Hormone boon goes bust

We’re finally getting answers, but not the ones we wanted, researcher says.

by Mary Jo Curtis

Women across the country were shocked recently when a national long-term study on hormone replacement therapy (HRT) revealed the treatment – long believed to help aging women maintain good health – actually increases their risk for several life-threatening diseases.

The findings are bittersweet for the women participating in the Brown-led arm of the Women’s Health Initiative, as well as their sisters elsewhere, according to Associate Professor of Community Health Annlouise Assaf (left).

“We’re finally getting answers now, but not the answers we wanted,” said Assaf, the principal investigator for the WHI’s Rhode Island and southeastern Massachusetts branch, coordinated locally by the Medical School, Memorial Hospital, Women and Infants Hospital, Rhode Island Hospital and the University of Rhode Island.

Past research lead doctors to believe HRT preserved cardiovascular health and reduced osteoporosis-related fractures – although that conclusion was based on observational studies. According to Assaf, that method made it impossible to know for certain whether hormones made women healthier, or if healthy women were more likely to take hormones. Still, experts estimate U.S. physicians prescribe hormone therapy for up to 13 million American women.

“I can’t imagine any drug [that many] men would take every year without it being properly tested,” said Assaf. “Women are learning to speak up for themselves.”

The multifaceted Women’s Health Initiative represented that effort. Half of the 16,608 women recruited for its double-blind hormone study were randomly assigned to take a combination of two hormones, estrogen and progestin; the other half took a placebo. Although the study was slated to continue another three years, Assaf and her colleagues sent letters in July to the 582 local participants instructing them to stop taking their drugs; the researchers had become increasingly certain the women on HRT were at a greater risk for heart attacks, strokes, blood clots and breast cancer.

“The women in the studies have been so phenomenal,” said Assaf. “We thought they’d be upset about the findings, but they’re actually relieved they’ve been able to find answers for their daughters and granddaughters. They’ve been so unselfish.”

As head of the largest of the WHI’s 40 clinical centers nationwide, Assaf and her team have since 1991 recruited more than 6,200 area women ages 50-79 to take part in five studies on women’s health issues for nine to 12 years. They’re among some 160,000 women participating in the WHI nationwide. Assaf hopes the women in the hormone group will continue to participate in the wider study.

“Their information is even more important now,” she explained. “We want to see if there are any changes in any of the risk factors, how they will react, and which symptoms will re-emerge. We will also follow lifestyle factors.”

While the risks of HRT are becoming clearer, the drugs are clearly effective in controlling the hot flashes, night sweats, mood swings and others symptoms of menopause. What women on hormone therapy should do now depends on their circumstances.

“We’ve been telling [women] to schedule an appointment with their physician and find out why the drugs were prescribed to begin with,” she said. “If it’s for osteoporosis, there are many other treatments – and probably more effective ones. If it’s for cardiovascular disease, it’s certainly not recommended” since the data showed that HRT not only didn’t prevent that, but increased the risk.

For menopausal symptom control, “you must look at the risk factors and decide if you should continue,” Assaf added. “From our data we can’t tell what the risk is, short-term. Cardiovascular problems showed in two years, breast cancer in 5.2 years, so we don’t know what’s safe or for how long…. Certainly the shorter the time and the lower the dose the better.”

Though some women may turn to herbal remedies for relief, Assaf cautions that herbs have not been tested in clinical trials. Part of what’s needed is attitudinal, she suggests.

“We’re getting away from usage of the term HRT, which suggests we’re replacing something that’s missing. We’re not,” she said. Author Gail Sheehy “says it better; these are not hot flashes, they’re power surges. We have to accept that women go through this; it’s a natural part of life.”

Assaf and colleagues are setting up several public information sessions here in Rhode Island and on Cape Cod. For more information on the study, visit www.whi.org.