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The Right Thing continued...
Lawrence Phillips, MD, principal investigator at the Emory University site of the Women's Health Initiative, says the NIH did the right thing.
"It is pretty clear the NIH and the WHI investigators have bent over backward to put the participants in the study first. That is important," Phillips tells WebMD. "The government needs to be applauded for doing it right. They made the decision that there wasn't any point in putting anybody at risk when there was nothing more to learn."
No Change in Treatment Needed for Women on HT
The study results will be published in a medical journal in about two months. Meanwhile, Phillips says, there's no reason for any woman to change her therapy until these results come out. Phillips' comments to WebMD represent his own opinions and do not represent official statements from the WHI.
"One of the messages that needs to be understood is this is one form of estrogen and one group of women. It may or may not apply to all estrogens and all women," Phillips says. "These women had an average age of 63 when they started the study. That is somewhat older than the age at which estrogens usually are started. When the data becomes available, we will have to look closely to see how to get the best translation for an individual patient."
Indeed, the women enrolled in the WHI trial are not like most women who begin menopausal hormone therapy these days. Study participants were not taking HT to fight serious symptoms of menopause, but to try to improve their long-term health. That didn't work, but there's still broad agreement that hormone therapy is the most effective treatment for women with severe menopausal symptoms.
"The lesson of WHI is that HT should not be given for quantity of life. It has always been intended for those who need help with the quality of their lives," Robert Rebar, MD, executive director of the American Society for Reproductive Medicine, tells WebMD.
The NIH advises women to follow FDA recommendations on hormone therapy. That advice: To discuss the risks and benefits of menopausal hormone therapy with their doctors. Hormone therapy is the only truly effective treatment for severe menopausal symptoms. But because of the risks, the FDA and drugmakers recommend using it at the lowest effective dose for the shortest possible time.
Indeed, Wyeth's Premarin and Prempro -- the estrogen and estrogen plus progestin drugs used in the WHI study -- are now sold at doses half as strong as those used in the trial. Victoria Kusiak, MD, Wyeth's North American medical director, says patients should try the lowest dose first. While these lower doses do help relieve hot flashes, the risks are largely unknown. Wyeth is a WebMD sponsor.