Black Cohosh in the news

A new study came out a few days ago that finds 160mg of powdered Black Cohosh (Cimicifuga / Actaea racemosa) root daily is ineffective for hot flash symptoms in peri- or post-menopausal women aged 45-55. And, or course, the media frenzy ensues: a quick Google News search reveals almost 400 reports with various defaming titles all claiming to show "proof" that this herb has no effect (my favorite: "Black Cohosh a Flash in the Pan for Menopause Symptoms". Who comes up with these amazing witticisms?)
A closer look at the study itself reveals a few interesting facts:

  • The material used: powdered herb (root, I most certainly hope, although even this is unclear). This is in contrast to the multiple studies (see below) that demonstrated Black Cohosh's effectiveness for the vasomotor symptoms associated with perimenopause: most of the previous research focused on hydroalcoholic extracts of the root, not powdered root.
  • The dose: 160mg (solo) to 200mg (in combination) daily, barely 1/5 of a gram. If an herbalist told me they were using this dose to help control hot flashes in one of their clients, I'd tell them to go back and study their phytopharmacology. Bottom line: this is a ridiculously small dose compared not only to previous modern research, but also to the tried-and-true experience of Eclectic physicians (see King's dispensatory) who recommend 1/2 to 2 drams (about 2 to 8 fluid ounces) of a 1:1 fluid extract, equivalent to about 2-8 grams (2,000mg to 8,000mg) of raw plant material! Who's doing the research for this new study? Where did they come up with the 160mg daily dose?
  • Although the study author kindly comments that "the trials did not simulate the whole person approach used by naturopathic physicians", this study doesn't even make an attempt to classify the types of women in the treatment group (other than by age and whether they were peri- or post-menopausal). Many other studies are more comprehensive in their analyses, and find that women with "excess estrogen" patterns earlier in life (defined by menstrual history and/or estrogen-dependent breast cancer) benefit much more from this botanical. Its weak estrogen receptor antagonism and its ability to block LH have been hypothesized as possible mechanisms of action (see studies below).
So in sum, another poorly-designed clinical trial receievs undue media hype. I will most certainly continue to grow and use Black Cohosh in my practice (and not only for hot flashes, which isn't even its most beneficial application). A couple of studies (one from Europe, the other from the Mayo clinic) are included below for further reading.



Animal models have some serious flaws

Medical research, whether focused on pharmaceutical or herbal medicines, often makes use of animal models in the initial phases of study. For many herbal remedies, animal studies are the only data (other than, of course, thousands of years of traditional and experiential knowledge) available to the scientific community, and often these data are used to dismiss phytomedicines as ineffective. In an article in the British Journal of Medicine, researchers identify potential shortcomings of the animal model in drug trials. It comes down to two main conclusions: first, animal studies are often methodologically flawed (not sure why this is, perhaps people pay less attention if only little mice are involved). Second, the animal model has serious predictive deficits and very often has no relevance to actual human therapeutics.
We can speculate endlessly as to why this may be. An interesting thought comes from the European Journal of Cancer: perhaps mice that are genetically engineered to produce "research cancers" exhibit tumors that are substantially different in morphology and behavior from those that develop slowly and naturally in humans (or in pet dogs, as was the focus of this study). These differences may account for the discrepancy between the artificial models and actual human beings. But regardless of the "why", the bottom line remains a challenge to the established phase I, II, III drug trial model. It should also be food for thought for herbalists who are relying on animal models for therapeutic data. And perhaps, if this challenge remains relevant, the entire medical community can start to think about different research strategies that don't involve torturing and killing animals...


The cholesterol conundrum

Pfizer has halted clinical trials of its new cholesterol medication, which was designed to increase HDL ("good") cholesterol levels in human blood. The hope: to get everyone on the planet to take a statin/torcetrapib combination and get everyone's cholesterol numbers into a "happy" testing range. Turns out the torcetrapib actually increases one's chances of dying. So Pfizer pulled the plug (at least they had the decency to do that, unlike Merck's Vioxx fiasco).
I have two main problems with the line of research pharmaceutical companies are pursuing regarding cholesterol. First off, why not consider a combination of herbal therapies, perhaps featuring Fenugreek (Trigonella faenum-graecum) along with other botanicals, which have not only been proven to lower LDL cholesterol, raise HDL, but also manage blood sugar, improve and soothe digestive function, and actually enhance life? Lack of patentability would be my first guess.
Secondly, the whole approach of attempting to alter serum levels of cholesterol and their lipoprotein packages seems like "teaching to the test" rather than trying to improve final outcomes. Sure, high cholesterol levels seem to be present when there is dangerous heart disease. But I haven't yet found conclusive evidence that there is a causal relationship between the two, and I am beginning to suspect that underlying cardiovascular inflammation is at the root of both conditions. It would seem that devising new drugs that are specific only for improving your cholesterol numbers on a blood test misses the point and can, apperently, be quite dangerous. My humble suggestion: if you and/or your doctor are concerned about high cholesterol levels, consider herbal therapy alongside nutritional intervention. There's a great track record out there, with no increased mortality risk.