The American Herbal Pharmacopoeia (AHP) is bringing its monograph series up to 16 with the release of four new monographs. The goldenseal (Hydrastis canadensis L., Ranunculaceae) root monograph was released in August 2001, and the monograph on bilberry (Vaccinium myrtillus L., Ericaceae) was published in December 2001. Black cohosh (Actaea racemosa L., Ranunculaceae syn. Cimicifuga racemosa) and cranberry (Vaccinium macrocapon Aiton, Ericaceae) are expected to be published by March 2002.
The goldenseal monograph is unique in that it includes research on berberine, one of goldenseal’s active compounds, and information on goldenseal’s conservation status. International trade in wild and cultivated goldenseal, listed in Appendix II of CITES (the Convention on International Trade in Endangered Species of Wild Fauna and Flora), is regulated to protect the species’ wild status.
The bilberry monograph includes quality control standards to help assure authenticity and purity, and provides a therapeutic compendium that critically reviews all current pharmacological and safety data, much of which has been unavailable in the U.S.
"Each monograph represents the most thorough and critical review of all aspects of the plant available. It provides complete and reliable information regarding the true therapeutic potential and safety of the herb so that consumers and health professionals can make educated decisions about its use," said Roy Upton, AHP’s executive director.
AHP intends to publish 300 monographs on the most commonly used herbs from Ayurvedic, Chinese, and Western traditions. Each monograph takes about one year to complete and several are in development concurrently, explained Upton. Monograph development depends primarily upon financial support from the herb industry.
"With the recent downturn in certain segments of the industry, fundraising has been difficult and time consuming. However, it is important for the industry to understand that the information provided by the AHP monographs is essential for the manufacture of quality products," Upton said. "An industry whose product quality is above reproach will grow and flourish, or if lacking, will continually struggle to build product confidence."
In Upton’s opinion, increased product quality will lead to physicians and pharmacists prescribing herbal products, as is common in parts of Europe, and to insurance companies reimbursing consumers. According to Upton, "Booms in individual herbs (like St. John’s wort) aside, this is what will lead to future sustained growth of the herbal products industry to a degree currently not envisioned by members of the industry."
AHP monographs provide the most accurate information on herbs and herbal compounds to the medical community, the herbal industry, and to consumers according to Upton. "Much of the already existing information is inconsistent or is not utilized by much of the industry. Even something as seemingly elementary as knowing the proper identification or optimal time and conditions for harvesting and drying are not commonly known. Ultimately, our goal is to provide the information needed to produce a true quality product and how to use it appropriately," Upton said.
The selection of species for monographs results from three general methods. In the first and most commonly used method, a prioritization committee — made up of herbalists, naturopathic physicians, and herbal education and industry representatives — compiles a list of the top 100 selling herbs from informal surveys. The committee evaluates the feasibility of completing a monograph on those species and narrows the list to a top 30, a top 20, and the top 10. Once the first 30 monographs are completed, the committee will determine the next 30 most needed (see Table 1).
Some herbs are selected due to safety concerns. One such example is the adulteration of common Chinese herbs with plants from the family Aristolochiaceae. The U.S. Food and Drug Administration (FDA) issued a warning to consumers in April 2001 about the dangers of kidney failure and cancer associated with one species of this plant, Aristolochia fangchi (Y.C. Wu ex L.D. Chou & S.M. Hwang), which may be accidently substituted in weight-loss products that contain Chinese herbs*. AHP is collaborating with the Australian Therapeutic Goods Agency, the Chinese State Drug Administration, and the American Herbal Products Association to develop a monograph that contains authentication testing for plants of family Aristolochiaceae and those plants that are commonly adulterated with them. Work on this monograph is progressing, but since it is outside the normal monograph production and requires separate funding, it does not appear on the general list.
Finding direct sponsors provides a second method of monograph selection. Producing a monograph costs from $25,000–$40,000 with additional publication costs of $3,000–$6,000, depending upon length of the monograph and quantity produced. A third means of monograph selection is opportunistic, building on prior work. For example, the monograph on black haw (Viburnum prunifolium L., Caprifoliaceae) was quickly produced after the literature retrieval process for cramp bark (Viburnum opulus L., Caprifoliaceae) provided complete information on it.
Monograph development requires exhaustive literature research in order to provide a comprehensive description of the botanical’s historical use, commercial sources, botany, chemistry, pharmacognosy, analytical methods, and clinical therapeutics. With a large percentage of Americans using herbal products, healthcare practitioners, regulators, retailers, manufacturers, and the public need to have access to accurate information concerning pharmacology, indications, dosages, side effects, contraindications, drug interactions, and toxicology. AHP often translates source materials from Chinese, Hungarian, Japanese, Russian, and, most commonly, German and French literature.
A single writer or writing committee with appropriate specialization drafts a section, which is reviewed by an AHP editor and an expert in that field. After each section is reviewed, the entire monograph is sent out to 40–50 experts in botanical medicine, including botanists, chemists, herbalists, pharmacists, pharmacognosists, pharmacologists, physicians, and specialists in Western, Chinese, and Ayurvedic medicine. Peer reviewers have included researchers from the FDA; Food and Drug Department of the State of California; U.S. National Cancer Institute; U.S. National Institutes of Health; London University School of Pharmacy; Pasteur Institute at the University of Strasbourg; University of Vienna; Weber State University; and members of the herbal industry. After review, the entire monograph is subjected to a final review by a select group of specialists.
Producing monographs fulfills AHP’s mission: to set and promote quality control standards for the safe and effective use of herbal medicines and to provide accurate and comprehensive information to the herbal industry, healthcare professionals, educational institutions, regulating bodies, and the general public about the appropriate use of botanicals.
"AHP monographs provide the foundation for the manufacture of safe and efficacious herbal products and to promote their ethical marketing. Few other monograph systems provide the depth, comprehensiveness, or critical review achieved by the AHP monographs," said Upton. "Additionally, each monograph provides detailed color photographic images of the plants that are invaluable for assessing identification and quality control. This is a unique feature of AHP monographs not found in any others."
* Editor's note: For more on this subject, see Chen J. Nephropathy Associated with the Use of Aristolochia. HerbalGram 2000;48:44-5.
[American Herbal Pharmacopoeia. Announcing the Publication of AHP Monograph; Goldenseal Root Hydrastis canadensis. [Press release]. August 3, 2001.
American Herbal Pharmacopoeia Releases Bilberry Monograph [Press release]. December 1, 2001.
American Herbal Pharmacopoeia website. <www.herbal-ahp.org>.
Foster S. Goldenseal’s future. 2000. <www.stevenfoster.com>.
Herb guides get APHA blessing. Nutrition Science News. March 2000. <www.healthwellexchange.com>.
"Special alert: potential danger in Chinese herbal formulas. Herbal News from Herbal Musings. June 2001. <www.herbalmusings.com>.
Upton R. Personal Communication. October 2, 2001.]