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Long term HRT trial stopped early

A second trial looking into the long term effects of hormone replacement therapy (HRT) has been stopped early. The UK Medical Research Council (MRC) announced recently that a decision had been taken to halt the women's international study of long duration oestrogen after menopause for scientific and practical reasons.

Long term HRT trial stopped early

A second trial looking into the long term effects of hormone replacement therapy (HRT) has been stopped early. The UK Medical Research Council (MRC) announced recently that a decision had been taken to halt the women's international study of long duration oestrogen after menopause for scientific and practical reasons. The trial, was due to be completed in 2016. The researchers were 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. In July one part of the US women's health initiative (WHI) study, a similar trial involving more than 16,000 women, 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. The WHI's data and safety monitoring board concluded that these risks outweighed the decreased rates of osteoporotic fractures and bowel cancers. But the other part of the WHI study, comparing the effects of oestrogen alone with placebo in women who have had a hysterectomy, is still ongoing. The trial aimed to include 16,000 postmenopausal women from the United Kingdom plus 6,000 from Australia and New Zealand, but it had recruited only 5,700 women with the relevant criteria since 1999. According to a statement issued by the MRC the IIC (Independent International Committee) was concerned by the slow progress of the trial and considered that the results of the trial, which would not be available for another decade, would be unlikely to influence clinical practice. Further, trials looking at the timing and type of HRT would pose logistical difficulties because of the numbers of women required.

BMJ November 2002, Vol. 325 (7371)
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