HRT and the WHI study

http://www.imsociety.org/PDF/news_guides.pdf

Yesterday, I completed a two day review of psychopharmacology given by the University of Arizona Medical School. Dr. Elizabeth Lee Vliet presented two topics. the first was: "After the WHI: Rational Hormone Therapy Options and Approaches to Minimize Interactions with Psychotropic Medication." The second topic was : "Obesity in Women: Hormone, Nutritional and Medication Issues Affecting Responses to Weight Loss Programs."

Dr. Vliet practices at HER PLACE. Offices in Tucson and Dallas. You can read about her services and publications at " target="_blank">www.herplace.com

I founder her intelligent, warm, and empathic to the needs of women.

I was going to summarize her presentation for the review of WHI study. As many of her comments came from Executive Committee of the International Menopause Society, I decided to give you the reference and then hang out for discussion.

If you are female and 45 or over or if you love a female who is 45 or over, please go to the site and read the summary. Many, many American doctors and their patients are being misled by the WHI and will miss a chance for a happier, healthier life after 45 because of this piece of faulty research. Two weeks ago, I took a seminar in gerontological assessment and dementias. The author referred to this study and the effects of hrt as being of little or no value to brain health. After several minutes of agruing on the merits of the research, I gave up out of courtesy to the speaker--after all I was there to review assessment. So read the study and be prepared to take better care of the women in our lives.

THe WHI study was on eof the of the poorest reported and panic laden stduies that i have read in a long time. It is hard to know where to start. MY interest is primarily in the estrogen alone study portionof the protocol since that is what my wife is on, HOWEVER, she is not taking horse urine derived hormones but rather menest a naturally derived hormone. She also is only taking 1/2 the recommended dose(one half of a .625mg pill per day) since that is all that is required for symptomatic relief and , finally, she is nowhere the minimum age reported in the study of 65.

jb

btw, i would love to hear your synopsis DOc.

jb

The WHI and the Heart and Estrogen/progesterin replacement study(HERS) was intended to be a ten year study of how hrt could help health women who were just becoming symptomatic of menopausal. Woman who had a hysterectomy were to receive estrogen alone and who had not had a hysterectomy received estrogen and progesterin. This was a hugh study involving over 16000 women and a stratified randomized design to assess benefits in the cardiovascular desease, cancer, and osteoporosis.

--this was interpreted as a test of an entire class of intervention, rather than a test of the two medications used in fixed doses. Conjugated equine estrogens (CEE) and medroxyprogesterone acetate (MPA) in fixed doses were used. This fails as a test of the class of intervention as alternative meds were and are available. Further, the dosing was insensitive to need--everyone got the same. The dosing was of a size appropriate for much younger women.

--the women were not healthy. Ovr 30% had high blood pressure, were overwieght or obese. Over 10 % were on medication for CHO, had a family history of breast cancer.

--the average age was 63 and almost 30% were over 70.

--the interventions were limited to oral medications. This then involves "first pass" problems with the liver. Topicals and patches were and are available which avoid this issue.

--despite what was released to the press early on with the termination of the CEE/MPA arm of the study, the estrogen only arms resulted in deceased risk of hip fractures, no increase risk of breast cancer, no increase risk of a corinary event. The increase risk of stroke was prevelant in both arms of the study. However, this may be more attributable to age alone.

My comments would not be complete without some observations about what could have been accomplished under a better design or even analyses with the given design.

with the current design: this is a very expensive piece of research. Given the size of the samples, I would go back and start to examine partial correlations. I would use multivariate analyses to statistically define "success" and "failure" at both ends of the entire population of women studied regardless of which treatment cohorts they were assigned. Success and failure could be either singularly or multiply defined relative to outcomes. Once these factors were defined, I'd then go back and re-examine the statistical weight of each intervention or sample characteristic. Believe it not, there were women whose health was improved--I'd want to know how or what made the difference.

with a more sensitive design: get the age appropriate women to target. Evidently the new Kronos study will do this. I'd vary the type of substances used (synthetic vs. bioidentical), the doses used, the methods of delivery(oral, topical, vaginal, and IM). I'd take an additional sample that is comparable to the WHI and HERS and include them with some of same sensitivity to route of administration and individualize dosing as suggested above. Finally, and this is beyond what any researcher would conceive, I'd go back to women in both arms of the WHI and HERS with an offer of more individualized dosing and differnet routes of application.

quote:

---

Yesterday, I completed a two day review of psychopharmacology given by the University of Arizona Medical School. Dr. Elizabeth Lee Vliet presented two topics. the first was: "After the WHI: Rational Hormone Therapy Options and Approaches to Minimize Interactions with Psychotropic Medication." The second topic was : "Obesity in Women: Hormone, Nutritional and Medication Issues Affecting Responses to Weight Loss Programs."

---

Do you have any references about what Vliet said in that second presentation? Thanks.

I recently relocated most of my printed files. So I cannpt put my hands on what you requested. This is Dr. Vliet's site

http://www.herplace.com/

well, low and behold, a new analysis of the WHI showed lower rates of breast cancer for the women on estrogen. There is no change in the findings of the women on estogen and progestins. Remember, the authors used progestines not progesterone. Progestines are artificial progesterones.

http://www.eurekalert.org/pub_relea...a-wua040706.php

the original publications really pissed me off when they threw a whole class of women on hrt into a panic calling their doctors when after a careful read it was found not to apply to the mono hormone therapy. this of course is good news for thousands of women, my wife included, who use estrogen only .

jb

my wofe has been on bioidentical HRT which includes estrogen, progesterone, and testosterone, thyroid,. and HGH for about a year. She has had a very difficult winter with asthma and allergies. She has been unable to exercise since Thanksgiving. She is just starting to hike and bike again. However, her blood and urine value and all other aspect her "well woman " check up are ideal. Her HDL was 60! Her BP is ideal--even with a family hx of hypertension.