WISDOM ends - funding withdrawn for HRT study

Thursday, 24 October 2002

The Medical Research Council (UK) has decided to withdraw its funding for the world's longest and largest trial of hormone replacement therapy, called WISDOM (Women's International Study on long Duration Oestrogen after Menopause).

The decision was made this week by the MRC, which is the main funding body for WISDOM, despite recommendations by the trial's data monitoring and steering committees that it was ethical and scientifically valid to continue the trial.

WISDOM was put on hold in July this year to further evaluate the premature end of a similar American trial of combined oral oestrogen and progestogen HRT when more adverse outcomes than benefits were reported. The American trial's oestrogen-only arm continues, but both HRT arms of WISDOM are to stop.

"There are now no ongoing quality trials to evaluate the safety and value of long-term combined HRT," says the leader of the WISDOM research team in Australia, Professor Alastair MacLennan (Department of Obstetrics & Gynaecology, University of Adelaide).

"Sadly we shall probably never truly know the risks and benefits of HRT beyond five years of use."

The US trial had shown an extra risk of breast cancer after five years of combined HRT in eight out of every 10,000 women, which was matched by a similar decrease in bowel and uterine cancers. The US trial had recruited relatively elderly women, who also had other risk factors for established blood vessel disease, and they showed a trend towards more heart attacks and stroke on combined HRT.

WISDOM had been recruiting younger and healthier women with less chance of established heart disease to test the hypothesis that HRT may prevent cardiovascular disease before it becomes established. Other putative benefits of HRT that now may never be confirmed are a possible reduction in dementia, urinary problems, arthritis, and skin problems, and improvement in long-term quality of life, Professor MacLennan says. Similarly, long-term risks cannot be evaluated.

"HRT has proven its usefulness in the control of menopausal symptoms, and it is also well proven to be effective in prevention and treatment of osteoporosis," Professor MacLennan says.

The US trial confirmed a reduction in the risk of osteoporotic fractures after five years of combined HRT, but the probable increased numbers of fractures that would be prevented by this therapy after 10 years of therapy will now never be known, he says.

Professor MacLennan has contacted the 1120 Australian women who had entered the WISDOM trial to notify them of its cessation.

"We are now unwinding an elaborate community research structure which had been enthusiastically supported by general practitioners in Adelaide, Melbourne and Newcastle, and had been awarded grants from the Australian NHMRC, the National Heart Foundation of Australia, the Cancer Council (South Australia) and the Australasian Menopause Society.

"WISDOM had intentionally only sought independent funds to assess HRT," Professor MacLennan says, "and we have deliberately not sought funding for the trial from the pharmaceutical industry."

The total cost of the 15-year trial involving 22,000 women in Australia, New Zealand and the UK was estimated at $AUD 100 million. The bulk of this funding was to have come from the Medical Research Council (UK).

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