A major multi-centre clinical trial, the Women's Health Initiative, was halted in July 2002 when experts judged that health risks outweighed benefits for combined estrogen+progestin. The rate of women experiencing coronary heart disease increased by 29% (relative to a placebo), stroke rate was 41% higher, the incidence of blood clots doubled, and there was a 26% increase in invasive breast cancer. The benefits included a 37% reduction in colorectal cancer rates and a one-third reduction in hip fractures. "The trial results indicate that treatment for up to 5.2 years is not beneficial overall. The risk/benefit profile is not consistent with the requirements for a viable intervention for the primary prevention of chronic diseases ... . We recommend that clinicians stop prescribing this combination or long-term use."
(Journal of the American Medical Assoc., July 17, 2003)
Such was the hype surrounding these combination hormones that many doctors and women found it difficult to accept these findings. Many women thought that hormone therapy made them feel better, more energetic, mentally sharper and more sexually responsive. Or so they thought. Based on the random assignment of 16,000 women to take either the estrogen/progestin combination or a placebo, "study results show that the pills had no significant effect on the quality of life of a large group of post-menopausal women. Women who took the pills did not feel any healthier or more vital than comparable women who took placebos, nor did they have more sexual pleasure. Compared with those in the placebo group, their minds were no clearer, their memories no better and their mental health no different... . The results should shake the confidence of everyone who has believed, on the basis of anecdotal reports and less rigorous scientific studies, that hormone treatments made women feel better. A lot of the presumed benefit may have had a placebo effect."
(New England Journal of Medicine)
Nor is the news any better for women on estrogen only, i.e., women who have had hysterectomies. In March of this year, the U.S. National Institutes of Health halted the estrogen-only arm of the Women's Health Initiative. This involves 11,000 women who were taking Premarin, the best-known and most thoroughly tested of any synthetic estrogen product for menopause.. "With an average of nearly seven years of follow-up completed, estrogen alone does not appear to affect (either increase or decrease) heart disease, y question of the study," said the National Heart, Lung and Blood Institute in a prepared statement. "At the same time, estrogen ... appears to increase the risk of stroke and decrease the risk of hip fracture. It has not increased the risk of breast cancer during the time period of the study." Because the increased risk of stroke is similar to that found with the estrogen/progestin combination, it was decided to halt the study.
(Reuters Health Information)