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The Woman's Health Initiative Study (WHI) has just stopped the estrogen-only part of the research. It was back in July of 2002 that the estrogen+progestin part of the research was stopped because the combination-hormone-pill, "PremPro," was shown to increase the risk of breast cancer, heart attacks, strokes and blood clots. Now, the second part of the study (where women only took the estrogen, Premarin) has been stopped because they found the same increased risk of strokes as they found earlier in the PremPro part.
What was very interesting was that the women who only took Premarin did not have any increase in heart attacks -- and, more dramatically, they did not have any increase in breast cancer. So from this monumental study, we now have strong evidence that taking estrogen alone does not increase the risk of breast cancer, and does not increase the risk of heart attacks.
The increased risk of having a stroke was 8 per 10,000 woman, per year - in women who took Premarin 0.625 mg. every day. That is a risk of 0.08% per year. That means if you take Premarin every day for 12.5 years, you increase your overall risk of having a stroke by 1%. (Do the math.)
Questions remain. What if you take an aspirin every day with your Premarin? Aspirin most likely reduces the risk of a stroke more than 0.08% per year . . . so you may come out with an overall reduced risk.
Another unanswered question is - what if you get your estrogen transdermally (by way of a skin patch, vaginal ring or estrogen lotion) rather than by taking a pill. Transdermally the hormone avoids the first pass through the liver and therefore you prevent certain harmful changes in the blood clotting factors that occur as a result of taking hormone pills. You may avoid the increased risk of having a stroke.
The bottom line is, "We don't know." And as a result of the hoopla, confusion and hysteria surrounding the WHI, we probably never will. Read the story as just reported:
NIH halts study of estrogen therapy
BY RONI RABIN
March 3, 2004
March 3, 2004
For the second time in two years, the National Institutes of Health has halted a massive women's health study, telling postmenopausal participants to stop taking estrogen because it does not protect them from heart disease even as it increases the risk of stroke. Preliminary review of the study's findings indicates that estrogen does protect women from hip fractures, but also may slightly increase the risk of developing dementia or mild cognitive impairment, NIH officials said.
"This reinforces the previous recommendation that women should not take hormone therapy to prevent heart disease," said Dr. Barbara Alving, director of the Women's Health Initiative. If women are considering estrogen therapy for relief of severe menopausal symptoms such as hot flashes, she said, "they should use it at the lowest doses, for the shortest period of time."
"This reinforces the previous recommendation that women should not take hormone therapy to prevent heart disease," said Dr. Barbara Alving, director of the Women's Health Initiative. If women are considering estrogen therapy for relief of severe menopausal symptoms such as hot flashes, she said, "they should use it at the lowest doses, for the shortest period of time."
Hormone treatments are still approved for relief from moderate to severe hot flashes and symptoms of vulvar and vaginal wasting.
The estrogen-only study followed 11,000 healthy postmenopausal women, aged 50 to 79, who had previously undergone hysterectomy. It became apparent fairly early that women taking estrogen faced a slightly higher risk of stroke than the control group taking a placebo pill, NIH officials said, and participants were warned about the increased risk.
Women taking estrogen had eight more strokes a year for every 10,000 women, an increase in risk similar to the increased risk of women taking a combination of estrogen plus progestin, NIH officials said.
One intriguing finding was that estrogen alone, long suspected as a culprit in breast cancer, did not increase the risk during the time period of the study. "We were surprised," Alving said. "There was a great deal of conjecture about this."
More detailed analysis of data from the study will be reported in the next two months and published in medical journals, NIH officials said.
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