“All menopausal symptoms can be prevented or improved with a healthful lifestyle. One thing you can do is critique your caloric consumption and quit consuming crap!”

Last week, I attended the annual conference of the North American Menopause Society (NAMS), where 1500 attendees – physicians and scientists– gathered to hear the latest research findings concerning women’s health in midlife. The conference began appropriately with a full day devoted to hormone therapy:  what is known about the risks and benefits; the safety and impact of different delivery methods (transdermal vs. oral); the effects of
estrogen on mood and memory; and a look at the myths and facts about Bioidenticals.

Research presentations on subsequent days covered a wide range of health concerns including the possible link between hot flashes and cardiovascular disease; vaginal health, and hormone-free remedies for hot-flashes.  In the next few weeks, I’ll be sharing what I learned from these presentations as well as my conversations with physicians. For now, here are some of my initial take-aways:

1. Mention bio-identicals to 1500 gynecologists, as Dr. JoAnn Pinkerton, Director of the Midlife Health Center, University of Virginia, did in her presentation and you’ll hear a loud, collective groan. Suzanne Sommers and even Oprah continue to be a flash point for this group. Many of their patients want what they have without really knowing what it is they’re asking for.
2. “Adrenal fatigue” gets the same response. “It’s not a medical term,” Dr. Pinkerton explained to me. “Adrenal insufficiency, on the other hand, is a diagnosable condition that you can test for. Often, she told me, her patients self-diagnose their “constellation of conditions” such as fatigue, lethargy, and cravings for sweets, as adrenal fatigue, based on what they’re reading on the internet or in popular books.
3. There was lots of talk about vaginas:  happy ones and sad, dry ones too.  Apparently, too many 50+ women are not having sex due to the pain.  There are solutions. More on that in a future blogpost.
4. Women are at higher risk for depression than men and most vulnerable during times of hormonal fluctuations such as PMS, Peri-menopause and the early transition into menopause. In recent studies on menopause-related depression, transdermal Estradiol therapy proved to be helpful in women during the peri-menopausal phase or early post-menopause.
5. Hot flashes –  When it comes to Vasomotor research, the go-to person in this country is Rebecca Thurston Ph.D., an impressive scientist at the University of Pittsburgh, who is young enough to never have experienced one herself.  She’s investigating a potential link between hot flashes and cardio-vascular disease and if our BMI score influences the severity of hot flashes.  I spoke with her about her research and I’ll summarize what I learned in a separate blogpost.
6. There was a lively debate over whether hormone therapy, with its proven benefits for bone and vaginal health, should be recommended to women who don’t have symptoms. The arguments were compelling on both sides but the case made in favor of this approach prevailed by a hair. (so the debate doesn’t end here.)
7. The safety of estrogen is a point of contention between oncologists and gynecologists. To the former, who treat breast cancer patients, Estrogen is “the devil.”  To the latter group, it enhances a woman’s quality of life,  maintains their vaginal health (and thus their sex lives) during cancer treatments, and offers protection against  osteoporosis, if the latest research holds up.  Unfortunately, breast cancer patients find themselves  caught between conflicting recommendations.
8. More women die of cardiovascular disease than cancer yet more than 90% of the cases are preventable. Lifestyle factors such as diet, daily exercise, and getting enough sleep, can have a huge impact in the prevention of CV disease and diabetes, said Dr. Lori J. Mosca, Director of Preventive Cardiology at Columbia University.
9. Many women are taking too much Calcium, the result of overlapping doses among all the supplements they ingest. “More is not better,” said Dr. Steve Harris, an endocrinologist at University of California, San Francisco. He told the conference that the recommended dose is usually 1000-1200 mg per day, with an upper limit at 2,000 mg/day.
10. Finally, according to Dr. Patricia Sulak, Medical Director, Department of Obstetrics & Gynecology at Texas A&M College of Medicine, all menopausal symptoms can be prevented or improved with a healthful lifestyle. Her advice?  ”Critique your caloric consumption and quit consuming crap!”

In this study of 248 women ages 45 to 60, half were were given 200 milligrams of soy isoflavones daily (a much bigger dose than you or I would ever consume) and the other half were given a placebo.  At the outset, nearly all complained of the most common menopausal symptoms; hot flashes, night sweats, insomnia, loss of libido and vaginal dryness.

After two years, the study participants were tested for changes in bone mineral density and in menopausal symptoms. Despite the large dose of soy isoflavones, researchers found no difference in the rates of bone loss between the two groups.  There also was no significant change in other symptoms such as hot flashes.  In fact, by the end of the study, more women in the soy group reported hot flashes compared to the placebo group, 48 percent to 32 percent. Moreover, almost all of the participants (those taking the soy tablets as well as the placebo) reported adverse effects such as constipation, bloating and vaginal bleeding.

Many women who fear hormone therapy, or just want to try natural remedies, turn to soy tablets or a diet heavy in soy, thinking that it will prevent the common symptoms of menopause.  But this study showed that soy isoflavones are too weak an estrogen to make a difference. “Soy supplements can’t be considered a remedy for menopausal symptoms or prevention of bone loss,”  Nancy Strickman-Stein Ph.D., the epidemiologist and analyst for the study told me today. “Women will need to reach out to more traditional modalities to prevent bone loss and hot flashes, including the use of FDA approved drugs and exercise.”

While waiting for my physician, I saw a new wall display containing a collection of ten brochures on a wide range of health topics, including menopause. Branded as “Healthy Advice,” it acknowledged “the generous sponsors who support this educational program.” I was already skeptical but curious.  I picked up the booklet on Menopause and turned to the back page to confirm who I thought the sponsor would be. Pfizer. Yes! I knew it.  They are the makers of the hormone therapy replacement drug, Prempro, which contains estrogens from horse urine and Progestin, a synthetic form of Progesterone.  Inside, under “latest findings,” the authors caution us against using soy to ease menopause symptoms because “the benefits are still questionable.”  They also caution us against trying a vitamin, supplement or other natural product to help with symptoms since “some of these may make things worse.” The brochure also advises patients on hormone therapy to “take the smallest dose that works for you for the shortest amount of time. This helps lessen the risks.”

Those hormone replacement therapy risks, barely alluded to in the sponsored brochure, were explained in greater detail today in front-page news stories about the results of an 8-year follow-up study of nearly 13,000 women who participated in the federally financed Women’s Health Initiative (WHI). That study was halted in 2002, three years ahead of schedule, when researchers saw that the hormones were causing an increased risk of breast cancer, strokes and blood clots in the lungs.  This is the first report from the WHI that includes death rates from breast cancer related to hormone use.

Researchers concluded that Prempro, already linked to higher breast cancer and heart disease rates, was tied to increase mortality from tumors. In other words, women who took hormones after menopause and developed breast cancer were more likely to die from the disease than breast cancer patients who had never taken hormones. The study’s lead researcher, Dr. Rowan T. Chlebowski, an oncologist who treats breast cancer patients at the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, pointed out that today’s assumption that women can safely take hormones for four or five years for menopause symptoms, like hot flashes and night sweats, is no longer valid.  As quoted in the New York Times today, he added, “I don’t think you can say that now. I know some people have to take it because they can’t function, but the message now is that you really should try to stop after a year or two.” He told the reporter, Denise Grady, that it is not known whether there is any length of time for which these hormones can be taken without increasing breast cancer risk.

In an editorial accompanying an article about the study’s results in The Journal of the American Medical Association, Dr. Peter Bach, a physician at Memorial Sloan Kettering Cancer Center in New York wrote; “If you care about preventing this disease and keeping women from suffering and dying from it, then it’s hard to look at these drugs and not have serious concerns about them being used, even for what are intended to be relatively short periods of time.”

Back to my doctor’s examination room and the educational brochures from Healthy Advice, a company that offers drug makers a way to deliver patient education and brand messages in more than 21,000 primary care physicians’ exam rooms. They claim on their website that the brochures result in “a better-educated” and “more compliant” patient with an average new prescription lift of 10.24%.  So, the pharmaceutical companies are now able to leap-frog the traditional sales pitch to doctors and bring their messages directly into the examination room where doctors can be their ambassadors in creating awareness and demand for their products.  It’s a reminder that we should always investigate the source of the “advice” we are receiving, even if it is from our own physician’s office.

• The Women’s Health Initiative Study, the largest government-financed study of women’s health that linked hormone use with health problems, was deeply flawed. As one doctor put it, they tested “the wrong drugs” on the “wrong population.”  The study used estrogens made from the urine of a pregnant mare (sold as Premarin and Prempro by Wyeth) and enrolled women whose average age was 63 – a good ten years after their final menstrual period.  In short, the study wasn’t designed to answer the question of hormone safety in women just entering menopause.

• The estrogen used in transdermal patches (e.g. Vivelle-dot, Climara) is different from the estrogen used in the WHI study. As the author explains, “pharmaceutical estradiol comes from plants whose molecules have been “tweaked”  in labs until they are atom for atom identical to human estradiol, the most prominent of the estrogens pre-menopausal women produce naturally on their own.”  As Gorney further clarified online; “although there’s nothing that proves Premarin carries more risk, estradiol was the form preferred by all the researchers I talked to who either use estrogen or said (esp if they were men) that they’d have no problem using it.”

• The author reports that researchers are focusing on what they refer to as the “timing hypothesis – the proposition that estrogen could bring great benefit to a woman who start it in her 50s while having the reverse effect on a woman 10 years older.” Gorney writes that though this “timing hypothesis” is still experimental, scientists know there are ways estrogen improves and protects the brain when it is added to healthy tissue.  But the converse is true too. If estrogen is given to brain cells that are aged or otherwise damaged, it appears useless and can even be harmful. That is why the WHI also reported that hormones increase the risk for aging-related dementia. (remember, many of the test participants were aged 65 when they started the hormones).

• There is such a thing as “perimenopausal depression,” that can be set off by “ricocheting hormones.” Doctors seem quick to prescribe anti-depressants when often estrogen replacement will correct the hormone fluctuations that are causing the sudden onset of depression.

If you are considering whether or when to take hormones to alleviate perimenopausal symptoms including depression, sleep disorders, hot flashes and lack of focus or concentration, be sure to read this article for an explanation of HRT today.  You’ll be more informed and able to make a decision based on facts and unbiased thinking thanks to the reporting of Cynthia Gorney.  Tara Parker-Pope also writes about this article in her most recent blogpost, The Mental Chaos of Menopause, in the New York Times.  The comments left by readers are just as interesting.

The appeals court said “the evidence presented could allow a jury to find or infer that Wyeth was guilty of malicious conduct.”  According to the news report, Pfizer’s lawyers argued that the plaintiff received ample warning about the cancer risks tied to the company’s Prempro and Premarin drugs and chose to continue using them.

Editor’s note:  Earlier this month, I wrote about a webinar on Bioidentical Hormone Therapy,  that was “supported” by Ascend Therapeutics, makers of an FDA-approved topical estrogen gel that competes with compounded hormone products.  There’s a companion magazine, “The Buzz on Bioidenticals,”  that is available free online and in doctors’ offices and it, too, is “supported”  by Ascend. The publication repeatedly cautions women against using compounding pharmacies and, in an article called “Why You Should Avoid Compounded Hormone Therapy” the writers suggest that doing so poses a risk to our health.

In the interest of fairness and to contribute to a balanced discussion that will help you make an informed decision about using compounded, bio-identical hormones, I contacted Christine Givant (pictured below), a pharmacist and founder of La Vita Compounding Pharmacy, in San Diego, to ask her to respond to some statements made in the “Buzz on Bioidenticals” publication.

Wendy:  First, explain what a compounding pharmacy does and why a woman on hormone therapy would choose to have her hormones “compounded.”  What does that mean exactly?

Christine:  A compounding pharmacy serves many vital purposes. To begin with, it allows the physician the opportunity to customize therapy to a patient’s individual needs. For example, Ascend Therapeutics offers a hormone product that comes in one strength, one dosage form, and one delivery device. Well, that will work for some women, but not all. A compounding pharmacy would be able to make it in the exact strength your physician determines you need and put it in a variety of dosage forms depending on your lifestyle (i.e gel, cream, suppository, lozenge, capsule, sub-lingual drop). A compounding pharmacy could also combine a daily hormone regimen into one cream, which could result in increased compliance and a lower cost to the patient.

Wendy:  In the Buzz on Bioidenticals article, “Why You should Avoid Compounded Hormone Therapy,” the writers state that “the FDA is concerned that patients may be in danger since the agency does not have oversight over compounding pharmacies and that it won’t approve compounded products because they’re not standardized.”  How are compounding pharmacies regulated, if not by the FDA?

Christine:  No pharmacy, not even the ones you find at WalMart or Walgreens, is regulated by the FDA. Its jurisdiction lies instead with commercial medications. All pharmacies, including those that offer compounding services are, in fact, highly regulated by the State Board of Pharmacy. We undergo regular inspections by the Board of Pharmacy and are required to have independent certification companies inspect and certify our clean rooms every six months.

Wendy: The article suggests that pharmacy oversight on a state-by-state level can result in problems since each state has different laws and different methods of oversight.

Christine: The Boards of Pharmacy have been regulating pharmacies since the beginning. All have stringent regulations regarding compounding. State regulations are often more stringent than the FDA regulation would be if applicable.

Wendy:  Another concern expressed in the article pertains to the possible inconsistency of compounded hormone products since “each compounding pharmacy makes hormones with various different ingredients and doses” and “batches can vary in potency.” Can you explain the compounding process?  Are you using the same FDA-approved, bio-identical Estradiol in your pharmacy that Ascend Therapeutics is using in their EstroGel product?

Christine:  The compounding process is pretty straight forward.  If a prescription calls for Estradiol 1 mg/gm cream for example, a formula is created and entered into the computer by a pharmacist and a log of the formula with a unique lot number is printed out. The log reflects the exact amount of each ingredient in the cream that needs to be weighed or measured along with detailed instructions on the proper compounding techniques.  Our scales are connected to printers that record the weight of each ingredient and we attach this printed document to the log.  This allows for a “checks and balances” system to ensure that the exact weights are weighed correctly.

The final compound and the log are checked by another pharmacist for accuracy and quality assurance. Once determined that the process used to make the compound and the weights of ingredients are accurate, the second pharmacist initials the log for approval to release to the patient.  We only utilize chemicals that are obtained from FDA approved chemical houses. We also randomly batch test our compounds and send samples into an independent lab for either potency and/or stability testing.

Of course, it is important to check out the compounding pharmacy you work with or ask your physician if they have done some investigation to ensure they are following similar practices.

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Note from Wendy: If you want to listen to the on-demand web cast of the “Buzz on Bioidenticals” presentation and read the accompanying magazine, click here.

You should be aware that both the webinar and the magazine are supported “by an educational grant” from Ascend Therapeutics, which makes EstroGel, an FDA appproved estrogen gel that competes with the Vivelle-Dot estrogen patch  as well as hormone products formulated by compounding pharmacies.  That explains the repetitive advice you’ll find throughout the magazine against using compounded hormone products (i.e. “you don’t need to go to a compounding pharmacy to obtain bioidentical hormone therapy” and  “there is no need to risk using a compounding pharmacy.”)

As I’ve written here before, the debate continues over the safety of bio-identical hormones, the reliability of saliva tests and the safety and consistency of compounding pharmacies.  It’s hard to evaluate claims when the information we receive is “sponsored” by an interested party.  All I can say is read and listen to everything, ask questions and know the source.

Current guidelines state that vasomotor symptoms last anywhere from 6 months to 2 years.  Another report claims that hot flashes resolve in most women within 4 to 5 years.  So, to find an estimate based on real data, researchers at the Melbourne Women’s Midlife Health Project tracked more than 400 Australian women, ages 45-55, from pre-menopause through the menopausal transition.  After thirteen years, they recently reported that hot flashes, for these women, averaged nearly SIX YEARS (!!!) in hormone users and just over FIVE YEARS (!!!) for nonusers.

Two other noteworthy findings:  There was a connection between high exercise levels and shorter hot flash duration;  and the longer women experienced hot flashes, the lower the average positive mood score.  That’s certainly not a surprise.

Researchers wrote last year in the Archives of Internal Medicine (9/8/08)  that hormone use was associated with 37% to 66% higher risk for Gerd symptoms, depending on the preparation used.  They concluded that “physicians prescribing hormone therapies should inform patients about possible Gerd symptoms, and those evaluating patients with new Gerd symptoms should ask about hormone therapy use as a possible contributing factor.”  Characteristics of Gerd include:

• Heartburn
• Acid regurgitation
• Chest pain
• Dysphagia (difficulty swallowing)
• Indigestion
• Estraesophageal symptoms (chronic cough, wheeze, laryngitis)

If any of these symptoms look familiar, and you’re using hormone therapies, you should discuss this possible linkage with your physician.

Researchers spent four years investigating the effects of the menopause transition and hormone use on three areas of cognitive function; processing speed, verbal memory and working memory.  They concluded that mid-life women, particularly those in the late-perimenopause stage (they haven’t have a period in three to 11 months) were not able to learn as well as they had during pre-menopause.  The good news is that their test scores eventually improved and rebounded to pre-menopause levels once they hit post-menopause (no period for 12 months), indicating that “menopause related cognitive difficulties may be time-limited.”

The impact of hormone treatments on cognitive function were also evaluated. They found that if you started taking hormones before your final menstrual period, the hormones had a “beneficial effect” on cognitive function. The opposite was true for women who began hormone therapy during the post-menopause transition. In those cases, cognitive performance was worse!

So, if you’re a mid-life woman (mid 40s to early 50s) who is struggling to learn new computer skills, or returning to school for a degree, cut yourselves some slack and know that your body’s hormones, which have always been in control, will take a temporary performance break as you approach menopause.

Be sure to read (Bay area physician) Doc Gurley’s humorous take on this study:  “Are You Moron-o-pausal? which appears in her City Brights online column for the San Francisco Chronicle.