Talk:Fermented wheat germ extract

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[edit] POV

A few points. No RCT evidence is cited. The Human Clinical Trials section cites animal and basic science papers for the following statements: "In tests to determine whether FWGP might interfere with conventional therapy, the compound did not lessen the therapeutic benefit of any conventional therapy." and "Researchers attributed the increased relapse-free survival to the compound’s antimetastatic effect related to its inhibition of cell proliferation and cell adhesion, its promotion of apoptosis and antioxidant effects." The entire How FWGP Works section is unreferenced, and part of it is spurious. There may be RCT evidence out there, and it should be added to the article; otherwise, the evidence cited does not back many of the claims made -- Samir धर्म 09:04, 22 November 2006 (UTC)

Samir, thanks for your comments. Let me address your concerns, and perhaps together we can improve the article.

You mention that "No RCT [randomized clinical trial] evidence is cited." True. And RCTs are the "gold standard" for judging the value of pharmaceutical drugs meant to treat disease. However, RCTs are not by any means the only useful and meaningful evidence to weigh. Gleevec, for example, was approved for use against the cancer, gastrointestinal stromal tumor (GIST)without RCT evidence it was useful for that cancer, and thank goodness it was! And this substance, FWGE, is not a cure for cancer; it is, as the article states, a plant extract approved in Europe as a medical nutriment to be used in support of cancer treatment. And people in the US (and probably in Canada, where you are) are using it as a dietary supplement. The question in both cases is "Why?" Well, because there is a lot of evidence out there ("out there" being in peer-reviewed published study literature on PubMed/Medline) and it's reasonable to look at the evidence. In the pediatric cancer trial, FWGE helped "to reduce the incidence of treatment-related febrile neutropenia in children with solid cancers." (It lessened white blood cell count accompanied by high fever, in lay terms.) Chemo is hard on the immune system. When chmotherapy, which typically targets all fast-growing cells, kills large numbers of immune system cells, neutropenia -- too few such cells -- can result. Accompanied by high fever, that is febrile nuetropenia. Because a weakened immune system leaves patients vulnerable to life-threatening infections, febrile neutropenia can be a serious complication of chemotherapy for cancer. It can and does kill some patients. Yet, in the pediatric cancer study cited, febrile neutropenic episodes were experienced by only 24.8% of kids getting FWGE with their chemo, compared to 43.4% of those getting only chemo. This is a significant difference. So, many of these kids -- and their parents -- were spared these dangerous episodes of high fever and low white blood cell count and the extra treatment that can be necessary to return immune system cell counts to normal. Even in the more rare instances when the children getting FWGE did experience neutropenia, their overall white blood cell counts and their lymphocyte counts were higher than in those children having febrile neutropenia who did not get FWGE. This is a good thing.

Samir, you mentioned that there were statements in the Human Clinical Trials section supported by evidence from cell and animal studies. Yes. That's because in the pediatric cancer study, for example, such animal and cell studies are mentioned -- and cited -- by the authors of the paper, in the Discussion section. As you know, this is not an unusual phenomenon in clinical trial reports, for authors to talk about the history of evidence, as it accumulates through cell, animal, and human studies, and to speculate on the mechanisms of action responsible for specific observed effects. What seems more important, though, usually, are the actual clinical effects, which in that study were quite significant.

The colorectal cancer human clinical trial study, also published in a quality, peer-reviewed journal, the British Journal of Cancer, also showed significant benefit to those patients getting FWGE, compared to those not getting it. It improved both overall survival and progression-free survival. The authors of that study, too, in their Discussion section, went into great detail about the specific mechanisms of action seen in previous cell and animal studies that were likely the reasons for the improved results seen among patients who got the FWGE, compared to those who did not.

In re-examining that section, I did find I'd mis-referenced info about the antioxidant mechanism of action mentioned, so I have corrected that. And in one human clinical trial study in which the authors discussed possible mechanisms of action, I left out some mechanisms of action they mentioned in the earlier cell and animal studies, as possibly the ones responsible for the anti-metastatic effects they saw: up-regulation of ICAM-1 and TNF-a, for example), so I may go back and add those.

I've removed the "How FWGE Works" section, because mechanisms of action are covered -- and referenced -- in the earlier sections (on cell studies and animal studies), so it was largely redundant. Earlier, I did not cite references for that section, since the evidence for those statements came from the cell and animal studies already cited in other sections.

Samir, when you make a statement that an author makes "claims that are spurious" I think you owe it to readers to be specific, especially when asked to do so, as was requested of you many weeks ago here. Alternatively, it seems to me you should re-think that statement, and consider withdrawing it. Otherwise, the question arises whether you are simply giving vent to a bias against nutritional supplements, because they are not pharmaceutical drugs. Such a bias is of questionable value in a time when even such institutions such as the National Institutes of Health (NIH), the National Cancer Institute (NCI) and other responsible medical organizations are trying to stem the alientation of a large portion of the public from conventional medicine, by encouraging all parties, on either side of the debate about what's best -- conventional or alternative medicine -- to abandon their pre-conceived notions and look to scientific studies to determine what works and what doesn't.

There is a very large body of evidence from cell, animal, and human studies showing the results FWGE has produced, and explaining what is known about how the compound works. I agree that evidence from large, randomized clinical trials would be a very significant addition to the accumulation of evidence from the cell and animal and human clinical trial studies that have been done, and my guess is, that such large RCTs will be done, especially as NIH and the NCI and other orgs continue to accelerate their research in the complementary and alternative medicine (CAM) arena. But what I see when I look at all the research I can find on this topic, from peer-reviewed journals published and available on MedLine/PubMed, is a consistent indication of value in a lengthy chain of evidence that is logically coherent, internally consistent, and of rather large volume. I think that is significant, and something people might want to know about. Clearly, based on all the published, peer-reviewed evidence, I believe this substance has utility. I have done my best to present the information in a neutral voice. Wiki doesn't ask that we not have an opinion on whether something is good or not; only that we present information without point of view (POV) bias. I hope I have done so; if not, please point me again to areas you think need improvement. I welcome any additional suggestions you may have for improving the neutrality of the article's tone or voice. Especially, please let me know a "claim" made that you believe is not supported by the evidence.

And Samir, if you cannot, or choose not, to follow up on your assertion that the article on this nature-based nutritional supplement does not have a neutral point of view -- which you have done by flagging it as such -- then please consider whether you have an obligation to withdraw such a negative statement that is itself without supporting evidence, and which criticizes an article composed mostly of cited evidence. Otherwise, it seems you may run the risk of simply demonstrating a bias that can promote a schism -- a "great divide" -- between conventional medicine and nature-based health practitices that many on both sides of it are working hard to heal, for the benefit of the public that needs to learn to rely more -- not less -- on evidence in making decisions about health. It's that kind of bias that can drive people who need to trust their medical providers farther away from conventional medicine, which, like other alternatives, can be life-saving in the right context(s), that is, where evidence clearly shows its value.

Thanks very much.