Study of Hormone Replacement Therapy

ADELAIDE University has been awarded the Australian arm of a major international study to examine the long-term effects of hormone replacement therapy (HRT).

The study is arguably the world's biggest and longest randomised clinical trial, stretching over 22 years and involving 36,000 women internationally.

The Medical Research Council in the UK has already awarded more than $1 million to the Adelaide research team, with a further $10 million to follow. The team is headed by Associate Professor Alastair MacLennan (Department of Obstetrics & Gynaecology) and Professor John Marley (Department of General Practice).

The project, known as WISDOM (Women's International Study of long Duration Oestrogen after Menopause), will see the Adelaide team joining an international effort to study up to 36,000 women aged 50 to 69 years.

These women will receive 10 years of treatment and will be followed up for a further 10 years. All types of outcomes will be assessed, including quality of life, heart attacks, fractures, dementia, cancer and even death.

"Such a large trial is necessary to inform women throughout the world whether or not they should take long-term oestrogen replacement therapy after menopause," says Dr MacLennan, the chairman of WISDOM Australia.

"Although the benefits of postmenopausal HRT are well established in the short-term for the control of menopausal symptoms, such as hot flushes, there are no quality trials of the benefits and harms of long-term HRT," he says.

The possible benefits of long-term HRT include the prevention of heart disease, osteoporosis, dementia, urogenital atrophy and some types of blindness, arthritis, skin disorders and even tooth loss.

However, possible harms also remain a risk, such as increased rates of blood clotting disorders (thromboembolism), cancers and gall bladder disease.

"The relative rates of these potential long-term outcomes cannot be assessed without a long-term randomised clinical trial where volunteers randomly receive either HRT or a placebo [a dummy tablet]," Dr MacLennan says.

Currently the only evidence about the long-term benefits and risks of hormone replacement therapy comes from less reliable observational studies, he says.

"A large, long-term trial that can eliminate all biases is necessary to understand the true benefits, risks and cost of taking or not taking HRT for many years after menopause.

"This will be a landmark trial in women's health, and Australia will make a major contribution to this international research having secured significant overseas funding for the trial," he says.

A further $10 million in funding will be provided to the Adelaide team once enough Australian women are enrolled in the study. In addition, further funding is being sought from the National Health & Medical Research Council in Australia.

Dr MacLennan says postmenopausal women in South Australia aged 50 to 69 will be contacted over the next 18 months by their general practitioner with the offer of further detailed information.

MEDIA CONTACT

Associate Professor Alastair MacLennan; business hours - page him on (618) 8204 7000; or call after hours on (618) 8338 1419; or email - [email protected]

A photograph of Dr MacLennan is available on our Media Photos website: http://www.adelaide.edu.au/PR/media_photos/

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