Note: hormone therapy (HT) may also be referred to as hormone replacement therapy (HRT).
Background
The Women’s Health Initiative (WHI) was a very large study with two arms focusing on hormone therapy (HT). Commencing in the United States of America in 1997, the study examined the role of long-term use of oral hormone replacement therapy in women aged 50-79 years in preventing heart disease. It did not address the benefits of hormone therapy for the relief of menopausal symptoms.
The first arm of the study - the combined oral oestrogen plus progestin therapy arm of the study was stopped in 2002. At this stage women had been participating for 5.2 years on average. It was stopped because there was a slightly greater rate of invasive breast cancer among the women taking the hormone therapy compared with women on the study who were not taking the hormone therapy but were taking a placebo (dummy) therapy.
Why was the oestrogen only arm of the study halted?
The oestrogen only arm of The Women’s Health Initiative study has been stopped after 7 years because a beneficial effect of hormone therapy on heart disease risk was not observed in the study.
Furthermore, a small increase in strokes was noted while hip fractures were reduced and, importantly, breast cancer was not increased.
WHI researchers have begun a detailed analysis of the data from the oestrogen-alone study and expect to report full results in the next two months.
A safety monitoring committee was responsible for ensuring that neither the women treated with hormone therapy, nor the women taking the placebo, were put at risk because of treatment or lack of treatment.
| "We have now been informed that the second arm of the WHI study, in which women were treated with oestrogen only (versus placebo) has been stopped, before the intended completion date in 2005.
This study is important because it adds further to our understanding of the risks and benefits of hormone therapy. Our understanding to date is that there is no increase in risk of cardiac events or of breast cancer in this oestrogen only arm of the study. We await the release of exact data."
Professor Susan R Davis |
Conclusion
The Jean Hailes Foundation, an NHMRC Centre of Clinical Research Excellence in women’s health, reconfirms that short-term use of hormone therapy for the management of menopause symptoms that unacceptably impair a woman’s quality of life remains a reasonable option. However, long term use of hormone therapy for women over 50 years of age is rarely indicated.
Each individual woman should weigh up the benefits and risks of hormone therapy in consultation with her health practitioner.
Content updated March 03, 2004
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