We have done this for a variety of reasons, some of which are no doubt obvious to regular readers of ABC publications.

First, ABC has recognized that much of the pharmacological and clinical literature on herbs and phytomedicinal products are frequently based on specific proprietary commercial products. Such research is often, but not always, funded by the manufacturers of such products, generally in an attempt to substantiate the products’ safety and efficacy, as well as for marketing purposes. For the past 20-30 years or so a majority of such proprietary phytomedicinal research has been in Western Europe—particularly Germany—where the regulatory systems have been based on a drug model, often requiring substantiation dossiers on specific products as a precondition of their being licensed for sale in the respective countries.

A second reason is the appropriateness of publicly acknowledging those companies (and their products) that do invest in clinical research. Over the past several decades there has been a growing tendency by the media and the market in the United States and elsewhere to “genericize” the categories of herbs where clinical research is based on only one or a few leading commercial products. In some cases, this has led consumers, some inadequately informed health professionals, and others to refer to all the commercial products of an herb as if they were all the same. Thus, all black cohosh (Actaea racemosa, Ranunculaceae; syn. Cimicifuga racemosa) products, or all garlic (Allium sativum, Liliaceae) products, are often viewed as either similar or the same, even though the research is usually based on a chemically distinct preparation (i.e., the manufacturers of the clinically-tested phytomedicinal products may have employed techniques of chemical standardization to ensure levels of specific chemical compounds and/or a group of similar compounds, such as ginsenosides in root extracts of ginseng [Panax spp., Araliaceae]).

One of the salient examples here is black cohosh, increasingly popular in the past decade for its safety and effectiveness in helping to treat symptoms related to menopause in women. Most of the clinical research conducted on black cohosh, as cited in the Black Cohosh clinical monograph in The ABC Clinical Guide to Herbs, is based on the well-known isopropanolic extract of the root and rhizome of black cohosh, Remifemin®, manufactured and marketed since the mid-1950s by Schaper & Brümmer of Salzgitter, Germany. Further, if one were to look at the literature of the past 5 years, many of the black cohosh trials have been conducted on either Remifemin or an ethanolic extract known as BNO 1055 (Klimadynon®, Bionorica AG, Neumarkt, Germany).

Similarly, the first standardized extract of the leaf of ginkgo (Ginkgo biloba, Ginkgoaceae)—which is still the leading phytomedicinal ginkgo preparation worldwide, both in sales as well as in extent of pharmacological and clinical research—is the extract of ginkgo known officially as EGb 761®. (This is known as Tebonin® in Germany, Rokan® in France, Ginkgold® in the United States, etc., and it is manufactured and marketed by Dr. Willmar Schwabe Pharmaceuticals in Karlsruhe, Germany.)

Further examples abound, including garlic. The leading product is Kyolic® Aged Garlic Extract, produced by Wakunaga of Japan, and secondarily, Kwai® made by Lichtwer Pharma of Berlin. Research based on these 2 products dominates the clinical literature. Likewise the leading clinically researched product for St. John’s wort (Hypericum perforatum, Clusiaceae) extract or aerial parts is LI 160® or Jarsin® by Lichtwer. For more information on clinically-researched herbal preparations, see The ABC Clinical Guide to Herbs¹ and Marilyn Barrett’s two-volume Handbook of Clinically Tested Herbal Remedies.²

All this is not to imply that the somewhat “generic” herbal products are not effective. Such a suggestion would be hubristic. It should be noted here that the lack of published clinical trials on any particular product is not evidence of its lack of efficacy; it is simply a lack of positive published clinical evidence of any defined or suggested activity. People have successfully employed herbs and herbal preparations medicinally for millennia, long before the advent of randomized controlled trials in the past few decades.

In order to help the public access a comprehensive state-of-thescience compilation of the published (and in some cases, unpublished) pharmacological and clinical literature available on specific products and ingredients made from medicinal plants, as well as some common foods, ABC has initiated a new series of publications that we are describing as Product-Specific Monographs (PSM). The first such PSM was initially introduced online by ABC in March 2007, announcing the e-publication of the monograph on the proprietary and patented extract known as CVT-E002, or COLD-fX®.^3,4 CVT-E002 is a unique phytomedicinal product and represents a new generation of botanically-based preparations. Instead of being simply a standardized extract from the roots of American ginseng (Panax quinquefolius, Araliaceae), CVT-E002 is made from only the saccharide fraction of the American ginseng roots and standardized to at least 80 to 90% poly-furonosyl-pyranosyl-saccharidess, without the biologically active ginsenosides, the triterpene glycosides that characterize most herbal products made from the roots of various species of Panax.

In producing the PSM on CVT-E002 ABC is not endorsing the manufacturer, CV Technologies of Edmonton, Alberta, Canada, or the product itself. In producing this PSM, and publishing the Clinical Overview section on the following two pages, ABC is introducing its new PSM series. The complete monograph, including discussion of the product’s chemistry, patents, pharmacology, dosage recommendations, reviews of the clinical trials, and references, as well as a one-page Patient Information sheet and the Clinical Overview, is available on the ABC Web site at http://content.herbalgram.org/abc/ Press/files/5594COLD-fX.pdf.

Additional PSMs are scheduled to follow in 2008 and beyond. These will include PSMs on POM® Wonderful Pomegranate Juice made by POM Wonderful in Los Angeles, California; Pycnogenol® French Maritime Pine Bark Extract made by Horphag Research in Geneva, Switzerland; and i-flex^TM Danish Rose Hip Powder produced by Hyben Vital ApS of Tranekaer, Denmark, and marketed internationally by DSM, an international manufacturer and supplier of fine chemicals and other ingredients for the pharmaceutical and nutrition markets.

Interestingly, the POM Wonderful monograph may be the first-ever peer reviewed clinical monograph on a conventional food product, often referred to in the US market as a so-called “functional food” (a marketing term for which there is no corresponding regulatory category). Further, both Pycnogenol and i-flex are actually clinically-tested ingredients; they are not products per se. Unlike COLDfX and POM Wonderful, which are commercial retail products, Pycnogenol and i-flex are intended to be sold as ingredients in other branded commercial products.

We should emphasize that ABC’s agreement to produce a PSM on a particular product or ingredient should be interpreted as ABC’s recognition that the current level of clinical research is sufficient to support potential use or application of such a product or ingredient. In numerous cases, the research ranges from studies with outcomes that are merely suggestive (with more clinical research needed), to highly compelling, with more research perhaps still advisable. In either case, we welcome additional research to help document suggested uses and possibly additional therapeutic applications.

We are deeply grateful for the excellent services of our good friend and ABC Advisory Board member Don Brown, ND, who has acted as the consulting editor and co-author of three of these new publications.

Herbal, phytomedicinal, “nutraceutical,” and related natural products and ingredients are experiencing a maturational stage in their evolution, particularly here in the United States, characterized in part by attempts by manufacturers to differentiate their ingredients and products via the filing of patents (either composition, process, and/or use patents) and a growing body of pharmacological and clinical research. This increased research will result in a wider variety of high-quality natural ingredients and dietary supplement products with more documented safety and efficacy. Ultimately, this trend portends wider nutritional and therapeutic options and greater benefits for both consumers and health professionals.

On the following pages we offer the Clinical Overview on COLDfX, clinically-relevant information condensed from the COLD-fX PSM. We offer this as an example of a product that represents a new class of phytomedicinal products, based on a chemical and pharmacological technology blended with modern clinical research. As a service to our readers and to the general public, in the future, we may also make available in these pages other Clinical Overviews of other clinically researched products or ingredients.