In another blow to the long-term hormone therapy prospects, the Medical Research Council UK (MRC) today set a term to a large British study planned to enroll at least 20,000 women. The decision is a direct consequence of the judgment of a similar trial in the US there are 3 months, which found that the benefits of the same combination of hormones outweigh the increased risk.
Researchers have long debated the pros and cons of "replace" hormones decline in postmenopausal women with pills. To the surprise of many, the National Institutes of Health recently decided to stop an important part of the Initiative for Women's Health (WHI), which tested a combination of popular hormone called Prempro. An interim analysis showed that hormones increased the risk of heart disease and breast cancer more they reduced the chances of osteoporosis, bone fractures, and colorectal cancer ( Science NOW, the July 9).
Initially, the leaders of the international study of long duration estrogen women after menopause (WISDOM), which began in the UK in 1999, said trial could continue. The results of the WHI have left enough room for scientific doubt, they argued, to continue the enrollment of women ( Science NOW, July 23). But two weeks later, the MRC Council overturned this decision and asked an independent committee to examine more closely. Now, that group concluded that WISDOM should stop too. The study of $ 32 million was already years behind because the enrolled women have proved much more difficult than researchers had thought, said the Chairman of the Committee, Ray Fitzpatrick of the University of Oxford. In addition, the results not expected before 2016, were unlikely to differ much from those of WHI, he said.
WISDOM researchers are "very disappointed" Janet Derbyshire, director of the MRC Unit for clinical trials, wrote in a press release. Richard Gray, who chaired the WISDOM of monitoring data and the Ethics Committee, called the "premature" decision. It is very unlikely that anyone will fund a similar randomized trial of hormone therapy in the future, he said, which means that questions about its effectiveness persist.
But WISDOM would continue ethically questionable, given the results of previous tests, says Elizabeth Barrett-Connor of the University of California, San Diego - and the increased risk would have made recruiting participants even more difficult. "It is simply not a glimmer of hope."
Related Sites
MRC press release about the decision, additional information about WISDOM
Learn more about the health of women stopped Initiative trial
of in the paper Journal of the American Medical Association with the results of the WHI study
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