Midlife and Menopause
Menopause and Hormone Therapy
For years women’s health activists urged caution in the use of hormone therapy (HT), arguing that the long-term benefits and risks were scientifically undocumented. In 2002 the first major clinical trial to assess HT use by healthy women confirmed what some of us feared: that there are serious health risks associated with the long-term use of hormones, and that these risks may outweigh the health benefits.
The Women's Health Initiative (WHI) was a 15-year national health study designed to address the most common causes of death, disability, and poor quality of life in postmenopausal women -- cardiovascular disease, cancer, and osteoporosis. Sponsored by the National Institutes of Health (NIH), WHI began in 1991 and followed more than 160,000 generally healthy post-menopausal women. The clinical trials tested the effects of postmenopausal hormone therapy, diet modification, and calcium and vitamin D supplements on heart disease, fractures, and breast and colorectal cancer.1
The WHI included two hormone therapy trials: a estrogen plus progestin study of women with a uterus and an estrogen-alone study of women without a uterus. The estrogen plus progestin arm of the study was halted in July of 2002, three years before its scheduled conclusion, because investigators found increases in breast cancers, heart disease, strokes, and blood clots in women who took estrogen-progestin pills. Additional analysis of the data showed that the estrogen-progestin combination did not help with depression, sexual function, vitality, or cognition, and doubled the risk of developing dementia.2 The combination did reduce the risk of fractures and colon cancer.
The estrogen-alone study was stopped in March 2004, when investigators announced three findings: estrogen alone does not appear to affect heart disease, does appear to increase the risk of stroke, and does appear to decrease the risk of hip fracture.3
While media coverage of the study has been extensive, few have probed beyond the actual results to the larger questions raised. For years healthy women were advised by physicians and medical advisory bodies to take HRT during and after menopause to help prevent heart disease and osteoporosis. How did an unproven treatment become the standard of care for millions of healthy women? Below are several resources that explore this question in depth.
- In her new book, The Greatest Experiment Ever Performed on Women: Exploding the Estrogen Myth Barbara Seaman examines how and why hormones were manufactured, marketed, and prescribed, despite a lack of evidence on efficacy and safety and in spite of mounting evidence of risk. Her book shows that the widespread belief that hormones were good preventive medicine was a triumph of marketing over science. We’ve posted a review of the book by the National Women’s Health Network’s Cindy Pearson.
- In The Medicalization of Menopause, Kathleen O'Grady of the Canadian Women’s Health Network discusses the risks of viewing menopause as a disease or an ailment rather than as a natural stage of a woman’s life. Her analysis of the hormone therapy debacle points to the need for revisions in guidelines for pharmaceutical companies and the importance of basing medical recommendations on evidence-based research.
To find out more about "natural" or bioindentical hormones, see:
1 Some aspects of the WHI, including the observational study, the community prevention study, and the dietary modification and calcium/vitamin D trials, continue today. For more information see the Women’s Health Initiative website
2 Hays et al, “Effects of Estrogen plus Progestin on Health-Related Quality of Life.” NEJM, 3/17/03. http://content.nejm.org/cgi/content/abstract/NEJMoa030311v1
3 NHLBI Press Release: WHI Study Finds No Heart Disease Benefit, Increased Stroke Risk with Estrogen Alone, April 13, 2004 http://www.nhlbi.nih.gov/new/press/04-04-13.htm
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