Guidelines advocate a more tailored approach in
management of Menopause!
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| 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
