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 MoreBioidenti what?
Bioidentical hormones (also known in many circles as “compounded biodentical hormones”) are compounds that have exactly the same chemical and molecular structure as hormones produced in the human body. The term is most often used in the context of estrogen and progesterone (and androgens), although any hormone can be made this way. Notably, there are a few of these agents that are actually FDA-regulated and available from retail and not compounding pharmacies (meaning that dosage and purity are theoretically on par with synthetic types).
There’s been a lot of hullaballoo over these products from many of the major associations that are involved in women’s health (e.g. The Endocrine Society, North American Menopause Society) primarily because: 1) they are not regulated by the FDA or have any oversight whatsoever and 2) potency is inconsistent. In fact, the FDA sent warning letters to nine pharmacies in January due to what the agency felt were unsupported claims about safety and effectiveness.
FDA does not just randomly go after pharmacists who practice traditional compounding and who don’t make false claims about their products. Traditional compounding, in fact, involves the preparation of a drug for a specific patient based on a doctor’s request.
Consequently, FDA action might have been driven, in party, by Wyeth Pharmaceuticals, who filed a Citizens Petition that claimed: 1 that compounding pharmacies were not actually compounding but “manufacturing” mimics of approved agents; 2) that they used a form of estrogen known as “estradiol” not commonly found in “traditional” hormone therapies; 3) that they were engaging in illegal promotional practices. (BTW, Wyeth manufactures several estrogen products, including Premarin, Prempro, and Premphase.) You can read the rest of the petition here.
It’s important to recognize that not all compounded products are bad. In fact, compounding pharmacies continue to provide options to patients with contraindications to commercially-produced therapies. An article in a large monograph sponsored by the North American Menopause Society explains that pharmacies were compounding micronized progesterone years before an agent (Prometrium) was approved in the US. It also goes on to highlight several advantages that 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.
Organizations such as the International Academy of Compounding Pharmacists (IACP) have become quite outspoken about what they consider to be the FDA’s interference in physician decisions to prescribe estriol to their patients. Congress has even introduced a bipartisan-sponsored bill (Resolution 342) to reverse the FDA’s decision on estriol. There’s a website that further explains these efforts.
In the meantime, if you decide you want to try bioidentical hormones, speak to your health practitioner. S/he can devise a regimen that best meets your needs (and not the needs of the masses) and may be able to recommend a credible compounding pharmacy. The IACP might also be able to assist with your search.
Read MoreHRT Personalized?
Have you heard of personalized medicine? This burgeoning movement in healthcare focuses on the individual and not the masses and relies on our unique biological and genetic profiles to guide therapy choice.
With all the hullabaloo over hormone replacement therapy (HRT), mixed data about risks and benefits and a lack of a clear path for women who choose to go this route, personalized medicine might hold the answer. In fact, in an online review in Metabolism, authors are exploring the very idea that some women may be more ideally suited than others for hormone therapy. Personalized medicine may also make it possible to tailor dosing, formulation and even route of delivery to make the benefit-risk ratio, which we know has been swinging toward the negative, more balanced and favourable.
Although a recent report has come out disputing the role of hormone therapy in increasing risk for heart issues, data from the Women’s Health Study showed that compared to placebo, women who took combination hormones were 24% more likely to develop heart disease (i.e. heart attack or coronary death), up to 40% liklier to have a stroke and twice as likely to develop a blood clot in the lungs. Women who took estrogen only had almost a 40% increased risk for stroke and a trend towards an increased risk for developing a clot in the arteries leading to the lungs. Yet, these results might not be applicable to all as research suggests that factors such as age, time since the onset of menopause, LDL and other cholesterol levels and the presence or absence of metabolic disease may be able to help identify women who are better versus worse candidates for HRT (and likely or less likely to have elevated risk). Moreover, emerging evidence suggests that women who already have an elevated risk for stroke should either avoid systemic hormone therapy or choose a safer delivery method, e.g., a transdermal (through the skin).
A number of experts believe that using lower doses of hormones, bioidentical compounds, and going the transdermal route may very well change the benefit/risk ratio as well, primarily due to reduce blood levels of circulating hormones or as with transdermals, the fact that the drug doesn’t pass through the liver. In some cases, however, the data are scant and randomized clinical trial evidence, also referred to in medical circles as evidenced-based medicine, may be lacking. Still, I do believe that personalized medicine may hold the key for millions of women who can’t find relief through alternative strategies or simply desire more immediate relief. Perhaps some of these very factors that researchers are exploring will remove some of the roadblocks. Meanwhile, pay attention to the variety of factors that may the golden ticket — factors like age, time since menopause, heart health, existing breast cancer risk, biomarkers in the blood and genetic predisposition. Who knows? HRT personalized might be just around the corner.
Read MoreWednesday Bubble: diabetes and the ‘pause
When I saw a post on my Facebook stream linking hormonal imbalance to diabetes, I become intrigued, ever more so when I ran across the following headline in my daily newsfeed:
“Does menopause matter when it comes to diabetes?”
So, does it or doesn’t it?
According to the first piece that resides on the website of the hormone franchise, BodyLogic MD, imbalances of hormones other than insulin can promote insulin imbalances or resistance that is especially evident during menopause. Their hypothesis? Hormone replacement will correct these imbalances and prevent millions of women from developing diabetes.
In fact, there is evidence that as endogenous androgen levels rise and estrogen levels fall, there is a predisposition to glucose intolerance (i.e. a struggle to convert blood sugar or glucose into energy) and by default, diabetes. Moreover, estrogen therapy has been shown to reduce fasting blood glucose levels in menopausal women (fasting blood glucose or sugar measures glucose levels in the bloodstream and is a test for pre- and full blown diabetes). However, it is unknown if menopause itself is associated with high glucose levels or plays a role in influencing factors such as insulin secretion and insulin resistance that mediate glucose tolerance. Nevertheless, it is possible that menopause status may tip the scales in women who are already at high risk for diabetes or even influence activities undertaken to prevent the condition.
In a soon to be published study (August issue, Menopause journal), researchers compared perimenopausal women to women who had entered menopause naturally and those who had had their ovaries removed. All participants were between the ages of 45 and 58, and part of a larger Diabetes Prevention Program trial, meaning that they already had been diagnosed with having impaired glucose tolerance and fasting glucose levels and were at risk for diabetes. Of the 1,237 women studied, they had either been assigned twice daily diabetes medication (Metformin), twice-daily placebo tablet or an intensive lifestyle intervention to achieve and maintain a weight reduction of at least 7% (through a low-calorie, low-fat diet, and at least 150 minutes moderate physical activity weekly).
Read MoreFeeling like a ‘raging maniac?’ There’s a Facebook app for that!
Truly, I am appalled.
BodyLogicMD, a national network of physician-owned practices that specialize in biodentical hormone replacement therapy, wants you to ‘Rate the Raging Maniac‘ in your life. (Note: you have to “like” the Facebook page in order in play.)
According to Vice President for Marketing, Jill Swartz “With the Raging Maniac Quiz on Facebook, we’re able to poke fun at the otherwise serious symptoms of hormon conditions like perimenopause, menopause and thyroid imbalances. This is a playful quiz we think people will have a great time socializing with.”
Okay. Let me get this straight.
Waning estrogen is wreaking havoc on your moods, causing swings, depression, anxiety, anger and short temper. You feel miserable and perhaps you are making your partner, friends or colleagues a wee bit miserable too. Or, you have a friend who’s hormonal swings are making her into ‘Bitchy Betty.’
The answer?
Visit the Facebook BodyLogic page, play ‘Rate the Raging Maniac,’ and up your social status by determining if you or your friend is “Hormonally Happy,” “A Mild Maniac,” or a “Raging Maniac.” Better yet, Raging Maniac allows you to select a friend to play with and after the results are in, you can post them results to your friend’s wall. Game on! She can take the quiz to see if you are a raging maniac too.
Guess what BodyLogic?
I don’t know one woman who wants to be rated as a raging maniac, publicly or otherwise. I don’t know any friends, colleagues, or intimate partners who would be so insensitive to rate people in their lives as raging maniacs or those ridiculous quirky character pseudonyms that your marketing folks have come up with, characters like “Sexi Lexi,” “Forgetful Fran” or “Negative Nancy.” I don’t know who your social marketing person is but you may want to think about replacing them with someone who understands women.
In the interim, one can only surmise that if you’re deemed a Raging Maniac, well, then, you need to contact one of BodyLogicMD’s physicians and get that prescription for biodentical hormones pronto!
Or is that the booby prize?
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