Bio-Identical Hormone Replacement Therapy

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What Are bio-identical hormones?

Bio-identical hormones have the same structure as hormones found in the human body. Their purpose is to fully replicate the function of naturally produced hormones.  Synthetic hormones such as Premarin, Prempro and Provera do not have the same chemical structure as hormones made by the body. They are derived from animal sources or chemically generated in the laboratory and are metabolized along different pathways that can be harmful to the cardiovascular system. They do not lend themselves to hormonal balance. Since bio-identical hormones cannot be patented –remember they are naturally occurring- there is little incentive for drug companies to sponsor scientific studies or manufacture them. Although some bio-identical hormones are not FDA approved this is not necessarily a bad thing. Women using bio-identical hormones tend to have far closer surveillance of their hormonal balance and a far greater range of safety compared with their synthetic counterparts.

Goals of Bio-Identical Hormone Therapy

The purpose of BHRT is to replace any deficiency with a natural product that closely resembles the same balance of estrogens made by the body.  Replacement with synthetic hormones, such as Premarin, Prempro and Provera can be effective; however, the body does not recognize these substances and lacks the enzymes needed to break down synthetic hormones into harmless substances. It only makes sense to use natural plant derived hormones the body recognizes as ‘bio-identical’ for ideal symptom relief and acquire the anti-aging benefits of naturally occurring hormones.

Bio-identical hormones have to be compounded on an individual basis, since every woman has her specific needs for symptom relief, improved libido and sexual responsiveness, alleviation of fatigue and depression. Creating just the right dose and combination of estrogen, progesterone, androgen (male hormone) along with supplements for adrenal fatigue requires fine orchestration between your nurse practitioner, compounding pharmacist and laboratory to provide the best possible results.

For Men and Women

Since the Women Health Initiative study of 2005 which brought to the forefront the risks of heart disease and cancer with the use of synthetic hormone replacement (HRT), more and more women now are looking for alternatives and turning to bio-identical hormone replacement. Bio-identical hormone therapy (BHRT) is gaining fast popularity in treating menopausal symptoms, balancing hormones, and slowing the aging process. More recently, men are becoming aware of the benefits of bio-identical male hormone therapy. Many men using bio-identical hormone therapy are finding improvement in their general health, mood, wellness, strength, muscle tone, and sexual function and libido.

What Are Bio-Identical Hormones?

Bio-identical hormones are hormones that are plant derived and are identical to the structure of the natural hormones found in our bodies. Bio-identical hormones are compounded at special compounding pharmacies into different forms of application. Because they are identical to the structure of hormones found in the body, adverse side effects and risks for cancer and heart disease are significantly reduced.

Where do natural hormones come from?

The bio-identical estradiol, estriol, progesterone and testosterone we prescribe are derived from plant based yam or soy. These molecules are then modified to become exact replicas of the hormones currently in your body. In every case they fit into the hormone receptors in exactly the same way as the hormones you produce in your body do. Unlike synthetic hormones, which are derived from animal sources or are chemically formulated in the laboratory, the body recognizes natural hormones as identical to what is made in the human body. Women have the enzyme systems to both maximally utilize them and rapidly eliminate their breakdown products. The body does not have the enzyme systems to efficiently breakdown synthetic hormones, which tend to linger, provoke inflammation and can unnecessarily stimulate division of breast cells.

What is the difference between bio-identical and synthetic hormones?

Bio-identical hormones are plant-derived and identical to the body's hormones. Because they are natural they cannot be patented by pharmaceutical companies and must be compounded by the pharmacy. They can be compounded into any form of application and any strength of dosage to accommodate each individual's uniqueness and requirement for hormone therapy. Bio-identical hormones are personalized to the patient's needs.

Synthetic hormones such as Prempro and Premarin are similar but not identical to the body's hormones. The chemical structure of these synthetic hormones is changed slightly in order for the substance to be patentable. This slight chemical shift however creates a mismatch between the body's receptors and the synthetic hormones leading to adverse reactions and long-term health risks. Synthetic hormones are also standardized to few dosages and cannot be individualized to the needs of each patient.

Are bio-identical hormones safe?

The answer to the above question is clearly yes. The most comprehensive analysis to date, published in the prestigious Postgraduate Medical Journal (Volume 121 No. 1), showed that bioidentical hormones are associated with reduced health risks and are more effective than their synthetic counterparts. Synthetic forms of hormone replacement therapy such as Premarin, Provera and Prempro present real health concerns with increased risks for breast cancer, stroke and heart attack. On the other hand, there is no evidence to show bio-identical hormones pose a greater risk than other commercially marketed natural formulations.

When bio-identical hormones are used at physiological doses to match the individual's inadequacy of hormones, they are safe. However, when these hormones are over-dosed, the safety of these hormones declines. More studies to evaluate the long-term effects of high dose bio-identical hormones are still needed. Progesterone (bio-identical hormone) has been shown to reduce the risk of breast cancer while progestin (synthetic hormone) increases the risk of breast cancer. Several recent studies have shown that bio-identical testosterone therapy for men reduces the risk of prostate cancer. Those with prostate cancer also do not have an increase risk of progression of their cancer from the use of bio-identical testosterone therapy. In fact, recent studies have indicated that men who have low testosterone levels are at higher risk for prostate cancer.

The FDA questions the safety of bio-identical hormones and does not approve them. Why not?

Good question. Despite over 30 years of use with an excellent safety record the FDA has yet to do definitive studies on these products. Estriol, the major estrogen used in compounding, is the weakest and least stimulatory estrogen to breast cells in the laboratory. Furthermore, it is the predominant form of estrogen in pregnancy, reaching blood levels many times higher than more potent estrogens naturally found in the body such as estrone and estradiol.

Interestingly, the synthetic estrogens and progestins such as Premarin, Prempro and Provera, do have a long history of significant adverse side effects and risks yet are still approved by the FDA with some qualifications as ‘safe and effective’.

Will I benefit from bio-identical hormone replacement therapy?

Undoubtedly yes. Unlike conventional treatment, bio-identical hormone replacement therapy is highly individualized to your specific needs and addresses not only symptoms of estrogen deficiency but treats lack of desire, diminished sexual response and adrenal fatigue. Not only will you benefit from the correct balance of hormones, herbals and nutritional supplements, you will be closely monitored with periodic laboratory tests to assure you are safely receiving the correct amount of medications.

How do I know if bio-identical hormones are for me?

Keesha Ewers, ARNP will run urinary or blood or saliva tests to evaluate the level and function of your hormone production. Estradiol, estrone, estriol, progesterone, DHEA-S, testosterone (free and total), TSH, FT3, FT4, cortisol, pregnenolone, SHBG are some of the basic hormones that may be checked for both men and females. Your family history, medical history, and current symptoms will be evaluated in light of the findings with the diagnostic tests. Options for bio-identical hormones, herbs, vitamins and lifestyle and diet therapy will be discussed with you for your particular situation and together with your medical provider you decide which route to take.

Can I still use bio-identical hormones if I am using synthetic hormones?

Yes. Your medical provider can switch you from the synthetic to the bio-identical hormones after evaluating you. The switch may initially cause a recurrence of menopausal type symptoms like hot flashes, insomnia, mood swings until your body has detoxified the synthetic hormones and the proper dose of bio-identical hormone therapy is found. Remember that if you are drinking caffeine, alcohol or consuming sugar, these symptoms will be much worse.

I am interested in getting started. What is the process?

You can start by scheduling a comprehensive consultation which lasts 45 minutes to an hour. It will include a detailed discussion of your symptoms, expectations, benefits and risks, and will go over possible side effects and potential adverse reactions. A complete medical history and partial physical examination will be undertaken and a thorough explanation of the role of laboratory testing, selection of medications, supplements and costs will be discussed. Keesha will explain the schedule of follow up office visits and laboratory testing necessary to achieve the best results.

What are the costs and do you bill insurance?

Yes, we do bill your insurance. The cost of the initial office consultation is $325. We do bill your insurance for you, so if Keesha Ewers, ARNP is in your plan, it is likely that your office visits will be covered.  She will want to do initial baseline blood work, which is usually covered by your insurance (it is up to you to know your benefits). Initial baseline saliva hormone testing for adrenal and hormone levels will be approximately $300. Saliva testing is repeated at 2-3 months and then every 6 months to yearly. Medications from the compounding pharmacy are shipped overnight directly to you. Costs vary depending upon the composition of the prescription drugs. Herbals and supplements can be sent from the compounding pharmacy as well or you can purchase them directly from our office.

How are bio-identical hormones administered?

A combination of estrogen and testosterone are rubbed into the forearm or upper arm (depending on the need for slow or slower release which is determined by lab work) in a small volume of compounded cream, usually on a daily basis. Progesterone is included in the cream unless you have a sleep disturbance, in which case we take advantage of natural progesterone’s sleep inducing effects by swallowing it at bedtime. DHEA is taken as a pill, lozenge or spray under the tongue. All other herbals and supplements are taken orally.

Why is trans-dermal estrogen so important? Isn’t it easier to swallow a pill?

When estrogen is placed on the skin it is immediately absorbed and goes directly to targeted cells before circulating through the liver and broken down. Estrogen taken by mouth is absorbed by the intestine and goes directly to the liver, which not only degrades the hormone but also generates inflammatory byproducts that can affect the cardiovascular system and potentially increase your risk for blood clots and stroke. This is true even when natural estrogen is taken by mouth. Progesterone is very efficient when taken trans-dermally but is highly effective and safe when taken by mouth at bedtime to induce sleep.

Will I have a period when I take bio-identical hormones?

If you are perimenopausal the medications are taken to simulate your natural menstrual cycle. After you have transitioned into menopause it is not necessary to bleed regularly when on bio-identical hormone replacement therapy.

Do I need progesterone if I have had a hysterectomy?

Yes. For years gynecologists believed the only reason to take progesterone with estrogen was to prevent uterine cancer. We now know that progesterone plays many different roles in the body, such as balancing estrogen levels, supporting bone strength and helping to prevent cardiovascular disease. It is an integral part of all hormone replacement regimens.

My doctor prescribes estrogen topically along with a natural progesterone pill. I feel great. Why should I consider changing to bio-identical hormone therapy?

If you are happy with your present combination therapy then by all means don’t change!

All topical estrogens and oral natural progesterone are superior to estrogens taken by mouth and can provide excellent relief of symptoms. However, they often do not address diminished libido, absence or difficulty achieving orgasm or adrenal fatigue. You generally do not have the intense surveillance to optimize safe estrogen ratios routinely done with bio-identical hormone therapy or ability to measure androgen and adrenal breakdown products to assure maximal benefit and safety.

The FDA says there is no standardization of compounded hormones. Why use a compounding pharmacy?

Traditional compounding involves combining, mixing or altering ingredients to produce a drug by a licensed pharmacist in response to a doctor’s prescription to meet your specific medical needs. Compounding pharmacies are the only way to use bio-identical hormones and individualize their composition. In particular, a key estrogen called estriol is the primary ingredient in compounded formulations. It is not available in any commercially produced product but is critical for replacement therapy.

The compounding pharmacies we work with are members of national organizations which assure the quality and consistency of the formulations and certify they comply with the highest standards of the industry. These compounding pharmacies submit samples of their products at least twice a month to outside independent laboratories for confirmation of quality and verification of potency.

Patient Resources

  1. Bioidentical Hormones_ Why Are They Still Controversial_ The White Paper. 2009
  2. The Bio identical Hormone Debate
  3. Mainstream Medicine Stunned by New Findings on Bioidentical Hormones
  4. The Estrogen Dilemma (New York Times, 4/12/2010)

RECOMMENDED READING

Avoiding Breast Cancer While Balancing Your Hormones by Joseph McWherter, MD, 2005

SUMMARY OF MAJOR MEDICAL ARTICLES

WOMENS HEALTH INITIATIVE STUDY (WHI)

*Used synthetic estrogen and progesterone (Prempro) not natural hormones
*Oral administration not transdermal
Increased Risks: Stroke(Up 41%), Heart Disease(Up 29%), Thrombosis(Up 111%), Breast CA(Up 26%)
Protective: Colon CA(Down 37%), Hip Fracture(Down 34%)
J. American Medical Association 2002; 288:321

WOMENS HEALTH INITIATIVE STUDY (WHI)
PREMARIN ONLY (NO PROVERA)

Increased Risk: Stroke(Up 39%), Thrombosis(Up 33%),
Protective:HeartDisease(Down9%), BreastCA(Down23%), ColonCA(Down8%),Hip Fracture(Down39%)
J. American Medical Association 2004; 291:1701

FURTHER ANALYSIS OF THE WHI STUDY

For women on estrogen< 10 years since menopause there is a decreased coronary heart disease risk
For women on estrogen< 10 years since menopause there is a decreased mortality risk
*Conclusion: Estrogen may have a negative effect on damaged arteries but may have a positive effect on healthy vessels
J. American Medical Association 2007; 297:1465

RELATIVE RISKS OF BREAST CANCER

Genetic Mutation (BRCA 1/2) 10:1
Late age at first childbirth: 2:1
Benign breast disease: 1.5:1
Alcohol use: 1.4:1
Hormone replacement therapy: 1.3:1

RISK FOR BLOOD CLOTS, PHLEBITIS AND DEEP VEIN
THROMBOSIS WITH ORAL ESTROGEN

First Pass through the liver increases clotting factors
*No increase in phlebitis and clot formation shown with trans-dermal preparations
J. American Medical Association 2004; 292:1581
Lancet 2003; 362:428
Circulation 2007; 115:840

DEMENTIA AND ALZHEIMERS DISEASE STUDIES
WITH ESTROGEN USE

Cash County Memory Study: Estrogen use greater than 10 years reduced the risk of Alzheimers Disease to that of men of the same age (note that women have twice the incidence of Alzheimers disease compared with men)
J. American Medical Association 2002; 288:2123

WHIMS Study: Women who used any form of hormone therapy before the age of 65 were 50% less likely to develop Alzheimers disease or Dementia.
(Presented at the American Academy of Neurology Annual Meeting, May 2007)