Personalized Care

Any medical treatment should be considered specific to the needs and hormone concentrations of each individual patient. This is why we share our full breadth of knowledge about endocrinology, medical safety, and treatment efficacy in addition to treating gynecologic function and overall wellness.

So we were dismayed to read that the U.S. Preventive Services Task Force (USPSTF) final recommendation statement on the use of menopausal hormone therapy in post-menopausal women, citing health risks such as breast cancer, heart attack, dementia, and stroke. The key words are post-menopausal. The USPSTF recommendations did not address the overwhelming evidence that hormone therapy (HT) greatly benefits women who are going through the menopausal transition (aka with menopausal symptoms) and who do not have additional health problems. The USPSTF again failed to highlight the population of women who need hormones the most and are most likely to benefit from taking them (see Part 1 of this two-part blog). We can agree with their statement that women who START on their hormone therapy when they are older than 60, or more than 10 years following their last menstrual period, shouldn’t use hormones for the prevention of most diseases. But it doesn’t apply for the women a decade younger; that is, the patient population most often experiencing the symptoms that need treatment (hot flashes, night sweats, vaginal dryness, painful intercourse, mood swings, etc.). The safest time to use HT is during the so-called “estrogen window,” which is the decade-long time-frame between the ages of 50 and 60, or 10 years from the time of menopause (where menopause is defined as the start of at least 12 consecutive months menstrual period-free.

Hormone Therapy (HT) Is Effective for Hot Flashes, Night Sweats, and More

The North American Menopause Society’s most recent position statement (2017) concludes that HT remains the most effective (italics are mine) treatment for hot flashes and night sweats and the genitourinary syndrome of menopause (vaginal atrophy, painful intercourse, recurrent urinary tract infections, etc.), and it has been shown to prevent bone loss and fractures (osteoporosis). The risks of HT differ depending on type, dose, duration of use, route of administration, timing of initiation, and whether a progestogen or progesterone is used. Treatment should be individualized to identify the most appropriate HT type, dose, formulation, route of administration, and duration of use, using the best available evidence to maximize benefits and minimize risks. Also, check-ups with each patient during this time to evaluate benefit should be ongoing.

Where the Women’s Health Initiative (WHI) Erred

The WHI hormone studies have increasingly come under fire for the way they were designed, most importantly for the inclusion of women up to age 79, and results reported as if all women are the same. The results of these studies have reverberated through the medical community, causing changes that may have been both too broadly applied and, in some cases, simply incorrect (see commentary by David. L. Katz, MD, MPH, FACPM, FACP on such overgeneralizations. The findings that hormone therapy was putting many women at risk for conditions like breast cancer and cardiovascular conditions caused many women to go off their hormone-replacement therapy “cold turkey” without knowing how to address the consequences and not fully understanding the risks versus rewards. For example, some of the patients in the WHI study were already at increased risk for cancer or cardiovascular disease because of lifelong smoking, being overweight and the age at which they started hormone therapy (> 60 years, and up to age 79). However, otherwise healthy women should be able to use these therapies to ward off the symptoms that affect sleep, mood, sexual health, pleasure, etc.

We’ve Done Our Homework

In wanting to help my patients find effective ways to treat their symptoms, I analyzed a database of 13 million patients to investigate whether two forms of estrogen therapy (oral versus transdermal) differed in how patients experienced negative effects, particularly focusing on heart attacks, strokes and deep vein thromboses (blood clots in the veins) (see: Simon JA, Laliberté F, Duh MS, Pilon D, Kahler KH, Nyirady J, Davis PJ, Lefebvre P. Venous thromboembolism and cardiovascular disease complications in menopausal women using transdermal versus oral estrogen therapy. Menopause. 2016 Jun; 23(6): 600-10). I concluded that patients who used transdermal estrogens had significantly fewer blood clots in their veins, pulmonary emboli, and heart attacks than those who took an oral estrogen (i.e., pills). Stroke risks were also slightly lower for transdermal estrogen users.

I used this information to hypothesize just how different the WHI results would have been had that study used transdermal estradiol and micronized progesterone (see: Simon JA. What if the Women’s Health Initiative had used transdermal estradiol and oral progesterone instead? Menopause. 2014 Jul; 21(7): 769-83.). Those investigations showed that HT type, dose, formulation, route of administration, and duration of use can be tailored to maximize benefits while reducing or eliminating risks. “One size doesn’t fit all,” as the USPSTF suggested.

Key Points

• HT benefits in early menopausal women include reduced coronary heart disease and all-cause mortality.
• Randomized trials in women initiating HT after age 60 have shown benefit primarily for osteoporosis and fracture but overall increased harm.
• Reassessment of clinical trials in women initiating HT treatment close to the onset of menopause and newer studies and meta-analyses now show benefit and rare risks.
• More studies show benefit with estrogen alone than with estrogen plus progestogen.
• No available medication except HT has demonstrated prevention of osteoporotic fractures in women not previously identified as having osteoporosis.
• The effects of reduced cardiovascular disease and mortality in women initiating therapy around menopause (the “estrogen window”), and the beneficial effects of HT on the skeleton at any age, together suggest a role for hormone-replacement therapy in disease prevention.

Stop Suffering, Start Living

Please contact our office at (202) 293-1000, and make an appointment to get your questions answered and determine the best course of HT treatment that is specifically tailored to you.

We unequivocally support the use of menopausal hormone therapy to mitigate menopause symptoms and prevent disease for a variety of patients. Let’s review the facts of the case. THIS IS NOT FAKE NEWS!

When our institutions fail us, it’s time to openly and directly say so. No, this is not a political rant. I’m talking about the United States Preventative Services Task Force (USPSTF), a well-meaning, highly educated group of 12 so-called experts (no endocrinologists, no reproductive endocrinologists, and no menopausal specialists), consisting of two pediatricians, a PhD specialist in health management and public policy, four internists, four family physicians, and our token Ob/Gyn (who isn’t a menopause or hormone therapy expert). Yes, this is the same group (some different players) who recommended every-other-year mammography — and you may remember the backlash and public outcry over that suggestion. (FYI, the major organizations in women’s healthcare didn’t accept that recommendation.)

Well, this group is at it again, this time over postmenopausal hormone therapy. Last month (December 2017), the group gave a “D” recommendation for the use of postmenopausal hormone replacement therapy for disease prevention in both naturally menopausal women and women who have had a hysterectomy. A “D” recommendation means: recommends against the use of combined estrogen and progestin (in women with a uterus) or estrogen alone (in women who had a hysterectomy) for the primary prevention of chronic conditions in postmenopausal women. You can read their recommendations for yourself.

So, what happened? First, let’s be clear. Experts looking at the same scientific information can disagree on its meaning. But that’s not what happened here. I know this because a real group of menopause and hormone therapy experts replied to the draft recommendations of the USPSTF, attempting to explain the errors of their draft recommendations (see: Langer RD, Simon JA, Pines A, Lobo RA, Hodis HN, Pickar JH, Archer DF, Sarrel PM, Utian WH. Menopausal hormone therapy for primary prevention: Why the USPSTF is wrong. Menopause. 2017 Oct; 24 (10):1101-1112. doi: 10.1097/GME.0000000000000983., Or Langer RD, Simon JA, Pines A, Lobo RA, Hodis HN, Pickar JH, Archer DF, Sarrel PM, Utian WH. Menopausal hormone therapy for primary prevention: Why the USPSTF is wrong. Climacteric. 2017 Oct; 20(5): 402-413. doi: 10.1080/13697137.2017.1362156. Epub 2017 Aug. 14.).

These two publications are essentially the same. One was meant for the U.S. audience of menopause and hormone therapy experts, the other for the international menopause and hormone therapy audience. These same recommendations were sent to and received by the USPSTF during their comment period. Nothing from our suggestions was incorporated into the USPSTF documents. One conclusion could be that the USPSTF didn’t care, they had their minds made up, and no amount of scientific information was going to change their opinion. That’s not what happened, in my opinion.

The USPSTF opted to do two things to support their forgone conclusions:

1. They so severely limited the evidence they were willing to consider that they made their judgement based only on the evidence in support of their opinion
2. They made simplified judgments to apply to every menopausal woman as if they were all the same.

This first tactic is prime territory for every lawyer. You define the evidence in such a limiting way as to exclude all evidence not in support of your client. The USPSTF, by excluding so much of the scientific information available, was left with only a few important studies … the usual suspects, the Women’s Health Initiative (WHI) being so large and all encompassing, that it overwhelmed any analysis of the other studies considered.

The second tactic, treating all menopausal women as if they were the same, fits well into tactic 1, since the WHI Investigators initially reported on their study “overall” (Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women’s Health Initiative Investigators. JAMA. 2002 Jul 17; 288(3): 321-33.), lumping together women aged 50 through 79 as if they were all the same. And that was 15 years ago (prehistoric in scientific years).

These two errors in judgment are elegantly summarized by David. L. Katz, MD, MPH, FACPM, FACP who published another paper showing that NOT taking estrogen therapy following a hysterectomy actually resulted in a minimum of 18,601 — and as many as 91,610 postmenopausal women — dying prematurely because of the avoidance of estrogen therapy (ET) over a 10-year span, starting in 2002. Prevention of death is what I would call the ultimate prevention of disease. (See: The mortality toll of estrogen avoidance: an analysis of excess deaths among hysterectomized women aged 50 to 59 years. Sarrel PM, Njike VY, Vinante V, Katz DL. Am J Public Health. 2013 Sep;103(9):1583-8. doi: 10.2105/AJPH.2013.301295. Epub 2013 Jul 18.)