Last year I wrote a review of a dubious herbal combination product called Protandim. At that time, my bottom line conclusion was:
The underlying theory used to promote this product, that anti-inflammatory and anti-oxidant effects are always safe and beneficial, is highly doubtful. There is only weak in vitro and animal model research to indicate that the ingredients in Protandim, or the combination product, have potentially useful effects on cells or biochemical markers. There is absolutely no clinical trial evidence to indicate Protandim has any of the claimed benefits in humans or animals. While the absence of evidence is not proof the product is unsafe or ineffective, it is absolutely a reason to be skeptical of wild claims of miraculous benefits. At best, using this product is simply rolling the dice and hoping for the best. That seldom works out for gamblers in Vegas, and it is not an appropriate approach to healthcare except in the most dire of circumstances.
Dr. Harriett Hall at the Science-Based Medicine Blog has recently provided an update on this product and a recent clinical study investigating it. The study was bizarre and it is amazing any ethics committee would approve it. It is also not prominently featured on the Protanidim web site, no doubt because no effect was seen. Here are a couple of highlights from Dr. Hall’s summary:
To recap their chain of reasoning: alcoholics might develop lung disease, that lung disease might be correlated with abnormal epithelial permeability, protein levels measured by bronchoalveolar lavage (BAL) might be a valid measure of permeability, permeability might be affected by underlying oxidative stress, and Protandim might reduce oxidative stress by stimulating the body to produce its own antioxidants. Do they perhaps think that lots of “mights” add up to a “mighty” argument?
The second listed author, Joe McCord, has a vested interest: he is an officer of the LifeVantage company, the manufacturer of Protandim. They explain that Protandim is “a nutraceutical with a lengthy history of use in homeopathic, Ayurvedic, and traditional Chinese medicine.” An interesting statement, since Protandim was invented only a few years ago by a person with no medical background and it was patented in 2007. Doubly interesting since it belies the common myth that natural medicines are not profitable because they can’t be patented.
They assessed alveolar epithelial permeability by measuring the total protein in bronchoalveolar washings. Total protein levels did not change in either experimental group. They also found no change in oxidative stress indices, epithelial growth factor, fibroblast growth factor, interleukin-1?, interleukin-10, liver function tests, or other blood chemistry tests. The one finding that was statistically significant was a significant decrease in plasma thiobarbituric acid reactive substances (TBARS), a marker of lipid peroxidation — but that was only in the placebo group!
In short, Protandim was significantly (p<0.01) worse than placebo. No wonder they’re not bragging about this study!
Big Pharma gets a lot of criticism, but aren’t Big Supplement and Big Multi-Level Marketing every bit as guilty of self-interest, distortions, and profit motives? At least Big Pharma can’t make its big bucks without first demonstrating effectiveness and safety to the FDA with clinical trials.
Does Protandim provide any real benefit to its customers? I don’t know, and they can’t hope to know unless they do proper clinical studies.