Wednesday, 21 October 2015

SPHPM's Professor Susan Davis' involvement on developing evidence-based recommendations for the menopause

SPHPM’s Professor Susan Davis is a member of the Task Force invited by the Clinical Guidelines Subcommittee of the Endocrine Society to develop evidence-based recommendations for the menopause.  The other 6 Task Force members were researchers from the University of California, the University of Glasgow, Universit√© Paris Descartes, The Mayo Clinic, and the University of Virginia. In order to create such recommendations, the Task Force conducted three systematic reviews of the data published on menopause and various treatments. Furthermore, The Australasian Menopause Society, European Menopause and Andropause Society, the British Menopause Society, the International Menopause Society, and the European Society of Endocrinology were all part of the review and commentary of the guidelines draft. 

Menopause is identified as the time after a woman’s menstrual cycle stop, indicating that a female’s ovarian function and fertility has stopped. Common symptoms are hot flushes and night sweats (together called vasomotor symptoms or VMS), disrupted sleep, anxiety and disturbed mood and joint pain. Vaginal dryness and painful intercourse develops over time. The symptoms of menopause often start commence in the years before a woman has her last menstrual period and may continue up to 15 or more years.

Estrogen therapy is the most effective method of treatment for menopausal symptoms. While this is acknowledged, the number of prescriptions for menopausal hormone therapy (MHT) has seen a reduction after a 2002 study published data that stated oral conjugated equine estrogens (CEE) were connected to risks that outweighed the benefits. However, studies conducted after this have advised that the benefits do overshadow the risks in most women and now women do have access to more treatment options, with the choice of MHT dose, type and the method of administration.

The task Force concluded that MHT remains the most effective form of treatment for menopause symptoms. The benefits also outweigh the risk for most symptomatic postmenopausal women who are below 60 years of age or have been menopausal for less than ten years. The researchers also indicated that health care providers need to tailor treatment according to their patient’s needs, preferences and any associated clinical factors. This may also involve screening of women for breast cancer and cardiovascular risks before commencing MHT. Treatment options should always be recommended based on the consideration of both benefits and risks, and patients should be completely informed and equipped with the knowledge allowing them to make a decision that is best for them.

A summary of recommendations is detailed below:

1.0 Diagnosis and symptoms of menopause
1.1 We suggest diagnosing menopause based on the clinical criteria of the menstrual cycle.
1.2 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, we suggest making a presumptive diagnosis of menopause based on the presence of vasomotor symptoms (VMS) and, when indicated, laboratory testing that includes replicate measures of FSH and serum estradiol.

2.0 Health considerations for all menopausal women
2.1 When women present during the menopausal transition, we suggest using this opportunity to address bone health, smoking cessation, alcohol use, cardiovascular risk assessment and management, and cancer screening and prevention.

3.0 Hormone therapy for menopausal symptom relief
3.1 Estrogen and progestogen therapy.
3.1a 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), we suggest initiating estrogen therapy (ET) for those without a uterus and estrogen plus progestogen therapy (EPT) for those with a uterus.

Cardiovascular risk
3.1b For women age 60 or 10 years past menopause onset considering MHT for menopausal symptom relief, we suggest 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.
3.1c For women at high risk of CVD, we suggest initiating nonhormonal therapies to alleviate bothersome VMS (with or without climacteric symptoms) over MHT.
3.1d For women with moderate risk of CVD, we suggest 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.
Venous thromboembolic events
3.1e
For women at increased risk of venous thromboembolism (VTE) who request MHT, we recommend a nonoral route of ET at the lowest effective dose, if not contraindicated (1QQEE); for women with a uterus, we recommend a progestogen (for example, progesterone and dydrogestone) that is neutral on coagulation parameters.

Breast cancer
3.1f
For women considering MHT for menopausal symptom relief, we suggest 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.
3.1g For women at high or intermediate risk of breast cancer considering MHT for menopausal symptom relief, we suggest nonhormonal therapies over MHT to alleviate bothersome VMS.

Tailoring MHT
3.1h
We suggest 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.

Custom-compounded hormones
3.1i
We recommend 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.
3.2 Conjugated equine estrogens with bazedoxifene 3.2 For symptomatic postmenopausal women with a uterus and without contraindications, we suggest the combination of conjugated equine estrogens (CEE)/bazedoxifene (BZA) (where available) as an option for relief of VMS and prevention of bone loss. 

3.3 Tibolone
3.3a For women with bothersome VMS and climacteric symptoms and without contraindications, we suggest tibolone (in countries where available) as an alternative to MHT.
3.3b We recommend against adding tibolone to other forms of MHT.
3.3c We recommend against using tibolone in women with a history of breast cancer.
3.4 Clinical management of patients taking hormone therapies Monitoring during therapy.
3.4a For women with persistent unscheduled bleeding while taking MHT, we recommend evaluation to rule out pelvic pathology, most importantly, endometrial hyperplasia and cancer.
3.4b We 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.
3.4c We suggest 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.
3.4d 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 considerations
3.4e
For women preparing to discontinue MHT, we suggest a shared decision-making approach to elicit individual preference about adopting a gradual taper vs abrupt discontinuation.

4.0 Nonhormonal therapies for VMS
4.0 For postmenopausal women with mild or less bothersome hot flashes, we suggest 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.

4.1 Nonhormonal prescription therapies for VMS
4.1a 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)/serotoninnorepinephrine reuptake inhibitors (SNRIs) or gabapentin or pregabalin (if there are no contraindications).
4.1b 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, we suggest a trial of clonidine (if there are no contraindications).

4.2 Over-the-counter and alternative nonhormonal therapies for VMS
4.2 For women seeking relief of VMS with over-thecounter (OTC) or complementary medicine therapies, we suggest 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.

5.0 Treatment of genitourinary syndrome of menopause
5.1 Vaginal moisturizers and lubricants
5.1a For postmenopausal women with symptoms of vulvovaginal atrophy (VVA), we suggest a trial of vaginal moisturizers to be used at least twice weekly.
5.1b For women who do not produce sufficient vaginal secretions for comfortable sexual activity, we suggest vaginal lubricants.

5.2 Vaginal estrogen therapies
5.2a 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, we recommend low-dose vaginal ET.
Practice statement
5.2b In women with a history of breast or endometrial cancer, who present with symptomatic GSM (including VVA), that does not respond to nonhormonal therapies, we suggest a shared decision-making approach that includes the treating oncologist to discuss using low-dose vaginal ET.
 5.2c 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, we suggest adding low-dose vaginal ET.
5.2d For women using low-dose vaginal ET, we suggest against adding a progestogen (ie, no need for adding progestogen to prevent endometrial hyperplasia).
5.2e For women using vaginal ET who report postmenopausal bleeding or spotting, we recommend prompt evaluation for endometrial pathology.

5.3 Ospemifene
5.3a For treatment of moderate to severe dyspareunia associated with vaginal atrophy in postmenopausal women without contraindications, we suggest a trial of ospemifene.  
5.3b For women with a history of breast cancer presenting with dyspareunia, we recommend against ospemifene.


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