The national heart, lung and blood institute of the national institutes of health has put an early stop to a major clinical trial of the risks and benefits of combined estrogen and progestin in healthy menopausal women.
"The decision to stop early was made because there was increased risk of breast cancer. This was a 26 percent increase in the treatment group versus the placebo group. Plus there was no evidence of overall benefit."
As reported in the Journal of the American Medical Association, Dr. Jacques Rossouw of the National Heart, Lung and Blood Institute and the Women's Health Initiative, directed a randomized, controlled clinical study of more than 16,000 healthy women with intact uteruses between the ages of 50 and 79.
The subjects were given either a placebo or combination therapy of estrogen plus progestin, a combination known to prevent endometrial cancer of the uterus, which is a risk from taking estrogen alone.
The trial was intended to last eight and a half years, but was stopped shortly after five years because of the increased risk of breast cancer. The study also shows an increased risk of heart disease, strokes and blood clots in the legs and lungs from the combination hormone.
"The bottom line is that long-term treatment of estrogen plus progestin to treat chronic diseases is not a viable proposition," said OB/GYN Margery Gass, president-elect of the North American Menopause Society. "By long-term, I mean more than four or five years. Specifically, it should not be used for prevention of coronary heart disease or strokes. It should not be initiated or continued for the prevention of heart disease or strokes. Even for osteoporosis prevention, physicians should consider alternatives."
The study did show a reduction in hip fractures and a reduction in colorectal cancer. But researchers say the risks of long-term use far outweigh the benefits.
"Short-term therapy would be anywhere from one to four years. We think the risks are fairly low at that point. But I still think it prudent for a woman to review all of these risks and benefits in making that decision and to review those with her clinician."
A separate women's health initiative study of estrogen alone in women who had a hysterectomy before joining the whi hormone program continues unchanged because at this point, the balance of risks and benefits of estrogen alone is still uncertain.
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