Cold-FX is a product derived from the roots of North American ginseng (''

Panax quinquefolius American ginseng (''Panax quinquefolius'') is a herbaceous perennial plant in the ivy family, commonly used as an herb in traditional Chinese medicine. It is native to eastern North America, though it is also cultivated in China. Since the 18th ...

''). It was formulated by Jacqueline Shan and originally manufactured by her company, Afexa Life Sciences (formerly called CV Technologies), which was acquired by

Valeant Pharmaceuticals Bausch Health Companies Inc. (formerly Valeant Pharmaceuticals International, Inc.) is a Canadian multinational specialty pharmaceutical company based in Laval, Quebec, Canada. It develops, manufactures and markets pharmaceutical products and ...

in 2011. There is little evidence to support that Cold-fx is effective in the

common cold The common cold or the cold is a viral infectious disease of the upper respiratory tract that primarily affects the respiratory mucosa of the nose, throat, sinuses, and larynx. Signs and symptoms may appear fewer than two days after exposu ...

. All trials have been done by the manufacturer and there has been poor

data reporting Data reporting is the process of collecting and submitting data which gives rise to accurate analyses of the facts on the ground; inaccurate data reporting can lead to vastly uninformed decision-making based on erroneous evidence. Different from da ...

. 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". COLD-FX is licensed by Health Canada as a Natural Health Product.Health Canada Natural Health Product Database. 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 articlesMcElhaney 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: 25-29Vohra 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.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.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.

Medical uses

There is no evidence that Cold-fx is effective in those infected with the

. The effect of preventative use is not clear. When used preventively it makes no difference on the rate of infections. It also appears to have no effect on how bad the infections are. There is tentative evidence that it may lessen the length of sickness when used preventively. 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.,

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.

Criticism

The product has not been shown to reduce the number or severity of common colds. There is tentative evidence that it may shorten colds in people who are otherwise healthy adults when taken preventively. All studies posing 'significant' results on its efficacy were funded by the manufacturer. Other criticisms point out that these studies have been small scale, with conspicuously shallow participant pools and lopsided gender distributions. 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. Scientists have argued that the product has not been tested for its ability to treat a cold after an individual has been infected. 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. 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. 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. In 2015 a class action lawsuit was launched that claimed that the manufacturer misled people. A B.C. Supreme Court judge refused to certify the class-action, but did not rule on the claim itself. The appeal on this case has been dismissed.

References

External links

*{{Official website, http://www.cold-fx.ca Herbalism