HERBALCONSULTS

Women Shunning Hormone Replacement Therapy
By Colette Bouchez
HealthDay Reporter

Women are giving up hormone replacement therapy in record numbers, following the news last year that it may not be safe or helpful for a variety of menopause-related health concerns, including the prevention of heart disease.

That's the word from one of the first statistical studies of hormone replacement therapy (HRT) usage following a report in July 2002 that taking hormones may not have all the positive effects doctors once thought -- and could, in fact, increase the risk of some types of cancer.

Dr. Koon Teo, who presented his findings Nov. 12 at the American Heart Association's annual conference in Orlando, Fla., says women appear to be turning away from HRT in record numbers.

"We did not set out to do this study as a primary purpose -- we had been conducting a mega cardiology-related clinical trail involving 30,000 patients across the world, including over 8,000 women," explains Teo, a professor at McMaster University in Ontario.

But the Canadian study spanned the time period both before and after the July 2002 publication of the Women's Health Initiative (WHI) study on the effects of HRT. And it involved questioning the women about their use of HRT. So, Teo says he knew his research held some valuable information about the impact of the news about the use of hormones.

"Our study provided a snapshot of the women using hormone replacement therapy both before and after the publication of the study results from WHI. And by looking at that trend, we found that right after the publication of the results, there was a very sharp drop in the use of hormone replacement therapy by women who were being recruited for our trial," Teo says.

The Women's Health Initiative is an ongoing 15-year research project instituted by the National Heart, Lung, and Blood Institute. One goal of the project was to examine the risks and benefits of HRT in pre- and postmenopausal women. Before the study, doctors believed HRT might protect women against a host of health problems, including heart disease, cancer, osteoporosis and other age-related diseases, as well as the classic symptoms of menopause, including hot flashes and mood swings.

However, the early analysis of WHI data showed hormone replacement therapy appeared to have no benefits for the heart and might increase the risk of certain cancers, particularly ovarian and breast cancer. As a result, the part of the trial using the hormones estrogen and progestin together was stopped before completion.

Teo says that news prompted many women to give up HRT -- or never start it.

For menopause expert Dr. Steven Goldstein, the finding reflects a trend he sees in his own practice.

"Previous studies of pharmacy records have shown that prescriptions for HRT dropped dramatically after the publication of WHI results. But the change is also something I see everyday in my office. Women who were on HRT want to get off, and many of the women facing the opportunity for the first time are declining," says Goldstein, a professor at New York University's School of Medicine.

While Goldstein believes short-term use of hormone replacement therapy can help some women get through specific menopause-related symptoms, he also says any decision must be made on a case-by-case basis.

"The decision to use HRT and for how long must be made one woman at a time. And in order for a woman to make that decision, she has to turn to her own doctor, discuss her personal risk factors and her personal needs. This is not a decision a woman should be making on her own," Goldstein says.

However, it appears that many women are doing just that. In a new survey released by the National Women's Health Resource Center, up to 70 percent of women remain confused over the risks and benefits of HRT, and some 50 percent say they are getting their information through magazines or other media sources.

"While this statistic is understandable given the flurry of news over the past year and a half, it helps explain why women still need help in putting the study findings in proper perspective," Amy Niles, president and chief executive officer of the National Women's Health Resource Center, says in a statement.
"Furthermore, many women (42 percent of those surveyed) are not familiar with the many hormone therapy options that make individualizing therapy possible, such as patches, creams, vaginal rings and gels," she says.

The study done by Teo and his colleagues at McMaster included 6,623 women aged 55 and over who were involved in a national cardiology drug trial.

As part of the study protocol, the women were questioned on drug use, including hormone replacement therapy. The answers came in two waves -- first from a group who entered the trial before the WHI study release on HRT, and then from a second group who came on board after the WHI results were announced.

"The decrease in the use of HRT by women in North America after the WHI announcement was clear and unmistakable," Teo says.

The study found that nearly 6 percent of women in the cardiology trial were taking hormone replacement therapy prior to the WHI study release. That number dropped to just 3.9 percent after the news that HRT might not be so helpful.

Teo says statistics show a similar drop in HRT use among women in Europe and other parts of the world.

WHI Findings Summary
Effects of estrogen plus progestin on health-related quality of life: Findings from the WHI clinical trial of estrogen plus progestin

The purpose of the Women’s Health Initiative Hormone Program was to study the health benefits and risks of hormones for postmenopausal women. In July 2002, we asked women in the Estrogen plus Progestin part of the program to stop taking their study pills. For women taking estrogen plus progestin, the overall risks (breast cancer, heart attacks, stroke, and blood clots) outweighed the benefits (fewer fractures and colorectal cancers). These results were published in the Journal of the American Medical Association (JAMA) and have prompted new guidelines for the use of these combined hormones. Women are now being told to take hormones only for symptom relief.

One of the questions not addressed in the JAMA paper was whether taking estrogen plus progestin does improve women’s quality of life. These data have now been analyzed and appear on-line in the New England Journal of Medicine issue for Monday, March 17.

The 16,608 postmenopausal women 50 to 79 years old in the Estrogen plus Progestin study received either a daily hormone pill or a placebo pill. Researchers collected information about the participants’ quality of life when they joined the study and after one year. They also collected data from a random subgroup of 1,511 women at three years.

Quality of life is a measure of how someone’s health affects perceived well-being and ability to function (physically, mentally and socially). To assess quality of life, WHI participants answered questions about their general health, physical functioning, bodily pain, energy, social functioning, mental health, depression, sleep disturbances, sexual satisfaction, and symptoms associated with menopause.

The results showed there were no clear benefits for those taking estrogen plus progestin on any of the quality of life measures. There were no significant improvements on perceptions of general health, energy, social functioning, mental health, depression, or sexual satisfaction. There were slight improvements in women's physical functioning, bodily pain, and sleep disturbances at one year. These effects were very small, however. The average increase in physical functioning, for example, was less than one point on a 100-point scale. Most women would not notice such small differences in every-day life, nor would these effects outweigh the risks of estrogen plus progestin hormones for heart attack, stroke, blood clots, and breast cancer.

Researchers then analyzed the data from younger women (50-54 years of age) who reported having hot flashes and night sweats -- the symptoms that cause some women to seek treatment. There were no improvements in quality of life for these 574 women except a small improvement (1 point on a 20-point scale) in sleep disturbance.

These results do not apply to women who are taking estrogen-alone. This part of the WHI Hormone Program is still continuing, and the results are not yet known.

These results also may not apply to the women who seek medical care for menopausal symptoms. Participants in the WHI study volunteered to be assigned to either the combined hormone group or a placebo group. Women who were not willing to be in the placebo group did not participate in the WHI.

Future WHI publications will address a variety of other conditions--like diabetes, ovarian cancer, dementia and cognitive function--that estrogen plus progestin may impact in favorable or unfavorable ways.