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Hormone Replacement Therapy: Research Update

Rosemark is dedicated to providing you with the latest research findings regarding Hormone Replacement Therapy (HRT) and to helping each woman determine if HRT is right for her.

HRT is the female hormones—estrogen and progesterone—that a woman can take to alleviate menopausal symptoms such as hot flashes, moodiness, insomnia, and vaginal dryness. (Please read our article about Menopause for further information). After reading this article, discuss your individual case, concerns, and questions with your health care provider. What is best for your sister or friend may not be best for you.

The Study

The Women’s Health Initiative (WHI) is a long-term study sponsored by the National Institute of Health (NIH) that is looking at ways to prevent heart disease, breast and colon cancers, and osteoporosis.

One arm of the study followed 16,608 healthy postmenopausal women (with a uterus), ages 50-79. Women in this arm of the study were randomly put into one of two groups: the first group of women took Prempo (which is Premarin or conjugated equine estrogen 0.625 mg/day and Provera or medroxyprogesterone acetate 2.5 mg/day); and the other group took a placebo (sugar pill).

The other arm of the study looked at women with no uterus. These women were given estrogen-only therapy.

The study was designed to assess the major benefit and risks of HRT with regard to heart disease, blood clots in the lungs, breast cancer, colon cancer, and osteoporosis/bone fractures. Other factors, such as reduction in hot flashes, moodiness, and vaginal dryness, were not assessed.

During the study, the data collected during the first 3-4 years indicated a small increase in heart attacks, strokes, and blood clots in women taking hormones. But it was not until the 5th year of the study that the data indicated for the first time that the number of cases of invasive breast cancer in the Premarin (estrogen) and Provera (progestin) group had crossed the boundary established as a signal of increased risk. The study was halted in May 2002 with this group in the study; however, the other part of the study with the groups of women taking estrogen-only therapy and placebo continues.

Putting the Risks into Perspective

The data indicated that if 10,000 women take the studied HRT regimen for one year, as compared to 10,000 women taking placebo, the following risks would occur:

Negative predictions:
  -8 more women will develop breast cancer
  -7 more women will have a heart attack
  -8 more women will have blood clots in the lungs
  -8 more women will have a stroke
Positive predictions:
-6 fewer women will have colorectal cancer
-5 fewer women will have hip fractures

The increased breast cancer risk did not appear in the first 4 years of use. Increased risk for blood clots was greatest during the first 2 years of hormone use. The reduced risk of colorectal cancer occurred after 3 years of hormone use.

Limitations of the Study

The study does not look at the benefits of HRT to relieve menopausal symptoms, such as hot flashes, moodiness, insomnia, and vaginal dryness. For many women, these benefits are very important! (See our article about Menopause for treatments of these symptoms).

The study used only ONE preparation of HRT (Premarin 1.625 mg/day and Provera 2.5 mg/day). The data from the WHI cannot be applied to ALL of the different HRT therapies containing estrogen and progestin, such as Estrace, Prometrium, and the HRT patch (these contain different types of estrogens and progestins). However, other HRT therapies have NOT been studied in this way, so it cannot be assumed that they are different (better or worse) than those studied.

Until more studies are completed on other HRT therapies, it is recommended women using all types of HRT talk to their health care provider and weigh the risks and benefits as discussed in this update.

Applying the Risks to Individual Situations

The percentage of women in the WHI study who actually had negative effects from HRT was small, as was the size of the risk for each individual woman taking HRT.

For example, while the increased risk of breast cancer for the group taking HRT was 26%, an individual woman’s increased risk for breast cancer with HRT use was less than one tenth of the percent a year, according to the study authors. However, this small increase in individual risk goes up over time. In other words, the longer a woman stays on HRT, the more risk she has for developing breast cancer—even a higher risk than would normally occur with advancing age.

Recommendations for Women Who Want to Take HRT

If you are presently taking HRT, it is very important to talk to your health care provider before changing your therapy or stopping HRT. Together, you can determine what is best for you in regard to HRT!

Short-Term Relief of Menopausal Symptoms	For women taking HRT for short-term relief of menopausal symptoms, the benefits of HRT are likely to outweigh the risks.
Long-Term Relief of Postmenopausal Symptoms	Women may find that longer-term use of HRT to relieve symptoms such as vaginal dryness, hot flushes, and insomnia coupled with the proven benefits of prevention of fractures and reduction of colon cancer may outweigh the risks of HRT. You should discuss alternative treatments for these symptoms, as well as an assessment of your individual risks for heart disease, stroke, and breast cancer, with your doctor.
Alternative Treatments for Symptoms	These lifestyle changes can reduce (not eliminate) symptoms of menopause: Stop smoking. Avoid triggers to hot flashes such as spicy foods, caffeine, and alcohol. Decrease stress. Exercise regularly. Wear loose clothes
Other Medications	clonidine (high blood pressure medication) particular antidepressants, and estrogen vaginal cream. There have been few studies regarding herbal preparations and effective treatment for menopausal symptoms and the results of these studies are conflicting and inconclusive. Some women have found the following to be helpful: soy products and black cohosh (to help with hot flashes), chaste-tree or vitex (to help with loss of sexual interest and vaginal dryness), and others. Remember, many herbal preparations are not well-studied and none are regulated by the government—so you cannot be certain what or how much of an herb or contaminant you are getting in a given bottle. It is recommended you talk to your health care provider about alternative methods to relieve menopausal symptoms.
Cardiac Protection	If you are taking or considering HRT only for the prevention of heart disease, we encourage you to talk to your health care provider about other methods to lower your risks.
Osteoporosis	If you are taking or considering HRT only for the prevention of osteoporosis, we encourage you to talk to your health care provider about your personal risks and benefits for continuing the drug therapy. There are alternatives to long-term prevention of osteoporosis that should be considered.
Individualized Care	For individual care, we encourage you to talk with your health care provider about your particular symptoms, risk factors, options, and the benefits that best suit your current needs.
Women with a Hysterectomy	So far, the arm of the WHI study that concerns women with a hysterectomy continues. The same proportion of risks to benefits has not appeared. Complete results probably will not be known until later in 2005. Individual consideration should apply to these women, as well. If you fit into this category, talk to your health care provider. Note: Women who have a uterus should NOT take estrogen alone – it has been proven to increase risk for uterine cancer. Also, if a woman has had a hysterectomy and had endometriosis, she may still need progesterone to control growth of implants. 16 cases in literature have been reported in which malignancy developed in endometrial tissue of women when treated with unopposed estrogen.

References

Birge, SJ, Gass, M, & Ravinkar, VA. (2003). The Women’s Health Initiative: Where do we go from here? The Female Patient, Supplement Jan 2003, 1-24.

Hendrix, SL. (2002). Summarizing the evidence. The Female Patient, Supplement Nov 2002, 32-34.

Lobo, RA. (2002). HRT and menopausal health: Clinical implications of recent data. Baltimore, MD: The John Hopkins University School of Medicine and The Institute for John Hopkins Nursing.

NAMS Report. (2003). Amended report from the NAMS Advisory Panel on postmenopausal hormone therapy. Menopause, 10(1), 6-12.

Zacur, H, Appling, SE, Freedman, M, & Rice, VM. (2002). Menopausal health and hormones: Enhancing patient management. Baltimore, MD: John Hopkins University School of Medicine and The Institute for Hopkins Nursing.

Other Resources

Grady, DA. (2002). A 60 year old female trying to discontinue HRT. JAMA 287, 2130-2137.