Archive for Menopause Management

Women in Midlife

From Australian Family Physician

Members of The Jean Hailes Foundation have produced a series of articles for the November 2004 issue of Australian Family Physician, the RACGP’s journal, that focus on health issues for women in their midlife.

Articles cover

  • hormone replacement therapy (also known as hormone therapy)
  • menopause including the psychosocial issues, as well as dysfunctional uterine bleeding.

Hormone therapy – weighing up the evidence

Hormone therapy (HT) use is well established for menopausal symptom relief, but its use is not currently considered justified for the prevention of disease.

Dr Teede reviews the recent literature on the risks and benefits of HT in postmenopausal women.

Menopausal symptoms are severe in around 20% of Australian women and HT effectively relieves these symptoms. Controversy still surrounds the risk profile of HT in women at the time of the menopausal transition, although risks are likely to be small. Recent literature has demonstrated that the role of HT in disease prevention is limited, based primarily on the lack of preventive benefits rather than on the small but present adverse effects of HT use. Historically, the HT literature holds many salient lessons for clinicians. These include the shortcomings of animal data, observational human data, and human trials focussing on intermediate end-points in guiding clinical practice. The HT story also reinforces the principle that health prevention strategies in low risk primary prevention settings should be lifestyle based. Pharmacological therapy, with its inherent risks, even if small, should be reserved for high risk settings.

Assessment of women in midlife

Midlife is much more than menopause. At the time of their life when women may be experiencing symptoms relating to decreased ovarian function, they are also confronted with a range of physical and psychosocial issues that may affect their wellbeing.

Dr Reddish outlines the range of clinical presentations of women in midlife and discusses assessment of these presentations in the context of the individual woman’s life.

Women in midlife present to doctors for a variety of reasons including information and preventive health, vasomotor or other symptoms of oestrogen deficiency, menstrual disorders, breast disorders, sexual difficulty, relationship and family issues, or mood disorders. Forming an effective doctor-patient partnership to address these issues requires time, empathy, good interpersonal skills, comprehensive and sensitive history taking and examination skills, and a good knowledge of relevant research.

Is this menopause? Women in midlife – psychosocial issues

Psychosocial influences have been found to impact on the symptoms a woman may experience as she moves through the menopause transition. Consequently any assessment of the menopausal woman should include an exploration and understanding of how the many psychosocial factors influence the experience of menopause and midlife.

Dr Deeks describes the many psychosocial factors that influence the experience of menopause including midlife issues, role and purpose in life, interpersonal relationships, libido, personality, psychological history and present psychological functioning, body image and sociocultural issues. Case studies are included to illustrate the importance of including psychosocial factors in the assessment and treatment of the menopausal woman.

Any assessment of the menopause experience should include psychosocial influences and the context of women’s lives. In a consultation where both the physical and psychosocial issues are explored, we come closer to addressing the true needs of each patient.

If not hormones – then what?

The Women’s Health Initiative study has made women reconsider their use of hormone therapy and made medical practitioners review the risks and benefits to each patient. The significance of lifestyle, nonprescription, and prescription therapies for menopause management are of increasing relevance.

Dr Murkies reports on the evidence from randomised controlled clinical trials and population based cohorts on nonhormonal management of menopause symptoms and on the role of diet and exercise in osteoporosis prevention. Personal tips are included.

Menopausal consultations should include a discussion of diet and exercise, and education of available over-the-counter therapies. For those women in whom oestrogen is contraindicated, prescriptions of serotonin noradrenergic reuptake inhibitors or clonidine may be indicated.

Dysfunctional uterine bleeding

Dysfunctional uterine bleeding is the major cause of heavy menstrual bleeding and impacts on women’s health both medically and socially.

Dr Farrell reviews the management of dysfunctional uterine bleeding

Dysfunctional uterine bleeding is defined as heavy menstrual uterine bleeding not due to any recognisable cause and is therefore a diagnosis of exclusion. Other conditions such as uterine fibroids, endometrial polyps and systemic diseases should be excluded by appropriate investigations. In the adolescent, investigations for a coagulopathy should be performed. The pathophysiology of DUB is largely unknown but occurs in both ovulatory and anovulatory menstrual cycles. Medical treatments include nonsteroidal anti-inflammatory drugs or antiprostaglandins, tranexamic acid, the progestogen releasing intrauterine device, combined oral contraceptive pills, and other hormonal therapies. As no medical treatment is superior to another, each woman should be individually assessed as to appropriate management. Surgical treatments include endometrial ablation and hysterectomy.

Menopause forum – a case discussion on midlife issues

The authors discuss their approach to the assessment and management of a woman presenting with issues relating to menopause and midlife.

Helen is 45 years of age. She has a partner, two teenage children, is a nonsmoker and is not taking any medication. She presents with hot flushes and premenstrual tension, and has regular menstrual cycles.

Menopause – a treatment algorithm

Dr Reddish has developed an algorithm that can assist GPs in the assessment and treatment of women experiencing menopause.

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Testosterone Therapy for Women

Women normally have circulating in their blood three major sex hormones: oestrogen, testosterone and progesterone. Each of these is produced by the ovaries. Oestrogen is also made throughout the body but particularly in body fat. Testosterone can be made by the adrenal glands and in other parts of the body from hormones (DHEA and DHEAS) that are produced by the adrenal glands.

At the time of natural menopause or surgical removal of the ovaries, oestrogen and progesterone levels fall precipitously.

Testosterone and DHEAS levels however, fall more gradually with increasing age such that a woman in her forties has on average only half of the testosterone and DHEAS circulating in her bloodstream as does a woman in her twenties. After a woman has her ovaries removed by surgery testosterone levels can fall by up to 50 per cent. However testosterone does not change across menopause, although this varies somewhat between women.

Testosterone and other related hormones (DHEA and DHEAS) in the body (also known as androgens) have known physiological roles in women. Firstly, oestrogen is actually made from testosterone and DHEA, and without the ability of our bodies to make testosterone we cannot make oestrogen. Testosterone and DHEA appear to have direct independent effects in different parts of the body, and some women may experience a variety of physical symptoms when their blood levels fall. Such symptoms may include:

  • Impaired sexual interest (loss of libido or sexual desire), and lessened sexual responsiveness
  • Lessened wellbeing, loss of energy

Testosterone therapy may be beneficial for some women who have had their ovaries surgically removed or in some who have significant symptoms in the form of loss of libido, fatigue and diminished wellbeing.

Caution

Testosterone therapy will not be the answer for someone who has a poor partner relationship, depression or poor wellbeing due to other causes.

Measuring testosterone

All women should have a blood test, preferably in a laboratory which uses a sensitive assay specially adapted to use in women, to measure their testosterone level before starting any testosterone replacement – mainly to exclude higher levels of testosterone.

There is no set lower level of testosterone which suggests or guides treatment, but it is essential that women with normal or high levels are not misdiagnosed and treated with androgens.

Women should have thyroid disease and iron deficiency excluded as possible causes of their symptoms by having a blood test for these conditions.

Most methods for measuring testosterone are fairly imprecise and become even more inaccurate when blood levels of testosterone are low. Blood should be taken ideally between 8:00am and 10:00am as testosterone levels vary throughout the day. For women who have regular cycles, blood should not be taken during the menstrual phase as testosterone levels are low at this time in most women and thus the result may be misleading. Blood should be drawn at least eight days after the start of menstruation.

Recent Jean Hailes research has shown no relationship between testosterone levels and loss of libido and sexual dysfunction in a community-based sample of women who had no concerns about their general or sexual health. This study has provided an important database for the normal ranges of testosterone as a function of age. Women with levels around or below the lower limits of normal for their age can be assessed as having levels consistent with but not diagnostic of androgen deficiency. In the presence of a history of unexplained fatigue, together with loss of libido for which no other cause can be identified, such low levels would support the diagnosis of possible androgen deficiency, which may warrant a trial of testosterone treatment.

The factors that do influence libido are discussed by psychologist, Dr Mandy Deeks PhD, in her “10 tips for understanding and improving your libido”. It is important to note that for many women sexual desire occurs only in response to an appropriate stimulus – so-called responsive desire.

[More detail on the 10 tips is available at Libido]

10 tips for understanding and improving your libido

1.  What influences your libido? Hormones, illness, medication and the state of your relationships can all influence your libido. Your personality and history of sexual realtionships, as well as society’s expectations and attitudes to sex, can also play a part. Is there one thing that has influenced your libido or many things?
2. Assess your own libido Some people want to participate in sexual activities all the time, while others never think about it and wouldn’t care if they never had sex again. Low libido is only a problem if you perceive it to be so. If your libido level worries you or is very different to your partner’s and causes you distress, you may want to seek some advice as to what you can do about it. Ask yourself what level of libido would you be happy with?
3. Why do you have sex? Lust or desire is only one reason why we have sex. Sometimes we do it to create intimacy, or because it’s fun and pleasurable. Sometimes it’s because we it makes us feel special, or to reproduce, and sometimes even to avoid conflict. Think about the reasons you have sex.
4. As time goes on When we first get together with our partner there is often lots of sex and intimacy, but it’s natural for desire levels to fall away after the ‘honeymoon’ period. It’s very important to understand this and know that there is nothing wrong with you if the desire levels fall over time. Has your desire for sex fallen with time? How do you feel about this?
5. Understand the physical We often have sexual relationships without really knowing what happens to our bodies when we become intimate. When we experience a problem with sex it can be helpful to understand what happens physically during sexual activity, where things can go wrong and what we can do to improve our sex life.
6.  Is there a difference between men and women Many women (not all) prefer talking, emotional intimacy and being romanced to sex. Many men (not all) tend to be less affected by a bad day or fatigue, and respond to spontaneity, visual stimulation like pornography, or just having a willing partner. It can be helpful to understand these generalisations and discuss any differences in libido with your partner.
7. Stop comparing Don’t worry about when or how often others have sex. What’s important is whether you and partner are happy with your level of sexual activity. Do you compare?
8. Watch out for depression and anxiety One in five Australian adults experience anxiety or a depressive disorder, which can impact negatively on libido. If you’re suffering from a mood disorder it’s important that you seek help. Is your mood impacting on your sex life?
9. It’s okay not to always feel desire when you have sex: put time aside for sex  It’s ok to have sex even if you don’t feel lust or desire. It can be important to put time aside for a date night and sex for example. Remember there are many reasons to have sex: because it creates intimacy, it is pleasurable etc. The important things are that there is no coercion, abuse or pain and you find sexual activity enjoyable.
10. Seek help if you need to If you’re worried about your libido or it’s causing you problems, seek professional help, either alone or, if appropriate, with your partner, from a health practitioner or specialist psychologist.

Dr Mandy Deeks PhD, The Jean Hailes Foundation

 

For those women with persistent low libido in whom lifestyle and relationship issues have been addressed, testosterone therapy may be appropriate. Therapy may improve libido, especially in oophorectomised women.

However with libido and testosterone therapy in women, there are areas that need further research, these include:

  • Defining the clinical features of androgen insufficiency in women
  • Appropriate testing/investigation
  • Appropriate testosterone preparation availability for women
  • Safety data on longer-term use

If testosterone therapy is used

Testosterone can be taken as tablets, by injection, as an implanted pellet, as a cream, as a skin patch (unavailable in Australia), gel or spray (not yet available).

Currently no form of testosterone therapy is officially approved in Australia by the Therapeutic Goods Administration for women. However for many years testosterone has been in used in public hospital specialist clinics, and in private practices for postmenopausal women with low testosterone levels. Decisions on use need to be made in partnership between women and their doctors.

For many years the most commonly used form of therapy for women has been with a testosterone implant pellet. This is a very small pellet which is implanted in the fat of the front lower abdomen, using a small incision (less than 1 cm). The procedure takes approximately 10 minutes to perform. The pellet releases testosterone over a period of three to six months, after which time it needs to be replaced. We most commonly recommend the use of 50 mg of the testosterone implant, although rarely 100 mg is required.

Testosterone tablets (Andriol®) are available on prescription however they are only available in a dose form developed for men, and much less is known about their action in women or about what is the most suitable and effective dose. Blood levels vary widely after tablet use. The use of testosterone tablets by women can not be recommended.

Testosterone injections can also be used, however these result in very high levels of testosterone as they were developed for use in men, and little is known about the actual release dynamics of the injections in women. Their use cannot be recommended.

Testosterone skin patches have been developed and are now undergoing research trials which are addressing their safety and efficacy. Similarly studies are underway evaluating the safety and effectiveness of a testosterone gel and a skin spray in women.

A testosterone cream is available in Western Australia that has been approved by Western Australian health authorities for use in women. It is called Androfeme®. This cream has been used in some short-term studies, however there is no long-term safety information regarding the use of the cream, nor of any other form of testosterone.

Some physicians and pharmacists are promoting the use of testosterone and DHEA (another androgen) in the form of lozenges (also called troches), which are sucked in the mouth or given as creams. These have been labelled as being ‘bio-identical’ however they are no more bio-identical than the other forms of testosterone that are available or undergoing research. The lozenges result in extremely high blood levels of testosterone, well above those appropriate for women. There is no research evidence that they are safe or even effective, and their use cannot be recommended.

A recent well-designed trial of two years of DHEAS therapy suggests no benefits on wellbeing, libido, sexual function, cardiovascular risk factors and other ageing related endpoints. More research is needed. DHEAS is currently banned from importation into Australia and is not approved for use.

Side effects of testosterone treatment

Short-term side effects of testosterone therapy appear uncommon when testosterone is used in appropriately selected women and given in the appropriate dose. However side effects will occur in any woman if the dose of the testosterone is in excess of her needs. Such side effects include masculinisation with acne and excess body hair, scalp hair loss, fluid retention, deepening of the voice, enlargement of the clitoris and adverse effects on blood cholesterol. It is our experience that these side effects are rarely encountered if the appropriate dose of testosterone is administered and blood levels are regularly monitored.

Women with severe acne or severe excess body hair or with thin scalp hair should not use testosterone. Women with very low levels of SHBG may be at increased risk of side effects of testosterone and therapy should be used very cautiously with careful monitoring. Similarly, testosterone should not be used by women who are pregnant or lactating or who have a suspected cancer. Some studies have shown that high levels of testosterone are more common in women who develop breast cancer, however the data to indicate any association between testosterone replacement and breast cancer is controversial.

Testosterone levels must be monitored during treatment and blood levels achieved with therapy should be kept within the normal range for women.

 

The current settings in which testosterone therapy may be beneficial in women include

  • Early ovarian failure.
  • Symptoms due to menopause following surgical removal of the ovaries, chemotherapy or radiotherapy.
  • Symptoms in women with premature spontaneous menopause
  • Symptoms in women who fulfill the criteria for possible androgen deficiency

 

 

Warnings

    • Any woman using testosterone during child-bearing years must have reliable contraception as testosterone may result in virilization of a female foetus if it is used after conception.
    • All women using testosterone cream should have a blood test after three weeks use and should be reviewed at six to eight weeks by their doctor.
    • No woman should continue treatment beyond six months if a clear benefit has not been achieved.
    • There is no information regarding the safety of the use of testosterone in women long-term.

Testosterone is not currently approved for use in women by the TGA and FDA pending further research.

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Lowered Mood, Body Image and Appearance

BODY IMAGE AND APPEARANCE

Most of us need to feel we look good to feel good. This includes men and women. To achieve this you need to eat a healthy diet, enjoy adequate exercise and be happy with what you are doing in life. Being dissatisfied with how you are coping with life may in itself be sufficient to distort your body image.

Deep down we all know that few women are born to be super models and most of us are plain old Ms Average, but somehow women have been programmed to physically expect more of themselves, well beyond what they mostly are. It seems that one of the hardest things in life for a woman to achieve is acceptance of herself. But self-esteem is a key ingredient to really be happy and for this each woman has to learn to like herself.

Self-punishment with diets and smoking won’t achieve the new look woman nor will alcohol excess hide feelings of inadequacy. Anti depressants have become the new crutch of a society which cannot face the plight of women struggling to be well and find happiness. Everyone deserves to feel well enough to enjoy life. But for most women it shouldn’t be that this can only be achieved through antidepressant pills.

Many women know deep down that they are not actually depressed but they are searching for the reason that they persistently feel down, tired and have loss their spark.

LOWERED MOOD (DEPRESSION) AND DIMINISHED WELL BEING

Many women experience lowered mood through to depression. Depression affects one in four women, but only one in 10 men. Too often a woman’s complaints of low mood, loss of well being and fatigue are attributed to various life stresses (for example being a working mum, or a relationship difficulty), however there are several underlying causes that should be considered. These include:

Poor diet – iron deficiency is not uncommon in women during the child bearing years. A blood count may be normal even when iron stores are low, so iron levels need to be checked to exclude this as a cause. Iron deficiency may be due to heavy menstrual loss, poor diet or a combination of the two. A generally poor diet can also result in poor health and fatigue.

Being unfit – women who are physically very unfit may experience fatigue at low levels of activity and hence lowered mood.

Thyroid disorders are common in women and may need to be excluded.

Hormonal disorders may underlie many of the health problems women experience.

HORMONAL DISORDERS

A common hormonal disorder in women is polycystic ovarian syndrome. This is characterised by irregular periods, weight gain and development of obesity, excessive body hair and infertility. It is associated with a high risk of developing diabetes in later life. Up to 10% of women may have this problem. Women with this disorder generally struggle with their weight from early adolescence.

Premenstrual symptoms (PMS) are due to a woman’s responses to the fluctuations in her hormone levels towards the end of the menstrual cycle. Some women experience no premenstrual symptoms where as others are quite debilitated. Cyclical depression and headaches are probably the 2 most debilitating symptoms. These can sometimes be alleviated with medical therapies, hence women suffering these symptoms should seek out a physician interested in this field.

Many women begin to experience lowered mood, depression, fatigue or even PMS for the first time, in their late reproductive years (early forties) and in the years leading up to their natural menopause. There is evidence emerging that subtle hormonal changes precede the menopause and may indeed underlie the depression or lowered mood and well being experienced by many women through their forties. Typically such women are labelled as stressed, working to hard or actually depressed.

Hormones produced by the ovaries, androgens, oestrogens and progestins each influence mood and sense of well being. The complex interactions between these ovarian hormones and chemicals that transmit messages in the brain (neurotransmitters) can only be guessed at. Clinical experience indicates that testosterone exerts a major positive influence on mood, however conclusive data is lacking. We have hypothesized that the fall in testosterone during the reproductive years may contribute significantly the symptoms diagnosed as depression in many women.

The classic symptoms with which women with low testosterone present include loss of well being, persistent fatigue and blunted motivation in tandem with diminished libido. Conservatively these are also classic symptoms of depression. So one must consider both conditions when depression is present. Research has now shown that in men mood is significantly and inversely associated with testosterone levels independent of age and weight change. Physical activity and testosterone replacement restores mood and alleviates depression in men with testosterone deficiency.

What is the evidence that testosterone may benefit women? Following removal of the ovaries (surgical menopause) the addition of testosterone therapy to oestrogen replacement results in women feeling more composed, elated, and energetic than with oestrogen alone. Other studies have reported positive effects of testosterone in peri- and naturally postmenopausal women.

Transdermal testosterone replacement by a testosterone patch in surgically menopausal women significantly improves a specific general well being score over placebo (dummy therapy), with the greatest change being in improved general wellbeing and less depressed mood.

DHEA, currently available over-the counter in the USA but not in Australia, given orally (50mg/day) or transdermally (by a 10% DHEA cream) has been associated with a marked improvement in well being over placebo in SMALL studies only. Oral DHEA improves well being and depression and anxiety scores in women with adrenal insufficiency. However not all DHEA trials have been positive. Larger prospective trials with this steroid are required before definitive guidelines can be made for its use clinically.

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Recommendations on Postmenopausal HT

Recommendations on postmenopausal hormone therapy

February 27, 2007

The following Statement expresses the views of the International Menopause Society (IMS) on the principles of hormone therapy (HT) in the peri- and postmenopause period. Throughout the statement, the term HT will be used to cover all therapies including estrogens, progestogens, combined therapies and tibolone.

The previous IMS Statement in 2004 is still valid and serves as a basis for the current updated version.

We are aware of the geographical variations related to different priorities of medical care, different prevalence of diseases, and country-specific attitudes of the public, the medical community and the health authorities toward menopause management, which may all impact on hormone therapy. The following recommendations, therefore, give a global and simple overview that serves as a common platform on issues related to the various aspects of hormone treatment. This statement was reviewed and discussed by representatives of more than 60 National and Regional Menopause Societies from all continents. These recommendations can be easily adapted and modified according to local needs.

Governing Principles

Hormone therapy should be part of an overall strategy including lifestyle recommendations regarding diet, exercise, smoking and alcohol for maintaining the health of postmenopausal women. HT must be individualized and tailored according to symptoms and the need for prevention, as well as personal and family history, results of relevant investigations, the woman’s preferences and expectations. The risks and benefits of HT differ for women around the time of menopause compared to those for older women.

HT includes a wide range of hormonal products and routes of administration, with potentially different risks and benefits. Thus, the term ‘class effect’ is confusing and inappropriate.

Women experiencing a spontaneous or iatrogenic menopause before the age of 45 years and particularly before 40 are at higher risk for cardiovascular disease and osteoporosis. They will benefit from hormone replacement, which should be given at least until the normal age of menopause.

Counselling should convey the benefits and risks of HT in simple terms, e.g. absolute numbers rather than as percentage changes from baseline. This allows a woman and her physician to make a well-informed decision about HT.

HT should not be recommended without a clear indication for its use.

Women taking HT should have at least an annual consultation to include a physical examination, update of medical history, relevant laboratory and imaging investigations and a discussion on lifestyle.

There are no reasons to place mandatory limitations on the length of treatment.

Whether or not to continue therapy should be decided at the discretion of the well-informed hormone user and her health professional, dependent upon the specific goals and an objective estimation of benefits and risks.

Dosage should be titrated to the lowest effective dose. Lower doses of HT than have been used routinely can maintain quality of life in a large proportion of users. Long-term data on lower doses regarding fracture risk and cardiovascular implications are still lacking.

In general, progestogen should be added to systemic estrogen for all women with a uterus to prevent endometrial hyperplasia and cancer. However, progesterone and some progestins have specific beneficial effects that could justify their use besides the expected actions on the endometrium. Low-dose vaginal estrogens administered for the relief of urogenital atrophy do not require progestogen co-medication. Direct delivery of progestogen to the endometrial cavity from the vagina or by an intrauterine system is logical and may minimize systemic effects.

Androgen replacement should be reserved for women with clinical signs and symptoms of androgen insufficiency. In women with bilateral oophorectomy or adrenal failure, androgen replacement has significant beneficial effects, in particular on health-related quality of life and sexual function.

Benefits of Hormone Therapy

General

HT remains the most effective therapy for vasomotor and estrogen-deficient urogenital symptoms. Other menopause-related complaints, such as joint and muscle pains, mood swings, sleep disturbances and sexual dysfunction (including reduced libido) may improve during HT. Quality of life and sexuality are key factors to be considered in the management of the aging individual. The administration of individualized HT (including androgenic preparations when appropriate) improves both sexuality and overall quality of life.

Postmenopausal osteoporosis

HT is effective in preventing the bone loss associated with the menopause and decreases the incidence of all osteoporosis-related fractures, including vertebral and hip, even in patients at low risk. Although the magnitude of decline in bone turnover correlates with estrogen dosage, even lower than standard dose preparations maintain a positive influence on bone indices in most women. Based on updated evidence on effectiveness, cost and safety, HT is an appropriate first-line therapy in postmenopausal women presenting with an increased risk for fracture, particularly under the age of 60 years and for the prevention of bone loss in women with premature menopause. The protective effect of HT on bone mineral density declines after cessation of therapy at an unpredictable rate, although some degree of fracture protection may remain after cessation of HT.

The initiation of standard-dose HT is not recommended for the sole purpose of the prevention of fractures after the age of 60 years. Continuation of HT after the age of 60 years for the sole purpose of the prevention of fractures should take into account the possible long-term effects of the specific dose and method of administration of HT, compared to other proven therapies.

Regulatory Authorities should review their current recommendations as a priority.

Cardiovascular disease

Cardiovascular disease is the principal cause of morbidity and mortality in postmenopausal women. Major primary prevention measures (besides smoking cessation and diet control) are weight loss, blood pressure reduction, and diabetes and lipid control. There is evidence that HT may be cardioprotective if started around the time of menopause and continued long-term (often referred to as the ‘window of opportunity’ concept). HT reduces the risk of diabetes and has positive effects on other risk factors for cardiovascular disease such as the lipid profile and metabolic syndrome.

In women less than 60 years old, recently menopausal and without prevalent cardiovascular disease, the initiation of HT does not cause early harm and may reduce cardiovascular morbidity and mortality. Continuation of HT beyond the age of 60 should be decided as a part of the overall risk–benefit analysis.

Other benefits

HT has benefits for connective tissue, skin, joints and intervertebral disks. HT may reduce the risk of colon cancer. HT initiated around the time of menopause or by younger postmenopausal women is associated with a reduced risk of Alzheimer’s disease.

Potential Serious Adverse Effects of Hormone Therapy

Studies on the risks of postmenopausal hormone use have mainly focused on breast and endometrial cancer, venous thromboembolism (pulmonary embolism or deep vein thrombosis), stroke and coronary events.

Breast cancer

The incidence of breast cancer varies in different countries. Therefore, currently available data cannot necessarily be generalized. The degree of association between breast cancer and postmenopausal HT remains controversial.

Women should be reassured that the possible risk of breast cancer associated with HT is small (less than 0.1% per annum). For combined HT, observational data from the Million Women Study suggested that breast cancer risk was increased as early as the first year, raising serious reservations on possible methodologic flaws. On the contrary, randomized controlled data from the Women’s Health Initiative (WHI) study indicate that no increased risk is observed in women initiating HT, for up to 7 years. It should be noted that the majority of subjects in the WHI were overweight or obese.

Data from the WHI and Nurses’ Health Study suggest that long-term estrogen-only administration for 7 and 15 years, respectively, does not increase the risk of breast cancer in American women. Recent European observational studies suggest that risk may increase after 5 years.

There are insufficient data to evaluate the possible differences in the incidence of breast cancer using different types and routes of estrogen, progestin and androgen administration.

Baseline mammographic density correlates with breast cancer risk. This does not necessarily apply to the increase in mammographic density induced by HT.

The combined estrogen–progestogen therapy-related increase in mammographic density may impede the diagnostic interpretation of mammograms.

Endometrial cancer

Unopposed estrogen administration induces a dose-related stimulation of the endometrium. Women with a uterus should have progestogen supplementation.

Continuous combined estrogen–progestogen regimens are associated with a lower incidence of endometrial hyperplasia and cancer than occurs in the normal population.

Direct intrauterine delivery systems may have advantages. Regimens containing low-/ultra-low-dose estrogen and progestogen cause less endometrial stimulation and less bleeding.

Thromboembolism and cardiovascular events

The HT-related risk for serious venous thromboembolic events increases with obesity and thrombophilia. By avoiding first-pass hepatic metabolism, transdermal estrogen may avert the risk associated with oral HT. Late starters of standard-dose HT may have a transient slightly increased risk for coronary events. The risk of stroke is correlated with age. HT may increase the risk of ischemic stroke.

Safety data from studies of low-dose and ultra-low-dose regimens of estrogen and progestogen are encouraging.

Alternative Treatments

The efficacy and safety of complementary alternative medicines have not been demonstrated and further studies are required.

Selective serotonin reuptake inhibitors, selective noradrenaline reuptake inhibitors and gabapentin are effective in reducing vasomotor symptoms in short-term studies. Their long-term safety needs further evaluation.

There are no medical or scientific reasons to recommend unregistered ‘bioidentical hormones’. The measurement of hormone levels in the saliva is not clinically useful. These ‘customized’ hormonal preparations have not been tested in studies and their purity and risks are unknown.

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Hormone Replacement Therapy In The Early Menopause

Introduction

Hormone replacement therapy (HRT) remains the first-line and most effective treatment for menopausal symptoms. But, despite massive, good-quality clinical outcome data on efficacy and safety when HRT is begun for symptoms in the early postmenopause, many physicians and lay people believe that hormones are risky and undesired even in the most appropriate case scenarios. Many misconceptions and misperceptions play roles in this complicated situation: some are purely scientific, others are cultural or social. The importance of the media and internet as effective, but unmonitored, means for dissemination of information, interpretation and recommendations cannot be ignored. Actual scientific facts and data have become trivialized in the mass media, often receiving less editorial scrutiny than normal journalism. Furthermore, many HRT prescribers and users do not attempt to broaden their knowledge on menopause and its treatment beyond capturing headlines or short commentaries, often produced by unqualified or prejudiced sources or unprofessional people.

As a result, a gap has formed between the actual clinical evidence and the way it is perceived by all concerned.

The results of the Women’s Health Initiative (WHI), a very large, government-sponsored study of hormone treatment regardless of indications (in contradistinction to normal practice that is based on clinical symptoms and signs), were prematurely released before the study was completed and before the results could be properly evaluated. As a result, the results were over-interpreted and negatively slanted. It was viewed as a negative study by its investigators and failed to emphasize the data, which pointed at the vast importance of age and time since menopause as major determinants of the benefit-risk equilibrium of HRT and the many benefits from timely employment of HRT. This was a catalyst for negative sentiments toward HRT. By the time that more detailed analyses from the WHI study could be published in the past 2 years, much ground was lost for all concerned and much remains to be set right for patients and caregivers, alike. At present, it is clear that the WHI showed that properly timed HRT is safe for healthy women in their early postmenopause and has major preventative effects against fractures. It reduces mortality and this may be, in large part, due to prevention of heart disease.

The premature evaluation of the WHI includes statements and warnings from many health authorities, such as the US Preventive Services Task Force (USPSTF) and the European Agency for the Evaluation of Medicinal Products (EMEA) that sent a message that still prevails: the use of HRT is dangerous and therefore should be avoided, unless there is a substantial reduction in quality of life because of menopausal symptoms, in which case treatment should be given for the shortest possible duration. This seems untenable in light of the presently available data, the opinion of skilled and experienced health professionals, and even some of the WHI investigators themselves.

The aim of the International Menopause Society (IMS) in developing the Zürich Summit was to openly discuss and better understand the current situation in various areas of the globe. The knowledge and perspectives of scientists, consumers and the media were sought to recommend ways to narrow the gap between the evidence and its perception by health professionals and the lay public. The forum, which included experts from the various fields of menopause medicine and representatives of 40 national and regional menopause societies, agreed that the following summary of the scientific data will be addressed as the ‘Evidence’. Each statement will quote its scientific level of evidence, and a list of the corresponding references is attached at the end of the document. Level A evidence refers to data from

randomized controlled trials, whereas Level B evidence comes from case-control/observational studies. As pointed out in the Summit’s title, the focus of discussions was the effects of HRT first administered during the early postmenopausal period.

Quality Of Life And Menopause

The perception of menopause and its impact on quality of life vary in different areas of the world1-5. In some places, menopause leads to a higher social status, in others – not. The forum agreed that the issue of quality of life is pivotal for any discussion on menopause management and the evaluation of the benefits versus the risks of HRT. Quality of life may be defined in many ways, based on medical, cultural and social parameters, but is largely subjective and therefore not easy to evaluate under a global, unified scale. Some may say that menopause is just a physiological stage during a woman’s life cycle and therefore its associated adverse consequences of quality of life should not be medicalized. Others may argue that the risks of HRT do not justify its use unless quality of life is substantially compromised. The negative sentiments coming from the WHI publications and the related media coverage intimidate women and health-care providers and in a way lead to confusion and to a degraded credibility of the medical profession over these issues, but the WHI Quality of Life analysis started with only 11% of subjects who had moderate or severe hot flushes and did not have the power to determine a comparative improvement in the treatment vs. placebo group. Such a low incidence of climacteric symptoms is not representative of the healthy peri- and early postmenopausal women treated in everyday practice.

  • In symptomatic postmenopausal women, quality of life and sexuality are improved by HRT and, in the presence of symptoms of androgen deficiency, by additional androgen administration.
  • In some cultures, and for some women, vaginal bleedings are unacceptable; if bleeding cannot be eliminated, alternatives to HRT may be used.
  • There is no evidence that so-called ‘natural’ products and unregulated hormone products (compounded bio-identical) significantly improve quality of life.

Perceptions Vs. Scientific Data (The ‘Evidence’)

HRT, coronary heart disease, stroke and thromboembolism

Perceptions

  • HRT increases coronary heart disease (CHD) risk throughout the whole postmenopausal period.
  • HRT causes an increase in coronary events in the first 1-2 years in all women.
  • Stroke risk is substantially increased in women receiving HRT.
  • The risk of both venous and arterial thromboembolism is increased during HRT.

The evidence

  • HRT in women aged 50-59 years does not increase CHD risk in healthy women and may even decrease the risk in this age group. [A]
  • Estrogen-alone therapy in the age group 50-59 was associated with significantly less coronary calcification (equivalent to a smaller plaque burden), which is consistent with findings of a lower coronary intervention score in women of this age in the WHI study. [A]
  • Early harm (more coronary events during the first 2 years of HRT) was not observed in the early postmenopausal period. The number of CHD events decreased with duration of HRT in both WHI clinical trials11. [A]
  • Data derived from randomized controlled trials in the age group 50-59 are similar to the older observational data suggesting a protective effect of HRT on coronary disease. [A, B]
  • It is unclear at present whether there is a statistical increase in ischemic stoke with standard HRT in healthy women aged 50-59. The WHI data showed no statistically significant increase in risk; nevertheless, even if statistically increased, as found in the Nurses’ Health Study, the low prevalence of this occurrence in this age group makes the attributable risk extremely small. [A,B]
  • The risk of venous thrombosis is approximately two-fold higher with standard doses of oral HRT, but is a rare event in that the background prevalence is extremely low in a healthy woman under 60 years of age. [A]
  • The risk of venous thrombosis is possibly less with transdermal, compared with oral estrogen therapy. [B]

Breast

Perceptions

  • All types of HRT cause an increased risk of breast cancer within a short duration of use.
  • HRT causes an increase in mortality from breast cancer.
  • The reported decline in breast cancer rates in the US following the publication of the WHI proves that HRT causes cancer.
  • HRT causes an increase in mammographic breast density.
  • Increase in mammographic breast density is associated with an increased risk of breast cancer.

The evidence

  • There is a wide variation across the world in the incidence of breast cancer and its risk factors.
  • There are multiple risk factors for breast cancer, including life-style factors especially alcohol intake, obesity and lack of exercise. These need to be included during counselling to put the magnitude of risk of HRT into an appropriate perspective. [B]
  • After 5 years’ use of combined estrogen and progestogen, there is a small increase in risk of breast cancer in North American women of about eight extra cases per 10,000 women per year. However, no significant increase was seen in women without prior use of HRT in the WHI study. [A]
  • Estrogen-only use does not cause an increase in breast cancer for up to 7 years. [A] In observational studies, a small increase in the risk with estrogen-alone therapy appears with long-term use. [B]
  • Women using combined HRT before a diagnosis of breast cancer have a reduced mortality. [B]
  • A decline in the incidence of breast cancer in the USA started before the WHI publication and can be partially related to fluctuation in screening. There has been no decline in breast cancer registration in the UK following the Million Women Study report, nor in Norway, Canada, the Netherlands and countries with stable screening programmes. [B]
  • Combined estrogen and progestogen therapy may cause increased breast density in up to 50% of postmenopausal women, dependent on the regimen (dosage, type of progestogen). The effect of estrogen alone is smaller. [A]
  • The effect on breast density is dose-related. Ultra-low-dose regimens do not cause any perceptible change in density. [A]
  • The average increase in breast density under standard-dose HRT is only about 5-10%. [A]
  • Increased baseline breast density is a risk factor for breast cancer. There are no data to support a direct association between HRT-induced breast density changes and the risk of developing breast cancer.
  • Many women who develop breast cancer have no known risk factors other than growing older and most women with known risk factors do not develop breast cancer.
  • Individual risk analysis for breast cancer is strongly recommended in clinical practice.

Bone

Perceptions

  • HRT should not be used for bone protection because of its unfavorable safety profile.
  • HRT is not as effective in reducing fracture risk as other products, e.g. bisphosphonates.
  • Official recommendations by health authorities (EMEA, FDA) limit the use of HRT to a second-line alternative. HRT could only be considered when other medications failed, were contra-indicated or not tolerated or in symptomatic women.

The evidence

  • Overall, HRT is effective in the prevention of all osteoporosis-related fractures, even in patients at low risk of fracture. [A]
  • Although no head-to-head studies have compared HRT to bisphosphonates in terms of fracture reduction, there is no evidence to suggest that bisphosphonates or any other antiresorptive therapy are superior to HRT.
  • It is therefore suggested that, in 50-59-year-old postmenopausal women, HRT is a cost-effective first-line treatment in the prevention of osteoporotic fractures.
  • Even lower than standard-dose preparations maintain a positive influence on bone indices such as bone mineral density. [A]
  • HRT has a positive effect on osteoarthritis and the integrity of intervertebral disks.

Cognition

Perceptions

  • Menopause transition is associated with cognitive decline.
  • HRT increases the risk of cognitive/memory impairment and dementia at any age.
  • Progestogens counteract estrogen effects in the brain.

The evidence

  • At present, there is no evidence of substantial cognitive decline across the menopausal transition. [A] However, many women experience cognitive difficulties in association with vasomotor symptoms, sleep disturbances and mood changes.
  • Verbal memory performance relates with the objective number of hot flushes women experience but not to the number of hot flushes they report35.
  • Clinical trial findings currently find no cognitive benefit among women initiating HRT late in the postmenopausal period (i.e. after age 65).
  • Cognitive benefits from estrogen replacement therapy appear to depend on age of initiation.
  • Observational studies show a decreased risk of Alzheimer’s disease in hormone users and typically involve women who initiated estrogen therapy early in the menopausal transition. [B]
  • Limited data exist on the effect of progestogen added to estrogen in the early postmenopause period. Clinical trial data suggest no cognitive benefit with MPA early in the menopause. [A]

Actions to be Taken

The forum agreed that education and dissemination of the clinical data are crucial in the process of closing the gap between the scientific evidence on HRT and its

perception. Three main targets were identified: the health-care providers, the consumers and the journalists. The forum did not believe that actions should be taken vis-à-vis the regulatory/health authorities, since the chance of changing their opinion at this moment is slim. In order to avoid any debate over the ‘Evidence’, it was based entirely on high-quality information, derived from randomized clinical trials whenever possible. Through presentations from each continent, it became quite clear that menopause symptoms and the incidence of illnesses associated with menopause or HRT may vary to a large extent in different parts of the world, as well as priorities in medical care. In addition, cultural and social attitudes may have a substantial impact, all affecting perceptions and decision-making in regard to menopause management and the use of hormones. Therefore, each regional/national menopause society should adapt the general framework according to its local situation and needs. The message to be delivered should be simple and clear, stressing the benefits of HRT and relieving fears according to the best quality clinical evidence. The most frequent misperceptions should therefore be identified and balanced by the corresponding data that were published in the medical literature. The above bullet points may serve as a template to be used locally by the societies.

Disclosure of Interest

The International Menopause Society was able to hold the Global Summit Meeting with the assistance of unrestricted educational grants received from three pharmaceutical companies: Wyeth Pharmaceuticals, Bayer Schering Pharma and Novo Nordisk Femcare. The industry had no influence on the choice of speakers, the content of the meeting, the discussions or the final statement. The signatories to the summary statement have no associations or financial links with any pharmaceutical company, but have received honoraria for lecturing at scientific meetings and research grants.

References

Quality of life

1. Haines CJ, Yim SF, Chung TK, et al. A prospective, randomized, placebo-controlled study of the dose effect of oral oestradiol on menopausal symptoms, psychological well being, and quality of life in postmenopausal Chinese women. Maturitas 2003;44:207-14

2. Haines CJ, Xing SM, Park KH, Holinka CF, Ausmanas MK. Prevalence of menopausal symptoms in different ethnic groups of Asian women and responsiveness to therapy with three doses of conjugated estrogens/medroxyprogesterone acetate: The Pan-Asia Menopause (PAM) study. Maturitas 2005;52:264-76

3. Lock M. Ambiguity of ageing: Japanese menopause. Culture, Medicine and Psychiatry 1986;10:23-47

4. Obermeyer CM. Menopause across cultures: a review of the evidence. Menopause 2000;7:184-92

5. Tan D, Haines CJ, Limpaphayom KK, Holinka CF, Ausmanas MK. Relief of vasomotor symptoms and vaginal atrophy with three doses of conjugated estrogens and medroxyprogesterone acetate in postmenopausal Asian women from 11 countries: The Pan-Asia Menopause (PAM) study. Maturitas 2005;52:35-51

6. Hays J, Ockene JK, Brunner RL, et al. Women’s Health Initiative Investigators. Effects of estrogen plus progestin on health-related quality of life. N Engl J Med 2003;348:1839-54

7. Wiklund I, Karlberg J, Mattson L-A. Quality of life of postmenopausal women on a regimen of transdermal estradiol therapy: a double-blind placebo-controlled study. Am J Obstet Gynecol 1993;168:824-30

8. Syrjala KL, Roth-Roemer SL, Abrams JR, et al. Prevalence and predictors of sexual dysfunction in long-term survivors of marrow transplantation. J Clin Oncol 1998;16:3148-57

HRT, coronary heart disease, stroke and thromboembolism

9. Rossouw JE, Prentice RL, Manson JE, et al. Postmenopausal hormone therapy and risk of cardiovascular disease by age and years since menopause. JAMA 2007;297:1465-77

10. Manson JE, Allison MA, Rossouw JE, et al. Estrogen therapy and coronary-artery calcification. N Engl J Med 2007;356:2591-602

11. Lobo R. Evaluation of cardiovascular event rates with hormone therapy in healthy, early postmenopausal women: results from 2 large clinical trials. Arch Intern Med 2004;164:482-4

12. Grodstein F, Manson JE, Stampfer MJ. Hormone therapy and coronary heart disease: the role of time since menopause and age at hormone initiation. J Womens Health 2006;15:35-44

13. Hendrix SL, Wassertheil-Smoller S, Johnson KC, et al. Effects of conjugated equine estrogen on stroke in the Women’s Health Initiative. Circulation 2006;113:2425-34

14. Grodstein F, Manson JE, Stampfer J, Rexrode K. Postmenopausal hormone therapy and stroke. The role of time since menopause and age of initiation of hormone therapy. Arch Intern Med 2008;168:861-6

15. Cushman M, Kuller LH, Prentice R, et al. Estrogen plus progestin and risk of venous thrombosis. JAMA 2004;292:1573-80

16. Canonico M, Oger E, Plu-Bureau G, et al. Hormone therapy and venous thromboembolism among postmenopausal women: impact of the route of estrogen administration and progestogens: the ESTHER study. Circulation 2007;115:840-5

Breast

17. Parkin DM, Bray F, Ferlay J, Pisani P. Global Cancer Statistics 2002. CA Cancer J Clin 2005;55:74-108

18. Clemons M, Goss P. Estrogen and the risk of breast cancer. N Engl J Med 2001;344:276-85

19. Veronesi U, Boyle P, Goldhirsch A, et al. Breast cancer. Lancet 2005;365:1727-41

20. Chlebowski RT, Hendrix SL, Langer RD, et al. Influence of estrogen plus progestin on breast cancer and mammography in healthy postmenopausal women: the Women’s Health Initiative randomized trial. JAMA 2003;289:3243-53

21. Stefanick ML, Anderson GL, Margolis KL, et al. Effects of conjugated equine estrogens on breast cancer and mammography screening in postmenopausal women with hysterectomy. JAMA 2006;295:1647-57

22. Chen WY, Manson JE, Hankinson SE, et al. Unopposed estrogen therapy and the risk of invasive breast cancer. Arch Intern Med 2006;166:1027-32

23. Newcomb PA, Egan KM, Trentham-Dietz A, et al. Prediagnostic use of hormone therapy and mortality after breast cancer. Cancer Epidemiol Biomarkers Prev 2008;17:864-71

24. Li CI, Daling JR. Changes in breast cancer incidence rates in the United States by histologic subtype and race/ethnicity, 1995 to 2004. Cancer Epidemiol Biomarkers Prev 2007;16

25. Ponti A, Rosso S, Zanetti R, Ricceri F, Tomatis M, Segnan N. Re: Breast cancer incidence, 1980-2006: combined roles of menopausal hormone therapy, screening mammography, and estrogen receptor status. J Natl Cancer Inst 2007;99:1817-8

26. Greendale GA, Reboussin BA, Sie A, et al. Effects of estrogen and estrogen-progestin on mammographic parenchymal density. Postmenopausal Estrogen/Progestin Interventions (PEPI) Investigators. Ann Intern Med 1999;130:262-9

27. Lundström E, Bygdeson M, Svane G, Azavedo E, von Schoultz B. Neutral effect of ultra-low-dose continuous combined estradiol and norethisterone acetate on mammographic density. Climacteric 2007;10:249-56

28. Hofling M, Lundström E, Azavedo E, et al. Testosterone addition during menopausal hormone therapy: effects on mammographic breast density. Climacteric 2007;10:155-63

29. Boyd NF, Rommens JM, Vogt K, et al. Mammographic breast density as an intermediate phenotype for breast cancer. Lancet Oncol 2005;6:798-808

30. Santen RJ, Boyd NF, Chlebowski RT, et al.; Breast Cancer Prevention Collaborative Group. Critical assessment of new risk factors for breast cancer: considerations for development of an improved risk prediction model. Endocr Relat Cancer 2007;14:169-87

Bone

31. Jackson RD, Wactawski-Wende J, LaCroix AZ, et al. Effects of conjugated equine estrogen on risk of fractures and BMD in postmenopausal women with hysterectomy: results from the Women’s Health Initiative randomized trial. J Bone Miner Res 2006;21:817-28

32. Cauley JA, Robbins J, Chen Z, et al. Effects of estrogen plus progestin on risk of fracture and bone mineral density: the Women’s Health Initiative randomized trial. JAMA 2003;290:1729-38

33. Huang AJ, Ettinger B, Vitinghoff E, et al. Endogenous estrogen levels and the effects of ultra-low-dose transdermal estradiol on bone turnover and BMD in postmenopausal women. J Bone Min Res 2007;22:1791-7

Cognition

34. Meyer PM, Powell LH, Wilson RS, et al. A population-based longitudinal study of cognitive functioning in the menopausal transition. Neurology 2003;61:801-6

35. Maki PM, Drogos LL, Rubin LH, et al. Objective hot flashes are negatively related to verbal memory performance in midlife women. Menopause 2008;in press

36. Woods NF, Smith-Dijulio K, Percival DB, et al. Symptoms during the menopausal transition and early postmenopause and their relation to endocrine levels over time: observations from the Seattle Midlife Women’s Health Study. J Womens Health 2007;16:667-77

37. Espeland MA, Rapp SR, Shumaker SA, et al. Women’s Health Initiative Memory Study. Conjugated equine estrogens and global cognitive function in postmenopausal women. JAMA 2004;291:2959-68

38. Bagger YZ, Tankó LB, Alexandersen P, Qin G, Christiansen C. Early postmenopausal hormone replacement therapy may prevent cognitive impairment later in life. Menopause 2005;12:12-17

39. Kawas C, Resnick S, Morrison A, et al. A prospective study of estrogen replacement therapy and the risk of developing Alzheimer’s disease: the Baltimore Longitudinal Study of Aging. Neurology 1997;48:1517-21

40. Zandi PP, Carlson MC, Plassman BL, et al. Hormone replacement therapy and incidence of Alzheimer’s disease on older women the Cache County study. JAMA 2002;288:2123-9

41. Tang M-X, Jacobs D, Stern Y, et al. Effect of oestrogen during menopause on risk and age at onset of Alzheimer’s disease. Lancet 1996;348:429-32

42. Maki PM, Gast MJ, Vieweg AJ, Burriss SW, Yaffe K. Hormone therapy in menopausal women with cognitive complaints: a randomized, double-blind trial. Neurology 2007;69:1322-30

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Hormone Replacement Therapy (HRT) and Breast Cancer Study

Comments from researchers at the Jean Hailes Foundation for Women’s Health

Introduction

The Foundation strongly advocates that women and health professionals take a balanced, evidence-based and informed approach to health. All risks and benefits should be taken into perspective when considering the use of HRT for menopausal symptom relief.

For example, having more than two standard drinks per day, being overweight or obese, having your first child over the age of 35 or going into menopause at a later age are higher risk factors for breast cancer than taking HRT.

The context of the study

Study summary

Research published in Medical Journal of Australia on June 2, 2008 has found that the decline in HRT use in Australia is linked to a decline in breast cancer rates among women aged 50 and over (calculated to equal 600 fewer cases of breast cancer among Australian women).

This research has found that the use of HRT dropped by 40 per cent between 2001 and 2003 following the US Women’s Health Initiative Study. At the same time the study found that breast cancer rates fell by almost 7 per cent among women aged 50 and over.

HRT has been used to effectively relieve symptoms for women for whom quality of life is affected by moderate to severe symptoms. However, recent media on HRT has raised concerns which need to be evaluated and understood in context.

The data presented in the Medical Journal of Australia on June 2, 2008 is observational and can not determine cause and effect. Trends are observed, but the reasons for these trends can not be determined from this data. For example the data also showed that HRT use declined from 2001 to 2002 – in the year before the US Women’s Health Initiative report linked HRT to breast cancer. Rates for breast cancer also fell between 1998 and 1999, yet at this time HRT use was actually increasing.

The International Menopause Society who held their latest congress in Madrid, Spain two weeks ago, confirms  that for women aged 50 to 59, HRT remains the first line and most effective treatment for menopausal symptoms. For women in this age group there is no significant increase in risk in using HRT – in fact the benefits outweigh the risks.

All the precautions mentioned in the study only refer to women who still have a uterus who were taking combined oestrogen and progestin – it is quite clear from the best available data that taking oestrogen alone in women who have had a hysterectomy may actually reduce breast cancer risk.

This study also does not cover the marked improvement in quality of life which HRT gives to symptomatic women and neglects to point out that by stopping HRT, a woman will lose the benefits such as freedom from symptoms, and potential protection against heart attack, fracture and colon cancer.

Current guidelines

Current guidelines recommend that women who take HRT for menopausal symptoms take the lowest effective dose for the shortest time period to alleviate symptoms.

HRT can be stopped at any time with the guidance of your medical practitioner. Once you’ve stopped treatment any increase in breast cancer risk lessens over time and is lost within five years. The Foundation recommends that each woman discuss her decision about taking HRT regularly with her health practitioner or whenever she has any concerns.

Frequently asked questions

What does this study mean for women?

It is of no significance for healthy women taking hormone therapy at the time of menopause for 2-5 years for the relief of menopausal symptoms. For women on longer term treatment, when breast cancer risk may begin to rise, the findings reinforce the advisability of regularly reviewing the reasons to continue or not.

Can the decline in breast cancer be attributed to the decline in HRT use?

The decline in breast cancer can not be conclusively attributed to the decline in HRT use. Similar declines have been observed in some countries but not in others. There is data for only one year after the US-based Women’s Health Initiative (WHI) report and it would be essential to see longer term data. Women in the US who stopped HRT after the WHI trial was terminated showed no decline in breast cancer diagnosis in the subsequent three years.

Do I need to stop taking HRT?

There is no indication from this study for stopping HRT used for symptom relief in younger healthy women.

What is the risk of breast cancer relating to HRT?

For otherwise healthy women under 60 years of age taking combined oestrogen and progestin therapy there is a small increased risk of breast cancer after five or more years of treatment.

What other risk factors can affect my chance of getting breast cancer?

Drinking more than two standard drinks per day, being overweight or obese, having children later in life or going into menopause at a later age can all put you at an increased risk of getting breast cancer.

How often do I need to see my doctor to review my use of HRT?

Best practice guidelines for treatment of the menopausal woman indicate an annual review. However, if concerns exist more regular review is reasonable.

What else can I take to relieve my symptoms?

For women who experience menopausal symptoms and have their quality of life impacted on or compromised, there are a number of approaches to manage their symptoms. These include education and awareness of symptoms, management of stress, regular physical activity and a healthy diet – resources are available on these options online at www.jeanhailes.org.au or by calling the Jean Hailes Foundation for Women’s Health tollfree on 1800 151 441.

Many women find that simple measures, such as wearing lighter clothing or keeping room temperatures low at night, can make a big difference. These changes won’t eliminate all symptoms, but can make them manageable. Some women may find complementary therapies helpful.

If hot flushes continue to make your life miserable, talk to your health practitioner about the different types of hormone therapy currently available – many of which come in much lower doses than the medication used in the WHI study.

Where do I go for further information?

The Jean Hailes Foundation has a variety of up to date information and free health resources to help you make informed health choices about menopause and other health issues.

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Menopause Management

A thorough assessment of the menopausal woman should culminate in a management and/or treatment plan, outlining to the woman her options so that she may decide on choices to improve or maintain her quality of life, at the same time developing an empathic, communicating and ongoing relationship for the woman with her doctor.

In every case the woman should be advised about improving her lifestyle by having a healthy eating plan, maintaining consistent and individually appropriate physical activity and managing stress.

Smoking is particularly associated with postmenopausal morbidity and mortality.

Alongside lifestyle improvements, a therapeutic regimen may be developed which may include non-prescriptive or complementary therapies as well as prescriptive medicines.

Management plans may include:

1. Therapy for symptom relief, either hormonal or non-hormonal

2. Contraceptive advice

3. Preventative therapy eg for osteoporosis, including lifestyle, calcium, hormone therapy, vitamin D

4. Therapy for osteopenia or osteoporosis, either hormonal or non-hormonal, such as the bisphosphanates, SERMS

5. Therapy for present cardiovascular risk eg. hypercholesterolaemia

6. Referral for surgery for either pelvic or breast pathology

7. Counselling, either psychosexual or psychotherapeutic

8. Assessment of Incontinence, referral to pelvic floor rehabilitation physiotherapist.

9. Lifestyle, nutition, exercise advice as well as giving information or providing educational resources.

Regular follow-up, with two visits in the initial six months after commencing a treatment plan, provides an opportunity for both the woman and her practitioner to discuss her progress, side effects to medication or difficulties in management and treatment.

Yearly assessments should then occur. If therapy is necessary long term, annual review should occur to re-examine risks and benefits and to discuss any new options.

 

There are many ways to manage this time in your life, both in physical and psychological terms. Decisions about therapies depend on your:

  • Current symptoms and their severity
  • Current health status
  • Long-term health risks
  • Personal life expectations

Healthy eating

Take some time to review your daily nutrition and physical activity to assist in managing any symptoms you may experience.

  • Have plenty of fresh vegetables, fruits, cereals and wholegrains
  • Drink six to eight glasses of water daily
  • Decrease intake of caffeine (coffee, tea, cola, chocolate)
  • Limit alcohol to one to two standard drinks, or less, per day
  • Eat high-calcium, low-fat dairy foods
  • Include lean meat, fish or chicken in your diet
  • Phytoestrogens (plant oestrogens) replace some natural oestrogens lost during menopause, and may reduce symptoms, cholesterol and blood pressure – good sources include soy and linseed bread, soy beans, tofu, wholegrains and legumes

For more information see Nutrition

Regular physical activity

Aim for 30 minutes of moderate physical activity on most days of the week to maintain general health, control weight and help keep bones healthy.

For more information see Physical Activity

Avoid smoking

Need help quitting smoking?

See Giving up smoking

Look after your emotional health

During menopause, you may experience mood changes such as mild depression and irritability, which are often related to physical changes like hot flushes, night sweats and interrupted sleep. Talk to a health practitioner about controlling the physical symptoms to help improve your general wellbeing.

For more information see Emotional Health

Have regular Pap tests and breast checks

See your health practitioner for a Pap test every two years and regularly check your breasts.
Mammograms are free if you are over 40 years of age – phone BreastScreen on 13 20 50.

For more information see Pap Test and Breast Health

What therapies can help you manage symptoms?

Hormone Therapy (HT) (also known as Hormone Replacement Therapy – HRT)

Hormone therapy (HT) can help relieve the symptoms of menopause, but no treatment is without side effects. Any decision about HT is an individual one, so talk to your health practitioner about risks, benefits, concerns and other alternatives.

It is important that all women using HT be reviewed once a year by their health practitioner.

Find out more…

Other (complementary) therapies

Various other therapies such as complementary therapies can be of benefit to some women. It is important to remember that herb and plant medications can have unpleasant side effects in some women, as can prescribed western medications. For long-term guidance and balance through the menopausal years it is important to see a registered naturopath.

Other therapies can often be taken in conjunction with hormone therapy; however it is important to let both your doctor and naturopath know exactly what each has prescribed.

Find out more…

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Substance: Drostanolone Propionate
Manufacturer: Kalpa Pharmaceuticals
Unit: 10 mL vial (100 mg/mL)

Trenbolone 100

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Substance: Trenbolone Acetate
Manufacturer: Dragon Pharma
Unit: 10 mL vial (100 mg/mL)

Parabolan 100

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Substance: Trenbolone Hexahydrobenzylcarbonate
Manufacturer: Dragon Pharma
Unit: 10 mL vial (100 mg/mL)