I’d like to clear up some confusion regarding the use of estrogen to offset the symptoms of menopause. I won’t bury the lead; vaginal estrogen IS a safe menopause treatment for almost all menopausal women to use. Women using vaginally applied estrogen to minimize menopause symptoms do not increase their risk of heart disease, stroke, deep vein thrombosis, dementia or certain cancers including breast cancer in spite of what it might say in the Information for Patients (the package insert) which comes with this therapy.

But now, the back story.

The federally funded Women’s Health Initiative (WHI) Clinical Trials studies documented that oral estrogen or oral estrogen plus progesterone pills increased the risks for heart disease, stroke, deep vein thrombosis, dementia and certain cancers including breast cancer. These results from studies published in 2002 and 2004 have come into much clearer focus more recently. Unfortunately, the patient population evaluated in these studies included women who had pre-existing health conditions such as being overweight, having high blood pressure, etc., and most importantly the study participants outside of the “estrogen window” for safety FOR SYSTEMIC HORMONE THERAPY. This confounded the results of the study, since most of the study participants were over 60 years old, and some were 79 years old, when they started on their treatments. However, the WHI researchers continued to look into safer options for the correct patient population, in order to alleviate symptoms which hinder a women’s overall quality of life and sexual wellness.

The “Estrogen Window”

Following the confusing outcomes of the WHI Randomized Clinical Trials (referred to above), researchers began to closely review other WHI data. The latest publication from the Observational part of the WHI (Carolyn J. Crandall, MD, and colleagues. Breast cancer, endometrial cancer, and cardiovascular events in participants who used vaginal estrogen in the Women’s Health Initiative Observational Study. Menopause: The Journal of The North American Menopause Society. Vol. 25, No. 1, pp. 000-000, 2017. ePUB ahead of print) focuses on vaginal application of estrogen only for the treatment of vaginal symptoms of menopause. These included women’s experiences related to the deficiency of estrogen on the vagina, bladder and urethra, and particularly focused on the safety of vaginal estrogen treatments.

These symptoms investigated include:

  • dyspareunia (insertional or deep pain during sex)
  • lubrication/dryness issues during sex
  • vaginal atrophy
  • recurrent urinary tract infections
  • painful urination
  • generalized vulvar or vaginal discomfort
  • bleeding after sex

The one common group of symptoms that vaginal estrogen does not mitigate is hot flashes, night sweats, and disturbed sleep.

Risks and Rewards

The team aimed to find out if and how severe health risks affected women who were using this vaginal form of estrogen. Cardiovascular disease, breast, colorectal, and endometrial cancer, as well as deadly blot clots were health events that warranted a risk assessment in this study.

The data showed that among women with an intact uterus, the risks of stroke, invasive breast cancer, colorectal cancer, endometrial cancer, and pulmonary embolism/deep vein thrombosis were not significantly different between vaginal estrogen users and nonusers.

I will emphasize that this was estrogen-only administration of therapy and none were taken by mouth. Oral therapies that travel through a patient’s digestive system and blood stream may also be safe for many, but that is not the administration route under the microscope in this paper recently published in the Menopause journal; by the North American Menopause Society. The “take home” message: vaginal estrogen can be safely used without fear of cardiovascular events caused by such therapy, after menopause.

It is important to visit a practice like ours that understands hormones and the role that they play during each phase of a woman’s life. The fluctuations you experience are not only normal, but very treatable. If you have questions about hormones, the menopause window, or whether you can safely use hormones, please call our office at (202) 293-1000 to make an appointment with our compassionate and knowledgeable staff.

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.

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).
breast cancer awareness

Breast cancer treatment can bring about urinary/vaginal issues

breast cancer awarenessAs if women with breast cancer haven’t endured enough already, they often develop painful changes in their vaginas or urethras — urogenital or vulvovaginal atrophy — as a result of their breast cancer treatment. The most common breast cancer treatments are tamoxifen and aromatase inhibitors. Tamoxifen works by blocking estrogen receptors on breast and breast cancer cells. Tamoxifen grabs that “parking space” (the breast/breast cancer estrogen receptor) so that estrogen can’t “park” there. Aromatase inhibitors are chemicals that work by suppressing estrogen production in the body. While women treated with aromatase inhibitors — Arimidex, Aromasin and Femara — tend to have more symptoms than those treated with tamoxifen, either approach can produce symptoms.

Symptoms of urogenital/vulvovaginal atrophy

The most common symptoms of urogenital or vulvovaginal atrophy include vaginal dryness, itching and irritation, painful intercourse/urination and frequent urinary tract infections. Unfortunately, these symptoms are often not diagnosed, and women continue to suffer in silence. And worse than that, even when diagnosed, symptoms are often left untreated, especially in breast cancer patients.

Don’t suffer — treatments are available

Typically, I recommend non-hormonal vaginal moisturizers/lubricants and lifestyle modifications — avoiding scented hygiene products as well as smoking cessation and stress management — to help relieve symptoms in women with a history of breast cancer. Believe it or not, regular intercourse can actually help if not too painful because the progressive stretching and increased blood flow improve a woman’s vaginal health. If none of these approaches provide adequate relief, topical estrogen therapy is a good alternative. Applied only to the affected area, a minute amount of estrogen is absorbed into the bloodstream through the vagina. Best of all, this low dose can be quite effective in relieving symptoms. It must be noted, though, that risk of breast cancer recurrence following localized estrogen therapy is uncertain. That’s why the decision to start this therapy should be made jointly with your gynecologist and oncologist.


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