Article Archive
July/August 2013

Hormone Therapy for Menopausal Symptoms?

By Lindsey Getz
Today’s Geriatric Medicine
Vol. 6 No. 4 P. 28

Women and their physicians have long experienced confusion regarding hormone therapy (HT). Recently, the Society for Women’s Health Research (SWHR) held a scientific roundtable addressing HT in perimenopausal, menopausal, and postmenopausal women, exploring some of the issues associated with differing medical perspectives on HT use. The group examined the most recent and broadest group of studies available and provided recommendations based on the stage of life in which a woman begins HT. The result was a series of statements aimed at shedding light on HT and holding the potential for practice-changing outcomes.

Raising Concerns
In 2002, the Women’s Health Initiative (WHI) examined HT and found that in a small number of women, HT use increased the risk of breast cancer, stroke, and heart disease, among other possible negative health outcomes. Some of the women in the study took hormone replacement therapy (estrogen and progestin) while others took estrogen replacement therapy (estrogen only). Each group was compared with women who took a placebo.

While the study looked at 26,000 women in the hormone research portion of the study and was no small-scale effort, several critics have surfaced since the findings were released. A major critique suggests that the study undersampled younger women (those aged 50 to 54). The recent scientific roundtable analyzed the data from the WHI as well as much of the other research that has been conducted.

“There has been a tremendous amount of research conducted over the past decade, and the results vary greatly depending on the type of hormone therapy used and time in the menopausal transition that a woman initiates treatment,” says Shelley Salpeter, MD, a clinical professor of medicine at Stanford University and a panel participant. “Our goal was to establish clearer recommendations for women so they can get the appropriate treatment they need without concerns about jeopardizing their health.”

Salpeter says it’s important to recognize that HT has very different effects when started in women in the early postmenopausal period (within 10 years of menopause) vs. starting in older women (greater than 10 years from menopause). “In early postmenopausal women, HT has the greatest benefit and the lowest risks,” she says. “Treatment reduces heart disease and heart attacks, reduces osteoporosis and hip fracture, improves lipid profiles, reduces the development of diabetes, and improves quality of life and menopausal symptoms. On average, it also reduces total mortality by 40% compared with no treatment. While estrogen and progesterone together increase the risk of breast cancer, estrogen treatment alone does not. HT also increases the risk of stroke in younger women, but the reduction in heart attacks is much greater than the increase in stroke.”

There also is some evidence that HT may reduce the risk of colon cancer, Salpeter adds. She says the key is timing HT in relation to menopausal transition. “When treatment is started in older women who have been off hormones for many years and may have developed heart disease already, HT increases the risk for clotting complications, including heart attacks, and does not reduce total mortality,” she notes. “However, if older women have been on HT for many years, the continued treatment is associated with benefits such as reduced hip fracture and improved metabolic parameters.”

Benefits and Risk
As with any treatment, the idea is to weigh the potential benefits against the risks. Wulf H. Utian, MB, BCh, PhD, DSc, FRCOG, FACOG, FICS, a roundtable panelist, an independent consultant in women’s health issues, and the executive director emeritus/honorary founding president of The North American Menopause Society, says the “do no harm” component of the Hippocratic Oath has translated into “the benefit must outweigh the risk.”

“That’s how drugs are studied, and that’s how physicians look at whether they should prescribe a treatment or not,” Utian says. “I call the last decade ‘the new chapter of medicine’ where we’ve also begun to look at quality of life. When you take into account the benefits outweighing the risks and the idea of improving quality of life, hormone therapy is a no brainer, and I fail to see why there’s so much debate. The problem is educating the public.”

Utian says that following the release of the WHI study findings, women stopped using HT in droves, and many physicians became convinced that the risks outweighed the benefits. “This extensive roundtable has released statements that we hope physicians will now consider in practice,” Utian says.

The seven statements or key findings, as the SWHR terms them, are the following:

• Roundtable participants unanimously agreed that the HT benefit-risk profile is more favorable for younger, newly menopausal women.

• The panelists unanimously agreed that HT provides a significant benefit in quality-of-life measures in early postmenopausal women, mainly through the relief of symptoms, but treatment may result in a global increase in a sense of well-being.

• The majority of panelists agreed there is consistent evidence that HT reduced total mortality in early postmenopausal women. Most importantly, the panel uniquely distinguished between ages beginning HT vs. extrapolating data to all women.

• The majority agreed that in younger symptomatic postmenopausal women, the benefits of estrogen and progestin for at least five years outweigh the risks, which for the first time gives formal guidance on HT duration.

• Panelists unanimously agreed that in younger postmenopausal women with hysterectomy, the benefits of unopposed estrogen treatment for at least 10 years outweigh the risks. Treatment recommendations for this group of women have not been specifically addressed in other recent reports.

• The majority agreed that HT in early postmenopausal women does not increase the risk of coronary heart disease and actually may reduce it. However, there is insufficient evidence for HT use in the primary prevention of coronary heart disease.

• The panel agreed (with the exception of two abstaining votes) that estrogen can be used for the prevention of osteoporosis (an FDA-approved indication) in early postmenopausal women with an increased risk of fracture. The optimal duration for treatment is not known. If HT is discontinued, the benefits dissipate. Therefore, in patients at high risk of osteoporotic fractures, continued estrogen treatment or other alternative treatments should be considered.

Beyond Menopausal Symptoms
It seems clear that the panelists agreed there is nothing as effective as HT for true menopausal symptoms, such as hot flashes and night sweats. However, the statements regarding HT for the treatment of osteoporosis and chronic disease are unique among the roundtable findings. Utian says the use of these treatment theories was considered in the past, but physicians moved away from the idea following the WHI study. “Now we’re moving back to the idea of utilizing HT for not only menopausal treatment but for things like chronic disease prevention,” Utian says. “Our consensus is that it is not inappropriate to consider HT for these issues.”

Of course, not every panelist was fully comfortable with every statement. Jane A. Cauley, DrPH, a professor in the department of epidemiology at the University of Pittsburgh, who has spent the past 15 years as an investigator of numerous research projects examining the physical and psychological changes that occur in postmenopausal women, remains uncomfortable with the use of HT for chronic disease prevention or as a primary treatment or prevention for osteoporosis. But she agrees that women who have had difficulty in the menopausal transition and are experiencing numerous symptoms would make ideal candidates for HT. “To me, the bottom line is that it’s an individual decision the physician needs to make on a case-by-case basis,” Cauley says. “I think it can be beneficial to women who are suffering from symptoms like night sweats and hot flashes but I’m still an advocate of the lowest dose and the shortest duration possible when it comes to treatment.”

Regarding the ideal candidate, Utian stresses that it has less to do with age than to the “recency to menopause. Some women go into menopause at 45, while others are in their late 50s. While they are different ages, both have been producing adequate levels of estrogen up until the point of menopause. If you were to start hormones for the first time in a woman who was 10 or more years beyond menopause, you are increasing her risk for cardiovascular disease or coronary events. So the general consensus is that timing is important. Starting within 10 years of menopause is considered OK, and why would you start later anyhow? That is one of the biggest criticisms of the WHI.”

Salpeter adds that the best candidate for HT is a younger woman who is going through the menopausal transition or who recently has entered menopause and is symptomatic. She agrees with the consensus that women with a high risk of osteoporosis make good candidates for long-term HT and does not believe that all cases warrant the “lowest dose and shortest duration.”

Cauley and Salpeter agree the bottom line is that physicians need to make treatment decisions on a case-by-case basis. “The most important thing for doctors to do is understand the risks and benefits of HT for different ages and to treat each patient as an individual,” Salpeter says.

— Lindsey Getz is a freelance writer based in Royersford, Pennsylvania.