23 July 2002



 U.K. Hormone Study to Proceed


  When a huge U.S. study of hormone drugs was called off 2 weeks ago, women health experts wondered whether an even bigger trial in the United Kingdom would be halted as well. Apparently not. Unconvinced by the results from the U.S. study, the steering committee decided last week to forge ahead. Some U.S. 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 U.S. study is part of a big research program called the Women Health Initiative (WHI). More than 16,000 women had been enrolled in a trial that tested a combination of estrogen and progestin. Millions of women take these hormones to counter menopausal symptoms such as hot flashes and insomnia, or to prevent chronic diseases, such as osteoporosis and heart attacks. On 31 May, the panel independent data and safety monitoring board (DSMB) concluded that increased risk of breast cancer caused by hormones had crossed a pre-established line, and it stopped the trial (ScienceNOW, 9 July). The study had also found that hormone replacement therapy hiked the risk of heart disease and stroke, although it cut chances of bone fractures and colorectal cancer.

The DSMB for the British study--the Women's International Study of long Duration Oestrogen after Menopause (WISDOM)--does not dispute the increased risk of breast cancer and stroke. Both these risks were expected to rise 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 unconvinced by the increase in heart disease observed in WHI trial, he says--especially because this finding was unexpected and contradicts earlier studies. As a result, the balance between risks and benefits is still uncertain, says Gray, and it ethical to keep enrolling women.

What unclear is whether the WHI outcomes will stunt future recruitment for the trial. WISDOM has enrolled 5000 British women so far but aims to recruit 17,000 more in the United Kingdom, Australia, and New Zealand. All current and future WISDOM participants will be told about the U.S. results, says Oxford epidemiologist Rory Collins, who chairs the trial steering committee.


Related sites
Press release about the decision to continue WISDOM
More information about the WHI study and the reasons it was stopped
JAMA paper describing the results from WISDOM


 © 2001 by the American Association for the Advancement of Science.