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Study says pivotal hormone therapy trial was flawed

...But At the time of the WHI trial's design, hormone replacement therapy usually involved cyclical progesterone, meaning that it was taken just 10 or 12 days a month, he said.

But the daily combined drug was deemed more convenient because patients didn't have to remember which days to take a second pill and because it eliminated a monthly menstrual period, the researcher said.

"The results might have been different if they had used a different form of estrogen that resembled a normal cycle," Klaiber said.

The WHI study's other major flaw was that participants were older - the mean age was 62.7 - and thus at greater risk of cardiovascular problems.

"The incidence of heart disease is 12 times higher for women in their 80s than it is in the 50s," Klaiber said.

As a result, the WHI study began hormone therapy for the first time in women who already had heart disease, and "we know that's not a good idea," he added.

Klaiber believes that earlier studies showing that cyclical hormones are protective against heart disease are probably valid.

"One of the reasons we started giving estrogen to menopausal women was because of the gender differential - men have a lot more heart attacks and have them earlier," he said.

He is hopeful that a m...

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