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The American Botanical Council (ABC) has issued a monograph prepared by leading U.S. cold and flu and medicinal plant experts, concluding that a new-generation cold and flu remedy from Canada has demonstrated “impressive” benefits. The monograph, covering the published chemical, pharmacological, and clinical studies on the health benefits of CVT-E002, the active ingredient in COLD-fX®, is available for download from: http://www.herbalgram.org/files/pdfs/5594COLD-fX.pdf.1 COLD-fX is marketed as a “natural health product” in Canada and was recently introduced as a dietary supplement in the United States.
The comprehensive medical expert review by ABC was conducted by University of Wisconsin at Madison Professor Bruce Barrett, MD, PhD, and Donald J. Brown, ND, President of Natural Product Research Consultants in Seattle, WA. Dr. Barret is one of America’s leading experts on the scientific and clinical research conducted on herbs and herbal preparations for cold and flu symptoms. Dr. Brown is widely acknowledged as a leading expert of clinical trials conducted on herb and phytomedicinal preparations. Both authors are members of ABC’s Advisory Board. As is standard for all ABC publications, Drs. Barrett and Brown’s comprehensively detailed review was subjected to additional peer review evaluation, in this case by 3 leading medical and scientific experts. Based on the available research, the ABC review suggests that COLD-fX is effective in helping to prevent the incidence of colds and flu, and the authors recommend additional research for further confirmation of the effectiveness of COLD-fX.
The therapeutic monograph is the first in a series of Product-Specific Monographs that ABC is publishing, focusing on the pharmacological and clinical research on specific commercial herbal preparations.
The publication of ABC’s COLD-fX monograph followed a February 15 announcement that the Canadian government’s Natural Health Products Directorate (NHPD), a division of Health Canada, approved the following claim for COLD-fX: it “helps reduce the frequency, severity and duration of cold and flu symptoms by boosting the immune system.”2 In Canada, COLD-fX is one of the few medicines approved for daily use as a preventive medicine as well as for providing symptom relief for colds and flu. Herbal preparations are sold as “natural health products” in Canada and are evaluated for a specific claim by the NHPD according to existing scientific and clinical trial data.
Since its introduction in Canada in 1996, COLD-fX has found increased popularity as a natural immune-enhancing remedy to help prevent or treat the symptoms of colds or the flu. It is reported to be the number-one selling cold and flu remedy in Canada. Last fall COLD-fX was cleared for the first time for sale in the United States as a dietary supplement by the US Food and Drug Administration (FDA).
The authors of the COLD-fX monograph reviewed the results of all conducted clinical trials, two of which they describe as preliminary or Phase 2 trials. They found the highest level of evidence in the third one, a confirmatory or Phase 3 trial. The authors concluded that, “All three of these found some evidence of preventative efficacy.”
The ABC monograph emphasizes the uniqueness of COLD-fX. Since it is a chemically distinct fraction (a group of chemically similar compounds, in this case complex sugars called saccharides) isolated from the roots of cultivated American ginseng (Panax quinquefolius), COLD-fX has biological properties different from more conventional preparations made from the same ginseng root. Further, it contains no ginsenosides, the well-known and frequently-researched chemicals that are characteristic of various types of ginseng. Thus, most of the historical, scientific and clinical literature on American ginseng root is not directly applicable to COLD-fX.
The authors also comment on the safety of COLD-fX. Based on the available evidence they could find no evidence of any risks that would require label warnings. Additionally, there are no clear contraindications for its use; that is, there are no persons or conditions for which the use of COLD-fX must be avoided. The scientific review also notes that, based on the extensive use of the product in Canada over several years, relatively few adverse events have been reported, only one of which was considered serious.
Drs. Barrett and Brown state in the monograph that if additional clinical research continues to support the results from the existing clinical trials, COLD-fX will be in a class of its own as it would “become one of very few-if any-therapies that are proven to prevent respiratory infection.”
The review raises the possibility that, “If it turns out that specially formulated extract preparations from ginseng such as [COLD-fX] are effective for prevention of influenza illness, the next question will be whether these preventive phytomedicines can enhance the effects of flu shots, prevent infection, and reduce morbidity and mortality.”
Approximately 5 to 20% of Americans become ill with the flu each year. In addition, an estimated 36,000 Americans die each year and an estimated 200,000 are hospitalized for flu-related complications, according to the Center for Disease Control and Prevention in Atlanta.3
Dr. Brown noted, “This scientific monograph will serve as an educational tool because many physicians have not been exposed to scientific clinical research on natural alternatives. We as health professionals have a responsibility to evaluate the science on herbal dietary supplements in order to guide our patients appropriately.” He further adds, “The monograph provides an excellent overview for clinicians as well as patients who want to better understand the science behind COLD-fX.”
ABC emphasized that the publication of the monograph should not be interpreted as a promotion or endorsement by the authors or ABC of COLD-fX or its manufacturer. As an independent nonprofit research and education organization, ABC has compiled and published this review for educational purposes only. The public should recognize that there is a growing body of scientific research on herbal dietary supplements that support their safety and potential benefits, and much of this research is based on specific commercial products.
The monograph can be accessed by logging onto ABC’s website at www.herbalgram.org. Included in the extensively-referenced monograph is a discussion of clinical trial data with a table summarizing clinical trials. For consumers, the site will also host a one-page Patient Information Sheet that is based on information condensed from the larger scientific monograph. A condensed 2-page Clinical Overview for quick reading is also available. These publications follow the format established by ABC in its highly-acclaimed reference book, The ABC Clinical Guide to Herbs, which is accredited for continuing education for physicians, pharmacists, nurses, dietitians, and other healthcare professionals.
-Mark Blumenthal
References
1. Barrett B, Brown DJ. Proprietary Phytomedicinal Product Therapeutic Monograph: CVT-E002 (COLD-fX®). Austin, TX: American Botanical Council, 2007. Available at: http://www.herbalgram.org/files/pdfs/5594COLD-fX.pdf.
2. Product License Issuance NPN 80002849 Non-Traditional - Cold-fX®. Letter received by CVT from the NHPD, February 13, 2007. Approval listing available at: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/lists/listapprnhp-listeapprpsn_e.html
3. Centers for Disease Control and Prevention. The flu: Questions & Answers: The disease. Available at: http://www.cdc.gov/flu/about/qa/disease.htm. Accessed February 20, 2007.
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