HERS II: HRT Provides No Heart Benefits

July 3, 2002 -- Postmenopausal women who stay on hormones in hopes of reducing risk of heart disease may not get the benefits for which they once hoped.

A new study, the "Heart and Estrogen/Progestin Replacement Study II," or HERS II, shows that long-term use of hormone replacement therapy does not, in fact, protect women against heart disease. The results of the trial were published in this week's Journal of the American Medical Association.

The previously reported HERS I trial examined the role of hormone replacement therapy, or HRT, on heart disease risk in 2,300 postmenopausal women with heart disease. That study found that while HRT raised the risk of heart problems in the first year of treatment, it seemed to lower it during years three through five.

This finding had led to the widely held "don't start, don't stop" approach to HRT. That is, a woman should not consider initiating hormones for heart-protective reasons, but if she was already taking them and had weathered the first year's increased risk, she could be in a position to reap heart health rewards.

But now HERS II, which extended the follow-up of the previous trial to almost seven years, tells a different story. "It suggests that HRT should not be continued with the expectation that it is cardioprotective," says Dr. Brian Walsh, director of the menopause center at Brigham and Women's Hospital in Boston.

Don’t Start, But Stop?

With no long-term cardiovascular benefits and demonstrated increased risk in the short term, some experts feel women should rethink their reasons for taking HRT, as well as the "don't start, don't stop" message.

"Right now, given what we know, any woman continuing on HRT should first of all question "Why [am I] taking it?" says Stacie Geller, director of the Center for Excellence in Women's Health at the University of Illinois, Chicago. "If she is taking HRT for long-term [problems] associated with aging, then she needs to reconsider. If it is secondary protection [of the heart], the data is clear: It does not work."

Hormone replacement therapy is also linked to increased risk of non-cardiovascular diseases. Long-term use has been associated with an increased risk of breast cancer, blood clots, and even gallbladder disease.

But HRT also has demonstrated non-cardiovascular benefits. It is effective in treating menopausal symptoms like hot flashes and has also been proven effective in preventing bone loss that can lead to osteoporosis.

And while alternative treatments like the herb black cohosh for hot flashes may soon be available, experts defending HRT point out that no scientifically proven alternatives exist for treating menopausal symptoms and say that the "don't start, don't stop" still has validity.

"The message from the original HERS results was intended to avoid the excess coronary events seen in women initiating HRT," says Dr. Judith Hsia, professor of medicine at George Washington University in Washington. "This still applies as long as women are taking HRT for an appropriate [non-cardiovascular] reason."

Hope Not Lost

While for many hope has faded for HRT's role in further heart-disease prevention, all is not lost, some experts maintain. It may still be beneficial, they explain, for preventing the disease in women who do not have heart disease.

While insufficient clinical data exists to confirm healthy women who take HRT may be protected against heart disease, data from some animal studies support the hypothesis that if coronary disease is not present, then HRT may protect against it in the future, says Dr. Howard Zacur, director of the division of reproductive endocrinology at Johns Hopkins in Baltimore.

Human evidence on the subject is expected to come with the results of the so-called Women's Health Initiative study funded by the National Institutes of Health and scheduled to end in 2005. The WHI is examining HRT use in more than 27,000 women, fewer than 2 percent of whom have heart disease. It is expected to provide answers to questions about the roles of HRT in heart disease and increased breast cancer risk in these healthy women.

"Until those results are available, women and their health care providers should exercise their best judgment in light of current evidence," says Hsia. "Individual women's decisions about HRT are highly personal."