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COLD-FX
InventorAfexa Life Sciences Inc.
ManufacturerValeant Pharmaceuticals International
AvailableAvailable
Current supplierValeant Pharmaceuticals International
Websitewww.cold-fx.ca

COLD-FX is a product derived from the roots of North American ginseng (Panax quinquefolius). It was formulated by Jacqueline Shan[1] and originally manufactured by her company, Afexa Life Sciences Inc. (formerly called CV Technologies Inc.).[2] It was headquartered in Edmonton, Alberta, Canada and subsequently, the company and lead product was acquired by Valeant Pharmaceuticals International (headquartered in Laval, Quebec, Canada) in 2011.

The active ingredient in COLD-FX® Daily Support is a patented extract from North American ginseng (Panax quinquefolius). There is mixed reviews about the efficacy of COLD-FX.[3][4] The efficacy of this extract has been tested in clinical trials conducted in collaboration with researchers from Canadian universities. COLD-FX has been assessed in 6 published randomized, double-blinded and placebo controlled clinical trials and 20+ published articles.[5][6][7][8][9][10] In vitro and clinical studies showed that COLD-FX helps to reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system.[11] COLD-FX is licensed by Health Canada as a Natural Health Product.[12] A review by Dr. Barrett and Dr. Brown from University of Wisconsin, which was published in American Botantical Council (A North America’s leading nonprofit research and education organization on herbal medicine) concluded that the clinical research on COLD-FX is “impressive” and promising, and these studies showed “evidence suggesting ability to prevent acute respiratory infections.”[13][14] According to Health Canada's Natural Health Product Directorate records, COLD-FX claims to "help reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system".[12] However, there are conflicting opinions regarding the efficacy of COLD-FX in the prevention of the common cold. Others, took a more skeptical view on the efficacy of this herbal remedy. A common issue faced by most natural supplements such as:[3][4] That there is no evidence that it is effective in those infected with the common cold,[3] and the effect of preventative use is not clear.[3]

  • Medical uses

COLD-FX has a portfolio of natural health products that provides (proactive) Daily Support (Daily Support, Extra Strength and Chewables) and Symptom Relief of cold and flu symptoms (COLD-FX First Signs). The original COLD-FX products were formulated with the active ingredient extracted from North American ginseng, which has shown to have immune modulating effect. The patented extract used in COLD-FX is one of the few natural supplements which has gone through rigorous clinical studies.[15] Blumenthal from American Botanical Council suggested that COLD-FX “represents a new class of herb-based therapeutic products” and is a “result of intensive scientific research on a natural herb”. Clinical studies involving more than 1600 patients, showed that the active ingredient in COLD-FX can help reduce and prevent common cold and flu symptoms when taken daily.,[7][8][9][10][16][17]

  • Adverse effects

Individuals requiring anti-coagulant therapy such as warfarin should avoid use of American ginseng. Not recommended for individuals with impaired liver or renal function. It is not recommended in those who are pregnant or breastfeeding. Other adverse effects include: headaches, anxiety, trouble sleeping and an upset stomach.[3][6]

  • Criticism

The efficacy of COLD-FX has been covered in the media. In 2015 a class action lawsuit was launched that claimed that the manufacturer misled people.[18] The lawsuit was subsequently dismissed in a B.C. Supreme Court ruling in 2017.[19] The appeal on this case was dismissed in 2018.[20] All studies posing 'significant' results on its efficacy were funded by the manufacturer.[4] Other criticisms point out that these studies have been small scale, with conspicuously shallow participant pools and lopsided gender distributions.[21] 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.[22] Scientists have argued that COLD-FX has not been tested for its ability to treat a cold after an individual has been infected.[23] 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.[21] 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.[24] 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.[25]

References

  1. ^ Keung, Nicholas (16 June 2014). "From Chinese village girl to Canadian CEO: Cold-FX founder writes her story". Toronto Star. Torstar. Retrieved 17 June 2014.
  2. ^ Ramage, Norma (30 March 2009). “CV Technologies Rebrands as Afexa.”Marketing Magazine.
  3. ^ a b c d e Nahas, R; Balla, A (Jan 2011). "Complementary and alternative medicine for prevention and treatment of the common cold". Canadian Family Physician. 57 (1): 31–6. PMC 3024156. PMID 21322286.
  4. ^ a b c Seida, JK; Durec, T; Kuhle, S (2011). "North American (Panax quinquefolius) and Asian Ginseng (Panax ginseng) Preparations for Prevention of the Common Cold in Healthy Adults: A Systematic Review". Evidence-based complementary and alternative medicine : eCAM. 2011: 282151. doi:10.1093/ecam/nep068. PMC 3136130. PMID 19592479.
  5. ^ Predy GN, Goel V, Lovlin RE et al . 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
  6. ^ a b McElhaney J., et al. COLD-FX® Stimulates Cell Mediated Immune Response of Peripheral Leukocytes ex-vivo to Influenza Virus in National Hockey League Players. The Open Nutraceuticals Journal, 2010; 3: 25-29
  7. ^ a b Vohra S, Johnston BC, Laycock KL et al. 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:e402-10.
  8. ^ a b 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.
  9. ^ a b 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.
  10. ^ a b 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.
  11. ^ Product Information. Archived from the original on 2013-10-23.
  12. ^ a b Health Canada Natural Health Product Database.
  13. ^ Barrett and Brown. Therapeutic Monograph for CVT-E002 (COLD-FX). American Botanical Council.
  14. ^ American Botanical Council. New Release.
  15. ^ Herb Experts Report on Benefits of Canadian Remedy for Cold and Flu Symptoms.
  16. ^ 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.
  17. ^ 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.
  18. ^ "Cold-FX users were misled about top-selling cold and flu remedy, lawsuit alleges". National Post. March 31, 2015. Retrieved 23 June 2015.
  19. ^ “Cold-FX class action lawsuit tossed – Toronto Star”.  Thestar.com
  20. ^ B.C. Appeal Court rejects class action lawsuit aimed at Cold-FX". financialpost.com May 2, 2018.
  21. ^ a b Fighting the common cold. ABC news. 2005-10-25
  22. ^ William Lin (2007-02-16). "Does ginseng really work? It depends on who you ask". The Ottawa Citizen.
  23. ^ Ginseng Unproven in U.S." Los Angeles Times. 2008-02-18.
  24. ^ Charlie Gillis (2007-03-26). "COLD-fX catches the sniffles again". Macleans Magazine. Archived from the original on 2012-02-07.
  25. ^ "COLD-FX Sets Record Straight: Health Canada's Approval of New Medical Claims Unchanged" (PDF). CV Technologies. March 5, 2007.

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TekConnect (talk) 00:21, 4 October 2018 (UTC)

Reply 04-OCT-2018

[edit]

  Edit request declined   This diff shows the major differences between the article as it exists now and the proposed changes on this talk page. Those changes include:

  1. Deletion of secondary source discussing the purported inefficacy of the product while simultaneously adding primary source documents discussing the product's purported efficacy. Per WP:MEDRS, references to secondary sources are suggested to use.[1]
  2. Numerous errors in formatting and WP:MOS adherence (e.g., the addition of ® at several points in the article, non-standard capitalization, etc.) are also preventing this text from being found acceptable.

Regards,  Spintendo  08:15, 4 October 2018 (UTC)

References

  1. ^ "Wikipedia:Identifying reliable sources (medicine)". Wikipedia. 25 September 2018. Retrieved 4 October 2018. Controversies or uncertainties in medicine should be supported by reliable secondary sources describing the varying viewpoints. Primary sources should not be aggregated or presented without context in order to undermine proportionate representation of opinion in a field. If material can be supported by either primary or secondary sources – the secondary sources should be used.
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