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Alternatives to HRT

Alendronate (FosamaxTM), the first non-hormonal osteoporosis drug approved by the FDA, protects bone from breakdown by bone-eating osteoclasts, and it may help build new bone. However, it must be used for a long period of time to gain maximum benefit, and long-term side effects are unknown.

Calcitonin is a hormonal drug that also appears to inhibit osteoclast activity. The drug is now available in a nasal spray. Unfortunately, some patients report irritating side effects from the spray. Like Alendronate, Calcitonin’s long-term safety has yet to be established. Both drugs are expensive.

SERMs, (Selective Estrogen Receptor Modulator) include Reloxifine and Tamoxifen. Both exhibit estrogen-like action in some tissues without some (although not all) of estrogen’s defects. Reloxifine is FDA-approved for prevention and treatment of osteoporosis in postmenopausal women, and it appears not to increase the risk of breast cancer. Tamoxifen is FDA-approved for treatment of breast cancer, and it also seems to reduce bone loss.
Reloxifine and Tamoxifen resemble estrogen in that they increase the risk of blood clots. Also, neither reduces vaginal dryness; and Tamoxifen and Reloxifine actually increase hot flashes.

Plant-based estrogens (phytoestrogens) found mainly in soy and other bean products. These relieve hot flashes for some women, but may present the same threats as HRT. There are no long-term evaluations of their safety, and with soy-based products you don’t get progestin–the other component of HRT combination therapy–which is protective against pelvic cancers.

Black cohosh (for hot flashes) and wild yam root (said to promote progesterone production), have demonstrated promise, and several clinical trials are under way. But standard dosages and quality control remain to be established.

In the last two decades, millions of American women made hormone replacement therapy (HRT)–taking combined estrogen and progestin in pill form–a regular part of their daily routine. HRT’s possible benefits, from controlling menopause symptoms to offering protection from osteoporosis, Alzheimer’s and heart disease, were outlined by doctors and touted in articles and books.

Last spring, however, the National Heart, Lung, and Blood Institute of the National Institutes of Health halted their Women’s Health Initiative (WHI) study of Prempro®, an HRT drug combining estrogen and progestin, because results indicated that women taking it were somewhat more likely than the control group to suffer a heart attack or stroke. The risk of breast cancer was also slightly increased. Since then, gynecologists have been besieged by women asking about HRT’s safety, and many women who previously took HRT simply stopped on their own.
What is the story? Should all women taking HRT stop, and menopausal women plagued by hot flashes, mood swings, vaginal dryness, sleep problems, and other symptoms seek other ways to address them? And are there good alternatives? "This has created a big problem for physicians and their patients," says gynecologist Ozgul Muneyyirci-Delale, MD. "The announcement caught physicians by surprise, and the explosion of reports in the media put a lot of women in a panic. Women are very confused and stressed about this."

Now that doctors have had time to review the issues, most have changed how they prescribe HRT, but many women continue on HRT anyway because of the benefits it confers. Are they gambling with their lives? "This study focused on one brand of HRT drug only, and it did not deal with all age groups, or ask all possible questions," says Dr. Muneyyirci-Delale. "I don’t think we should completely rule out HRT, but women need to understand the arguments for and against it."

Heart Disease and Stroke Risk
A slight increased risk of heart disease in women taking HRT was the WHI study’s biggest surprise. Previous studies saw a cardiovascular benefit for women taking HRT. Analysts speculate that the earlier studies focused on women who actively chose to take HRT. Such women might be especially health conscious– more likely to exercise and control their weight than others–thereby reducing their cardiovascular risk.

The WHI study took a broader cross-section of women who were randomly assigned to either the HRT group or the non-HRT group. Result: women taking HRT had 7 more cardiovascular events per 10,000 women than those not taking HRT. This was a small increase, but the risks may rise the longer a woman takes HRT. The WHI study also reported increased risk of stroke and pulmonary embolism (blood clots in the lungs) in women taking HRT. This supported the results of previous research.

Breast Cancer Risk
It has long been known that estrogen promotes the growth of cancerous breast and pelvic tumors. But in the 1980s, pharmaceutical companies began to add a natural or synthetic form of the female hormone progestin (or progesterone) to the estrogen in their HRT preparations. This was thought to modify estrogen’s tumor-promoting effects. While the WHI study seemed to confirm that progestin does protect against cancers of the endometrium (uterine lining), breast cancers actually increased among study subjects taking HRT.

In the WHI study, for every 10,000 women taking combined estrogen-progestin HRT therapy, 38 women developed invasive breast cancer, versus 30 per 10,000 in women who took no hormones. As with elevated cardiovascular risk, the increased breast cancer risk in women taking HRT is
small, but it is believed to be cumulative over time.

HRT Benefits
Against the increases in heart disease, stroke and breast cancer risk, the WHI study found some benefits to taking HRT: reduced incidence of colon cancer; and decreased risk of fractures related to bone loss caused by osteoporosis.

Summarizing "Pros" and "Cons"
Because HRT effectively relieves menopause symptoms, from hot flashes to bone loss, national experts still endorse its short-term use. However, most physicians have modified their prescribing practices based on recommendations from the American College of Obstetrics and Gynecology. The recommendations: that estrogen dose be reduced to the minimum effective dosage, and that HRT therapy be limited in duration. Physicians are urged to monitor and evaluate each woman’s risk factors carefully before prescribing HRT, and to remind patients about its risks at every visit.
For some women, HRT is easy to rule out. Factors arguing against HRT:

• cardiovascular risk factors, including active heart disease, blood clots or history of stroke
• breast lesions and/or history of breast cancer
• long-term exposure to estrogen (taking HRT for 5 years or more)
• unusual vaginal bleeding
• liver dysfunction or disease

For other women, HRT remains an option, despite potential risk. Factors that might predispose a woman to use HRT include troublesome menopause symptoms that don’t respond to alternative treatment, or low risk factors for breast cancer and cardiovascular disease.
Questioning the WHI Study

Dr. Muneyyirci-Delale and others have misgivings about the extent to which the WHI study results already have curtailed HRT use. They point to possible flaws in the study’s design, and many believe it was ended prematurely. Women should be aware, they say, that the WHI study is probably not the final word on HRT. They point out:

• Women involved in the WHI study took a specific HRT product, Pempro®, containing particular types of estrogen and progesterone. Although probable–it is not certain –that the study’s findings apply equally to other HRT products.

• Statistically, women involved in the WHI study had a mean age of 63, and they took Prempro® (or a dummy pill, if they were in the control group) for an average of 5.2 years. The outcome might have been different if the women had begun therapy at an earlier or a later age. And, because the study was halted prematurely, it is not certain what the long-term effects of HRT therapy might be with respect to Alzheimer’s disease and long-term health.

• The WHI study focused on outcomes in terms of disease, but it did not address such quality of life issues as overall physical, mental, and emotional well-being: how the women felt, their energy levels, their joy in life.

Questioning the WHI Study
"Quality of life is important to women, and an individual might want to weigh that when deciding whether or not to take HRT," Dr. Muneyyirci-Delale says. "I have patients who stopped HRT therapy when the WHI study came out, but then went back because they weren’t sleeping well or just didn’t feel good."

If a woman knows she is at risk for breast cancer, heart disease, or stroke, the increased incidence linked to HRT should probably make her forgo HRT’s benefits. Otherwise, says Dr. Muneyyirci-Delale, "Every woman should have all the facts at her disposal, and then she should make up her mind for herself."

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