Raj K. Syal, M.D., F.A.C.O.G.    |    Jenna A. Everson, M.D., F.A.C.O.G.    |    Holly Westmoreland, M.D., F.A.C.O.G.    |    Kellyn Rielly D.O.   

Yes, You Should Take Hormones.

hormones therapy with Woodlands OBGYN Associates | Woodlands TX I am asked this question daily, and the reason I am asked this question is due to all the misinformation women are bombarded with by the media, bad science, and uninformed friends and health care providers. The simple answer for most patients is “yes.”

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 of these organs are affected negatively by insufficient hormone levels. Simply put, the aging process accelerates without proper levels of hormones.

Prior to 2002, most of my patients were eager to take hormones to help improve their sleep, hot flashes, 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 post-menopausal women. This multi-million dollar, 15-year project, sponsored by the National Institutes of Health (NIH), and National Heart, Lung, and Blood Institute (NHLBI), involved 161,808 women aged 50-79. The 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 that was reported on May 31, 2002, after a mean of only 5.2 years of follow-up, recommended stopping the trial of estrogen plus progestin versus placebo. The study was stopped due to a 26 percent (26%) increase in invasive breast cancer in the group that was taking estrogen and progesterone as 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 harmful and should be avoided at all cost. A 26 percent increase of a small number is still a small number. Patients lost trust not only in hormone replacement therapy, but in their physicians as well, as they became confused over who to trust.

Since this study in 2002, patients have feared hormone replacement therapy and have deprived themselves of the benefits of hormone replacement, and have been 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.

Now, 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 since 2002, and supports a return to a “rational use of hormone therapy (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 Vol. 15, No. 3, pp. 206-213.

Dr. Robert Langer, principal scientist at the Jackson Hole Center for Preventive Medicine in 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.”

“Over-generalizing the results from the women who were — on average — 12 years past menopause to all post-menopausal 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 as being apologetic for the disservice to women for the past ten-plus 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. The bottom line, in my opinion, is this was a poorly designed study with poor interpretation by the investigators.

Professor Matthew Allison of the University of California, San Diego (one of the WHI researchers), stated:

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 that 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, thus 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 the researchers concluded. Unlike most research findings, these findings were first released to the press and not to a 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-plus years. This latest release by the principal investigators is even more confusing. I am not sure why they made these recent comments.

However, there’s still hope through a recent study which resulted in another plus for hormones. This study was released from Finland designed to evaluate the risk of death due to heart disease, stroke, or any disease among users of an estrogen-based hormone therapy. Almost 500,000 women were followed from 1994 to 2009 (a total of 3.3 million years of hormone exposure).

A total of 28,734 women using hormones died during the study. Heart disease was responsible for 3,843 deaths and 2,464 deaths were due stroke. This risk was compared to an age-matched population of non-hormone users over 1, 3, 5, and 10+ years of hormone users.

The risk of heart disease was reduced by 18-54% in patients on hormone therapy, and had a positive relationship to the time of hormone exposure.

The risk of stroke decreased by 18-39% in the group using hormones.

Risk of all-cause mortality was reduced in the hormone users by 12-38%, and had a strong correlation with the duration of hormone use.

In this study, the risk reduction occurred without regards to the age of initiating hormone therapy. However, the benefits are magnified by starting hormones close to the onset of menopause.

(Mikkola, Tomi S.; Tuomikoski, Pauliina; Lyytinen, Heli; Korhonen, Pasi; Hoti, Fabian; Vattulainen, Pia; Gissler, Mika; Ylikorkala, Olavi. “Estradiol-based Postmenopausal Hormone Therapy and Risk of Cardiovascular and All-cause Mortality” Menopause. Sept. 2015: Vol.22- Iss. 9. Pp. 976-83. Print.)

In my many 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 “anti-aging” benefits they offer in the context of overall health. At Woodlands OBGYN Associates, 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.

If you are experiencing symptoms of menopause, speak with us and we will develop a specific plan to bring your hormones in balance, allowing you to continue a healthy, robust, and fulfilling life.

Raj K. Syal, MD, FACOG
Raj K. Syal, MD, FACOG