Cold-FX helpt bij griep en verkoudheid
Heel toevallig stuitte ik op een
Amerikaanse firma die natuurgeneesmiddelen
wil ontwikkelen op basis van serieuze onderzoeksmethodes (double blind,
placebo controlled trials). Een produkt van deze firma dat is getest op 679 mensen mbt
verkoudheid en griep toont een vermindering van 56% op infecties die hierdoor ontstaan. Is
dus de moeite waard om eens naar te
kijken. Ik weet niet of produkt hier al te koop is maar er zal zeker wel een
slimme zakenman wakker worden. Het produkt is gebaseerd op een extract
van de Noord Amerikaanse ginseng (Panax quinquefolium) plant.
Ron
COLD-fX® reduces risk of colds,
flu and respiratory illness by 89%.
A US FDA authorized randomized
double-blind, placebo-controlled trial of COLD-fX® (CVT-E002), in institutionalized older
adults, demonstrated COLD-fX® significantly reduced the risk, by 89%, of developing
laboratory confirmed influenza or respiratory syncytial virus (RSV) in a senior population
after 8-12 weeks of treatment. At a dose of 400 mg daily (2 X 200 mg), COLD-fX® was shown
to be safe, well tolerated, and effective for preventing acute respiratory illness due to
influenza and RSV. This trial also demonstrated COLD-fX is safe and complimentary to the
flu vaccine.
A double-blind, placebo controlled study
of COLD-fX® in an immunocompetent community dwelling of adults aged 65 years or older
demonstrated a statistically significant reduction in the number of illnesses, the
majority of which were associated with respiratory symptoms. The significant results
included a greater incidence of respiratory symptoms in the placebo group, 76%, versus 45%
in COLD-fX® group after 4 months of treatment at 400mg (2 X 200mg) daily. COLD-fX® was
shown to be safe and well tolerated.
References
- Gerald N. Predy, Vinti Goel, Ray Lovlin,
Allan Donner, Larry Stitt and Tapan K. Basu. Efficacy of an extract of North American
ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper respiratory
tract infections: a randomized controlled trial. Canadian Medical Association Journal,
2005, 173 (9): 1043.
Abstract not
available.
- Predy G, Goel V, Lovlin R, and TK Basu.
Efficacy of COLD-fX® in the prevention of upper respiratory tract infections in healthy
adults. CVT Clinical Report 2004.
- Wang M, Guilbert LJ, Li J, Wu Y, Pang P,
Basu TK, and JJ Shan. A Proprietary Extract from North American Ginseng (Panax
Quinquefolium) Enhances IL-2 and IFN-? Productions in Murine Spleen Cells Induced by
Con-A, International Immunopharmacology, 2004, 4: 311-315.
Abstract
A patented aqueous extract from North American ginseng (Panax quinquefolium), containing
mainly oligosaccharides and polysaccharides, is commercially available over the counter as
COLD-FX (CVT-E002). This proprietary extract is used for the treatment of upper
respiratory tract infections. Its in vitro stimulating effects on the immunoglobulin
production by B lymphocytes and on natural immune responses by peritoneal exudates
macrophages have been previously reported. Using C57 BL/6 mice, an ex vivo study was
conducted to examine Con-A-induced splenocytic productions of interleukin-2 (IL-2) and
interferon-gamma (IFN-gamma) as markers of acquired immune responses. CVT-E002 (10-500
microg/ml) significantly increased Con-A-induced IL-2 and IFN-gamma productions in spleen
cells in a dose-dependent manner. Such response was seen by the ginseng extract originated
from three different lots, suggesting consistency between the lots.
- Goel DP, Geiger JD, Shan JJ, Kriellaars D,
and GN Pierce. Doping control urinalysis of ginseng extract, COLD-fX®, in athletes. International
Journal of Sport Nutrition and Exercise Metabolism, 2004, 14(4): 473-80.
Abstract
Nutraceuticals may induce doping infractions through contamination of the product itself
or their ingestion might be metabolized within the body to create a positive doping
control test. We tested this possibility using a commercially available, proprietary
ginseng root extract (Cold-FX, CV Technologies Inc., Edmonton, AB). After athletes
ingested Cold-FX for 28 d at 400 mg/d, urine samples were collected and processed under
strict IOC doping control guidelines and then analyzed for a full screen of IOC
banned/restricted substances by an IOC-approved laboratory. There were no positive tests
for any banned substances in any of the subjects. Our study demonstrates that ingestion of
Cold-FX for 28 d at 400 mg/d does not represent a doping concern for athletes. Carefully
controlled clinical studies like this one are necessary to provide the athlete, the
nutraceutical industry and IOC regulatory bodies with information to avoid inadvertent
exposure to banned/restricted or potentially unhealthy substances.
- Deng Y. American ginseng extract, CVT-E002
stimulates macrophages and activated killer cells to secrete interferon-gamma in response
to influenza infection. CVT Internal Report.
- McElhaney JE, Gravenstein S, Cole SK,
Davidson E, O’Neill D, Petitjean S, Rumble B, and JJ Shan. A Placebo-Controlled Trial
of a Proprietary Extract of North American Ginseng (CVT-E002) to Prevent Acute Respiratory
Illness in Institutionalized Older Adults, Journal of American Geriatrics Society,
2004, 52:13-19.
Abstract
OBJECTIVES: To compare a proprietary extract of American ginseng, CVT-E002, with placebo
in preventing acute respiratory illness (ARI) in an institutional setting during the
influenza season. DESIGN: Two randomized, double-blind, placebo-controlled trials
conducted late in the 2000 (8 week) and 2000-2001 (12 week) influenza seasons. SETTING:
Long-term care setting that included nursing home and assisted living at three sites.
PARTICIPANTS: Eighty-nine (2000) and 109 (2000-2001) enrolled subjects, average age 81 and
83.5, respectively; 74% women. Approximately 90% had received influenza vaccine in each of
the 2 years. INTERVENTION: Oral twice-daily administration of a proprietary ginseng
extract, CVT-E002, 200 mg or placebo. MEASUREMENTS: ARI was defined as two new respiratory
symptoms or one with a constitutional symptom. Confirmation of viral ARI was by culture
(influenza or respiratory syncytial virus (RSV)) or serology for influenza. Laboratory
safety monitoring was done at 0, 4, and 8 or 12 weeks. RESULTS: An intent-to-treat
analysis of pooled data corrected for drug exposure time showed that the incidence of
laboratory-confirmed influenza illness (LCII) was greater in placebo- (7 cases/101
subjects) than CVT-E002-treated (1/97) groups (odds ratio (OR)=7.73, P=.033). Combined
data for LCII and RSV illness were also greater in placebo- (9/101) than CVT-E002-treated
(1/97) groups (OR=10.50, P=.009), for an overall 89% relative risk reduction of ARI in the
CVT-E002 group. CONCLUSION: CVT-E002 was shown to be safe, well tolerated, and potentially
effective for preventing ARI due to influenza and RSV.
- Ueng Y and C Chen. Effects of CVT-E002, a
proprietary extract from North American ginseng (Panax quinquefolium) on drug-metabolizing
enzymes, Journal of Chinese Medicine 2002, 13: 89-96.
Abstract CVT-E002, a proprietary extract from
North American ginseng (Panax quinquefolium) showed immunomodulating activity. Cytochrome
P450 (CYP), UDP-glucuronosyl transferase (UGT), and glutathione S-transferase (GST) are
important drug-metabolizing enzymes. Modulation of drug-metabolizing enzymes is a main
cause of drug interactions. To assess the possible metabolism-based drug interaction of
CVT-E002, effects of CVT-E002 on hepatic CYP, UGT, and GST were studied in C57BL/6J mice.
Treatment of mice with 5g/kg/day CVT-E002 for three days had no effects on liver
microsomal CYP and cytochrome b3 contents and NADPH-CYP reductase activity. CVT-E002 had
no effect on microsomal CYP catalytic activities of the oxidations of 7-ethoxyresorufin,
7-methoxyresorufin, benzo(a)pyrene, 7-ethoxycoumarin, benzphetamine,
N-nitrosodimethylamine, erythromycin, and nifedipine in mouse liver. Hepatic microsomal
UGT and cytosolic GST activities were not affected by CVT-E002 treatment. These results
suggested that CVT-E002 had no effects on hepatic CYP, UGT, and GST activities in mice
under this treatment regimen. There might be low potential of incidence of
metabolism-based drug interaction by CVT-E002.
- Wang M, Guilbert LJ, Ling L, Li J, Wu Y,
Xu S, Pang P, and JJ Shan. Immunomodulating Activity of CVT-E002, A Proprietary Extract
from North American Ginseng (Panax Quinquefolium), Journal of Pharmacy and Pharmacology,
2001, 53: 1515-1523.
Abstract
The activity of CVT-E002, an aqueous extract containing mainly oligosaccharides and
polysaccharides from North American ginseng (Panax quinquefolium), as an immunobooster on
murine spleen cells and peritoneal macrophages, was studied in-vitro. CVT-E002 stimulated
the proliferation of normal mouse spleen cells, of which the major responding
subpopulation was identified as B lymphocytes. CVT-E002 also activated peritoneal exudate
macrophages leading to enhanced interleukin-1 (IL-1), interleukin-6 (IL-6), tumour
necrosis factor-alpha (TNF-alpha) and nitric oxide (NO) production. In addition, CVT-E002
stimulated in-vivo immunoglobulin G (IgG) production in treated mice. These results
identify some of the immunomodulating activities of CVT-E002 and suggest its use
clinically for the modulation of immune responses.
- McElhaney JE, and D Reid. Summary of
studies with COLD-fX® in high performance athletes assessing the tolerability and
outcomes related to cold and flu like symptoms. Presented at the First International
Scientific congress on Nutrition Athletic Performance, Edmonton, Alberta. August 2001.
Abstract not available.
- Pierce GN, Goel DP, Geiger JD, et al.
Doping control urinalysis of ginseng extract, COLD-fX®, in Canadian athletes presented at
the First International Scientific congress on Nutrition Athletic Performance, Edmonton,
Alberta. August 2001.
Abstract not
available.
- McElhaney JE, Gravenstein S, Shan JJ, et
al. A double-blind, placebo-controlled study of CVT-E002 in immunocompetent, community
dwelling adults ages 65 years or older. University of Alberta, Internal Clinical Report,
1999.
- ChemBioPrint: The discovery and
standardization of beneficial natural health product mixtures. CVT Internal Report.
Efficacy of an extract of North
American ginseng containing poly-furanosyl-pyranosyl-saccharides for preventing upper
respiratory tract infections: a randomized controlled trial
Gerald N. Predy, Vinti Goel, Ray Lovlin,
Allan Donner, Larry Stitt and Tapan K. Basu
Background: Upper respiratory tract
infections are a major source of morbidity throughout the world. Extracts of the root of
North American ginseng (Panax quinquefolium) have been found to have the potential to
modulate both natural and acquired immune responses. We sought to examine the efficacy of
an extract of North American ginseng root in preventing colds.
Methods: We conducted a randomized,
double-blind, placebo-controlled study at the onset of the influenza season. A total of
323 subjects 18–65 years of age with a history of at least 2 colds in the previous
year were recruited from the general population in Edmonton, Alberta. The participants
were instructed to take 2 capsules per day of either the North American ginseng extract or
a placebo for a period of 4 months. The primary outcome measure was the number of
Jackson-verified colds. Secondary variables measured included symptom severity, total
number of days of symptoms and duration of all colds. Cold symptoms were scored by
subjects using a 4-point scale.
Results: Subjects who did not start
treatment were excluded from the analysis (23 in the ginseng group and 21 in the placebo
group), leaving 130 in the ginseng group and 149 in the placebo group. The mean number of
colds per person was lower in the ginseng group than in the placebo group (0.68 [standard
deviation (SD) 0.82] v. 0.93 [SD 0.91], difference 0.25%, 95% confidence interval [CI]
0.04–0.45). The proportion of subjects with 2 or more Jackson-verified colds during
the 4-month period (10.0% v. 22.8%, 12.8% difference, 95% CI 4.3–21.3) was
significantly lower in the ginseng group than in the placebo group, as were the total
symptom score (77.5 [SD 84.6] v. 112.3 [SD 102.5], difference 1.5%, 95% CI 1.2–2.0)
and the total number of days cold symptoms were reported (10.8 [SD 9.7] v. 16.5 [SD 13.8]
days, difference 1.6%, 95% CI 1.3–2.0) for all colds.
Interpretation: Ingestion of a
poly-furanosyl-pyranosyl-saccharide–rich extract of the roots of North American
ginseng in a moderate dose over 4 months reduced the mean number of colds per person, the
proportion of subjects who experienced 2 or more colds, the severity of symptoms and the
number of days cold symptoms were reported.
Source http://www.cmaj.ca/cgi/content/full/173/9/1043
Persbericht
CV Technologies Inc. (CVT) today reported
on clinical trial results of a year-long pivotal study of COLD-fX conducted by a senior
Canadian Researcher and Edmonton's Medical Officer of Health which showed that the natural
compound cut recurrent colds by more than half.
President, CEO & Chief Scientific
Officer, Dr. Jacqueline Shan said, "This trial, which is the first to be completed
under Health Canada's new Natural Health Products legislation, displayed impressive
results for COLD-fX. It showed that in a group of trial subjects who regularly get at
least two colds a year, COLD-fX reduced their chance of getting a second cold by 56%. That
will save a lot of people a lot of misery."
Dr. Shan said, "This is a
significant scientific and business milestone for CVT. It further confirms that COLD-fX is
effective in preventing viral Upper Respiratory Infections including colds and flu in the
general population."
The independent double-blind
placebo-controlled trial was conducted on the company's behalf by Edmonton's Medical
Officer of Health, Dr. Gerry Predy of Capital Health and an associate professor at the
University of Alberta, and internationally recognized Nutritional Biochemist Dr. Tapan
Basu, a professor at the University of Alberta. Three hundred and twenty-three healthy
adults from the general population (18-65 years of age) with a history of at least two
upper respiratory infections (colds) in the previous year were recruited for the trial.
Each participant was instructed to take two capsules a day of COLD-fX or placebo for a
period of 4 months during the winter of 2003/4. (Neither the participants nor the
investigators were aware of who was receiving which).
Dr. Basu called the findings,
"statistically highly significant". He said "The results are a positive
indication that COLD-fX has good potential to minimize incidence of recurrent colds in
people who tend to get more than one cold per year."
The results showed a statistically
significant reduction (26%) in the average number and frequency of cold infections per
person in the COLD-fX group. Even more striking though, was the fact that the data showed
that recurrent infections were reduced by 56%, i.e., of those participants reporting one
cold infection, the likelihood of (them) contracting additional infections was reduced by
more than half. Moreover, of those trial participants taking COLD-fX, there was a 45%
reduction in the total number of cold days suffered per participant and a 31% reduction in
the severity of their symptoms.
Dr. Predy said, "Our research showed
the total number of days with upper respiratory infections per participants for the
placebo group was 10.9 days and that was cut to 6.0 days for the people who received
COLD-fX. This may give both the public and health care providers further ammunition for
preventing and managing viral-induced upper respiratory infections, including the common
cold."
In parallel, the ability of COLD-fX to
strengthen the immune system was also investigated in this trial. In blood tests of those
who were treated with COLD-fX there was a significant increase in the total number of
T-lymphocytes and the number of Helper T-lymphocytes, all key in fighting off viral
infections. The level of Natural Killer (NK) cells, a critical component of our innate
immune system which kills invading viruses, was also significantly increased. These
findings confirm earlier clinical and laboratory results showing the efficacy of COLD-fX
in preventing respiratory syncytial virus (RSV) and influenza infection and the
strengthening of viral-specific killing mechanisms of the immune system.
Dr. Basu said, "This trial was very
unique in that it examined a natural compound with the same degree of scientific rigor
used for conducting trials of drug candidates in the pharmaceutical industry, a practice
that is rarely found in the natural health product (NHP) business." NHP products
typically lack proper standardization whereas COLD-fX is standardized through CVT's
proprietary ChemBioPrint technology. Dr. Basu said, "COLD-fX was well-tolerated and
showed little or no side effects of any kind." He added, "The market is
inundated with many NHP preparations making various claims as to their beneficial effect
in counteracting colds and flu. COLD-fX is unique in the way that it acts and performs
which is confirmed by high-standard clinical trials, such as the current one."
Dr. Shan said, "We are very excited
by the promise that these results offer in the search for a cure for the common cold. The
efficacy and mechanism of action of COLD-fX demonstrated in these findings may provide
some clue as to how to prevent other viral infections an area warrants further study
in a systematic and controlled clinical trial."
Alberta Minister of Economic Development,
Mark Norris, said "CV Technologies and its pioneering research are helping to shape
Alberta's biotech sector. This emerging sector is important to Alberta's future and
furthering its development is critical. I congratulate this industry leader on its success
and urge CVT to remain committed to its groundbreaking biotech research."
The study was approved by the Human
Research Ethics Board of the Faculty of Agriculture, Forestry and Home Economics of the
University of Alberta and the Capital Health/U of A Research Ethics Board. The study was
also approved by Health Canada.
Two of the previous six trials done on
COLD-fX. were published this year in respected medical journals. COLD-fX is a proprietary
natural health compound as a result of 10 years of research and development by 25
scientists at a cost of $15 million. In lab and clinical studies it has been showed to
have an excellent safety profile with no adverse effects. COLD-fX is available nationally
through leading pharmacies, grocery and health food stores such as Shoppers Drug Mart,
Wal-Mart and Costco.
Links:
http://www.ctv.ca/servlet/ArticleNews/
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