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Menopause Matters

Professor Susan Davis
President of the International Menopause Society and Past-President of the Australasian Menopause Society

Menopause impacts women in different ways. Some women breeze through and hardly notice a change - they are the fortunate few. BUT, not having symptoms does not mean that bone loss and other metabolic changes aren’t happening as these do not cause symptoms.

The majority of women will experience symptoms associated with menopause. Here are some facts from published research involving over 2000 Australian women aged 40 to 65 years:

  • 75% of postmenopausal women aged less than 55 years have hot flushes/night sweats
  • 28% of postmenopausal women aged less than 55 years have MODERATE TO SEVERE hot flushes/night sweats
  • 42% of women aged 60 to 65 years still have hot flushes/night sweats
  • Flushes and sweats severely impact wellbeing- the effect on wellbeing is similar to having insecure housing, so the effects is substantial
  • Women with moderate to severe flushes and sweats are almost 3-fold more likely to have moderate-severe depressive symptoms than other women
  • Other common menopausal symptoms include anxiety, disturbed sleep, joint pain and vaginal dryness

Anyone who suggests that most women can live with their symptoms is ill informed

Menopause is also associated with

  • bone loss and increased risk of osteoporosis and fragility fracture
  • increased central abdominal fat, even without an increase in body weight
  • increased risk of developing diabetes and cardiovascular disease

Undisputedly menopausal hormone therapy (MHT) is the most effective way for women to alleviate symptoms and prevent bone loss, and other negative consequences of menopause. As with all therapies, treatment needs to be individualised in terms of dose and formulation, and there are absolute and relative contraindications to MHT use.

Understandably women and their health care providers are uncertain and confused about MHT

This is due to the spread of misinformation, unfortunately sometimes by people who stand to profit by creating frightening stories about MHT.  As a result, vast numbers of women experiencing severe menopausal symptoms are struggling without appropriate treatment. Many are using unproven, often ineffective and occasionally unsafe alternatives- which may be costly.  Unfortunately, some of these ineffective alternatives are promoted by celebrities with no medical qualifications, for commercial gain.

So is MHT safe? and should women stop MHT because of a paper published in the Lancet1 in recent weeks?

Well let’s look at the facts.

The Lancet paper was what we call an “observational study”. This means information is collected about people and then the impact of different behaviours is compared. These studies are done to guide future clinical trials. Their findings are not conclusive, as sometimes the findings are later disproven. For example, large observational studies suggested vitamin D prevented cancer and heart disease. These studies were followed by big clinical trials in which people were randomly allocated placebo or vitamin D and followed up. The clinical trials proved that vitamin D supplements did not prevent heart disease or cancer.

How does this apply to the Lancet paper?

  • Much of the information included in this paper came from data bases of health information routinely collected in health care practices- so there would be missing data and some uncertainty.
  • Many of the included studies relied on women remembering what they had taken previously and for how long, and involved populations of women that are not typical of the average woman, such as nurses (the Nurses Health Study), or women having mammograms who at the time were invited to participate in a study of the breast effects of MHT. So, the women in these studies do not represent the general population.
  • Treatment was not randomly allocated and so there were always reasons why some women chose to, or not to take MHT.
  • The data was mostly old and reflects past MHT prescribing, not what is recommended today.
  • It was certainly not “world-wide” with over 90% of the information from the UK and USA.
  • Unjustifiable claims were made in the paper such as use of progesterone for 5-14 years was associated with a 2-fold risk in breast cancer- but the authors failed to add that this was based on only 38 cases, so statistically this is unsound.

Because of all of these sorts of limitations, observational studies frequently overestimate treatment effects by over estimating the risks or benefits of a specific treatment. This is exactly what we see in the Lancet paper. It suggested a 2-fold greater risk of breast cancer with oestrogen plus synthetic progestins, whereas big high-quality clinical trials (where women are randomly allocated to placebo or active therapy and everything is thoroughly documented) showed a lower risk (1.25-fold)2. For oestrogen-only (women who have had a hysterectomy) the Lancet paper suggested a 1.3-fold greater breast cancer risk, whereas the large Women’s Health Initiative clinical trial showed no increased risk2.

The most reliable data is from the Women’s Health Initiative because these were placebo-controlled trials and everything was thoroughly documented.

BUT BE MINDFUL, menopause is multidimensional and treatment plans must be about the whole woman - it goes well beyond breast cancer risk

MHT cannot be seen in one dimension – ie only one benefit or one risk. You have to look at the effects on other cancers, heart disease and fracture, and of course wellbeing and quality of life.

  • Oestrogen plus progestogen users are at reduced colon cancer risk, reduced uterine cancer risk and experience fewer fractures2
  • Oestrogen-alone is associated with reduced heart disease and fractures2.
  • If women have had their ovaries removed before the age of 45, oestrogen therapy is associated with approximately a 30% lower mortality3.

The clearest evidence for safety is from the Women’s Health Initiative studies follow up. This included 27347 women, treated with oestrogen or oestrogen + progestin for 5-7 years and followed for 18 years. 

There was no difference in deaths from any cause, and no difference in cancer-related deaths ( including death from breast cancer) for MHT users compared with placebo users 4.

Women who started MHT aged 50-59 women were 31% less likely to die during the intervention phase than women treated with placebo (hazard ratio 0.69 (95%CI 0.51-0.94, p=0.01) 4.  

However, women who were aged 50-59 when treated with estrogen-only who had had their ovaries removed before age 45 were 32% less likely to die during the 18 year follow up (hazard ratio 0.68 (CI, 0.48 to 0.96)3.

Of great concern is the danger that women with early menopause not take MHT.

The “norm” for women younger than 45 is to be premenopausal. Therefore, the 10% of women who have menopause before the age of 45 years are hormone deficient, and MHT is a physiological restorative therapy. Without MHT young postmenopausal women have greater risks of osteoporosis, heart disease and critically, premature death5. Unless contra-indicated, young postmenopausal women should take MHT.

So, taking a multidimensional approach, the evidence overall is that for most women who experience menopause after the age of 45 years, MHT will relieve symptoms but have no impact of life expectancy. For younger women, MHT is restorative therapy, replacing what is natural for a young woman, with the benefits outweighing the risks.

Anyone who says “the dangers have been shown to override the benefits” is ill informed.

What about women who choose not to, or cannot take MHT? 

Any claim that nutritional supplements or herbs will “balance your hormones” cannot be substantiated. These are unproven therapies and not without potential side effects- that’s why Chinese doctors call them “medicines” to be prescribed after a personalized assessment (face to face to ensure potential side effects are minimised) and in individualized doses, not thrown together in a pill. There is no evidence that pill forms of traditional herbs will even be absorbed.

Studies have consistently shown no meaningful benefits of herbal remedies (such as phytoestrogens, black cohosh, sage etc ) over placebo for hot flushes/night sweats, and these treatments do not prevent bone loss or protect against heart disease.

Women considering herbal or naturopathic remedies should have a face-to-face consultation with a qualified therapist (as opposed to an internet-based chat) to ensure their full symptom and health profile is documented and any other medications they are taking are known to avoid drug interactions.

For information about other treatment options women can go to the Australasian Menopause Society website and there are several informative short YouTube videos from the International Menopause Society (in English, Cantonese, Vietnamese and mandarin).

https://www.youtube.com/playlist?list=PLAjwoYuItHS-4jvjL6gJgM7o-vpr0PVk6

Also available from the Vimeo platform (should access to YouTube not be available) 

References

  1. Collaborative Group on Hormonal Factors in Breast Cancer. Type and timing of menopausal hormone therapy and breast cancer risk: individual participant meta-analysis of the worldwide epidemiological evidence. Lancet 2019.
  2. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal Hormone Therapy and Health Outcomes During the Intervention and Extended Poststopping Phases of the Women's Health Initiative Randomized Trials. JAMA 2013; 310(13): 1353-68.
  3. Manson JE, Aragaki AK, Bassuk SS, et al. Menopausal Estrogen-Alone Therapy and Health Outcomes in Women With and Without Bilateral Oophorectomy: A Randomized Trial. Ann Intern Med 2019.
  4. Manson JE, Aragaki AK, Rossouw JE, et al. Menopausal Hormone Therapy and Long-term All-Cause and Cause-Specific Mortality: The Women's Health Initiative Randomized Trials. JAMA 2017; 318(10): 927-38.
  5. Muka T, Oliver-Williams C, Kunutsor S, et al. Association of Age at Onset of Menopause and Time Since Onset of Menopause With Cardiovascular Outcomes, Intermediate Vascular Traits, and All-Cause Mortality: A Systematic Review and Meta-analysis. JAMA Cardiol 2016; 1(7): 767-76.

 

Content created September 2019