Colds and Flu Cut by 1/3 in Four-City Trial of COLD-FX®
News Sep 16, 2008
CV Technologies Inc. has announced preliminary results of a clinical trial demonstrating that COLD-FX® significantly supplements the flu shot's effectiveness in seniors and cuts colds and flu by one-third. This result was obtained through a randomized, double-blind, placebo-controlled multi-centre trial investigating the potential benefit of supplementing the flu shot in seniors with COLD-FX, the Company's lead product and Canada's number one selling cold and flu remedy.
The multi-centre trial involved 780 healthy seniors who took the flu shot just prior to the six-month treatment phase of the study, which was led by Dr. Gerald Predy, Medical Officer of Health for Alberta Health Services.
Dr. Predy collaborated with Dr. Janet McElhaney, an internationally recognized influenza expert and Division Head, Geriatric Medicine at the University of British Columbia and Providence Health Care, and infectious disease experts Dr. Andrew Simor, Head of Infectious Diseases and Microbiology at Sunnybrook Health Sciences Centre in Toronto, and Dr. Shelly McNeil, Associate Professor of Internal Medicine at Dalhousie University.
Commenting on the trial, Dr. Predy said: "Considering the risks that upper respiratory infections present to seniors in particular, it's encouraging that the study showed greater protection when COLD-FX is taken in addition to the flu shot."
Participants took daily doses for six months of either 400 milligrams of COLD-FX (standard dose), 800 milligrams of COLD-FX (high - double the standard dose), or a placebo. They were asked to report respiratory infections and record their symptoms.
The study addressed viruses responsible for cold and flu symptoms. Throat swab samples were taken from anyone reporting an infection and analyzed for viruses known to cause upper respiratory infections. The viral analysis was conducted in the lab of internationally recognized flu expert, Dr. Albert Osterhaus.
For prevention of colds and flu (and symptomatic relief), Health Canada has approved daily use of 400 milligrams of COLD-FX. CV Technologies has a product license and natural product number (NPN) for COLD-FX. Recently launched COLD-FX Extra Strength, which is recommended for acute symptom relief, was not studied in the multi-centre trial.
Investigators used two principal methods of verifying upper respiratory infections in trial participants: Jackson-confirmed (a rigorous and validated scientific tool for assessing clinical symptoms) and laboratory confirmed. While both methods were utilized, the Jackson method is actually more sensitive than laboratory testing in confirming symptomatic upper respiratory infections and gauging their severity.
Compared to study participants who took the placebo, the mean number of Jackson-confirmed upper respiratory infections per person was 36% lower in the standard dose COLD-FX group and 33% lower in the high dose COLD-FX group. In other words, both COLD-FX doses produced similar and statistically significant reductions in the number of upper respiratory infections per individual relative to the placebo.
Considering the groups as a whole, the number of Jackson infections experienced by the standard group was 31% less than the placebo group, while infections for the entire high dose group were 33% below the result for the placebo group. The difference in result between the placebo group and the COLD-FX groups was statistically significant - but the differences between the two COLD-FX groups were not.
Additional trial results consistent with these findings may be clarified during the peer review process and published in a scientific journal. Among these are reductions in the severity and duration of Jackson-confirmed infections in the COLD-FX groups, and an indication that COLD-FX may decrease the proportion of severely symptomatic infections among all infections confirmed in the lab.
The safety and tolerability of both COLD-FX doses was validated by the study results. Adverse events were not statistically significantly different than for the placebo group, with one notable exception: a reduction in cardiovascular events in both COLD-FX dose groups. The implications of this result are consistent with the efficacy of COLD-FX in reducing upper respiratory infections, which are known to be associated with adverse cardiovascular events in seniors.
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