All natural? $15 billion worth sold annually

Dr Melissa Walton-Shirley

Disclosures

March 27, 2012

I don't really get how anyone could feel more comfortable taking something that's not been studied formally, whose purity is not guaranteed, and whose components are not uniformly distributed from pill to pill. I'm phobic enough about medications in general that I don't even want to take those that have been studied extensively and whose side effects and interactions are widely known. Dr Rhonda Cooper-DeHoff, a Pharm-D at the University of Florida, stated that 100 million Americans now utilize alternative medications or supplements. Interestingly, users tend to be female, richer, more educated, and American Indian or white. And America's penchant for dosing ourselves with entities that have almost no evidence of benefit costs a hefty $15 billion each year. Alternative companies claim they can't afford to perform randomized controlled trials, yet their products account for 33% of the total out-of-pocket medical expense of Americans.

Patients utilize alternative meds for various reasons. In a 2006 survey, 66% of individuals indicated they used supplements to treat a specific health condition, 65% intended them to enhance overall wellness, and 42% aimed to prevent illness. Love them or hate them, supplements are here to stay . . . but Dr Cooper- DeHoff pointed out there have been significant shifts in trends. 
In 2002, echinacea reigned king, and ginseng, garlic, and St John's wort were exceedingly popular. Five years later, fish oil, of which there is at least some evidence of benefit, is now a dominant choice, followed closely by glucosamine and chondroitin. "Physicians are now recommending more physical activity, which means more joint pain," Dr Cooper- DeHoff reasoned. Echinacea is decreasing in popularity, flaxseed oil is emerging, and we now see very little St John's wort. Interestingly, Co-Q 10 is becoming a major player.

Dr Cooper-DeHoff pointed out that as Americans utilize green tea and caffeine for weight loss and as an energy source, they garner the side effects of anxiety and tachycardia. In my office setting, I see tons of folks every year who suffer from caffeine intolerance and although caffeine in normal amounts won't kill you, (unless you have a long QT), it can certainly make you think you're dying and generates scores of unnecessary office visits and testing. Energy drinks that are typically sugar laden can contain up to 360 mg caffeine, or the amount found in three to four cups coffee. This excessive amount of caffeine is a structural analog of adenosine that generates side effects of nausea, palpitations, protracted vomiting, rhythm issues, and seizures. Even more confounding is the fact that caffeine intoxication is not detected on blood screening.

Dr Cooper-DeHoff pointed out that side effects of other supplements could also be serious and even devastating. A brand known as Total Body has been associated with a 10 000-fold increase in selenium levels, producing significant liver toxicity, pulmonary edema, and even death. She then described a common issue with red-yeast rice, used as a condiment in Asia with the active ingredient shared by the cholesterol-lowering drug lovastatin called monacolin K. "The difficulty is the variability in concentration," she points out, "which varies lot to lot and bottle to bottle, and there are even significant variations from manufacturer to manufacturer." For instance, some brands suggest two capsules twice per day. "This means that if the patient switches brands, they could actively change their dose of lovastatin from 4 mg per day to up to 40 mg per day unknowingly," she warned. A most horrifying fact about red-yeast rice is that the supplements routinely contain arsenic and citrinin. Citrinin is a known nephrotoxin. With regard to arsenic, I found it interesting that the Dr Oz–generated warning about apple juice containing miniscule amounts of arsenic a few months back caused a full-fledged panic nationwide, yet the arsenic issue with red-yeast rice was no more than a blip on the screen.  "I note while walking up and down the aisles of places like Wal-Mart that the compounds or byproducts are not listed on the label," Dr Cooper-DeHoff pointed out. She then went on to add that even relatively safe entities like Co-Q 10 are not without problems. Advertised as a "miracle antioxidant" for hypertension, Alzheimer's, and statin-induced myopathy, few understand that Co-Q 10 is structurally similar to vitamin K and can decrease the INR in warfarin users, a result that can be devastating for patients with heart-valve problems, prior stroke, or atrial fibrillation.

Although we as practitioners may loathe supplements, it is our responsibility to be educated so that we can help our patients navigate their risks. The results of a 2006 AARP survey revealed that 77% of patients did not share their supplementation use with their doctors: 12% felt their healthcare providers would be dismissive or would tell them not to utilize them anymore; 30% didn't think it was important for their doctors to know what they were taking; but most damning for us as a profession is the fact that 50% of patients surveyed said their physicians never even asked if they were taking supplements.

Patients think that "natural is safe," said Dr Cooper-DeHoff when she rolled her next slide of devastating complications with supplement use. More adverse effects included heart-transplant rejection with St John's wort, seizures with ginkgo, rhabdomyolysis with Commiphora mukul, interactions of fish oil and gingko with warfarin, diabetes insipidus with Solanum indicum, and exacerbations of hemochromatosis with milk thistle. She cited both pharmacodynamic augmentation as well as impacts on the pharmacokinetic issues of absorption, distribution, metabolism, and elimination of several major drug groups with alternatives.

"Herbal supplements need to suggest some benefit or some efficacy in order to sell," said Dr Cooper-DeHoff, and sell they do, to a tune of 363 million annually in the weight-loss arena. In October of 2011, supplements by the names of Advanced Slim, Botanical Slimming, Magic Slim Tea, Pai You Guo, Slender Slim 11, A-slim, Lose Weight coffee, and p57 Hoodie were found to contain sibutramine, a compound pulled from the US market in 2010. Increases in BP, stroke, and heart attack were reported side effects. Many were obtained over the internet, so no one has any idea what else might be in them.

If energy and vitality or illness prevention won't sell, sexual enhancement always will. The FDA warned about 12 products containing sildenafil, including Magic Power Coffee, Man King, Via-Xtreme, Black Ant, Hard Ten Days, and Man Up, all of which actually contained compounds that could be fatal with the heart medications that contain nitroglycerin.

"Bath salts" are also not benign. The white-powder crystals contain elements of the khat plant or cathinones, a synthetic derivative that can increase HR and BP and cause sweating and agitation. Unfortunately, the symptoms can be confusing to practitioners. Like caffeine, cathinones will also not appear on a standard drug screen, so it's important to ask the patient or significant others about their supplementation histories.

Driving the point home about how prevalent alternative supplementation has become, Dr. Cooper-DeHoff snapped a picture with her cell phone of an innocent-appearing piece of chocolate placed on her pillow this week at the Hyatt McCormick. On the label was the wording "sleep" and "good night," which upon closer inspection contain valerian extract. "What if someone waited until in the morning to eat their chocolate? They would wonder why they were so sleepy all day," she quipped.

I tell my patients that anything that is processed isn't natural. Earthquakes, tornados, and appendicitis are all natural but aren't desirable. A pair of sneakers, the Mediterranean diet, and yoga are more effective and tons cheaper in the long run than anything the supplement industry offers. When it comes down to it, there is nothing natural about selling nature in a bottle, period.

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