Hormone Therapy: where to now?

July 2002 – Breast Cancer menopause May 2003 – Dementia/Stroke June 2003 – Breast Cancer August 2003 – Coronary Heart Disease August 2003 – Breast Cancer Hormone Therapy in perspective Summary Making Informed Decisions What to ask your health professional Conclusion

Although women may be alarmed by the reporting of these research findings in the press, it is important to realise that these findings are contributing to our full understanding of the health effects of HT. The concepts discussed in the research reports are often complex, and understanding the added contribution of HT to the background risk of developing a condition such as breast cancer, is difficult.

New findings must also be interpreted in the light of what has already been established in previous studies. It is important that women are kept informed of new findings so that they can be fully involved with their doctor in the decision making about their individual use of HT. A key role of The Jean Hailes Foundation is the translation of the research reports appearing in the medical literature, into language that is accessible to everyone. As reports are released, summaries are prepared into both hard copy and loaded onto our website. Our aim is to assist women to work through the issues that are identified in new studies and put them into the context of our current understanding.

July 2002 – Breast Cancer menopause

In July last year women around the world were shocked to learn that oral HT may not be safe in the long term. The WHI trial, which looked at the long term use of oral HT in older women in the United States for the prevention of disease, was stopped after an average of 5.2 years participation because the incidence of invasive breast cancer exceeded the safety level set by the WHI.

In this study 16,608 women (who were postmenopausal and had a uterus) randomly received either Prempro (0.625mgs of conjugated equine oestrogen + provera 2.5mgs) or a placebo (dummy pill). The oestrogen only arm (for women without a uterus) of the study remains ongoing. So far, risks have not been found to outweigh benefits. We will see these results in the next few years.

May 2003 – Dementia/Stroke

More detailed information became available about the outcomes of the WHI study regarding the effects of the combined oral oestrogen/progestin therapy in postmenopausal women. One study showed a small increase in risk of stroke in users of oral combined HT compared with non users. The increase in risk translates to 1 extra case for every 200 women treated for 5 years.

The second study was restricted to women over the age of 65 and showed an increased risk of dementia in the women receiving combined oral HT that translated to 1 extra case for every 100 women being treated over 4 years. Of note, these women started HT late in life and these findings may not relate to women who start HT at the time of menopause. While these studies are important, they are specific to the type of HT used in this older group of women and may not necessarily apply to the use of oestrogen alone, non oral HT or other oral therapies. We await further studies to answer these questions.

The findings may not apply to the more conventional use of HT in the younger woman around the time of menopause for symptom relief. The findings of the study reinforce to women the importance of the use of HT being tailored to individual needs, addressing all potential benefits and risks.

June 2003 – Breast Cancer

This report reconfirms the same known increased risk of breast cancer as the original 2002 study report in users of oral combined (conjugated equine oestrogen 0.625mg/d and medroxyprogesterone acetate 2.5mg/d) HT compared with non users. The increase in risk translates to 8 extra cases (41 women versus 33) for every 10,000 women treated for one year.

Of note, the rate of breast cancer was 33 for every 10,000 women/year for women treated with placebo. Women aged 50 – 69 should have a regular mammogram and examination for this. Women on oral combined (conjugated equine oestrogen 0.625mg/d and medroxyprogesterone acetate 2.5mg/d) HT have a higher incidence of abnormal mammogram reports requiring further tests, although the large majority of these reports are not cancer.

August 2003 – Coronary Heart Disease

Again, this is not a new study but a more detailed report on heart disease and HT expanding on the original results. The report describes a small increase in risk of fatal and non fatal heart attack in users of oral combined HT, most of whom are several years past menopause, compared with non users. The research was using a specific HT, which may not apply to other forms of therapy prescribed around the time of menopause for symptom relief. Further research is needed. It is important to remember that in Australia coronary heart disease is the number one killer of both men and women overall. After midlife, a woman’s risk of heart disease increases.

August 2003 – Breast Cancer

Results published for a study of over 1 million UK women aged 50 - 64 years who had provided information about their use of HT prior to a screening mammogram and were followed up for cancer incidence and death. The study reported findings in relation to risk of breast cancer for women on combined oral therapy very similar to those of the WHI study in 2002 and 2003.

The findings provide further information about the risk of breast cancer with HT. For 1,000 women who go through menopause aged 50 and who do not take HT, 27 breast cancers would be expected to be diagnosed by the age of 55 years. If the 1,000 women had 5 years of combined oral HT, a total of 34 breast cancers (an extra 7 cancers) would be expected. This is the first report of an increased risk of breast cancer for women taking oestrogen alone (oral, skin patch or implant), progesterone or tibolone.

The authors estimated that, if 1,000 women took oestrogen alone for 5 years, there would be a total of 28.5 cases of breast cancer (an extra 1.5 cases per 1,000).

An increase in risk, similar to that of oestrogen only, was also observed for progesterone alone and tibolone. In a previous publication the authors of the study themselves have urged people to be cautious in interpreting the findings from this study. This is because the design of the study is weaker than the WHI randomised trial, so the conclusions are not as reliable.

HT in Australia is prescribed for the management of symptoms that significantly impair a woman’s quality of life. Based on the findings of this study continued use for this purpose remains appropriate where the woman is fully informed about the associated risks.

Hormone Therapy in perspective

All the reports add a further piece of information about HT. They emphasise the importance for women on HT or considering the use of HT, to be clear in their own mind that the benefits exceed the risks for them at a particular stage of their lives. Regular discussion and review with their prescribing practitioner, in the light of new information, is needed.

These studies remind us that any decision about HT is an individual one and should be made after each woman is informed about her individual risks, benefits, needs and concerns in consultation with her prescribing practitioner.

Making Informed Decisions

When considering therapies for menopausal symptoms and deciding what is right for you, ask yourself a series of questions:

• How much do my symptoms impact on my quality of daily life?

• What treatment/intervention choices are available to me?

• What are the possible benefits or risks of the different choices?

• How reliable is the evidence for these proposed benefits or risks?

• How do the benefits and risks weigh up for me?

• Have I now gathered enough information to make my decision? Women need to assess the choices available, based on best evidence from clinical trials and to consider:

• Resources available (ie cost and access to services)

• A woman’s personal values

What to ask your health professional

It is important to visit a health professional with some questions already planned. Write your questions down. This will promote clear and concise communication between you and your practitioner. It is often a good idea to book a longer consultation time.

Some examples may be:

• Are the findings of these studies relevant to my situation and my treatment?

• What treatment/intervention choices are available to me?

• What are the possible benefits and risks of the different choices?

• What might happen if I stop taking my HT immediately?

• Where else can I gather information? ie websites, services, printed material

• How often does my treatment need to be reviewed?

• Do I need to have a mammogram?

• Should I stop my HT prior to having a mammogram?

• What will happen if I have an abnormal mammogram?

Conclusion

The Jean Hailes Foundation concurs that new information from American studies released reconfirms that the use of HT after menopause should primarily be used for short term symptomatic relief in women with significant symptoms.

The Jean Hailes Foundation is committed to undertaking research in this area and keeping up to date with new research findings and communicating these findings to women and their families.

The Jean Hailes Foundation’s aim is to assist women to become well informed so that they can be active participants with their health professionals, in decision making about issues that affect their health and wellbeing.

Midlife – Choices for Health and Wellbeing

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Menopause Resources Stress Management Breast Health Herbal Therapies Therapies to manage symptoms Emotional Health	Nutrition Relationships & Lifestyle issues Hormone Therapy Self Management Osteoporosis Cardiac Disease Meditation

The Jean Hailes Foundation magazine is designed to be informative and educational. It is not intended that The Jean Hailes Foundation magazine provide specific medical advice or replace advice from your health professional. The Jean Hailes Foundation does not accept any liability to any person for the information or advice (or the use of information or advice) which is provided in this magazine or incorporated into it by reference. Information is provided on the basis that all persons reading the magazine undertake responsibility for assessing the relevance and accuracy of its content. 

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Note: This article is an archive. Whilst the Jean Hailes Foundation for Women’s Health has made every effort to ensure this information was accurate at the time of publication, the article content has not been updated since the date listed below.

Content created November 05, 2003