174.112.42.106 (talk) →Medical uses: the content medicinal use is for indication, this portion talks about ineffectiveness in treating the common cold, which is stated again in the section below. Tag: section blanking |
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There is little evidence to support that Cold-fX is effective in the [[common cold]].<ref name=Nah2011/><ref name=Seida2011/> All trials have been done by the manufacturer and there has been poor data reporting.<ref name=Nah2011/> Health Canada's Natural Health Product Directorate states that it claims to "help reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system".<ref>http://webprod3.hc-sc.gc.ca/lnhpd-bdpsnh/info.do?lang=eng&licence=80002849</ref> |
There is little evidence to support that Cold-fX is effective in the [[common cold]].<ref name=Nah2011/><ref name=Seida2011/> All trials have been done by the manufacturer and there has been poor data reporting.<ref name=Nah2011/> Health Canada's Natural Health Product Directorate states that it claims to "help reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system".<ref>http://webprod3.hc-sc.gc.ca/lnhpd-bdpsnh/info.do?lang=eng&licence=80002849</ref> |
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==Medical uses== |
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There is no evidence that Cold-fX is effective in those infected with the [[common cold]].<ref name=Nah2011>{{cite journal|last=Nahas|first=R|coauthors=Balla, A|title=Complementary and alternative medicine for prevention and treatment of the common cold.|journal=Canadian family physician Medecin de famille canadien|date=2011 Jan|volume=57|issue=1|pages=31–6|pmid=21322286}}</ref> The effect of preventative use is not clear.<ref name=Nah2011/> When used preventatively it makes no difference on the rate of infections.<ref name=Seida2011>{{cite journal|last=Seida|first=JK|coauthors=Durec, T; Kuhle, S|title=North American (Panax quinquefolius) and Asian Ginseng (Panax ginseng) Preparations for Prevention of the Common Cold in Healthy Adults: A Systematic Review.|journal=Evidence-based complementary and alternative medicine : eCAM|year=2011|volume=2011|pages=282151|pmid=19592479}}</ref> It also appears to have no effect on how bad the infections are.<ref name=Seida2011/> There is tentative evidence that it may lesson the length of sickness when used preventatively.<ref name=Seida2011/> |
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==Adverse effects== |
==Adverse effects== |
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|work= |
|work= |
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|publisher= CV Technologies|format=PDF}}</ref> |
|publisher= CV Technologies|format=PDF}}</ref> |
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==Mechanism of Action== |
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COLD-FX is a proprietary extract (CVT-E002) from the root of Panax quinquefolius (North American ginseng), composed of poly-pyranosyl-furanosyl saccharides. These molecules have been shown to stimulate cytokine production that leads to an increase of immune cells in the innate and adaptive systems. In particular, natural killer cells, B-lymphocytes, T cell stimulation have been recorded in both in vitro and in vivo experiments. |
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Lab Experiments: |
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CVT-E002 was found to stimulate the production of mouse spleen cells in vitro – most notably B lymphocytes – leading to increased production of cytokines interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), as well as immunoglobulin-G (IgG) (Wang 2001). Additionally, CVT-E002 was found to significantly increase Con-A induced murine splenocyte productions of interleukin-2 (IL-2) and interferon-gamma (IFN-γ) ex vivo, in a dose dependent manner (Wang 2004). Other studies in mice also showed moderate levels of CVT-E002 (40mg/day) can elevate absolute numbers of natural killer cells and monocytes in mice with impaired immune function (induced Friend leukemia virus/erythroleukemia model) (Miller 2008, 2009, 2011). Finally, studies using human monocyte-derived dendritic cells (moDC) and autologous T cells exposed to CVT-E002 with or without virus (RSV or influenza) showed an increased T-cell activation (CD4+CD45RO+) and release of IFN-γ, TNF-α and interleukin-12 (IL-12) cytokines (Ilarraza 2011). |
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Clinical Experiments: |
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Blood samples taken from 42 subjects in the Predy et al. (2005) trial receiving 400mg/day of COLD-FX for four months, were found to have increased proportions of T-helper and natural killer cells, and decreased IgA levels (Predy 2006). In the study by McElhaney et al. (2010), peripheral blood leukocytes taken from athletes using COLD-FX at 400mg/day for four months showed higher levels of TNF-α and IL-2 compared to placebo when cultured with various strains of influenza virus. |
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==Safety and Toxicology Data== |
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Reports of adverse events (AEs) from taking COLD-FX in both clinical trials and postmarketing surveillance have been extremely low to date. The number of AEs in clinical trials has not been significantly higher in subjects taking COLD-FX compared to placebo (Predy 2005; McElhaney 2004, 2006, 2011). Other studies have shown COLD-FX is safely tolerated in children (3-12 years old) (Vohra 2008) and chronic lymphocytic leukemia patients (High 2012). Laboratory studies have also demonstrated that COLD-FX does not affect major liver enzymes responsible for drug metabolism, including (but not limited to) cytochrome P450 and associated conjugation enzymes (Ueng 2002). COLD-FX should not be used by individuals with ginseng allergies, taking anti-coagulant medications, who are pregnant or breastfeeding, or those with impaired liver or kidney function; individuals should avoid exceeding the recommended daily dose of COLD-FX. |
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==References== |
==References== |
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==External links== |
==External links== |
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*[http://www.cold-fx.com/ Cold-fX website] |
*[http://www.cold-fx.com/ Cold-fX website] |
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'' |
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'''Primary Clinical Trial Articles –Safety and Efficacy:''' |
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Goel DP, Geiger JD, Shan JJ, Kriellaars D, Pierce GN. Doping-control urinalysis of a ginseng extract, Cold-FX®, in athletes. Int J Sport Nutr Exerc Metab. 2004;14:473-480. |
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High KP, Case D, Hurd D, Powell B, Lesser G, Falsey AR, Siegel R, Metzner-Sadurski J, Krauss JC, Chinnasami B, Sanders G, Rousey S, Shaw EG. A randomized, controlled trial of panax quinquefolius extract (CVT-E002) to reduce respiratory infection in patients with chronic lymphocytic leukemia. J Support Oncol. 2012;10:195-201. |
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McElhaney JE, Gravenstein S, Cole SK, Davidson E, O'neill D, Petitjean S, Rumble B, Shan JJ. A placebo-controlled trial of a proprietary extract of North American ginseng (CVT-E002) to prevent acute respiratory illness in institutionalized older adults. J Am Geriatr Soc. 2004;52:13-19. |
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McElhaney JE, Goel V, Toane B, Hooten J, Shan JJ. Efficacy of COLD-fX in the prevention of respiratory symptoms in community-dwelling adults: a randomized, double-blinded, placebo controlled trial. J Altern Complement Med. 2006;12:153-7. |
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McElhaney JE, Simor AE, McNeil S, Predy GN. Efficacy and safety of CVT-E002, a proprietary extract of panax quiquefolius in the prevention of respiratory infections in influenza-vaccinated community-dwelling adults: a multicenter, randomized, double-blind and placebo-controlled trial. Influenza Res Treat. 2011; 2011: 1-8. |
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Predy GN, Goel V, Lovlin R, Donner A, Stitt L, Basu TK. Efficacy of an extract of North American ginseng containing poly-furanosyl-pyranosyl-sacchardies for preventing upper respiratory tract infections: a randomized controlled trial. CMAJ. 2005;173:1043-1048. |
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Vohra S, Johnston BC, Laycock KL, Midodzi WK, Dhunnoo I, Harris E, Baydala L. Safety and tolerability of North American ginseng extract in the treatment of pediatric upper respiratory tract infection: a phase II randomized, controlled trial of 2 dosing schedules. Pediatrics. 2008;122:e402-410. |
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'''Clinical Trials -Mechanism of Action''' |
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McElhaney JE, Guilbert LJ, Reid D, Lowe K, Hooten J, Shan JJ. COLD-FX® stimulates cell mediated immune response of peripheral leukocytes ex-vivo to influenza virus in National Hockey League players. Open Nutraceuticals J. 2010;3:25-29. |
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Predy GN, Goel V, Lovlin RE, Basu TK. Immune modulating effects of daily supplementation of COLD-fX (a proprietary extract of North American ginseng) in healthy adults. J Clin Biochem Nutr. 2006;39:162-7. |
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'''Laboratory Experiments –Mechanism of Action''' |
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Durairaj P, Miller SC. Neoplasm prevention and immuno-enhancement mediated by daily consumption of a proprietary extract from North American ginseng by elderly mice of a cancer-prone strain. Phytoher Res. 2013; 27(9):1339-1344. |
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Ilarraza R, Wu Y, Davoine F, Ebeling C, Adamko DJ. Human dendritic cells promote an antiviral immune response response when stimulated by CVT-E002. J Pharm Pharmacol. 2011;63(5):670-8. |
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Miller SC, Delorme D. An extract of North American ginseng stimulates spontaneous immunity in infant mice: sustained augmented immunity in adulthood long after withdrawal of the extract. J Complem Int Med. 2008;5(1):1-18. |
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Miller SC, Delorme D, Shan JJ. CVT-E002 stimulates the immune system and extends the life span of mice bearing a tumor of viral origin. J Soc Integr Oncol. 2009;7(4):127-36. |
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Miller SC, Delorme D, Shan JJ. Extract of North American ginseng (Panax quinquefolius) administered to leukemic, juvenile mice extends their life span. J Complement Integr Med. 2011;8(1). |
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Miller SC, Ti L, Shan JJ. 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. Phytother Res. 2012;26(5):675-681. |
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Wang M, Guilbert LJ, Ling L, Li J, Wu Y, Xu S, Pang P, Shan JJ. Immunomodulating activity of CVT-E002, a proprietary extract from North American ginseng (Panax quinquefolium). J Pharm Pharmacol. 2001;53(11):1515-23. |
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Wang M, Guilbert LJ, Li J, Wu Y, Pang P, Basu TK, Shan JJ. A proprietary extract from North American ginseng (Panax quinquefolium) enhances IL-2 and IFN-gamma productions in murine spleen cells induced by Con-A. Int Immunopharmacol. 2004;4(2):311-5. |
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''' |
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Laboratory Experiments - Drug Safety and Tolerance''' |
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Ueng YF, Chen CF. Effects of CVT-E002, a proprietary extract from the North American ginseng (Panax quinquefolium) on hepatic drug-metabolizing enzymes in C57BL/6J mice. Journal of Chinese Medicine. 2002;13(2):89-96. |
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[[Category:Drugs]] |
[[Category:Drugs]] |
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Revision as of 08:54, 22 January 2014
Cold-fX is a product derived from the roots of North American ginseng (Panax quinquefolius). Originally manufactured by Afexa Life Sciences Inc. (formerly called CV Technologies Inc.),[1] headquartered in Edmonton, Alberta, Canada, the company and lead product was acquired by Valeant Pharmaceuticals International (headquartered in Laval, Quebec, Canada) in 2011.
There is little evidence to support that Cold-fX is effective in the common cold.[2][3] All trials have been done by the manufacturer and there has been poor data reporting.[2] Health Canada's Natural Health Product Directorate states that it claims to "help reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system".[4]
Adverse effects
Individuals requiring anti-coagulant therapy such as warfarin should avoid use of COLD-FX. Not recommended for individuals with impaired liver or renal function. Do not exceed the recommended daily dose.
Individuals with known allergies to ginseng should avoid use of COLD-FX. Do not use if you are pregnant or breastfeeding.
Other adverse effects include: headaches, anxiety, trouble sleeping and an upset stomach.[2]
Criticism
There is doubts in the medical and scientific community that Cold-fX is effective.[3] All the studies posing 'significant' results favoring the efficacy of ColdFX have been funded by the manufacturer.[3]
Other criticisms point out that these studies have been small scale, with conspicuously shallow participant pools and lopsided gender distributions.[5] Researchers have pointed out that there aren't enough studies on the effects of any form of Ginseng on the common cold to form any conclusions.[6]
Scientists have argued that Cold-fX has not been tested for its ability to treat a cold after an individual has been infected.[7] In addition, no studies have yet been performed to assess the possible long term side effects of taking the pills every day during the cold and flu season.[5] Afexa Life Sciences Inc. (formerly called CV Technologies Inc.), the makers of Cold-fX, were criticized for making health claims about the product that have never been tested or verified scientifically. Up until February 2007, the company advised a regimen of 18 pills over a course of 3 days in order to obtain "immediate relief" from a cold. Health Canada's review of the scientific literature confirmed that this is not a claim that CV Technologies Inc. is entitled to make.[8] The company formulated a separate product for this usage. A CV Technologies press release explained the change in the dosing regimen as a choice to take a two-tier approach application to Health Canada.[9]
Mechanism of Action
COLD-FX is a proprietary extract (CVT-E002) from the root of Panax quinquefolius (North American ginseng), composed of poly-pyranosyl-furanosyl saccharides. These molecules have been shown to stimulate cytokine production that leads to an increase of immune cells in the innate and adaptive systems. In particular, natural killer cells, B-lymphocytes, T cell stimulation have been recorded in both in vitro and in vivo experiments.
Lab Experiments: CVT-E002 was found to stimulate the production of mouse spleen cells in vitro – most notably B lymphocytes – leading to increased production of cytokines interleukin-1 (IL-1), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α), as well as immunoglobulin-G (IgG) (Wang 2001). Additionally, CVT-E002 was found to significantly increase Con-A induced murine splenocyte productions of interleukin-2 (IL-2) and interferon-gamma (IFN-γ) ex vivo, in a dose dependent manner (Wang 2004). Other studies in mice also showed moderate levels of CVT-E002 (40mg/day) can elevate absolute numbers of natural killer cells and monocytes in mice with impaired immune function (induced Friend leukemia virus/erythroleukemia model) (Miller 2008, 2009, 2011). Finally, studies using human monocyte-derived dendritic cells (moDC) and autologous T cells exposed to CVT-E002 with or without virus (RSV or influenza) showed an increased T-cell activation (CD4+CD45RO+) and release of IFN-γ, TNF-α and interleukin-12 (IL-12) cytokines (Ilarraza 2011).
Clinical Experiments: Blood samples taken from 42 subjects in the Predy et al. (2005) trial receiving 400mg/day of COLD-FX for four months, were found to have increased proportions of T-helper and natural killer cells, and decreased IgA levels (Predy 2006). In the study by McElhaney et al. (2010), peripheral blood leukocytes taken from athletes using COLD-FX at 400mg/day for four months showed higher levels of TNF-α and IL-2 compared to placebo when cultured with various strains of influenza virus.
Safety and Toxicology Data
Reports of adverse events (AEs) from taking COLD-FX in both clinical trials and postmarketing surveillance have been extremely low to date. The number of AEs in clinical trials has not been significantly higher in subjects taking COLD-FX compared to placebo (Predy 2005; McElhaney 2004, 2006, 2011). Other studies have shown COLD-FX is safely tolerated in children (3-12 years old) (Vohra 2008) and chronic lymphocytic leukemia patients (High 2012). Laboratory studies have also demonstrated that COLD-FX does not affect major liver enzymes responsible for drug metabolism, including (but not limited to) cytochrome P450 and associated conjugation enzymes (Ueng 2002). COLD-FX should not be used by individuals with ginseng allergies, taking anti-coagulant medications, who are pregnant or breastfeeding, or those with impaired liver or kidney function; individuals should avoid exceeding the recommended daily dose of COLD-FX.
References
- ^ "What is COLD-fX intended for?". Cold-fX: Frequently Asked Questions. Retrieved 2007-11-24.
- ^ a b c Cite error: The named reference
Nah2011was invoked but never defined (see the help page). - ^ a b c Cite error: The named reference
Seida2011was invoked but never defined (see the help page). - ^ http://webprod3.hc-sc.gc.ca/lnhpd-bdpsnh/info.do?lang=eng&licence=80002849
- ^ a b "Fighting the Common Cold". ABC News. 2005-10-25.
- ^ William Lin (2007-02-16). "Does ginseng really work? It depends on who you ask". The Ottawa Citizen.
- ^ "Ginseng Unproven in U.S." Los Angeles Times. 2008-02-18.
- ^ Charlie Gillis (2007-03-26). "COLD-fX catches the sniffles again". Macleans Magazine.
- ^ "COLD-fX Sets Record Straight: Health Canada's Approval of New Medical Claims Unchanged" (PDF). CV Technologies. March 5, 2007.
External links
Primary Clinical Trial Articles –Safety and Efficacy:
Goel DP, Geiger JD, Shan JJ, Kriellaars D, Pierce GN. Doping-control urinalysis of a ginseng extract, Cold-FX®, in athletes. Int J Sport Nutr Exerc Metab. 2004;14:473-480.
High KP, Case D, Hurd D, Powell B, Lesser G, Falsey AR, Siegel R, Metzner-Sadurski J, Krauss JC, Chinnasami B, Sanders G, Rousey S, Shaw EG. A randomized, controlled trial of panax quinquefolius extract (CVT-E002) to reduce respiratory infection in patients with chronic lymphocytic leukemia. J Support Oncol. 2012;10:195-201.
McElhaney JE, Gravenstein S, Cole SK, Davidson E, O'neill D, Petitjean S, Rumble B, Shan JJ. A placebo-controlled trial of a proprietary extract of North American ginseng (CVT-E002) to prevent acute respiratory illness in institutionalized older adults. J Am Geriatr Soc. 2004;52:13-19.
McElhaney JE, Goel V, Toane B, Hooten J, Shan JJ. Efficacy of COLD-fX in the prevention of respiratory symptoms in community-dwelling adults: a randomized, double-blinded, placebo controlled trial. J Altern Complement Med. 2006;12:153-7.
McElhaney JE, Simor AE, McNeil S, Predy GN. Efficacy and safety of CVT-E002, a proprietary extract of panax quiquefolius in the prevention of respiratory infections in influenza-vaccinated community-dwelling adults: a multicenter, randomized, double-blind and placebo-controlled trial. Influenza Res Treat. 2011; 2011: 1-8.
Predy GN, Goel V, Lovlin R, Donner A, Stitt L, Basu TK. Efficacy of an extract of North American ginseng containing poly-furanosyl-pyranosyl-sacchardies for preventing upper respiratory tract infections: a randomized controlled trial. CMAJ. 2005;173:1043-1048.
Vohra S, Johnston BC, Laycock KL, Midodzi WK, Dhunnoo I, Harris E, Baydala L. Safety and tolerability of North American ginseng extract in the treatment of pediatric upper respiratory tract infection: a phase II randomized, controlled trial of 2 dosing schedules. Pediatrics. 2008;122:e402-410.
Clinical Trials -Mechanism of Action
McElhaney JE, Guilbert LJ, Reid D, Lowe K, Hooten J, Shan JJ. COLD-FX® stimulates cell mediated immune response of peripheral leukocytes ex-vivo to influenza virus in National Hockey League players. Open Nutraceuticals J. 2010;3:25-29.
Predy GN, Goel V, Lovlin RE, Basu TK. Immune modulating effects of daily supplementation of COLD-fX (a proprietary extract of North American ginseng) in healthy adults. J Clin Biochem Nutr. 2006;39:162-7.
Laboratory Experiments –Mechanism of Action
Durairaj P, Miller SC. Neoplasm prevention and immuno-enhancement mediated by daily consumption of a proprietary extract from North American ginseng by elderly mice of a cancer-prone strain. Phytoher Res. 2013; 27(9):1339-1344.
Ilarraza R, Wu Y, Davoine F, Ebeling C, Adamko DJ. Human dendritic cells promote an antiviral immune response response when stimulated by CVT-E002. J Pharm Pharmacol. 2011;63(5):670-8.
Miller SC, Delorme D. An extract of North American ginseng stimulates spontaneous immunity in infant mice: sustained augmented immunity in adulthood long after withdrawal of the extract. J Complem Int Med. 2008;5(1):1-18.
Miller SC, Delorme D, Shan JJ. CVT-E002 stimulates the immune system and extends the life span of mice bearing a tumor of viral origin. J Soc Integr Oncol. 2009;7(4):127-36.
Miller SC, Delorme D, Shan JJ. Extract of North American ginseng (Panax quinquefolius) administered to leukemic, juvenile mice extends their life span. J Complement Integr Med. 2011;8(1).
Miller SC, Ti L, Shan JJ. 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. Phytother Res. 2012;26(5):675-681.
Wang M, Guilbert LJ, Ling L, Li J, Wu Y, Xu S, Pang P, Shan JJ. Immunomodulating activity of CVT-E002, a proprietary extract from North American ginseng (Panax quinquefolium). J Pharm Pharmacol. 2001;53(11):1515-23.
Wang M, Guilbert LJ, Li J, Wu Y, Pang P, Basu TK, Shan JJ. A proprietary extract from North American ginseng (Panax quinquefolium) enhances IL-2 and IFN-gamma productions in murine spleen cells induced by Con-A. Int Immunopharmacol. 2004;4(2):311-5. Laboratory Experiments - Drug Safety and Tolerance
Ueng YF, Chen CF. Effects of CVT-E002, a proprietary extract from the North American ginseng (Panax quinquefolium) on hepatic drug-metabolizing enzymes in C57BL/6J mice. Journal of Chinese Medicine. 2002;13(2):89-96.