GEORGE F. LEE / GLEE@STARBULLETIN.COM
A national study involving post-menopausal women over the past eight years was discontinued because the combination of hormones that some participants had been taking may increase their risk of breast cancer. University of Hawaii medical researchers Dr. Helen Petrovitch, co-principal investigator, left, and Dr. J. David Curb, principal investigator, shown here yesterday at the Thomas Square Center Building, oversaw 265 Hawaii women who are part of the study.
Breast cancer risk A large national study involving 265 Hawaii women was discontinued because the combination of hormones that some participants had been taking may increase their risk of breast cancer.
ends study
265 isle women are involved
in research on hormones taken
by 6 milllion peopleBy Pat Gee
pgee@starbulletin.comDr. David Curb of the University of Hawaii's medical school, which has taken part in the study involving post-menopausal women over the past eight years, said the women are being notified of the possible danger today by the National Institutes of Health. The study was supposed to have continued until 2005.
There are 16,608 women involved in the study conducted by the Women's Health Initiative, the largest study ever done of this kind, he said.
The Journal of the American Medical Association was to release a special report on its Web site (jama.com) today -- more than a week earlier than its July 17 publication -- because of the importance of the information, officials said.
The hormone therapy, a combination of estrogen and progestin, was given to relieve women, ages 50 to 79, of post-menopausal symptoms, such as hot flashes, insomnia, mood swings and night sweats, and as a way to prevent heart disease, Curb said.
Curb, principal investigator of the Women's Health Initiative's Hawaii research center and a professor in UH's geriatric division, said half of the 265 Hawaii participants are on a placebo pill.
But he said the women on the active pill should not be too worried because "overall, there's only a slight negative effect. ... For most women the real picture is not that bad."
An estimated 6 million women take the drugs estrogen and progestin to replace hormones lost at menopause. The hope was that the drugs would not just relieve the hot flashes, night sweats and vaginal dryness that can plague women at menopause, but that they would also improve women's health.
That, the study investigators report, did not happen. The results of this study have been long anticipated because it is the first and only large study to compare the effects of hormone replacement therapy with placebos in healthy women.
The Women's Health Initiative sent letters to the study's participants, which they should receive today, telling them to stop taking their medications.
Dr. Jacques Rossouw, acting director of the Women's Health Initiative, stressed the importance of understanding how the risk to an individual woman can be low but the risk to the population at large can be great, according to a National Institutes of Health release.
"Individual women who have participated in the trial and women in the population who have been on estrogen and progestin should not be unduly alarmed," he said.
Rossouw advised women in the general population who are taking the hormones to consult their doctors.
Those who are taking it for short-term relief from menopausal symptoms may want to continue "since the benefits are likely to outweigh the risks," he said. But he added that long-term use "must be re-evaluated given the multiple adverse affects noted."
Other risks to women on the hormones compared with those who took the placebo included a 41 percent increase in strokes, a 29 percent increase in heart attacks, a doubling of rates of blood clots and a 22 percent increase in cardiovascular disease.
On the upside of the study, the same women would have a 37 percent reduction in cases of colorectal cancer, a one-third reduction in hip fracture rates and a 24 percent reduction in total fractures.
Josephine Nicolo, the nurse practitioner who has examined the 265 isle women in the study since it began, said most of the women when informed of the study results "will not be horrified, shocked or scared." The three women she spoke to had "no regrets" about participating, she added.
"These women are awesome, very sophisticated and very informed. They're committed to this study. ... I'm so grateful to them and the study because now doctors won't indiscriminately prescribe hormone replacement for everybody over 50. We'd still be in the Dark Ages if it weren't for these women," she said.
As part of the study protocol, any woman with breast problems was taken off the pill just to be safe, according to Nicolo.
An objective of the study was to examine the effect of estrogen plus progestin in the prevention of heart disease and hip fractures, but the bottom-line answer is that this combination of hormone therapy is unlikely to benefit the heart or anything else, researchers said. A 26 percent increase in breast cancer risk is considered too high a price to pay, they said.
Dr. Helen Petrovitch of UH, a co-principal investigator, said once they stop taking the pill, some women will experience a return of menopausal symptoms. If the symptoms are severe, those women should see their doctor.
Their doctors could advise them to taper off the pills slowly to avoid the symptoms, but the doctors would have to supply the pills instead of the Women's Health Initiative study center at Kuakini Hospital, Petrovitch said.
She said "the best thing" to do is to stop the pills and see if any symptoms occur at all.
"A lot of women won't have any side effects or problem at all -- it's a very individual response," Petrovitch added.
The New York Times contributed to this report.
