Treatment of symptoms of the menopause: an Endocrine Society clinical practice guideline.

In the month of November 2015, a task force from the Endocrine society released the clinical practise guidelines on the Treatment of symptoms of the menopause. Following are its major recommendations:-

Diagnosis and Symptoms of Menopause

The Task Force suggests diagnosing menopause based on the clinical criteria of the menstrual cycle.

If establishing a diagnosis of menopause is necessary for patient management in women having undergone a hysterectomy without bilateral oophorectomy or presenting with a menstrual history that is inadequate to ascertain menopausal status, the Task Force suggests making a presumptive diagnosis of menopause based on the presence of vasomotor symptoms (VMS) and, when indicated, laboratory testing that includes replicate measures of follicle-stimulating hormone (FSH) and serum estradiol. (2)

Health Considerations for All Menopausal Women

When women present during the menopausal transition, the Task Force suggests using this opportunity to address bone health, smoking cessation, alcohol use, cardiovascular risk assessment and management, and cancer screening and prevention. (Ungraded best practice statement)

Hormone Therapy for Menopausal Symptom Relief

Estrogen and Progestogen Therapy

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 Task Force suggests initiating estrogen therapy (ET) for those without a uterus and estrogen plus progestogen therapy (EPT) for those with a uterus. (2)

Cardiovascular Risk

For women <age 60 or <10 years past menopause onset considering MHT for menopausal symptom relief, the Task Force suggests evaluating the baseline risk of cardiovascular disease (CVD) and taking this risk into consideration when advising for or against MHT and when selecting type, dose, and route of administration. (2)

For women at high risk of CVD, the Task Force suggests initiating nonhormonal therapies to alleviate bothersome VMS (with or without climacteric symptoms) over MHT. (2)

For women with moderate risk of CVD, the Task Force suggests 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. (2)

Venous Thromboembolic Events

For women at increased risk of venous thromboembolism (VTE) who request MHT, the Task Force recommends a nonoral route of ET at the lowest effective dose, if not contraindicated (1); for women with a uterus, the Task Force recommends a progestogen (for example, progesterone and dydrogesterone) that is neutral on coagulation parameters. (1)

Breast Cancer

For women considering MHT for menopausal symptom relief, the Task Force suggests evaluating the baseline risk of breast cancer and taking this risk into consideration when advising for or against MHT and when selecting type, dose, and route of administration. (2|)

For women at high or intermediate risk of breast cancer considering MHT for menopausal symptom relief, the Task Force suggests nonhormonal therapies over MHT to alleviate bothersome VMS. (2)

Tailoring MHT

The Task Force suggests a shared decision-making approach to decide about the choice of formulation, starting dose, the route of administration of MHT, and how to tailor MHT to each woman's individual situation, risks, and treatment goals. (Ungraded best practice statement)

Custom-compounded Hormones

The Task Force recommends using MHT preparations approved by the US Food and Drug Administration (FDA) and comparable regulating bodies outside the United States and recommend against the use of custom-compounded hormones. (Ungraded best practice statement)

Conjugated Equine Estrogens with Bazedoxifene

For symptomatic postmenopausal women with a uterus and without contraindications, the Task Force suggests the combination of conjugated equine estrogens (CEE)/bazedoxifene (BZA) (where available) as an option for relief of VMS and prevention of bone loss. (2|+++O)

Tibolone

For women with bothersome VMS and climacteric symptoms and without contraindications, the Task Force suggests tibolone (in countries where available) as an alternative to MHT. (2)

The Task Force recommends against adding tibolone to other forms of MHT. (1)

The Task Force recommends against using tibolone in women with a history of breast cancer. (1)

Clinical Management of Patients Taking Hormone Therapies

Monitoring During Therapy

For women with persistent unscheduled bleeding while taking MHT, the Task Force recommends evaluation to rule out pelvic pathology, most importantly, endometrial hyperplasia and cancer. (1)

The Task Force recommends 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. (1)

The Task Force suggests that the decision to continue MHT be revisited at least annually, targeting the shortest total duration of MHT consistent with the treatment goals and evolving risk assessment of the individual woman. (Ungraded best practice statement)

For young women with primary ovarian insufficiency (POI), premature or early menopause, without contraindications, the Task Force suggests taking MHT until the time of anticipated natural menopause, when the advisability of continuing MHT can be reassessed. (2)

Stopping Considerations

For women preparing to discontinue MHT, the Task Force suggests a shared decision-making approach to elicit individual preference about adopting a gradual taper vs. abrupt discontinuation. (2)

Nonhormonal Therapies for VMS

For postmenopausal women with mild or less bothersome hot flashes, the Task Force suggests a series of steps that do not involve medication, such as turning down the thermostat, dressing in layers, avoiding alcohol and spicy foods, and reducing obesity and stress. (2)

Nonhormonal Prescription Therapies for VMS

For women seeking pharmacological management for moderate to severe VMS for whom MHT is contraindicated, or who choose not to take MHT, the Task Force recommends selective serotonin reuptake inhibitors (SSRIs)/serotonin-norepinephrine reuptake inhibitors (SNRIs) or gabapentin or pregabalin (if there are no contraindications). (1)

For those women seeking relief of moderate to severe VMS who are not responding to or tolerating the nonhormonal prescription therapies, SSRIs/SNRIs or gabapentin or pregabalin, the Task Force suggests a trial of clonidine (if there are no contraindications). (2)

Over-the-Counter and Alternative Nonhormonal Therapies for VMS

For women seeking relief of VMS with over-the-counter (OTC) or complementary medicine therapies, the Task Force suggests counseling regarding the lack of consistent evidence for benefit for botanicals, black cohosh, omega-3-fatty acids, red clover, vitamin E, and mind/body alternatives including anxiety control, acupuncture, paced breathing, and hypnosis. (2)

Treatment of Genitourinary Syndrome of Menopause

Vaginal Moisturizers and Lubricants

For postmenopausal women with symptoms of vulvovaginal atrophy (VVA), the Task Force suggests a trial of vaginal moisturizers to be used at least twice weekly. (2)

For women who do not produce sufficient vaginal secretions for comfortable sexual activity, the Task Force suggests vaginal lubricants. (2)

Vaginal Estrogen Therapies

For women without a history of hormone- (estrogen) dependent cancers who are seeking relief from symptoms of genitourinary syndrome of menopause (GSM) (including VVA) that persist despite using vaginal lubricants and moisturizers, the Task Force recommends low-dose vaginal ET. (1)

Practice Statement

In women with a history of breast or endometrial cancer who present with symptomatic GSM (including VVA) that does not respond to nonhormonal therapies, the Task Force suggests a shared decision-making approach that includes the treating oncologist to discuss using low-dose vaginal ET. (Ungraded best practice statement)

For women taking raloxifene, without a history of hormone- (estrogen) dependent cancers, who develop symptoms of GSM (including VVA) that do not respond to nonhormonal therapies, the Task Force suggests adding low-dose vaginal ET. (2)

For women using low-dose vaginal ET, the Task Force suggests against adding a progestogen (i.e., no need for adding progestogen to prevent endometrial hyperplasia). (2)

For women using vaginal ET who report postmenopausal bleeding or spotting, the Task Force recommends prompt evaluation for endometrial pathology. (1)

Ospemifene

For treatment of moderate to severe dyspareunia associated with vaginal atrophy in postmenopausal women without contraindications, the Task Force suggests a trial of ospemifene. (2)

For women with a history of breast cancer presenting with dyspareunia, the Task Force recommends against ospemifene.