Unsolved:Cold-fX

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Cold-FX
ColdFX Logo 8091.png
The logo for 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 (formerly called CV Technologies),[2] which was acquired by Valeant Pharmaceuticals in 2011.

There is little evidence to support that Cold-fx is effective in the common cold.[3][4] All trials have been done by the manufacturer and there has been poor data reporting.[3] According to Health Canada's Natural Health Product Directorate records, the company claims that it may "help reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system".[5] COLD-FX is licensed by Health Canada as a Natural Health Product.[6] 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[7][3][8][9][10][11]

Medical uses

There is no evidence that Cold-fx is effective in those infected with the common cold.[12] The effect of preventative use is not clear.[12] When used preventively it makes no difference on the rate of infections.[4] It also appears to have no effect on how bad the infections are.[4] There is tentative evidence that it may lessen the length of sickness when used preventively.[4] 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.,[8][9][10][11][13][14]

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.[12]

Criticism

The product has not been shown to reduce the number or severity of common colds.[4] There is tentative evidence that it may shorten colds in people who are otherwise healthy adults when taken preventively.[4] 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.[15] 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.[16]

Scientists have argued that the product has not been tested for its ability to treat a cold after an individual has been infected.[17] 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.[15] The manufacturer was criticized for making health claims about the product that have never been tested or scientifically verified. 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 it was entitled to make.[18] 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.[19]

In 2015 a class action lawsuit was launched that claimed that the manufacturer misled people.[20] A B.C. Supreme Court judge refused to certify the class-action, but did not rule on the claim itself.[21] The appeal on this case has been dismissed.[22]

References

  1. ↑ Keung, Nicholas (16 June 2014). "From Chinese village girl to Canadian CEO: Cold-FX founder writes her story". Toronto Star (Torstar). https://www.thestar.com/life/2014/06/16/from_chinese_village_girl_to_canadian_ceo_coldfx_founder_writes_her_story.html. 
  2. ↑ "What is COLD-fX intended for?". Cold-fX: Frequently Asked Questions. http://www.cold-fx.ca/faq.htm#1. 
  3. ↑ 3.0 3.1 3.2 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
  4. ↑ 4.0 4.1 4.2 4.3 4.4 4.5 4.6 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 2011: 282151. doi:10.1093/ecam/nep068. PMID 19592479. 
  5. ↑ "Product Information". http://webprod3.hc-sc.gc.ca/lnhpd-bdpsnh/info.do?lang=eng&licence=80002849. 
  6. ↑ Health Canada Natural Health Product Database.
  7. ↑ 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
  8. ↑ 8.0 8.1 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.
  9. ↑ 9.0 9.1 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.
  10. ↑ 10.0 10.1 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.
  11. ↑ 11.0 11.1 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.
  12. ↑ 12.0 12.1 12.2 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. PMID 21322286. 
  13. ↑ 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.
  14. ↑ 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.
  15. ↑ 15.0 15.1 "Fighting the Common Cold". ABC News. 2005-10-25. https://abcnews.go.com/GMA/Flu/story?id=1247773. 
  16. ↑ William Lin (2007-02-16). "Does ginseng really work? It depends on who you ask". The Ottawa Citizen. http://www.canada.com/ottawacitizen/news/story.html?id=9c59543e-3d59-4673-8538-ab20e05c20eb. 
  17. ↑ "Ginseng Unproven in U.S.". Los Angeles Times. 2008-02-18. http://www.latimes.com/features/health/la-he-ginseng18feb18,0,4445115.story. 
  18. ↑ Charlie Gillis (2007-03-26). "COLD-fX catches the sniffles again". Maclean's Magazine. http://www.macleans.ca/homepage/magazine/article.jsp?content=20070326_103302_103302. 
  19. ↑ "COLD-fX Sets Record Straight: Health Canada's Approval of New Medical Claims Unchanged". CV Technologies. March 5, 2007. http://cnrp.ccnmatthews.com/cnrp_files/20070305-305CVQ.pdf. 
  20. ↑ "Cold-FX users were misled about top-selling cold and flu remedy, lawsuit alleges". March 31, 2015. http://news.nationalpost.com/news/canada/cold-fx-users-were-misled-about-top-selling-cold-and-flu-remedy-lawsuit-alleges. 
  21. ↑ "Cold-FX class action lawsuit tossed - Toronto Star". 16 November 2016. https://www.thestar.com/business/2016/11/16/cold-fx-class-action-lawsuit-tossed.html. 
  22. ↑ "B.C. Appeal Court rejects class action lawsuit aimed at Cold-FX". http://business.financialpost.com/pmn/business-pmn/b-c-appeal-court-rejects-class-action-lawsuit-aimed-at-cold-fx. 

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