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Observations:
Bio-identical Hormone Replacement Therapy


[Editor]:
Menopause:
For forty years, women enjoyed relief from the multitude of menopausal symptoms (hot flashes, flushes, mood swings, insomnia, lack of libido, vaginal dryness, inablity to focus, lack of energy) by taking various prescription hormonal replacement therapies, predominantly Premarin/Provera conjugated equine estrogen(CEE)/medroxyprogesterone acetate (MPA). Then in 1991 through 2002 a billion dollar, government backed, long-term study called the Women's Health Initiative (W.H.I.) by Wyeth-Ayerst revealed that older women (average age 68) who took Premarin®/CEE (conjugated quine estrogens (mixed estrogens from horse urine) and Provera®/meproxyprogesterone acetate (MPA) had an increased risk of breast cancer. The fear drove 75% of women away from taking hormone replacement therapy (HRT). The sales of tranquilizers, antidepressants, Selective Estrogen Receptor Modulators (SERMs), and other prescription medications increased in response.

Then in 2004, the second arm of the W.H.I. was published showing that the incidence of breast cancer was 33% less than placebo in the group who took only estrogen. The British study showed that replacing Provera® with Aygestin®/norgestrel had no increase in breast cancer compared to placebo.

Clearly, Provera®/MPA was the primary culprit. But, although the F.D.A. stopped the study, and the study participant average age was 68, not the typical 50, they approved Premarin®/Provera® (Pempro®), albeit, in lower doses, to be taken for a 'few' years.

The Nurses' Study had a subset of women who used bio-identical estradiol patches, and they fared better than the CEE/MPA group. And why would a woman refuse estrogen when 10-years post-hysterectomy/oophorectomy the women on no HRT experience 2.2 times the incidence of heart disease? Twenty years later, the no HRT experiences up to 20 times more Alzheimer's Disease not to mention the much greater incidence of osteoporosis? these women all the time face the symptoms of hot flushes, insomnia, forgetfulness, lack of energy, loss of libido, vaginal and skin dryness and urinary urgency/ bladder incontinence?

*Estrogen preparations
1. Not bio-identical: Premarin® and Ogen® tablets, Premarin® vaginal cream
2. Bio-identical estradiol (E2): Estrace®/estradiol tablets, Vagifem®/estradiol vaginal tablet, Estrace®/estradiol vaginal cream, Minvelle®/ Vivelle®/ Climara® estradiol patches
3. Bio-identical Estrone (E1) and Estradiol(E3): The post-menopausal women derives her predominantly estrone from adrenal conversion of DHEA. Estriol is only normally present in trace amounts except during pregnancy when predominates. Compounding pharmacies can prepare mixtures of E2, E1, and E3 which may relieve symptoms. But as will be further explained, the topical preparations are rarely given in dosages that significantly affect the extensive disease of untreated menopause.

Note that compounded estradiol cream, equal in strength to Estrace® or Premarin®, will cost one-fourth as much.

2. Progesterone: Natural progesterone is available over-the-counter and by prescription. The commercial product is Progesterone®/progesterone and the vaginal product Crinone®/progesterone. Compounded progesterone is usually 4%; over-the-counter products vary. The problem with progesterone is that a good percentage of women with an intact uteri will spot or menstruate. that is why progesterone is given every day and the gynecologist must explain that this can be expected. When in doubt, an ultrasound can measure the thickness of the endometrial lining. Less than 5mm predicts that there is no cancer or urgency.

The question is 'Should women who have had a hysterectomy take progesterone? This is a matter of her choice, as some report better sleep cycles.

*DHEA. DHEA is considered by Labrie as the hormone that is necessary inside every cell. Only 17% of DHEA converts to testosterone; only 14% converts to Estrone. With such small rates of conversion, the measurements of serum estrogens will be very low.

*Testosterone. Testosterone has been combined with CEE for almost 50 years as Estra-Test®; now avialable as Covaryx®. Testosterone can offer the woman more energy, libido, mental focus, less depression and less osteoporosis as she ages. Testosterone can be compounded in the creams and in Europe is available as a patch, Intrinsa®. Testosterone pellets are available as Testopel®/75mg and compounded. Only Covaryx®/CEE-methyl testosterone, is routinely covered by insurance. Note that methyltestosterone in not bio-identical; only testosterone in creams and pellets.

Focus Point:
At issue is the dosage. If one follows the F.D.A. low dose Prempro® or the typical mixture of compounded BHRT creams, the pituitary pre-hormones, Follicle Stimulating Hormone (FSH) and Luteinizing Hormone (LH) are not suppressed. Failing this, the woman may still have the same risks of heart disease, osteoporosis, Alzheimer's Disease as a woman doing no H.R.T. The fact that she feels better is positive, but not therapeutic.

In conclusion, if the FSH and LH return to premenopausal levels, the therapy of bio-HRT is complete.

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