Confessions of a Quackbuster

This blog deals with healthcare consumer protection, and is therefore about quackery, healthfraud, chiropractic, and other forms of so-Called "Alternative" Medicine (sCAM).

Sunday, July 03, 2005

Protandim claims debunked

The following article has since been improved and is best viewed here:

Protandim: Another Kind of Antioxidant



This message from Dr. Hall just has to be shared. As usual she does an excellent job of debunking:


Got this from a friend and answered it below. See http://www.protandim.com/ Hope some of the real scientists on the list can chip in from the biochemical standpoint. I suspect there are some serious flaws in their rationale that I'm not knowledgeable enough to spot.

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Your Doctorship,

As you are aware, I am in awe of your interest in pushing pins into inflated balloons of psuedoscience and phony medical claims. Now along comes yet another product to join the anti-aging fad. A product called Protandim which has received considerable publicity on National television and elsewhere. After looking at their website, it appears to me that this is just another, among many ways, to cash in by creating fear in the populace which, amazingly enough, can be effectively treated by an overpriced, unproven stroke of genius which has somehow been overlooked by the Medical community at large. I have a knee-jerk response to these types of things because I believe that they are phony and the only health improvements to be seen is that of the bottom line of the companies which produce them. Unfortunately, I have a dear friend who is vigorously touting this stuff and I need some reasoned ammunition if you have any, to discredit this latest craze.

Much appreciation in advance for your advice and assistance.

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Your instincts are correct. This is total bullshit, and is only one of hundreds of similar products offered on the web and supported only with the most flimsy excuses for evidence. There is so much wrong here that I hardly know where to start.

In the first place, the usual disclaimer is present: THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE. To translate for your credulous friend, this means that there is no acceptable evidence that it works. It means that the law only allows them to sell it under the category of "diet supplement" with vague claims that it "supports" body functions. It means that Protandim IS NOT INTENDED TO TREAT OR PREVENT AGING OR ANY DISEASE RESULTING FROM OXIDATIVE STRESS. So if he's taking it for those reasons, he's taking it for something it wasn't intended for. There's some big-time cognitive dissonance here.

The website says "The "Free Radical Theory of Aging," is now widely held as fact." That's a gross misrepresentation of the status of current scientific knowledge. There's a good summary at http://www.accessexcellence.org/LC/ST/bgfreerad.html. Note that antioxidants can sometimes become oxidants, that antioxidants in fruits and vegetables (not pills) are recommended, and that the most promising anti-aging treatment appears to be calorie restriction.

They say: "A recent position paper published by over 50 preeminent antioxidant/anti-aging researchers in Scientific American, stated that no effective therapy exists to combat age-related oxidative stress. The author did assert, however, that a promising avenue would be "enhancing the body's own production of free-radical scavengers." This is exactly what Protandim does!" No, that is exactly what they SAY it does; and there is no evidence that it does, and even if it did, it would only amount to a "promising avenue" for research. And to quote the article again, "NO effective therapy exists to combat age-related oxidative stress." That's what it said and that's what it meant.

This company is trying to jump on the band-wagon. Anti-oxidants are popular right now. They are claimed to do all kinds of good things, but it seems the more studies we do, the less benefit we find. Just one example of many: vitamin E has antioxidant effects and has long been thought to reduce the risk of heart disease, but several recent studies have shown that those taking vitamin E supplements were MORE likely to develop heart problems.

They claim that "Protandim's unique botanical formulation turns on your body's system to naturally produce more of the key antioxidants that it already makes." The evidence to support that statement is pretty flimsy. They quote a total of two (2) scientific studies on their website:

(1) Done on a small number of mice - showed Protandim decreased lipid peroxidation measured by TBARS.

(2) Done on 13 people - showed TBARS is higher in older people and showed Protandim decreased lipid peroxidation measured by TBARS, showed that catalase (antioxidant enzyme) and uric acid levels increased on Protandim.

Their own footnote says it all: "Due to the small number of persons who participated in this study, as well as other features of it, we are not suggesting that its results would be the same or similar to the results of a more comprehensive well-designed and controlled study or that you can reasonably expect to experience the same or similar results if you ingested Protandim at the same levels as that administered in the study."

Now, even assuming that they could establish that their product lowered lipid peroxidation and raised catalase and uric acid levels, that doesn't necessarily mean that those altered blood levels will result in any clinical benefit. In fact, one could argue that raising the uric acid level is a bad idea - it could lead to kidney stones, gout and other health problems. I don't want to know if my lipid peroxidation level will decrease, I want to know if I will be healthier or live longer.

Another claim is that the product "restores oxidative balance to the levels found in a 20-year-old" - this is nonsense. They did an inadequate preliminary study on 13 people, and if they showed anything, it was a change in the TBARS test, not a "restoration of oxidative balance." I don't know what they even mean by oxidative "balance." That's not scientific terminology.

The ingredients of Protandim are: Milk thistle, Bacopa extract, Ashwagandha, Green tea extract, and Turmeric extract.

I looked these up in the "Natural Medicines Comprehensive Database." None of them is known to have any significant clinical benefit from antioxidant effects. Some of them are listed as "not enough information" to know if they are safe. One has estrogenic properties and more than one has potential interactions with other drugs and known side effects. The only one that even sounds remotely like it might have some pertinent data behind it is green tea.

Green tea contains antioxidant catechins that are "thought to possibly have a protective effect against atherosclerosis and heart disease" and contains flavonoids that "might reduce lipoprotein oxidation; however benefits have not yet been described in humans."

If there is an active ingredient in Protandim, what is gained by using whole plant extracts and including all the hundreds of other organic compounds found in those plants? What are the chances that some of those unwanted ingredients will be counterproductive or will interact with each other in some harmful way? What are the chances of unwanted side effects from those other molecules? Despite extensive pre-marketing studies, unexpected side effects often turn up in prescription drugs after marketing - how can they say Protandim is safe when they have never even tested it in large scale studies?

The big question I have with all these products that contain mixtures of herbs: how did they decide which herbs to mix and in what quantities? How do they know that any individual ingredient is effective and how do they know that that particular combination is more effective? If you ask them, they may give you some half-assed rationale, but the real answer is they have no evidence that that particular combination is better than any other - it was guesswork pure and simple.

If you want to waste $50 a month on somebody's guesswork and slick merchandising, go ahead - although I really fail to see how you can rationally choose this product above all the hundreds of others with similar claims. If you want to follow the best recommendations science can give you at the moment, eat more fruits and vegetables and restrict your total calorie intake. It's cheaper and a lot more likely to benefit you.

Harriet Hall, M.D.


(Used here by permission.)


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More: http://quackfiles.blogspot.com/2005/07/protandim.html