This blog continues at www.menopausetheblog.com.

Please visit me at www.menopausetheblog.com for continually updated content about menopause.

I’m now blogging at www.menopausetheblog.com

There is new content at www.menopausetheblog.com, where I will continue this blog going forward. Please visit me there!

About Bio-Identical Hormone Therapy – From the FDA

Note:  This Blog is now being published at www.menopausetheblog.com. Please visit and continue reading about Menopause there.

For an explanation of Bio-Identical Hormone Replacement Therapy (BHRT) — a term that the FDA does not recognize — and the issues that led to the FDA’s action this week against certain compounding pharmacies, see the agency’s latest update, “Bio-Identicals: Sorting Myths from Facts.” What is your point-of-view on BHRT. Has it made a difference for you?

Is the FDA Looking Out for Women or Wyeth?

Note: This Blog is now being published at www.menopausetheblog.com  Please visit and continue reading about Menopause at this new URL.

 

The FDA announced that it will be “cracking down” on pharmacies that sell customized hormone mixtures prescribed by physicians to alleviate menopause symptoms.   This is the latest move in an ongoing debate over the growing use of  “compounded” hormone products.  In 2006, The American Medical Association  passed a resolution concerning compounded hormones and the U.S. Senate circulated a copy of proposed draft legislation called the Safe Drug Compounding Act of 2007 , which opponents – namely the trade association of compounding pharmacists – said would give FDA “unprecedented” authority and greatly restrict access to compounded medications. (To see their response to the FDA’s latest action this week, click here.)  And finally, in 2006, Wyeth filed a petition with the FDA  asking the agency “to address the growing trends of unlawful manufacture and marketing of so-called bio-identical hormone replacement therapies (BHRTs).” Since Wyeth makes Premarin and PremPro, both made from the urine of pregnant mares and used in HRT, one could surmise that the company is asking the government to eliminate competition from plant-based hormones. The FDA denies a connection between their action this week and the Wyeth complaint, but it does raise the question – is the FDA looking out for women or the drug company?

Specifically, the FDA told seven individual pharmacies that they couldn’t sell hormone mixtures containing Estriol, an estrogen produced by the human body, that the agency views as a new drug that hasn’t been approved.  In addition, these pharmacies are to refrain from using the word “bio-identical” to describe the compounded mixtures. 

The interest in and increasing use of “bio identical” hormones has resulted from the fact that there are an estimated 6,000 women reaching menopause every day (according to the North American Menopause Society) and many are seeking natural alternatives to HRT given their potential hazards. 

Elizabeth Lee Vliet, M.D.is a physician who specializes in individualized hormone therapy and the author of several books including Women, Weight & Hormones, and  The Saavy Women’s Guide to Hormone Headlines.  She weighed in on this debate in an email that was sent today to subscribers of her newsletter. She offered, I believe, a balanced perspective on the issue.  Though she is a proponent of “proper use of compounded medications” she “applauds the FDA’s action” and stated her concern about unregulated “natural” hormone mixtures. “Many of these formulas advertised on pharmacy websites on the internet contain hormones that can have adverse effects, or doses that are potentially dangerous, she explained.”   

As someone who has considered using bio-identical hormones, I’m more confused than ever about their efficacy and safety. Whom should we trust to give us straight answers?  Dr. Vliet states that she is not paid by nor is she is any way affiliated with pharmaceutical companies or other advocacy groups, so I’ll be tuning in to her Blog Talk Radio program on Monday, Jan. 14^th  (9pm est), when she will talk about  “bio-identical hormones – sorting out myths and facts.” You can find details about this program on her website and at Blog Talk Radio. 

I’m interested in hearing from anyone who has used bio identical hormones. Have they worked for you?  

Power Surge + Hot Flash = Insomnia

It happens just about every night.  After reading for about a half hour, I’m finally sleepy and relaxed. I turn out the light and sink into my down pillows and high thread-count sheets. I’m just falling asleep when, wham – it happens. It feels like my body has been plugged into an electrical socket and… who turned up the heat?  I throw off the covers, grab my fan and contemplate another sleepless night ahead.  

I know I’m not alone.  I’ve spoken with many women who often experience this combination of a “power surge” and hot flash during the night and like me, are sleep deprived as a result.  Hot flashes are one of the first symptoms to appear in pre-menopausal women and they can last for as long as five years after the last menstrual cycle, according to a study conducted by Stanford University researchers that investigated the link between hot flashes and insomnia. The results of this study was published in the June 26, 2006 issue of Archives of Internal Medicine.  

In the Stanford study, 982 women aged 35 to 65 years were questioned about their sleep “dissatisfaction,” occurrences of hot flashes, and their menopausal status.  What I find particularly interesting is that the highest prevalence of hot flashes (79%) and chronic insomnia (56%) occurred among perimenopausal women – those who had had a period at least once in the previous 12 months. By contrast, the occurrence of hot flashes and insomnia in post menopausal women (defined as not having had a period in the previous 12 months) was 39 percent and 51% respectively.

The study concluded that “severe hot flashes are strongly associated with chronic insomnia in midlife women.”  

Exercise Doesn’t Alleviate Hot Flashes After All

Contrary to what we’ve read (and hoped was true), exercise is not a cure for hot flashes, according to a study whose results were just published in the January issue of Medicine & Science in Sports & Exercise.  Researchers had hoped to prove that exercise could be an alternative to HRT for women suffering from hot flashes.  They followed 380 women, average age 42, who walked between 15 minutes and 90 minutes daily for up to five times a week.  (At the beginning of the study, all of the women were not menopausal. By the end, more than half had experienced hot flashes).  The good news is that it’s apparent that even a low level of physical activity helps reduce anxiety and stress. The disappointing news is that like Black Cohosh, exercise doesn’t help hot flashes.

Recommended Reading: “Women, Weight and Hormones”

As we wind up the holiday season, and resolve to shed the pounds we’ve gained from all the over-eating, this seems to be a good time to talk about the connection between weight gain and menopause.  I’ve been reading Dr. Elizabeth Lee Vliet’s excellent book, “Women, Weight and Hormones,” in which she explains the crucial role that hormones play in keeping our bodies humming …until menopause, that is – when changing estrogen and progesterone levels cause a slowing of our metabolisms. 

Her big-picture approach – that is, looking at the entire endocrine system- is what I think makes this book so valuable.  After reading it, you’ll have a better understanding about why familiar diets don’t work for menopausal women trying to shed pounds (or “muffin top” as a friend recently referred to her new, middle bulge brought on by menopause). 

Dr. Vliet offers a thorough explanation about how chronic stress and sleep deprivation impedes our body’s ability to function optimally and why they are contributing factors to weight gain.  She also provides what she calls a “power plan” with advice on balancing hormones and maintaining a diet of frequent, small meals to keep glucose levels steady.  And if you’re baffled by the huge assortment of vitamins and over the counter supplements to choose from, Dr. Vliet explains what we need and which ones can help with weight loss. 

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Those Lucky Chimpanzees?

The intriguing headline on the Science Daily Website, “Male Chimpanzees Prefer Mating with Old Females,” is just too good to not to comment on.  Apparently, female Chimpanzees do not experience Menopause as humans do and as a result, older females were more likely to be approached for copulation.  What’s more, “they copulated more frequently with high-ranking males and gave rise to higher rates of male-on-male aggression in mating contests!”  Of course, we humans live long after our fertility stops, whereas Chimpanzees’ reproductive system declines in tandem with overall mortality.  I guess you can’t have it all.

A Second Try

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I came home from the naturopathic doctor with a shopping bag full of products to try.  Though I still have half-full containers of supplements prescribed by a nutritionist I consulted a year ago, I’m giving this approach a second try, albeit with different remedies that are intended for overall well-being, not just menopausal symptoms.  Hopefully, the saliva testing I went through helped the doctor pin-point exactly what I’d benefit from.  

The most intriguing product is something called “Sex Essentials” (you can see the ingredient label here), which claims to “increase libido, improve lubrication and promote overall well-being.” The doctor said there are good reports about it. But, frankly I’m afraid to take it!  The pre-dominant ingredient is L-Arginine Hydrochloride, which according to some articles I read, improves blood circulation and stimulates the release of growth hormone. I think I’ll pass on that one.

On the other hand, Remifemin is a well known product sold over the counter for alleviating hot flashes. Dr. Christine Northrup mentions it in her book, “The Wisdom of Menopause.”   It’s basically just Black Cohosh extract. I know there’s ongoing debate over whether it really works, but I’m willing to give it a try, since it does work for many women and I may get a good night sleep as a result.

What’s in a Name?

There’s something about the word Menopause that sounds…well, old.  I went to a BlogHer gathering a few days ago and while I’ve become accustomed to being one of the older people at any tech event here in San Francisco,  I felt particularly matronly as I told other, younger attendees, some of whom write “Mommy” blogs,  that I blog about Menopause.  “Wow, how interesting. I’ll tell my mother about it,” was the general response. Even I cringe when, at my husband’s prodding, I tell dinner guests what my blog is about. (Did they think that I was younger? Do they now see me as “over the hill?”) There’s always a pregnant pause in the conversation following that admission, followed by an uncomfortable, “that’s nice, Wendy.”

 

I’ve learned that “meno” comes from the Greek word meaning month (thus, menses and mentrual); the “pause” in the word is derived from the Latin, pausa, meaning to stop or cause to cease.  But in plain ‘ol English, menopause sounds like the combination of men and pause.  Not a good connotation.  Perhaps this is why it’s often referred to as “the big M,” “the change of life,” or simply, “the change,” and women avoid acknowledging it publicly, even while they’re perspiring  profusely, fanning themselves and wearing sleeveless shirts in the middle of winter.   Maybe the embarassement of being menopausal, or talking about it, would evaporate if there was a new, better word for it. Something that describes beauty, power, renewal and strength. Any ideas?