Women’s Health Initiative data—what were the real conclusions and how will these studies impact the pelvic floor?

Excerpt

After the recent publication of the “Women’s Health Initiative” studies [1, 2] on hormone replacement therapy, lay publications throughout the United States and the world issued the statement that based on a major study, hormone replacement therapy does not keep postmenopausal women generally healthy and could spur heart attacks, strokes, and other illnesses. Since that time millions of women have quit taking hormone replacement therapy. The proven benefits of hormone replacement therapy are to treat vasomotor symptoms and atrophic vaginitis and to prevent postmenopausal osteoporosis. The two “WHI” studies that have recently received the majority of the attention were directed at trying to determine if estrogen alone or estrogen in conjunction with progesterone in patients who still had a uterus had an impact on cardiovascular disease. A secondary goal was to determine the impact of these hormone replacement regimens on breast cancer. The estrogen plus progesterone study which was performed in healthy, asymptomatic postmenopausal women was terminated in May 2002 after an average of 5.2 years follow-up, the reason being the safety monitoring board concluded that the risks of combined hormone therapy outweighed the benefits. This study concluded that there was a 22% increase in cardiovascular disease, 26% increase in breast cancer, a 37% decrease in colorectal carcinoma, and a 24% decrease in fractures. The estrogen-only arm was continued and was terminated in February 2004 after nearly 7 years of follow-up. The reason this study was terminated is that the monitoring board felt that estrogen alone did not effect cardiovascular disease. This study also showed a 23% reduction in breast cancer [2]. The first study that was terminated was aggressively promoted by lay publications and the perception that there was a significant increase in heart disease and stroke with hormone replacement therapy was what led most women to discontinue their systemic estrogen. Another conclusion that was promoted was that it did not improve quality of life. There were many flaws with this study and many of these perceptions were not objectified when the data were analyzed closely. For example, the quality of life piece was an inaccurate statement as these patients were asymptomatic when they entered into the study. So, it would be difficult to improve their quality of life. They did not allow women who were having menopausal symptoms enter into the study as this would have potentially led to a high dropout rate in the placebo arm. Secondly, the mechanism for defining cardiovascular disease was not objectified prior to termination of the study. When these patients were revisited, 10% of them who were felt to have developed cardiovascular disease, in reality, had not. Unfortunately, we are now left with a huge population of menopausal women who are not and will not be on any systemic estrogen. …