[Research on identification of American ginseng and panax ginseng by near infrared spectra of samples' cross section].

In order to identify American ginseng and panax ginseng samples accurately and rapidly, the authors acquired the NIR spectra of the samples' cross-sections. Then the spectra were respectively analyzed according to the samples' physical structure factors and chemical factors. The authors selected appropriate bands and built a physical factor leading model, a chemical factors leading model as well as a comprehensive factor model. The authors found that all the three models' discriminant rates were above 96 percents, which can meet the needs of the rapid detection of raw Chinese medicinal crop materials. While the physical factors model had a simple operation, the discriminant rate was relatively low. The chemical factors model' discriminant rate was higher, but the computation is much more complex. Among the three models, the mixed factor model had the best result with the highest discrimination rate (100 percents) and a smaller number of principal components (4). The effect was the most ideal. It proved that physical factors play an important part in NIR modeling. The cross section method is accurate and convenient which can be used in the quality control in enterprise, realizing the rapid screening of the medicine raw materials.

The sustained influence of short term exposure to a proprietary extract of North American ginseng on the hemopoietic cells of the bone marrow, spleen and blood of adult and juvenile mice.

This study assessed the influences of CVT-E002, a proprietary extract of North American ginseng, Panax quinquefolius (Afexa Life Sciences, Inc., Edmonton, AB, Canada), in vivo, on murine hemopoietic and immune cells when administered as a dietary additive. The extract was given daily to young, adult mice for a period of 4 weeks, immediately following which one group was euthanized and the hemopoietic and immune cells of their bone marrow, spleen and blood were assayed for CVT-E002-mediated alterations in any of five cell lineages (lymphocytes, nucleated erythroid cells, granulocytes, immature granuloid precursors and monocytes). Another group of these mice was left for a subsequent 8 weeks on control diet, following which the same organs and cell lineages were analysed. In another study, juvenile mice immediately upon weaning (age: 4 weeks), were subjected to the above protocol, and their organs/cell lineages assayed. The results revealed that CVT-E002 had a long-lasting, positive quantitative effect on the lymphocytes and monocytes, regardless of age at commencement of daily, dietary CVT-E002. CVT-E002 may therefore have a prophylactic disease defense, immunostimulatory role, or potentially, even a therapeutic role.

Extract of North American ginseng (Panax quinquefolius), administered to leukemic, juvenile mice extends their life span.

In a recent study involving normal, juvenile mice, we showed that CVT-E002, a proprietary extract (Afexa Life Sciences, Inc.) of North American ginseng, Panax quinquefolius, significantly enhanced the absolute levels of cells acting at the first line of defense in tumor combat, i.e., natural killer (NK) cells. The present study evaluated the effect of CVT-E002, on life span when administered intraperitoneally to leukemic, infant/juvenile mice. The extract was administered to groups of mice daily for 14 days in several dosing groups up to 50mg/day from age 7 to 21 days. The tumor was administered intraperitoneally under sterile conditions, in a laminar flow hood at 7 days of age (0.5 x 10(6) leukemic cells), immediately preceding the first CVT-E002 injection for each dose group. The data revealed that CVT-E002 significantly extends the life of leukemic, young mice in a dose-specific manner, i.e., 20 mg/day was effective in extending life, while lower doses of 5, 10 mg as well as higher doses of 30, 40, 50 mg per day were completely ineffective. We have already shown that CVT-E002 significantly elevates NK cells in normal and leukemic, adult mice, as well as in normal, infant/juvenile mice, and we have also shown that CVT-E002 significantly extends the life span of leukemic, adult mice. The results of the present study did indeed show that (i) CVT-E002 extends the life span of leukemic, infant/juvenile mice, and (ii) that the dose of CVT-E002 is critical in achieving life span augmentation in these leukemic infant/juvenile mice.

[Research on fast discrimination between Panax ginseng and Panax quinque folium based on near infrared spectroscopy].

Near infrared spectroscopy combined with pattern recognition techniques were applied to develop a method of fast and nondestructive discrimination between Chinese ginseng and American ginseng. A total of 90 representative ginseng samples including root, fiber and powder were collected. NIR spectra of the samples were obtained directly with wrapped polyethylene packing film. MSC and first derivative were performed after the elimination of notable packing film absorbance in raw spectra. Then the informative wave bands were chosen by moving window partial least-squares regression method. PLS-DA, PCA-DA and SVM discrimination models were founded and their results were compared. SVM was proven to be the most effective method with 100% accurate identification rate for validation set. It indicates that the method founded is precise and convenient and can be practically used in practice for quality control and fast screening of raw herb materials.

CVT-E002 stimulates the immune system and extends the life span of mice bearing a tumor of viral origin.

The present study evaluated the dose-related effects of CVT-E002, a proprietary extract of Panax quinquefolius (CV Technologies Inc., Edmonton, AB), in the treatment of a tumor of viral origin, that is, erythroleukemia, in mice. Three treatments including ingestion of 2, 40, and 120 mg/d were compared. The study revealed that the dose of 40 mg/d was particularly effective in stimulating cells mediating nonspecific immunity and extending the life span of tumor-bearing mice. This study represents the first in vivo demonstration of the anticancer efficacy of CVT-E002 in an animal model. CVT-E002 treatment significantly elevated the absolute numbers of natural killer cells and monocytes and reduced the number of tumor cells in the bone marrow and spleen. This study has shown that (1) approximately 30 to 50% of tumor-bearing mice administered CVT-E002 at a dose of 40 mg/d achieved a significantly extended life span, and (2) dosage is critical in producing these ameliorative effects.

Challenges in natural health product research: The importance of standardization.

Before there can be acceptance of natural health products (NHPs) or "phytomedicines" by the Western medical community, questions related to active ingredients, mechanisms of action, toxicology, and drug interactions will need to be satisfactorily addressed. Since NHPs are generally manufactured from highly variable raw materials, identifying the therapeutically active ingredients can be challenging. Standardization according to all known bioactive components is critical to ensure consistent pharmacological and clinical results. CV Technologies, Inc. has made great strides in resolving these challenges through the patented technology, ChemBioPrint. During early ChemBioPrint product development, the optimal active components of a natural extract are identified and characterized chemically (chemical fingerprinting) and pharmacologically through a variety of activity assays (biological fingerprinting). Subsequent manufacturing steps ensure each batch is standardized accordingly and has consistent composition and efficacy. Case studies will be presented on two commercially available ChemBioPrint products: COLD-fX (an immune-modulator) and REMEMBER-fX (a neuro-modulator). Unique and important structure-function relationships exist between the major classes of bioactive molecules from the shared source material of these two products, Panax quinquefolius. Through numerous published and ongoing clinical trials and pharmacological studies, these ChemBioPrint products have been shown to be consistent, safe and effective. The future directions of NHP research will be discussed, including the requirements for accurate reporting of study results related to ingredient and standardization descriptions.

Efficacy of COLD-fX in the prevention of respiratory symptoms in community-dwelling adults: a randomized, double-blinded, placebo controlled trial.

BACKGROUND: COLD-fX (CVT-E002), a proprietary extract of the roots of North American ginseng (Panax quinquefolium), rich in poly-furanosyl-pyranosyl-saccharides, has been found efficacious in the prevention of respiratory infections in institutionalized seniors and healthy adults. OBJECTIVE: We examined the efficacy of COLD-fX in the prevention of acute respiratory illness (ARI) in community dwelling seniors. DESIGN: This was a randomized, double-blind, placebo controlled trial. INTERVENTION: The participants were asked to take 2 capsules/day of either COLD-fX or placebo (200 mg/ capsule) for a period of 4 months. SUBJECTS: A total of 43 community-dwelling adults aged 65 years or older were recruited. Following one month of intervention, subjects were immunized with influenza vaccine. OUTCOME MEASURES: Subjects recorded the incidence and duration of respiratory symptoms during the study. They also recorded the incidence of adverse events during the study. RESULTS: The frequency and duration of ARI during the first two months of the study was found to be similar in the two groups. However, during the last 2 months (November and December) significantly fewer subjects in the COLD-fX group 32% reported ARI compared to the placebo group 62%. The duration of symptoms during the last 2 months was significantly shorter in the COLD-fX group than the placebo group (5.6 days in the COLD-fX group vs 12.6 days in the placebo group). There was no influenza illness circulating in the community during the period of the study. CONCLUSIONS: Ingestion of COLD-fX by immunocompetent seniors during an early "cold and flu" season reduced the relative risk and duration of respiratory symptoms by 48% and 55%, respectively. Daily COLD-fX administration can thus be a safe, natural therapeutic means for the prevention of ARI in healthy seniors.

Doping-control urinalysis of a ginseng extract, Cold-FX, in athletes.

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.

A proprietary extract from North American ginseng (Panax quinquefolium) enhances IL-2 and IFN-gamma productions in murine spleen cells induced by Con-A.

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.

A placebo-controlled trial of a proprietary extract of North American ginseng (CVT-E002) to prevent acute respiratory illness in institutionalized older adults.

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.

Enhanced survival and regeneration of axotomized retinal ganglion cells by a mixture of herbal extracts.

The aim of this study is to investigate the effects of Panax quinquefolius L. extract (PQE), Ginkgo biloba extract (GBE), and Hypericum perforatum extract (HPE), in combination or alone, on the survival and regeneration of axotomized retinal ganglion cells (RGCs) in an optic nerve transection model in adult hamsters. Unilateral transection of the optic nerve was performed to evaluate the effects of herbal extracts on the survival of axotomized RGCs. Effects of the herbal extracts on axonal regeneration of axotomized RGCs, on the other hand, were studied by attaching a peripheral nerve graft onto the transected ocular stump to induce regeneration. Operated animals received daily oral administration of vehicle or herbal extracts (PQE, GBE, and HPE), alone or in combination, for 7 and 21 days, respectively, in the survival and regeneration experiments. Surviving and regenerating RGCs were retrogradely labeled with Fluoro-Gold. The eyes were then enucleated and the retinas were flat-mounted for the counting of the labeled RGCs. Treatment with PQE, GBE and HPE alone failed to offer neuroprotection to injured RGCs. However, treatment with Menta-FX, a mixture of PQE, GBE, and HPE, significantly augmented RGC survival 7 days postaxotomy. Treatment with Menta-FX also induced a significant (87%) increase in the number of regenerating RGCs 21 days after optic nerve transection. This study demonstrates that herbs can act as a potential neuroprotective agent for damaged RGCs. It also suggests that the therapeutic value of herbal remedies can be maximized by the use of mixtures of appropriate herbs.