The Truth about
Bioidentical Hormone Therapies—
Are There Risks?
by Rashmi Gulati, MD
Because bioidentical hormones are structurally the same as biological hormones, their use has long been supported by health professionals committed to providing natural health care for their patients. Although compelling clinical data for some of these treatments were still unavailable, these doctors stood by the logic that bioidentical hormones would be metabolized in the same ways as biological hormones, thus producing byproducts the body would recognize. Bioidentical hormones seemed the best way to maximize the health benefits of hormone replacement while minimizing the risks of side effects and complications. But more compelling is the results they observed and continue to note in their patients.
Those skeptical of the benefits of bioidentical hormones were quick to point out that these novel hormone therapy protocols were untested and unsupported by conventional medicine. They boasted the safety profiles of many commonly prescribed synthetic hormone therapies, and made accusations about the lack of FDA approval for bioidentical hormones. As it turns out, there are quite a few bioidentical hormones on the market that are FDA-approved (and have been since the early 1990s), and researchers have continued to investigate their potential for many years.
In a peer-reviewed study published in January 2009, hormone replacement researcher Kent Holtorf, MD revealed his comprehensive analysis of the available studies on bioidentical hormones. (See Postgraduate Medicine, Vol. 121, No. 1, pp 73–85.) Specifically, Dr. Holtorf examined the safety and efficacy of bioidentical estradiol, estriol, and progesterone in hormone replacement therapies for menopausal women. He compared the impact of the hormones on patient symptoms, the physiological responses that occurred, and the risks of cancer and heart disease to synthetic hormones. His conclusion:
"Based on both physiological results and clinical outcomes, current evidence demonstrates that bioidentical hormones are associated with lower risks than their nonbioidentical counterparts. Until there is evidence to the contrary, current evidence dictates that bioidentical hormones are the preferred method of HRT."
Bioidentical Hormones—What's the Risk-Benefit Ratio?
The risks of hormone therapy vary greatly, depending on the individual and the particular hormone being replaced. As described in the previous section, short-term use of melatonin for jet lag poses minimal risk. Thyroid hormone supplementation is considered one of the safest of the long term treatments, given that the activities of the hormones are typically well-regulated in the body through internal feedback mechanisms. The thyroid hormone most commonly replaced is l-thyroxine (T4), the precursor to the more potent thyroid hormone. The body can convert this prohormone to its more active form, triiodothyronine (T3) whenever greater thyroid hormone activity is needed. This conversion ceases when there is sufficient active thyroid hormone available, limiting the risk of thyroid hormone overdose. However, not all persons make the conversion effectively, and there may be resistance at any one of several different hormone receptors also. At Patients Medical we have found a number of situations where a more individualized approach, using combination T4 and T3, along with micronutrient supplementation such as iodide, can more safely, effectively restore harmony to the thyroid axis.
Insulin treatments for diabetics likewise have an excellent track record, though such long term treatments require vigilance from the patient. Both the timing and the quantity of the insulin dose are critical for properly controlling blood glucose. Dosages must be adjusted on an individual basis, selecting the route and concentration based on how quickly the insulin should act. Food intake, exercise, and any illnesses can all require adjustment of dosages, as well. If not enough insulin is available, the diabetic will suffer the effects of their high blood sugar. Excess insulin in the blood can potentially be lethal, so managing doses carefully and knowing how to respond in an insulin emergency are critical for all diabetics and their families. Less life-threatening yet still troublesome manifestations of insulin resistance, such as polycystic ovarian syndrome, also respond well to individualized hormonal adjustment, with great benefit and minimal risk to the patient.
Adrenal insufficiencies such as Addison's disease are normally treated through replacement of adrenal hormones, such as cortisol. Daily doses are formulated to mimic the natural levels of this corticosteroid hormone, which fluctuates during the day and has a wide variety of effects on other aspects of body physiology. Insulin efficacy, immunity, inflammation, electrolyte balance, blood pressure, and bone formation are just some of the bodily processes that can be affected by adrenal hormone levels. Low levels of adrenal hormones may also be prescribed for more moderate adrenal insufficiencies, such as those related to adrenal fatigue. If the adrenal gland is still functional, special care must be taken to regulate dosage to avoid side effects, such as immunosuppression, which can leave a person susceptible to infection and illness. High blood sugar, bone loss, weight gain, and loss of muscle mass are also risks. The adrenal gland may additionally decrease output if the hormones are externally supplemented for extended periods of time, so dosages should be appropriately tapered toward the end of treatment to avoid withdrawal.
Testosterone replacement for men who have diminished testicular function due to cancer or other diseases has long been accepted as an appropriate way to maintain the strength of secondary sex characteristics and healthy "maleness." There has been much discussion regarding the appropriateness of testosterone replacement for aging men, however. The effects of reduced testosterone as a natural part of aging leads to thinning hair, weight gain, sexual problems, and other symptoms that many men would rather not face. Although restoration of testosterone can somewhat reverse these effects, it is important for patients to thoroughly discuss their cases with their doctors to determine whether there are other acceptable options. Low testosterone as a result of aging does not, in itself, pose health risks. Testosterone replacement therapies, however, may raise blood pressure, thicken the blood, raise cholesterol levels, and increase the risk of prostate cancer.
There have been many warnings in recent years surrounding the replacement of estrogen and progesterone in women experiencing menopause. While there are certainly significant benefits to relieving symptoms and promoting well-being, a 2002 report called into question whether these benefits outweighed the potential for side effects and complications. Although osteoporosis rates were lower, the incidence of stroke, heart attack, and blood clots were modestly higher in women taking synthetic estrogen and progestin (the synthetic replacement for progesterone used in conventional protocols). Breast and uterine cancers were also slightly more prevalent than in women not receiving these hormone replacements.
Following these reports, however, hormone replacement has ceased to be the default treatment for menopausal women. It was concluded that further study was needed to more closely examine the risks and benefits of these conventional hormone therapies, as well as the emerging protocols involving bioidentical hormones. Since then the data have been further analyzed, and much of the risk is believed to be contingent upon age at initiation of menopausal hormone replacement, the forms of estrogens and progesterone, the individual's genetic make-up and health history, and the method used to deliver the hormones. In other words, the decision regarding risks versus benefits of hormones is one that is best made weighing an individual's unique hormonal profile and medical history. Given the recent data regarding the increased safety and efficacy of bioidentical hormones, many women are now choosing these over traditional synthetic hormone mixes.
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imbalance, and to support her recovery of balance.
Connecting the Dots of Hormonal Imbalance
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Date of Publication: 09/05/2005
Article Last Updated: 12/10/2013