Asia-Pacific Menopause Federation Consensus Statement on the

advertisement
Asia-Pacific Menopause Federation Consensus Statement on the Management of
the Menopause April 2008
Asia-Pacific Menopause Federation is a federation of 14 member national
societies from across the Asia-Pacific region.
 Australia/New Zealand Malaysia
 China
Pakistan
 India
Philippines
 Indonesia
Singapore
 Hong Kong
Taiwan
 Japan
Thailand
 Korea
Vietnam
 The statement is intended to aid gynaecologists, family physicians and other
health-care professionals in providing optimal care to menopausal women in
the Asia-Pacific region
 The statement represents the combined opinion of representatives from 14
countries comprising the Asia Pacific Menopause Federation.
 The Consensus Meeting was held in Ho Chi Minh City, Vietnam from April
11-13, 2008
Participants
Australasia: Professor Henry Burger (Facilitator)
Dr Alice MacLennan, Dr Elizabeth Farrell
China: Professor Lin Shouqing, Professor Yu Qi
Hong Kong: Professor Christopher J. Haines
India: Dr Behram Ankelsaria, Professor Meeta Singh
Indonesia: Dr Tina Agoestina, Dr. Rama Tjandra
Japan: Professor Takeshi Aso
Korea: Professor Heung Yeol Kim
Malaysia: Dr. Liew Fah Onn, Dato' Professor Dr. Nik Nasri
Pakistan: Professor Syeda Batool Mazhar,
Professor Rubina Hussain
Philippines: Dr Blanca de Guia, Professor Delfin Tan,
Singapore: Dr Loh Foo Hoe, Dr Chua Yang
Taiwan: Professor Ko-En Huang
Thailand: Professor Kobchitt K. Limpaphayom, Dr. Sukanya Chaikittisilpa
Vietnam: Dr Mai Thi Cong Danh
Background
 The Asia-Pacific region contains more than 50% of the world’s population and
is made up of ethnically diverse populations representing a wide range of
socioeconomic and educational circumstances.
 Within this region there are large differences in accessibility to information
about the menopause, to health care services and to health care professionals
with an interest in menopause
 The availability of some investigations generally considered desirable for
menopausal women e.g. mammogram and bone mineral density, is limited in
many regions
Decision-making regarding the menopause
Each woman should be given the opportunity to participate in the decision-making
process with respect to menopause management including hormone replacement
therapy (HRT).
 Prior to the start of HRT, a woman’s health care provider should inform her
about the risks and benefits of therapy, its potential general side effects, and
side-effects that may specifically apply to her situation.
 This should be repeated at each of her periodically scheduled follow-up visits
during therapy.
 Use of HRT should be individualized.
 Treatment goals should take into account symptoms that may impact quality
of life e.g. decreased sexual function and insomnia.
 When counselling patients, risks should be conveyed in absolute numbers
rather than percentages to avoid unnecessary alarm.
Adapted from Asian Guidelines 2006
Recommendations: Healthy Lifestyle
 Any physical activity is better than being sedentary. Regular exercise reduces
total and cardiovascular mortality.
 Better metabolic profile, balance, muscle strength, cognition and quality of life
are observed in physically active persons. Heart events, stroke, fractures and
breast cancer are significantly less frequent.
 Benefits far overweigh possible adverse consequences: the more, the better,
but too much may cause harm. Injury to the musculo-articulo-skeletal system
should be avoided.
 Optimal exercise prescription is at least 30 minutes of moderate-intensity
exercise, at least three times weekly. Two additional weekly sessions of
resistance exercise may provide further benefit.
IMS Recommendations 2007
 Obesity (body mass index >30 kg/m2) affects significant segments of the
population and is becoming an increasing problem in postmenopausal women.
 Weight loss of only 5–10% is sufficient to improve many of the abnormalities
associated with the insulin resistance syndrome associated with obesity.
 The basic components of a healthy diet are: four to five servings/day of fruits
and vegetables, whole grain fibres, fish twice a week, and low total fat.
Consumption of salt should be limited and the daily amount of alcohol should
not exceed 20 g for women.
 Smoking and tobacco chewing should be strongly discouraged.
 Lifestyle modifications include socializing, and being physically and mentally
active.
Adapted from IMS Updated Recommendations 2007
Indications for Hormone Replacement Therapy (HRT)
 HRT is recommended as the primary and most important option to alleviate
menopausal symptoms (vasomotor symptoms, sleep disturbances associated
with vasomotor symptoms, and urogenital complaints).
 When hormones are considered solely for the treatment of vulvovaginal
symptoms, primary consideration should be given to the use of topical vaginal
products.
 HRT remains an option for the prevention of osteoporosis.
 When prescribing solely for the prevention of osteoporosis, HRT should be
considered along with non-oestrogen medications for women at significant
risk of osteoporosis.
 By decreasing menopausal symptoms, HRT may improve the overall healthrelated quality of life.
IMS Recommendations 2007
HRT Dosage recommendation
 The lowest effective dose consistent with treatment goals should be used.
 Lower doses than the presently used standard doses should be considered,
such as daily oral doses of 0.3 mg conjugated estrogens or 0.25- 0.5 mg
micronized 17ß-estradiol, tibolone 1.25 mg, transdermal 0.025 mg 17ßestradiol, or the equivalent.
 Doses higher than those conventionally used for menopause management
should be considered for women with premature menopause
Duration of therapy
 From available evidence, there is no reason to place mandatory limits on the
duration of treatment.
 HRT should be given for as long as the benefits outweigh the risks.
 Risks/benefits should be periodically assessed.
 The greatest benefits of HRT occur when it is initiated during the menopausal
transition or in the early menopause.
Rationale for adjunctive progestogen
 In women with a uterus, oestrogen therapy causes a dose- and durationdependent increase in the risk of endometrial cancer.
 The primary menopause-related indication for progestogen therapy is
endometrial protection from unopposed oestrogen.
 Ordinarily, postmenopausal women without a uterus should not be prescribed
progestogen.
 Oestrogen therapy should usually be given continuously, e.g. without a drugfree interval.
 Adjunctive progestogen may be given continuously or cyclically, e.g. for 12
days each month.
 Long-cycle adjunctive progestogen therapy, such as continuous oestrogen with
adjunctive progestogen every 3–6 months for 12–14 days, is not recommended
because the safety of long-cycle regimens has not been sufficiently
documented.
 There are insufficient safety data to support the use of a progestin-containing
intrauterine device or the safety of ultra-low doses of oestrogen therapy
without adjunctive progestogen.
IMS recommendations 2007
Vaginal Oestrogen Therapy
 Oestrogen therapy improves urogenital changes of the menopause.
 When prescribing solely for atrophic symptoms, local low dose vaginal
products are the treatment of choice.
 Most vaginal oestrogens produce minimal rises in serum oestradiol and the
potential for endometrial proliferation with long-term use seems very low
 Current data are insufficient to make a recommendation regarding endometrial
protection for durations of use of oestrogens greater than 1 year.
Adapted from Suckling J et al Cochrane Review 2003
Androgen Therapy
 Menopausal women (especially after bilateral oophorectomy) complaining of
distressing low sexual desire (hypoactive sexual desire disorder) and/or
unexplained tiredness persisting after adequate oestrogenization may be
counselled about the possibility of testosterone supplementation
The long-term safety of androgen treatment has not been adequately studied
 It is noted that at present few if any testosterone preparations suitable for
treatment of postmenopausal women are available in the Asia-Pacific region
Alternatives to hormone therapy
 Women who wish to avoid HRT, or in whom HRT is contraindicated, may
choose therapies other than hormonal preparations to relieve their menopausal
symptoms.
 These include SSRIs, SNRIs, clonidine, gabapentin, complementary and
alternative medicines
 The degree of symptom relief is lower than that attained with HRT and there
may be side-effects.
 Long-term safety and efficacy data are lacking.
 Women choosing to use complementary and alternative medicines to relieve
menopausal symptoms should be made aware that the efficacy is less than that
of HRT and quality control is questionable.
Premature menopause (under age 40 years)
 Women with premature menopause have special needs and may require
additional counselling
 Whenever possible, the ovaries should be conserved in premenopausal women
having hysterectomy for benign disease
 Doses higher than those conventionally used for menopause management
should be considered for women with premature menopause
 HRT is recommended at least until the age of normal spontaneous menopause,
after which the woman should be managed according to normal guidelines for
a postmenopausal woman
 After surgical menopause, oestrogen as well as androgen therapy can be
considered
Recommended Initial Assessment for peri- or postmenopausal women
 The Consensus group emphasized the need to educate all healthcare
professionals and postmenopausal women regarding the management of the
menopause including HRT.
 Initial assessment by any practicing healthcare professional should include:
History:
symptoms
general medical history
gynaecological history
family history (especially malignancy)
sexual history
risk factors for menopause related diseases such as
osteoporosis
Examination:
general, including weight, height, blood
pressure
breast, pelvic examinations
Investigations: Advised only
Pap or cervical smear, Complete blood count, Fasting
blood sugar, Fasting Lipid profile
Other investigations: to be ordered on a case to case basis could include:
Liver function tests, thyroid function tests, mammography, bone mineral
density, pelvic ultrasonography
Recommended Management at Follow-Up
 History: including response to treatment, side-effects and related problems
 Examination: Blood pressure, weight, height, breast and pelvic examination
 Investigations: Fasting lipid profile, Fasting blood glucose, pap or cervical
smear (as per local guidelines)
 Other investigations: to be ordered on a case-to-case basis could include liver
function tests, thyroid function tests, mammography, bone mineral density,
pelvic ultrasonography
Frequency of Follow-Up
In rural areas in many Asia-Pacific countries, there is a lack of state-of-the art
medical facilities and instrumentation, such as equipment for mammography and
bone mineral density.
 Therefore, while encouraging medical surveillance to the fullest extent
possible, the Consensus Group considered it inappropriate to provide generally
applicable guidance on frequency of medical assessments prior to and during
HRT.
 Whenever possible, at least annual re-assessment is advised.
Menopause specific issues:
Osteoporosis
HRT is effective in preventing the bone loss associated with the menopause and
decreases the incidence of all osteoporosis related fractures, including vertebral
and hip fractures, even in patients at low risk for fractures.
 HRT is indicated for the prevention of bone loss in women with premature
menopause and secondary amenorrhoea.
 HRT is indicated in postmenopausal women in the age group 50–60 years
presenting with a risk for fracture. Potential adverse effects of HRT can be
limited by using lower than standard doses or by avoiding oral administration,
without compromising the beneficial effect of HRT on bone.
 The protective effect of HRT on bone mineral density is lost after cessation of
therapy at an unpredictable rate. Although some degree of fracture protection
may remain after cessation of HRT, the patient at risk for fracture should
receive additional therapy with proven bone sparing medication.
 The continuation of HRT after the age of 60 for the sole purpose of the
prevention of fractures should take into account the possible side effects in the
individual of the specific dose and method of administration of HRT,
compared to other proven therapies.
 The initiation of HRT for the sole purpose of the prevention of fractures is not
recommended after the age of 60 years.
IMS recommendations Climacteric 2007
 HRT may be recommended as a first-line therapy in postmenopausal women
below the age of 60 at risk of osteoporosis-related fractures, in the absence of
data for the efficacy and safety of alternative preparations
Breast cancer
 Oestrogen/progestogen therapy for up to 5 years does not add significantly to
lifetime risk of breast cancer.
 Beyond that time, the increase in risk is small, and comparable to other risks
such as being obese or drinking more than 2 standard drinks of alcohol per day
 Oestrogen-only therapy for up to 7 years does not significantly increase breast
cancer risk.
 Young postmenopausal women starting on combined HRT for the first time
should be advised that breast cancer risks do not appear to increase in the first
7 years of use.
 Hysterectomized women on unopposed oestrogen are not at increased risk of
breast cancer and some may even have a small reduction in risk.
Cardiovascular disease
 Current evidence supports the cardioprotective effects of HRT when initiated
within 5 years of menopause or under age 60. Young healthy postmenopausal
women can therefore be started on HRT when clinically warranted without
fear of increased cardiovascular disease risk.
 HRT is not recommended exclusively for primary or secondary prevention of
cardiovascular disease.
 Oral HRT should not be prescribed to women with a previous episode of
venous thromboembolism.
 Women seeking HRT who have potential or confirmed risk factors for venous
thromboembolism and stroke need individualized counselling; in these
situations, transdermal HRT might be preferable to oral formulations.
Colon cancer
 Evidence supports the fact that combined HRT reduces colorectal cancer risk.
 However, HRT is not recommended exclusively for prevention of colon
cancer.
Cognitive impairment and dementia
 Evidence supports the fact that oestrogen therapy may reduce the risk of
Alzheimer’s dementia when initiated near to the time of menopause
 HRT should not be used exclusively for prevention or treatment of cognitive
impairment, Alzheimer’s disease or other forms of dementia.
Adapted from IMS Recommendations
Menopause in the Asia Pacific region: special considerations
Experience of the menopause
 There is considerable diversity regarding culture, customs and religious
practices within the Asia-Pacific region. As a result, the management of the
menopause may differ across countries in the Asia-Pacific region and across
different areas within a given country or region.
 In any given country or region, major differences in the experience and the
response to the menopause may be found in rural/urban regions, at different
educational levels and in different lifestyles.
 Individualizing menopause management is therefore of special importance.
Adapted from Asian Guidelines Climacteric 2006
Menopausal symptoms
 The prevalence of menopausal symptoms varies within the Asia-Pacific region
and is different from that usually reported in predominantly caucasian
populations.
 Whilst vasomotor symptoms are less frequent and intense in the Asia-Pacific
region, somatic symptoms (e.g. muscle and joint pain, dizziness, irritability
and insomnia) appear to be more common than in predominantly caucasian
populations.
Cardiovascular disease
 The prevalence of obesity, diabetes mellitus and hypertension is rapidly
increasing in the Asia-Pacific region with a consequent increase in
cardiovascular risk.
 This is a matter of great public health concern.
 Dietary and lifestyle modification should be promoted as first-line prevention
and treatment.
 The use of HRT may have a beneficial impact on these factors but its role
remains to be determined.
Use of HRT
 Low dose HRT is especially appropriate for women in the Asia-Pacific region
who in general have a low incidence and severity of vasomotor symptoms
 Some somatic symptoms commonly experienced by postmenopausal women
in the Asia-Pacific region respond to treatment with low dose HRT
Resources
Resources used in the preparation of this statement include:
 Guidelines for hormone replacement therapy of Asian women during
the menopausal transition and thereafter. Climacteric 2006;9:146-151
 IMS Updated Recommendations on postmenopausal hormone therapy.
Climacteric 2007;10:181-1
 Updated practical recommendations for hormone replacement therapy
in the peri and postmenopause. Climacteric 2008;11:108-123
 Suckling J, Lethaby A, Kennedy R. Local oestrogen for vaginal
atrophy in postmenopausal women. Cochrane Database System
Review 2006 Oct 18;(4):CD001500.
 Data presented for each country by the national representatives at the
Consensus Meeting
Declaration
 The APMF Consensus meeting was supported by unrestricted educational
grants from Bayer Healthcare, Wyeth Pharmaceuticals, Organon (ScheringPlough) and Novo Nordisk (Australia).
 No representatives of these companies were present during the discussions and
development of the statement.
Download