Hormone replacement therapy: The answers are in
August 19, 2003 | 12:00am
The whole subject of hormone replace-ment therapy (HRT) for post-menopausal women has swirled in uncertainty for years. Physicians encouraged its use and experts cited scientific evidence to back up the practice. Then, in July 2002, the landmark Women’s Health Initiative (WHI) study, the best research ever done on hormone replacement therapy in healthy women, showed that the treatment actually increases the risks of heart disease and breast cancer, outweighing any protection against fractures and colon cancer.
True, the study showed that if taken for less than four or five years, hormone therapy is a reasonably safe way to deal with menopausal symptoms. But this is a far more modest benefit, overall, than most women had been led to expect. "Risk shmisk," some women may say after years of conflicting messages from doctors and the medical media.
Now, women are asking, "What in the world do I do now?" and "Have I done myself real damage in taking this stuff?" The answer to the first question is complicated; the answer to the second is probably no.
Hormone therapy started some 30 years ago. It comes in two types: Estrogen alone (ERT) or the combination of estrogen and progestin, known as (HRT). The idea that taking estrogen after menopause helps protect women against osteoporosis has been well established. And there’s logic to the idea that it should also protect against cardiovascular disease. Numerous studies have found benefits. And hormone therapy can counteract unpleasant (and occasionally unbearable) menopausal symptoms, such as hot flashes, vaginal dryness, night sweats, and mood swings.
There were also claims (totally unfounded) that hormone therapy would keep a woman "forever feminine" and "forever young." The companies that made the hormones helped promote the notions, and journalists quickly joined the parade. Understandably, women today want to stay healthy into old age, especially now that it’s reasonable to expect to live 20 or more years past menopause. Doctors were (and are) eager for medications that would help.
All along, however, there were questions. ERT was shown to promote cancer of the uterus, but it turned out that this effect could be countered by adding progestin to the pill – hence, HRT. (Estrogen by itself was reserved only for women who had had hysterectomies.) Whether HRT raised the risk of breast cancer was another troubling problem. Many doctors were reluctant to prescribe HRT for women at high risk for breast cancer. But as a way to reduce the risk of cardiovascular disease and bone loss, ERT and HRT continued to look promising.
Yet, one thing was missing: A large-scale, well-designed clinical trial that tested the safety and efficacy of hormone therapy as a way to prevent disease in healthy women. That is what the WHI study was designed for. It was one of the largest randomized, blinded, placebo-controlled prevention trials ever conducted.
The trial was to have lasted eight-and-a-half years, but was terminated after just over five years, when they determined that the risks of HRT exceeded the benefits. Here are the increased and decreased risks documented during those five years:
• Bone fractures. Loss of bone density may lead to fractures, frequently in the hip or spine. Compared to the women who took the placebo pill, women on HRT were at 24 percent lower risk for all fractures, and 34 percent lower risk for hip fractures.
• Colon cancer. In a surprising finding, women on HRT were at 37 percent lower risk for colon cancer.
• Breast cancer. Women who took HRT were at 26 percent increased risk of breast cancer.
• Heart disease. Women on HRT were at 29 percent increased risk of adverse cardiac events, such as heart attacks and chest pain.
• Stroke. Women on HRT were at 41 percent increased risk of stroke.
• Blood clots. This risk refers to clots that form in the large veins of the legs. These may then break off and travel into the lungs and block the pulmonary artery, causing pulmonary embolism. In the WHI trial, women on HRT showed a more than twofold risk of pulmonary embolism, which is potentially fatal. The overall risk of venous blood clots was 111 percent higher, and is greatest in the first year of HRT, decreasing afterwards.
On the surface of things, HRT may now seem like a poor bargain – perhaps even a dangerous one. But it is not necessarily a case that all women on HRT should immediately stop. The WHI study is an opportunity for women to reassess the reasons why they are on HRT, what they expect to get out of it, and what risks it may pose on them.
"What I usually ask my patients is, what was the purpose of the estrogen replacement therapy? What do they see as the benefit that they derive from HRT?" says Dr. Rainier Soriano, MD of the Mount Sinai School of Medicine in New York. The answers to those questions will guide your decision on HRT. "Is it for osteoporosis? Well, we have other medications for osteoporosis. Is it for Alzheimer’s? There’s no real benefit that we can see. For preventing heart disease? It doesn’t work for that."
Dr. Soriano says that even before the WHI study findings were released, doctors were moving toward an approach based on "targeted therapy." In practice, this means taking steps to reduce the specific health risks a woman faces after menopause, as opposed to prescribing HRT in the hope of reducing multiple risks with a single treatment. These include:
• Cardiovascular disease. Numerous studies show that it’s possible to significantly reduce your risk for heart disease and stroke through a combination of lifestyle changes (weight control and exercise) and appropriate medications.
• Osteoporosis. For a woman who chooses to discontinue HRT, prevention of osteoporosis is a priority. The first step is making sure you are getting adequate calcium, vitamin D, and weight-bearing exercises. Together, these help to preserve bone mineral density.
For women who already have below-average bone density or confirmed osteoporosis, a family of medications called bisphosphonates (such as Fosamax and Actonel) can help rebuild lost bone strength or at least slow further decline. Other options include raloxifene (Evista) and calcitonin (a hormonal nasal spray).
Some women may be reluctant to stop HRT for fear that they will experience menopausal symptoms again, such as hot flashes. To start, Dr. Soriano suggests that his patients taper off gradually to see how they feel. If menopausal symptoms return, they may fade over time. If they do not, talk to your doctor about your options. One is to go back to HRT again, but at a lower dose. Or you can find ways to address the following specific symptoms:
• Hot flashes, night sweats. Selective serotonin reuptake inhibitors (SSRIs) may help, according to preliminary research. Also, some women may be able to use a hypertension medication called clonidine (Catapres). Another measure is to avoid things that trigger hot flashes, such as caffeine, alcohol, or spicy foods.
• Sexual function. Over-the-counter lubricants and moisturizers may reduce discomfort during sexual intercourse due to vaginal thinning and dryness. Use of topical estrogen creams or vaginal tablets and rings may also help. These act locally, without raising estrogen levels in the body.
So, for hormone therapy, the take-home messages are these: If you have been on HRT for some period of time and want to stop ...
• Do not stop taking HRT without discussing it with your doctor.
• Before discussing this decision with your doctor, make a list of the pros and cons of HRT as you understand them.
If you decide to stay on HRT to treat menopausal symptoms, use the lowest effective dose for the shortest period of time.
But it does look like it is the end of an era for hormone replacement therapy!
True, the study showed that if taken for less than four or five years, hormone therapy is a reasonably safe way to deal with menopausal symptoms. But this is a far more modest benefit, overall, than most women had been led to expect. "Risk shmisk," some women may say after years of conflicting messages from doctors and the medical media.
Now, women are asking, "What in the world do I do now?" and "Have I done myself real damage in taking this stuff?" The answer to the first question is complicated; the answer to the second is probably no.
There were also claims (totally unfounded) that hormone therapy would keep a woman "forever feminine" and "forever young." The companies that made the hormones helped promote the notions, and journalists quickly joined the parade. Understandably, women today want to stay healthy into old age, especially now that it’s reasonable to expect to live 20 or more years past menopause. Doctors were (and are) eager for medications that would help.
All along, however, there were questions. ERT was shown to promote cancer of the uterus, but it turned out that this effect could be countered by adding progestin to the pill – hence, HRT. (Estrogen by itself was reserved only for women who had had hysterectomies.) Whether HRT raised the risk of breast cancer was another troubling problem. Many doctors were reluctant to prescribe HRT for women at high risk for breast cancer. But as a way to reduce the risk of cardiovascular disease and bone loss, ERT and HRT continued to look promising.
Yet, one thing was missing: A large-scale, well-designed clinical trial that tested the safety and efficacy of hormone therapy as a way to prevent disease in healthy women. That is what the WHI study was designed for. It was one of the largest randomized, blinded, placebo-controlled prevention trials ever conducted.
• Colon cancer. In a surprising finding, women on HRT were at 37 percent lower risk for colon cancer.
• Heart disease. Women on HRT were at 29 percent increased risk of adverse cardiac events, such as heart attacks and chest pain.
• Stroke. Women on HRT were at 41 percent increased risk of stroke.
• Blood clots. This risk refers to clots that form in the large veins of the legs. These may then break off and travel into the lungs and block the pulmonary artery, causing pulmonary embolism. In the WHI trial, women on HRT showed a more than twofold risk of pulmonary embolism, which is potentially fatal. The overall risk of venous blood clots was 111 percent higher, and is greatest in the first year of HRT, decreasing afterwards.
"What I usually ask my patients is, what was the purpose of the estrogen replacement therapy? What do they see as the benefit that they derive from HRT?" says Dr. Rainier Soriano, MD of the Mount Sinai School of Medicine in New York. The answers to those questions will guide your decision on HRT. "Is it for osteoporosis? Well, we have other medications for osteoporosis. Is it for Alzheimer’s? There’s no real benefit that we can see. For preventing heart disease? It doesn’t work for that."
Dr. Soriano says that even before the WHI study findings were released, doctors were moving toward an approach based on "targeted therapy." In practice, this means taking steps to reduce the specific health risks a woman faces after menopause, as opposed to prescribing HRT in the hope of reducing multiple risks with a single treatment. These include:
• Cardiovascular disease. Numerous studies show that it’s possible to significantly reduce your risk for heart disease and stroke through a combination of lifestyle changes (weight control and exercise) and appropriate medications.
• Osteoporosis. For a woman who chooses to discontinue HRT, prevention of osteoporosis is a priority. The first step is making sure you are getting adequate calcium, vitamin D, and weight-bearing exercises. Together, these help to preserve bone mineral density.
For women who already have below-average bone density or confirmed osteoporosis, a family of medications called bisphosphonates (such as Fosamax and Actonel) can help rebuild lost bone strength or at least slow further decline. Other options include raloxifene (Evista) and calcitonin (a hormonal nasal spray).
Some women may be reluctant to stop HRT for fear that they will experience menopausal symptoms again, such as hot flashes. To start, Dr. Soriano suggests that his patients taper off gradually to see how they feel. If menopausal symptoms return, they may fade over time. If they do not, talk to your doctor about your options. One is to go back to HRT again, but at a lower dose. Or you can find ways to address the following specific symptoms:
• Hot flashes, night sweats. Selective serotonin reuptake inhibitors (SSRIs) may help, according to preliminary research. Also, some women may be able to use a hypertension medication called clonidine (Catapres). Another measure is to avoid things that trigger hot flashes, such as caffeine, alcohol, or spicy foods.
• Sexual function. Over-the-counter lubricants and moisturizers may reduce discomfort during sexual intercourse due to vaginal thinning and dryness. Use of topical estrogen creams or vaginal tablets and rings may also help. These act locally, without raising estrogen levels in the body.
So, for hormone therapy, the take-home messages are these: If you have been on HRT for some period of time and want to stop ...
• Do not stop taking HRT without discussing it with your doctor.
• Before discussing this decision with your doctor, make a list of the pros and cons of HRT as you understand them.
If you decide to stay on HRT to treat menopausal symptoms, use the lowest effective dose for the shortest period of time.
But it does look like it is the end of an era for hormone replacement therapy!
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