« Evidence, Medicine, and EBM | Main | Video now available »

Feb 14, 2010

TrackBack

TrackBack URL for this entry:
http://www.typepad.com/services/trackback/6a0120a692721d970b01287792aa3d970c

Listed below are links to weblogs that reference Evidence and Snake Oil:

Comments

Feed You can follow this conversation by subscribing to the comment feed for this post.

Wonderful synopsis of what appears to be the latest and greatest complimentary/alternative treatment for the common cold. Below is the link to the other published article that I was able to find.

http://www.jssm.org/vol8/n4/3/v8n4-3pdf.pdf

I realize that we simply cannot expect to have a systematic review for every treatment that is out there. Heck, as it is, the evidence is thin for many many widely accepted treatments today. I wonder though, can we simply dismiss these claims because there are bigger fish to fry? Our patients look to us as the authority on these treatments and we need to give them an evidence-based answer. I suppose what inevitably will happen (at least for now) is that as long there is no clear harm in the treatment, we will go on record as saying that as long as the perceived benefits outweigh the perceived risks, then its their dime to spend.

You are right on!

It was unfortunate that Dr. Rind did not have access to the body of research that supports the health benefits of Wellmune WGP®. This natural ingredient is clinically proven to support the immune system. Biothera, a biotechnology company dedicated to improving immune health, has conducted numerous safety (toxicology), preclinical and human clinical studies with Wellmune WGP. Wellmune WGP is a FDA-GRAS food ingredient that can be found in a growing number of foods, beverages and supplements. We are excited to be an ingredient in Mona Vie’s (M)mūn™, the company’s new addition to its line of acai berry juice–based nutritional and energy drink products.

To aid readers in considering the totality of data available on Wellmune WGP, several abstracts and papers of studies published in peer-reviewed scientific and medical journals can be found at http://www.wellmune.com/scientificliterature.html. These include:

1) Mechanism by Which Orally Administered ß-1,3-Glucans Enhance the Tumoricidal Activity of AntiTumor Monoclonal Antibodies in Murine Tumor Models. The Journal of Immunology. 2004: 173: 797-806. This article details the unique mechanism of action – how Wellmune WGP works in the body. The mechanism is applicable beyond the tumoricidal activity discussed in the paper and includes activity on any non-self cell with complement deposition on its surface.

2) Three peer-reviewed clinical trials with individuals experiencing high physical or lifestyle stress or exposure during cold/flu season (additional clinical publications are planned). These studies demonstrate that Wellmune WGP lowered the incidence of upper respiratory tract infection symptoms and improved the participants’ reported overall health and well-being. We use stress models in our clinical research because increased physical and psychological stress often lead to a higher incidence of upper respiratory tract infections. Using stress models allows us to evaluate the potential benefits of routine consumption of Wellmune WGP in the diet.

• Beta 1,3/1,6 Glucan Decreases Upper Respiratory Tract Infection Symptoms and Improves Psychological Well-being in Moderate to Highly-Stressed Subjects. Agro Food Industry Hi-Tech (2010) 21:21-24. (This paper was published after Dr. Rind wrote his review.)

• Effect of Beta 1, 3/1, 6 Glucan on Upper Respiratory Tract Infection Symptoms and Mood State in Marathon Athletes. Journal of Sports Science and Medicine (2009), 8:509-515.

• Randomized Phase II Clinical Trials of Wellmune WGP® for Immune Support During Cold and Flu Season. The Journal of Applied Research (2009), 9:20-42.

3) Wellmune WGP is GRAS (Generally Regarded As Safe) under regulations of the FDA. In addition, Wellmune WGP has received regulatory approval for use in foods, beverages and supplements in other countries worldwide. The toxicology paper that was part of the Wellmune GRAS dossier submitted to the FDA for review is listed below:

• Toxicological Assessment of a Particulate Yeast (1,3)-ß-D-Glucan in Rats. Food and Chemical Toxicology (2007), 45:1719-1730.

4) In addition, Biothera has completed human clinical biomarker studies that demonstrate Wellmune WGP increases the phagocytic index of innate immune cells, which measures the cells ability to “eat” or destroy foreign challenges. Other human biomarker studies show that Wellmune enhances immune function without increasing pro-inflammatory cytokines. These internal studies have not yet been published (publication is planned).

We encourage interested parties to review the available data on the application of Wellmune WGP to human health. We believe that when one considers the totality of the data available for Wellmune a conclusion that Wellmune WGP supports a healthy immune system is a credible finding. For the record, we do want to clearly state that Wellmune WGP is not a medicine, it is a food ingredient that may provide health benefits with routine consumption. Finally, we routinely encourage customers to seek advice from a medical professional if they have a medical condition and want to include Wellmune WGP in their diet.

Don Cox, Ph.D.
Vice President, Research & Development
Healthcare Group
Biothera

Don Cox: Access to the full texts of the articles listed would be helpful. As Dr. Rind has pointed out, the abstract does not always tell the whole story.

The publication record itself does not also tell the full story, especially if negative trial results are kept in the file drawer. Does Biothera register all clinical trials that it undertakes with databases like clinicaltrials.gov?

Providing full text of articles may violate copyright issues. However, the complete articles are available through the publication. Clinicaltrials.gov is for Investigational New Drugs that have been approved for use in clinical trials by the FDA. As a functional ingredient (not a drug) for foods, beverages and supplements, Wellmune research would not be included on this website.

"The credulous, on the other hand, might believe that meetings like this are exactly where health breakthroughs are presented because the mainstream media and mainstream doctors would never allow such information to be presented in a medium that they control."

Really. Are there not controversies that are only worthy of thought by the credulous?

1. fluoride in water causes health damage
2. chlorine in water causes/contributes to heart disease
3. cholesterol does not cause heart disease
4. homocysteine is the best marker for CVD (folic acid reduces CVD)
5. Vitamin D reduces cancer
6. Vitamin D enhances immune system
7. Synthetic Vitamins not the same as natural (eg: D, K, E)
8. Sunshine (not sunburn) good for your health (via Vitamin D3 production)

Again, must I be credulous to believe the above is worthy of consideration?

Ted Smythe
5.

See, there's the exploited flaw in our capitalistic society. 'Supplements' are unregulated, in class with ingredients in food... yet not intended to be ingested as such.

The comments to this entry are closed.