A friend of mine asked me the other day to offer my opinion on Protandim. A friend of hers markets the product, and she is interested in trying it. At the time, I had never heard of Protandim. While I am an immediate skeptic of any supplement that is marketed in multi-level fashion, I did not wish to render any opinion without researching the product. So I’ve spent some time reviewing the Protandim website and the peer-reviewed literature and would like to share my thoughts.
What is Protandim?
Protandim is a nutritional supplement that is comprised of five botanical excipients: Bacopa monnieri (water hyssop), Silybum marianum (milk thistle), Withania somnifera (ashwagandha), Camellia sinensis (green tea extract), and Curcuma longa (turmeric). This combination is suggested to increase the activity of a substance in the body called Nrf2, which regulates the expression of the majority of anti-oxidant genes in the body. Anti-oxidants have been long been promoted and researched as weapons against cancer, cardiovascular disease, and aging in general.
What is Protandim used for?
The makers of Protandim do not directly promote it for the treatment or prevention of any disease (law prohibits them from doing so since it has not gone through the FDA approval process). The proposed benefit of Protandim is the reduction of oxidative stress. The following comment is stated on their website: “Protandim activates Nrf2, which communicates with cells, instructing them to do what they’re already designed to do: up-regulate “survival genes,” genes that enable cells to survive in the face of stress from free radicals and other oxidants, and down-regulates other genes to help the body function at an optimal level.”1
Given that Protandim is sold via a multi-level marketing process, I imagine direct salespersons of the product are likely to make more direct claims about its usefulness and effectiveness. These may include claims of it being an anti-aging product, or that it reduces the risk of cancers or other chronic diseases. This isn’t directly promoted by the company, but the salespeople have incentive to increase sales of the product and I doubt they are closely monitored by the company or regulatory agencies in terms of the content of their pitches.
Is Protandim effective?
Keeping in mind that it is being promoted purely for its anti-oxidant capabilities, let’s first address the broad issue of the clinical value of anti-oxidants. Anti-oxidants are substances that help the body rid itself of toxins known as free radicals. There is a good amount of evidence suggesting that free radicals play a role in numerous disease processes. Accordingly, there has been much interest in studying anti-oxidants as a potential cure or preventive strategy against disease and aging. Broad observational studies have noted that people who eat diets high in fruits and vegetables (which are generally high in anti-oxidants) suffer from less cancer and cardiovascular disease. But well performed studies that aim to identify a direct correlation between anti-oxidants and disease prevention have not been positive. In some studies, anti-oxidants have actually been shown to increase the incidence of disease or death. Unfortunately, it is not uncommon to identify substances or drugs in the lab that in theory would improve health but when tested rigorously in humans show no benefit or even show harm. That being said, let’s review the evidence on Protandim…
Is Protandim an effective anti-oxidant?
Several small studies in lab animals or test tubes have suggested that Protandim exerts anti-oxidant activity. Only two studies have actually tested this in living humans, however:
One study performed in 29 healthy adults showed an average 40% decrease in a marker of oxidative stress after 30 days of supplementation.2 The same study showed an increase in two anti-oxidant substances, and no change in a third. Also, the study examined the effect of Protandim on a marker of inflammation called C-reactive protein and on cholesterol levels, but there was no difference noted in either.
The other study was performed in 30 adults with alcohol use disorder who were healthy otherwise. The results of this study did not show a statistically significant change in blood tests indicating oxidative stress after 7 days in the patients taking Protandim.3
So the actual human studies are mixed. This doesn’t mean that Protandim lacks significant anti-oxidant activity. It appears to stimulate anti-oxidant activity in test tubes and animal studies. Larger and longer studies in humans could very well show a more consistent effect. But it would be hard to conclude this as true with the available evidence.
Can Protandim help combat aging and prolong survival?
I suspect this is what the Protandim salespeople want you to believe. While not directly stated, I personally get the sense that this is also suggested on the Protandim website. The short answer to this question is that this is unknown, since it has not been studied. However, I think it is unreasonable to even suggest this given that no well conducted randomized-controlled trial has proven any anti-oxidant to prolong life. Not saying that anti-oxidants are bad, but there is not scientific justification to conclude that they improve health.
There is no direct evidence in humans that Protandim provides any health benefit. Proponents of Protandim are presuming that because laboratory studies suggest it increases anti-oxidant activity, that this conveys a health benefit. As previously stated, there is no direct evidence that this would be the case either.
I’m sure there are many personal testimonials about how this product has changed their life (I’ve gotten numerous emails about similar products). That’s all fine and dandy, but these reports often lack a clear cause and effect relationship and thus do not constitute reliable evidence. More importantly, they are often followed with a link to their affiliate page to purchase the product.
Is Protandim Safe?
Unfortunately, there are no large studies in humans that can shed some good light on the safety profile of Protandim. The prior mentioned study of 29 healthy patients stated that no side effects were noted in any patients after 120 days of supplementation. This is too small of a population to get information about serious side effects that may be less common or occur after longer periods of time.
The FAQ on the Protandim website states the following: “We do not expect there to be any side effects for the typical Protandim consumer. However, some individuals have natural allergic responses to one or another of the ingredients, just as some people are allergic to pine pollen or penicillin. These allergic responses to Protandim generally appear as gastrointestinal disturbances (i.e., stomach ache, diarrhea, vomiting) or sometimes as a headache or rash on the hands or feet.”4
Some lots of the product were recalled in 2012 due to a possibility of metal fragments in the capsules. This was due to a contaminated turmeric batch that was used to create the product. These are risks with any product, including prescription drugs, but the risk is higher with dietary supplements given the less stringent oversight on manufacturing.
As far as drug interactions go, once again there are no studies to provide any guidance. All of the substances in Protandim have been reported to cause numerous drug interactions, so the potential is huge. Their website downplays this, which is ridiculous. This list of potential interactions is very long, so if you are curious about a drug you are taking click my contact link or just comment on this post.
There are no studies in pregnant or breast-feeding women. In the Protandim FAQ, the following statement is made: “if your obstetrician approves Protandim, there is no known reason for concern.”4 If your obstetrician approves Protandim, I would suggest that you find a new one. Since there is no evidence of any specific health benefit from this product, there is certainly no justification to expose a baby to it when the side effects are unknown. This is very inappropriate marketing material.
The Medicine Guy says:
I do not recommended the use of Protandim. There is no evidence that it provides a health benefit to humans. In addition, there is inadequate evidence on its safety, and there is always the concern of contamination and sub-standard manufacturing. There is potential for many drug interactions. And I can think of many things that you could spend $40 to $50 a month on that could positively affect your health without the unknown risk. More fruits and vegetables perhaps?
And a word to those that sell Protandim: remember that you are not selling ties, watches, or shoes. You are selling a product that could potentially affect the health of your customer. It could be good, or it could be bad (or neither). The fact is that there is no good evidence that it does or doesn’t work, that it is or isn’t safe. So please don’t mislead your consumers.
Any questions, or if you sell or take Protandim and are pissed off, please comment below!
The Medicine Guy