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The Womens Health Initiative, a perspective re HRT
"How do you feel about the Women's Health Initiative Study and how do you council your patients?" - Moshe Dekel. M.D.

"This might be one of the ones, you know where the comedian keeps talking as the credits start to roll at the end of the show? I'll just start going and we'll see where this ends:" "The Women's Health Initiative Study has been profoundly interesting to me because it shows how well informed humans can screw things up. When the study came out and they started with their conclusion that was flaw #1 because it was designed as a Premarin and Provera study, and Premarin is a non-bio-identical substance, it has been around for years. So I will answer some of the other part of the question as we go. So here you have these two inferior products, now scientifically we have bio-identical products. Yet the people who designing this study insisted on proceeding with basically an equine derived array of 30 plus female horse hormones, and when they looked at their results and presented them, their overall conclusion was: "Premarin yielded these findings, therefore Hormone Replacement Therapy is not appropriate for women." That is truly, I think the intellectually equivalent to saying: Since Gentomicin does not treat strep pneumonia we should not use antibiotics to treat pneumonia. They went from a very narrow finding to a broad conclusion." Anton Dotson, M.D.

"There are some other issues here that are so important and are also well documented: That Premarin raises C-reactive protein significantly. This is documented throughout much literature. We all are reading the same things in the lay press and the medical press about some inflammatory issues being, if not the root cause, a strongly contributing cause to both Cancer and Heart Disease. There are studies primarily out of Europe: France and the Netherlands that looked at transdermal Estrogen and found no inflammatory response, no change in the C-reactive protein. So if we isolate the inflammatory (response which occurs in oral estrogens therapies, and Premarin is among the worst) from Estrogen, which does not cause an inflammatory response transdermally, we don't necessary come to the same conclusion at all. Our philosophy has been and is standing us in good stead, not only with patient results that we are not ready to release yet, and I don't even want to repeat them on the conference call. I will talk to the physicians individually regarding the number of cancers we have seen, which are a single digit and have no "s" on the end. As well as the number of heart attacks with have seen which are absolutely minimal, and are a fraction of the general population. We know that our philosophy of hormonal balance for hormones other than insulin and cortisol which we want to lower, at the upper end of the normal range for the patients age balanced so that all the hormones are working together the way they were designed to do like a symphony orchestra, we're going to get the best results. Men need Estradiol, and having adequate Estradiol levels in men is excellent. What we don't want to do is go above the 50, which is the upper number in the Estradiol range. Men should be in the 25-45 ranges. Men need estradiol just like women need Testosterone. As we get older we still need these hormones. As Anton said really bright people are jumping the gun on conclusions that really have no barring even when you analysis the data that they represent." - Alan Mintz, M.D.

"With the W.H.I. study, you could have predicted the outcome from the previous Premarin study. In studies where they were looking at risk for heart disease in the H.E.R.S. Study, they took retired nurses with known heart disease average age 52 and treated them with Premarin. In the first 1-3 years they had a higher incidence of M.I.'s. Patients who stayed on that program beyond the 8th year started to actually out perform women on placebo. So that's where that relative contraindication came in regarding pre-existing heart disease. When the W.H.I. study was organized, they did not prescreen for heart disease and their inclusion criteria were 50-year-old women. With out prescreening you're including a group of women with pre-existing heart disease & you could have predicted within that 1-3 years they would have seen a higher incidence, and that's what they did see, and they aborted the study. Also in terms of blood clots in the other studies it was age 52 and above before women instituted HRT that put them in as the only risk group for increased incidence of DVT, and here with the WHI Study they basically replicated a pre-existing starting group and got the same conclusion. What they didn't mentions is that the women on Statin drugs or on routine Aspirin each day had half the incidence of DVT as women who were on no HRT had. So when you look at the way the WHI was set up those finding were pre-ordained." -AD

"Ok, do I understand that you'd rather have them use a transdermal preparation than say the other oral preparation like say the Orthoprefast or phemhart et. - MD

"Correct Oral Estradiol supplementation is associated with a decline or a limitation of response with IGF-1 levels (Oral Estradiol supplementation causes a reduction in Growth Hormone-not something we would like to see). With topical preparations this is not seen. The difference was as much as 20% in one study. That it why we use that drug topically." -AD

"This is also the reason why, when women go on oral estrogens that they tend to gain weight. If you are lowering their growth hormone, then isn't that a possible reason why women tend to gain weight on Oral Estrogen? - AM

"Yes it's a possibility!" AD

"Now on the transdermal do you like just the estrogen preparation or do you add some progesterone to the cycle or do you like combination patch? - MD

I like Estradiol as a topical & Progesterone as an oral because it is bio-identical and it absorbs well, and we get great 100% correlation with dose and circulating levels." - AD

"Now do you like the conjugated progesterone better or say the prometruim?" MD

"I like the prometruim form, bio-identical micronized is fine." AD "And you use in on say an 11-12 day cycle?" MD

"Yes for women who aren't done cycling I'll do in on day 13-25 of their cycle. For fully post-menopausal women I will have them take is as a daily dose." -AD

"Of what? 200mg? - MD

"Our average dose is about 50mg each night. Maybe with 1/4 of the women we will go as high as 100mg per night. It is rare that a woman requires a higher dose than that to get an adequate Progesterone level. -AD

"OK are we talking about prometruim then? - MD "Yes Prometruim of if you can find it at one of the compounding pharmacies: Bio-identical progesterone, that's absolutely fine! - AD

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