Like millions of other women, Donna Packard quit taking hormones after hearing that they increased her risk for heart attacks and breast cancer. But three miserable months later, Packard was back on them.
“Within a week, I was having hot flashes during the day and waking up four or five times a night,” said Packard, 56, of Ivy, Va. “I was cross, and unpleasant, and disagreeable and irritable. I kept saying, ‘It’s going to get better. It’s going to get better.’ But it didn’t. Finally, I just said, ‘I’m not living the rest of my life this way.’ ”
Women across the country have had the same experience over the past year, as they tried to wean themselves off estrogen and progestin after a landmark federal study concluded that the hormones’ risks outweighed their benefits.
The findings of the Women’s Health Initiative shocked doctors and women, who had been using the hormones for decades not only to alleviate hot flashes, moodiness and other symptoms of menopause, but also to protect women’s hearts. The study’s final results, published in today’s issue of the New England Journal of Medicine, confirm the preliminary findings: that the hormones used in combination do not protect the heart, and may increase the risk of a heart attack or stroke.
Hormone sales plummeted when the initial results were announced last year as millions of women stopped taking the drugs. But interviews with doctors, women’s health advocates and experts, and women around the country indicate that a significant minority of those women suffered severe symptoms of menopause sometimes more severe than before they started taking hormones when they tried to stop.
“What’s the definition of an addictive drug? It’s a drug that if you take it you feel good and if you don’t take it you feel bad,” said Deborah Grady, a professor of epidemiology and medicine at the University of California at San Francisco. “I don’t think it’s really the right terminology to use. I think it’s an inflammatory word. But there are some parallels.”
There are no estimates of the number of women who have gone back on hormones. But obstetrician-gynecologists around the country report spending a significant part of their day counseling women who want to resume hormone treatment.
Many doctors estimate that 10 percent to 25 percent of their patients on hormones decided to keep using them or went back on them, and some say it could be as high as 40 percent.
“It’s without a doubt one of the most common problems women are dealing with right now,” said JoAnn V. Pinkerton, director of the Women’s Place Midlife Health Center at the University of Virginia Health System in Charlottesville.
The phenomenon is putting doctors in a difficult position: having to decide whether to allow women to take drugs that increase their risk for serious diseases to alleviate menopause symptoms that are annoying, perhaps even incapacitating, but not life-threatening. Many express frustration because there has been no research to guide them on how best to get women off the hormones or whether lower doses are safer.
“I don’t discourage or necessarily encourage women,” said Chasheryl Leslie of Premier OBGYN in Bowie. “It’s something that patients need to evaluate for themselves and make a personal decision.”
After several months of trying to live without hormones, Susan Sentrulla, 56, of St. Peter’s, Ind., chose to start taking them again.
“It’s wonderful. I feel like I’m back 20 years. I am in such a good mood. I can sleep. I’m active,” Sentrulla said. “You know, I’ll probably die at 65. But why would I want to live dysfunctionally? It affects your marriage, your work. I really think that if you need it, you need it.”
Because the increased risk for heart attacks, stroke, blood clots and breast cancer appears to be relatively low, many doctors say they will put patients back on hormones as long as they understand the risks, especially if they have no family history of heart disease or breast cancer.
“I assess each patient individually,” said Marilyn C. Jerome of Foxhall OB-GYN Associates in Washington. “When I have a patient who has some serious risk of cardiovascular disease or breast cancer, I will encourage them to go off the hormones. If I have somebody who really wants to be on hormones because their symptoms are very bothersome, I don’t discourage them if they understand the risks.”
Some women’s health advocates worry that criticism of the Women’s Health Initiative may have created undue skepticism about the risks, fueling a backlash.
“I’ve heard reports from some doctors at medical education meetings that the presentations being given are putting out a lot of criticisms that are misleading,” such as assertions that the women in the study were too old or tended to be sick, said Amy Allina of the National Women’s Health Network.
Adriane Fugh-Berman, an assistant professor in the department of physiology at Georgetown University School of Medicine, said she is concerned that many obstetrician-gynecologists are too inclined to prescribe hormones.
“OB-GYNs still think that hormones are good,” Fugh-Berman said. “If they are telling women that the Women’s Health Initiative was a very flawed trial and they shouldn’t believe it applies to them, that’s very worrisome.”
The additional analysis of the Women’s Health Initiative being published today found no evidence that hormones protected the hearts of any subgroup of women, as some doctors and women had hoped and speculated. Researchers are still evaluating the effects of estrogen used alone.
“A lot of women held on to the belief that there was still might be some benefit,” said Marcia L. Stefanick of Stanford University. “This is very clear: There is no benefit.”
Many women’s symptoms will subside with time, according to Margery Gass, a professor of obstetrics and gynecology at the University of Cincinnati and president of the North American Menopause Society.
“I think it’s important to talk to people about the transitory nature of this phenomenon,” Gass said. “They’re not generally permanent problems or chronic problems. Most of the time those symptoms will resolve. It’s more like a phase people go through and they reach a new plateau of comfort.”
But Gass, along with officials at the American College of Obstetricians and Gynecologists and the Women’s Health Initiative, said it is reasonable for some women to take the hormones for relief of menopausal symptoms if they understand the risks.
Federal health officials recommend that if women continue using hormones to alleviate menopausal symptoms, they take the lowest possible dosage for the shortest possible time. This assumes they will have less risk, but there are no studies that prove that.
Most doctors recommend women first try alternatives for hot flashes, such as soy products and black cohosh. Antidepressants such as Paxil also help some women with mood swings. Vaginal gels can alleviate dryness.
If nothing works, doctors will typically put women back on hormones, although they usually try prescribing much lower doses.
Many doctors encourage women who want to go off the hormones to wean themselves off slowly.
“In my experience, that seems to be a more effective way to go,” said Isaac Schiff of Massachusetts General Hospital in Boston, who chairs the American College of Obstetricians and Gynecologists’ task force on hormone therapy.
Grady, however, tells women to try stopping all at once. If they have problems, they can go back on and try skipping their weekend pills. If that works, Grady then advises them to drop the Friday pill and continue that pattern until they are down to two or three doses a week.
“It can take six months to a year,” she said.
Grady is conducting a survey to get a better sense of how many women are going back on hormones. The Women’s Health Initiative is conducting follow-up research to determine what proportion of women experience severe symptoms when they discontinue their hormones, what they did about it and what method of stopping works best.
In the meantime, women such as Sentrulla and Packard are happy to be back on their hormones.
“It’s sort of scary,” said Packard. “But when I tried to live without them I said to my husband, ‘Honest to goodness, I’d rather live 10 years less than live the rest of my life like this.’ It was just awful.”