Myth Busters:
Nutritional Supplements With Overblown Claims
TYP
The health and supplement world is full of great agents full of promise. But it's also tainted by the overblown claims of over-enthusiastic retailers. Don't waste your time and health on the false promises of these "treatments".
Success in gaining control of coronary plaque lies in choosing strategies that are truly effective. There's no worse tragedy than wasting your time and health on some promise of spectacular success, only to be disappointed some time later as plaque continues its exponential growth. You've not only wasted time and money, you may have also sacrificed health and safety. The museum of medical curiosities is filled with such failures.
Here's our list of false hopes to avoid.
Policosanol
Policosanol is a sugar cane derivative that initially held huge promise, based on the extensive work from a Cuban research group reporting reductions in LDL cholesterol of up to 30%, increased HDL 15%, improved blood sugars, and reductions in lipoprotein(a)—too good to be true. Unfortunately, many of the preparations available in the U.S. are derived from beeswax and have a different profile of ingredients than the sugar cane source.
We and others have used preparations identical to that developed by the Cuban group repeatedly, only to fail to reproduce any of these benefits.
Reference:
Castano G, Fernandez L, Mas R, et al. Comparison of the efficacy, safety and tolerability of original policosanol versus other mixtures of higher aliphatic primary alcohols in patients with type II hypercholesterolemia. Int J Clin Pharmacol Res 2002;22:55,66
Red yeast rice
The currently available versions of red yeast rice vary wildly in quality and content. Initial published reports suggested that this agent does indeed reduce cholesterol by a route identical to prescription statin drugs.1 Theoretically, red yeast rice was proposed to be safer, since it was a combination of small quantities of several naturally-occurring statin-like agents called monacolins. Before the manufacturer of red yeast rice was sued by the patent-holder of the drug mevacor (Merck Pharmaceuticals), the earlier version did indeed result in modest reductions in LDL. Minus the small quantity of mevacor (around 5 mg per capsule), now removed as a consequence of the lawsuit, the majority of preparations don't seem to work at all. A UCLA study (by the same group that published the initial favorable report) of nine red yeast rice preparations showed that only 1 of 9 tested actually contained the standard quantity of monacolins.
In our experience, the majority of commercially available red yeast rice preparations result in little or no improvement in LDL cholesterol. Until a broadly-applied method of standardization is available, we do not recommend that you use red yeast rice.
Should you choose to give red yeast rice a try, you should have your LDL cholesterol tested, along with the usual liver and muscle precautions that apply to prescription statin agents (since side effects can develop, just like the drugs). You and your doctor can therefore base your decision on whether the expected reduction in LDL cholesterol has occurred. But, in our experience, 9 times out of 10 you'll see nothing happen.
References:
Heber D, Yip I, Ashley JM, Elashoff DA, Elashoff RM, Go VL. Cholesterol-lowering effects of a proprietary Chinese red-yeast-rice dietary supplement. Am J Clin Nutr 1999 Feb;69(2):231-6
Heber D, Lembertas A, Lu QY, Bowerman S, Go VL. An analysis of nine proprietary Chinese red yeast rice dietary supplements: implications of variability in chemical profile and contents. J Altern Complement Med 2001 Apr;7(2):133-9.
Guggulipid
Guggulipid is an Ayurvedic preparation that held promise in experimental, non-human settings, and even in some preliminary human trials conducted in India. However, a well-conducted British trial comparing guggulipid to placebo showed no effect on LDL whatsoever.1 This calls into question the quality or potency of the preparations used, even though efforts were made in the British trial to standardize the preparation by guggulsterone content.
Our experience is similar to that of the British—no measurable effect. Our anecdotal experience with guggulipid does, of course, not constitute a clinical trial. But several attempts using several different manufacturer's preparations yielded no LDL-reducing effect. We do not recommend use of guggulipid.
Reference:
Szapary PO, Wolfe ML, Bloedon LT, et al. Guggulipid for the treatment of hypercholesterolemia: a randomized controlled trial. JAMA 2003;290:765-72.
Chelation
Chelation is the practice of administering a substance called EDTA, either intravenously or orally, to bind "toxins". EDTA is indeed a legitimate and proven treatment for lead poisoning. However, some advocates make extravagant claims over "curing" heart disease.
This practice has proven profitable for its practitioners who often charge substantial amounts to administer the intravenous agent. Chelation agents are also available in health food stores as an oral "supplement". To date, five small studies have examined the value of chelation. All were relatively weak studies based on "soft" measures like exercise time on a treadmill. Nonetheless, all studies suggested no benefit from chelation.
We've had several patients who, on their own, underwent thousands of dollars of chelation therapy and assessed their response by heart scan score. These people experienced marked progression of their plaque, i.e., increased heart scan scores— similar to that experienced with no treatment whatsoever.
Because of the vigorous advocacy for chelation from its practitioners, the National Institutes of Health is conducting a large multi-center trial applying chelation in the manner practiced by its advocates to determine once and for all whether the practice has any merit. We are skeptical. In the meantime, the bulk of evidence suggests chelation is without benefit in your program. Save your money for now and await the results of this well-designed NIH trial.
References:
Ernst E. Chelation therapy for coronary heart disease: An overview of all clinical investigations. Am Heart J 2000 Jul;140(1):139-41.
Knudtson ML, Wyse DG, Galbraith PD et al. Chelation therapy for ischemic heart disease: a randomized controlled trial. JAMA 2002 Jan 23-30;287(4):481-6.
No-flush niacin, nicotinamide
Some people are frightened by the flush caused by taking niacin preparations, even the lesser flush caused by extended release niacins (e.g., Niaspan®). No-flush niacin and nicotinamide have been promoted as methods to obtain all the benefits of niacin (increased HDL, decreased small LDL, reduced triglycerides, reduced lipoprotein(a), reduced total LDL) without the flush. Unfortunately, in our experience, these two agents don't do a darn thing, even at high doses. Experiences from other practitioners suggest the same: big doses, no effect.
No-flush niacin, or inositol-hexaniacinate, is a complex molecule that contains six niacin molecules bound to one molecule of inositol. Although it was initially effective in an animal model, it failed to show any effects whatsoever in humans, perhaps due to the extended period of time required for the molecule to dissociate in the human body (48 hours).1 It is also quite expensive, with many preparations costing $30–40 a bottle.
Likewise, nicotinamide exerts no lipid or lipoprotein effects. The use of nicotinamide was explored several years ago as a diabetes preventive, but this also failed to pan out. In fact, nicotinamide was shown to increase resistance to insulin.
There's no trial evidence to support the use of either of these agents as alternatives to niacin. Don't waste your time and money on them. Stick with tried-and-true niacin. It really works.
Three sustained-release preparations are available that yield less hot flushing than the immediate-release form of niacin, and all three have published safety and efficacy data for their preparations: Niaspan® (FDA approved as a prescription agent), and Slo-Niacin and Enduracin (both over-the-counter "nutritional supplements"). You should strongly consider working with a physician when taking any niacin preparation, especially with doses of 500 mg per day or greater.
Reference:
Meyers CD, Carr MC, Park S, Brunzell JD. Varying cost and free nicotinic acid content in over-the-counter niacin preparations for dyslipidemia. Ann Intern Med 2003;139:996–1002.
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