I am asked this question daily. The reason I am asked this question is due to all the confusion women are bombarded with by the media, bad science, and uninformed friends and health care providers. The simple answer for most patients is yes. Yes you should take hormones. Hormones influence every part of your body starting from your hair down to your feet. Your brain, teeth, heart, skin, colon, bones, vagina, bladder, muscles, and eyes are all affected by hormones. Unfortunately all these organs are affected negatively by the lack of hormones. Simply the aging process accelerates without hormones.
Prior to 2002 most of my patients were eager to take hormones to help improve their sleep, hot flushes, memory, focus, and bone strength. Then suddenly in July of 2002 the investigators of the Women’s Health Initiative (WHI) revealed their findings. The Women's Health Initiative is a long-term national health study that has focused on strategies for preventing heart disease, breast and colorectal cancer and osteoporotic fractures in postmenopausal women.This multi-million dollar, 15-year project, sponsored by the National Institutes of Health (NIH), and National Heart, Lung, and Blood Institute (NHLBI), involves 161,808 women aged 50-79. This study had the potential to be one of the most definitive and far-reaching clinical trials of post-menopausal women's health ever undertaken in the U.S.
The conclusion these investigators reported on May 31, 2002, after a mean of only 5.2 years of follow-up, recommended stopping the trial of estrogen plus progestin vs. placebo. The study was stopped due to a 26 percent increase in invasive breast cancer in the group taking estrogen and progesterone compared to the placebo group. But, let’s look at the actual numbers. The group not taking hormones had 30 cases of breast cancer per 10,000 women. The group taking hormones had 38 cases per 10,000. For an increase of 8 cases per 10,000, women were told hormones are clearly harmfuland should be voided at all cost. A 26 percent increase of a small number is still a small number. Patients lost trust not only in hormones, but their physicians as well as they became confused over who to trust. Over the past ten years patients have feared hormones and deprived themselves of their benefits and seeking alternatives that have little proven benefit. To this day, I still do not understand the rational for the design of this study and why they felt these findings were significant enough to stop the study and alter treatments that have many years of clinical support. I also do not know why this one study was considered so influential by the medical community.
Let’s forward to May 22, 2012. A major reappraisal by international experts, published as a series of articles in the peer-reviewed journal Climacteric (the official journal of the International Menopause Society), shows how the evidence has changed over the last 10 years, and supports a return to a "rational use of HT, initiated near the onset of menopause". Ironically several of the same investigators from the WHI study are now offering a different opinion. I have included quotes from the paper along with my interpretation and comments. Have we come full circle-or moved forward? The Women's Health Initiative 10 years on", by R.D Langer, J.E Manson, and M.A. Allison, Climacteric Vol15 no 3 pp206-213.
Dr. Robert Langer, Principal Scientist at the Jackson Hole Center for Preventive Medicine, Jackson Wyoming, was the Principal Investigator of the WHI Clinical Center at the University of California, San Diego. He said:
"With 10 years hindsight we can put the lessons learned from the WHI HT trials into perspective. In some ways we've come full circle – studies in recently menopausal women that suggested protection against major diseases led to testing whether that would carry over to older women who have even greater risks of heart attacks and fractures. That hope proved false. Unfortunately the results were wrongly generalized back to women like those who inspired the study. Information that has emerged over the last decade shows that for most women starting treatment near the onset of menopause, the benefits outweigh the risks, not just for relief of hot flashes, night sweats and vaginal dryness, but also for reducing the risks of heart disease and fractures".
"Overgeneralizing the results from the women who were -- on average -- 12 years past menopause to all postmenopausal women has led to needless suffering and lost opportunities for many. Sadly, one of the lessons from the WHI is that starting HT 10 years or more after menopause may not be a good idea, so the women who were scared away by the WHI over this past decade may have lost the opportunity to obtain the potential benefits."
I interpret Dr. Langer’s comments as a total discredit of the original findings and almost apologetic for the disservice to women for the past ten years. He states studies that had previously shown benefits in women who started taking hormones close to the onset of menopause did not apply to women who started taking hormones at an earlier age. Then he states these results were “wrongly generalized” to younger women. He even admits to the benefits of hormones beyond hot flashes.
Professor JoAnn Manson (Harvard Medical School and Brigham and Women's Hospital, Boston, MA), who has been one of the WHI Principal Investigators since the study started, said:
"An important contribution of the WHI was to clarify that, for older women at high risk of cardiovascular disease; the risks of HT far outweighed the benefits. This halted the increasingly common clinical practice of prescribing HT to women who were far from the onset of menopause. Unfortunately, these findings were extrapolated to newly menopausal and healthy women who actually had a favorable benefit: risk ratio with HT. The WHI results point the way towards treating each woman as an individual. There is no doubt that HT is not appropriate for every woman, but it may be appropriate for many women, and each individual woman needs to talk this over with her clinician"
I think Dr. Manson is trying to justify the importance of the WHI study. Bottom line this was a poorly designed study with poor interpretation by the investigators.
WHI researcher Professor Matthew Allison (University of California, San Diego), said:
"It is important to put the results of the WHI trials into context. That is, being obese, not exercising or excess alcohol consumption confers higher absolute risks for breast cancer than HT use."
I wish professor Allison had made this clear to the media back in 2002. His statement also indicates to me WHI had no significant findings.
The authors note that the initial press reaction, following the lead of the WHI press release, over-emphasized a relatively small increase in breast cancer, so distorting the overall view of the report.
Why did they not realize this was a small increase back in 2002? The press did not misreport the data-- they reported what these researchers concluded. Unlike most research these findings were first released to the press not peer review.
By now it is obvious that I do not like or trust the findings of the WHI study. WHI has done a tremendous disservice to women for the past 10 years. This latest release by the principal investigators is even more confusing. I am not sure why they made these recent comments.
In my last 21 years of practice, I have seen many patients benefit from the use of hormones. I do support the use of hormones to help with the symptoms of menopause as well as the “antiaging” benefits they offer in the context of overall health. We promote weight control, exercise, balanced diet and nutritional supplements in addition to hormones. We use all types of hormones including compounded bio-identical hormones and testosterone pellets to balance your symptoms.
Raj Syal MD,FACOG