Is It for Me?
For some, the troublesome symptoms that come along with perimenopause, can be unbearable. When lifestyle changes aren't making a difference, there are other options to provide relief from the hot flashes and night sweats. But is hormone therapy the best solution for you?
Marilyn Joseph, a 59-year-old graphic designer from Portland, Ore., has strong memories of the turbulent years surrounding menopause. "Although the hot flashes were unpleasant, they were, at least, predictable, unlike my emotions, which were all over the place," she says. When her doctor prescribed oral estrogen therapy, Joseph thought she had a solution. "It was fantastic. I was back to the premenopause me-levelheaded, reliable, and capable of watching a movie without bursting into tears every five minutes."
However, within a few months, Joseph started to experience irregular uterine bleeding. In retrospect, she says, "Hormone therapy suits some women, but I had to accept that I wasn't one of them." Joseph eventually managed to reduce her symptoms with herbal medicine, but it took a lot of trial and error, and maybe it was just the passage of time.
Like Joseph, not all women are convinced that the benefits of hormone therapy outweigh the risks. Indeed, many women are decidedly cautious-partly due to the well-publicized results of the Women's Health Initiative (WHI), a federally funded study of the effects of the most common form of oral hormone therapy used by postmenopausal women in the United States.
The WHI's goal was to see if most postmenopausal women should use hormone therapy (HT) to prevent heart disease. The findings were surprising. One part of the study, which included 16,608 healthy postmenopausal women aged 50 to 79 who still had their uterus, found a small increased risk of heart attack, blood clots, stroke, and breast cancer in those taking oral Prempro(r), an estrogen/progestogen form of hormone therapy (EPT). A second arm, studying 10,739 older women who had had hysterectomies, found an increased risk of stroke in those taking oral Premarin(r), estrogen-only therapy (ET).
In the aftermath of the findings, millions of women quit using hormone therapy. The FDA directed that estrogen products approved for hormone therapy needed to state in their prescribing information that hormones should be used for the shortest possible time and the lowest possible dose. The North American Menopause Society (NAMS) has published a series of position papers on hormone use. They conclude, "current evidence supports the use of ET and EPT for menopause related symptoms and disease prevention in appropriate populations ... of women."
Basically, hormone therapy continues to be prescribed because nothing seems to work as well for moderate to severe hot flashes, night sweats, sleep disturbances, and vaginal changes associated with menopause.
"Hormone therapy is the drug of choice for these symptoms," says Wulf H. Utian, M.D, Ph.D., NAMS executive director and a menopause researcher. "With the information that we have, it's a remarkably safe approach."
The WHI also confirmed that hormone therapy helps prevent osteoporosis and bone fractures and may have a positive effect on other conditions, such as colon cancer risk.
"Because the WHI findings were based on older (average age 63), postmenopausal women with minimal symptoms, it's unclear what the results mean for younger women whose symptoms are more severe," says Utian.
A re-analysis of the WHI study data found reduced mortality rates where women were younger than 60, but no change for women over 60. Further research is needed to determine the difference in the way women of differing ages respond to hormone therapy. The suggestions are clear: use of hormone therapy should be examined on an individual basis, taking into account age, symptoms, and risk factors.
"The risks are very small," says Susan Hendrix, D.O., a professor of obstetrics and gynecology at Wayne State University School of Medicine in Detroit and a principal investigator in the WHI. "But they're real risks. They're life-altering events (stroke, heart attack, breast cancer), and they can be serious."
The hormones studied in the WHI were oral therapies providing "systemic" levels of hormones throughout all the body's systems. These medications are proven to be effective for treating most menopause symptoms, including hot flashes and vaginal dryness. However, if vaginal dryness is the only reason for considering hormone therapy, local estrogen therapy applied inside the vagina is the best choice. Nothing else works as well-and risks are thought to be minimal.
A Personal Decision
The decision to use hormone therapy, to try an alternative, or to simply adopt a healthy lifestyle and wait out menopause symptoms with no treatment, is highly personal. Each woman needs-and deserves-individualized care, not a blanket one-size-fits-all prescription. Although healthcare providers continue to learn more about the effects of hormone therapy on groups of women, they will never know the complete impact for each individual. What's important is that you make your decision fully aware of what is known about any potential consequences and what is uncertain.
"What you choose should be based upon your health, symptoms, lifestyle concerns, and discussions with your healthcare provider about the pros and cons, as they apply to you," says Marcie K. Richardson, M.D., director of the Harvard Vanguard Menopause Consultation Service in Boston. "I say to women, 'These are what the benefits might be. These are what the harms might be. How scary are these harms to you? How important are these benefits?' If the potential benefits outweigh the potential harms, then a trial of hormone therapy-starting with a low dose-has very little downside for most women."
It's worth remembering the effect of hormones on your bones. After menopause, without using systemic estrogen, bone strength falls off rapidly. Long-term estrogen therapy helps keep bones strong, but its associated risks limit its use for this purpose alone.
Time to End the Hormones?
As you progress into menopause and your symptoms subside, reduce or stop hormones as appropriate and in consultation with your healthcare provider. If symptoms persist, hormone therapy can be resumed.
In Richardson's practice, women had a wide range of experiences when they ended hormone therapy after WHI. "Some went off and didn't notice much of a difference. Some went off and had horrendous symptoms." Some even had worse symptoms after stopping the medication than when they first started taking it, she adds.
Richardson advises her patients to taper off, although she admits there is few data on whether this limits symptoms. "If a woman doesn't want to go back on estrogen, I try to help her find alternatives," she says. "If someone's symptoms are making her miserable, and she understands the potential risks, I help her go back on hormones, identifying the lowest dose that provides enough relief of symptoms to make her comfortable."
Hot flashes generally end eventually, usually a few years after menopause is reached, although sometimes they go on longer. Vaginal dryness can continue to worsen as women age. As you progress beyond menopause and your symptoms subside, it may be time to rethink your options-again.
When you shouldn't take HT
• If you are experiencing undiagnosed, abnormal genital bleeding
• If you have or suspect you have breast cancer
• If you have or suspect you have any estrogen-dependent neoplasia (benign or cancerous growths)
• If you have a history of blood clots in your legs (deep vein thrombosis) or lungs (pulmonary embolism)
• If you have had a stroke or heart attack in the past year
• If you suffer from liver dysfunction
• If you may be pregnant
• If you have a known hypersensitivity to HT
What Does The Women's Health Initiative (WHI) Study Mean for Hormones?
The WHI was the largest scientific research trial ever conducted using the most widely prescribed hormone therapy. Initially, it was an inquiry into whether estrogen, with or without added progestogen, had a cardiovascular benefit in postmenopausal women. The participants were healthy postmenopausal women with an average age of 63. It studied women who used estrogen-progestogen therapy (EPT) consisting of Prempro(r), a pill combination of an estrogen (conjugated estrogens) and a progestin (MPA), as well as women who had had a hysterectomy and who used estrogen therapy (ET) alone, consisting of just an estrogen pill (Premarin(r)). In 2002, the EPT part of the study was halted early when analysis found a small increased risk of developing breast cancer, blood clots, and stroke. In 2004, the ET part of the study ended because of increased risk of stroke. Neither part showed any reduction in coronary heart disease risk, as the study hoped to prove. Both EPT and ET were found to reduce risk of fractures from osteoporosis, while EPT reduced colon cancer risk. The data gathered during WHI continues to be studied and reported upon.
Bioidentical Hormones
When scientists and healthcare providers talk about "bioidentical" hormones, they're usually referring to products that are chemically identical to those produced by premenopausal women, such as 17 beta-estradiol or progesterone. Some bioidentical hormones made by drug companies are available in FDA-approved products.
Bioidentical hormones are also available as custom-compounded formulations, sometimes referred to as BHT (bioidentical hormone therapy), and are usually prepared at special compounding pharmacies. These individualized doses and combinations of hormones are based on a healthcare provider's prescription. But compounded formulations have not been tested for effectiveness and safety, and custom-made prescriptions are not approved by the FDA. In fact, the FDA recently issued warning letters to many of these pharmacies forbidding them from making false and unsupported claims of effectiveness and safety of their BHT products.
Further research is needed to establish the benefits and harms of BHT, as they have not been proven to be safer than FDA-approved hormones. And both the North American Menopause Society and the Endocrine Society have issued statements that there isn't yet enough scientific evidence to support claims that there is an increased efficacy or safety of custom-compounded formulations, including BHT. It is recommended that before you decide to start BHT that you speak with a qualified healthcare provider to discuss your options.
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