American Botanical Council Publishes Major Scientific Review of COLD-fX, a Canadian Government-Approved Natural Remedy for Cold and Flu Symptoms
(Austin, TX) The American Botanical Council (ABC), North America’s leading nonprofit research and education organization on herbal medicines, issued a report on March 1, 2007 prepared by some leading U.S. cold and flu and medicinal plant experts concluding a new-generation cold and flu remedy from Canada demonstrated “impressive” benefits. The report involved a major scientific review (monograph) of the published scientific and clinical studies on the health benefits of CVT-E002, the active ingredient in COLD-fX, a dietary supplement recently introduced into the United States from Canada, available for download from: http://abc.herbalgram.org/site/DocServer/5594COLD-fX.pdf?docID=481. 1
The comprehensive medical expert review by ABC was conducted by University of Wisconsin Professor Bruce Barrett, MD, PhD and Donald J. Brown, ND, President of Natural Product Research Consultants in Seattle - two of America’s leading experts on the scientific and clinical research conducted on herbs and herbal preparations for cold and flu symptoms. The ABC review suggests that COLD-fX is effective in helping to prevent the incidence of colds and flu.
After reviewing both pharmacological and clinical trial data on COLD-fX, Barrett and Brown write that the clinical trial research on COLD-fX is “impressive” and promising, pointing out that the research “found some evidence of preventive efficacy” and “evidence suggesting ability to prevent acute respiratory infection.”
“Five independent physicians and scientists with substantial experience and credentials have been involved in the writing and editorial review of this monograph, making it a significant contribution to the understanding of natural medicines,” said Mark Blumenthal, ABC’s Founder and Executive Director. He added that these authors and reviewers collectively have significant experience in the fields of natural remedies used for upper respiratory tract infections, family practice medicine, and the chemistry, quality control and regulation of herbal preparations in the United States and Canada.
Blumenthal also noted that COLD-fX is a unique, patented product and is the result of extensive scientific research. “COLD-fX represents a new class of herb-based therapeutic products,” he said. “Unlike many herbal products that are based on respected historical and traditional uses that go back hundreds or even thousands of years, COLD-fX is the result of intensive scientific research on a natural herb, American ginseng root.”
ABC’s monograph comes on the heels of 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.” In Canada, it is one of the very few medicines approved for daily use as a preventive medicine as well as providing symptom relief for colds and flu. Such comprehensive therapeutic claims require support by high level scientific evidence: randomized, double-blind, placebo-controlled clinical trials.
Since its introduction in Canada in 1996, hundreds of thousands of Canadians have used COLD-fX as a natural immune-enhancing remedy to 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 U.S. as a dietary supplement by the U.S. Food and Drug Administration (FDA).
The ABC review 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 have reviewed all the trial results and describe two of them as preliminary or Phase 2 trials, but more importantly, 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 authors note that COLD-fX is quite safe. 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 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 also state in their review that if additional clinical research continues to support the results from the existing clinical trials, COLD-fX would 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 [plant-based medicines] can enhance the effects of flu shots, prevent infection, and reduce morbidity and mortality.”
Approximately five to 20 percent 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. 2
The authors recommend additional research for further confirmation of the effectiveness of COLD-fX. As is standard for all ABC publications, Drs. Barrett and Brown’s comprehensively detailed review was subjected to additional editorial evaluation (the oversight process known as peer review in medical and scientific journals) by three leading medical and scientific experts.
Dr. Brown, co-reviewer and lead editor of the review said, “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.”
The ABC therapeutic review, or 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 products.
“There has been considerable confusion in the media about the extent of research supporting the safety and benefits of many herbal dietary supplements,” noted Blumenthal. “In the many years that ABC has been reporting on this research, we realized that much of the scientific and clinical research in the literature is based on specific commercial products, so we decided to review and evaluate studies on these products. This is the first in a series that ABC plans to publish in the next few years,” he added.
Blumenthal also emphasized that the publication of the scientific review or 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, we have compiled and published this review for educational purposes only,” he added. “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.”
Consumers, health professionals and researchers can obtain the COLD-fX clinical review by logging onto ABC’s website at www.herbalgram.org. Included is the extensively-referenced review (monograph) of COLD-fX for health professionals containing a discussion of clinical 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 two-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. The book is accredited for continuing education for physicians, pharmacists, nurses, dietitians, and other healthcare professionals.
About the American Botanical Council
Founded in 1988 the American Botanical Council is the leading nonprofit organization in the United States addressing research and educational issues regarding herbs and medicinal plants. ABC’s members include academic researchers and educators, universities and libraries, health professionals and medical institutions, botanical gardens and arboreta, government agencies, members of the herb, dietary supplement, cosmetic, and pharmaceutical industries, journalists, consumers, and other interested parties from over 70 countries. The organization occupies a historic 2.5-acre site in Austin, Texas where it publishes HerbalGram, a peer-reviewed journal on herbal medicine, a monthly e-newsletter, reference books and other educational materials. ABC has published a reference book and a continuing education course for healthcare professionals, The ABC Clinical Guide to Herbs, containing extensive monographs on the safety and efficacy of 29 popular herbs. The CVT-E002/ COLD-fX review will be incorporated in the forthcoming online version of this publication. Information: Contact ABC at P.O. Box 144345, Austin, TX 78714-4345, Phone: 512-926-4900. Website: www.herbalgram.org.
About Professor Bruce Barrett, MD, PhD
Bruce Barrett MD, PhD, MSPH holds twin doctorates - one in medicine and the other in anthropology from the University of Wisconsin - both awarded in 1992. He did post-graduate work as a fellow of John Hopkins University working in Guatemala, and currently holds joint appointments in Family Medicine, Population Health and Anthropology at the University of Wisconsin in Madison. Dr. Barrett is regarded as an expert in upper respiratory infection (URI) and is a regular guest on radio and TV including National Public Radio, CBC-Radio and has been interviewed by U.S. News & World Report, Fitness magazine, FDA Consumer magazine, Milwaukee Journal, Baltimore Journal, American Medical News, Science News and Consumer Reports. He developed the Wisconsin Upper Respiratory Symptom Survey, an outcomes instrument designed to measure symptoms and dysfunctions from URI. Researchers in 20 groups in 12 countries have expressed intentions of using this instrument. He has been a visiting professor in herbal medicine at other American universities and has written extensively on herbal medicine and respiratory illnesses in dozens of peer-reviewed publications. He has been a principal investigator of two National Institutes of Health (NIH)-sponsored studies, including a trial testing both echinacea and placebo effects in common cold. He is or was a member of the board or advisory board of various peer reviewed journals including the American Botanical Council’s HerbalGram, plus FACT (Focus on Alterative and Complementary Therapies), and a reviewer for various peer-reviewed journals including Annals of Family Medicine, British Medical Journal, The Lancet and the Cochrane Collaboration.
About Donald J. Brown, ND
Donald J. Brown is a naturopathic physician and one of the leading authorities in the U.S. on evidence-based herbal medicine and the safety and efficacy of dietary supplements. A former assistant professor at the Bastyr University of Natural Health Sciences in Seattle and a member of the Advisory Board of the American Botanical Council, Dr. Brown has served as an advisor to the Office of Dietary Supplements at the National Institutes of Health (NIH). Dr. Brown is a regular contributor and editor for the journal HerbalGram produced by the American Botanical Council. He is the author of Herbal Prescriptions for Health and Healing (Lotus Press, 2003) and contributor to numerous books, including the Natural Pharmacy (Prima Publishing, 2006), the A-Z Guide to Drug-Herb-Vitamin Interactions (Prima Publishing, 2006), and The Textbook of Natural Medicine (Churchill Livingstone, 2006). He authored the Phytotherapy Review & Commentary column in the Townsend Letter for Doctors for over a decade.
1. Barrett B, Brown DJ. Proprietary Phytomedicinal Product Therapeutic Monograph: CVT-E002 (COLD-fX®). Austin, TX: American Botanical Council, 2007. <http://www.herbalgram.org/files/pdfs/5594COLD-fX.pdf>.
2. Centers for Disease Control and Prevention. The flu: Questions & Answers: The disease. <http://www.cdc.gov/flu/about/qa/disease.htm>. Accessed February 20, 2007.