I am glad to hear that ABC and AHPA are challenging these allegations regarding black cohosh. There are huge gaps in the information available. I believe the Australian assertions were based on a compound extract. I am unclear about the formulations in the other cases. Without the important details, it is very difficult to ascertain what is going on for the unfortunate souls involved. I look forward to reading AHPA’s review.
My overall comments are thus:
I have utilized black cohosh for many years without any untoward side-effect.
However, I never suggest that anyone take black cohosh daily, in any form, for an extended period of time without a break. I believe this to be true for most herbs, supplements, foods, beverages, etc. For chronic use, I prefer to make use of healing agents on a “course” basis – taking the substance daily in 2 or more doses for about 10 days. Then if it seems that the person and the herb are compatible I would usually opt for a dose given regularly 2 or more times a day for 4 – 5 days a week for 3 – 6 weeks and then taking a break of a couple weeks. I have seen liver enzyme changes, with no other overt symptoms, in clients who have taken various herbs and compounds on a regular basis for months at a time. I have also seen those liver enzyme changes reversed when these products are discontinued for a period of weeks. Thus I feel that a course of therapeutic agents may be better than chronic use. I would never purport that my experience is scientifically based.
Secondly, I have grave concerns about solvents used in many of the herbal products now available on the marketplace. Though I regard ethanol to generally be a suitable solvent with low toxicity when properly used, in the case of Eleutherococcus’ body of Russian literature, dogs that were administered 33% ethanol extracted Eleuthero had deleterious side effects. On further research, it was ascertained that the dogs were reacting to the ethanol. What about hexane and other commonly used herbal solvents? Even trace amounts of these, when taken repeatedly, can have significant adverse effects. Yet, there is little discussion regarding this.
An over-arching concern revolves around the abundance of poor science being manufactured. Over the past three decades, I have written and spoken to numerous people involved in herbal research around the world, pleading for more rigorous protocols to be used when researching botanicals. Most of the time when I read a scientific article, I am dismayed by the information that is not available regarding the product (macro-microscopic identifying details; times and places of growth and harvest; whether it was dried, fresh, etc.; exactly how it was further prepared including percentage of solvents, etc.) Due to the lack of this information, as well as other anomalies often present in research articles, such as lack of exact botanical nomenclature, misspellings and other obvious errors, I have continued to pull away from using scientific writings in my teachings, finding them untrustworthy and confusing.
The herbal network, for the most part, has empowered the scientific community in many ways. Instead I would like to see movement toward legitimate challenges, as noted above. More importantly, as herbalists we should be challenging science on their ethics. We could start with the torture of animals. An easy way to challenge them is to simply provide photographs and details of the way studies were carried out. This is what I did in my last years as botanical instructor at the naturopathic colleges. I didn’t need to go on a rant about inhumane rat paw edema studies proving the efficacy of calendula flower extracts on inflammation and infection. The students were outraged when I simply read them the protocols. However, the overall preference of naturopathy to embrace science while clamoring for validation, as well as the funding that comes to members of that “club”, has only escalated.
Unfortunately, any herbal “bad” press, no matter how unrigorous the science was, is flooded broadly and loudly. This makes for much confusion for health practitioners, manufacturers, consumers, teachers and students. Whether we would prefer to ignore it or not, those of us bridging the world of plants and people get pulled into the pseudoscience moat and must help dispel the continual churning out of the new herbal myths.
These are just some of the reasons why I am so adamantly opposed to following through with the creation of some sort of “traditional medicines” category. It simply further empowers arenas that simply don’t understand, and don’t see a need to understand, even the rudimentary basics of the herbal field, not to mention the power and importance of nature.
Thanks for sharing this release with us, Lynda.
Cascade Anderson Geller
On Jul 25, 2006, at 7:35 PM, Sara wrote:
Ditto Mindy. This is based on very inconclusive information. In Europe they look at herbs as drugs, and as such, are obliged to report any indication of a problem in order to alert people to the possibility so that more data is forthcoming. From my understanding, there is very little to support any liver toxicity with black cohosh. AHPA is undertaking a review/analysis of the reported cases.
On Jul 25, 2006, at 1:51 PM, Mindy Green wrote:
I assume you have seen the rebuttal from ABC? Overall, bogus. Check the website…
From: Lynda LeMole [mailto:email@example.com]
Sent: Tuesday, July 25, 2006 3:50 PM
To: Rosemary; Cascade Anderson Geller; Betzy; Nancy Scarzello; Mindy Green/Aveda; Gigi Stafne; SaraKatz
Subject: Black Cohosh label warning
What are your comments about this recent label warning for black cohosh? Lynda
Black cohosh raises liver concerns
The UK has joined Australia in requiring black cohosh products to carry label warnings after the Medicines and Healthcare products Regulatory Agency (MHRA) issued a statement expressing its concern about “links between black cohosh and the risk of liver disorders.”
The MHRA took advice from two expert committees that concluded liver damage was possible, if unlikely, from using the menopause-specialist herb. “In the light of this advice, the MHRA is working with the herbal sector to ensure that labels of black cohosh products carry updated safety warnings,” said MHRA Chief Executive Kent Woods. “The labels will point out the possible symptoms so that appropriate action can be taken without delay.”
Philip Routledge, chair of the Herbal Medicines Advisory Committee, said the association between black cohosh consumption and liver disorders was rare but “can be serious.”
The European Medicines Agency advised those taking black cohosh to cease and consult their doctor if liver damage symptoms developed, such as tiredness, loss of appetite, yellowing of the skin and eyes, severe upper stomach pain with nausea and vomiting or dark urine. It based its warning on a review by its Committee on Herbal Medicinal Products which found cases of hepatotoxicity in black cohosh users.
After a ruling by the Therapeutic Goods Administration earlier this year, black cohosh products sold in Australia are required to carry the following statement: “Warning: Black cohosh may harm the liver in some individuals. Use under the supervision of a healthcare professional.”
A 2004 US National Institutes of Health workshop on black cohosh safety concluded the evidence for liver toxicity risks from black cohosh “remains equivocal but certainly warrants continued monitoring.” The NIH added: “At this time, there is no known mechanism with biological plausibility that explains any hepatotoxic activity of black cohosh.”
Cheryl Thallon, managing director of supplements manufacturer Viridian, told Natural Products magazine that the response to black cohosh is disproportionate and unscientific. “It’s disproportionate because the reported cases are very few in number and not individually especially serious,” she said. “It’s unscientific because there is apparently no consideration given to the dose at which black cohosh becomes toxic – is it 1mg, 200mg or 1000mg?”
A study in the May/June issue of Menopause: The Journal of the North American Menopause Society found more than half of surveyed women believed herbal menopausal remedies such as black cohosh were a safer alternative to hormone therapy. Just under half said they wanted to use a “natural” product.
Black cohosh has been used as a North American Indian medicine for centuries and in Europe since the early 1800s.
Lynda E. LeMole
United Plant Savers