Page 1 of 7I want to begin by spending some time looking at the WHI (Women's Health Initiative) because we have a problem in this country, and that stems from the fact that when you hear in the media, and at this point this is not just the media that is responsible for this with the WHI, it was the responsibility of the authors of the study who fed the media the information.
They used two words that really upset me, and those two words are women and hormones. I hope that you will understand by the end of this commentary, that this is not a study about women, and it's not a study about hormones. So with that in mind, let's move ahead and see what the study is actually about.
The WHI study was a randomized, controlled study primary prevention trial. Now the question being a primary prevention trial is the key to this, and we'll look at that in a moment. This was the study of 16+ thousand women, ages 50 to 79. It was a planned trial of 8 1/2 years. We were told that the study was stopped because there was an increase in breast cancer and along with that, which was expected, there was also an increase in "cardiovascular disease."
To begin with, is this the study of hormones? The answer, no.
This is a Prempro study. Prempro in this study, consists of the oral estrogen and progesterone (medroxy-progesterone acetate, MPA), which is the single most potent progestogen that we have in this country. The question is: since Prempro was the only form of HRT studied, is it even possible to extrapolate from the WHI study, the potential for risk using the other kinds, other modes, and other delivery systems of hormone replacement therapy. MPA is a synthetic progestin that is 35 times more potent than progesterone. The potency of progestin is very important, because we use it to protect the lining of the uterus, the endometrium. How does it do that? It down-regulates the estrogen receptor. While the benefits of a good, potent progestin to down-regulate the estrogen receptor and protect the endometrium are well known, the concomitant down-regulation of the estrogen receptor in the brain, the bone, the genitalia, the skin, the eyes, is what leads to the hot flashes, memory and mood changes, vaginal dryness, dry skin, etc.
The next question: was this a primary prevention study? Answer, no.
Approximately 70% of the women were between the ages of 60 and 79. Of this, 1/3 were hypertensive, 1/2 were smokers, and 1/3 were obese. While these women hadn't had MIs before, they certainly were at higher risk for this. So the question is, if this is a primary prevention study, why did they do this study on much older women? The answer, if you really want to show an impact, you want to show it on women at higher risk for these problems. So it makes sense that these were the women chosen as the study population. But therein lies the problem- you can't extrapolate the findings from this study population to the women in their mid fifties that are showing up to their doctors office in hoards. Now, some would say, well, if 2/3 of the patients were between 60 and 79, that means that 1/3 were between the ages of 50 and 59, and so that's a pretty fair study. Let's take a look at that. You see, approximately 1/3 were between the ages of 50 and 59 but far more importantly, 63% of these women were between 10 and 25 years postmenopausal. In fact, they averaged 12 years postmenopausal and that is before having taken any medication. Now, how does that impact the coronary heart disease outcome? In this study, the only statistical significance for coronary heart disease appeared at or after 20 years postmenopausal.
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