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Recent Findings from the Women's Health Initiative Trial Regarding Risks and Benefits of Estrogen-Progestin (Combined Hormone Replacement Therapy) in Healthy Postmenopausal Women

July 26, 2002, Acurian


Source: Brigham and Women's Hospital



On July 10, 2002, the results of a large study looking at the effects of hormone replacement therapy (a combination estrogen-progestin pill, also known as Prempro) on healthy postmenopausal women was published. This study, the Women's Health Initiative, is a federally funded, national study. Brigham and Women's Hospital is one of the 16 Vanguard Centers in this study of about 16,000 healthy postmenopausal women, half of whom took a combination pill of estrogen and progestin and the other half took a placebo, or "dummy" pill.


1. Why is this study in the news at this time?


The study was stopped early (after average follow-up time of 5.2 years) because the risk of invasive breast cancer was found to be slightly increased in the women who were taking the estrogen-progestin pills. In addition, the overall risks of the hormones were found to be greater than the benefits at this point.


2. What were the key findings of the study?


There were slight increases in the rates of heart attacks, breast cancer, blood clots in the lungs, and stroke. The total number of women who had these outcomes was very small, but more women in the hormone group had these events than women in the placebo group. Overall, it was calculated that if 1000 women took the medication for 10 years, there would be 7 more heart attacks, 8 more cases of breast cancer, 8 more strokes, and 8 more blood clots in the women who took the hormones compared to those who did not.


3. If I am taking hormone replacement therapy, should I stop?


This depends on why you are taking the medication and for how long. If you have been taking the medication for over five years, you should talk to your doctor about stopping. If you were started on this medication for hot flashes that were preventing you from performing your daily activities, and you have been taking the medication for less than 5 years, you should discuss staying on the medication with your doctor. This would be a good time to review the risks of the medication once again with your doctor.


4. What if I am taking estrogen only?


There is a separate study being conducted by the Women's Health Initiative that is looking at the effects of taking estrogen only (no progestin, such as Provera). This study has NOT been stopped, since so far, there is no evidence of increased risk of breast cancer. You should only be on estrogen alone if you do not have a uterus (in other words, if you have had a hysterectomy). If you are taking estrogen alone and have a uterus, please talk to your doctor about this, since there is an increased risk of uterine cancer in women who have a uterus taking estrogen without a progestin.


5. What about transdermal estrogens (skin patches), or other forms of hormone replacement therapy?


The Women's Health Initiative specifically studied the effects of the combination premarin (conjugated equine estrogens) and provera (medroxyprogesterone acetate) since this is the preparation that was shown to be beneficial in previous observational trials. Although these findings do not directly apply to other types of hormone replacement therapy, such as skin patches, synthetic estrogens, or other forms of progestin, there is very little evidence that these other forms of estrogen provide any benefit and they are not recommended at this time.


6. Are there any benefits to being on HRT?


The study did find small decreases in the risk of bone fractures and colon cancer, but these benefits are smaller than the risks listed above. The National Cancer Institute has stated specifically in response to this study, however, that HRT should not be used for the purpose of preventing colon cancer.


7. Is there a greater risk of death for people on HRT?


No, this study did not show an increase in death rates in the women taking the medication.


8. If I choose to stop the medication, can I quit "cold turkey"?


Yes. If you have a return of your menopausal symptoms after quitting, you can go back on the medication and discuss with your doctor a slower tapering of the medication.


9. Do I need to quit taking the medication immediately?


No, this is not an emergency. The absolute risk of being on this medication is still quite low, but enough to raise concerns about staying on the medication long-term. You may wait until your annual appointment with your doctor to discuss more fully.



10. What else could I use for my menopausal symptoms?


Other treatments are available for the treatment of hot flashes, including medications called SSRIs, which are also used for depression or (MaryO Note:  They didn't say what went after the "or"). For symptoms of vaginal dryness, vaginal estrogen preparations may be used, which are absorbed only minimally into the bloodstream. Some patients have used soy supplements or increased their dietary soy intake and have found this to be effective in reducing hot flashes, although there are no good studies proving that soy products are really beneficial.


11. What if I was taking HRT to reduce my risk of osteoporosis or heart disease?


There are several other excellent treatment options for osteoporosis which you should discuss with your doctor. At the present time, there is no evidence that combination hormone replacement therapy prevents heart disease. However, there are other medications that have been shown to prevent heart disease (such as aspirin, cholesterol lowering drugs, and others) and you should discuss whether any of these medications would be of benefit to you. Finally, many lifestyle changes, such as getting regular exercise, eating a healthy diet, maintaining a healthy body weight, quitting smoking, and limiting your alcohol intake have been shown to be very effective in preventing heart disease.

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