Two-and-a-half years ago, the announcement of the risks found with long-term use of hormone replacement therapy in a large federally funded study (the Women’s Health Initiative) caused 65 percent of menopausal women to “cease and desist” their hormone use. Since then, however, this “all hormones are harmful” concept has been reevaluated, and some of our fears assuaged. What has changed? Medical contributor Dr. Judith Reichman was invited on the “Today” show to share the latest information and recommendations on hormone replacement therapy.
First, let’s briefly go over the results of the study that caused so many women to stop taking their hormones.
One portion of this study followed approximately 7,000 menopausal women taking the HRT Prempro (Premarin, an estrogen, together with Provera, a progestin) and 7,000 similar women who were not on hormone therapy. Based on follow-up for less than five years, the researchers calculated that if 10,000 women took Prempro for one year and were compared to women not taking Prempro there would be:
- 8 more women who would develop breast cancer
- 7 more would have a heart attack
- 8 more would have a stroke
- 8 more would develop blood clots
On the other hand:
- 5 fewer would fracture their hip
- 6 fewer would develop colon cancer
This study was designed, among other issues, to see if Prempro protected women from heart disease. Since this did not happen and there was also an increase in breast cancer and clots, the Prempro portion of the WHI study was abruptly terminated and the women were advised to stop this therapy (and the panic began).
What has changed since then?
First, there has been time to analyze the data, look at some newer studies and assess the impact of new types of HRT as well as lower doses. The WHI study unfortunately looked at an “older” population of menopausal women. The average age of the women at onset of the study was 63. Many of these women were in their late 60s or even their 70s once the various components of the hormone study were completed. Moreover, most of the women did not have significant symptoms; (who wants to enter a study where there’s a 50 percent chance of being given a placebo for over five years while suffering from severe hot flashes, night sweats, sleep disturbances, short-term memory loss and more?). And these women were frequently overweight or obese (the average BMI, or body mass index, was 28. Remember that a BMI of more than 24 is considered overweight, and over 30, clinically obese). This represented a risk for heart disease and breast cancer.
Another portion of the WHI examined the affect of Premarin (estrogen) on postmenopausal women who had had a hysterectomy; these women were compared to similar women who did not take estrogen. In the estrogen-only study no increase in the incidence of breast cancer was found, even after five years. Based on this, we now feel that whatever small increased risk for breast cancer that may occur with HRT is most likely due not to the estrogen but to the addition of progestin (or progestogen). In short, estrogen-only therapy for 5 years or less (and in some studies, 25 years) does not appear to increase the risk of breast cancer.
Lower doses of the progestogens, or less frequent use, may diminish its affect on breast tissue. So we are currently trying innovative ways to either lower the dose or prescribe it less frequently.
What are the new guidelines and where are they coming from?
The North American Menopause Society (NAMS) created a hormone-therapy advisory panel composed of acknowledged experts in women’s health and hormone therapy. The panel also included researchers from the WHI study. They stated that the “decision to use long-term hormone therapy for prevention of disease or enhancement of quality of life is in part a lifestyle choice, and needs to be considered both in the context of risk versus benefit of the hormone therapy itself, as well as in comparison to other therapies or lifestyle choices.”
Here are some of the other important issues they addressed in their recommendations:The data from the WHI study should not be applied to symptomatic, post-menopausal younger women (less than age 50) or those who are at low risk for coronary heart disease, stroke or breast cancer. The absolute risk in these individuals is likely to be even smaller than that seen in the WHI.
Lower than standard doses (less than the equivalent of 0.625 mg. Premarin) ET and HRT should be considered. Many studies show that their benefits for symptom relief and preservation of bone density may be equivalent. (Some women may need additional local vaginal estrogen therapy for persistent vaginal symptoms of dryness and discomfort with sex.)
There is no need to add progestogen to estrogen for endometrial protection in women who have had a hysterectomy, but for all women who have not had a hysterectomy, if they take estrogen they should also take adequate progestogen.
Hormone therapy should not be used for primary or secondary protection of coronary heart disease or stroke prevention in women with a history of CHD or cerebral vascular disease. Estrogen therapy does not significantly increase stroke risk.
Non-oral (not a pill) routes of estrogen or HRT (skin patches, gel, cream or vaginal products) may offer some advantages (and disadvantages) due to the fact that the hormones do not pass directly through the liver as they enter the body and blood stream. There is some evidence that when estradiol (the most commonly used form of non-oral estrogen) is administered in this way it is less likely than oral estrogen to increase the risk of clots (and may be safer with regards to any potential risk for coronary heart disease).
Breast cancer risk probably increases with HRT use beyond five years, but in absolute terms, this risk is small in the WHI and of possible statistical significance. There is no substantial data reporting an increase in mortality with HRT. Studies have not clarified whether the risk differs between continuous and sequential use of progestogen (Taking it for 12 days a month or every day).
Available evidence suggests that estrogen alone for fewer than five years has little impact on breast cancer risk.
Initiating HRT after age 65 should not be recommended for protection of dementia, as it may increase the risk in this population after five years of use. (But that doesn’t mean it will have an adverse effect if started at the onset of menopause, at a much younger age).
Every systemic and local form of estrogen is government (FDA) approved for treating moderate to severe symptoms of vulva and vaginal atrophy (thinning and dryness which causes dysparunia, in less medical terms, pain during intercourse). When this is the only symptom and only reason to consider hormones, local estrogen therapy is generally recommended.
I realize that this is a long and somewhat complicated list of reasons to consider or reject use of ET or HRT. I want to emphasize that for women who undergo premature menopause and early menopause due to removal of the ovaries, there may actually be an increased risk of osteoporosis and cardiovascular disease and that the risk noted in the WHI and those that have abounded in the warnings, probably do not apply. I tell my patients who have become menopausal in their forties that they can probably go on HRT to “give back” what their ovaries should have been producing until their early fifties; without undo concern. Only after their early 50s, when they prolong hormonal action beyond the normal age of menopause, do concerns come to fore.
Finally, we’ve heard a lot about bioidentical hormones. Are they considered safer?
The committee reviewed the evidence and concluded that these are no safer than FDA approved therapies, and that all the same risks and benefits apply. (Despite what celebrity authors and Web sites proclaim.)
In short, the NAMS committee and many experts now agree that the decision to start and/or continue using HRT is a lifestyle choice and needs to be considered in the context of each woman’s risk benefits and symptoms. If a woman feels awful, especially during the first few years of menopause, making a quality of life decision to take hormones need not cause horrific guilt. The data does not support a collective clutching of our breasts or pangs in our hearts.
No, there are no “free hormones” … but neither is there a free calorie-laden lunch, sedentary lifestyle or for that matter, ride in a motor vehicle!Dr. Judith Reichman, the “Today” show's medical contributor on women's health, has practiced obstetrics and gynecology for more than 20 years. You will find many answers to your questions in her latest book, "Slow Your Clock Down: The Complete Guide to a Healthy, Younger You," published by William Morrow, a division of .