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Colds and flu cut by one-third in study of Canada's top cold fighter in vaccinated seniors

September 16, 2008

A winter free from colds and flu? Not yet. But a new study offers new evidence that Canada's top cold and flu-fighting product provides significant help. The three-year study showed that trial participants who took COLD-FX were about one-third less likely to get a "Jackson" cold or flu. The very sensitive Jackson scoring method is a well-accepted scientific approach for judging clinical symptoms, which include coughing, sneezing, runny noses and others. COLD-FX is a unique extract of North American ginseng discovered by 25 Canadian scientists. The multi-center study also revealed that COLD-FX gave trial participants added protection on top of the flu shot's benefit.

The multi-centre study confirmed the results of previous clinical trials reviewed by Health Canada, the federal government's regulatory body. One study published in the Canadian Medical Association Journal showed that for trial participants who regularly suffer two colds a year, COLD-FX reduced their chance of getting a second one by 56%. Health Canada approved strong claims for the product last year.

The multi-centre trial involved 780 healthy seniors in four major Canadian cities who took the flu shot just prior to their six-month treatment phase as part of the study. Participants were given either the standard dose of two capsules a day or double the standard dose or a placebo. The study was led by Dr. Gerald Predy, Medical Officer of Health for Alberta Health Services, in collaboration with various leading Canadian researchers. Neither the participants nor the investigators were aware of who was receiving what in this double-blind, placebo controlled trial.

The viral analysis was conducted in the lab of internationally recognized influenza expert, Dr. Albert Osterhaus. Based in the Netherlands, Dr. Osterhaus is one of the world's leading virologists and utilizes the most sensitive test methods available. Among his achievements and those of his group of 100 scientists were the identification of the first human infection with avian flu H5N1 in 1997 and the identity of the SARS virus during the first outbreak in Hong Kong in 2003.

Investigators employed two principal methods to check on upper respiratory infections: lab tests and the Jackson method. (A third method - non-Jackson assessment of symptoms in combination with lab tests - was also used.) While both methods were utilized, the Jackson method is actually more sensitive than lab testing in confirming symptomatic upper respiratory infections and gauging their severity.)

Compared to the placebo, both COLD-FX regimes produced similar and statistically significant reductions in the number of upper respiratory infections per individual - 36% for the lower dose and 33% for the higher dose.

Also, the number of Jackson infections in the standard dose COLD-FX group was 31% less than for the placebo group, while infections for the double dose group were 33% below the placebo group - statistically significant results.

However, investigators did not find statistically significant differences in confirmed infections, compared to placebo, when they looked at the data in a couple of other ways: based on lab testing alone; and considering lab plus symptom-based (but not Jackson) testing. It's possible the differences weren't statistically significant in these scenarios because the overall influenza numbers were so low during the two flu seasons studied. Also, the trial wasn't designed to measure viral load (the amount of virus in the body). So COLD-FX may actually have reduced the degree of infection in some people but the trial didn't check this.

It did confirm that both COLD-FX dosage levels were safe and well tolerated. Adverse events in the COLD-FX groups showed up at about the same rates as for the placebo group - with one intriguing exception. Both COLD-FX groups showed fewer negative cardiovascular events. The reason might be found in COLD-FX's effectiveness in reducing upper respiratory infections, which often go hand in hand with cardiovascular problems in seniors. This result was obtained through assessing safety aspects of the trial. It represents a potential new application for COLD-FX which, if pursued, would require more in-depth review.

Other than COLD-FX, there is no known clinically proven therapy for both prevention and treatment that naturally enhances the immune system to fight viral respiratory infections.

CV Technologies Inc.