The Women’s Health Initiative is a long-standing nationwide health study that has been concentrating on ways to prevent a variety of diseases and conditions in women who are in the postmenopausal stage of life. Some of these diseases and conditions include: cancers of the breast and colon, heart disease and osteoporotic fractures. The hormone replacement therapy (HRT) trials focused on the effects of estrogen and a combination of estrogen and progestin. The women who participated in the trials were placed into one of two groups: women who took the hormone pills and women who took a placebo. Each woman participated in her respective therapy and follow-up.
Estrogen- Plus Progestin Study
On July 7, 2002, the Estrogen plus Progestin Study conducted by the Women’s Health Initiative came to a halt. Originally there were two groups of women involved in the hormone replacement therapy study: women taking the study hormone replacement pill and women taking a placebo. During the study it became evident that those taking the active pill were experiencing a higher risk of breast cancer and heart disease than those who were taking the placebo. The study revealed that those women taking the hormone replacement pill were at a higher risk of developing breast cancer, heart disease, stroke, and blood clots but were at a lower risk for colon cancer and fractures. Generally speaking, the study came to the conclusion that the health risks outweighed the health benefits.
A follow up study was conducted between July 8, 2002 and March 31, 2005. The follow up study was done to assess the effects of the hormone replacement therapy on the women after it was discontinued. The focus was on the benefits and risks involving breast cancer and heart disease as well as stroke, endometrial cancer, hip fractures, colorectal cancer, pulmonary embolism and death resulting from other causes.
At the end of the three year follow up study, the Women’s Health Initiative found that the risk of heart disease, blood clots, and stroke had decreased in those women who had taken the active estrogen plus progestin pill. The risks were now the same for both study groups. In addition, the low risk factor for colorectal cancer had disappeared for those women who had taken the hormone replacement pill. Furthermore, the results also revealed that the benefit for fractures had also disappeared for those taking the study pill. On the contrary, the study did find that the women who had taken the hormone replacement pill were at a higher risk for a variety of cancers. The results revealed that after discontinuing the hormone replacement therapy, those women who had taken the hormone replacement pill had a slightly higher rate of death, regardless of cause, than those women who had taken the placebo.
Based on the information found from this study, it can be concluded that the health risks are much greater than the health benefits. In addition, the study found that hormone replacement therapy is not an option for preventing disease in healthy, postmenopausal women.
Estrogen- Only Study
The Estrogen only study was focused on women who had had a hysterectomy. The hormone replacement therapy ended in March of 2004. Again, these women were randomly placed into one of two groups: those who took the estrogen study pill and those who took a placebo. The initial findings mimicked those of the estrogen plus progestin study in that estrogen did not guard against heart disease. The results also found that the women who took the estrogen pills were more at risk of having a stroke, and developing deep vein thrombosis, which could lead to lethal blood clots. The women were followed for seven years after the estrogen therapy was discontinued. The results revealed that the effects the hormones had on a woman’s health could be reversed if the estrogen therapy was not used for an extended amount of time.
When not to use hormone therapy
Based on the Women’s Health Initiative findings, the following has been concluded: Hormone replacement therapy is not effective in preventing heart disease. The results found that estrogen- plus progestin essentially increase the possibility of a first heart attack. In addition, it also increases the risk of breast cancer. Furthermore, it is highly recommended that women who have heart disease do not use HRT to prevent future heart disease. The risk of blood clots increases with the use of the hormone therapy.
Recommendations for the Menopausal Years
• Schedule breast exams and mammograms on a regular basis
• Schedule clinical exams on a regular basis
• Check blood pressure at least once every two years
• Check cholesterol count at least once every five years
• Check blood glucose level at least once every three years
• Check bone mineral density occasional
• Check Body Mass Index (BMI) and waist circumference at least every two years
Recommendations for Lifestyle Changes
• Stay physically active
• Follow a healthy nutrition plan: dark, green vegetables, whole grains, fruits, low amounts of cholesterol, salt, saturated fats, and trans fats.
• Supplement diet with calcium and vitamin D for strong, healthy bones
• Keep blood pressure under control
• Keep diabetes under control
• Refrain from smoking
• Consider alternative medication options
U.S Food and Drug Administration Guidelines for Menopausal Hormone Replacement Therapy
Hormone replacement therapy is useful in treating moderate to severe night sweats, hot flashes, and vaginal dryness. In treating osteoporosis, doctors are encouraged to use other treatment options before turning to hormone replacement therapy. If HRT is used for osteoporosis, then the risks of osteoporosis must be greater than the risks of estrogen- plus progestin or estrogen. If hormone therapy products are being prescribed to treat only vaginal symptoms, it is highly recommended that doctors use topical vaginal products. Hormone replacement therapy is not approved for memory loss, Alzheimer’s disease and other cognitive disorders. Furthermore, the Women’s Health Initiative found that the risk of developing dementia is higher in women who have been treated with HRT. It is recommended that menopausal hormone replacement therapy be used in low doses for a limited time. At this time, the doses that cause the least amount of serious side effects are not known.
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