Genitourinary syndrome of menopause (GSM) is defined as symptoms of vaginal dryness, painful intercourse, vulvar discomfort, urinary frequency and urgency, incontinence, and increased frequency of bladder infections. These symptoms are caused by the thinning of the estrogen sensitive tissues of the vagina after menopause, due to the lack of estrogen in these tissues. The most effective treatments for these symptoms are topically applied vaginal estrogen products. Women who are at risk for breast cancer or who have had breast cancer are often very reluctant to use any products that contain estrogen, even if the dose is small.
The North American Menopause Society along with the International Society for the Study of Women’s Sexual Health have collaborated to review the literature in this area and have developed a consensus statement to guide physicians regarding the safety of prescribing vaginal estrogen for women who are at high risk for developing breast cancer, or who have already had breast cancer.
There are over 3 million breast cancer survivors in the US. Many survivors experience GSM symptoms, and often at a younger age because of treatments which decrease estrogen. It is important to discuss these symptoms with your health care provider and know your options. Some clinicians are reluctant to treat patients because of the lack of data that assures safety in particular populations.
In approaching the discussion with your physician, begin by noting your symptoms: vulvovaginal burning and dryness, painful intercourse, inability to have penetration, urinary frequency and urgency, incontinence, and increased frequency of urinary tract infections. Your physician should examine you to determine if there are any conditions such as a vaginal infection or inflammation that could lead to these symptoms.
Next, consider breast cancer risk which can be determined by several models that can be easily calculated. For women who are breast cancer survivors, consideration for risk of recurrence should take into consideration factors including the time since diagnosis, stage and grade of disease, hormone receptor status, use of aromatase inhibitors, severity of GSM symptoms and their effect on quality of life. Consultation with your breast cancer oncologist should be included in decision making.
Here are the options for treatment:
1. Vaginal moisturizes are used for symptoms of dryness and must be used frequently and independently of intercourse.
2. Lubricants are used during intercourse to reduce pain from penetration and friction. The ideal lubricant has the same pH and osmolality of the vaginal tissue and should not include parabens, flavors or scents, glycerin and spermicides that can be irritating.
3. Vaginal dilators in graduated sizes can be used to maintain the caliber of the vagina and stretching of the tissues.
4. Vaginal vibrators can be used independently or with other sexual activity.
5. Pelvic floor physical therapy can relieve pain from pelvic floor muscle spasm and vaginismus (involuntary muscle spasm of the vagina which makes penetration difficult).
6. Vaginal estrogen can be inserted as a cream, pill or vaginal ring. Because of the difference in products, methods of administration, amount of cream administered and site of administration (lower vagina vs. upper vagina), and the quality of the vaginal tissue (thinner vaginal epithelium is more absorptive than thicker tissue), the amount of systemic absorption varies. Observational studies including data from the Women’s Health Initiative have not shown any evidence of an increased risk of breast cancer in women who used vaginal estrogens. One study did not find an increased risk of recurrent breast cancer in women who used vaginal estrogen products after the diagnosis of breast cancer. The message here is that the available evidence is reassuring, but in making a decision, risk should be considered.
7. Vaginal DHEA, prasterone, has shown evidence of improvement in sexual function. The suppositories are used daily, at least in the first month of use. The DHEA is converted to estrogen and testosterone in the body, although the levels are small and in the postmenopausal range, the difference is significant. It has not been tested in breast cancer survivors.
8. SERMs: Ospemifene if a selected estrogen receptor modulator which acts like estrogen on the vaginal tissue. It is an oral table taken daily. It is not approved in the US for use by women with breast cancer, and its effect on breast tissue has not been studies.
9. Topical lidocaine 4% applied to the vaginal opening prior to penetration can reduce pain, but it can also reduce sensation.
10. Vaginal testosterone can be compounded for use as a vaginal gel, but is not FDA approved. Testosterone is converted to estrogen in the body, and there is evidence that use of vaginal testosterone increases serum estrogen levels.
11.. Estriol is considered a weaker estrogen produced in women during pregnancy. It can be compounded but is not FDA approved and there is not data to determine its safety in patients with breast cancer.
12. Vaginal lasers are now being used to improve the integrity of the vaginal epithelium.The effect of the vaginal laser is to increase vascularization of the vaginal epithelium which increases lubrication with sexual excitation. It also increases the thickness of the vaginal epithelium as well as increased collagen and elastic fibers in the submucosa.Studies in breast cancer survivors demonstrated significant improvement in GSM symptoms and improved sexual function.
As with other medical conditions, an evaluation with a gynecologist is the best way to evaluate risks and determine which treatment is appropriate for your individual situation.
Reference: Consensus Recommendations: Management of genitourinary syndrome of menopause in women with or at high risk for breast cancer: consensus recommendations from the North American Menopause Society and the International Society for the Study of Women's Sexual Health, Menopause. The Journal of the American Menopause Society, Volume 25, No. 4, 2018
Some women go through menopause with severe symptoms and are advised not to use hormonal therapy. Women who have had breast cancer or deep vein thrombosis are at increased risk if they use hormones. So, how do you treat menopausal symptoms if you cannot use hormones?
The North American Menopause Society has collected data on which treatments work and which do not. Most women, 50-80%, try some type of non-hormonal treatment for menopausal symptoms. Most women are not fully informed about the benefits and risk of herbal therapies. Because of these uncertainties, many women use the wrong supplements or inadequate dosing, and suffer from bothersome symptoms when they could be using more successful treatments. Many supplements have risks which are not well known.
What does work?
Two mind-body therapies have proved to be successful in clinical studies. Cognitive behavioral therapy has good evidence of efficacy by reducing the discomfort of symptoms, while not really decreasing the frequency of symptoms.Hypnosis, using the Elkins protocol, has also proved effective. This protocol involves in-person hypnosis and at-home self-hypnosis. In women withmore than 50 episodes of vasomotor symptoms per week, the frequency and severity of symptoms were reduced. When breast cancer survivors were treated, there was a significant decrease in symptoms, as well as in improvement in sleep and mood.
Medications that improve menopausal symptoms include antidepressants and gabapentin.
The FDA has approved low-dose paroxetine for the treatment of vasomotor symptoms. Other SSRI’s and SNRI’s have been proven to be effective in case controlled studies. The drugs that have been shown to significantly decrease menopausal symptoms are paroxetine, escitalopram, citalopram, venlaflaxine, and desvenlaflaxine. Your physician can best determine which of these drugs would be best for you while taking into account past history and use of medication, and other medical problems and prescription therapies . If a mood disorder is a significant menopausal symptom, these drugs can be very helpful. These medications are often started at lower doses and titrated up the the most effective dose. The benefits and side effects should be monitored every 6-12 months. It is important when trying to go off of these medications, the dose is tapered over two weeks to minimize side effects.
Gabapentin, which is a drug used for seizures and pain, is also effective. When given before bed, it can be very helpful for patients who suffer from insomnia and night sweats.
Other therapies that show some evidence of benefit include weight loss, mindfulness based stress reduction, the s-equol derivative of soy, and stellate ganglion block (although I have yet to find a practitioner who performs this).
What doesn’t work?
The therapies that have proven to provide not benefit through studies that look at their effectiveness include vitamins, over-the-counter supplements, herbal remedies, chiropractic therapy, and relaxation techniques. For many years, black cohash has been recommended for hot flashes with some anecdotal evidence of success. Although it could be a placebo effect, studies have not shown it to be effective.
Cooling techniques and avoiding triggers are often recommended and may provide some symptomatic relief, but do not actually decrease the frequency and severity of symptoms. Although providing other health benefits, yoga, exercise and acupuncture have not been found to be effective strategies for the treatment of symptoms.
The bottom line is that there are useful strategies for the prevention of menopausal symptoms in women who cannot or choose not to take hormones, You do not need to suffer, so ask for help and your physician can determine which treatment might be most successful for you.
Marilyn C. Jerome, MD Foxhall OB-Gyn Associates
North American Menopause Society: Key Points from the 2015 Position Statement of the North American Menopause Society
The November, 2017, issue of the American Journal of Obstetrics and Gynecology discussed the benefits of removing fallopian tubes at the time of vaginal hysterectomy. Removal of the tubes at the time of abdominal or laparoscopic hysterectomy done for benign disease is becoming more routine. It was thought that removing the tubes during a vaginal hysterectomy would lead to more complications and blood loss, but the study published demonstrated that the risks were quite low when compared to the decrease in ovarian cancer and deaths. The authors recommended that prophylactic removal of the fallopian tubes be considered when a vaginal hysterectomy is done. This can be accomplished in about 80% of patients, while in 20% it may not be possible to remove both tubes. Why take out the tubes when not planning to remove the ovaries?
As more prophylactic salpingo-oophorectomies (removal of the tubes and ovaries for prevention) have been performed, largely due to increased testing for the BRCA gene, pathologists have noted that women at high risk for ovarian cancer have been found to have more serous intraepithelial cancers in the fallopian tubes. These are felt to be the precursor lesions for high grade ovarian and peritoneal cancers. The removal of the fallopian tubes can lower the risk of a subsequent diagnosis of ovarian cancer. In women with the BRCA gene, it is recommended that the ovaries be removed after childbearing. Removing ovaries in a premenopausal women can have serious health consequences including menopausal symptoms, vaginal dryness and painful intercourse, and an increased risk of heart disease and osteoporosis. Removal of the fallopian tubes, with subsequent removal of the ovaries after menopause, is a strategy that may reduce ovarian cancer risk, but optimize the benefits of estrogen for women in their 40's who are at risk for ovarian cancer. Although more studies are in progress, the current data points to a favorable risk/benefit ratio in favor of removing fallopian tubes during hysterectomy for benign disease.
Marilyn Jerome, MD Foxhall Ob-Gyn Associates
References: American Journal of Obstetrics and Gynecology, November 2017 Risks and benefits of opportunistic salpingectomy during vaginal hysterectomy: a decision analysis. Cadish, et al. Feasibility of prophylactic salpingectomy during vaginal hysterectomy. Antosh, et al. Prophylactic bilateral salpingectomy at vaginal hysterectomy: time for a "policy"?, Rosanne Kho, MD
The dietary supplement industry brings in $30 billion dollars per year, with 90,000 products on the market. Understanding the benefits of supplements can be very difficult, as one year we may see an article that touts the benefits of a certain supplement, and the next year the data is debunked. Some studies also shows that high doses of some supplements can actually cause harm.
Dr. JoAnn Manson and Dr. Shari Bassuk authored an article in the Journal of the American Medical Society on February 5, 2018. The purpose of their article was to help physicians understand which supplements had value and which did not, and which could possibly be harmful.
The key point that physicians should stress to their patients is the importance of obtaining micronutrients from food sources. When obtained through food, micronutrients are absorbed better and there is a lower chance of side effects. A diet which is well-balanced will provide an optimal balance of nutrients and is preferred to taking isolated compounds in concentrated forms.
For the general population dietary supplements are not recommended, but there are certain high-risk groups for whom it is difficult to meet nutritional requirements through the diet. For example, pregnant women are encouraged to take folic acid and prenatal vitamins. Adults at midlife and beyond may benefit from supplements of Vitamin B12, vitamin D and calcium.
Adults older than age 50 may not absorb vitamin B12. Vitamin B12 levels can be checked through routine blood work, and may need to be supplemented with food sources or supplementation. Pernicious anemia requires even higher doses of vitamin B12.
Requirements for vitamin D are 600 IU/day for adults under age 70, and 800 IU/day over the age of 70. Many physicians recommend 1000-2000 IU/day, but the benefit of thissupplementation has been debated. There are ongoing studies to prove the benefits of this supplement. Vitamin D levels can also be tested in routine blood work.
Recommended daily intake of calcium is 1200 mg per day in women over the age of 50. It is recommended that calcium is obtained mostly through food sources, with supplementation to reach a total of 1200 mg per day. There have been some concerns that excessive calcium may increase the risk of kidney stones or heart disease, so excessive doses are not recommended. There is data that suggests that supplementation with a moderate dose of calcium, less than 1000 mg/day, plus vitamin D greater than 800 IU/day may reduce the risk of bone loss and fractures in adults over the age of 65.
Multivitamin supplements are not recommended for generally healthy adults. There are studies underway that will clarify whether multivitamin supplements are related to decreases in cancer and heart disease.
Physicians are advised to take a complete medication and supplement history for their patients, as supplements can adversely effect the benefits of certain medications.
Patients are advised that the US FDA does not regulate the safety and efficacy of supplements. Many supplements are certified by independent testing agencies and these are less likely to contain harmful toxins or heavy metals. Such certifying agencies include ConsumerLab.com, US Pharmacopeia, NSF International, and UL.
Here are some conditions that require special consideration: Osteoporosis and other bone issues: supplement with calcium, Vitamin D, and magnesium
Age-related macular degeneration: specific combination of antioxidants, zinc and copper
Bariatric surgery: fat-soluble vitamins, B vitamins, iron, calcium, zinc, copper and multivitamins Inflammatory bowel disease and celiacs: iron, B vitamins, vitamin D, zinc and magnesium
Pernicious anemia: vitamin B12
It is obvious from this article that considering all of the supplements out there, very little is recommended for the average menopausal women who is generally healthy and eats a well-balanced died. So save your money, and eat well!!
Marilyn Jerome, MD
The Journal of the American Medical Association. Viewpoint: Vitamin and Mineral Supplements. What Clinicians Need to Know. JoAnn Manson, MD, DrPH, Shari Bassuk, ScD
An article that was published in the New York Times discussed reasons that women have more difficulty losing weight as they age.
As we get older, we lose muscle mass. Our peak muscle mass is in our 30's, and after that, our lean muscle gets replaced with fat. Muscle is more metabolically active than fat, so the less muscle mass, the lower our metabolism will be. A lower metabolism results in a lower caloric need to maintain weight. Therefore, if your caloric intake remained the same, over time, it would result in weight gain.
Menopause, accompanied by decreased levels of estrogen and testosterone, adds to these changes in metabolism. Many women believe that hormone replacement causes postmenopausal weight gain, but studies do not confirm that women who take hormones gain more weight than those who do not. Average weight gain in menopause is about 5 pounds.
Dr. Leslie Cho, a cardiologist from the Cleveland Clinic, noted that women who have lost weight will have a lower metabolism than women of a similar weight that have not lost weight. The reason for this is that fat cells hold on to calories consumed because they have been starved previously. So women who have lost weight, will have even lower metabolic rates.
As we age, physical ailments such as arthritis and joint pain may make exercise more difficult, and some people become more sedentary.
Dr. Cho recommends a healthy lifestyle for older women, focusing on fitness and healthy eating, rather than attempting to achieve a particular weight loss goal. Weight training that increases muscle mass will increase metabolism at rest, and aerobic activity will also burn calories. A combination of weight training and aerobic activity, along with healthy eating choices are the recommended combination to maximize good health.
The New York Times: Is It Harder to Lose Weight When Your're Older? by Karen Weintraub, March 31, 2017
Many women worry about the risks of cancer related to oral contraceptives. Few women appreciate that oral contraceptives actually decrease the risk of some cancers in women.
A study published last week in the journal, JAMA Oncology, looked at almost 200,00 women ages 50-71. The study compared those who took oral contraceptives during their reproductive years vs. those who had not.
The study demonstrated that women who had used oral contraceptives for more than 10 years had a 34% decrease in their incidence of endometrial cancer. Women who smoked and were obese, whose risk was greatest, saw the most benefit. Oral contraceptive users had a 40% reduced risk of ovarian cancer, with decreased risk in smokers, the obese, and those who rarely exercised (women in a higher risk category). These results are highly significant.
Additional data did not demonstrate an increase in breath cancer in previous users of oral contraceptives.Colorectal cancer risk was also not increased.
TheNIH-AARP Diet and Health Study was prospective and began in 1995 and continued to 2011. Thestudy included at least 100,000 previous users of birth control pills. The decrease in ovarian cancer was similar along modifiable lifestyle factors, and the decrease continued with the duration of use. Similarly, the decrease in uterine cancer strengthened with duration of use.
Physicians believe that these benefits are derived from the changes in uterine and ovarian function in oral contraceptive users. Oral contraceptives providea level of progesterone that decreases proliferation or growth of the endometrial lining, which is why menstrual bleeding is so much less on the pill . Endometrial cancer is caused by increased growth in the lining of the uterus.
Epithelial ovarian cancer develops from the surface of the ovary.The surface is disrupted each month during ovulation. Oral contraceptives inhibit ovulation and therefore a disruption of the epithelial surface of the ovary. Women who have had pregnancies (lack of ovulation for at least 9 months each time) have fewer ovarian cancers than women who have never conceived.
How does this information apply to women in their later reproductive years? Use of oral contraceptives will provide excellent birth control and regulate menstrual cycles which often become irregular and heavier in the peri-menopausal years. Oral contraceptives can regulate hormone levels during the years when there are more swings in levels which can affect mood, headaches, PMS, etc. In most peri-menopausal women, oral contraceptives can be used until the average age of menopause, age 52, if there are no contraindications such as hypertension, blood clots, and heart disease. Your gynecologist can determine if this is a good option for you.
Marilyn C. Jerome, MD Foxhall OB-Gyn Associates
New York Times. January 19, 2018. Oral Contraceptives Reduce Risk for Ovarian and Endometrial Cancers JAMA Oncology.Modification of the Association Between Duration of Oral Contraceptive Use and Ovarian, Endometrial, Breast and Colorectal Cancers. January 18, 2018, by Kara Michels, PhD
Gynecologists treat “genitourinary syndrome of menopause” with many modalities, but a common treatment is vaginal estrogen. Many women are concerned about the risks of estrogen, and there are very significant differences in the absorption of topical vaginal estrogen and systemic hormones, taken orally or topically as a patch or gel.
First, let’s define genitourinary syndrome of menopause. The lack of estrogen in the vaginal wall and vulvar tissues causes thinning of the tissue and decreased blood supply. The symptoms include vaginal dryness, burning, irritation, decreased lubrication, painful intercourse, and urinary symptoms of urgency, frequency, painful urination, incontinence and increased urinary tract infections. Quality of life can be adversely affected. The frequency of these symptoms is reported in 20-45% of postmenopausal women, but actually most women experience at least one of these symptoms.
Vaginal estrogen products are provided in creams, vaginal pills, and and a silicone ring that is left in place for three months.Although the serum level of estrogen rises when these products are first administered, the maintenance dose results in a serum estrogen level that remains in the postmenopausal range. The question is whether these products are related to in increase in blood clots, heart attacks, strokes, and breast cancer.
The significant symptoms of genitourinary syndrome and the need for long-term use of vaginal estrogen makes it critical that studies be done to demonstrate safety. A study in Menopause: The Journal of the American Menopause Society, published in January, 2018, analyzed data from the Women’s Health Initiative. The use of vaginal estrogen was evaluated through self-assessment questionnaires, but type of vaginal estrogen was not stratified. The average age of patients in the study was 65 years, and mean follow-up was 6-7 years, with an average time using the products was about 40%.
The study results demonstrated that postmenopausal women who took vaginal estrogen had similar risks of breast cancer,stroke, colon cancer, endometrial cancer, blood clots and pulmonary emboli as those who had not used vaginal estrogen. The study actually demonstrated decreased risks of hip fracture and coronary artery disease.
Breast cancer patients on aromatase inhibitors will exhibit an increased serum estrogen level than the reduced level of estrogen derived from use of these medications, and probably should not use vaginal estrogen products. Women who have or have had breast cancer may be able to use vaginal estrogen if approved by their oncologist on a case by case basis.
If you read the package insert of vaginal estrogen products, the labeling is the same as higher dose systemic products. The American Menopause Society is advocating for a change in the labeling because this study and almost every other observational study done thus far do not demonstrate an increasedrisk for vaginal estrogen users. Currently the FDA is considering a proposal to change the warning label. Stay tuned!
Marilyn C. Jerome, MD Foxhall OB-Gyn Associates
References: Menopause: The Journal of the American Menopause Society, Volume 25, Number 1, January 2018. Breast cancer, endometrial cancer, and cardiovascular events in participants who used vaginal estrogen in the Women’s Health Initiative Observational Study. Carolyn Crandall, MD, et al.
New guidelines were recently issued by the American College of Cardiology and the American Heart Association regarding ideal blood pressure values in adults. The guidelines were revised from the previous ones after a panel of 21 experts reviewed more than 900 studies. The new guidelines are as follows:
BP < 120/80is normal
BP 120-129/<80 is considered elevated
BP 130-139 systolic or 80-89 diastolic is Stage 1 hypertension
BP 140-159 systolic or 90-99 diastolic is Stage 2 hypertension
BP >160 systolic and >100 diastolic is Stage 2 hypertension
BP >180 systolic and >120 diastolic is considered a hypertensive crisis and demands immediate treatment. The scientists emphasized the accuracy of BP measurements, and the importance of considering an average of several BP’s taken at several visits. They also emphasized at-home blood pressure monitoring.
These new definitions will categorize almost half of the US adult population as having hypertension, and more than 80% of those over the age of 80 will fall into the hypertensive range.
Not all of those with the new diagnosis of hypertension will need medication as treatment. The physician takes into account a person’s cardiovascular risk factors as can be determined by several algorithms. A person already diagnosed with heart disease should always be treated, as well as anyone over the age of 65.
The primary treatment for hypertension for those with a lower risk is considered lifestyle modifications. These modifications include losing weight, following the DASH diet (Dietary Approaches to Stop Hypertension), reducing salt intake to less that 1500 mg per day, while increasing potassium intake to 3500 mg per day in the diet. It is also recommended that physical exercise should be at least 30 minutes three times per week, and alcohol limitedto two drinks per day or less for men and one drink per day or less for women.
Older adults who aggressively treat hypertension have demonstrated lower cardiovascular mortality and morbidity without being subjected to increased risks of hypotension and falls.
Around the age of menopause, women are less likely to be hypertensive than men, but as women age, their prevalence of hypertension is greater than men of the same age.
It used to be that medication was considered if the BP was greater than 140/90, but now the threshold is 130/80 unless lifestyle modifications are successful. It seems that ideal BP is 115/75 or less. The reason for this change is that individuals with blood pressures above this range do show increases in cardiovascular risk, and earlier intervention can lower these risks. An app called the ASCVD Risk Estimator (http://tools.acc.org/ASCVD-Risk-Estimator) can determine if a person’s 10 year risk of developing heart disease is greater than 10%, and therefore should be treated with medication.
More aggressive treatment of hypertension is expected to save lives by preventing coronary artery disease, strokes, and kidney failure. Reducing systolic blood pressure by just 10mm Hg will result in a 20% reduction in major cardiovascular events, with a 17% reduction in coronary artery disease, a 27% reduction in strokes, and a 28% reduction in heart failure. Mortality for all causes decreases 13%. Larger decreases in blood pressure result in even greater reductions of morbidity and mortality.
The purpose of the new guidelines should raise awareness of the importance of BP on heart disease risks, promote lifestyle modifications, and support the use of antihypertensive medication in those with higher blood pressures, or increased risk of cardiovascular disease.
P.S. In my medical practice, I encourage patients to purchase a BP monitoring device. They are inexpensive and easy to use. I ask patients to monitor their blood pressures over several weeks, taking measurements at different times of the day, and providing their primary care practitioners with a log of BP measurements. This attempt at more accurate data will hopefully help practitioners determine who will benefit from medication intervention.
Stay tuned for a future blog which will explain the DASH diet.
Marilyn C. Jerome, MD Foxhall OB-Gyn Associates
References: The North American Menopause Society: First to Know, November 17, 2017. Revised ACC/AHA guidelines categorize many more midlife women with high blood pressure. By Howard Hodis, MD