What are conjugated estrogens? Conjugated in this context means "formed by the union of two compounds." The phrase conjugated estrogens refers to an FDA-approved synthetic product derived from the urine of pregnant mares—hence the brand name "Premarin." It also refers to an FDA-approved plant based product called Cenestin. The molecular structure of these products is not identical to the estrogen produced by a woman's body. No one knows whether or not this is clinically significant.
What is unopposed estrogen? This phrase refers to estrogen that is not balanced by progesterone. In the 1970s, researchers linked unopposed estrogen therapy with an increased risk of uterine cancer.
What are bio-identical hormones? These are products with molecular structures that are the same as those of the hormones produced by a woman's body before menopause. Again, no one knows whether or not this is clinically significant. Bioidentical hormones are often called "natural." However, they are synthesized in laboratories from plant sources such as Mexican wild yams (not the same as sweet potatoes!) and soy. In that sense, they can be called "synthetic."
Are there any bio-identical hormones approved by the FDA? Yes. Several bio-identical estrogen (estradiol) products made from yams were approved during the 1990s. One, with the brand name Estrace, is made from both yams and soy. An FDAapproved progesterone product, Prometrium, is a "micronized" form of the hormone that is easy for the body to process.
What is a compounding pharmacy? These are pharmacies that custom mix drugs according to a physician's prescription. Media attention has recently focused on their role in creating bio-identical preparations. One reason a doctor might tailor a prescription for a menopausal woman would be to treat her with testosterone for low libido. Some doctors customize an HT prescription based on the results of a saliva test but these tests are unreliable. Also, the position of the American College of obstetricians and Gynecologists on this issue is that "hormone therapy does not require customized dosing."
Why doesn't the FDA approve preparations made by compounding pharmacists? The FDA can only approve products that are standardized and that have been shown in clinical trials to be safe and effective. A corollary of this fact is that insurance companies may not pay for hormones compounded by a pharmacy. Therefore the cost to the consumer can be greater than for pharmaceutical-grade hormones.
Can herbal supplements relieve menopausal symptoms? Probably not and they may not be safe. A 2005 study done by the National Center for Complementary and Alternative Medicine (NCCAM) of the National Institutes of Health (NIH), reported that there is not as yet enough evidence to support the belief that "botanicals" such as black cohosh, red clover, ginseng, dong quai, and kava reduce menopausal symptoms or that they cause no harm. None of these preparations are FDA-approved. NCCAM also cautions that herbal remedies can have adverse interactions with over-the-counter and prescription medications.
What does "oral medication" mean? This refers to drugs in pill or capsule form. Among the drawbacks of oral hormone medications is that when the liver processes them, they stimulate proteins associated with heart disease and stroke.
What does "transdermal medication" mean? This refers to products such as patches, creams, and gels, which allow drugs to be absorbed through the skin. This method bypasses the liver. Another way to bypass the liver is to deliver medication through the vagina such as with intravaginal estrogen.
What is "continuous therapy"? This means that estrogen and progesterone therapy are taken every day without interruption even though a pre-menopausal woman does not produce progesterone every day of the month. A combination pill such as Prempro (Premarin plus Provera, a synthetic version of progesterone called progestin) constitutes continuous therapy. Women may bleed erratically at first but most women stop bleeding altogether on continuous therapy.
What is cyclical therapy? This means that a form of continuous estrogen therapy is teamed with separate progesterone therapy that is purposely interrupted for several days a month to mimic a woman's natural hormonal cycle. Women will typically bleed in a cyclic fashion, although the bleeding is usually minimal and sometimes stops altogether.
If a woman is going to use an HT regimen, when should she start? The earlier during perimenopause the better. HT should not be started by post-menopausal women in the hopes of preventing health problems such as Alzheimer's or heart disease. There is no evidence that HT provides this kind of protection and starting hormones that late may pose health risks.
Why are current HT doses lower than in the past? Low doses have been shown to be effective and they are safer than the higher doses prescribed in previous years.
Does HT significantly increase the risk of breast cancer? The risk is small, especially when it comes to women who don't have high risk factors in the first place. (See the sidebar "Who Shouldn't Take Hormone Therapy?" on page 183.) Women who have disabling symptoms of menopause may decide in conjunction with their physicians that the benefits of HT outweigh the slight risk. Also, the risk has been shown to disappear completely within a short time if a woman stops HT.
How long should a woman stay on an HT regimen? The answer varies from woman to woman. Many women stop after symptoms such as hot flashes and night sweats have subsided. Other women who continue to be bothered by symptoms such as vaginal dryness and itching that compromise sexual pleasure may choose in conjunction with their physicians to continue a safe and effective form of HT indefinitely. (See my Five Factors on page 185 for the regimen I recommend.)
Now that you have a good grasp of what's involved in considering HT, let's look closely at the timeline of events precipitated by the latest highly publicized scare. In 2002 the National Institutes of Health abruptly halted the Women's Health Initiative (WHI) study because the risks of Premarin and Prempro were proving to be greater than the benefits. Headlines that were splashed across newspapers as well as articles that were rushed into the major women's magazines warned that HT had been shown to raise the risk of heart disease and breast cancer. The study also showed that the risks of bone fractures and colon cancers were reduced, but that did little to assuage everyone's fears. Scores of women immediately stopped their HT regimens.
I was one of them. However, I wasn't willing to give up on HT altogether. For one thing, because I had read the fine print of the WHI study, I knew that it was flawed. This has been confirmed in the years since. The subjects were not perimenopausal women seeking symptomatic relief. The participants in the trial, with the goal of finding out whether HT could protect women against heart disease, were largely postmenopausal women. The mean age was sixty-three. Most of them were overweight or obese and most of them had not taken HT when they were younger or they had stopped years earlier. Not only that, but most of them had no symptoms or only mild symptoms. After all, why would a woman with disabling symptoms agree to be in a trial in which she might be one of those receiving a placebo? Also, the researchers were discouraged from enrolling women with severe hot flashes and other symptoms because the active treatment would markedly relieve symptoms and this would essentially "unblind" the researchers because they would then know which pill the symptomatic patients were taking. Those facts said to me that the results of the study were far from representative of the effects of HT on women like me. I had started therapy early when the timing was right and I didn't have breast cancer as a family risk factor so that wasn't a worry. On the flip side, I did have concerns about cardiac disease and low bone density so I wanted the possible protection that hormome therapy could give me.
Even so, because I had been taking a combination of synthetic oral estrogen and progestin, I did reconsider my HT options. In fact I wrote an op-ed piece that was published in the Philadelphia Inquirer explaining why I chose my new regimen. First, I switched to Vivelle-dot, a transdermal ("through the skin") patch that had been approved by the FDA
in 1994. It delivers a bio-identical form of estradiol (a type of estrogen) derived from yams. The molecular structure is chemically the same as the estradiol produced by a woman's body before menopause.
Next, because the dangers of taking estrogen that is unopposed by progesterone have long been known, I coupled the patch with cyclical oral doses of Prometrium, a bio-identical micronized form of progesterone that had been approved by the FDA in 1998. Again, the source of the hormone is yams and the molecular structure is the same as that of endogenous progesterone. There is to date no transdermal FDA-approved form of progesterone. If there were, I would prefer it to the oral medication. (Prometrium isn't used in birth control pills. See chapter 5.)
The patch delivers a very low dose of estrogen that goes directly into the bloodstream rather than going to the liver as all orally ingested pills do. The liver is nature's digestive clearinghouse. When you take hormones orally, you need a dose that's about ten times higher than the dose required if you have a patch because the liver will break down the dose and send only about one-tenth of it into your system to do its work on most tissues in the body.
Beyond that, any estrogen delivered transdermally—whether by the patch, the spray recently approved by the FDA, or a cream or gel—doesn't carry the risk of an increased tendency to blood clots or high blood pressure. In addition, it doesn't cause an increase in blood inflammation as measured by a simple, inexpensive blood test called the C-reactive protein test. It does help to improve blood cholesterol although the "good cholesterol" will not go up as high as it does with oral HT. However, the other benefits of transdermal delivery outweigh this small drawback.
The 2008 Danish Sex Hormone Register Study confirmed what I have been saying for years about transdermal estrogen and cyclic oral progesterone. This is the first large-scale observational study that addresses the influence of various regimens, doses, and delivery systems. The researchers found that transdermal estrogen did lower the risk of heart disease while they found that continuous combined oral estrogen progesterone regimens such as the one used in the WHI trial were associated with higher risks.
Bio-Identical Preparations Made by Compounding Pharmacies
Along with the mass retreat from HT that happened in the wake of the 2002 Premarin and Prempro scare when the WHI study was stopped, a lot of women jumped on the bio-identical hormone bandwagon. However, instead of taking the FDA-approved brands made by drug companie as I did, many women got prescriptions from their physicians based on the results of saliva tests. These prescriptions purportedly customize the hormone dosages to suit any given woman's needs. The problem with that approach is two-fold. First, the saliva tests are unreliable. Second, the preparations mixed by the compounding pharmacists have never been tested for safety or efficacy. Ironically, proponents of the bio-identicals made by compounding pharmacies often claim that these preparations are safer because they are "natural." That's such a comforting word but there's no proof to back up the claim. Again, let me underscore that what does make a difference is the delivery system and dose. Transdermal wins hands down over oral as far as I'm concerned.
Should Menopause be "Medicalized"?
Yet another response to the WHI scare was the emergence of a school of thought that says menopause is a natural event in a woman's life that shouldn't be "medicalized" and that women should simply avoid hormones at all costs. I don't buy that. My stance is that if you are in the throes of menopause, don't hesitate to talk to your doctor about the pros and cons of HT given your unique medical history. The final word on the benefits of HT at menopause for some women has not yet been spoken.
There's no one-size-fits-all answer. Whenever I hear people insist that menopause is a natural event that shouldn't be "medicalized," I can't help but think about one of my patients. Diana was forty-three when she came to me and said, "Please, please, turn off the water! I totally soak the sheets with night sweats and I get barely any sleep. My husband ends up on the couch half the time. We hardly ever have sex anymore and my moods are all over the place. I have trouble concentrating at the office and I have a hot flash like every other minute during the day. I can't go on like this for another ten years! Help!"
I did help her. She was not at high risk for breast cancer so I felt she was someone for whom HT, especially transdermal, was an option for which the benefits would outweigh any slight risks. In a situation like Diana's, I see absolutely no need to tell her to tough it out. Margaret Mead's proclamation about "menopausal zest" notwithstanding, Diana was miserable to the point that her marriage and her job performance were suffering. For someone like her, HT is the only remedy that really works to relieve the most severe symptoms.
Having said that, if you're in the 80 percent who could use some relief, I strongly recommend that you ask your doctor about the transdermal method I prefer and prescribe. I have had patients resist me by saying that the patch seems like too much trouble or doesn't appeal to them because it's visible to the men in their lives and might be something of a turn-off. These seem like very weak arguments given the health benefits of transdermal delivery over oral delivery. However, if you absolutely don't want to try the patch, then ask about some of the newer and lower-dose oral estrogen and progesterone products. The most frequently prescribed combination still consists of conjugated equine estrogen tablets (brand name Premarin) and medroxyprogesterone acetate (MPA) tablets (brand name Provera). The dose of CEE in most HT regimens is now typically 0.625 mg or 0.3 mg. The MPA is usually given in a dosage of 10 mg for ten to twelve days a month. Some physicians give the MPA in a lower dose such as 5 mg or only once every second or third month to decrease the incidence of PMS-like effects. However, there's a trade-off in that the protection of the uterine lining is lessened, although if your estrogen dose is only 0.3 mg, this is rarely a concern.
Additional formulations of estrogen and progesterone have been developed and are often substituted these days for Premarin and Provera. Micronized estradiol (brand name Estrace) is a bio-identical drug that was approved by the FDA in 1993. It is made from a plant source and has the hypothetical advantage of actually being estradiol, the bioactive form of estrogen, although the micronized oral drug is altered by the liver just as any other oral preparation would be. In this case, the estradiol turns into a weaker form of estrogen called estrone. Some other brands of oral estrogen preparations include Ogen and Estratab. There is also a new oral HT called Angelique, but long-term safety has not yet been established. The transdermal CombiPatch delivers the same estradiol as other patches but also contains a synthetic progestin, which I don't recommend. Both Angelique and the CombiPatch not only have synthetic progestins but they also deliver the progestins continuously. I prefer the transdermal estrogen along with cyclical use of the oral micronized progesterone, Prometrium. It seems to cause fewer PMS-like symptoms in women who are sensitive to progestin, and it's bio-identical so it produces none of the androgenic side effects. It is distributed in 100 or 200 mg capsules and is usually given in a dose of 200 mg for ten to twelve days a month. So far micronized progesterone is only available as an oral medication. Pharmaceutical companies are having difficulty manufacturing a delivery system for transdermal progesterone that is consistent and predictable. There are also ongoing studies using intravaginal progesterone in postmenopausal women but the results have not yet been published.
In the end, only you can decide what's right for you. Listen to your body. If the method of HT you're using works, stick with it. If you're getting annoying symptoms such as heavy bleeding, you may not be taking enough progesterone or you may be inadvertently skipping doses. Another possibility is that you're making quite a bit of endogenous (internal) estrogen in your visceral fat. This may sound good but it's not. For one thing, you're no longer making endogenous progesterone to balance out the endogenous estrogen, and for another, the bleeding is a tip-off to your doctor that you're carrying a dangerous amount of belly fat that can lead to metabolic syndrome or worse. You don't need to be taking more exogenous (from an external source) estrogen on top of what you're making. You need to lose weight and get your waist measurement under thirty-five inches or at least lose one or two inches. That will be enough to make a big difference to your future health risk! Sorry to sound like a scold, but this is so vital. I'll help you out when we get to chapter 11.
The bottom line is that each woman should stay attuned to how she feels and what is or isn't working for her and tailor her choices accordingly.
Health Strategies to Help You Live Long and Well
Whether you breeze through menopause with minimal complaints or you suffer from every symptom in the book, your body will be different when the process is complete, as we have seen. This is true, by the way, even if taking HT gives you the illusion that you're still menstruating. HT doesn't do anything to slow down or reverse the aging of your reproductive system, or any other system for that matter. Years ago HT was touted as an elixir of youth, but while it may do a little something to stave off wrinkles, it can't keep you forever young. In fact, lifestyle measures—my mantra, the "Lifestyle Pill"!—such as diet, exercise (especially weight-bearing), getting enough sleep, minimizing alcohol consumption, and wearing sunscreen and wide-brimmed hats will do more in the end to give you the good looks and vigor that will belie your age. My "Lifestyle Pill" is still better than any other pill or medication we have to offer for keeping you humming along with good health, good spirits, and good looks!
Here's what I recommend:
Know your baseline bone density (see chapter 3, page 116).
Take 1,200 mg of calcium daily.
Take at least 1,000 IU of vitamin D daily. (This is based on new research about the many benefits of increased amounts of vitamin D, especially for postmenopausal women.)
Keep your waist measurement under thirty-five inches. (See chapter 11 for tips on how to do this with exercise and good nutrition.)
Know your C-reactive protein, triglyceride level, cholesterol level, and breakdown (see chapter 3, pages 107–8).
Know your blood pressure and keep it below 130/80 with lifestyle measures and possibly medication.
If you're at high risk for heart disease because of family history or because you smoke, have high C-reactive protein, or have abnormal blood fats such as high LDL cholesterol and/or low HDL cholesterol and high triglycerides, talk with your doctor about a special cardiac test that measures your calcium score on a CT scan.
Have a colonoscopy at age fifty.
Take cat naps. Researchers from Harvard School of Public Health found that midday naps reduced coronary death by about one-third in women.
Try acupuncture. Research results are inconclusive, but some studies suggest that acupuncture works well in relieving menopausal symptoms.
Try daily fish oil capsules, particularly if you are at risk for heart disease. They are chock-full of healthful omega-3s—I take two to four capsules daily. I don't have "hard" proof yet of the benefits, but evidence is mounting that more omega-3s are important for so many vital functions.
Behind Closed Doors: The Best Sex Now
As we age, the need for intimacy, connectedness, and some type of sexual activity actually increases. So do the benefits of sex. Also, as many of us have discovered to our delight, menopause often ushers in an era when lovemaking can be more spontaneous and spicy than ever before. Long-married couples eventually have the house and their free time all to themselves after decades of fitting in sex around the kids' needs and schedules. Suddenly single women often report that being free at last from concerns about unplanned pregnancies adds extra sizzle to the dating scene. Some of them find themselves involved with men several years their junior—the so-called cougar-and-cub phenomenon. As one of my patients confided, "He's forty-five and pre-Viagra. I'm fifty-four and post menopausal with no need for birth control. We got ourselves checked for STIs so we aren't even using condoms. We just can't keep our hands off each other. I've never had so much fun in my life!"
However, she wouldn't have been having all that fun without a little help from modern medicine. She was my patient for a reason. She had come to me early in the relationship with the new man in her life because she was, as she put it, "not juicy down there anymore." Her first attempts at sex with him were painful. Also, penetration was difficult. I wasn't surprised. One of the most common features of the postmenopausal body is a condition called atrophic vaginitis. When estrogen levels decrease, the tissues of the vagina and the labia become thinner and drier. Even when a woman is sexually aroused, she may have soreness and she may not have enough lubrication.
I know whereof I speak. The symptoms of atrophic vaginitis sneak up on you. In retrospect I can't come up with a precise time of the onset of this condition for me, but over a few years time, I had noticed a change in my vulvar and vaginal tissues and my comfort with sex. Since this was so subtle at first, it was not until I was finally treated and suddenly felt normal again that I realized how compromised sex had been. My sex "life" was still great and frequent, but "sex" per se was compromised because of the worry about pain. I still seemed to have some lubrication with sex although that too had diminished somewhat.
As recently as 2001 a Gallup poll showed that by the average age of fifty-seven, 50 percent of women had stopped having sex for a number of different reasons, one of the most common being pain with intercourse because of a dry vagina. Yet when the women who reported vaginal dryness were asked whether there was anything that could be done about the problem, 90 percent of them responded that there was not. Oh, but there is! I'll tell you all about it. But first I'll tell you how to be sure that you do have atrophic vaginitis.
Tests for Atrophic Vaginitis
Your Pap smear result is often the earliest clue. The cells under the microscope may show an increased proportion of parabasal cells and a decreased percentage of superficial cells. Take a look at the copy of your Pap smear report. Does it say something about abnormal cells consistent with atrophic vaginitis or inadequate or low estrogen effect? It could also show, as mine did, what is called an "ASCUS" result. (Note: ASCUS in young women is more often due to an HPV infection, whereas in older women it is commonly caused by low estrogen.)
If you test your vaginal pH with a home test kit, it may be high, usually over five, because of the loss of estrogen. (See chapter 7, page 203.)
An intravaginal ultrasound to measure the uterine lining will show a very thin atrophic endometrium between four and five mm.
Treating Atrophic Vaginitis
Sexual activity itself is just what the doctor ordered. In addition to all the other health benefits covered in chapter 2, sex has been shown to increase vaginal elasticity and lubrication. However, sex does nothing to restore or maintain estrogen levels, so you will almost certainly need some help, as my "cougar" patient and I did, in getting past the pain.
Taking some form of estrogen is an incredibly effective treatment. Estrogen restores normal pH levels and thickens the vaginal, urethral, and vulvar tissues. Estrogen will also increase the number of superficial cells seen on the Pap smear, and therefore your Pap smear may now report "normal estrogen effect." In addition to the HRT options detailed in this chapter, you may also want to consider intravaginal tablets, creams, gels, or rings. Your vaginal tissues—and your sex partner—will thank you. I know. I've been there! Also, I've been prescribing estrogen cream for my patients with atrophic vaginitis for years.
You could notice a difference in a few weeks' time, although you may need a few months to feel normal again. Women who have severe atrophic vaginitis have a diminished blood supply to the vaginal tissues so that at first not much estrogen gets absorbed systemically. As the tissues improve, the blood supply does as well. Eventually more estrogen gets absorbed. The level is so low that you probably won't need to take progesterone to balance out the lining of your endometrium. Even a woman with prior breast cancer can use small intravaginal doses of estrogen for comfortable sex as long as her oncologist agrees. On occasion, doctors will prescribe a ten-day course of progesterone and wait occur, which suggests higher-than-expected systemic levels of estrogen from fat cells, your doctor will probably recommend that you take intermittent progesterone along with the intravaginal estrogen after other possible causes, such as cancer, have been ruled out.
Lubricants do nothing to thicken, strengthen, or repair vaginal tissue. They provide lubrication or slipperiness only for a brief time after they are inserted, so they do make sex more comfortable. Many women try lubricants before making a decision about topical hormone treatment or they use lubricants while waiting for the hormones to kick in or to supplement the topical hormones.
Water-based vaginal lubricants, such as K-Y Jelly, are inexpensive and work great. There are many generic brands at your local pharmacy. Just make sure the label says "water soluble." Petroleum-based products such as petrolatum or petroleum jelly can break down latex condoms, increase the risk of vaginal infections, and form a barrier so that water-soluble lubricants or your own natural lubricants won't work. They quickly lose their lubricating ability as soon as they are warmed up in the body or on the hands. I tell my patients to keep the lubricant in the refrigerator although even that doesn't help for very long after you apply the product.
Replens Vaginal Moisturizer, a popular water-soluble lubricant, is advertised to work for two to three days after a single application.
Vitamin E capsules or suppositories inserted into the vagina about three times per week apparently work quite well.
A final word about sex and the menopausal woman: If you think your sex life is just fine, it is. A 2008 study done by Massachusetts General Hospital showed that while close to 45 percent of the women in the study reported issues such as low desire or orgasm difficulties, only 12 percent of them overall and only 8.9 percent of those over sixty-five said the problems caused them distress. The researchers concluded that labeling the women who reported no distress as being sexually dysfunctional would be inappropriate. Was it good for you? That's good enough!
Now we've completed Part II and you know all about the three seasons of your life as a woman. Many of the world's religions, ancient and modern, have versions of the Triple Goddess. One of these is the Apaches' Changing Woman that you learned about in chapter 4. Nice concept!
We all ought to celebrate the miracle of our tripartite feminine existence. Even so, glorifying those womanly deities doesn't address one little detail: Goddesses are immune to the problems "down there" that can plague us flesh-and-blood females. In Part II, I'll teach you about vaginal, bowel, and urinary troubles. You'll find frank explanations and real solutions. What are you waiting for? Turn the page!