Cold FX, Take Two

[Eos of the Eons]

Okay, independent studies and data complilation of many studies done. Cold FX not found to prevent colds, but MAY lessen them.

Quote:

Conclusions: There is insufficient evidence to conclude that ginseng reduces the incidence or severity of common colds. North American ginseng appears to be effective in shortening the duration of colds or ARIs in healthy adults when taken preventatively for durations of 8–16 weeks.
COLD-fX® appears to be effective in reducing the duration of ARIs after onset, showing a mean decrease of 6 days in the length of colds/ARIs of the COLD-fX® group compared to the placebo group. This result was statistically significant, however, it should be noted that this finding was based on only two trials whose populations were heterogeneous in terms of age. The heterogeneity of the populations and small sample size of one of the pooled studies may have contributed to the wide confidence interval of the estimate.

This is the response I got from them a while back when I emailed them about their product.

Quote:

Dear ******,

Thank you for taking the time to email us with your question, and for your interest in our product.

I am very sorry but we cannot share any further information on which polysaccharides are in COLD-fX. Both the ingredients and the manufacturing are patented.

CV Technologies develops and manufactures evidence based natural health products for disease prevention and health maintenance. We are firmly committed to the manufacture and sale of only the finest quality products and are grateful that you took the time to contact us.

If you have any questions, please do not hesitate to contact us by e-mail or call us at 1-888-843-7239.

Sincerely,

Aren't patents public information? Why can't they tell me what they stuff in their capsules?

How would ginseng carbs "boost" or "strengthen" the immune system? They offer no hard evidence, and the studies indicate it may or may not help to shorten the duration of a cold, and that there is not enough evidence that it prevents a cold (colds are usually caused by rhinoviruses).

Their websites claim it will keep you healthy. I don't feel the studies support that. That is why I find this product no better than all the rest of the supplement offered up to us, but they have at least done more than most supplement makers to make their product legite. That said, shouldn't cold FX be regulated as a drug since they DO make health claims (especially since their claims are not well supported)?

I just find it annoying that it is so expensive and people think of it as a drug, but it's not regulated as one. I find that, well, wrong. It's like thinking chiropractors went to med school, or that homeopathy has ingredients.

[Northernskeptic]

The efficacy of COLD-FX is certainly questionable since the science they base it off is shaky at best. What follows here is one of the best articles in the media I've seen to date tearing down the claims of an herbal remedy.

http://www.canada.com/vancouversun/n...a-1b9d5de47dce

I also find it disturbing that they have been pushing its use for treating Leukemia patients, just watch them start to rely on it instead of the meds to help save them with their compromised immune systems.

http://www.canada.com/edmontonjourna...c-2aa1e646bd1d

One of the most frustrating pieces of news about the product is how my home city of Edmonton has actually paid Tax dollars for a stockpile of this stuff for use against a pandemic.

http://www.medicalnewstoday.com/articles/71637.php

[Eos of the Eons]

I can't find the results for the NCI study for involving leukemia patients. I am dying to know how that turned out.

I did find another skeptical critique of the product though:
http://sciencebasedpharmacy.wordpres...02/27/cold-fx/

Pandemic? There's been no study on the products effectiveness against flu bugs either.

Okay. They are stocking the stuff. Is it a drug or is it not?? It is not classified as one, and not regulated as one. I guess Canada is not like the US then? In the US products that make health claims must be regulated by the FDA.

This is the biggest issue I have with the stuff. There is no verifiable mechanism of action on the body, and they are stockpiling it? They know how Tamiflu works, so why not demand to know what is actually in Cold FX and how it supposedly works before stockpiling it for use for a pandemic???

They say it has poly-furanosyl-pyranosyl-saccharides, but that is just carbs, nothing specific. Poly is many. Furanosyl is a five member carb ring and pyranosyl is six member carb ring. Saccharides is just the word for carbs. So it has many carbohydrate rings in it from the ginseng plant. We don't even know what part of the plant they are from?

Fructose is a furanoside. Is that the furano part of the furanosyl-pyranosyl compound of carb in Cold FX?

Once this stuff hits our digestive system, doesn't it just get broken down into monosaccharides???
Or is it a cellulose compound that will just pass on through us?

Well, they won't offer up the information, citing patent protection?

Argh!

[SezMe]

Originally Posted by Eos of the Eons

I can't find the results for the NCI study for involving leukemia patients. I am dying to know how that turned out.

Hmmm, little play on words there?

Anyway, more seriously, I have absolutely no expertise in this area but I wonder about a product that claims to boost the immune system. Wouldn't that be bad for people with autoimmune problems?

[Eos of the Eons]

Ah, here's the link I was looking for

Quote:

Five membered sugars resemble furan, hence furanoses.
Six membered rings resemble pyran, hence pyranoses.

Sucrose is a six member ring.
Glucose is a five member ring.
I'm guessing that lactose is a six member ring?

So, we have sucrose and glucose from ginseng stuck into a capsule??

How is that NOT just a capsule full of "sugars"???!!

[Eos of the Eons]

Originally Posted by SezMe

Hmmm, little play on words there?

Anyway, more seriously, I have absolutely no expertise in this area but I wonder about a product that claims to boost the immune system. Wouldn't that be bad for people with autoimmune problems?

Heh heh. Well yeah. And what about allergies?

But if it is just glucose and fructose, lactose, etc. then how does that "boost the immune system" any more than chewing on candy, or eating an apple?

[Eos of the Eons]

Can I call Cold FX a "sugar pill" now? Or does that still work only for if it is just lactose alone?

[tesscaline]

By way of some clever usage of the US Patent Office's search function, I think you're looking for patent number 7,413,756

Go to http://patft.uspto.gov/netahtml/PTO/srchnum.htm and type in that number. Pulls up a patent that references the doctor that ColdFX says invented their process.

The text of the patent is not something I understand (too much medical/technical jargon), but the claims of the patent are... Well... Really messed up.

Most notably:

Quote:

The invention claimed is:
...
5. A method of preparing a pharmaceutical composition suitable for treating a condition characterized by low immunity, wherein said method comprises combining an effective amount of the ginseng fraction PQ.sub.223 according to claim 3 and, optionally, combining an effective amount of another medicament that is suitable for treating a condition characterized by low immunity, with at least one pharmaceutically acceptable excipient to produce a pharmaceutical composition suitable for treating a condition characterized by low immunity.

6. The method of claim 5, wherein the condition is selected from the group consisting of common cold, influenza, chronic fatigue syndrome, AIDS and cancer.

So they're trying to say this junk can treat AIDS now???

[RodSkeptographer]

Interesting information, both of you. It does seem to work to reduce the duration of a cold only, and only with long term use. But looking at the numbers in the article NorthernSkeptic cited, it seems that you would be spending much more money trying to fight off the cold with this product than the economic cost of the cold. If I calculated correctly, it costs the economy about $80 per cold. Long term use of the product would cost much more than that. So even though it works in one respect, it still makes no economic sense to use it. There may be other considerations, like being in danger of dying from colds, or being rich, for instance.

I'm confused by the bolded quote. I quote from two different places:

“However, COLD-fX® appears to be effective in reducing the duration of ARIs after onset, showing a mean decrease of 6 days in the length of colds/ARIs of the COLD-fX® group compared to the placebo group. This result was statistically significant, however, it should be noted that this finding was based on only two trials whose populations were heterogeneous in terms of age. The heterogeneity of the populations and small sample size of one of the pooled studies may have contributed to the wide confidence interval of the estimate (Fig. 2)”

but before that,

“The duration of colds and ARIs was reported in two trials (10,11). Colds or ARIs in the ginseng group were an average of 6.2 days (95% CI: 3.4–9.0) shorter than in the placebo group (Fig. 2). Heterogeneity between these two studies was negligible (I2 = 0%).”

Maybe they are talking about different types of heterogeneity? “Study” vs “Age”? Or maybe within groups vs between groups? Actually, there might also be a chance this is bad writing and/or editing, or the authors don’t completely understand what they are writing. I won’t go into the grammatical details of why I get the impression. And my confusion might just be from ignorance. But I have been warned by a genetics professor that you can’t assume everything in a peer reviewed paper is correct, even when written by the top experts in a field.

In any case, this paper has made me want to learn more about meta-analysis. That way I’d know for sure if that “contributed to the wide confidence interval” sentence was more of an excuse than a condemnation. After all, the bottom p value in Fig. 2 seems pretty good, so the effect is very likely to be real, even if you can’t be sure exactly how big it is due to the wide confidence interval. Even 3.4 days seems decent to me.

As to finding out more about the mechanism of the effect, I’d try searching for papers on the polysaccharide type they mention and the types of immune cells they mention at their health_mechanism page, which I cannot link to as I am a new user to this forum.

The argument from ignorance is a logical fallacy. Not knowing how something works does not even come close to being an argument that it probably does not work, especially when there are a couple of acceptable studies that show that it does. Remember that nobody knew how ASA worked until recently. What makes questioning the posited homeopathic mechanisms of action legitimate is that those mechanisms are implausible considering all we know about physics and chemistry. Cold-fX does not claim to be homeopathy, as far as I know. While homeopathy is alternative medicine, alternative medicine is not all homeopathy.

(Following our personal conversation: immune cells do have receptors. I checked a textbook. Neural cells don’t have a monopoly. ;-) )

As to how hard to be on the company, I’d argue (from the Joe Nickell perspective), not to dismiss them out of hand. As has been mentioned, they seem to be making a generally good-faith effort to do the science. They have even planned to do a molecular mechanism study as well as large clinical trial. However, I’d like to see them change their packaging to stop claiming that it can reduce the occurrence or severity of colds and just make the claim shown by this meta-analysis, that it can significantly reduce the length of a cold if you use it long-term. And yes, the government should regulate this stuff in terms of the science required to make claims. E.g. they should not make claims about leukemia until good evidence comes in that it works. Health claims can be very much like yelling fire in a crowded theatre.

[RodSkeptographer]

In case you are confused, I wrote my previous post off-line, when there were only two posts before me as far as I knew.

[Eos of the Eons]

Welcome Rod!

Quote:

As to finding out more about the mechanism of the effect, I’d try searching for papers on the polysaccharide type they mention and the types of immune cells they mention at their health_mechanism page, which I cannot link to as I am a new user to this forum.

To find out the mechanism they first have to permit us to verify what they stick in the capsules. From their ambiguous "big" chemistry words, I've pointed that it could be anything from fructose to glucose (whatever you could normally extract from ginseng), etc. This is because they are only 5 and six member carbs, and this means only mono- and di-saccharides (rather simple sugars).

So...... as far as I can tell from the information they will permit us to have, there is no plausible mechanism.

Quote:

The argument from ignorance is a logical fallacy. Not knowing how something works does not even come close to being an argument that it probably does not work, especially when there are a couple of acceptable studies that show that it does.

I'm still not sure the studies show that it really does even shorten the duration of a cold. The studies are "acceptable", but not great.

Well, first we need to find out what it is (which is apparent they are not forthcoming about). I know many things can work without us knowing why. If this is indeed something like glucose and fructose, then there is the logical argument that there is no plausible reason it would "boost the immune system".

You don't really feel we've dismissed them out of hand, do you? We've worked hard to try to find out where they are coming from. Homeopathy? Not sure what context that is coming from now. I tend to talk fast, and wonder if something came out garbled about that. I just find that homeopaths keep scrounging around for reasons that it might work and coming up with stupid things like "water memory". I'm finding CV Tech to be scrounging around the same way, but being closed mouthed instead of coming up with stupid excuses like water memory (which is probably smart).

Quote:

like to see them change their packaging to stop claiming that it can reduce the occurrence or severity of colds and just make the claim shown by this meta-analysis, that it can significantly reduce the length of a cold if you use it long-term. And yes, the government should regulate this stuff in terms of the science required to make claims. E.g. they should not make claims about leukemia until good evidence comes in that it works. Health claims can be very much like yelling fire in a crowded theatre.

Exactly. At least they haven't pushed it as an HIV treatment yet. I guess this is a hurry and wait scenario with them though. I have to see evidence there is anything in the bottle that can have any health claims made about it. They are ultra good at marketing and using "big impressive words".

Mannatech makes similar claims, and people are eating up their carbs too. CV tech seems to be better at walking the legal lines though.

I need a lab, and some eqipment (can anyone lend me a bunsen burner and some kind of spectography thingy?). Sighs. I feel like my hands are tied.

Thank you again for joining us RodSkeptographer!

[Eos of the Eons]

Originally Posted by SkeptiChick

By way of some clever usage of the US Patent Office's search function, I think you're looking for patent number 7,413,756

Go to http://patft.uspto.gov/netahtml/PTO/srchnum.htm and type in that number. Pulls up a patent that references the doctor that ColdFX says invented their process.

The text of the patent is not something I understand (too much medical/technical jargon), but the claims of the patent are... Well... Really messed up.

Most notably:

So they're trying to say this junk can treat AIDS now???

Oh Wow.

Quote:

conditions characterized by low immunity, such as the common cold, influenza, chronic fatigue syndrome, AIDS and cancer.

Since when is cold, flu, and most types of cancer characterized by "low immunity"??? You can have the most effective immune system in the world and that won't stop microbes from trying to use you as a host. HIV causes "low immunity". Cancer may be caused in immunocompromised people for a variety of reason, but even HPV can cause cancer in people with non "low immunity".

Quote:

For hundreds of years, the use of certain non-toxic agents such as herbal compounds has been widely accepted for a variety of physiological conditions, especially in the Orient.

Are they effective though? When the "ancients" had no idea what caused illnesses, they also had to grope around in the dark with the limited capabilities they had to get some kind of relief. That makes their methods outdated, not better.

Quote:

The important pharmacological activities of ginseng extracts, alone or in combination with other drugs, include alleviation of renal impairment, inhibition of carcinogenesis and prevention of stress. There are also a number of reports on the influence of ginseng on the immunological responsiveness of the individual. Some immunomodulatory properties that have been reported include enhancement of host resistance against infection, anti-inflammatory effect, inhibition of tumor growth, as well as modulation of some basic immune function at the cellular level. American ginseng, Panax quinquefolium, is another specie of ginseng which has gained popularity as a health supplement having many beneficial health effects. Several groups of scientists have attempted to isolate and elucidate the structure of the polysaccharides present in ginseng. Some of the polysaccharides have been demonstrated to be active in modulating the immune system.

Evidence? Seems this guy likes to go on rumors. People make all these same claims about homeopathy too.


Some folks from Japan isolated the following using the various methods:

Quote:

Ginsenan PB contained 11.0% arabinose, 32.2% galactose, 8.1% rhamnose, 39.9% galacturonic acid, and 5.0% glucuronic acid.

Ginsenan S-IA contains 42.3% arabinose, 50.8% galactose and 6.9% galacturonic acid with the molar ratio of 8:8:1. Ginsenan S-IIA is composed of 42.0% L-arabinose, 32.6% galactose, 6.2% glucose, and 19.2% galacturonic acid.

The strongly acidic polysaccharide fractions from the roots had a high content of uronic acid, even higher than 50%. Similar component sugars were detected from all fractions. They were rhamnose, arabinose, galactose, glucose, galacturonic acid, and glucuronic acid. Galacturonic acid was the main uronic acid component.


...G-115I1-IIa-2-3 was obtained. This polysaccharide was homogeneous. Its molecular weight was estimated to be 3.68.times.10.sup.5. It consisted mainly of arabinose, galactose and glucose in addition to small amounts of galacturonic acid, glucuronic acid and rhamnose.

Quote:

All of these polysaccharides showed hypoglycemic effects in normal and alloxan-reduced hypoglycemic mice.

So, giving mice carbs increased blood sugars levels. Why am I not surprised?

Quote:

An acidic polysaccharide with the molecular weight of 150,000, called ginsan, was isolated from Panax ginseng by a research group at the Laboratory of Immunology, Korean Cancer Center Hospital, Seoul, Korea..sup.[15] This polysaccharide was composed of 3.7% protein and 47.1% hexose (glucose and galactose) and 43.1% uronic acid (galacturonic acid). Ginsan induced the proliferation of T cells and B cells and generated lymphokine activated killer cells from both natural killer and T cells through endogenously produced multiple cytokines..sup.[16]

Okay, another study to dig up. Are these carbs 5 and 6 member rings? It seems they are more complex (including protein and uronic acid).

Quote:

The present inventors have found that certain American ginseng extracts have immunoregulating properties.

ImmunoREGULATING, not stimulating.

Getting to his invention... New post...

[Eos of the Eons]

Quote:

The present invention also includes ginseng fractions PQ.sub.2, PQ.sub.223 and CVT-E002, which are prepared according to the processes described above.

The invention further includes ginseng fractions having specific carbohydrate contents.

A first ginseng fraction has a carbohydrate content which comprises about 2-6 mol % rhamnose, about 41-49 mol % galacturonic acid, about 12-18 mol % glucose, about 16-22 mol % galactose and about 12-19 mol % arabinose.

A second ginseng fraction has a carbohydrate content which comprises about 3-8 mol % rhamnose, about 36-44 mol % galacturonic acid, about 2-7 mol % glucose, about 25-33 mol % galactose and about 17-25 mol % arabinose.

A third ginseng fraction has a carbohydrate content which comprises about 0.5-5 mol % rhamnose, about 11-22 mol % galacturonic acid, about 40-60 mol % glucose, about 10-19 mol % galactose and about 11-19 mol % arabinose.

The invention also includes pharmaceutical compositions, comprising the ginseng fractions of the invention, in combination with a pharmaceutically acceptable carrier.

I'm assuming the pharaceutical grade 'carrier' is listed under the non-medicinal ingredients?

Quote:

A first ginseng fraction has a carbohydrate content which comprises about 2-6 mol % rhamnose, about 41-49 mol % galacturonic acid, about 12-18 mol % glucose, about 16-22 mol % galactose and about 12-19 mol % arabinose. Preferably, the carbohydrate content comprises about 3-5 mol % rhamnose, about 43-47 mol % galacturonic acid, about 14-16 mol % glucose, about 18-20 mol % galactose and about 14-17 mol % arabinose. Most preferably, the carbohydrate content comprises about 4 mol % rhamnose, about 45 mol % galacturonic acid, about 15 mol % glucose, about 19 mol % galactose and about 15 mol % arabinose.

A second ginseng fraction in accordance with the invention has a carbohydrate content which comprises about 3-8 mol % rhamnose, about 36-44 mol % galacturonic acid, about 2-7 mol % glucose, about 25-33 mol % galactose and about 17-25 mol % arabinose. Preferably, the carbohydrate content comprises about 4-7 mol % rhamnose, about 37-42 mol % galacturonic acid, about 3-6 mol % glucose, about 27-32 mol % galactose and about 19-24 mol % arabinose. Most preferably, the carbohydrate content comprises about 5 mol % rhamnose, about 39 mol % galacturonic acid, about 4 mol % glucose, about 29 mol % galactose and about 21 mol % arabinose.

A third ginseng fraction according to the invention has a carbohydrate content which comprises about 0.5-5 mol % rhamnose, about 11-22 mol % galacturonic acid, about 40-60 mol % glucose, about 10-19 mol % galactose and about 11-19 mol % arabinose. Preferably, the carbohydrate content comprises about 1-3 mol % rhamnose, about 13-20 mol % galacturonic acid, about 42-57 mol % glucose, about 12-17 mol % galactose and about 13-17 mol % arabinose.

The invention also includes pharmaceutical compositions, comprising any of the ginseng fractions according to the invention in combination with a pharmaceutically acceptable carrier. Those of skill in the art are familiar with any pharmaceutically acceptable carrier which would be useful in this regard, and therefore the procedure for making pharmaceutical compositions in accordance with the invention will not be discussed in detail. Suitably, the pharmaceutical compositions may be in the form of tablets, capsules, liquids, lozenges, lotions or suppositories.

Quote:

In summary, the results of the present studies indicate that the ginseng fractions of the invention activate macrophages to produce cytokines such as IL-1, IL-6 and TNF-.alpha.. They also activate lymphocytes, particurlarly B-lymphocyte proliferation and antibody production. The overall humoral mediated immune system was stimulated indicating the preventive effects on infections. The reported action of TNF-.alpha. production includes antiviral and anti-tumor benefits. TNF-.alpha. has also been reported to be of therapeutic benefit in the treatment of a variety of parasitic infections.

These studies need replication and peer-review.

We need a chemist to decipher a lot of this. It's been over ten years since I took my college organic chem courses, and I don't use it... so have lost most of what I learned on that very basic level.

My basic understanding:
Arabinose is a crystalline pentose sugar.
Rhamnose is methyl pentose sugar.
(5-member sugars, monosaccharides)
More information:

Quote:

http://www.rspharmchem.com/rhamnose.htm

Rhamnose is a raw material for the chemical synthesis of furaneol, a strawberry flavour.

Quote:

http://www.bikudo.com/buy/details/50...arabinose.html
L-arabinose is a kind of aldopentoses, it's a low-calurie sweetener, it inhibits the sucrase activity and prevents increasing of blood glucose, therefore, it can prevent fat accumulation and against high blood glucose disease.

There's also D-arabinose.

Maybe CV Tech should just try to get the L-arabinose and market a weight control product.

So, still "just" monosaccharides and disaccharides.

Basically, Cold FX is cheap to make. They have spent a lot of money on marketing these cheap polysaccharides. You are paying for the marketing, and some small hope that it has an effect to shorten the duration of a cold.

Thank you for digging that up SkeptiChick!

[tesscaline]

Originally Posted by Eos of the Eons

Thank you for digging that up SkeptiChick!

You're quite welcome!

I hope someone can decipher the chemistry, because I'm really curious to see if the core ingredients really are what they seem to be.

I'd also love someone to tear apart the AIDS and Cancer claims in the patent. I'm wondering if there are any papers published on the ginseng "fraction" that the patent talks about using, but I don't have access to full text of journals.

[macdoc]

My finger in the wind assessment is the energy boost from the ginseng ( it has quite a kick ) makes you feel better.

That might be the extent of its action - not sure what the actual chemical impact of ginseng is.