Editor's note: Since we first went to press with this story, the National Institutes of Health has issued another strong warning about hormone replacement therapy (HRT). In a sub-study of 4,500 women aged 65 and older who participated in the Women's Health Initiative, researchers found that those on HRT were twice as likely to develop Alzheimer's disease or another form of dementia within five years as women who took dummy pills, or placebos. Although some scientists had previously thought that hormone therapy might help guard against dementia, this study overturned that notion. Judith Salerno, MD, the deputy director of the NIH's National Institute on Aging, said that researchers have concluded that hormone therapy should not be prescribed to older women to preserve brain function.

July 22, 2002 | It's been a roller-coaster two weeks for the 6 million American women taking the country's most popular hormone pill.

On July 9, the National Institutes of Health sent patients and doctors scrambling when it prematurely halted a huge study of women taking estrogen and progesterone. The NIH stopped clinical trials involving 16,608 women in a government-sponsored study known as the Women's Health Initiative because researchers found that over time the risks of heart disease, stroke, blood clots, and breast cancer from the hormone combination outweighed the benefits. Known as hormone replacement therapy (HRT), the combination drug has been a staple in the medicine chests of millions of women for decades.

Although hormone replacement therapy has long been touted as an effective treatment against heart disease and bone thinning, as well as menopausal symptoms, researchers now recommend that physicians no longer prescribe the combination of estrogen and progestin (synthetic progesterone) to prevent chronic disease. Instead, it should only be used for short-term relief from menopausal symptoms.

As soon as the announcement came down, doctors around the country weighed in. Many said they would no longer prescribe HRT on a routine basis, although they generally stood by the drugs as acceptable for short-term relief of severe menopause symptoms -- as long as women were aware of the small but real risks. In any event, the days of prescribing hormone replacement to women under the mistaken impression that it prevents heart disease are over.

"The bubble has burst," Dr. Isaac Schiff said last week. Schiff, chief of the gynecology service at Massachusetts General Hospital in Boston, will serve as chair of a task force for the American College of Obstetricians and Gynecologists that will advise doctors on what to do about hormone replacement drugs. Women's health organizations that had long criticized hormone replacement therapy for lack of reliable trials said the truth was finally out.

"The Women's Health Initiative has driven a stake into the heart of hormone replacement therapy," said Cynthia Pearson, executive director of the National Women's Health Network. "Millions of women took HRT on the advice of their physicians, who honestly believed that the treatment prevented heart disease, the biggest killer of women. HRT doesn't prevent heart disease."

[While most experts caution that the effects of hormone therapy on heart disease remains unclear, a 2007 WHI study concluded it was linked to health benefits in younger, postmenopausal women. In the study, women 50 to 59-years-old who took estrogen were 30 to 40 percent less likely to have calcium buildup in coronary arteries -- a marker for future risk of coronary artery disease. However, health experts continue to stress that the known risks of estrogen therapy outweigh the possible benefits, and for this reason estrogen should not be used for preventing cardiovascular disease. – Editor]

Last week, NIH delivered more bad news: Women on estrogen replacement therapy (ERT), which is estrogen alone, for 10 years or more were at "significantly" higher risk of getting ovarian cancer than women who weren't on supplemental estrogen. The risks of getting uterine cancer from estrogen alone were well-known, so the drug was prescribed only to women without uteruses. Now those women who had a hysterectomy with at least one ovary intact have a new worry -- ovarian cancer.

Not surprisingly, doctors' offices across the nation were deluged with phone calls, and women on hormone therapy drugs started burning up the Internet and talk shows with debates over what to do.

As soon as the news broke, Mary Ann Mancuso was on the phone to her doctor's office. At 47, Mancuso has been going through menopause for three years.

Before she started taking hormones, Mancuso couldn't sleep at night, and she had hot flashes every hour -- often accompanied by anxiety attacks. "You just kind of have to let everything around you disappear for a minute until you get through it," she says.

Three months ago, she was finally prescribed a low-dose birth control pill that made it possible for her to function normally. She planned to stay on the pills for a year. In light of the new evidence, Mancuso says, she urgently wants to know whether her doctor's opinion about her risk has changed. "I also want to know all the details and what my choices are," she adds.

A vice president of sales for an international staffing firm in California's Napa Valley, Mancuso works out regularly and eats a vegetarian diet rich in soy foods, both of which are supposed to help relieve menopause symptoms. Not so for her.

"I can't imagine going back to the way I was feeling. If my risks are still low based on my body, chances are I'll just continue to go with whatever they have planned for me," she says.

Dr. Paula Akin, an obstetrician/gynecologist in Napa, California, and her colleagues are one group of perhaps hundreds across the country who are planning community lectures to help people sort it out.

"Of course, everybody on hormones is calling the office asking, 'What do I do?' " says Akin, "In America, the number one thing people fear is cancer."

How afraid should women be? Should women with intolerable menopause symptoms somehow learn to live with them? Do they dare consider starting a short-term regimen of HRT? Should those who have been on it for years give it up?

While stopping short of advising women to halt HRT, the acting director of the Women's Health Initiative, Jacques Rossouw, M.D., said women should have a "serious talk with their doctor" about whether to continue.

"If they are taking this hormone combination for short-term relief of symptoms, it may be reasonable to continue since the benefits are likely to outweigh the risks," Rossouw said. But Rossouw noted that long-term use should be re-evaluated by a woman and her doctor.

According to the WHI study, taking combined hormone replacement therapy for five years or longer puts a woman at a 29 percent higher risk for heart disease than someone on a placebo (dummy pill). Also, the risk for stroke is 41 percent higher, and for invasive breast cancer, 26 percent higher. The drug was found to reduce colon cancer by 37 percent and hip fractures by a third, but researchers say those benefits aren't worth the risks.

Doctors caution, however, that the raw numbers of women falling ill from these hormones is small: As a result of taking the combined hormone pill, seven more women in every 10,000 will get heart disease, eight more will get invasive breast cancer, and eight more will have strokes.

"We have to be careful that we don't create a panic and that people don't discontinue their hormone regimen before discussing it with their doctors," says Akin, who estimates that as many as half of her patients are perimenopausal or postmenopausal women. For someone deeply worried about breast cancer, especially if she has a family history of the disease, it makes no sense to continue, she says. But for someone even more afraid of returning to hot flashes, deep depression, and sleepless nights for weeks on end, the benefits of HRT may still balance out the risks.

Some doctors have recommended stopping the drug "cold turkey." Other physicians say that for some women it's better to taper off slowly because women often experience the full force of menopausal symptoms if they stop precipitously.

Some gynecologists are experimenting with alternative forms of estrogen to those in the widely used combination HRT drug Prempro, which is made from the urine of pregnant horses. These "bio-equivalents" are made from yams and other plants and are touted as being chemically equal to human estrogens. Some doctors, including Marcey Shapiro, who has a family practice in Albany, California, work with pharmacies that mix hormones for women individually. Estradiol, estrone, and estriol -- all forms of estrogen that need to be in proper balance -- can be crafted, Shapiro says. All of Shapiro's patients on hormones, in fact, take this type. However, no long-term studies have been done on them, she says, and no one knows whether these hormones are safe for long-term use, either.

"Nonetheless," Shapiro says, "as a result of the studies, lot of people are interested in going off HRT if possible. This is kind of a final straw for them."

The main reason to be on HRT now is to manage symptoms, Shapiro says. There are other drugs for preventing osteoporosis, and heart medicines abound. For a more holistic approach to maintaining healthy bones, she recommends Tai Chi, yoga, and calcium supplements; other doctors advise strength training and daily weight-bearing exercises, such as walking. For treating hot flashes and other symptoms, women may find that black cohosh or Chinese herbs are effective. It's important to tell your doctor what herbs you're using because some can interfere with prescription medications; in addition, these herbal remedies have not been widely studied for either safety or effectiveness.

When the dust settles, perhaps some researchers will turn their attention to naturopathic and other alternative remedies for relief from menopausal symptoms. Dr. Christiane Northrup, author and frequent talk-show guest on the subject of menopause, has been promoting holistic alternatives to HRT for years, saying that menopause is a natural process, not a disease to be conquered.

Over the years, Akin has seen her patients -- and other doctors -- becoming more receptive to alternative treatments.

"I think women will be less likely to want to take hormones, and they're going to start to be more inclined toward alternatives like acupuncture," Akin says. "This information will definitely revolutionize the way we deal with menopause."

-- Elaine Herscher is a senior editor at Consumer Health Interactive and a former health reporter at the San Francisco Chronicle.

References

First published July 19, 2002
Last updated September 14, 2007
Copyright © 2002 Consumer Health Interactive