Bioidentical Hormones and Hormone Replacement Therapy

Menopause is defined as the cessation of menses, the first day after the last day of the last period.  It is a time of change…it is The Change.  During this transition, women may experience symptoms, the hallmark hot flashes as well as vaginal dryness, urinary symptoms, and others, as a result of their changing hormone levels, particularly their declining estrogen levels. 

How do we know when a woman is menopausal?  There are tests available that can measure a woman’s hormone levels in blood, saliva or urine, but because an individual’s hormone levels fluctuate from day to day and throughout the day, and because an individual’s symptoms may not correlate with an absolute hormone level, those tests are limited in what they can tell us. 

Menopause is currently diagnosed clinically and retrospectively, by the absence of menses for a full year.  The average age of menopause is 51, but it is really a process that may span the course of many years. 

In some cultures, a woman’s life is looked upon as having three major phases, with menopause marking the passage into the third phase, a time of wisdom and respect; it is the time of the Wise Woman.  Some women pass through menopause without any symptoms or problems whatsoever.  Other women may experience minor difficulties, and may be able to cope with them effectively by making adjustments in lifestyle factors.  For other women, the symptoms may be more significant, requiring more intervention in order to maintain quality of life.  For some symptoms such as hot flashes and vaginal changes, hormonal therapy may be one of the most effective interventions, although other forms of treatment are also available and may also be effective.

For a period of time, it was suggested that hormone replacement therapy (HRT) might be beneficial in the prevention of some diseases, and many women were some form of estrogen, with or without another hormone called progesterone.  Then, the results seen in a large clinical study called the Women’s Health Initiative indicated that, for the women in this study, the risks of HRT seemed to outweigh the benefits.  In this study, which was done using an estrogen called Premarin and a progesterone called Provera, they found that for every 10,000 women taking these hormones for the course of a year they were seeing: 

7 more cases of heart disease
8 more cases of breast cancer
8 more cases of stroke
18 more cases of blood clots

While this translates into only a small risk for any one individual, these results were important in looking at menopausal women as a group and significant enough to change the way we looked at the use of HRT.  Organizations such as the American Association of Obstetricians and Gynecologists (ACOG) now recommend that the decision of whether or not to take hormone therapy should be individualized based on a woman’s personal health, risk factors, and wishes.  While women who are taking hormone replacement therapy for the relief of their menopausal symptoms may also receive some protection against other conditions such as osteoporosis, colorectal cancer, and possibly heart disease, it is recommended that hormones should not be used with the intention of the prevention of disease, but only for the relief of moderate to severe menopausal symptoms, and in the lowest effective dose for the shortest time needed.

What is a hormone?  A hormone is a substance that influences a physiological process.  Generally, a hormone is produced in one tissue of the body and influences the workings of another.  When we talk about hormones in the context of hormone replacement therapy, we are talking about substances that are produced synthetically from some base product.  Even when we talk about “bio-identical” and “natural” hormones, it is important to remember that all hormonal medications are synthetically produced.

Premarin, the estrogen used in the WHI, is produced using the urine from pregnancy mares as its base substance.  The end result is a product that has a chemical structure very similar, but not identical, to the forms of estrogen our bodies produce.  “Bio-identical” indicates that the chemical structure of the hormone is the SAME as that of the hormones that our bodies produce themselves.  They are considered to be more “natural” because of this, and because they are produced from plant-based soy and yam sources.  But, they are still synthetic. 

Sometimes the term “bio-identical” is used in reference to preparations made by a pharmacist in a traditional compounding process according to a prescription from a licensed medical professional in order to meet an individual’s specific needs.  Traditional compounding serves a purpose:  it can customize a medication for someone allergic to a dye or preservative in a commercial product and it can produce a dosage, a mixture of products, or a form of a medication not available commercially.  Some people believe that these products can be specially formulated for an individual based on salivary hormone levels, but this practice is not supported by many professional organizations such as the North American Menopause Society (NAMS). 

There are concerns about compounded products.  In the process of compounding, active ingredients are mixed with inactive ingredients (what holds the pill together, or the cream, lotion, or gel base) and because these preparations do not go through testing processes, it is not known how well they are absorbed, whether the delivery is consistent from time to time, or how effective they actually are.  They also are not tested for purity and may contain unknown contaminants.  For these reasons, NAMS does not recommend these products over commercial products that can also be considered “bio-identical”, such as the estrogen products called Estrace, Climara, and Vivelle, and the progesterone product called Prometrium.

But, are these products any safer or any more effective than other hormone products?  The Women’s Health Initiative study was done using Premarin and Provera.  No similar large, long-term study has been done using bio-identical hormones, so we have to extrapolate the information; we don’t really know, so we have to assume the same profile of benefits and risks.    

As we go through changes, we make choices.  Wisdom implies an informed course of action and the ability to discern what is right.  Sometimes choices are not clear, and we make the best choices that we can, based on the best information that we have available at the time.

In summary, at this time, this is the best information that we know: 

• The primary intent of the use of hormone replacement therapy should be to relieve significantly bothersome symptoms such as hot flashes and vaginal symptoms.  The goal should be to effectively treat the symptoms using the lowest dose possible, and then to eventually decrease and stop the therapy.
• Other options are available.
• You should not use HRT if you have a history of breast cancer, coronary artery disease, a previous blood clot or stroke, or are at high risk for these problems.
• If you do choose to use HRT, you may also receive some benefit in the prevention of osteoporosis, colorectal cancer, and possibly heart disease if you take it before the age of 60, but you should not take HRT solely for those purposes.
• If you have a uterus and choose to use HRT with progesterone, you may also be at an increased risk for breast cancer and mammogram abnormalities.
• If you choose to use HRT, you may also be at risk for stroke and blood clots.
• If you start HRT long after the onset of menopause, you may be at increased risk of heart disease.
• There is no evidence at this time that bio-identical hormones are either more effective or safer than other forms of hormones.