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What is bioidentical hormone replacement therapy?

Bioidentical hormone replacement therapy (BHRT) is a philosophy or approach to hormone replacement that satisfies 3 key principles:

  1. All hormones used are chemically identical to human hormones. This means that if your body makes progesterone, which has a specific chemical structure, only that specific hormone is given as a replacement. Bioidentical hormones are derived from natural sources and then modified in the lab to become identical to human hormones. The image below provides an example of “biologically identical” progesterone versus synthetic, non-identical medroxyprogesterone (Provera). In bioidentical hormone replacement, only progesterone is given since it is exactly the same as what the body produces.   This kind of hormone replacement therapy allows for more predictable activity on human cells and more predictable metabolism of the hormones.

  2. Progesterone vs. Provera

  3. The dosage is individualized to a patient’s specific hormonal needs. Bioidentical hormone replacement therapy requires testing to determine an individual’s baseline hormone levels and rigorous symptom evaluation to create a customized dosage based on the individual’s particular hormone needs.

  4. The goal is to achieve a balance of activities of the hormones to improve quality of life and prevent disease. All the hormones work together in concert in the body, so optimizing the activity of one hormone enhances the effects of others, and vice versa. Balance is probably the most important concept in bioidentical hormone replacement therapy, and one that can often be overlooked, as there is a tendency to focus on only one or two hormones or one or two organs in the body. The human body is incredibly complex and intricate, and the purpose of treatment is not to override the body’s innate intelligence, but to facilitate it, restoring balance and improving quality of life.

When is bioidentical hormone replacement therapy used?

Bioidentical hormone replacement therapy is used to treat hormone imbalance most often during mid-life when a woman (or man’s) body goes through hormonal changes. However, this kind of therapy can be used for anybody experiencing symptoms of hormone imbalance, including symptoms of low thyroid or adrenal dysfunction, a condition often caused by chronic stress.

How does a person know if she or he could benefit from bioidentical hormone replacement therapy?

Not all women (or men) experience bothersome symptoms when their hormone levels change during mid-life, so for those people, treatment may not be warranted. General symptoms of hormone imbalance include hot flashes, brain fog, mood swings, low energy, acne, insomnia, weight gain, and headaches.  If a person is experiencing such symptoms, they can:

  1. Go through a symptom checklist.  If a person experiences several symptoms on the checklist, that may indicate that she/he might benefit from hormone balancing. 

    Click here for a comprehensive symptom checklist of hormone imbalance.

  2. Talk with a practitioner knowledgeable in the field of hormone balancing.In order to address a hormone imbalance, it is important to work with a practitioner with experience in this field. An experienced practitioner can help the patient evaluate the numerous factors that may be contributing to their symptoms, many of which can be addressed by incorporating healthy practices into one's daily life, such as a balanced diet and stress reduction techniques. An experienced practitioner will also be knowledgeable in the appropriate use of bioidentical hormones.

    Click here for referrals for Bay Area doctors experienced in the field of bioidentical hormone replacement.

    Click here for a checklist for healthy living.

  3. Get tested.  A person must measure hormones in order to balance hormones.  Hormones can be tested with a saliva, urine, blood or blood spot, and there are pros and cons to each method. Generally, the hormones that are tested are progesterone, estradiol, testosterone, DHEA-S, cortisol, and thyroid.

    Koshland Pharm offers many of these tests; call the pharmacy for more information at (415) 344-0600.

What are the hormones that are most often used in bioidentical hormone replacement therapy?

The hormones used in bioidentical hormone replacement therapy can be broken into two groups, the steroid hormones and the peptide hormones.  The general definition of a steroid hormone is any hormone that is based on the chemical structure of the cholesterol molecule.  Steroid hormones can be used to balance hormones to treat menopausal symptoms and to treat adrenal disfunction.  Peptide hormones are basically long chains of amino acids and are used to address low thyroid. 

Steroid Hormones
When people hear the word “steroid,” they often think of athletes using drugs to get pumped up. This type of “steroid” is more accurately called an “anabolic steroid.” Anabolic means “building up”, and these hormones, like testosterone, build up muscle. Testosterone is used in bioidentical hormone replacement therapy, but only at physiologic doses as a way to balance hormones and treat symptoms. 
Although there are lots of steroid hormones, bioidentical hormone replacement therapy generally focuses on the following hormones:

  • Estrogens – There are only 3 bioidentical estrogens, estrone (E1), estradiol (e2) and estriol (E3).  Estradiol is the most commonly used and the strongest of the three estrogens.  For a more thorough discussion of the 3 bioidentical hormones, see Peter's blogpost Bioidentical Estrogens Explained.
  • Progestin – There is only one progestin that the body uses and that is progesterone. Progesterone is an extremely important hormone and is often overlooked. For a more thorough discussion of progesterone, see Peter's blogpost The Power of Progesterone.
  • Testosterone – This is thought of as a hormone for men although women need it too, just not as much of it.
  • DHEA – This hormone is a precursor to testosterone and although current evidence suggests that the body doesn’t use DHEA directly, sometimes it is given to women who have low energy, muscle wasting, and low libido. 
  • Cortisol – aka “the stress hormone.” Cortisol is released from the adrenal glands in response to stress. Abnormal cortisol secretion and its resulting health problems are commonly known as “adrenal disfunction.”

Peptide Hormones
The most important peptide hormones are the thyroid hormones, namely levothyroxine (T4) and liothyronine (T3). T3 is the active thyroid molecule, meaning that it is the form that exerts its effects on the body’s cells. However, the body also produces T4 and converts it to T3 in the blood vessels. 
The most commonly prescribed thyroid supplementation is oral T4 or levothyroxine (i.e. Synthroid, Levoxyl). For many people, this is an adequate treatment for their symptoms of low thyroid. Some need T3 supplementation to effectively treat their symptoms. T3 can be given orally by a prescription off-the shelf medication (Cytomel), in combination with T4 (Thyrolar), or can be made by a compounding pharmacy in a sustained-release form. Another popular thyroid supplementation product is derived from the desiccated porcine thyroid gland (i.e. Armour thyroid, Nature-throid); it containes T3 and T4 as well as other constituents of the thyroid gland, which some practitioners have found helpful in supporting normal thyroid activity.

For a more thorough discussion of thyroid medications, see Perer's blogpost Thyroid Madness? Apparently So.

How is bioidentical hormone replacement therapy administered?

Bioidentical hormones are administered in a variety of different ways, including:

  • Topical creams
  • Capsules
  • Suppositories
  • Sublingual drops and troches

If using a cream as a form of administration, it is important to take some steps to make sure the hormones are not passed to others through skin-to-skin contact.  Here are a few tips when using bioidentical hormone creams:

  • Be mindful about the possibility of transferring your hormones to someone else. Once you know the risk, you’re more likely to be careful. The greatest risk comes from prolonged exposure right after application, such as holding a baby with your bare arms, cuddling your cat, or allowing your dog to lick the cream off your skin. Usually, just knowing the risk is enough to prevent problems.
  • Keep the part of your skin where you apply your hormones covered for at least two hours after application. This allows the hormones to absorb and reduces the risk of transference.
  • If you normally apply your hormones to your forearms, try applying them to your upper outer arms or your thighs, where you’re less likely to touch another person or animal.
  • If it’s too warm to stay covered, or your life requires frequent exposure to children or animals (such as a day care provider or veterinary technician), you may want to switch to another delivery method for your hormones, such as a patch or sublingual troches.

What makes bioidentical hormone replacement therapy controversial?

  • Pharmaceutical interests. Bioidentical hormone replacement therapy has been attacked by big pharmaceutical companies that manufacture synthetic alternatives. Most recently, in 2006, Wyeth Pharmaceuticals petitioned the FDA to impose far-reaching restrictions on physicians' ability to prescribe and pharmacists' ability to dispense bioidentical hormones. They did not succeed, in large part because of an outpouring of letters to Congress from women who wanted bioidentical hormone replacement as an option for treating menopausal symptoms. As a part of this controversy, a legitimate critique was made of some compounding pharmacies, which had made misleading claims about BHRT in their marketing materials (such as its ability to prevent diseases like Alzheimer's disease, a theory which is still being researched).  As a result of this critique, the FDA advised compounding pharmacies that they cannot claim that compounded bioidentical hormone products prevent or treat serious illnesses.
  • Differing interpretations of hormone studies. A large clinical trial (the Women’s Health Initiative) was halted in 2002 due to serious concerns it raised about the risks of synthetic hormone replacement therapy.  Some practitioners and organizations that initially supported synthetic hormone replacement therapy (such as the American Medical Association, the North American Menopause Society, and the American College of Obstetricians and Gynecologists) have issued statements that the WHI results should be assumed to be true for bioidentical hormone replacement therapy as well as synthetic hormone replacement. Other practitioners have concluded that the results of the WHI study cannot be applied to bioidentical hormone replacement therapy, since only synthetic hormones were used in the WHI trial.

Critics of bioidentical hormone replacement sometimes raise the concern that there is no double-blind, placebo-controlled trial looking at bioidentical hormones. It is true that more research needs to be done on the long-term effects of bioidentical hormones. Yet there is a body of research about bioidentical hormones that already exists and can be considered when weighing the potential risks and benefits of this kind of therapy. In looking at research about bioidentical hormone replacement therapy, it is important to consider questions such as:

  • What types of hormones are being studied?
  • What disease state end points are being looked at?
  • Is the study looking at breast cancer, cardiovascular disease, bone health?
  • What dosages of hormones are being used in the women?
  • Is there a uniform dose or is the dose being tailored to a specific patient based on lab values?
  • Are adrenal and thyroid health being looked at as part of the process? And if so, are lifestyle and diet modifications part of the treatment?

According to many practitioners, the studies that have been done about bioidentical hormones suggest that progesterone, estradiol, and testosterone, dosed at physiological levels to achieve hormone balance, have favorable long-term safety.

The following are some useful links to information that can help shed light on this subject:

  • There are also two studies currently underway related to bioidentical hormones, the KEEPS (Kronos Early Estrogen Prevention) study and the ELITE (Early Versus Late Intervention Trial with Estradiol) study. Results can be followed at www.clinicaltrials.gov.

It is important to talk about the research and its implications for your treatment with a knowledgeable practitioner.

  • Quality control of bioidentical hormone products. Some bioidentical hormones are mass-manufactured and FDA-approved, and other bioidentical hormones are custom-made at compounding pharmacies. Compounding pharmacies are regulated by state boards of pharmacy rather than by the Federal Drug Administration (FDA). Some practitioners prefer to use only FDA-approved bioidentical hormone products rather than those custom-made at a compounding pharmacy, feeling that the FDA-approved hormones are better monitored for quality. In the last five years, however, the Pharmacy Compounding Accreditation Board (PCAB) began reviewing and granting accreditation to compounding pharmacies that meet the highest standards for quality and safety in their profession.  Now, a PCAB accredited seal is a good way for a practitioner or patient to know that a compounding pharmacy makes high quality compounded products, including high quality bioidentical hormones.

    Click here to find out more about the Pharmacy Compounding Accreditation Board, the standards that pharmacies must meet to achieve accreditation, and a list of PCAB accredited compounding pharmacies in the Bay Area and nation-wide. Koshland Pharm is a PCAB accredited pharmacy.
  • Celebrity attention and confusion. Celebrities, most notably Suzanne Somers, have written books about bioidentical hormone replacement therapy and how it has helped them.  Suzanne Somers follows a hormone an supplementation regimen that some consider extreme in its approach and does not necessarily represent the overall field of bioidentical hormone replacement therapy. Celebrity attention has added to the plethora of information, and at times misinformation, in the media about bioidentical hormone replacement therapy.
What is Koshland Pharm's approach to bioidentical hormone replacement?

At Koshland Pharm, we believe the most successful outcomes happen when the pharmacist works closely with both patients and their doctors to help facilitate hormone balancing and optimize health.

To take the next steps to find out if bio-identical hormone replacement therapy might be useful for you:

 

This site is intended as a source of general health information. Because patients and health conditions are unique, it is important to consult with your doctor for medical advice to determine if a particular treatment is right for you.
Please note: only a licensed prescriber can order compounded medications. Prescriptions that are faxed and sent online will be verified by one of our staff members.

 

Koshland Pharm :: 301 Folsom St., Suite B, San Francisco, CA 94105 :: (p) 415-344-0600 :: (f) 415-344-0607 :: info@koshlandpharm.com

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