Guidelines advocate a more tailored approach in management of Menopause!

Guidelines advocate a more tailored approach in management of Menopause!

photo courtesy -dreams time

The evaluation and treatment of menopause has undergone a sea change in last two decades, but this was not always backed up by evidence.

The Endocrine Society has updated the latest guidelines, and the recommendations are all backed by solid clinical research. The guidelines were published online October 7 and appeared in the November issue of the Journal of Clinical Endocrinology & Metabolism.

The article is primarily derived from the journal article “Treatment of Symptoms of the Menopause: An Endocrine Society Clinical Practice Guideline.” In the November issue of The Journal of Clinical Endocrinology & Metabolism 2015 100:11, 3975-4011

In 2002, a large government study called the Women’s Health Initiative study generated intense scrutiny on the practice of menopausal hormone therapy due to concerns about increased risk for blood clots, stroke, breast cancer and heart attacks. Since then, physicians all over the world are very cautious in prescribing hormones as a therapy for management of menopausal symptoms.

The guidelines advocates that the individual risk is lower in younger women who have recently gone through menopause, and varies based on a woman’s health history, age and other factors. Developed by Endocrine Society menopause experts, the guideline provides recommendations on how to tailor treatments to suit a woman’s individual symptoms, health history and preferences and how to assess which women could consider menopausal hormone therapy.

The guidelines were developed by a panel of six experts on the subjects and were chaired by Cynthia Stuenkel, MD. She is a founding member of The North American Menopause Society (NAMS) and also a clinical professor of medicine at the University of California, San Diego School of Medicine and an attending physician for the university’s Endocrinology and Metabolism Service.

“There is no need for a woman to suffer from years of debilitating menopausal symptoms, as a number of therapies, both hormonal and non-hormonal are now available,” said Cynthia A. Stuenkel, MD, in a press release .She also said that “Every woman should be full partners with her health care providers in choosing whether treatment is right for her and what treatment option best suits her needs. The decision should be based on available evidence regarding the treatment’s safety and effectiveness, as well as her individual risk profile and personal preferences.”

Women are eligible for HRT if they are younger than 60 years old and are no more than 10 years into menopause, Dr Stuenkel emphasized.

Before putting a patient on Menopausal Hormone Therapy (MHT), clinicians need to assess a patient's baseline risk for cardiovascular disease or breast cancer -- a high risk for either condition can constitute a contraindication to use of HRT.
Standard cardiovascular disease risk-assessment scores from organizations such as the American Heart Association has Standard cardiovascular disease risk-assessment scores for women who are at moderate or low risk for cardiovascular events; women falling into both of these categories can be considered for HRT.
 National Cancer Institute Breast Cancer Risk Assessment Tool is utilized by clinicians to calculate a woman's 5-year risk for invasive breast cancer, whereas the International Breast Intervention Study calculator predicts a woman's 10-year and lifetime risk.
The Updated guidelines specifically targets vasomotor symptoms (hot flushes/flashes/night sweats) and genitourinary tract symptoms (vaginal dryness or discharge, pain, burning or itching, urinary frequency, recurrent urinary tract infections).
Menopausal symptoms typically start a year before the last period and can be very bothersome for unpredictable time period; it could be as little as few months or 10-14 years after the last period.
"The most effective therapy [for both sets of symptoms] is HRT," Dr Stuenkel said.
"But we have listed many other nonhormonal and over-the-counter [OTC] options that physicians can use as well, and each of these options can be discussed with patients."
Current evidence does not justify the use of MHT to prevent coronary heart disease, breast cancer, or dementia.
These guidelines emphasize safety in identifying which late perimenopausal and recently postmenopausal women are candidates for various therapeutic agents.
Dr Stuenke advocates that women for HRT can receive estrogen replacement alone if they are without a uterus; if women have a uterus, they require the combination of estrogen plus progestogen to prevent endometrial hyperplasia and cancer.
Additional hormonal options for women with a uterus include estrogen combined with bazedoxifene and tibolone where available.
Women in the United States and some other countries have a broader range of therapeutic choices than ever before, including: MHT dose, type, and route of administration; new selective estrogen receptor modulators (SERMs) as solo or combination therapies; and expanded choices of nonhormonal prescription medications.
Other medical options recommended by the Endocrine Society include

• Transdermal estrogen therapy by patch, gel or spray is recommended for women who request menopausal hormone therapy and have an increased risk of venous thromboembolism – a disease that includes deep vein thrombosis.
• Progestogen treatment prevents uterine cancer in women taking estrogen for hot flash relief. For women who have undergone a hysterectomy, it is not necessary.
• If a woman on menopausal hormone therapy experiences persistent unscheduled vaginal bleeding, she should be evaluated to rule out endometrial cancer or hyperplasia.
• Medications called selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), gabapentin or pregabalin are recommended for women who want medication to manage moderate to severe hot flashes, but either prefer not to take hormone therapy or have significant risk factors that make hormone therapy inadvisable.
• Low-dose vaginal estrogen therapy is recommended to treat women for genitourinary symptoms of menopause, such as burning and irritation of the genitalia, dryness, discomfort or pain with intercourse; and urinary urgency or recurrent infections. This treatment should only be used in women without a history of estrogen-dependent cancers.

Impact on quality of Life

The impact of severe menopausal symptoms on quality of life may be substantial," Dr Stuenkel noted.
In light of this, there are circumstances under which a woman with a history of coronary artery disease or even breast cancer might choose to accept a degree of risk that initially might outweigh the benefits of HRT.
Nevertheless, patients should be fully informed about the risks and benefits associated with HRT to enable them to make a decision that best balances these risk and benefits, Dr Stuenkel emphasized.
"We in the Endocrine Society were dismayed by the incredible drop-off in the use of HRT [following the Women's Health Initiative study]," she noted.
A 2012 Endocrine Society survey found that 72% of women currently experiencing menopausal symptoms had not received any treatment for them.
"And while we don't blame the average clinician for being confused or frustrated by all the contradictory data that have emerged over the past decade, we wanted to take a strong stance to simplify these data and to say that in carefully selected women, HRT will be the most effective therapy we have for menopausal symptoms," Dr Stuenkel added.
"So...the data we present in our guidelines help substantiate why HRT is a reasonable approach for carefully selected women, and physicians should be revisiting this question annually with their patients to discuss their decision regarding HRT and perhaps modify it if other health concerns have arisen in the preceding year."

Stopping the MHT

The guidelines also state that the approach to discontinuation of HRT is an individual choice, too.
Menopausal symptoms and joint pain can recur when HRT is discontinued, and depending on the severity of the symptoms, women may elect to restart HRT, perhaps at a lower dose, or seek relief with nonhormonal therapies.
"Anecdotally, some women find that a very low dose...maintains adequate symptom relief and well-being and prefer that to complete discontinuation," state the recommendations.
Resources for patients are available at www.menopausemap.org. The Hormone Health Network also offers a digital toolkit for healthcare providers.

Summary of Recommendations

·        The clinical symptoms, menstrual history, history of surgery (Hysterectomy with Bilateral oophorectomy) are sufficient to make the diagnosis of menopause for the majority of women. Laboratory studies are not a prerequisite for the diagnosis but may be used when necessary.

·        Menopausal Transition is also a good time for addressing other health issues   such as bone health, smoking cessation, alcohol use, cardiovascular risk assessment and management, and cancer screening and prevention.

·        For menopausal women < 60 years of age or < 10 years past menopause with bothersome VMS (with or without additional climacteric symptoms) who do not have contraindications or excess cardiovascular or breast cancer risks and are willing to take menopausal hormone therapy (MHT), the study suggest initiating estrogen therapy (ET) for those without a uterus and estrogen plus progestogen therapy (EPT) for those with a uterus.

·        Women at high risk for CVD, should receive nonhormonal therapies to alleviate bothersome VMS (with or without climacteric symptoms) over MHT.

·        Women at moderate risk  for CVD should  be started on transdermal estradiol as first-line treatment, alone for women without a uterus or combined with micronized progesterone(or another progestogen that does not adversely modify metabolic parameters) for women with a uterus, because these preparations have less untoward effect on blood pressure, triglycerides, and carbohydrate metabolism.

·        Non-oral estrogen is also preferred in the treatment of menopausal women with an elevated risk for venous thromboembolic disease. These patients should also receive a progestogen, such as progesterone or dydrogestone, which is more neutral in its effects on coagulation.

·        Women at high or intermediate risk of breast cancer considering MHT for menopausal symptom relief, the guideline suggest nonhormonal therapies over MHT to alleviate bothersome VMS.

·        The treatment plan should be reviewed annually, estimating the risk and benefits.

·        The taskforce also called on physicians to advise women about the uncertainty of over the counter medicines for menopause.

·        The study also  recommend informing women about the possible increased risk of breast cancer during and after discontinuing EPT and emphasizing the importance of adhering to age-appropriate breast cancer screening.

·        For young women with primary ovarian insufficiency (POI), premature or early menopause, without contraindications, we suggest taking MHT until the time of anticipated natural menopause, when the advisability of continuing MHT can be reassessed.

·        Stopping the MHT should be a shared decision-making approach to elicit individual preference about adopting a gradual taper vs abrupt discontinuation.

·        For women seeking pharmacological management for moderate to severe VMS for whom MHT is contraindicated, or who choose not to take MHT, we recommend selective serotonin reuptake inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitors (SNRIs) or gabapentin or pregabalin (if there are no contraindications).In  women not responding to these drugs  a trial of clonidine is suggested.

·        This new term “genitourinary syndrome of menopause” (GSM) combines the conditions of VVA and urinary tract dysfunction.

• Women with symptoms of vulvovaginal atrophy may be treated initially with a trial of vaginal moisturizers at least twice weekly. Low-dose vaginal estrogen therapy can be introduced if initial treatment is insufficient.
• Women with a history of endometrial or breast cancer may initiate treatment with vaginal estrogen therapy, but this decision-making process should involve the treating oncologist.
• Low-dose vaginal estrogen therapy does not require co-treatment with a progestogen.

·        Women with moderate to severe dyspareunia and vaginal atrophy may be offered a trial of ospemifene, which has been demonstrated to reduce dyspareunia and improve sexual satisfaction in randomized controlled trials.

·        Diabetes is considered by the AHA to be a CHD risk equivalent , which would suggest that women with diabetes should not take MHT. The evidence at this time is inadequate to make firm recommendations. An individualized approach to treating menopausal symptoms could be considered, with a low threshold to recommend nonhormonal therapies, particularly in women with concurrent CVD.

The Hormone Health Network, the Endocrine Society’s public education arm, developed an interactive digital resource called the Menopause Map^TM for women to explore the stages of menopause and learn about symptoms they may experience. The Menopause Map^TM related resources are available at
http://www.hormone.org/menopausemap/postmenopause.html

The Hormone Health Network also offers a digital toolkit for health care providers.

References :
http://press.endocrine.org/doi/citedby/10.1210/jc.2015-2236
http://www.medscape.org/viewarticle/853793
https://www.endocrine.org/membership/email-newsletters/endocrine-insider/2015/october-16-2015#/9
http://menopausehealthmatters.com/hormone-replacement-therapy/
http://answers.webmd.com/expert/39928/cynthia-stuenkel-north-american-menopause-society
https://www.endocrine.org/news-room/current-press-releases/experts-recommend-assessing-individual-benefits-risks-of-menopausal-therapies