Halt Hormone Therapy for Women
By Patricia Guthrie
Female replacement hormones may someday be remembered as the most recklessly prescribed and dangerous drugs of this century.
Researchers abruptly halted a major federal study of hormone replacement therapy - used by tens of millions of American women - because the drugs create what they consider an unacceptable risk for breast cancer, heart disease, strokes and blood clots.
The study found women taking a combination of estrogen and progestin are at increased risks that outweigh the benefits of the hormones, which were found to reduce the risks of colon cancer and hip fractures.
Findings from the study, called the Women's Health Initiative, had not been expected until 2008. But when evidence of the risks started accumulating after five years, a review panel ordered the clinical trial stopped - something rarely done in medical studies.
"The bottom line is that estrogen plus progestin is not a viable option to prevent chronic disease," said Dr. Gerardo Heiss, epidemiology professor at the University of North Carolina at Chapel Hill School of Public Health, who was on the study steering committee.
A hastily called news conference to discuss the findings is scheduled for this morning in Washington and at numerous participating academic centers.
The study is being released early on the Journal of the American Medical Association Web site www.jama.com before appearing in print July 17.
In the JAMA article, researchers noted: "Given these results, we recommend that clinicians stop prescribing this combination for long-term use."
The study involved 16,608 postmenopausal women, 50-79 years old, who had not had hysterectomies.
At Emory University, 286 metro Atlanta women were involved in the study, a spokeswoman said.
HRT is the second most frequently prescribed drug in America: 68 million prescriptions were written for the two most popular forms, Premarin and Prempro, in 2000. It has been prescribed for almost 60 years.
The trial was stopped early "because of a 26 percent increased risk for breast cancer and also a lack of overall benefit," Heiss said. "As soon as the increased risk for breast cancer was established, the independent data and safety monitoring board halted the study."
Experts advised women to consult their physician to discuss risks and benefits before stopping hormone therapy.
The drug relieves menopausal symptoms, such as hot flashes, night sweats and inability to concentrate. It is also prescribed in postmenopausal women for protection against heart disease and osteoporosis, indications suggested in previous studies.
Many studies in recent years have attempted to quantify the risks and benefits of hormone replacement therapy, such as the increased incidence of breast cancer or heart disease, or the reduced risk of osteoporosis among women who take HRT. But past research has typically examined various risks and benefits in isolation.
The latest study is believed to be the largest and most comprehensive to examine and quantify all known risks and benefits, and stack them side by side.
Although researchers advised doctors to stop prescribing HRT.
Of 10,000 women taking the estrogen/progestin combination, researchers estimated there would be seven more cases of coronary events, eight more breast cancers, eight more strokes and eight more blood clots - but six fewer colorectal cancers and five fewer hip fractures - than they would expect to find in women who don't take the drugs.
Women in the study were divided into two groups - those took the hormone therapy and those who took a placebo. Scientists compared health outcomes between the groups; the women were not told to which group they were assigned.
Another part of the study involved 11,000 women who have undergone hysterectomies and are taking only estrogen. That study has not been stopped because no adverse effects have been found, researchers said.
The study did not address the short-term risks and benefits of hormones given only for the treatment of menopausal symptoms.
Dr. Rogsbert Phillips, an Atlanta breast cancer specialist, said the findings were not that surprising, given past research that raised questions about the risks of HRT. The breast cancer/hormone replacement connection weighs heavily on doctors when they are assessing whether to place a woman on hormone replacement, she said.
"It's no question that we feel that HRT plays a role in development of breast cancer and as we continue to research, we'll find out how much," Phillips said.
The doctor said she rarely prescribes HRT for more than five years. However, she will make exceptions, she said, even for women who have experienced breast cancer.
"I had one patient who was a mathematician and she said she just couldn't think straight when she went off hormone replacement therapy. She was a 20-year breast cancer survivor," Phillips said. "But I put her back on them."
"There are some women who really, truly need it to manage these kinds of menopausal symptoms. Hormones can greatly affect a woman's equilibrium."
"What this Doctor is doing is what I call the height of stupidity!!! She is willing to risk her patients life instead of helping to balance her out with natural products known to work and at the same time being totally safe. To me the health industries, which includes all the drug industries and the doctors that prescribe their produces, are as bad as the stock and financial industries, namely the Merrill-Lynch's, Goldman-Sack's etc." - this quote by mindbodyheath.com
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