Black Cohosh and Liver Damage
After discovering that some of the Black Cohosh sold in the United States contains precious little of the active ingredient, we now learn that that may not have been such a bad thing.
In 2004, a Conference sponsored by National Center for Complementary and Alternative Medicine and Office of Dietary Supplements, National Institutes of Health indicated that Black Cohosh appeared to be safe. However, earlier this year, the regulatory authorities in Australia issued a policy statement about adding warnings about liver toxicity to all herbal products containing Black Cohosh. The European and British regulatory authorities followed suit.
This highlights a problem with which we’ve struggled before: are the reports of hepatotoxicity due to a “bad batch?” Adulterated perhaps, or collected incorrectly? Yet that highlights both the strength of natural remedies and also their Achilles’ heel. We have so little information about the purity of individual products.
The standardization of herbal medicines is difficult, particularly since herbals usually contain complex mixtures of constituents, some of which are active, and some not. We often do not know exactly which component of an herbal medicine is responsible for clinical effects. There are often also differences in the composition of herbal preparations among manufacturers and lots. There are also enormous variations in the identification of plants by the manufacturers, how they are handled and the presence of other chemicals. Just think of the variations in the taste of different types of coffee, and you will see the point.
This variation has important consequences in clinical trials, many of which have failed to address the question of whether the herbs that they were using were of high quality.
The information on the label does not always reflect the actual content of the preparation and it is difficult to give one standard dose for an herbal medicine.
I thought that I should give you the wording from The European Medicines Agency (EMEA) and the Committee on Herbal Medicinal Products (HMPC)”
“Following review of all available data, the HMPC considered that there is a potential connection between herbal medicinal products containing Cimicifugae racemosae rhizoma (Black Cohosh, root) and hepatotoxicity.
The EMEA therefore wishes to give the following advice to patients and healthcare professionals:
Advice to patients:
— Patients should stop taking Cimicifugae racemosae rhizoma (Black Cohosh, root) and consult their doctor immediately if they develop signs and symptoms suggestive of liver injury (tiredness, loss of appetite, yellowing of the skin and eyes or severe upper stomach pain with nausea and vomiting or dark urine).
— Patients using herbal medicinal products should tell their doctor about it
— Advice to healthcare professionals:
— Health care professionals are encouraged to ask patients about use of products containing Cimicifugae racemosae rhizoma (Black Cohosh, root).
— Suspected hepatic reactions should be reported to the national adverse reaction reporting schemes."