Hormone therapy too risky, study says
Advertiser Staff and Wire Reports
Hormone replacement therapy, the medication taken by millions of American women for relief of menopausal symptoms and prevention of other serious health problems, should not be taken long-term because it carries more risks than benefits, national researchers said today.
A study challenges the conventional wisdom imparted for nearly 60 years by most obstetrician/gynecologists on HRT, as it is called. The findings of the study were so dramatic that they prompted researchers to cut short that portion of the trial by three years.
Dr. David Curb is the principal investigator for a study in Hawai'i on hormone replacement therapy.
"There's 26 percent more breast cancers in people taking estrogen and progestin than in people not taking them," said Dr. David Curb, principal investigator for the study in Hawai'i.
There was also a 41 percent increase in strokes, a 29 percent increase in heart attacks, and a doubling of the rates of blood clots, according to the new data.
But it's important for women on hormone replacement therapy to put this new data in perspective, Curb said.
"If you're on estrogen it's not like you have to rush out and quit tomorrow and purge it from your system," he said. "The risk is long-term and relatively small for each person. But over the whole population it amounts to a huge increase in the number of breast cancers every year."
"The message is that estrogen plus progestin should not be used for the prevention of heart disease and other chronic diseases," said Dr. Susan Hendrix, an obstetrician and gynecologist at Hutzel Hospital in Detroit, which participated in the study.
Hendrix said she expects more women now will "get back to the basics" of controlling menopause and health problems with diet and exercise. Another choice, she said, is taking smaller estrogen and progestin doses.
Estrogen and progestin are used by 38 percent of women during and after menopause. Premarin and Prempro, the two top-selling HRT drugs among some 20 HRT choices, account for about 70 million prescriptions and $1 billion in yearly sales for Philadelphia-based manufacturer Wyeth-Ayerst Laboratories.
Estrogen treatment and HRT have been heavily promoted for decades. The latest campaign features singer Patti LaBelle and actress and model Lauren Hutton touting HRT's benefits for short-term relief of menopausal symptoms such as hot flashes and vaginal dryness.
"We think the results of the new study are largely consistent with what is already in the product labeling," said Dr. Victoria Kusiak, vice president and North American medical director for Wyeth-Ayerst. "We think it re-emphasizes the need to have an ongoing discussion with a woman's physician."
The Women's Health Initiative, the largest study ever conducted in the United States of women's midlife health issues, set out to study HRT in a careful, scientific way nine years ago. The University of Hawai'i John A. Burns School of Medicine is one of 46 participating sites and among the participants were 265 Hawai'i women.
Its findings were a surprise to researchers who expected the opposite results.
Between 1993 and 1998, 16,608 women ages 50-79 who had not had a hysterectomy were assigned to two groups taking either Prempro or a sugar pill. The combination pills contained .625 milligrams of estrogen and 2.5 milligrams of progestin, a common dosage.
The study had been intended to run until March 2005. Officials began alerting participants yesterday that their part in the research had been suspended and suggested they stop taking the replacement estrogen and progestin they've been using since this part of the study began in 1995.
The letter sent to participants informed them that for every 10,000 women taking HRT, experts could predict that seven additional women on HRT would have heart attacks, compared to those getting the placebo; 18 more would have blood clots; eight more would have a stroke; and eight more would have breast cancer.
By comparison, women taking HRT had six fewer cases of colo-rectal cancer, and five fewer hip fractures than those taking a placebo.
Translating the increased statistical risk into numbers, Curb said that the risk of breast cancer with a placebo is 3 cancers per 1,000 women. That risk increased to 4 cancers per 1,000 women with HRT.
"For the first four years there was no indication of any increased risk," Curb said. "This develops in women who have been on HRT for a while and it's greatest in women who had previously been on estrogen (before they joined the study). Those are the ones showing the greatest risk.
"What it indicates is that people who have been on hormones longer are more likely to have breast cancer so the risk appears to accumulate over time."
Dr. Claude Lenfant, national director of the study, recommended that women focus on well-proven treatments to reduce the risk of heart disease, including measures to prevent and control high blood pressure, high blood cholesterol and obesity.
"This effort could not be more important," Lenfant said. "Heart disease remains the number one killer of American women."
He called continuing to use HRT "too high a price to pay" for any of the benefits it may offer in reducing bone fractures and colorectal cancers.
The study was a randomized, controlled study, considered the gold standard of scientific research, compared with the population-based studies that form much of the HRT research base to date. Population-based studies report on health outcomes of people in a study. Because they often attract motivated, healthy research subjects, population-based studies are not as highly regarded.
The research will be published July 17 in the Journal of the American Medical Association.
Women in the HRT study will continue to be followed and medically screened for three more years, even though they're no longer taking the medications, said Hawai'i nurse practitioner Josephine Nicolo.
Advertiser staff writer Beverly Creamer contributed to this report.
