The American Herbal Pharmacopoeia (AHP) releases its quality control standards and therapeutic compendium for the botanical dietary supplement ingredient blue cohosh root and rhizome (Caulophyllum thalictroides (L.) Michx. and C. giganteum (Farw.) Loconte & W. H. Blackw.).
Each AHP monograph establishes standards for assuring authenticity, purity, and quality control of the monographed botanical and represents one of the most comprehensive reviews of the botanical in the English language. Each monograph addresses the historical use of the botanical along with multiple methods of analysis for ensuring the botanical’s authenticity that include both physical and chemical tests appropriate for individual dispensaries or small or large companies. The identification section provides detailed photographs and images with which to develop companies’ internal identification specifications.
Accompanying the standards is the AHP Therapeutic Compendium, which provides a complete and critical review of the pharmacological and safety data currently available, including information on pharmacokinetics, pharmacodynamics, actions, medical indications, historical and modern traditional use, structure/function claims, dosages, interactions, side effects, contraindications, toxicology, and more. All of this information can be used as part of a company’s product substantiation files in supporting structure-function statements as well as establishing the safety of their product.
Blue cohosh was historically one of the most widely used and highly relied-upon botanicals for augmenting labor for more than 100 years.
Conventional labor induction is one of the primary reasons why America has the worst infant mortality statistics of any similarly developed nation. Blue cohosh was one of the primary botanicals used to help to facilitate normal and efficient labor. Concerns based on case reports about its potential fetal toxicity have caused it to fall into disuse thus potentially eliminating a once very important herb from the material medica.
According to AHP’s Executive Director Roy Upton, “This has been the most challenging monograph AHP has developed to date. We had to weigh the traditional data, human experience, case reports, chemistry, and mechanistic plausibility for toxicity within the context of the often barbaric birthing practices employed in this country, the result of which causes more of our babies to die than in almost every other developed country; and then come up with the best guidance we could for its use.”
The monograph was coauthored and edited by herbalist, midwife, physician, and AHP Medical Director Aviva Romm and was based on her Yale doctoral thesis as well as her original work conducted with midwives. In addition to Dr. Romm’s blue cohosh review being vetted by the Yale doctoral review board, the monograph was subjected to review of traditional herbalists, midwives, naturopathic physicians, medical obstetrics experts, and integrative medical doctors, among AHP’s normal cadre of other experts, such as botanists and chemists.
According to Upton, “We embarked on the development of the blue cohosh monograph, first because of the importance of the botanical in the birthing and naturopathic medical communities, and then because of the concern for its potential toxicity. We worked hard to strike a balance between the potential benefit of the herb juxtaposed against any potential risk and fully informing the health care community and consumers about the strength of the evidence both ways.”
Another interesting finding was the recognition of a second North American Caulophyllum species, C. giganteum, proposed in 1981 and accepted in the Flora of North America in 1995. Caulophyllum giganteum and C. thalictroides have been used interchangeably throughout the history of use of the herb. There are morphological differences and similarities between the two species, and the chemistry appears to be the same. While C. giganteum is not listed in American Herbal Products Association’s seminal text on botanical nomenclature Herbs of Commerce, the recognition of the species is important from the perspective of GMP compliance.