Talk:Protandim/Archives/2009/May

Antioxidants

Name one antioxidant that improves outcomes? Vitamin E increased risks of lung cancer in smokers. Oxidation is used by your WCBs to kill cancer. Stopping this may increase cancer. Therefore protadime might be harmful. This hypothesis is as good as any other. Quackwatch needs to stay front and centre. A couple of tissue culture studies and a not controlled none blinded short term study is very weak evidence.--Doc James (talk · contribs · email) 22:39, 25 April 2009 (UTC)

By the way Joe M. McCord works for the MLM company LifeVantage http://www.mlm-thewholetruth.com/lifevantage.shtml This sort of stuff is your standard scam.--Doc James (talk · contribs · email) 23:01, 25 April 2009 (UTC)

I think I understand what your saying. There are studies (observational studies by the way) that suggest antioxidant supplements do not decrease probability of cancer and may, in some cases increase it. However, that is beside the point. We are talking about the quality of these studies. The protocol followed in the human study is appropriate for a preliminary investigation if it is deemed very unlikely that the observed effects would be caused by a placebo. It is not as if they are investigating something like an anti-depressant which would require a double blind protocol even in preliminary trials. If you give oral vitamin C or E to a patient. you certainly don't see anything like these effects occurring.

I double-checked the search for JM McCord. It is 125 papers in such journals as Am J Clin Path. J Biol Chem. J Clin Invest. Am J Physiol. It is not unusual for a medical scientist to occupy an advisory position with a pharmaceutical company. Such an arrangement is common and does not necessarily represent a conflict of interest. It is a serious thing to accuse someone of a conflict of interest. You would have to give very specific examples of bias to substantiate such an allegation. You say, "This sort of stuff is your standard scam." To what "stuff", exactly, are you referring? —Preceding unsigned comment added by 67.176.199.104 (talk) 00:11, 26 April 2009 (UTC)

The "oxidative stress" entered on Pubmed returns 63,958 results. It is a meaningful concept and it is studied extensively. Is reducing normal oxidative stress is good or not? This should be studied further and it certainly is. I am not sure that such a reduction would necessarily effect the use of superoxide by WBC. There are also many ways such a reduction might reduce the likelihood of cancer. —Preceding unsigned comment added by 67.176.199.104 (talk) 00:27, 26 April 2009 (UTC)

Antioxidants have been well studied and have NOT been found to be helpful for example: "Randomized trials that have examined the role of antioxidant supplements in reducing the risk of cancer and CVD have generally not found positive effects. As an example, a meta-analysis of randomized trials of antioxidant supplements for the prevention of gastrointestinal cancers found no decreased risk with supplementation" From Uptodate.

BACKGROUND: Oxidative stress can cause cancer. Our aim was to establish whether antioxidant supplements reduce the incidence of gastrointestinal cancer and mortality. METHODS: With the Cochrane Collaboration methodology, we reviewed all randomised trials comparing antioxidant supplements with placebo for prevention of gastrointestinal cancers. We searched electronic databases and reference lists (February, 2003). Outcome measures were incidence of gastrointestinal cancers, overall mortality, and adverse effects. Outcomes were analysed with fixed-effect and random-effects model meta-analyses and were reported as relative risk with 95% CIs. FINDINGS: We identified 14 randomised trials (n=170,525). Trial quality was generally high. Heterogeneity of results was low to moderate. Neither the fixed-effect (relative risk 0.96, 95% CI 0.88-1.04) nor random-effects meta-analyses (0.90, 0.77-1.05) showed significant effects of supplementation with beta-carotene, vitamins A, C, E, and selenium (alone or in combination) versus placebo on oesophageal, gastric, colorectal, pancreatic, and liver cancer incidences. In seven high-quality trials (n=131727), the fixed-effect model showed that antioxidant significantly increased mortality (1.06, 1.02-1.10), unlike the random-effects meta-analysis (1.06, 0.98-1.15). Low-quality trials showed no significant effect of antioxidant supplementation on mortality. The difference between the mortality estimates in high-quality and low-quality trials was significant (Z=2.10, p=0.04 by test of interaction). beta-carotene and vitamin A (1.29, 1.14-1.45) and beta-carotene and vitamin E (1.10, 1.01-1.20) significantly increased mortality, whereas beta-carotene alone only tended to increase mortality (1.05, 0.99-1.11). In four trials (three with unclear or inadequate methodology), selenium showed significant beneficial effect on the incidence of gastrointestinal cancer. INTERPRETATION: We could not find evidence that antioxidant supplements can prevent gastrointestinal cancers; on the contrary, they seem to increase overall mortality. The potential preventive effect of selenium should be studied in adequate randomised trials. PMID 15464182

More studies Randomized trials of vitamin E in cancer prevention include: The Women's Health Study followed 39,876 apparently healthy women ages 45 and older for a mean of 10.1 years [75]. Compared with placebo, supplementation with 600 IU of natural-source vitamin E on alternate days had no effect on the incidence of all cancer (relative risk (RR 1.01, 95% CI 0.94-1.08) or on breast cancer (RR 1.00), lung cancer (RR 1.09), colon cancer (RR 1.00), or cancer death (RR 1.12). The Polyp Prevention Study observed no reduction in colorectal polyps among subjects randomized to receive vitamin E [64]. The HOPE-TOO trial found no effect of vitamin E supplementation (400 IU daily) on cancer incidence or cancer deaths after a median follow-up of seven years [76]. An analysis of 7627 women who were free of cancer at random assignment in the Women's Antioxidant Cardiovascular Study found no effect of vitamin E (600 IU every other day) on the incidence of cancer after a mean follow-up of 9.4 years [59]. From Uptodate

Protamine has evidence for it that is meaningless and likely has no effect over that of placebo. There may be potential harm and this risk is at least as great as its potential benefit.--Doc James (talk · contribs · email) 00:45, 26 April 2009 (UTC)

Yes. As I said "There are studies that suggest antioxidant supplements do not decrease probability of cancer and may, in some cases increase it." I think that these LifeVantage people should have done a placebo study before putting the stuff on the market. I am always rather amazed by the list of effects observed in a placebo group. —Preceding unsigned comment added by 67.176.199.104 (talk) 01:02, 26 April 2009 (UTC)

And this is what makes me think this product is pseudoscience. Rather then doing a proper study they look at weak surraget makers in the hope of finding some that might by chance be positive than try to make money by promoting it.--Doc James (talk · contribs · email) 02:43, 26 April 2009 (UTC)

I have found new **(clinical)** studies that just came out from the University of LSU you can find all the information on www.plosone.com —Preceding unsigned comment added by 1alexh (talk • contribs) 22:10, 29 April 2009 (UTC)

Thanks. It is in mice. I guess we could add a section on treating mice at high risk of skin cancer and the effectiveness of this substance in a small trial than link it to this aricle. --Doc James (talk · contribs · email) 02:10, 30 April 2009 (UTC)

Then are you willing to go on the record by saying protandim is not something that could be a prevention of diseases in the human body? —Preceding unsigned comment added by 66.202.36.78 (talk) 11:36, 1 May 2009 (UTC)

I would say that there is not sufficient scientific evidence that protandim prevents diseases in human. But you do not have to listen to me the FDA says the same.--Doc James (talk · contribs · email) 13:52, 1 May 2009 (UTC)

So then it would also be fair to say you and the FDA can not say 100% it does not do anything? Since there is not enough sufficient scientific evidence? —Preceding unsigned comment added by 66.202.36.78 (talk) 22:37, 1 May 2009 (UTC)

I would not go so far as to say that the FDA has anything specific to say about Protandim as long as it conforms to the requirements for a GRAS (generally recognized as safe) product. The GRAS disclaimer is basically just legal boilerplate for this kind of product. At one time, the FDA was more adversarial towards nutriceutical products, for example, the case of FDA vs Life Extension Foundation. http://www.benbest.com/polecon/fdalef.html Eventually, this case was dropped. I think the FDA has become more tolerant of the idea that "Nutraceuticals" are a different paradigm from pharmaceuticals. The FDA disclaimer is saying that GRAS is outside the domain of concern of the FDA as far as validation of effectiveness goes. It doesn't mean that you can't do meaningful research in the field of wellness science. However, it tends to be a more problematic than studying a specific disease condition. I think with the new administration and a new surgeon general there will be more of a trend to re-examine the old paradigms and put more resource into studying ways by which health can be managed more effectively. —Preceding unsigned comment added by Entropy7 (talk • contribs) 23:26, 3 May 2009 (UTC)