HRT study should continue: recommendation

Friday, 19 July 2002

A UK-based committee has recommended that a major, long-term study of the effects of Hormone Replacement Therapy on women should continue.

Known as WISDOM (Women's International Study of Long Duration Oestrogen after Menopause), the study is the world's biggest and aims to involve around 20,000 women worldwide.

WISDOM is funded by the Medical Research Council (MRC) in the UK.

The chief investigators of WISDOM in Australia are Professor Alastair MacLennan, University of Adelaide, and Professor John Marley, University of Newcastle. Both support the recommendation, however, a final decisions rests with the MRC's governing body, which will meet next week to decide on the future of the trial.

In addition, the study in Australia will inform the relevant ethics committees and will seek endorsement from its co-funders - the National Health and Medical Research Council, the Cancer Council (South Australia), the National Heart Foundation of Australia, the Australasian Menopause Society and the Royal Australian College of Obstetricians and Gynaecologists (South Australia).

In common with all MRC-funded trials, WISDOM has two independent committees that oversee the running of the study - an independent Data Monitoring and Ethics Committee and a Trial Steering Committee, which assess any emerging information that may have implications for the safety of women participating in the trial.

This week the WISDOM Trial Steering Committee met to discuss the implications of the recent findings of a major HRT study in the United States, known as the Women's Health Initiative (WHI).

The Steering Committee was advised by the Data Monitoring and Ethics Committee that as long as women volunteering for the trial were fully informed of all the known risks and benefits of HRT, including the results of the WHI, the WISDOM study should continue.

The committee believes there are no strong ethical or scientific reasons to stop the trial and that there are still important questions about the balance of risks and benefits from taking HRT long-term that have not yet been answered.

These include:

• uncertainties about the role of the effects on vascular disease and on different types of cancer, such as colorectal cancer;
• the effects of HRT on dementia, cognitive decline, arthritis and other conditions that have a major impact in later life;
• the impact on overall quality of life.

The committee believes the increased number of breast cancers seen with HRT in the WHI study remains a relatively low risk. The committee also believes there are still questions over the size of any effects on heart disease, stroke, colorectal and other cancers.

Professor Rory Collins, Chair of the Trial Steering Committee, said: "I'll be briefing the MRC's Council on Wednesday. In the meantime, GPs and patients already involved in the trial were sent letters yesterday advising them of the recommendation to continue and the reasons for doing so.

"The WISDOM study aims to answer important questions about the long- term risks and benefits of taking HRT and the results of the study could provide important information for generations of women to come.

"It's vital that women already involved in the study are informed of all the known risks and benefits associated with taking HRT, including the new results from the WHI study.

"Until revised information has been prepared, and the MRC Council has made a decision, further women will not be recruited into the trial. But I hope very much that the women currently in the trial will wish to stay in it and that many more women will join in the future."

Women in the trial with questions or concerns should contact their GP or their WISDOM coordinator. There are currently around 300 Australian women in the trial.

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