Investigator: Marcia Stefanick
By Cristy Shauck
Until recently, most health studies were performed exclusively on men. The medical community assumed that what was good for men would also benefit women. Although no long-term studies have been performed on women to verify such a claim, doctors have been treating women for diseases in the same way they treat men--with the exception of hormone replacement therapy (HRT).
Ask a group of women what they know about HRT, and each woman will probably tell a different story. Depending on whether it was in fashion when she began menopause (the time when her doctor would discuss HRT) and on her health history, a woman would be told she should or shouldn't take estrogen.
In 1993, the National Institutes of Health began recruiting women for the Women's Health Initiative, a nine-year study that may yield some clear answers about the effect of HRT and diet on heart disease and bone fractures in women.
"We are not convinced that all women in this country need to be on hormones, or we would not be doing this study," said Marcia Stefanick, Ph.D., principal investigator for the Stanford WHI site. "It's much less clear to us that the benefits outweigh the risks."
Coronary heart disease is the no. 1 cause of death in women. "We think of it as a man's disease, but just as many women die of it as men. The difference is we're about 10 years older. Women start getting heart attacks at about age 65, right when they start retiring, and so they are out of the public eye."
Stefanick said the current hypothesis is that HRT will prevent heart disease in women.
"It's very important for women to understand that we do not have proof that hormones are going to prevent heart disease," she said. "That's what the study is going to find out--whether this is a good strategy for women."
Verle Waters and Rosalie Gailie are among the 150 women from the Los Gatos-Monte Sereno area participating in the study.
A retired nurse, Waters, 70, said the study is very important "because there's so much ambiguity about what can be done to prevent the major health problems of women."
She also said the study "shows promise for providing good answers for questions that have not had [answers]."
As a member of the dietary control group, Waters must conduct dietary spot-checks periodically and come in to the WHI site once a year.
"Participating in the study is, in a sense, a way of leaving a legacy for my granddaughters," Waters said.
Waters chose not to participate in the HRT study.
"I've been on hormones for a number of years at my doctor's suggestion. But I talked to a woman considering the HRT study who had never taken hormones and whose doctor had not recommended it. She has all the reasons and support behind her decision that I have behind mine, which shows what an ambiguous area it is."
Waters hopes the results of the study will unite the medical community in its efforts to prevent illness in postmenopausal women.
Gailie, 73, thought the study sounded interesting and signed up last fall. She's what researchers call a "combo," someone participating in both parts of the study.
Although she hasn't taken hormones before, Gailie says she doesn't care whether she is taking the placebo or the real thing.
"They say there are pros and cons to both," she said.
Gailie has four daughters whom she hopes will benefit from the study.
"I think it's rather interesting and fun to think that, nationwide, many people are involved in it," she said. "I think it's important for them to find out about women's health."
According to Stefanick, the Stanford WHI needs 2,000 more volunteers, age 54 to 79.
Volunteers for the HRT study must have stopped taking hormones for three months prior to joining the study. If they have breast cancer, they cannot participate. Women must have had a mammogram within the last 10 months before they can be accepted.
Volunteers for the diet study should be eating a typical American diet.
Those in the diet-change group will modify their diet to include more fresh fruits and vegetables and whole grains. "This is not a weight-loss diet," Stefanick said.
The diet study focuses on breast and colo-rectal cancer. Volunteers fill out a diet questionnaire when they come for the study orientation.
Those who aren't selected for the HRT or diet-change group can still provide valuable input.
"We have to have a group that doesn't change their diet so that we can have something to compare the diet change to," Stefanick said. "So you have to be willing to take either assignment the computer makes, based on nothing other than the fact that you are interested and eligible for the study."
The diet-change group must attend classes that are spaced farther apart as time goes by. The control group checks in annually.
Stefanick argues that the medical community screened out unhealthy women and only let healthy women go on estrogen. "We ended up with a separation of healthy women on estrogen and the less healthy being overrepresented in the group that wasn't on HRT," she said.
There are currently 40 million postmenopausal women in the U.S. By the end of the study, there will be 50 million. Stefanick is eager to provide these women with study results that will allow them to make informed decisions about health.
The Stanford Women's Health Initiative is located at 2680 N. First Street in San Jose. For more information or to volunteer for the study, call 944-9444.
This article appeared in the Los Gatos Weekly-Times, February 19, 1997.
©1997 Metro Publishing, Inc. All rights reserved.