Do Clinical Trials Support Cold FX - Find Out

What is Cold FX?

Cold-FX is a drug manufactured by Valeant Pharmaceuticals International. It contains a group of bioactive compounds extracted from the root of North American ginseng, Panax quinquefolius.

The active ingredients of Cold-FX are the polysaccharides known as poly-furanosyl-pyranosyl saccharides.

This drug is promoted for its immune-boosting properties and also its efficacy in the treatment of colds and the flu. Although Cold-FX is marketed to help prevent and treat cold and flu, there is still an ongoing debate over its efficacy for these conditions.

Even the manufacturer once stated on its US website that Cold-FX was not meant to prevent, treat or cure respiratory infections caused by cold and influenza viruses.

However, the Canadian site currently states that Cold-FX “helps reduce the frequency, duration, and severity of cold and flu symptoms by boosting the immune system”.

Cold-FX is formulated as capsules. Each capsule contains 200 mg of the active ingredient and the recommended dosage is 1 – 2 capsules taken 2 times daily. The manufacturer advised taking Cold-FX daily throughout the flu season to help bolster the immune system and fully protect against cold and influenza viruses.

However, a related product, Cold-FX Extra is recommended when cold symptoms are already present. It is also the drug to take if you come in contact with people already sick with cold or flu.

Cold-FX Extra contains 300 mg of the same proprietary polysaccharide complex found in Cold-FX.

The manufacturer recommends taking 1 capsule of Cold-FX Extra twice daily for 10 days.

Cold-FX is not recommended for those who are allergic to ginseng, those placed on blood thinners and those with impaired liver and kidney functions. Pregnant and breastfeeding women should also avoid this drug.

Cold-FX: A Brief History

In 1992, a team of 25 Canadian researchers from the University of Alberta were searching for natural medicines to boost the immune system. Their aim was to bridge the gap between Western science and traditional medicine by taking an herbal product and refining it with the techniques of modern science.

After screening thousands of natural remedies with a proprietary process known as ChemBioPrint (Chemical and Biological Fingerprinting), they found that the polysaccharide fractions of the Northern American ginseng possessed the strongest immune-boosting effects among a lot of remedies tested.

Then they extracted the polysaccharide fractions of this ginseng to formulate Cold-FX.

Cold-FX was originally manufactured by CV Technologies Inc. which later became Afexa Life Sciences Inc. before the company and its product were acquired by Valeant Pharmaceuticals International in 2011.

Cold-FX is actually well studied for a natural drug. This may be because it is the most popular cold and flu drug sold in Canada. Therefore, most of the studies investigating the efficacy of this product were done by Canadian researchers. By extension, most of the criticisms against it has come from Canada too.

There are studies that have found Cold-FX effective for boosting the immune system by enhancing the production and activities of such immune factors as Natural Killer cells, macrophages, lymphocytes, and cytokines.

Some of these studies found Cold-FX effective for reducing the frequency, duration, and severity of cold in healthy adults, the elderly and high-performance athletes.

There was once a fear that Cold-FX improved performance among athletes and may qualify to be banned for sportsmen. However, a doping study found that Cold-FX did not contain or produce banned substances.

Possible risk of doping is, unfortunately, not the only criticism leveled at Cold-FX.

Cold-FX: Effective or Not?

Some health experts contend that there are not enough well-designed studies to prove that ginseng (in any form) can prevent and/or treat the common cold and the flu.

Specifically, with regards to the studies that have found Cold-FX effective, critics believe that these studies were too short and too small to reach any conclusions. In addition, most of the positive studies have been funded or sponsored by the manufacturer.

Curiously, Cold-FX was promoted to provide immediate relief for cold even though there were no studies that demonstrated that it was effective when taken after the appearance of cold symptoms.

After regulatory bodies ruled that there was no evidence that Cold-FX can treat the common cold, the manufacturer introduced Cold FX Extra and a second dosing regimen for individuals who are already sick with a cold.

However, there is still no study to prove that higher doses and/or more frequent dosing of ginseng polysaccharide extracts are effective.

When questioned, representatives of Valeant Pharmaceuticals blamed the unproven claims on the old packaging of Cold-FX, a product they inherited.

Last year, they promised to phase out the packaging but Cold-FX is still boldly marketed as a “cure” for cold and flu on its website even as healthcare providers readily give it to patients at the first sign of cold symptoms.

Studies on Cold-FX

In Healthy Adults

A 2005 study published in the Canadian Medical Association Journal investigated the benefits of Cold-FX in a group of healthy adults aged 18 – 65 years.

For the study, the researchers recruited 323 participants who suffered at least 2 colds in the previous year.

Thereafter, they were divided into 2 groups. While one group was given a placebo, participants in the other group were given 2 capsules of Cold-FX per day over a period of 4 months.

The results showed that the Cold-FX group suffered fewer colds (0.25%) than the placebo group, fewer symptoms (1.5%) and fewer days of sickness (1.6%).

The researchers concluded that Cold-FX reduced the frequency, duration, and severity of colds compared to placebo.

However, a closer look at the results showed that the differences between the treatment group and the placebo group were barely statistically relevant. The data showed that those who took Cold-FX suffered from 0.25 fewer colds over 4 months.

This means that Cold-FX cannot even save users 1 cold per year. Therefore, Cold-FX may lower the risk of cold but it is a rather small difference.

In The Elderly

A 1998 study published in 2006 in The Journal of Alternative and Complementary Medicine investigated the efficacy of Cold-FX against acute respiratory illness in a group of community-dwelling seniors.

The researchers recruited 45 seniors aged 65 years and above. These participants were given either placebo or 2 capsules of Cold-FX (200 mg per capsule) per day over a period of 4 months.

The results showed that there was no difference between the two groups in the first 2 months. However, during the last 2 months (November and December at the peak of the flu season), there were fewer reports of respiratory infections in the Cold-FX group (32% vs. 64% in the placebo group).

In addition, those in the Cold-FX group who came down with respiratory infections experienced fewer days of symptoms (5.6 days vs. 12.6 days in the placebo group).

There was no report of the flu in the community during the study period.

The researchers, therefore, concluded that Cold-FX is a safe and effective drug for reducing the risk and duration of cold and flu-like symptoms in healthy seniors.

Some researchers criticized this study because of its small sample size, its design flaws, the delay in publication and the reputation of the journal.

A 2004 paper published in the Journal of the American Geriatric Society also investigated the benefits of Cold-FX for preventing respiratory illness in the elderly.

This paper actually combined two similar studies involving 198 healthy residents of a nursing home. Like the previous study, the dose of Cold-FX used in these studies was 200 mg taken twice daily over a period of 8 – 12 weeks.

The results found that Cold-FX did not perform statistically better than a placebo in each study. However, when the two studies were combined, the authors found that Cold-FX reduced the relative risks of cold and influenza infections (laboratory-confirmed cold and flu infections).

Combining two small studies into one already weakened the results and conclusions of this study.

Further doubt is cast on the results because both of the individual studies used showed that Cold-FX was ineffective for cold and flu.

Even after both studies were combined and the authors overreached to get statistically significant results for Cold-FX, what they found was that the drug only slightly reduced the risk of laboratory-confirmed cases of cold and the flu. The participants themselves reported that Cold-FX was not better than the placebo.

Cold-FX and the Immune System

A 2004 study published in the journal, International Immunopharmacology, compared the effects of Cold-FX and ginsenoside extract on immune function.

Ginsenosides are the most popular bioactive compounds found in ginseng. In contrast, the polysaccharide extract found in Cold-FX is not well studied and its mechanisms of action are still unclear.

For this study, the researchers got 4 groups of male rats. One group received 450 mg/kg of Cold-FX; the second group was given 900 mg/kg of Cold-FX; the third group got 450 mg/kg of ginsenoside, and the last group was given a control diet.

By studying the changes in the levels of certain immune factors, the researchers found out that both ginsenoside and Cold-FX affected the immune system but in different ways.

The higher dose of Cold-FX reduced the levels of CD3+ cells and activated T cells while increasing the level of the interleukin, IL-1 beta. In contrast, ginsenoside raised the level of the immunoglobulin, IgA.

These results do not show that Cold-FX boosts the immune system. The reduction in T cells, for example, can impair immune functions and reduce the ability of the immune system to cope with cold and influenza viruses.

However, Cold-FX can indeed boost other aspects of the immune system.

In vitro studies show that the drug can stimulate the production of B lymphocytes and macrophages as well as enhance the phagocytosis action of white blood cells.

For example, a 2004 study published in the same journal found that Cold-FX boosted acquired immune response by raising the levels of the interferon, IFN- gamma, and the interleukin, IL-2. These are specific antiviral immune factors that may indeed overcome cold and influenza viruses.

In addition, a 2006 study published in the Journal of Clinical Biochemistry and Nutrition found that Cold-FX increased the production of Natural Killer (NK) cells and T-helper CD8+ cells while lowering plasma IgA level.

A Canadian Review

In 2007, Anne Nguyen, the pharmacist coordinator of the British Columbia Community Drug Utilization Program at the Lions Gate Hospital in North Vancouver published a review of Cold-FX for family physicians in the journal, Canadian Family Physicians.

She quickly mentioned that there were no published studies to support the use of Cold-FX for the treatment of colds and flu.

Then she reviewed the 2005 study published in the Canadian Medical Association Journal discussed above. The reviewer criticized the design of the study especially its reliance on self-reporting of symptoms and not laboratory test data as well as the lack of differentiation between cold and flu infections.

In her opinion, the author found Cold-FX no better than a placebo and recommended proper hand hygiene rather than the drug for preventing colds and flu.

She recommended that family physicians should only prescribe Cold FX for their patients if only it was insisted upon. However, she cautioned that the drug should not be taken for longer than 4 months because that was the maximal duration of clinical trials investigating Cold-FX.

Cold-FX has met with more criticism from health experts especially as its endorsement by Canadian athletes drove its popularity.

Many experts believe that it is no better than placebo and that it does nothing to treat colds and flu.

It is difficult to argue with these conclusions because there is scant evidence to show that Cold-FX works. Of course, it produced a tiny benefit in a couple of sponsored trials but the small benefit is likely due to flaws in those studies, the enthusiasm of the researchers or the placebo effect.