[Image: Thomas L. Muller, The Lady Bird Johnson Wildflower Digital Image Library at the University of Texas, Austin]
I have written frequently about black cohosh on Flashfree. And consistently, the relationship between black cohosh and a decline in certain symptoms has been demonstrated in clinical trials. However, here’s the rub: both formulation and dose appears to matter.
About a year ago, findings from scientifically sound (i.e. randomized, controlled, double-blind) trial demonstrated that taking the higher dose formulation of a black cohosh extract (Ze 450) yielded greater benefits in terms of symptoms severity and quality of life in A group of menopausal women. However, what happens over the long term? Do symptoms reappear or do improvements continue? And, is it really true that dose matters?
In a follow up study, researchers selected over four hundred women with menopausal complaints who were seeing about 100 physicians in general and specialty practices. Initially, these women were treated with a high dose of black cohosh root extract (13 mg) for 3 months and either continued with that dosing for another 6 months or were told by their physician to take a smaller, 6.5 mg dose for 6 months. Overall, a majority of women had moderately severe symptoms (most commonly hot flashes, night sweats, insomnia, anxiety and depression) and about two thirds had received previous treatment for them. Importantly, none of the women taking concurrent hormone therapy were included in the final evaluation.
Over the course of 9 months, black cohosh extract significantly decreased symptom severity by roughly 56% as measured by a scientific menopause scale. More improvements continued to be seen over time, regardless of dose. However, almost 90% of women responded to the high dose extract versus 78% of women responding to the low dose; this suggests that greater benefit can be realized among greater numbers of women with a higher dose. Indeed, women taking the high dose, experienced improved relief of a variety of symptoms (e.g. hot flashes, sweating, dizziness, joint and muscle pain, etc) over time. Both doses were also well tolerated in about 95% of women, although the higher dose was associated with some gastro issues in 12 women).
Another interesting point about this study was that it was conducted in what researchers refer to an ambulatory setting, meaning that it was not a controlled trial situation. Because similar results were observed under controlled conditions, conducting the extension under a more realistic environment allowed them to draw the conclusion that the findings reflected those that would likely be seen in the general population.
The black cohosh extract used in these studies is called Cimefemin® uno (6.5 mg) and Cimefemin® forte (13 mg) and is not available in the States, at least not yet. Meanwhile, if you wish to try black cohosh, read through the archives, speak to your practitioner and used a standardized formulation. It looks like it’s a win-win.
That old black cohosh. Is it magic or not?
Investigators from the esteemed Cochrane Collaboration reviewed 16 studies enrolling 2,027 perimenopausal or postmenopausal women using oral black cohosh, a median 40 mg daily for at least 23 weeks. In no uncertain terms, the authors concluded that “there is currently insufficient evidence to support the use of black cohosh for menopausal symptoms. However, there is adequate justification for conducting further studies in this area,” and …”the effect of black cohosh on other important outcomes, such as health-related quality of life, sexuality, bone health, night sweats and cost effectiveness also warrants further investigation.”
The reasons for this conclusion were several-fold:
- There was a wide range of doses used in the studies examined, making comparisons difficult.
- Many studies reported data that could not be used for the purpose of the analysis.
- A number of different measures were used in the trials and few looked at the same outcome.
- A lack of complete reporting made it difficult to measure the effect of black cohosh on vaginal atrophy, health related quality of life, sexual dysfunction and bone health.
In other words, available data do not allow any definitive conclusions but they still think that the herb is worthy of further exploration.
Guess what? So do I!
The last time I wrote about black cohosh was in January. In that post, I pointed out that black cohosh formulations differ. Consequently, so do their effects. The good news? The compound is safe and as the Cochrane authors point out, any GI, muscle or tissue complaints are rare, mild and reversible.
Personally? I would say that the verdict is still out. In the words of that iconic song…that old black cohosh still got me in its spell. The same old flash that I feel inside. And when that elevator starts its ride, darling, down and down I go, round and round I go, like a leaf that’s caught the tide.I should stay away but what can I do. I feel the burn and I’m aflame, aflame with such a burning desire, that only black cohosh can put out the fire.
For me, only black cohosh can put out the fire. What about you?Read More
Love the first line of this editorial:
“Black cohosh preparations are not all the same.”
“Vigilance must be exercised when interpreting data.”
In other words, sometimes it appears that black cohosh is a significant and real alternative to hormones for battling hot flashes and even some other menopausal symptoms. And other times, it appears that it’s not. The reason? Product variability and dosage.
A bit of geek: you may recall that black cohosh is an herb from the buttercup family. Its scientific name is Cimicifuga racemosa. But, there are many different types (or species) of Cimicifuga and researchers say that when the continents split, these plants took different directions and ended up with distinct chemical compositions. Moreover, when they analyzed the products for certain active components, they found significant variability.
Add this to the fact that researchers studying black cohosh have used dosages ranging from 2.8 mg to 160 mg, and that these formulations were pure or were what they call “multibotanicals” (i.e. containing other herbs believed to be effective to qualm flashes and mood swings) and well, you have a veritable melting pot of clinical crap that defies logic. Add in a dash of more scientific geekdom know as a bell shaped response, in which low doses of a drug may be ineffective, moderate doses are effective and at higher doses, benefits disappear again, and well, it’s almost impossible to draw any firm conclusions.
Wow. Pretty scary, right?
The Menopause Industrial Complex will have you believe that the only effective preparations for ‘treating’ the disease they call menopause are pharmacological preparations manufactured by a large company and that has undergone rigorous, controlled scientific analysis. A lot of Western practitioners will have you believe that not only have herbs not be rigorously tested and studied under the same scientific conditions, but that they are downright ineffective and sometimes downright dangerous.
Both camps are incorrect. Because when you peruse the archives of the National Library of Medicine or esteemed journals like Maturitas or Menopause, you will find scientifically controlled evaluations of herbs. And, when researchers take the time to tease out data rather than drawing automatic conclusions (as the authors did in the piece I am referring to, which was published online in Maturitas at the end of December), they find that perhaps, the herbs are more effective than believed and that there are reasons for disparate results.
So, black cohosh, yay or nay?
Let’s get back to the original thought:
Black cohosh preparations are not all the same.
For me, a standardized extract that has undergone rigorous clinical study – Remifemin – works wonders. And I hear that it does for a lot of women. But not all women are the same either.
Don’t believe everything you read.
Happy New Year. Let’s approach this year as the year for opening our eyes and taking back our aging process.
Menopause? It’s not a disease and symptoms can be effectively and safely ameliorated with certain herbs. Just. Be. Vigilant.
Back in 2009, I wrote a post regarding black cohosh (better known in scientific circles as Cimicifuga racemosa) and potential safety issues, namely harm to the liver. In it, I discussed a small case review that showed no link between ingestion of black cohosh and liver toxicity. And yet, in 2006 the European Medicines Agency and the Committee on Herbal Medicinal Products released a public statement alerting health authorities to 42 suspected liver reactions among women taking black cohosh. In the very same report, they noted how inadequately adverse reactions were documented. Indeed, only 16 of the cases were considered to have sufficient data to allow for proper assessment of a potential link, and of these, only four showed any sort of association, albeit, unproven. Regardless, the statement resulted in Italian health authorities requesting a precautionary withdrawal of black cohosh preparations from the market, and UK authorities issuing strict label requirements and warnings.
Hence, I was intrigued when I ran across a detailed review of black cohosh safety, both from perspective of over 107 patient cases and of published study findings. Following is the lowdown:
- An Italian clinic regularly prescribed 500 mg or 1000 mg daily black cohosh, either alone or in combination with other herbs (e.g. soy isoflavones, red clover or alfalfa) for treatment of menopause symptoms and disorders (e.g. anxiety, depression, hot flashes and joint pain). None of these herbs were prescribed to women with previous cancer of the breast, ovaries, uterus or pituitary gland. Moreover, the researchers say that they had not received any reports of any sort of adverse event.
- Still, following the European health statement, they contacted 107 women in good health and in different phases of menopause, took blood samples, underwent clinical examination and participated in phone interviews to evaluate if they were still taking the herbs. Of these women, only five had chronic but benign liver disease and one, hepatitis.
The findings? Despite the four patients suffering from prior benign liver disease, there was no additional sign of liver problems nor altered laboratories indicating a worsening condition or a new condition. Nor were there any clinical signs of liver damage after a year of using high dosages of black cohosh.
The researchers who reviewed and examined patients as well as the published literature point out that the liver is central to metabolizing most drugs and hence, there is a potential for an adverse liver event from taking nearly every medication that involves liver metabolism. They note that a step-by-step examination is also necessary to rule out other causes of liver damage, including infection, alcohol use and related conditions. In so far as herbs go, they write that “it is very important before an official statement about any adverse reaction referred to an herb based product to know the brand, dose of substance assumed, type of extract [and] content of possible contaminants.” They go on to state that it is their opinion the statement could actually be used as proof that black cohosh liver toxicity is scarce because despite over a million doses used worldwide annually, there is not any fully proven case of liver toxicity. Moreover, they claim that black cohosh safety has already been established in over 3,800 participants in clinical trials. Their conclusion? black cohosh should be considered safe, at least in so far as liver toxicity goes.
What should you do?
If you wish to try black cohosh, speak to a licensed practitioner well versed in herbal medicines. Look for a standardized form to insure that the pills contain what they say they do. And if you start feeling poorly while taking black cohosh? Stop immediately and contact the person responsible for your care.
Black cohosh and liver toxicity. This one appears to be a bubble bursting worthy.Read More
I’m using this Bubble to burst a few illusions, such as hot flashes during menopause don’t actually last very long.
How about 10 years?!
Right now, one year for hot flashes to come and then go sounds pretty tempting, doesn’t it?
A few years ago, I wrote about a study in the journal Menopause that alluded to the fact that hot flashes were likely to last for five years or more. Just this week, I ran across another study in Obstetrics & Gynecology that adds another 5 years to the evidence. Yikes!
How long is long enough?
Clinical Guidelines suggest that hot flashes peak one year into menopause and for most women, last anywhere from six months to two years. So, why is popular opinion, if you will, being challenged in research circles?
Using data from the Penn Ovarian Aging Study, which followed and monitored women over a 13-year period, researchers evaluated moderate-to-severe hot flashes on average, every 9 months. The women did not report having hot flashes at the study’s start, but developed them between the first year and near the study’s end. During each assessment, interviews were conducted on overall health, height, weight, hip and waist measures were taken and blood samples collected (to evaluate hormone levels). Menopausal status was also delineated by five stages:
- premenopausal (regular menstrual periods)
- late premenopausal (cycle change of 7 days or more in either direction observed one time)
- early transition (change of 7 days or more observed at least twice in a row)
- late transition (three to 11 months without a menstrual cycle)
More than 90% of women in the study were pre or late premenopausal at the study’s start.
Unfortunately, the results of the study are not very promising. On average, the median duration of moderate to severe hot flashes was 10.2 years, with only 37% of women reporting that their hot flashes stopped during the study. However, researchers found a relationship between length of time and when hot flashes began. For example. hot flashes tended to last longer (i.e. more than 11 years) in women who reported their hot flashes started in the premenopausal or late premenopausal stage compared to women whose hot flashes began in the early transition (average 7 years) and late transition (average 4 years).
Age was also a factor as the median duration of hot flashes tended to be longest in women who started flashing before the age of 40. Most commonly, however, more than a third of women tended to have the worst flashes when they were between the ages of 45 and 49. Other factors such as African American race and a body mass index less than 30 were also associated with having hot flashes for longer periods of time.
If you are wondering about the silver lining in this story, there actually is one. The researchers say that it may be a good idea to start addressing vasomotor symptoms like hot flashes in younger women who are starting to have irregular menstrual periods. Because “traditional hormonal therapy may not be the ideal choice for this population, given, for example, the problems with breakthrough bleeding and the need for contraception,” other treatments need to be evaluated.
I’ve long espoused the value of taking steps to shut symptoms down sooner rather than later, which is why alternative strategies may be so useful. If duration of hot flashes last longer when they start a younger age, and it is recommended that hormonal therapy be used for the shortest period of time possible, it’s not a bad idea to speak to a health practitioner about incorporating things like black cohosh into a daily routine. As always, there’s no time like the present to start taking charge of your health and get ahead of the change.Read More