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Women's Health Initiative begins 2nd phase


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BETHESDA, Md. -- Yoga instructor Gail La Mar, one of 161,000 women who volunteered for a landmark government-sponsored initiative to study postmenopausal women's health, got right to the point.

"This is a legacy, but I like to think of it as maybe a jumping-off spot, too," La Mar, of Half Moon Bay, Calif., told the audience Wednesday at a National Institutes of Health conference on the effect of the Women's Health Initiative.

La Mar was one of more than 27,000 women who volunteered to be randomly assigned to hormone therapy or a placebo. Other components of the Women's Health Initiative were trials testing a low-fat diet and calcium and vitamin D supplements and an "observational study" that followed women who were not asked to make any changes in their normal routine.

The two-day meeting marked the end of the first chapter of the initiative and the launch of the second.

Although they have stopped taking their study pills, about 80% of eligible participants have signed up for a five-year extension that will end in 2010, said Jacques Rossouw of the National Heart, Lung, and Blood Institute.

During the follow-up period, the women will continue to provide information about their health.

Rossouw, who is project officer for the initiative, said he is interested in looking at the longer-term effects of a low-fat diet on breast cancer risk.

Overall, the initiative found a 9% decline in breast cancer risk among women asked to cut their fat consumption to 20% of calories, compared with those asked to continue eating their normal diet. But the finding wasn't statistically significant because it was so small, it could have been a result of chance.

However, Ross Prentice, lead scientist for the Women's Health Initiative's coordinating center at the Fred Hutchinson Cancer Research Center in Seattle, said the 9% reduction was greater than expected, given that there wasn't a huge difference in fat intake between the two groups.

The decline in breast cancer risk was more pronounced in women who initially consumed more fat at the start of the study and in those who stuck to the program. These findings suggest that a low-fat diet protects against breast cancer but don't settle the controversy, Prentice said.

The heart, lung and blood institute also has allocated $35 million for research involving the tens of thousands of blood samples and other biologic specimens collected from Women's Health Initiative participants. The specimens promise to yield a wealth of information about interactions among genes and between genes and the environment, he said.

"The study is poised to capitalize on the huge advances that have been made in the field of genomics," Rossouw said. "The best may be yet to come."

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