Controversies in Bioidentical hormone treatment

Michelle Indianer, D.O.

 Some basic points that most people agree with are:
    to use an effective dose,
    use a reputable compounding pharmacy for compounded hormones,
    find a physician well versed in these treatments to prescribe them for you (including but not just a blood         test, a saliva test or a pharmacists recommendation)
    and use them for specific symptoms.

    Even though Bio-Identical Hormones are manufactured, therefore not "natural" in an absolute sense, the reason these hormones are called "bioidentical" is that their chemical structure is the same as those naturally occurring in humans. This is not a small point. Premarin (the Prem part of PremPro) is produced  (inhumanely in my opinion) from pregnant mares. The main problem with this is that our bodies don't have the correct enzymes to metabolize (break down) horse hormones, many of which remain in our bodies way too long. Many of these metabolites are toxic and can lead to cancer. The Provera part of PremPro is NOT progesterone. It is a progestin, which is quite different in it's effects on the body. Most of the adverse side effects in the Women's Health Initiative (WHI) study were due to the use of Provera portion of the PremPro. I have rarely seen women tolerate Provera even in small doses. Again this is not a naturally occurring hormone in humans and the metabolism of it also isn't the same. It is not progesterone replacement and should not be advertised as such.

    By using hormones that are identical to the ones our bodies naturally produce we can metabolize them and then they can be removed from our body without causing excessive harm. Should we still be cautious with their use? Of course. However to invalidate the differences is naive and dangerous. The commercial brands can be good to use and insurance will pay.  The commercial brand of progesterone can be given orally. Many physicians who prescribe bioidentical hormones use the commercial estradiol patches and Prometrium(tm) with great success. This is bioidentical hormone replacement essentially, although the dose can not be customized to the lowest effective level often.

    It is often said that there are no long term studies about the effectiveness of bioidentical hormone replacement besides the WHI. This is not the case. There are numerous studies that do differentiate between various forms of replacement therapy. These do indicate that Provera is a dangerous drug. It increases the risk for cancer and stroke. The WHI was stopped early mainly because of the negative outcomes for the women on PremPro. The women on Premarin only had a decreased incidence of deaths from all caused mortality. What all these studies show is that the longer patients are on real hormone replacement therapy the more positive benefits they obtain. These hormones help protect women's brains, bones, heart and skin. The overall statistics show that Estradiol (the most active form of Estrogen) has no effect on breast cancer incidence and Progesterone actually deceases the incidence of breast cancer. There is no therapy with as positive effect on preserving, and replacing bone as Estrogen. The second most effective treatment is Vitamin D (actually a hormone, not a vitamin). When people are placed on Fosamax and other bisphosphonates they continue to lose bones. Yet the average doctor is more likely to prescribe these for bone loss rather than the combination of bioidentical hormone replacement and Vitamin D. This is an important issue, as more women will die from issues related to Osteoporosis that will die from the combination of Breast, Uterus and Ovarian Cancer.

    As far as the types of estrogen, there is some controversy in the field, but most people agree that as we age we produce too much estrone, whose 2,4,and 16 Hydroxy Metabolites can become excessive or imbalanced. These metabolites are believed to be formed less when using a supplement of combined estradiol  with estriol. Importantly, many practitioners use DIM (a supplement derived from cruciferous vegetables such as broccoli) and other supplements to help the body metabolize the hormone replacements more rapidly and with a better balance. Some women also have problems with absorbing though their gastrointestinal tract or liver and get better results with transdermal forms of the medications, which can be individualized to much lower doses that are available commercially, especially in the case of progesterone and testosterone. 

Some recent research has indicated the mechanism for some of the Cardiovascular advantages of oral Estradiol. When this form of estrogen passes through the liver there is excreted an enzyme that dissolves plaque formation in the blood vessels. Unfortunately, if they are started after the plaque had had many years to form and has a necrotic (dead) core, the dissolving of plaque will release particles that can break off and cause strokes. So, the oral is best started early in menopause, and again continued for as long as possible. The one caveat would be that it shouldn't be used in a woman with a clotting disorder. One mechanism for the problems in the WHI is that the average age of the women in the study was over 65 who had more than 10 years passage since the onset of menopause, thus they also probably had a lot of unstable plaque ready to get dissolved and dislodged by the oral form of estrogen given to them.
There is no therapy with as positive effect on preserving, and replacing bone as Estrogen. The second most effective treatment is Vitamin D (actually a hormone, not a vitamin). When people are placed on Fosamax and other bisphosphonates they continue to lose bone minerals. Yet the average doctor is more likely to prescribe these for bone loss rather than the combination of bioidentical hormone replacement and Vitamin D. This is an important issue, as more women will die from issues related to Osteoporosis that will die from the combination of Breast, Uterus and Ovarian Cancer. Estrogen combined with progesterone can be essential in the proper uptake of calcium and correct rebuilding of bone. Do not forget the importance of adequate magnesium, boron and Vitamin D for bone health. (By the way, Fosamax , Actonel and similar drugs put calcium in the bone, but in a haphazard way that doesn't make for strong bones--and you should check out the truly horrible side effect of severely painful bone loss in the jaws of many women taking these drugs.)
Some  people question the need for hormone testing prior to starting replacement therapy. Saliva versus blood testing has some controversial aspects, but saliva testing with a reputable lab is generally very accurate for baseline levels, and is reimbursed by Medicare and most other insurance companies. However, recent studies indicate that the Saliva tests stop being a reliable measure after the person starts taking hormone replacement therapy, especially transdermal. There is a belief that the hormones "hide" on the red blood cells thus making blood levels unreliable, but recent research has disproved this theory. The bulk of the research on effective levels of this hormone replacements is on serum (blood).

Many physicians give women  "hormones" without testing them first, at the "standard" dose, many times without even knowing that they aren't replacing the hormones with human hormones if they are using Oral Contraceptives or PremPro as the hormones they are giving. Just because this is common and less expensive does not mean it is good medicine. I addition to  using saliva or blood levels prior to doing replacement, obviously a history need to be taken, and symptoms need to be targeted. Most skilled physicians in the field still would never want to guess what needs to be replaced. By getting hormone levels first, you can replace hormones only if they are low. 
An extremely important reality is that many women in Perimenopause do not need estrogen at all even if they are plagued with severe hot flashes, but may need progesterone only. Progesterone increases the body's sensitivity to its remaining estrogen. Most women have adequate levels of estrogen until their late 40s or early 50s, whereas they may have inadequate progesterone as early as their mid 30s due to changes in ovulation. This is just one of the many reasons to make sure you get tested for the actual free hormone levels first. 
Many people in the Functional Medicine  or Anti-Aging Medicine fields (who are the ones generally concerned with these issues) are looking at many other factors with blood and/or saliva testing, including looking for adrenal fatigue or thyroid disease and "rebuilding" the adrenals and thyroid prior to starting sex hormone replacement therapy. Sometimes by getting the adrenal glands functioning well, they can produce enough of the sex hormones that further replacement isn't needed. This is especially true in the perimenopausal period. After menopause there are numerous reasons to take hormones replacement--again to preserve our brains, bones, hearts, blood vessels and skin.
One particularly bad mistake conventional doctors make is to give only estrogen if a woman has had a hysterectomy, as if he only purpose of progesterone is to protect the uterus instead of impacting many organ systems. Everywhere in our bodies that there is estrogen receptors, there is also progesterone receptors.  As stated above, the research indicates that progesterone is protective against breast cancer. Estrogen dominance (and the relative, or absolute,lack of progesterone) causes many problems including breast tenderness and bloating, fibroids in the uterus and severe perimenopausal PMS. Ironically, proper balancing with progesterone (not estrogens or oral contraceptives) might save many a woman her uterus! Using any of these hormones in an improper balance is just asking for trouble along the way.

Also giving testosterone  in women for sex drive without seeing if it is even lacking may cause  problems in many women. On the other hand,  oral estrogen causes an increase in sex hormone binding globulin, which will bind the free (active form of) testosterone, so these women usually need testosterone replacement therapy. Sexual function is many factorial, but the average Ob-Gyn physician is just too busy to take the time to find out what is really going on.
Yes, going once a year is cheap as is giving a common medicine without knowing if it is the right one, but that has little to do with quality of care. As I have been taught, the hormones are a symphony that needs the right balance for the individual patient. Just from the few things I have mentioned here you can see that this is a complicated field and good care may take several visits. 
I am a Psychiatrist. I began learning about this field and offering hormone replacement therapy about a decade ago when I began seeing patients whose psychiatric symptoms being impacted by hormone imbalances and I had no colleagues to send them to. My conventional psychiatric medications and therapy were often inadequate and I was seeking ways to relieve suffering. Since a primary philosophical goal in medicine is to "First do no harm" and because there was no way as I was approaching menopause that I would ever consider taking Premarin or Provera, (which I have always considered to be essentially poisons), I began to study this field and treat my patients myself. Make no mistake, many women fly through menopause with hardly any symptoms, and if their bone densities are good and they aren't losing calcium through their urine they probably will get by without hormone replacement therapy. The people who come to see me are usually suffering from myriad symptoms, and are very gratified when I can do an individualized treatment that is integrative of many forms of treatment including these hormones.