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FirstHealth of the Carolinas
Hormone therapy: Making sense of it all By Christine Cardellino
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If you’re going through menopause, or have been there, you’ve probably experienced some common symptoms of this inevitable life milestone: hot flashes, night sweats, headaches, mood swings and maybe even depression.

Hormone therapy—which comes in pills, patches and topical creams—is widely known to provide symptom relief, but many menopausal women are unsure about taking hormones because they’ve heard mixed reviews about the safety of long-term use.

According to Elizabeth Shaw, Ph.D., OGNP, a board certified OB/GYN nurse practitioner with Pinehurst Surgical Women’s Care Center, the widespread decline in hormone therapy began in 2002, after the National Institutes of Health (NIH) abruptly halted a major long-term clinical study designed to test the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer.

The study, called the Women’s Health Initiative (WHI), examined two types of therapy: an estrogen-plus-progestin study of women with a uterus and an estrogen alone study in women who had their uterus removed. In both hormone therapy studies, researchers randomly assigned women either to the study medication or placebo. More than 16,000 postmenopausal women participated in the studies.

“The WHI was halted prematurely after five years, because the findings suggested hormone therapy did not protect against heart disease as we once believed,” says Shaw. “On the issue of breast cancer and hormones, researchers also saw a small, but not statistically significant, increase in the risk of breast cancer among women taking combination therapy, which also led to the early termination of this study.”

Researchers also found an increased risk of blood clots, stroke and dementia in the women who took the combination estrogen-progestin pill. Faced with clinical evidence about these potential health hazards, the medical community began to reevaluate its use of hormone therapy in postmenopausal women.

William Terry, M.D., a board certified OB/GYN specialist with Pinehurst OB/GYN Associates, believes the WHI, although well intended, was not well designed. “The media gave the WHI more credibility than was due,” he says. “The study enrolled women who were not appropriate candidates for hormone therapy and excluded women with mood swings, hot flashes and other problematic menopausal symptoms. The wrong group of women was studied. It’s like evaluating a blood pressure medication but excluding people with high blood pressure.”

In October 2004, after reviewing WHI findings, the American College of Obstetricians and Gynecologists issued a task force report about menopausal hormone
therapy:

… It’s important to keep in mind that the WHI was designed to investigate whether or not hormone therapy or estrogen therapy could prevent disease—not whether they relieve menopausal symptoms. In fact, most of the women in the WHI were 10 years older than women who use hormones to relieve menopausal symptoms, and most of the WHI study participants had no menopausal symptoms while they were enrolled in the study. So although the WHI clearly showed that hormones should not be used for disease prevention, they are still appropriate as a treatment for the relief of menopausal
symptoms.

(Read more at www.acog.org/from_home/publications/press_releases/nr10-01-04.cfm)

Hormones do help
For many menopausal women, hormone therapy helps alleviate one of the most debilitating
symptoms of menopause: hot flashes. The American College of Obstetricians and Gynecologists (ACOG) hormone therapy task force found that menopausal hormone therapy, either in pill or patch form, can reduce hot flashes by up to 90 percent.

During a hot flash, the face and neck become flushed and blotches may appear on the chest, back and arms. Heavy sweating and cold shivering can follow.

“People often don’t realize how debilitating hot flashes can be,” says Dr. Terry. “They not only disrupt a woman’s sleep, but also have a ripple effect on mood, coping ability, and relationships at home and at work.”

With the loss of estrogen at menopause, women also can experience vaginal dryness or vaginal
atrophy, which can lead to painful intercourse. Physicians often prescribe hormone therapy to
treat this problem.

“After menopause, vaginal lubrication is diminished, and tissues become dry and irritated,” says
Shaw. “Even low-dose therapies and topical estrogen creams can relieve the dryness and significant discomfort that accompanies this condition.”

“Vaginal hormones, such as a slow-release ring, cream, or vaginal pill are necessary for a lot of
women,” says Dr. Terry. “The ring is particularly useful for women with breast cancer, because it
provides a low dose of estrogen that is released slowly.”

Hormone therapy also may protect postmenopausal women from osteoporosis, a potentially
disabling disease caused by loss of bone mass. According to the National Osteoporosis
Foundation, of the 10 million Americans believed to have osteoporosis, 80 percent are women.

Osteoporosis is a major cause of bone fractures in post-menopausal women.

“Estrogen therapies protect against not just osteoporosis, but also osteopenia (early-stage bone loss),” says Shaw. “We get very concerned about osteoporosis, because many active, healthy women suffer fractures that impact their mobility and quality of life. In fact, hip fractures in women are associated with significant morbidity and mortality. It’s important to help prevent this.”

Proceed with caution
Current guidelines from the ACOG and the North American Menopause Society emphasize that hormone therapy be prescribed at the lowest effective dose and used for the shortest duration possible.

“We used to prescribe very high doses of estrogen, telling patients they would be taking it for the rest of their life,” says Shaw. “Now we tell them therapy is for a limited time and get them on as low a dose as possible. We’re using five years as a guideline, although that is not supported by any medical research. After five years of menopausal hormone therapy, we evaluate a woman’s symptoms and medical history and make a mutual decision if she will continue treatment.”

For some women, a type of antidepressant known as a selective serotonin re-uptake inhibitor (SSRI) may relieve hot flashes in addition to depressive symptoms of menopause.

“Antidepressants don’t work for everybody, but they’re something to try and a good option for women with breast cancer who can’t take any kind of hormones for five years after their diagnosis,” says Dr. Terry.

Herbal hype
Herbal nutritional supplements and over-the-counter remedies promise to make menopause more comfortable and tolerable, but these products and their marketing claims are neither supported by scientific studies nor regulated by the U.S. Food and Drug Administration (FDA). Some of the most recognized herbal remedies for menopause include soy and isoflavones, St. John’s wort, black cohosh, evening primrose, dong quai and ginseng.

“One of our biggest concerns is that the herbal market is not regulated by the federal government and, therefore, medical providers do not have confidence in the control, safety or effectiveness of these products,” says Shaw.

“Potency can vary. Some have little estrogen—and some have a level of estrogen that puts people at high risk for abnormal bleeding and blood clots. There have been no large-scale studies to support use of these products, and we don’t know enough at this point to recommend herbal supplements.”

Shaw cautions against products that are labeled as “natural.”

“Someone has figured out when women see the word ‘natural,’ they feel the product is safe and better for them, and even without risks,” she says. “But it’s very important for women to understand that estrogen-containing products, whether prescribed by your health care provider or purchased over the counter, are made from the same synthetic, animal or plant source. Many of the products you can buy over the counter contain plant extracts in addition to chemically synthesized hormones.

If you decide to take herbal therapies or compounded hormonal therapies, you should tell your doctor, as these products have the potential to cause drug interactions with other medications you may be taking.”

A personal decision
If you are menopausal and considering hormone or antidepressant therapy to relieve your symptoms, talk to your health care provider.

“Therapy is very individualized now, and all women deserve in-depth education on the risks and benefits of hormone therapy to help them make an informed decision,” says Shaw. “Also, for women taking menopausal hormone therapy, it’s very important that they see their provider once a year to discuss whether they are ready to stop hormone therapy and see what new research is available to help them make that decision. All women also should continue their annual breast cancer screening, including a clinical breast examination and periodic mammograms, in addition to an annual gynecological exam.”