Date Published: 1 March 2007
Herb Experts Report on Benefits of Canadian Remedy for Cold and Flu Symptoms
The American Botanical Council (ABC), North America's leading nonprofit research and education organization on herbal medicines, issued a report on 1st March 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.
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 5-20% 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.
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.
Source: American Botanical Council.