Hormone Replacement Therapy

Estrogen replacement therapy (ERT), the use of estrogen to supplement that which is no longer being produced by the body, and hormone replacement therapy (HRT), in which estrogen and progestin (a synthetic progesterone) are used in combination, have been the subject of great controversy over the years.

To learn more about women's health, and specifically hormone replacement therapy, the National Heart, Lung, and Blood Institute of the National Institutes of Health (NIH) launched the Women's Health Initiative (WHI) in 1991. The study continues today and consists of a set of clinical trials and an observational study, which together involve more than 161,000 generally healthy postmenopausal women.

The  clinical trails were 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 hormone trial had two studies: the estrogen-plus-progestin (HRT) study of women with a uterus and the estrogen-alone (ERT) study of women without a uterus. Women with a uterus were given progestin in combination with estrogen, a practice known to prevent endometrial cancer. In both hormone therapy studies, women were randomly assigned to either the hormone medication being studied or to placebo (inactive substance). The initial phase in both studies has ended, and women are now participating in a follow-up phase, which should last until 2007.

The HRT study in initial phase, concluded in 2002, found that compared with the placebo, estrogen plus progestin resulted in:

• increased risk of heart attack
• increased risk of stroke
• increased risk of blood clots
• increased risk of breast cancer
• reduced risk of colorectal cancer
• fewer fractures
• no protection against mild cognitive impairment and increased risk of dementia (study included only women 65 and older)

The ERT study initial phase, which ended in 2003, found that compared with the placebo, estrogen resulted in:

• no difference in risk for heart attack
• increased risk of stroke
• increased risk of blood clots
• uncertain effect for breast cancer
• no difference in risk for colorectal cancer
• reduced risk of fracture
• findings about memory and cognitive function are not yet available

The WHI recommends that women follow the Food and Drug Administration (FDA) advice on hormone (estrogen-alone or estrogen-plus-progestin) therapy. It states that hormone therapy should not be taken to prevent heart disease.

These products are approved therapies for relief from moderate to severe hot flashes and symptoms of vulvar and vaginal atrophy. Although hormone therapy is effective for the prevention of postmenopausal osteoporosis, it should only be considered for women at significant risk of osteoporosis who cannot take non-estrogen medications. The FDA recommends that hormone therapy be used at the lowest doses for the shortest duration needed to achieve treatment goals. Postmenopausal women who use or are considering using hormone therapy should discuss the possible benefits and risks to them with their physicians.

The National Heart, Lung, and Blood Institute offers the following suggestions for women who are deciding whether or not to use postmenopausal hormone therapy:

• Because the study involved healthy women, only a small number of them had either a negative or positive effect from estrogen plus progestin therapy. The percentages describe what would happen to a whole population - not to an individual woman. In the estrogen plus progestin therapy study, the increased risk of breast cancer was less than a tenth of one percent each year. When this risk is applied to a large group of women and over several years, then the number of women affected becomes a public health concern.
• The most important thing a woman can do in deciding to continue hormone replacement therapy is discuss the current research with her physician and healthcare team.
• Women need to be aware that taking a combined progesterone and estrogen regimen or estrogen alone is no longer recommended to prevent heart disease. A woman should discuss other alternatives of protecting the heart with her physician.
• Women should discuss with their physicians the value of taking combined progesterone and estrogen replacement therapy or estrogen to prevent osteoporosis. There may be alternative treatments based on a woman's unique health profile.

Always consult your physician for more information.

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