Vol. 134 October 15, 2015 Supplements Are Not Harmless.

October 16, 2015

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“The belief is that they [dietary supplements] are entirely safe,
but now science says that they’re not.”
– Pieter Cohen, MD, Harvard Medical School

A recent study of 63 hospitals from 2004 to 2013 estimated that over 20,000 ER visits and 2000 hospital admissions annually in the U.S. were due to adverse effects of dietary supplements. Adverse events included allergic reactions, excess doses, unsupervised ingestion by children, or other events (e.g., choking). Cases involving death, intentional self-harm, drug abuse, or withdrawal were excluded.  Adverse effects commonly involved cardiovascular adverse effects from weight-loss or energy herbal products among young adults, unsupervised ingestion of micronutrients (iron) by children, and swallowing problems associated with micronutrients (multi-vitamins) among older adults. (1)

The supplements listed included orally administered herbal products (Echinacea, Coenzyme Q10, Gripe Water, etc.), complementary nutritional products (fish oil, body building protein , chondroitin/glucosamine, etc), vitamins and minerals (including calcium and iron), and topically administered herbal or homeopathic products. Energy drinks and herbal tea beverages were excluded from the study.

In the U.S. there were more than 55,000 dietary supplements on the market in 2012, and about half of all adults reported having used at least one dietary supplement in the past month. 150 million people in the U.S. take supplements, including children’s vitamins. In 2007, out-of-pocket expenditures for herbal or complementary nutritional products reached $14.8 billion, which equaled one-third of the total out-of-pocket expenditures for prescription drugs.

  • Weight loss supplements or herbal energy products led the list of supplements with adverse effects in this study.
  • More than half of emergency department visits for supplement-related adverse events involved female patients.
  • Sexual-enhancement products or bodybuilding products were implicated in 14% of emergency department visits for supplement-related adverse events among male patients; there were too few cases among female patients to calculate a reliable estimate.
  • 20% of ER visits involved children who took supplements without supervision.
  • Most ER visits for unsupervised ingestion of supplements by children involved multivitamins (34%), iron (12%), supplements for weight loss (11%), and supplements for sleep, sedation, or anxiety (9%). Child-resistant packaging is not required for dietary supplements other than those containing iron (the amount of iron in the usual bottle can be lethal to small children) , but despite such packaging, iron supplements were the second most commonly implicated type of supplement in unsupervised ingestion by children.

Although the numbers of ER visits and hospitalizations were less than the 5% of the ER visits that have been reported for pharmaceutical products, dietary supplements are unregulated and marketed under the presumption of safety. The FDA is actually BARRED from regulating dietary supplements by the Dietary Supplement Health and Education Act of 1994. (Wouldn’t you like to know the history of that particular bill, or at least, the lobbyists involved?)

When you or someone you know has a good effect from a supplement (like taking glucosamine for knee pain) it natural to think that anyone with knee pain should take it, and that every physician should know about this “miracle supplement”. In medicine that kind of anecdote is called a “case report”.  Case reports can lead to studies of a large number of people, called “statistical studies”. Results of those studies can be persuasive, but the truly scientifically skeptical physician will wait for the results of an organized, randomized, double-blind study with controls (people who don’t get the supplement). Such organized, controlled studies have not found a whole lot of benefit, if any, from taking dietary supplements, especially vitamins, but that is the subject for another whole blog… or two.

References;

1. Emergency Department Visits for Adverse Events Related to Dietary Supplements
Andrew I. Geller, M.D., et al, N Engl J Med 2015; 373: 1531-1540; October 15, 2015


Vol. 112 October 15, 2014 MORE Medical Mixed Messages?

October 15, 2014

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Science and medicine over time often seem to be giving us mixed messages. That is actually a good thing. It shows that medicine is always seeking and responding to new information, new data, and revising “the truth”. In our modern world, egged on by rapid technology upgrades and our insatiable demand for “no-risk” living, these “truth revisions” can be difficult to keep up with. Here is a brief update on some recent evidence-based revisions of the truth.

TREATMENT OF THE FLU
The World Health Organization for several years and still currently puts Tamiflu on its list of “essential drugs” and recommends its use in clinical practice as an anti-influenza drug.

A new Cochrane Collaborative meta-analyses of 20 controlled studies which included thousands of pages of previously unavailable data from drug manufacturers concluded that Tamiflu provided minimal benefit for treatment of flu symptoms. Flu symptoms in adults treated with Tamiflu were reduced from 7 days to 6.3 days, about 17 hours. In children, flu symptoms were reduced for a whole day (29 hours). Use of Tamiflu did not reduce hospitalizations and did not decrease complications like otitis media, pneumonia, or sinusitis. There were no flu-related deaths in any of the studies, so effect on mortality could not be determined. (1)

A 10 day course of 75 mg. per day of Tamiflu costs anywhere from $70 to $340 on the internet. At CVS and Kmart it costs about $125, or $12.50 a pill. The Cochrane study did show that if Tamiflu was taken as a drug to prevent flu symptoms after one was exposed to someone with flu, it could reduce the incidence of symptomatic flu by 55%.

So, like so many things in medicine, “ya (or your insurer) payz yur money and takes yur choice”.

VITAMIN SUPPLEMENTS AGAINST HEART DISEASE AND CANCER
In 2003 The United States Preventative Services Task Force (USPSTF) studied vitamin supplements as a means to reduce the incidence of heart disease and cancer. They concluded that there was insufficient evidence to recommend Vitamins A, C, E, folic acid, beta-carotene, or anti-oxidant combination supplements as beneficial in reducing the incidence of heart disease or cancer.

This year the USPSTF studied all evidence published since 2003, and came up with the same conclusion and recommendations. It reemphasized that Vitamin E “more certainly” does NOT reduce the risk of heart disease and cancer, and repeated its warning that the use of beta-carotene (vitamin A) pills actually increased the risk for lung cancer in smokers. The 2014 USPSTF report also added Vitamin D, calcium, and selenium (may actually increase risk of prostate cancer) to its “insufficient evidence of benefit” list. (2) In a separate study, swallowing omega-3 pills (fish oil) did not significantly reduce the risk of stroke or heart attacks. (3)

But remember, these vitamin supplement studies, perhaps spurred by the $28 Billion-plus vitamin supplement industry, are prompted by evidence showing that diets (real food, not supplements) rich in these trace vitamins and minerals are associated with decreased incidence of heart disease and cancer.
If the diet does it, why don’t the pills?
“The biology is complicated,” says Stephen Fortmann, MD, Kaiser Permanente Center for Health Research.

WHAT ABOUT HERBAL SUPPLEMENTS?
“Supplements are regulated (by the FDA) more like foods, which is to say, they’re generally considered safe unless proved not to be”.

A FDA 2013 study using DNA analysis of 44 readily available herbal products revealed that fewer than 50% could be verified as containing the advertised ingredient. Since 2008 the FDA has issued warnings about 330 supplement products that turned out to be adulterated with active drugs not listed on the label. (3)

Three herbal supplements NEVER to take because of serious adverse side effects:
Kava to relieve stress and anxiety can cause liver failure
Yohimba to treat erectile dysfunction can cause volatile blood pressures and rapid heart rate.
Aconite to relieve joint pain can cause nausea and vomiting, low blood pressure, breathing paralysis, heart rate dysfunction, and even death.

GLUCOSAMINE FOR KNEE PAIN
Many patients take and some physicians recommend glucosamine for knee and hip pain due to osteoarthritis because a few small studies have suggested a benefit.

A study of 201 adults with knee pain who were given 1500 mg of glucosamine daily for six months showed no benefits. Compared to the placebo there was NO protection against progression of MRI changes, reduction of biochemical markers of cartilage degradation, or reduction of pain. (4)

References:
1. Journal Watch, General Medicine, May 15, 2014, vol. 34, no. 10
2. Journal Watch, General Medicine, June 1, 2014, vol. 34, no. 11 3.
3. Consumer Reports on Health, June 2014, pg.4
4. Arthritis Rheumatol 2014 Apr; 66:930


Vol. 83 February 1, 2013 Antioxidants: Miracle or Myth?

February 1, 2013

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“The hallowed notion that oxidative damage causes aging
and that vitamins might preserve our youth is now in doubt”
-M. W. Moyer, Scientific American February 2013

It was not just a humble roundworm that got us into this debate. it was a MUTANT roundworm, a worm commonly used for the study of aging.

Since the 1960’s the dominant theory of aging blamed a rising level of free radicals. Free radicals are highly reactive organic molecules produced in our bodies by oxidation. We all know that oxidation is “bad” because we learned in high school that it is oxidation that turns steel into rust. Free radicals cause “rust” in our body by mangling other cells, proteins, and even DNA. Therefore, an antioxidant that reduces free radicals will slow cell “mangling”, destruction, and aging. Having lots of antioxidants around should retard our aging process. “Drink red wine and take vitamin E.”  More than half of Americans believe in this theory and take considerable amounts of antioxidants like Vitamin E, Vitamin C,  and beta carotene (carrot juice). (JAMA 2007)

MIRACLE: “These high powered, super antioxidants fight dangerous free radicals, the source of oxidative stress and a leading cause of premature aging. CALL NOW to Receive Your FREE 30-Day Bonus Supply!” (Cape Cod Times ad January 20, 2013, E4)

This super antioxidant is an organic chemical called oligmeric proanthrocyanide, or OPC. It is found in grape seeds and certain pine bark. This particular brand of OPC’s touted by Dr. Fred Vaginini includes some other organic chemicals found in grape skins (hence the benefits of red wine) and other botanicals. It is called OPC Factor (TM);  $59.95 for a month’s supply ($35.99 on Amazon). The “landmark, double blinded research study by the prestigious National Institutes of Health” cited to support the ad’s claims was actually a small study by an NIH grantee in Philadelphia to measure changes in energy levels in 25 adult men who took OPC. The 2006 study  results were posted in 2008 as inconclusive.

In the 1990’s genetic science advanced to the point that worm and mice genes could be manipulated to block antioxidant production resulting in very high levels of free radicals. Much to the surprise of the scientists running the experiments those worms and mice with the highest levels of free radicals lived the LONGEST.

Exercise increases free radicals, but exercise is beneficial. A 2009 study of humans who exercised revealed that the ones that did NOT pop a lot of vitamins to lower their free radical levels  were physiologically healthier than those who did!   A 2010 study of mice bred to overproduce a specific “super” free radical actually lived 32% longer than the others. Free radicals rise as one ages, but it may be a result of aging and not the cause. I remember the classic graph showing the number of lung cancer deaths increasing as the number of refrigerators (or  indoor bathrooms) increased in the U.S. during the early phase of that debate.

MYTH: A 2007 systematic review of 68 clinical trials concluded that antioxidants do not reduce the risk of death. When the analysis is restricted to only the most vigorous, double-blinded studies certain antioxidants were linked to a 5% INCREASED risk of death. The American Heart Association and the American Diabetes Association now advise “that people should not take antioxidant supplements except to treat a diagnosed vitamin deficiency”.

“The literature is providing growing evidence that these supplements- in particular at high doses -do not necessarily have the beneficial effects that they have been thought to…We’ve become acutely aware of potential downsides.” -D. Albanes, Senior Investigator, National Cancer Institute

References:
“The Myth of Antioxidants”, Scientific American, Febuary 2013, 64-66, Melinda W. Moyer


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