Oestrogen only arm of women's health initiative trial is stopped
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《英国医生杂志》
The oestrogen only study of the women抯 health initiative study sponsored by the US National Institutes of Health has been stopped early because of a slightly increased risk of stroke among women in the trial. The study included only women who did not have a uterus.
Dr Barbara Alving, director of the women抯 health initiative and acting director of the National Heart, Lung, and Blood Institute, said the study was stopped because treatment with oestrogen neither increased nor decreased the risk of heart disease, a question the study sought to answer.
The study, which involved nearly 11 000 women, showed that oestrogen only treatment did not increase the risk of breast cancer during the seven years of the study and reduced the risk of hip fracture. Oestrogen did, however, slightly increase the risk of stroke, and in women who were over 65 or over it seemed to increase the risk of dementia.
The current report relies on data from another part of the study, initially reported two years ago. That study was stopped in July 2002 because women taking a daily combination of oestrogen and progestogen had eight more strokes a year for every 10 000 women than women taking a placebo (JAMA 2002;288:321-33).
The National Institutes of Health panel thought that results would not change if the oestrogen only study continued. The earlier study also showed beneficial results in reducing the risk of hip fracture and colorectal cancer.
The new report covers women who had had a hysterectomy and thus were not at risk of endometrial cancer. It is usually recommended that women who have not had a hysterectomy and who wish to take hormone replacement therapy take a combination pill, because progestogen is thought to reduce the increased risk of endometrial cancer facing women who take oestrogen. Women who enrolled in the randomised controlled, double blind study were given a placebo or 0.625 mg/day of conjugated oestrogen.
The Food and Drug Administration said it would consider the results of the oestrogen only trial in determining possible labelling changes for hormone treatments for postmenopausal women.
Because data from the oestrogen only trial will not be published for two months, US doctors were cautious about commenting. Dr James Simon, president of the North American Menopause Society and professor of obstetrics and gynaecology at George Washington University, Washington, DC, argued that the study enrolled women who were not typical of women in their late 40s and early 50s who used hormone therapy for a short time to relieve symptoms. Women in the study were aged 50 to 79, the average age being 63. He said that the International Menopause Society disagreed with the design of the US study.
Dr Simon said that oestrogen should be used to relieve symptoms in women who are severely affected by menopausal disturbances of sleep, work, and concentration—at the lowest dose and for the shortest time.
Harvard professor Isaac Schiff, chairman of the American College of Obstetricians and Gynaecologists?task force, said the findings were reassuring for women who have had a hysterectomy, because the study showed no increase in the risk of breast cancer or heart disease. Commenting on the use of oestrogen to prevent osteoporosis, he said, "Twenty years ago oestrogen was the only thing we had to offer. Now we have other drugs: bisphosphonates, the SERMS ."
On the question of how long women should take oestrogen for, Professor Schiff said that before the July 2002 report he would have thought less than five years, because of the breast cancer risk. But now nobody knows, he said.(New York Janice Hopkins T)
Dr Barbara Alving, director of the women抯 health initiative and acting director of the National Heart, Lung, and Blood Institute, said the study was stopped because treatment with oestrogen neither increased nor decreased the risk of heart disease, a question the study sought to answer.
The study, which involved nearly 11 000 women, showed that oestrogen only treatment did not increase the risk of breast cancer during the seven years of the study and reduced the risk of hip fracture. Oestrogen did, however, slightly increase the risk of stroke, and in women who were over 65 or over it seemed to increase the risk of dementia.
The current report relies on data from another part of the study, initially reported two years ago. That study was stopped in July 2002 because women taking a daily combination of oestrogen and progestogen had eight more strokes a year for every 10 000 women than women taking a placebo (JAMA 2002;288:321-33).
The National Institutes of Health panel thought that results would not change if the oestrogen only study continued. The earlier study also showed beneficial results in reducing the risk of hip fracture and colorectal cancer.
The new report covers women who had had a hysterectomy and thus were not at risk of endometrial cancer. It is usually recommended that women who have not had a hysterectomy and who wish to take hormone replacement therapy take a combination pill, because progestogen is thought to reduce the increased risk of endometrial cancer facing women who take oestrogen. Women who enrolled in the randomised controlled, double blind study were given a placebo or 0.625 mg/day of conjugated oestrogen.
The Food and Drug Administration said it would consider the results of the oestrogen only trial in determining possible labelling changes for hormone treatments for postmenopausal women.
Because data from the oestrogen only trial will not be published for two months, US doctors were cautious about commenting. Dr James Simon, president of the North American Menopause Society and professor of obstetrics and gynaecology at George Washington University, Washington, DC, argued that the study enrolled women who were not typical of women in their late 40s and early 50s who used hormone therapy for a short time to relieve symptoms. Women in the study were aged 50 to 79, the average age being 63. He said that the International Menopause Society disagreed with the design of the US study.
Dr Simon said that oestrogen should be used to relieve symptoms in women who are severely affected by menopausal disturbances of sleep, work, and concentration—at the lowest dose and for the shortest time.
Harvard professor Isaac Schiff, chairman of the American College of Obstetricians and Gynaecologists?task force, said the findings were reassuring for women who have had a hysterectomy, because the study showed no increase in the risk of breast cancer or heart disease. Commenting on the use of oestrogen to prevent osteoporosis, he said, "Twenty years ago oestrogen was the only thing we had to offer. Now we have other drugs: bisphosphonates, the SERMS ."
On the question of how long women should take oestrogen for, Professor Schiff said that before the July 2002 report he would have thought less than five years, because of the breast cancer risk. But now nobody knows, he said.(New York Janice Hopkins T)