It’s all in the spin
I’d like to believe that researchers have patients’ best interest at heart but an article in this month’s British Medical Journal’s Drug and Therapeutic Bulletin has led me to believe that objectivity can be difficult.
The piece, entitled “Herbal medicine for menopausal symptoms,” positions itself as a review of the effectiveness and safety of herbal medicines commonly used for relief of vasomotor symptoms, including hot flashes and night sweats. The herbs covered within the piece include black cohosh, red clover, dong quai, evening primrose, ginseng, and briefly wild yam, chaste tree, hops, sage leaf and kava kava.
However, within the first two paragraphs, it becomes abundantly clear that the review is aimed at attacking the validity of so-called “alternative” therapies and consequently, attempts to provide the evidence that does so.
The author correctly points out that the consumer might automatically deem such products safe since they are natural, and that many products on the shelves do not comply with good manufacturing standards. In fact, I’ve written on these very essential considerations.
However, s/he blatantly (and incorrectly) states that “there has been a lack of studies of herbal medicines for menopausal symptoms,” emphasizing in particular (but not defining) the following: faults in study design, number of participants and length of study. The author also criticizes the use of traditional herbal systems (e.g., Traditional Chinese Medicine), which s/he says has little published research that supports its use in treatment of menopausal symptoms.
Although I did not review each study individually, I would like to point out that the author’s claim of a lack of published studies can be easily disputed. Using the search term:
- “Herbal medicine for menopause,” I pulled 6 pages (104 studies) of scientifically-designed, herbal medicine trials on the National Institute of Medicine’s Pub med database
- With the term “black cohosh,” I pulled 20 pages or 431 studies
- With the term “red clover,” I found an additional 76 studies
- Ginseng and menopause – 20 studies
- Traditional Chinese medicine and menopause – 47 studies
- Dong Quai – 24 studies
- Evening Primrose – 25 studies
Notably, I did not search databases that specialize specifically in complementary therapies or more importantly, the Traditional Chinese Medicine database.
The gist of the data cited within the DTB Review suggest that save for black cohosh, there is little or no evidence to support the utility or effectiveness of herbal medicines for relief of menopausal symptoms. Claiming that the “efficacy and safety of such products is under researched and information on potentially-significant herb-drug interactions is limited,” the author urges healthcare professionals to routinely ask their female patients if they are using such preparations.
A few bones to pick:
1) The author has reviewed only 8 trials on black cohosh, one meta-analysis of 30 trials on red clover, 1 trial of don quai, 1 trial in evening primrose, and 1 trial of ginseng. Yet, ten minutes on Pub Med revealed over 700 published trials.
2)The author has provided no indication of which database(s) s/he searched, which begs the question, is the identification of well-designed trials with ample numbers of participants been thoroughly conducted? What’s more, definitions of “well-designed” or “ample numbers” are not addressed within the entire review, leading one to believe that this assessment is subjective.
Give me a well-designed, well-defined review of the evidence and let’s talk. Think about the following and let’s have an intelligent dialogue. And in the interim, check out the topics in this blog. I think that you’ll find plenty of evidence to support the utility and safety of alternative therapies to address menopausal symptoms.
It’s all in the spin, isn’t it?
What do you think?
Read MoreOne-stop shopping
I recently ran across a press release for Menersa™, Vitaloix Labs’ neutraceutical that the company says addresses 34 common symptoms of menopause, including:
- weight gain
- hot flashes
- night sweats
- mood swings
- vaginal dryness
- urinary changes
- loss of sex drive
Wow! One pill that does ALL THAT. Company spokesperson Janice Greenberg, also says that “evidence suggests that it (Menersa™) is comparable to low-dose estradiol for relieving hot flashes.”
So, what is in this wonder “drug” anyhow?
According to the product website, Menersa™ is a combination of phytoestrogens, black cohosh, soy isoflavones and other natural ingredients.
I want to believe
Truly, I do. But if anything, science and medicine has proven that one size rarely fits all. What’s more, the company cites clinical studies that back their efficacy claims and yet the only thing on the web is a one-pager on the supplement that contains a description, testimonials and an order form.
As regular readers of this blog knows, I am a huge fan of herbal and alternative approaches to addressing menopausal symptoms. However, I am also a stickler for data that supports any claims.
So, Vitaloix. Show me the data. And if it does what it says it does, I’ll be an enduring fan.
Any of you try Menersa™ yet? Tell me about the product.
Read MoreThe Great Pretender
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Back in June, I wrote a post about the dangers of buying herbs for menopause right off the shelves. Consumerlabs.com is now reporting that testing shows great variation in the amount and quality of herbal menopausal products., including supplements containing black cohosh, soy isoflavones, red clover isoflavones and also, progesterone creams.
For example:
- One supplement contained only 30% isoflavones despite a guarantee and another, only 65% of a specific type.
- Two products failed to comply with FDA labeling that require detailed information on plant parts used as ingredients.
- Lead contamination was found in one product.
On a more positive note, ConsumerLab found that seven soy isoflavone products met their quality standards and provided at least 50 mg to 70 mg total soy isoflavones, which is the amount research has associated with relieving hot flashes. Additionally,
- Two red clover isoflavone products contained the correct amount (40 mg) associated with hot flash reduction.
- Six black cohosh products met quality standards.
- The progesterone creams tests provided the listed amount of progesterone, which ranged from 15 to 21 mg per gm.
You can read more about the tests at the company website.
So, what’s the take-away message from this research?
As Ellen Stern mentioned during our interview a few months ago, it’s critical to look for standardized herbs, meaning that they have undergone rigorous manufacturing practice and protocols to insure quality. She also recommended that search for “standardized x extract” on the American Botanical Council website. Finally a simple rule of thumb is that the least expensive product is not always going to be the best choice.
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My Dream: West Meets East…Someday
In 2005, a panel convened by the National Institutes of Health issued a statement emphasizing that menopause is not a disease. Yet, only yesterday, I ran across a newly-issued primer on menopause that is geared towards primary care physicians. In the introductory paragraph, I found the following statement:
“Managing menopausal health requires an ongoing effort to keep up with date with data on medical management of menopausal symptoms and treatments designed to prevent a number of disabling conditions associated with menopause and aging…”
Delving deeper, I found only eight paragraphs devoted to alternative therapies (namely, phytogestrogens, black cohosh and bioidentical hormones). What jumps out on the one full page on which they are reviewed are statements such as:
“…controversy regarding long-term safety issues.” (black cohosh)
“…these same hormones are used in less expensive, FDA-approved estrogen products.” (bioidentical hormones)
“…evidence to date suggests that phytoestrogens do not ameliorate hot flushes or other menopausal symptoms. In addition there are not data to support the safety of long-term therapy with phytoestrogens and other herbal medications.” (phytoestrogens).
I’ve got a few bones to pick.
- Historically, controlled studies with herbal preparations have been underfunded and undersupported by national institutions in this country, which is why the Western practitioner often claims “scant evidence.” Yet, if you do a search on alternative therapies on PubMed, there appears to be a growing interest in their utility and an increasing amount of time and resources devoted to studying them. Studies are published regularly in peer-reviewed journals such as Menopause. I’ve blogged about controlled evidence on a regular basis for months now. And, even the Nationa l Institutes of Health is in on the act; with trials currently underway evaluating the role of meditation, soy estrogens, herbal alternatives (e.g. black cohosh, red clover) for menopausal symptoms.
- The controversy over long-term safety issues and black cohosh is being seriously addressed. I blogged about this only a week ago, noting that the National Institutes of Health Office of Dietary Supplements has publicly stated that millions of individuals have safely used black cohosh with no ill effects.
- The North American Menopause Society-sponsored monograph highlights several advantages that bioidentical/compounded hormones might offer over conventional products, including greater dosing flexibility, lower doses for women who are especially sensitive and the avoidance of potential allergens.
The primer to which I refer was developed specifically to help primary care physicians understand the challenges that their menopausal patients face so that they can provide better care. However, the monograph does a great disservice by its sole emphasis on Western medical approaches verses Eastern whole-body approaches.
Physicians- if you’re listening, hear this:
MENOPAUSE IS NOT A DISEASE AND SHOULDN’T BE TREATED OR APPROACHED AS ONE.
A few thoughts:
- Please review your data, read alternative peer-reviewed journals and educate yourselves about alternatives for your patients who have been scared off by the negative findings surrounding HRT and antidepressants and other pharmaceuticals.
- Pay attention to the fact that well-respected journals such as Menopause and Climacteric and the Journal of the British Menopause Society actually devote pages to alternative therapies that have been evaluated in well-controlled studies.
- Embrace multidisciplinary collaboration and invite educated and credentialled alternative practitioners into your fold who might be able to offer you and your patients important solutions when Western ways fail.
Over 5,000 women enter menopause daily. Many of these women are going to call on your for help with managing this very natural transition that we call the menopause. Why not take a moment and meet the challenge without pigeonholing it?
Thoughts anyone?
Read MoreThat Old Black Magic
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Remember black cohosh? That wonderful herb in the buttercup family of plants that is commonly used to address hot flashes, mood swings, night sweats and other vasomotor symptoms? Black cohosh has been used in traditional folk medicine for centuries and was introduced to the settlers by Native American Indians, who incorporated the herb into their traditional medicines for women’s ailments.
I’ve discussed the utility of black cohosh for sleep and other disturbances in a previous post.
Personally, I’ve been using a standardized black cohosh formulation in combination with some Chinese herbs, (as recommended by acupuncturist and Chinese medicine specialist Elaine Stern) with great success for many months now. Hence, I am a huge fan. And in my book it is that ‘old black magic.” Still, I believe that it’s important to address warnings that link black cohosh to liver damage. Here’s what you need to know:
Based on recent statements that have been recently issued in Australia and the United Kingdom, The U.S. Pharmacopeia’s Council of Experts extensively analyzed data from 30 case reports, side effects reports and other sources to evaluate the association between black cohosh and liver damage. They concluded that there was enough evidence from case reports to suggest a possible link and proposed that a cautionary statement be included on manufacturer labeling.
So, what’s the bottom line? Overall, there are been few reports of liver damage but they have provoked enough concern to raise a red flag amongst several regulatory agencies worldwide. Here, the U.S, the National Institutes of Health Office of Dietary Supplements says that millions of people have safely used black cohosh without any apparent negative health effects.
As always, if you choose to go the herbal route, speak to an health professional who is well-versed in herbal medicine first. Try to select standardized formulation (it usually says it right on the label), which can help to insure that optimal and safe manufacturing processes have been followed and that you’re getting a pure form of the herb. Finally, be aware of potential side effects. In addition to liver damage, black cohosh has been linked with headache, dizziness, visual disturbance, constipation and intestinal discomfort, mostly at higher than recommended doses. Finally, remember that herbal medicine is medicine, and like Western preparations, requires vigilence, common sense, and can result in adverse effects if not used correctly.
Read MoreWednesday Bubble
I’m starting a new feature on Flashfree called the Wednesday Bubble. Every Wednesday, I plan to shed light on a popular misconception about a menopausal treatment or symptom, discuss research that proves or disproves a theory or simply highlight an important thought for hump day.
Onto today’s bubble!
In a recent post, I posted evidence debunking the beneficial effects of HRT with regard to pain during intercourse. Now, a Chinese herbal preparation has been shown to be ineffective.
Researchers from the Chinese University of Hong Kong have confirmed that the Chinese medicine herbal preparation, Dang Gui Buxue Tang (which contains the herbs Dang Gui and Huang Qi), has little effect on menopausal vasomotor symptoms such as hot flashes and night sweats.
Chinese herbal medicines containing Dang Gui and Huang Qi are commonly used in China for menopausal symptoms. Neither preparation has undergone rigorous Western testing for efficacy or safety.
Over a 6-month period, 100 women with acute menopausal symptoms took either Dang Gui Buxue Tang or placebo. The researchers found no difference in the frequency of mild, moderate or severe hot flashes between the study groups. In fact, Dang Gui Buxue Tang was found to be superior to placebo only for mild hot flashes. The researchers concluded that while Dang Gui Buxue Tang may be perceived as being beneficial for treating vasomotor symptoms, it is actually no better than placebo.
The placebo effect has been studied far and wide. Recently, it was attributed to the brain’s expectation of a future reward, meaning that if you think it, it will be. The findings of this particular study were interesting because the researchers actually expected these results. Keep in mind, however, that there are plenty of Chinese herbal medicine preparations that proving to be useful for menopausal symptoms. The most important consideration is that if you are considering using Chinese herbal medicine, consider the source. This means that you should consult a licensed practitioner and be sure any preparation you use is targeted for you and not simply purchased off the shelf or online without some sort of directive.
I want to hear from you. Let me know how you feel about the Wednesday Bubble. And if you have an idea for one, be sure to email me and let me know!
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