(WOMENSENEWS)—Dr. Howard N. Hodis would like to clear up some of the confusion surrounding hormone replacement therapy during menopause.
“There is no doubt, unequivocally no doubt, that estradiol reduces coronary heart disease and total mortality,” says Hodis, a professor of medicine and preventative medicine and the Harry J. Bauer and Dorothy Bauer Rawlins Professor of Cardiology at University of Southern California’s Keck School of Medicine. “Now, whether one chooses to use it to do that is entirely a different issue. Women and physicians need to make those decisions together.”
Hodis spoke recently in a phone interview following a talk he gave on estrogen and the heart earlier this month at Women’s Health Congress, an annual conference put on by the Academy of Women’s Health that looks at current clinical approaches to a range of concerns. Attended by physicians, nurses and researchers, this year’s topics ranged from sleep disorders to transgender health care.
In both his talk and our subsequent phone interview, he explained how a key difference in two different types of scientific studies had spewed a volcano of misunderstanding about hormone replacement therapy, or HRT, during menopause.
“What we knew for 40-plus years across dozens of observational studies was that women who selected hormone replacement therapy had reductions not only in cardiovascular disease but also significant reductions in total mortality,” says Hodis, referring to studies where a researcher simply observes behavior and effects.
But then came along the kind of controlled, randomized experimental trials that would give these studies the kind of credibility that was widely expected. Instead, one of the largest trials, published in 2002 by the Women’s Health Initiative, threw a boomerang. It concluded that there was no positive effect of HRT on cardiovascular disease and possibly an increase in both heart disease and breast cancer.
Why such a discrepancy? How could we be so wrong? Those were the questions, says Hodis, who had seen the effects in his own observational studies but was not part of the Women’s Health Initiative study.
It turns out one of the major differences between the observational studies and the controlled trials was age.
When physicians were performing observational studies, they were examining women between the ages of 45 to 55, the vast majority of whom had started HRT at the time of or just before the onset of menopause in order to mediate its symptoms.
By contrast, the participants in the Women’s Health Initiative were on average 63 years old, nearly 12 years past the age of menopause onset.
“The Women’s Health Initiative didn’t study the women that normally take hormones,” says Hodis. “They studied a completely different population of women.”
When age was factored in, studies found that women initiating HRT around the time of menopause showed reduced rates of heart disease. In a recent study published in the New England Journal of Medicine, Hodis and his fellow researchers found that if given within six years of menopause, estradiol, a type of estrogen, significantly reduced atherosclerosis, or the hardening of the arteries, whereas the hormone had no effect in women 10 years past menopause.
Heart health typically worsens with age and the study’s results suggest that hormone treatment may only have an effect when initiated before heart health begins to decline.
In observational studies, women remained on HRT between 10 to 40 years. Hodis’s work has shown that women who begin HRT at the appropriate time and continue the treatment for 15-30 years see significant benefits and can gain 1.5 years of healthy living compared to those without it.
Unfortunately, following the findings presented in the Women’s Health Initiative study a lot of women stopped using HRT, which affected them in a number of ways, according to Hodis.
For instance, HRT is known to improve bone health and women who ceased HRT after the study was published had a 55 percent greater risk of hip fracture than women who continued HRT. An important finding, as hip fractures are more dangerous and often deadly in older women.
Breast Cancer Concerns
Another issue surrounding HRT was and continues to be breast cancer. The Women’s Health Initiative study evaluated the effects of estrogen alone as well as estrogen and progestin together.
“In the estrogen only trial, breast cancer was actually reduced,” says Hodis. “What has overwhelmed the information is the other regimen of the estrogen and progestin, which was used on a daily basis, where breast cancer was increased by about 6 women for every 10,000 women per year of use. That’s less than 1 per 1,000 women.”
The Federal Drug Administration and other institutions like it around the world follow the recommendations laid out by the World Health Organization’s Council for International Organizations of Medical Sciences, which has stated that a drug effect occurring in less than 1 per 1,000 individuals is considered a rare effect.
“But women were told they were going to get breast cancer from hormones,” says Hodis. “What they weren’t told was that actually estrogen alone reduces breast cancer and that the rate of cancer caused by estrogen plus progestin is considered rare. In comparison, one or two drinks a day causes as much breast cancer as did this regimen and being overweight carries more risk of breast cancer than this hormone regimen did. Furthermore, we use other drugs that increase the risk of breast cancer to at least that level, such as statins. The risk was way overblown.”
Hodis believes this misinformation surrounding HRT and breast cancer has prevented women from seeking appropriate care for their menopause symptoms. “The cognitive changes and effects menopause has on sleep, on vaginal dryness and atrophy and on quality of life and relationships as well as bone loss and fractures, doctors’ and women’s fears of not using hormone therapy cause undue suffering of women,” says Hodis. “It’s actually unconscionable as to what has occurred in women’s health.”
We need to look at the entire body of data, adds Hodis. “We never base conclusions on one trial because we’ve been burned so many times doing that. We lost sight of that with hormone therapy.”
Though there is evidence that HRT can sustain heart health, it’s not yet considered a preventative treatment by most physicians.
“In general it’s not indicated for any kind of cardiovascular preventative reasons,” says Dr. Jennifer Haythe, a cardiologist at the Columbia University Medical Center, an assistant professor of medicine and the co-director of the Women’s Center for Cardiovascular Health. “However, if someone came to me as a patient asking for hormone therapy because of menopausal symptoms, then I would go through the risk assessment of whether it’s safe for them or not.”
Haythe’s recommendations to women concerned about heart health include seeing a doctor once a year to monitor blood pressure, cholesterol and blood sugar. She also says not to smoke and to practice the Mediterranean diet, or one high in olive oil, fish and legumes while low in saturated fats and meats. Exercise is also a must, but that can be as simple as walking for half an hour four times per week. Other recommendations include stress reduction and avoiding excessive drinking.
“I know we say red wine is good for your heart, but there are no real data to support that,” says Haythe. “Everything in moderation.”