Hormone Replacement Therapy: statement

Friday, 12 July 2002

STATEMENT ON IMPLICATIONS FOR THE 'WISDOM' TRIAL OF RESULTS OF THE WOMEN'S HEALTH INITIATIVE

The Medical Research Council (UK) has released the following statement concerning the Women's International Study of long Duration Oestrogen after Menopause (WISDOM) currently being conducted in the UK, Australia and New Zealand. The Australian arm of the study is led by Professor Alastair MacLennan of the University of Adelaide and Professor John Marley of the University of Newcastle. This trial is funded by the Medical Research Council (UK), 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).

The Medical Research Council statement is as follows:

"The Medical Research Council is funding the WISDOM (Women's International Study of Long Duration Oestrogen after Menopause) study. The trial, led by researchers at the MRC Clinical Trials Unit in London, is trying to find out if Hormone Replacement Therapy (HRT), both oestrogen combined with progestogen and oestrogen alone, lowers or increases the chances of developing diseases and conditions such as heart attacks, breast cancer, osteoporosis and dementias. The trial is also looking at the impact of HRT on quality of life.

The trial began recruiting in 1999 and is due to end in 2012. Women joining the trial are allocated at random to either HRT or a placebo pill. Throughout the UK, over 400 general practices, who are part of the MRC General Practice Research Framework, are helping with WISDOM. The WISDOM trial is a major research project, which will eventually involve over 16,000 post-menopausal women in the UK and a further 6,000 from Australia and New Zealand. To date, 5000 women have been recruited in the UK (and 300 in Australia).

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

The WISDOM Data Monitoring and Ethics Committee is arranging to meet early in the week beginning 15 July 2002 to consider the implications of the results of the Women's Health Initiative for the WISDOM study. The recommendations and deliberations will be sent to the Trials Steering Committee who will also meet urgently to discuss and take a final decision about implications for WISDOM. The outcome will be announced once known.

The Women's Health Initiative (WHI), an eight-year study of the long- term effects of HRT involving over 16,000 women in the United States, has been stopped early. The full results of the study will be published in the Journal of the American Medical Association on 17 July and are currently available on the journal's website at www.jama.com.

The WHI's Data and Safety Monitoring Board (DSMB) recommended stopping the part of the study that involved comparing a combined oestrogen/progestogen drug with a placebo (inactive) pill. Women on the combined treatment were found to have a small but significantly increased risk of developing a number of conditions (principally breast cancer, but also heart disease, stroke and blood clots) and the DSMB felt that this risk outweighed the apparent benefits of the treatment (decreases in hip fracture and colorectal cancer). The other part of the study, which involves comparing an oestrogen only drug with a placebo in hysterectomised women, has not been stopped."

Pending the outcome of the Data Monitoring and Ethics Committee meeting, recruitment for the Australian arm of this trial has been suspended. All participants are currently being notified about these developments.

 

Contact Details

Emeritus Professor Alastair MacLennan
Email: alastair.maclennan@adelaide.edu.au
Website: http://www.adelaide.edu.au/directory/alastair.maclennan
Head, Cerebral Palsy Research Group, Robinson Research Institute
The University of Adelaide
Business: +61 8 8313 1337
Mobile: +61 (0)400 383 144


Professor Nigel Stocks
Email: nigel.stocks@adelaide.edu.au
Head, Discipline of General Practice
School of Population Health
The University of Adelaide
Business: +61 8 8313 3462
Mobile: 0424 260 394


Professor Paul Komesaroff
Department of Medicine
Monash University, Melbourne
Mobile: 0417 55 26 59


Professor Dimity Pond
Discipline of General Practice
University of Newcastle
Business: +61 2 4968 6730


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Mr David Ellis
Email: david.ellis@adelaide.edu.au
Website: http://www.adelaide.edu.au/news/
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