Just what are “bioidentical hormones”?

Bioidentical hormones are manufactured in the lab to have the same molecular structure as the hormones made by your own body. By contrast, synthetic hormones are intentionally different. Drug companies can’t patent a bioidentical structure, so they invent synthetic hormones that are patentable (Premarin, Prempro and Provera being the most widely used examples).

Though bioidentical hormones have been around for years, most practitioners are unfamiliar with them. There are several branded versions now available for use in the kind of hormone replacement therapy (“HRT”) typical of synthetic hormones. This is generally a one-size-fits-all dosage regime.

In our practice, we have had the greatest success with an individualized approach. We begin with laboratory tests of hormone levels (a so-called “hormone panel”). When warranted, we then prescribe a precise dosage of bioidentical progesterone, estrogen, testosterone or DHEA that is made up at a compounding pharmacy. Each patient is then monitored carefully through regular follow-up hormone panels to ensure we get symptom relief at the lowest possible dosage. In the initial stages, we will do a hormone panel every three months. Once balance is restored, we’ll do one panel a year at the time of the annual exam.

Are bioidentical hormones better than synthetic hormones?   TOP

We long ago concluded that the answer to this question is yes. But that doesn’t mean bioidentical hormones are perfect.

The great appeal of bioidentical hormones is that they are natural, and our bodies can metabolize them as it was designed to do, minimizing side effects. Synthetic hormones are quite strong and often produce intolerable side effects. Moreover, the compounded bioidentical hormones can be matched individually to each woman’s needs — something that’s just impossible with mass-produced products.

Are bioidentical hormones safer than synthetics?   TOP

European medical studies suggest that yes; bioidentical hormones very well may be safer than synthetic versions. This makes perfect sense. But we must be cautious here, because they have not been well-studied, especially for long-term use. And in any case, we never recommend that a woman think of any drug as completely safe.

Let us note here that the WHI studies on the effectiveness and health risks of HRT were based on synthetic/equine-based hormones.

Do all women benefit from bioidentical hormones or are there other options?   TOP

There is clinical evidence to support the safety and efficacy of combining the benefits of bio-identical hormone replacement, stress reduction, nutritional and exercise modifications.  Our goal is to serve as your medical resource in this emerging field of medical science. Our goal is for you to be both healthier and happier.…now and for the rest of your life.  This requires a team approach identifying the issues and variables that exist for each individual and then scientifically testing, making adjustments in the individual’s life, exploring supplements and/or medications, and identifying preventive health measures to achieve our goal of long term health and happiness.
The great majority of women can rebalance their hormones without the use of synthetic drugs. We have found that about many women can find relief through an approach that combines medical-grade nutritional supplements, gentle endocrine support, and dietary and lifestyle changes. We would hope that every woman could start with this combination approach as a foundation of health.
We’ve developed a “Comprehensive Women’s Health Assessment” that evaluates the issues affecting a woman’s health and wellbeing….hopefully catching issues upstream of where problems arise.  This evaluation and program not only evaluates any current issues and identifies solutions, but also identifies lifestyle changes to more naturally deliver a healthier and happier lifestyle for the future.  It makes sense that this will then prevent progression of symptoms, illness, and disease in the future but we truly believe this requires a strong commitment of the individual to modify some of the choices they are making now for a healthier and more enjoyable life for the future. 

Often we ill be able to identify nutritional, stress, and exercise issues that may dramatically improve a woman’s symptoms without any prescriptions or supplements.  Even with this foundation, a minority of women will need to add prescription-strength hormone supplements to get complete relief, at least through a transition period. We recommend they use bioidentical hormones, preferably in a compounded form personalized to their needs by our experienced practitioner. It’s important that the hormones be used in addition to the combination approach outlined above.

We recommend that any hormones used long-term for symptom relief requires assessment, ongoing physical exams, tests, and monitoring.

What about bioidentical hormones for breast cancer patients?   TOP

The pendulum has swung so far that today; very few doctors will prescribe any type of HRT — synthetic or bioidentical — for women who have had breast cancer or even a family history of breast cancer. In fact, many such women are given anti-estrogen drugs.

There are breast cancer patients who, like Suzanne Somers, use low-dose bioidentical hormones by choice. These women have researched the issues, discussed them with their doctor, and made a well-informed decision for themselves.

Case study

Susan was a 54-year-old woman who presented with severe menopausal symptoms. We changed her diet to increase her protein and vegetables and reduce carbohydrates, added a pharmaceutical-grade nutritional supplement, and did a complete blood hormone panel.
At her first follow-up visit six weeks later, Susan definitely felt better, but she still suffered too many hot flashes and sleepless nights. Our next step would have been to increase her soy intake, but Susan wanted immediate relief and chose to try bioidentical hormone replacement therapy.
After reviewing her hormone panel we placed Susan on a combination of bioidentical estradiol (one of the three forms of estrogen), testosterone, DHEA and progesterone, all in cream form. Six weeks later Susan came back for another follow-up. “I feel fabulous,” she said, explaining she hadn’t felt this good since her early 30’s.

A year later Susan still feels great. She’s carefully compliant with her diet and exercise regime, and takes her bioidentical hormones faithfully. Her latest hormone panel shows she’s still in balance and there is no need to adjust her dosages.

Not every patient is as easy to help as Susan. Sometimes we have to adjust the formulas three to five times to get it right. But it’s a very effective solution.

What did the Women’s Health Initiative Study in 2002 actually show?   TOP

The Women's Health Initiative found that women taking the combination estrogen-progestin (Prempro –synthetic estrogen and conjugated form of progesterone) used in the study had an increased risk of developing certain serious conditions. According to the study, over one year, 10,000 women taking estrogen plus progestin compared with a placebo might experience:

• Seven more cases of heart disease
• Eight more cases of breast cancer
• Eight more cases of stroke
• 18 more cases of blood clots

Based on these numbers, the increased risk of disease to an individual woman is small. However, the overall risk to menopausal women as a group became a substantial public health concern. In addition, researchers found that women taking combination estrogen-progestin had an increase in abnormal mammograms. The higher number of false-positives — signs of possible breast cancers that ultimately prove inaccurate — was probably due to estrogen, which increases breast tissue density.

For women taking estrogen alone (Premarin), the WHI found no increased risk of breast cancer or heart disease. But researchers did find that over one year, 10,000 women taking estrogen compared with a placebo might experience 12 more cases of stroke and six more cases of blood clots in the legs, plus an increase in mammography abnormalities. This last point is important, because women who take estrogen or combination estrogen-progestin therapy may need more frequent mammograms and additional testing. There was no comparison performed with bio identical form of estrogen or progesterone as part of this study.

ARE THERE GROUPS AND PHYSICIANS CONCERNED ABOUT THE USE OF BIOIDENTICAL HORMONES?   TOP

In four years, 50 million American women will be in menopause. The federal government's decision in 2002 to suspend the use of synthetic hormone replacement therapy (HRT) in the Women's Health Initiative study , left many women and physicians uncertain about the safety of synthetic hormones and searching for alternatives. The increased interest in alternatives has raised the defenses of many physicians because of the “unknown”.  To the physician’s credit, their concern is a curse and a blessing.  We as a group of physicians want to see not just one, but many definitive studies confirming our practice styles.  Unfortunately the many studies are ongoing and the jury is still out.  Therefore, many physicians will take the opposing stance despite small and mid scale studies, anecdotal evidence and common sense telling them otherwise.

In a release October 2005, the American College of Obstetricians and Gynecologists (ACOG) stated that there was "no scientific evidence to support claims of increased efficacy or safety for individualized estrogen or progesterone regimens prepared by compounding pharmacies." It also noted the "lack of well-designed and well-conducted clinical trials of these compounded hormones." There are many other physician and physician groups that have appropriately questioned the safety and effectiveness of bioidentical hormones because of the lack of large government funded studies.  Because it is unlikely that any for profit corporation will fund a comparison study of bioidentical hormones to synthetic hormones vs. no replacement…we will need to rely on smaller scale studies that have proven safety, results, and benefits.  The ongoing popularity of BHRT in addition to the ignorance of many physicians “not in the know” about bioidentical hormone replacement will prompt further comparative studies.  Ultimately, this will result in greater appreciation for BHRT with other physicians.

Are there any studies that prove that bioidentical hormones relieve symptoms?   TOP

Yes there are many.  An example is a study, entitled Management of Menopause-related Symptoms Using Natural Bio-Identical Hormones, A Time Sequenced, Cohort Trial, that was conducted by Jan M. Seibert, ND,

Methodology

To assess the efficacy of nBHRT treatment of estrogen deficiency symptoms, progesterone-related symptoms, and the effects of hypothyroidism, 50 perimenopausal/menopausal women (PMPW) with low concentrations of progesterone and estradiol (blood and salivary tests), a body mass index (BMI)> 24, a low basal body temperature (<98.2) and menopausal symptoms volunteered to be included in a time-sequenced cohort. Women who had had surgical menopause, a history of long-term clinical depression, were taking synthetic ovarian hormones or who had had any estrogen-related cancers were excluded.

The group was subdivided into menopausal (n=30) and perimenopausal (n=20) women. During the baseline clinic visit, weight and basal temperature were recorded, and PMPW subjectively scored (0=none, 1=mild, 2=moderate 3=severe) the following:

-- Estrogen-related symptoms (hot flashes, night sweats, sleep disturbances, vaginal dryness)

-- Progesterone-related symptoms (mood swings, increased irritability, water retention)

-- Hypothyroid-related symptoms (depression, weight gain in waist, weight gain in hips, scalp hair loss).

The PMPW were then treated daily with (1) individualized, dose-specific nBHRT transdermal (cream) or drops of estradiol/estriol; (2) individualized, dose-specific transdermal progesterone; and (3) a multivitamin. Patients were also encouraged to eat a balanced diet with fruits and vegetables. They were seen in follow-up at 90-day intervals for one year. Weight, basal temperature and a subjective score of menopausal symptoms were obtained at each visit. Hormone dosing was then adjusted based on patient's symptoms.

Baseline scores for estrogen-, progesterone-, and hypothyroidism-related symptoms, as well as weight and basal temperatures, were compared to those obtained at six and 12 months post-nBHRT.

Results

-- Median scores assessing estrogen- and progesterone-related symptoms, as well as symptoms of hypothyroidism, were significantly lower (p< 0.0001) in PMPW at six and 12 months after initiating nBHRT.

-- Of the 50 women, 82 percent showed improvement in their estrogen-related symptoms.

-- Of the 50 women, 74 percent showed improvement in progesterone-related symptoms.

Conclusion

This study is limited by the fact that it is not a randomized placebo-controlled study and did not include a standardized diet plan or depression scale survey. In spite of these limitations, the study demonstrates that for this cohort of PMPW the nBHRT significantly reduced perimenopausal- and postmenopausal-related symptoms. These findings support the need for a large randomized trial of nBHRT.

I have heard Suzanne Somer’s is very involved in educating women about Bioidentical hormone replacement.    TOP

After the release of the landmark WHI findings in 2002, millions of American women found themselves in an ocean of hormone-replacement doubt and confusion. Soon afterward, Suzanne Somers’s best-selling The Sexy Years made another splash, as a much-needed life preserver, bringing new perspectives, solutions and above all hope to women, who must continue coping with the “curse” of menopause. This inspirational book helps untangle the confusion surrounding hormone replacement therapy, and reassures women about their bodies, and their options for not merely “surviving” menopause - but transforming it into the richest period of their lives. For Ms. Somers, this transformation turns on the use of bio-identical hormone replacement therapy - a subject on which we are answering more and more inquiries. In light of the recent WHI (Woman’s Health Initiative) findings on HRT health risk: women today want facts about bio-identical HRT.  Suzanne Somers has been proactive in educating women and the general public about bioidentical hormone replacement as an option.

What is the difference between Premarin, Provera and ioidentical Estrogen/Progesterone?   TOP

Women have for several decades been prescribed an estrogen product derived from the urine of pregnant mares (horses) called Premarin. (PREgnant-MARe-urINe) While this substance may be “natural” it is also very different from the hormones produced in human ovaries. Its active ingredient, “eqiillin” (from the Latin for horse, “equs") is known for its powerful impact and persistence on the human uterus. The main hormone produced in the female (human) ovary is Estradiol. Premarin does not match the human hormones it replaces, it is a substitution. We were not surprised to learn that Premarin was the only estrogen replacement substance used by the participants of the WHI studies.

The second hormone substitute in non-bio-identical HHT is the chemical Medroxyprogesterone Acetate, (sold as “Provera") which is purely synthesized in the lab, and does not match the naturally occurring progesterone that it replaces. This powerful chemical has been linked to several health risks, including significant bone mineral density loss, breast cancer, and side effects including headache, nervousness, abdominal pain, dizziness, weakness, or fatigue. Provera was the only progesterone replacement substance used by the participants of the WHI studies.

Again, bio-identical hormone replacement provides an exact duplication of the hormones that naturally occur in the body. In menopause, therefore, we replenish the primary estrogen “Estradiol” with bio-identical Estradiol, and we replenish diminished Progesterone with bio-identical Progesterone. The concept is straightforward: we replenish the body’s missing hormones with bio-identical ones. We don’t replace a hormone that isn’t missing.

Q: What’s the Big deal about Progesterone?   TOP

There are three sex hormones produced by the ovaries: estrogen, progesterone and testosterone. With age, progesterone levels are usually the first to decline; in fact, progesterone levels typically drop 120 times more rapidly than estrogen levels. Hormone imbalance begins in the early thirties; it is not just a female "menopausal issue." When progesterone levels decline, the body's natural hormone balance is upset and the body is left with too much estrogen. When estrogen levels are not balanced by progesterone, your health is at risk. For instance, too much estrogen in the body causes cells to proliferate, or grow too rapidly. Unchecked cell proliferation can be a precursor to cancer. Progesterone plays a critical role in that it opposes estrogen and neutralizes its damaging and carcinogenic effects.

In addition, progesterone also aids in:

• Serving as a natural anti-depressant
• Fostering a calming effect on the body
• Acting as a natural diuretic thereby preventing water retention or bloating
• Normalizing blood sugar levels
• Maintaining libido
• Promoting regular sleep patterns
• Restoring proper cell oxygen levels, thereby improving mental acuity and memory

There is clinical evidence to support the safety and efficacy of combining the benefits of bio-identical hormone replacement, stress reduction, nutritional and exercise modifications.  Our goal is to serve as your medical resource in this emerging field of medical science. Our goal is for you to be both healthier and happier.…now and for the rest of your life.  This requires a team approach identifying the issues and variables that exist for each individual and then scientifically testing, making adjustments in the individual’s life, exploring supplements and/or medications, and identifying preventive health measures to achieve our goal of long term health and happiness.

I hear some women may start having a menstrual cycle again with bioidentical hormone replacement.  Is this true?   TOP

Again, one the cardinal rules or bio-identical HRT is to mimic the body’s natural physiology as much as possible. The old method of “continuous combined therapy” violates this rule completely by “tricking” the body into believing it is pregnant - perpetually. In bioHRT we cycle the replacement estradiol and progesterone in a natural manner. Ideally during the first half of the cycle the estrogens dominate, and in the second part there will be more progesterone - thus fully restoring the woman’s natural, youthful hormone cycle. Normally this will reinstate the patient’s menses. If this is not desirable, we can adjust the therapy accordingly.

Bio-identical estrogens not only duplicate the naturally-occurring (human) estrogens, they also duplicate the effects of these estrogens. Through careful testing and monitoring we can reinstate and maintain a woman’s unique, naturally youthful hormone levels, providing natural relief from the distresses of menopause and related conditions - while minimizing potential adverse health risks.

Are Bio-Identical Hormones Safer?   TOP

While this question cannot be fully answered until appropriately-designed studies have been completed, many physicians and researchers currently believe that bio-identical hormones may be safer than synthetic HRT, for numerous reasons, including the following:

he studies linking HRT to long term health risks do not quantify bio-identical hormone use in their questionnaires or methodology.

The estrogens used in Natural HRT roducts are known to have weaker cancer risk associations than those used by the WHI participants.

The studies make no provisions for the type of estrogens or progestins used, but should, since studies have found that women using 17-beta estradiol transdermal patches had no increase in blood clots, while those using oral estrogens, such as Premarin, did have an increase.
Using hormones that are identical to those made by the body is a logical choice, especially when cancers are increasingly linked to environmental toxins and synthetic substances.

Why are the companies that make synthetic hormones not looking at making bioidentical hormone therapy as an alternative?   TOP

After the WHI and other studies proved the existence of major health risks associated with conventional HRT, the major manufacturer responded by simply reducing the recommended dose. Then they went ahead promoting and marketing their product as the “gold standard” in hormone therapy ... one may argue why anyone would continue to prescribe non-human estrogens - the very products used in the studies given the concerns for these synthetic hormones.

However some do. We cannot understate the influence Drug companies continue to exert upon many physicians and their treatment choices. After all, their research and products have for decades been the powerful “silent partners” standing behind the physician’s results and studies.
Upon further observation, it is obvious that the benefits of bio-identical HRT run counter to the profit needs of the large drug manufacturers. Points in fact:

Bio-identical hormone protocols are tailored according to each patient’s unique physiology and needs, and the prescription is then formulated by a compounding pharmacy. When effects are known, the formulation can be fine-tuned or adjusted until the patient attained optimal relief levels.
Drug manufacturers prefer products that can be mass-produced and distributed to economies of scale. For example, Wyeth maintains 700-800 horse-breeding farms in Canada where thousands of mares are kept pregnant in narrow stalls, year round, for the purpose of collecting their urine. (They are kept in perpetual thirst to concentrate their urine, and rarely allowed to run since that disturbs the collection tubes.) This super-concentrated equiillin-rich urine seasonal “crop” yields billions of doses of the patented drug Premarin, which is distributed world-wide at arbitrary pricing. ("whatever the market will bear")

When a product’s attributes suggest major profit potential (patentable, mass-production, large market) then a manufacturer can justify the major expense of long-term clinical trials to document that product’s safety and efficacy.

Because they occur naturally in the human body, bio-identical hormones are not patentable. Hence the large drug manufacturer has no reason to invest money in research trials to prove their safety. In fact, just the opposite may be true. Yet smaller, short-term studies on bio-identical hormones have reported good results and more importantly; no adverse effects.

Individual clinicians must rely on observational data, and we have never encountered adverse risks arising out of bio-identical HRT, nor are we aware of any other practitioner having reported the appearance of real or apparent adverse results.

Knowing there are risks and benefits to using ….or not using bioidentical hormone replacement….how do I decide?   TOP

Whether or not to use bio-identical HRT (or any form of HRT) is ultimately your decision to make. Before you make it, you should familiarize yourself with the risks of HRT. There are known risks - and even bio-identicals have not yet been proven completely safe. However we believe your risks can be reduced by using bio-identical hormones and a natural therapeutic approach.

Here are some sources to read what other patients say about their experiences with bio-identical hormones, in comparison to years of conventional HRT dosing.

xt step is identifying any additional risks you may have, based on your family history, current health, lifestyle, work and other factors that may influence your risk.

Risks must be evaluated in relation to what can be gained. For example, there are risks associated with chemotherapy, yet cancer patients willingly assume those risks because they stand to gain much more by defeating a life-threatening disease.

Only you can decide whether the symptom relief you can gain is worth the risks of hormone replacement therapy.

Your doctor should be your partner, strategist and ally, sharing your goals and committed to using every means at his or her disposal to help you achieve maximum relief and quality of life - while protecting your long term health.

So — are bioidentical hormones for you?   TOP

Our goal is to help inform women about their options so that they can make the choice that’s best for them. A woman’s hormonal balance is a dynamic equilibrium that shifts from day to day, week to week, and through the years. When you give your body the support it needs it can reset itself, because it’s equipped and programmed for balance and wellness. We recommend you start with a “Comprehensive Woman’s Health Assessment”. Taking a thorough assessment is in your best interests to get on the right track and assess all of the contributing factors to your good health and wellbeing.  We’ll support you in any way we can, each step of the way. The good news is that women can feel incredibly well right through menopause.

Specific Questions on Bioidentical Hormones and treatment?   TOP

Q: Where do natural hormones come from?

A: Some natural hormones come from the yam plant, soybean plant, or Barbasco plant (giant yam).

Q: What hormones are most frequently used for hysterectomy and oopherectomy patients?

A: Estradiol, testosterone, estriol, DHEA and progesterone.

Q: What is the best route of administration, e.g. Sublingual, gel, capsule, cream, pellet, tablet or patch?

A: Everyone is different. So what is best for one, may not be best for another. Sometimes you need to try 2 or 3 different delivery systems, until you find what works best for you.

Q: When is the best time of day to take my hormones?

A: Ideally the best way is to take one half of the daily dose every 12 hours for oral, sublingual and topical doses. However a testosterone sublingual for libido is best to take 2 hours before bedtime. Estrogen for night sweats is best to take with your evening meal. DHEA after is best taken after breakfast. Progesterone is often taken at bedtime.

Q: Will my symptoms be relieved more, the same or less with natural hormones compared to synthetic hormones?

A: Symptoms will usually be relieved equally or more, as long as the patient is balanced properly. Using saliva, urine, or blood hormone testing will accomplish this.
Q: How can I increase my libido?

A: Saliva testing for Testosterone, DHEA, Progesterone and Estradiol should be done. If these are low then natural HRT supplementation may be used. Moderate exercise is another natural means to increase testosterone and libido.

Q: Will my insurance pay for natural HRT?

A: 80% to 85% of the time most insurance companies will fill your prescription.  For others, their policy may restrict them to synthetic hormones.  Most patients will pay out of pocket for natural hormone supplementation even if their insurance does not cover because the benefits far outweigh the minimal daily cost of the medications.  The costs may vary from $50 to $150/month.

What dose should I use?   TOP

Dosing hormones should be an individualized analysis. Many synthetic hormones are limited in their dosing options and this is where there is a significant advantage to using bioidentical hormones.  The response to hormone therapy can be varied. It can be due to differences in the absorption of the hormone. Each patient can respond uniquely to a given dose. The best possible decisions about the prescribed dosage should be unique to each patient's medical and family history, current health status, personal habits, symptoms and priorities. By using a generic approach to hormone therapy that might meet the needs of some patients, many will be either over or under treated, with potential consequences. It is important to customize treatment to the individual patient and their symptoms. 

So — are bioidentical hormones for you?   TOP

Our goal is to help inform women about their options so that they can make the choice that’s best for them. A woman’s hormonal balance is a dynamic equilibrium that shifts from day to day, week to week, and through the years. When you give your body the support it needs it can reset itself, because it’s equipped and programmed for balance and wellness. We recommend you start with a “Comprehensive Woman’s Health Assessment”. Taking a thorough assessment is in your best interests to get on the right track and assess all of the contributing factors to your good health and wellbeing.  We’ll support you in any way we can, each step of the way. The good news is that women can feel incredibly well right through menopause.