What have we learned from the WHI?
Almost twenty years ago the NIH established the WHI, or Women's Health Initiative, with the overall goal of reducing coronary artery disease, osteoporosis, and breast and colorectal cancer in postmenopausal women. It was a combination of clinical trials and observational studies which were designed to test the effects of hormone therapy, diet modifications, and calcium and vitamin D supplements on these common causes of death, disability, and impaired quality of life in older women. Over 160,000 patients, ages 50-79, took part in this multi-million dollar program.
The studies have now ended; however, reports are continuing to come out as the "follow-up phase" concludes. Physicians and patients alike can learn much from the results and hopefully will utilize them to identify risk factors for these health problems, and ultimately prevent them.
Not surprisingly, menopausal women have been most concerned about the results of the studies which looked at the benefits and potential adverse effects of hormone therapy. For decades, these patients have almost routinely been prescribed hormones, and previous research studies have done little to clarify some of the controversial issues that have arisen through the years.
The WHI set out to examine the long term effect of Estrogen plus Progestin on the prevention of heart disease and osteoporotic hip fractures, while monitoring for possible increases in risks for breast and colon cancer. (Progestins are given to women who take estrogen and have an intact uterus, since progestins have been shown to protect against endometrial cancer, a known effect of unopposed estrogen.) A separate study of estrogen alone (in women who had undergone hysterectomies) was also begun. Both studies compared the hormones to placebos.
The main findings in the Estrogen + Progestin arm of the study are as follows:
- Compared to placebo, the number of women who developed breast cancer was higher in women taking the hormones (a finding noted abut 5 years into the study);
- The number of women who developed heart attacks, strokes, or blood clots in the lungs was higher in women taking the hormones;
- The number of women who had hip fractures or colorectal cancer were lower in the women taking the hormones;
- There was no difference in the number of women who developed endometrial cancer.
- Compared to placebo, estrogen alone resulted in no difference in risk for heart attacks, but there was a slight increased risk of strokes and blood clots;
- No absolute increase in breast cancer was found in women on estrogen alone;
- There was no difference in the risk for colorectal cancer;
- There was a reduced risk of osteoporotic hip fractures in women on estrogen alone, as compared to placebo.
So what are menopausal women supposed to do about those annoying symptoms? First of all, don't panic! Hormones are still approved by the FDA for relief of moderate to severe vasomotor symptoms (hot flashes) and symptoms of vulvar and vaginal atrophy. Secondly, although hormone therapy is effective for prevention of postmenopausal osteoporosis, it should only be considered for women at significant risk of fracture who cannot take non-estrogen medications. Thirdly, hormones should not be taken to prevent heart disease, as was commonly done before the results of WHI became available.
It is recommended to use hormone therapy at the lowest dose that improves the patients' symptoms and for a reasonably short duration of time. This will vary from patient to patient, of course.
There are alternatives to hormone replacement which have been shown to be somewhat effective against hot flashes. Also, lifestyle changes can make a difference. For example, dressing to avoid being too warm ("layer" clothes), avoiding spicy foods, alcohol, and caffeine, getting enough sleep, reducing stress, and being physically active may offer relief.
The most important thing women can do is to continue to educate themselves on these important issues. Keep up to date with your preventative physical exams and talk to your doctor about your own individual health risks. Not only could this add years to your life, but it may also greatly increase the quality of life you have during those years!