When a large US study of hormonal drugs was canceled two weeks ago, the women's health experts questioned whether an even larger trial UK would be arrested as well. Apparently not. Convinced by the results of the US study, the steering committee decided last week to move forward. Some American researchers criticize the decision, arguing that it puts participants at unnecessary risk. "It may be good for science," says epidemiologist Curt Furberg of Wake Forest University in Winstom-Salem, North Carolina, "but patients will pay the price."
The US study done part of a large research program called Initiative on women's health (WHI). More than 16,000 women were included in a trial that tested a combination of estrogen and progestin. millions of women taking these hormones to counter symptoms of menopause such as hot flashes and insomnia, or to prevent chronic diseases such as osteoporosis and heart attacks. on 31 May, the independent data and safety monitoring board of the board (DSMB) found that breast cancer increased risk caused by hormones had reached a pre-determined line, and he stopped the trial ( Science NOW, July 9). the study also found that hormone replacement therapy increased the risk of heart disease and stroke, even if it reduces the chances of bone fractures and colorectal cancer
the DSMB for the British study -. international study of long duration estrogen women after menopause (WISDOM) - does not dispute the increased risk of breast cancer and stroke. Both were expected to increase these risks on the basis of previous studies, says statistician Richard Gray of the University of Birmingham, U.K., who chairs the panel. But Gray panel is convinced by the increase in heart disease observed in the WHI trial, he said - especially because this finding was unexpected and contradicts previous studies. Consequently, the balance of risks and benefits is still uncertain, said Gray, and it is ethical to keep female enrollment.
It is unclear whether the results of the WHI will delay future recruitment for the trial. WISDOM has recruited 5,000 British women so far, but aims to recruit 17,000 more in the UK, Australia and New Zealand. All current and future WISDOM Participants will be informed of the results of the United States, said Oxford epidemiologist Rory Collins, who chairs the trial steering committee.
Related Sites
Press release on the decision to continue WISDOM
More information about the WHI and why he was arrested
JAMA paper describing the results of WISDOM
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