WISDOM Trial Stopped Early

A second trial looking at the long term effects of hormone replacement therapy (HRT) has been stopped early.

The UK Medical Research Council (MRC) announced last week that the Women’s International Study of long Duration Oestrogen after Menopause (WISDOM) had been stopped early due to ‘scientific and practical reasons’.

The trial has cost 10m Pounds (US$15.5m; Euro 15.9m) and was due to be completed in 2016.

WISDOM was investigating the long term effects of oestrogen combined with progestogen and of oestrogen alone on the incidence of, among other diseases, cardiovascular disease, breast cancer, dementia, and osteoporosis.

A similar trial in July by the US Women’s Health Initiative (WHI) was stopped early after a small increased risk of breast cancer, cardiovascular disease, blood clots, and stroke was found among the women taking the combined form of HRT.

Involving more than 16,000 women, the WHI’s data and safety monitoring board concluded that the risks outweighed the decrease rates of osteoporotic fractures and bowel cancers, however the other part of the study, comparing the effects of oestrogen alone with placebo in women who have had a hysterectomy is still ongoing.

WISDOM had aimed to include 16,000 postmenopausal women from the UK plus 6,000 from Australia and New Zealand, but it had recruited only 5,700 women with the relevant criteria since 1999.

Ray Fitzpatrick, professor of public health and primary care and director of the Institute of Health Sciences at the University of Oxford, said, ‘The IIC (independent international committee) was concerned by the slow progress of WISDOM and considered that the results of the trial, which would not be available for another decade, would be unlikely to influence clinical practice.’

Philip Hannaford, professor of primary care at the University of Aberdeen, said that further trials looking at the timing and type of HRT would pose logistical difficulties because of the numbers of women required.

For more information about the WHI trial, click on the Institute for Scientific Information (ISI) and HighWire (Medline) links above.

(Source: British Medical Journal)