N E W Y O R K -- Five years ago, hormone therapy was recommended to postmenopausal women almost as a matter of course as a way to protect them from age-related disease and to improve their overall quality of life. How times have changed.
In mid-2002, a major study revealed hormone therapy that combined estrogen and progestin increased heart disease and breast cancer risk and didn't affect well being. Prescriptions for hormone therapy dropped from 90 million to an estimated 57 million within a year.
Then, later data from the study, the so-called Women's Health Initiative, or WHI, showed risk of dementia doubled in women 65 and older who were taking postmenopausal hormone therapy. Prior to this finding, some women were taking hormones, in part, because they were under the impression that it might prevent Alzheimer's disease.
Now, just this week, the estrogen-only phase of the WHI was ended prematurely because not only did it not effect risk of heart disease, but also because it raised the risk of stroke. Even more women are now likely to discontinue hormone therapy.
Yet coming off the hormones is not always easy for women. It's estimated that about a quarter of women who stop hormone therapy resume taking them to ease debilitating withdrawal symptoms such as hot flashes. Quitting is especially difficult for women who have been taking hormones for 10 years or more.
Below, Marcia Stefanick, a professor of medicine at Stanford University and coauthor of a recent study about the national use of hormone therapy, discusses the medical community's latest approach to postmenopausal hormone therapy.
Was the drop in the use of postmenopausal hormone therapy significant?Yes, I think that there was a significant response to new evidence. I think the greatest response from the WHI was specific to combination estrogen/progestin therapy as opposed to estrogen-only therapy. (Estrogen-only therapy is prescribed to women who do not have a uterus.) This was appropriate as the women on estrogen/progestin therapy were the only group that the data related to.
It terms of the women who stayed on the therapy, it's a matter of teasing apart the estrogen-only from the estrogen and progestin combination therapy. My suspicion is that the estrogen-only women are the group that is primarily keeping the numbers up.
Why might women choose to stay on postmenopausal hormone therapy?There are still a lot of women who continue their hormones. They are either very happy on hormones or their physicians are still of the opinion that they are better off being on the hormones.
And there is a reason to be on hormones. Certainly many relatively young women going through menopause find those symptoms intolerable. Some women who came off the hormones probably had even worse symptoms than they had before they started.
A Kaiser Foundation study showed that one in four women in the group that came off went back on. So at least 75 percent of women who were on hormones didn't have a very good reason to be on them with respect to their own comfort level.
How do you think most women stopped taking postmenopausal therapy?I think the July 2002 data and the media attention to the risks caused many women to call their doctors and say, "I'm stopping my pills," and by and large physicians supported that decision to stop. And from that point on physicians no longer promoted hormones except for women who really had the symptoms for which the hormones are indicated.
Women may not have been responding out of a full comprehension of the risks and benefits but out of fear of the risks. I think that the women who are now going back on presumably are having those risk/benefit discussions with their physicians.
What are some of the withdrawal symptoms that women experience?The primary symptoms are the ones that we called menopausal symptoms. So hot flashes, night sweats and disturbed sleeping, probably because of the hot flashes and night sweats, and vaginal dryness. I think hot flashes are the main symptom that women have with menopause that drives them to seek hormones. And I think that's the main symptom that recurs when they come off the pills.
Do you think the withdrawal problems were due to coming off of postmenopausal hormone therapy too quickly?We don't really have the data on that, so that's where medicine is more of an art than a science. Tapering off is a strategy that physicians are using. It may work for some women, and it may not work for others.
The majority of women came off cold turkey and did fine. But based on that Kaiser survey there were a number of women — and I don't know exactly what percentage that is, whether that's the 25 percent that went back on, or whether it's a higher number — who had symptoms. But we don't really have good data on that.
It's very likely that the doses of hormone therapy that have been traditionally prescribed were higher than were necessary to treat those symptoms, so women's bodies reacted to the withdrawal of those high doses more strongly than it would if they were at lower doses and stopped.
What can women expect emotionally when going off postmenopausal hormone therapy?I think that most of the emotional symptoms are tied into the hot flashes and night sweats and disturbed sleeping. If you get those, then that can really affect other parts of your emotional state. I don't think that we have very good data on depression and other emotional issues that women talk about, so we can't say if they are separate from the night disturbances.
If women have depression, there is evidence now that some of the antidepressants can reduce hot flashes and night sweats. So if you have the combination of depression and symptoms, then you might want to go for something other than estrogen anyway. I think that we're in a new domain now where physicians are going to try to find one drug that can solve two problems if there are two problems.
When is postmenopausal hormone therapy appropriate?We're coming into a more moderate place where everyone is realizing that there still is a role for hormones in management of women. It's back to what hormones were indicated for, which is menopausal symptom relief.
These symptoms include hot flashes and night sweats, and vaginal and vulvar atrophy, so essentially dryness, which can result in itchiness and problems with sexual intercourse. But for vaginal problems, I think most people are recommending topical, lubricating vaginal creams, and maybe not even hormone creams as a first pass.
There still is an indication for preventing osteoporosis, but the labeling now makes it very clear that one should consider alternatives to estrogen and that it's only appropriate if women have menopausal symptoms and bone thinning.
So what is the current recommended dose for women wanting hormone therapy? I think the FDA has made it clear in their labeling, and many physicians and professional organizations, including the American College of Obstetrics and Gynecology and the North American Menopause Society, agree that women should go on the lowest effective dose for the shortest possible time and then reassess.
Similarly, for women who are going back on hormones, the recommendation is to go back on to a lower dose and then try again to slowly come off to reassess the need for the hormones.