Hormone debate renewed

[Guest guest]

I do not know, but if this new study is true to form, it will be structured to

prove what they want it to prove.

 

Up pops this foundation who just happens to be interested in " health care

issues " . I'll bet it isn't for altrusitic reasons.

 

Frank

 

 

http://www.biomedcentral.com/news/20031010/07

 

October 10, 2003

 

Hormone debate renewedA privately funded trial seeks to challenge conclusions of

the government study that gave HRT a bad rap | By Tabitha M Powledge

 

 

Researchers who want to reopen the question of whether hormone replacement can

stave off heart disease in middle-aged women say they have secured $12 million

to fund a pilot study that will begin next year. The study design differs from

the protocol used by the Women's Health Initiative (WHI), the 16,000-subject

clinical trial of postmenopausal hormone replacement therapy (HRT) that the

National Institutes of Health (NIH) shut down in July 2002, 3 years early.

 

The WHI data monitoring committee had concluded that small increases in breast

cancer, coronary heart disease, stroke, and pulmonary embolism were showing up

in the treatment group. Researchers mounting the new 5-year study hope its

results will be quite different. They say that animal work, observational human

studies, and even some data from the WHI itself suggest that other approaches to

HRT might yield cardiovascular benefits.

 

The group's aim is to persuade the NIH to fund a " WHI revisited " study—a big

clinical trial that looks at the risks and benefits of another sort of hormone

replacement in younger women, according to S. Mitchell Harman, director of the

Kronos Longevity Research Institute in Phoenix, Ariz., which is organizing the

new trial. " We want to provide groundwork that shows that estrogen given early,

at the menopausal transition, retards development of atherosclerosis, " he said.

 

The Kronos study plans to recruit 900 women between 45 and 54, much younger than

WHI subjects, who averaged 63 when they began taking hormones. Harman

acknowledged that recruiting study subjects will likely be a problem because of

the bad press HRT has received since the WHI's termination. The government now

recommends only short-term HRT, prescribed only for menopausal symptoms such as

hot flashes.

 

The new study will also use a different regimen than the WHI, which investigated

only Prempro. An oral compound taken daily, Prempro combines horse estrogens and

medroxyprogesterone acetate, a synthetic with some progesterone-like actions but

a different chemical structure. The Kronos group wants to compare transdermal

estradiol, the estrogen made in the human ovary and delivered continuously

through a skin patch, with oral estrogen and a placebo.

 

The estrogens will be combined with a progestogen, probably natural progesterone

administered intermittently, Harman told The Scientist. Progestogens are

incorporated into HRT to prevent uterine cancer, a possible side effect of

estrogen by itself. Final decisions about the protocol will be made by January

of next year, Harman said. The study will be funded by the Aurora Foundation, a

private foundation in Phoenix that is interested in health care issues.

 

" I suspect the sample size is too small. They only will have 300 women per

group, and with women this young, I doubt they'll see either benefit or risk, "

said Marcia Stefanick of Stanford University, a WHI principal investigator.

" There's value in the study, but they're not going to answer a question that the

WHI didn't answer. "

 

The study is valuable, she told The Scientist, because it will involve imaging

the carotid and coronary arteries in relation to hormone replacement and heart

disease, which has not been done before, and because it will study estradiol

delivered by skin patch. Some authorities believe transdermal estrogen may be

less harmful because it does not pass through the liver like oral estrogen. " I

agree with these folks that we need a lot more information about menopause and

dealing with menopausal symptoms, " Stefanick said. " What I don't think is that

this study is going to reverse any of our thinking about the role of hormones in

preventing heart disease. "

Links for this article

T.M. Powledge, " Hormone researchers revolt, " The Scientist, August 22, 2003.

http://www.biomedcentral.com/news/20030822/01/

 

S. Veggeberg, " NIH Women's Health Study takes a giant step forward, " The

Scientist, 6:0, November 23, 1992.

http://www.the-scientist.com/yr1992/nov/veggeberg_p1_921123.html

 

S. Mitchell Harman

http://www.kronosinstitute.org/Biographies/harman.html

 

 

 

 

 

 

 

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