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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.

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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.)

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Upon hearing a cancer diagnosis a person’s world changes immediately and forever. The person becomes a patient. The patient has to make myriad decisions about treatment plans, and the possibility of surgery, radiation, and chemotherapy. These treatments, while life-saving, are also life-altering. The side effects can modify body image, reduce or end fertility, change sexual identity and sexual function. Approximately 60 percent of cancer survivors have long-term sexual dysfunction. Oncology teams (who may focus more on the life-saving aspects of care) aren’t always taking the time to discuss fertility or sexual health matters as much as they should. But the good news is that our practice can help save a women’s eggs, or a man’s sperm for future use; mitigate and reverse most hormonal changes, and starting in September, we will also offer treatment for men with urological or sexual complaints in our practice. Our newest colleague, Rachel S. Rubin, MD, is specially trained to treat hormonal and sexual dysfunction in both men and women.

Talking about sexual health outside of the bedroom, in the office of a compassionate physician is key to holistic wellness. The emotions of being a cancer survivor can be overwhelming in and of themselves, but to add infertility or sexual dysfunction to the list of health issues can be daunting. We’re here to help you get back on track.

For Men
Following prostate cancer treatment, for example, the ability to have and maintain an erection becomes difficult and for some men, impossible, without help from a medical practice such as ours. Many men may not feel comfortable talking about these intimate issues, but there is help. Our compassionate and caring staff can help men who experiene treatable symptoms. It’s not just about physical symptoms, cancer affects sexual identity and when men are unable to perform as they could prior to cancer treatment, it can have a serious and detrimental effect on one’s psyche. Getting the courage to seek help is the first step to getting back to the “new normal.”

For Women
Breast cancer, when surgery is required, may alter a woman’s body and can hinder sexual identity and function. Breasts, once part of the sexual experience for both partners, are no longer the same. Even when reconstructed, the breasts may feel different, lack the pleasurable sensitivity they once had, or might even be painful and distracting. Sensation might even be completely gone. Partners may also feel hindered by the feeling of the new breasts. This can be uncomfortable for both partners. With any cancer treatment (i.e. chemotherapy, surgical removal of the ovaries or even hysterectomy) a patient may find herself in early/premature menopause with hot flashes, night sweats, disturbed sleep and weight gain. This is also accompanied by vaginal dryness, and pain with genital touching or intercourse. There are options to help enhance the sexual experience that we have available at the office, and that are not available anywhere else.

A wonderful Newsweek article about these issues does a deeper dive from both the patient and physician perspective that we welcome you to read for additional information.

If you are just starting cancer treatment, going through it, or are in the post-treatment phase and are facing future or current fertility concerns, hormonal deficiencies, or sexual dysfunction, we can help. Please call our office at (202) 293-1000 to make an appointment with one of our caring and compassionate members of Dr. James A Simon’s team.

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Leading researchers are urging the medical community to rethink how they treat patients who experience severe menopausal symptoms. Mache Seibel, MD., former 20-year veteran of Harvard Medical School faculty, editor of My Menopause Magazine and Professor of OB/GYN, University of Massachusetts –was inspired by his wife’s experience, and took it upon himself to help her and countless others, manage this important phase of life. Dr. Seibel studied the hormones given to women to treat symptoms and revisited the research in the Women’s Health Initiative (WHI) from 2002. After an up-close look at the data, he realized that further educating people about the role of hormones in health was necessary.


Jane Doe Lost Her Mojo
Many women who are in the prime of their lives and height of careers struggle with the debilitating symptoms associated with menopause. Consider this scenario: A healthy woman, aged 51, is looking forward to engaging in a night of foreplay, fun and sex with her partner, but is unable to enjoy herself, because of the lack of natural moisture she’s had all of her life until now. The “dry sex” she now has leads to pain during intercourse–two common symptoms of menopause. Following an unsatisfying sexual experience, she eventually falls asleep, only to be awakened by hot flashes and night sweats, soaking her sheets. The next day she wakes up tired, frustrated, and in a mental fog, only to have this experience happen the next night, and the next, and the next, and again the week after that. Knowing that sexual desire for women starts in the brain, she became unsure about how to connect her desire for intimacy with her body’s sexual response the way she used to, and her overwhelming fatigue makes her wonder if it’s worth the effort. The good news is that the experience of the menopausal transition can be positive, given the appropriate treatment, which varies depending on the age and health-status of each woman.

Understanding Menopause
The process of menopause is like the process of puberty—but in reverse, says Dr. Seibel in his revolutionary book, “The Estrogen Window: The Breakthrough Guide to Being Healthy, Energized, and Hormonally Balanced–through Perimenopause, Menopause, and Beyond.” Although puberty is well understood, menopause, which effects every woman, is less so. Women may assume that the surge of estrogen during early menses will suddenly shut off like a spigot, but it is more subtle and takes longer than one might imagine, leaving in its wake, uncomfortable symptoms, which were broadly treated with hormones such as estrogen and synthetic progesterone (progestin) until the WHI study results were released in 2002.

The WHI hormone studies have increasingly come under fire for the way they were designed, most importantly the inclusion of women up to age 79 years. The results of these studies have reverberated through the medical community as the changes they caused may have been both too broadly applied and in some cases simply incorrect. The findings that hormone therapy was putting many women at risk for certain conditions such as 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 risk for cancer or cardiovascular disease because of life-long smoking, being overweight and the age at which they started hormone therapy. However, otherwise healthy women should be able to use these therapies to ward off the symptoms that affect sexual health and pleasure.

Opening the Estrogen Window
Dr. Seibel calls the estrogen window, the “decade-long time-frame between the ages of 50 and 60, or 10 years from the time of menopause,” which is defined as at least 12 consecutive months menstrual period-free.

His book outlines important recommendations that are not a one-size fits all approach. Here are several key takeaways for improving and maintaining sexual vitality:

Low estrogen levels at midlife are common causes for genitourinary syndrome of menopause that causes bladder leakage, vaginal dryness, and elasticity in vaginal tissue to change–leading to discomfort during sex (location 3014).

The estrogen window for vaginal estrogen always remains open; it never closes (location 836).

Estrogen alternatives exist for women with medical histories (e.g., breast or endometrial cancers, blood clots, liver disease, pregnancy, undiagnosed uterine bleeding) that make it inadvisable to take estrogen (location ,787 814).

This book is available online and at the website drmache.com/Estrogen-window-book. This website contains downloadable bonus material, including the Menopause Checklist, Sleep Diary, and much more. Armed with this information, a visit to your gynecologist can lead to better overall health and importantly, a continuation of a satisfying sex life, well into advanced age.

To learn more please call the office at (202)293-1000 or email the practice at info@intimmedicine.com.

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James A. Simon, MD, reproductive endocrinologist, menopausal medicine specialist and Clinical Professor at George Washington University in Washington, DC, has been treating women for gynecologic issues and seeks to re-educate women and the medical community about the importance of and safety of menopausal hormone therapy.

Dr. Simon wants to debunk the long-held belief that hormone therapy for women in the early menopausal years leads to breast cancer. It is not that simple. Women’s health status, breast cancer status, lifestyle, age and other factors contribute to the risk of cancer, including breast cancer. Estrogen, once lauded as providing great relief to women experiencing hot flashes and night sweats, became vilified when The Women’s Health Initiative hormone study appeared to demonstrate a cause and effect between menopausal use of hormone and the risk of breast cancer. About 8-10% of women are walking around with breast cancer and don’t know it. Either they haven’t had a mammogram or the cancer is still too small to be detected. According to Dr. Simon, when women who have undiagnosed breast cancer go on hormone therapy, and it shows up in the follow-up mammogram, some will attribute the cancer to the hormone therapy. But did the hormone therapy cause the cancer?

Estrogen alone may actually have a protective benefit from breast cancer while helping with all the uncomfortable symptoms of menopause, and yet estrogen plus synthetic forms of progesterone, like those used in the Women’s Health Initiative, may increase the apparent risk of breast cancer, but the drugs themselves are not carcinogenic.

Estrogen versus Estrogen Plus Progesterone
Joann Manson, MD, professor of Medicine, Harvard Medical School, Brigham and Women’s Hospital, and Past President of the North America Menopause Society, echoes Dr. Simon’s point about the efficacy and safety of estrogen alone. Dr. Manson has worked for more than 20 years in the field of menopause. In a video on MyMenopause.com Dr. Manson who was involved in the Women’s Health Initiative (WHI) study offers key learning points from the WHI study:

  • Estrogen, given alone, without a progestogen to women who have undergone hysterectomy, had no increase in the risk of breast cancer.
  • In women who had an intact uterus and needed a progestogen to protect the uterine lining, who also took estrogen, were at higher risk for breast cancer. However, cancer was not detected until around year 4 or 5, so doctors do not recommend taking the combined medication for a prolonged period.

“I think it’s important to understand that all medications do have risks. It really comes down to the balance of benefits versus risk,” said Dr. Manson. “In a woman in early menopause who is having moderate to severe symptoms—hot flashes, night sweats, really worsening her quality of life, really interrupting her sleep and interfering with her daily activities, in most cases the benefits of hormone therapy outweigh the risk,” she adds.

Estrogen Timing Matters: The Estrogen Window
Dr. Simon recently spoke about this issue at the 2016 Annual Meeting of The American Congress of Obstetricians and Gynecologists (ACOG) and also in a video with Dr. Mache Seibel, a gynecologic expert and Editor of MyMenopause.com.

“Early use of hormone therapy…and by early I mean 50’s, is of overall benefit to women’s health in a variety of ways…If they are outside of the window, or late, they get mostly risk for being on estrogen only or hormone therapy,” says Dr. Simon.

So women should take hormone therapy early, during their late 40’s, or as close to menopause as possible, to benefit the most and experience fewer risks.

Women with BRCA Mutations
A portion of the women going through menopause carry BRCA gene mutations, which already puts them at an increased risk for breast and ovarian cancer. Susan Domchek, MD, of the University of Pennsylvania spoke at the 2015 North America Menopause Society Annual Meeting regarding this issue. Dr. Domchek’s recommendation is for women who have had their ovaries or ovaries and fallopian tubes removed to offset the risk of ovarian cancer, to add estrogen therapy in order to mitigate the risk of breast cancer.

“It’s important to know that women know that this is an option for them and they need to talk to their doctor about it,” Dr. Domchek.

Who May Have BRCA 1 or BRCA 2 Mutations?

  • Women with family members (sister, mother, aunt, or even father) who had early onset breast cancer (before the age of 40)
  • Women with family members who have had ovarian cancer
  • Women of Ashkenazi Jewish descent whose family members have had early onset breast, ovarian or pancreatic cancer.

SIDEBAR
Hormone Therapy and Breast Cancer Risk

  • Combination (estrogen and synthetic progestogen) hormone therapy increases breast cancer risk by about 26%. This sounds like a tremendous increase, but it represents the difference between 3.3 cases of breast cancer/1000 women increased to 4.1 cases of breast cancer/1000 for each year of hormone therapy…less than one women/year/1000.
  • Estrogen-only hormone therapy increases the risk of breast cancer, but only when used for more than 10 years. In the Women’s Health Initiative, estrogen-only hormone therapy reduced the risk of breast cancer by a similar amount (23%).
  • Whether an increase or a decrease, the size of these changes are considered to be rare. (=1/10,000 and < 1/1,000; =0.01% to < 0.1%; between 0.1 and 0.9/1000).

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