIn a report in MedPage Today, the medical newsletter of the University of Pennsylvania School of Medicine, researchers attending the meeting of the American Association of the Study of Liver Diseases reported a striking increase in the number of severe liver injuries reported in supplements between the years 2004 and 2012. They reported the number of cases increased from 7 – 20% and blamed the vast proportion of those cases on dietary and herbal supplements.  Particularly disturbing was the number of injuries in young people involved in bodybuilding.

Mary Rinella, MD of Northwestern Memorial Hospital in Chicago moderated a discussion group on the topic and mentioned what a large problem it is; “It’s made worse by the popular belief that such supplements are harmless, which leads patients to omit mentioning them when they are in a clinic or doctor’s office.”  She went on to say that, “We don’t know what’s in the products or even what’s in the bottle.” Rinella said.  “Dietary and herbal supplements are not considered drugs and so escape oversight by the FDA.”

Warren Kupin, MD, FACP of the University of Miami Miller School of Medicine division of nephrology delivered a similar message on the epidemic of kidney disease in young adults being caused by the contents of common herbs and supplements sold on our shelves with pleasant healthful sounding names. He raised the red flag on products produced in India and Asia or products containing materials from those areas which contain high levels of heavy metals such as mercury, cadmium, arsenic and others. The target market is young women of child bearing age and they expose their partners and children to these products.  He took a commonly sold supplement, opened the bottle and said that the aroma escaping contained so many heavy metals that if this was produced in a US factory OSHA would require the workers to be wearing respirators in that type of toxic environment.

Consumers need to read labels and ask questions of their doctors before they add an herb or supplement to their daily regimen.  Women of child bearing age need to be especially vigilant and discuss these supplements with their obstetricians and pediatricians before considering ingesting them. The National Institute of Health maintains a very objective website on alternative and complimentary medications at nccam.nih.gov/health/whatiscam that is a great resource and location of factual material.   

I always suggest that when you visit your doctor you bring all your medications, vitamins, minerals, herbs and supplements in a plastic bag with you so that the doctor can read the labels with you.  Accepting the advice you receive on the Internet or from the sales personnel at a vitamin and mineral store is not the most accurate way to learn the truth.  The public is injuring and maiming themselves by consuming too much of the wrong things and there is little or no government oversight and regulation of these products. Protect yourself and ask your doctor for assistance!

 

More Anti-Oxidants Provide No Benefit for Aging Eyes

Eye Glasses, Older WomanTwo papers presented at the Association for Research in Vision (ARVO) conference in Seattle emphasized that in a population of patients with adequate nutrition the addition of more antioxidants, vitamins and supplements do not help your vision or prevent progression or development of eye disease. In fact, not only did they not help but there was a significant concern that the addition of lutein and beta carotene to the diet of smokers and former smokers actually increased the risk of those individuals developing carcinoma of the lung. The studies were published in JAMA Ophthalmology and the Journal of the American Medical Association.

The study, known as Age-Related Eye Disease Study 2 (AREDS2), concluded that adding lutein, zeaxanthin, and fish oil to daily multivitamin supplements does not boost prevention of age related macular degeneration or cataracts in high risk individuals.

The original AREDS study showed that adding high doses of Vitamin C and Vitamin E, beta carotene and zinc slowed and lowered progression of early and intermediate age related macular degeneration and associated vision loss. That original study suggested that the addition of more antioxidants might help. This was the basis for the follow-up study AREDS2.  The follow up study randomized patients to receive lutein plus zeaxanthin, or omega 3 fatty acids, plus DHA and EPA, both, or a placebo. No benefit of adding these antioxidants was noted except in patients with extreme nutritional deprivation situations.

Vitamin C is a water soluble vitamin.  You keep what you need and the rest is eliminated harmlessly through the kidneys. Vitamin E is a fat soluble vitamin and excess intake is stored in the cells of your body.  Toxicity can occur from ingesting too much of Vitamin E or Vitamin A.  Beta Carotene has been postulated to have an effect on lung cancer in other studies.   The bottom line, too much of anything is not good for you. 

Patients should be asking their ophthalmologists about the constituents of the supplements being recommended to them for eye health.  If they are a cigarette smoker or former smoker they should question the need for beta carotene and lutein because of the association with lung cancer. They should review their total Vitamin A, E, D and K intake from their ophthalmologic vitamins and supplements and their other vitamins and supplements to insure that their total daily intake does not exceed recommended levels.

Multivitamins in the Prevention of Cancer in Men

Vitamin, mineral and supplement use in the United States is a multi-billion dollar industry. Despite many testimonials extolling the benefits of supplemental vitamins, there has been very little research that actually provides evidence that these supplements are beneficial. However, there is abundant evidence that over consumption of the fat soluble vitamins, A, E, D and K results in accumulation of the substances and eventual toxicity.  The 2010 Dietary Guidelines for Americans says, “For the general, healthy population, there is no evidence to support a recommendation for the uses of multivitamin or mineral supplements in the primary prevention of chronic disease.”

The Physicians Health Study II (PHS II), a randomized controlled study, followed 14,641 male U.S. patients initially aged 50 or older for a median of 11.2 years. Their results showed that “daily multivitamin supplementation modestly but significantly reduced the risk of total cancer.”  The study could not clarify or specifically define which nutrient or nutrients in their supplemental multivitamin were responsible for the effect in reducing cancer.

The study used the multivitamin Centrum Silver.  However, it did not examine the effect of multivitamins in women.  Nor, did it did allow participants to consume additional vitamins, minerals, supplements or herbs.

The message to individuals is clear. Eat a healthy and balanced diet that is prepared in a manner that does not destroy the nutrients.  A multivitamin such as Centrum Silver will reduce your risk of cancer minimally. There is no proof that taking additional products with the multivitamin will have a more positive effect.

“Buyer Beware”- Supplements Are Not What They Are Advertised to Be

According to an article authored by Maria Elena Martinez’s (Ph.D., University of California, San Diego) in the Journal of the National Cancer Institute, “Consumers need more information and guidance about the risks as well as the benefits, of using dietary supplements for cancer prevention.” Dr. Martinez states that dietary supplements have little supporting evidence for health benefits in disease prevention – particularly cancer.

“Despite this evidence, marketing claims by the supplement industry continue to imply anti-cancer benefits“ Martinez wrote.  “Insufficient government regulation of the marketing of dietary supplement products may continue to result in unsound advice to consumers. Both the scientific community and government regulators need to provide clear guidance to the public about the use of dietary supplements to lower cancer risk.”

Half of US adults use one or more daily dietary supplements. “Use of supplements has been fueled primarily by marketing oriented claims of wide ranging benefits,” Martinez and her co-authors wrote. “As a result, sales of dietary supplements have grown into a $30 billion a year industry.”

To assess the current status of evidence supporting use of supplements, Martinez and her associates reviewed literature for supplements that have been tested in adequately powered clinical trials or in large, well-designed observational studies.  The review looked at data for the use of antioxidants, folic acid, Vitamin D and calcium to prevent cancer.

Preclinical studies suggested that dietary antioxidants including beta carotene, alpha tocopherol, and Vitamin C encouraged growth of normal cells and tissue and inhibit growth of abnormal tissue. Clinical studies failed to support those ideas:

>  Beta carotene did not prevent recurrence of non melanoma skin cancer

>  Beta carotene, alpha tocopherol and Vitamin C failed to prevent recurrence of colonic adenomas

>  Beta carotene, Vitamin A and alpha tocopherol did not prevent lung cancer

>  Vitamins C and E did not protect against cancer

>  Alpha tocopherol, Vitamin C and beta carotene had no effect on cancer incidence or mortality

>  Vitamins A, C and E with beta carotene alone or in combination did not prevent gastrointestinal cancers

>  Alpha tocopherol and selenium failed to prevent prostate cancer in average risk men

In some instances studies actually showed an increased risk of cancer in those taking supplements.

Two different randomized trials showed an increased risk of cancer (prostate) and pre cancerous lesions (colonic adenomas) in individuals taking long term folic acid supplementation.

The paper was equally negative about Vitamin D use. They cited three short term studies that failed to demonstrate an effect of Vitamin D on cancer incidence or mortality. The authors went on to support the Institute of Medicine position that “there is not enough evidence to state that there is a causal association between low Vitamin D intake and increased cancer risk.”

The material was published in the Journal of the National Cancer Institute and summarized recently in the on line news service MedPage.

In my practice I will continue to emphasize that a balanced diet prepared in a manner to preserve the nutrients is the best way to meet your nutritional needs. I will screen for those malabsorptive states and surgical situations that require supplementation with vitamins and supplements. These are sufficiently rare. In some cases, administration of medications such as anti-cancer agents causes depletion or malabsorption of vitamins and trace elements. In those cases I will supplement.  Women requiring calcium to prevent osteopenia and osteoporosis should be supplemented. In most other instances, I will suggest a balanced diet and correct preparation of food which should provide all the vitamins, minerals and antioxidants needed to stay healthy