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Health Protocols

Female Hormone Restoration

Moving Forward with Bioidentical HRT

Given the evidence demonstrating the superiority of bioidentical HRT, one prominent HRT researcher proclaimed, “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their… animal-derived [non-bioidentical] counterparts. Until evidence is found to the contrary, bioidentical hormones remain the preferred method of HRT” (Holtorf 2009).

Women should always consult a physician before beginning any HRT, especially if they have had or are at high risk of developing hormone-responsive breast or endometrial cancer. In some cases, prescribing practitioners may want to monitor hormone levels periodically to ensure the attainment of safe and adequate levels (Sood 2011).

Dosing and Delivery Methods

Bioidentical hormone formulations can be obtained as FDA-approved preparations (Table 1) or from a compounding pharmacy with a physician’s prescription.

Various preparations and modes of delivery are available for bioidentical hormones. For example, estradiol is available in FDA-approved oral tablets; topical gels, patches, and creams; and vaginal rings and suppositories. Bioidentical micronized progesterone is available as FDA-approved oral pills or vaginal gel (Files 2011; Santoro 2016). There are no currently approved preparations combining both bioidentical estradiol and progesterone. No FDA-approved formulation currently provides bioidentical estriol (FDA 2017). Some authors suggest the current evidence indicates that oral micronized progesterone plus topical/transdermal estradiol is the optimal approach to bioidentical HRT (L'Hermite 2017).

Importantly, the non-oral route is preferred for bioidentical estradiol. This is because the liver metabolizes orally ingested estradiol before it is available to the rest of the body. This is called the “first-pass effect.” Also, oral estrogens, but not topical or vaginal estrogens, are associated with increased blood clot risk (Simon 2012; Binkowska 2014). Oral progesterone does not present this challenge and is an acceptable method of bioidentical progesterone delivery (Binkowska 2014).

The most commonly prescribed compounded bioidentical estrogen formulas are called bi-est and tri-est. Bi-est consists of 20% estradiol and 80% estriol, and tri-est contains 10% estradiol, 10% estrone, and 80% estriol (Taylor 2001). Bi-est and tri-est are available in various oral, transdermal, and vaginal preparations (Files 2011). Although some physicians prefer bi-est or tri-est formulations based on their clinical experience, studies have yet to establish that estriol-containing bi-est or tri-est formulations provide clear advantages over FDA-approved bioidentical products that contain estradiol (FDA 2017). In certain situations, an experienced physician tailors an individualized prescription based upon an assessment of symptoms, and sometimes lab values, to the needs of a specific woman. In addition to estrogens, a comprehensive hormone restoration program may include progesterone, DHEA, pregnenolone, and possibly testosterone (Files 2011).

To obtain contact information for physicians in your area who are knowledgeable about bioidentical HRT, call 1-800-226-2370.

Women taking any kind of estrogen replacement therapy (including bioidentical) should refer to the Breast Cancer protocol in order to understand the importance of making healthy lifestyle choices that could reduce the risk of breast cancer.


Table 1. FDA-Approved Bioidentical Hormone Preparations

Hormone

Delivery Preparation

Brand Name

Available Dosages/Strengths

Estradiol

Oral – Pill/Tablet/Capsule (NOTE: even though these preparations are bioidentical, the non-oral route of administration is preferred to avoid the hepatic first-pass effect)

Estrace

0.5 mg; 1 mg; 2 mg

 

 

generic

0.5 mg; 1 mg; 2 mg

 

Vaginal Cream

Estrace Vaginal

0.1 mg/g

 

Transdermal Patch (typically applied once or twice weekly)

Alora

0.025 mg/day; 0.05 mg/day; 0.075 mg/day; 0.1 mg/day

 

 

Climara

0.025 mg/day; 0.0375 mg/day; 0.05 mg/day; 0.06 mg/day; 0.075 mg/day; 0.1 mg/day

 

 

Menostar

0.014 mg/day

 

 

Vivelle-Dot

0.025 mg/day; 0.0375 mg/day; 0.05 mg/day; 0.075 mg/day; 0.1 mg/day

 

 

Minivelle

0.025 mg/day; 0.0375 mg/day; 0.05 mg/day; 0.1 mg/day

 

 

generic

0.025 mg/day; 0.0375 mg/day; 0.05 mg/day; 0.06 mg/day; 0.075 mg/day; 0.01 mg/day

 

Topical Gel or Lotion

Estrasorb

4.35 mg per packet

 

 

EstroGel

0.06% concentration: 0.75 mg per pump

 

 

Elestrin

0.06% concentration: 0.52 mg per pump

 

 

Divigel

0.01% concentration: 0.25 mg per packet; 0.5 mg per packet; 1 mg per packet

 

Topical Spray

Evamist

1.53 mg per spray

 

Vaginal Ring

Estring

Applied once every three months: 0.075 mg/day

 

Vaginal Tablet

Vagifem (estradiol hemihydrate)

Typically applied twice weekly: 0.01 mg per tablet

Progesterone (micronized)

Oral – Pill/Tablet/Capsule

Prometrium

100 mg per capsule; 200 mg per capsule

 

 

generic

100 mg per capsule; 200 mg per capsule

 

Vaginal Gel

Crinone

4% concentration: 45 mg per applicatorful; 8% concentration: 90 mg per applicatorful

How Compounded Bioidentical Hormones are Prescribed

Compounded bioidentical hormone prescriptions are primarily based on symptoms and, to some degree, blood test results. A physician experienced in writing compounded bioidentical hormone prescriptions will work closely with a woman to determine a starting dosage.

The strength of a compounded hormone preparation is generally indicated in milligrams (mg) per milliliter (mL) or per cubic centimeter (cc). A milliliter and a cubic centimeter have the same volume. A typical starting dose for bioidentical estrogen cream might read as follows:

estrogen cream  

Please note this is one example of an initial prescription. It represent the most commonly used bioidentical HRT script for a postmenopausal woman with typical symptoms. A physician experienced in bioidentical hormone replacement would tailor a prescription to the individual’s needs.

Women on an estrogen replacement regimen should also be prescribed progesterone (in contrast to synthetic progestin drugs like Provera which do not have the same molecular structure as natural progesterone). Progesterone has a number of benefits when properly balanced with estrogen (Prior 2015; Spark 2012), and is particularly helpful for menopause-related sleep disturbances (Leeangkoonsathian 2017; Caufriez 2011). For oral progesterone, a typical dose is between 100‒200 mg per day for 10–12 days per month; for transdermal progesterone, a typical dose is 50‒100 mg per day (Randel 2012; Cobin 2017). These dosages can vary depending upon a woman’s individual biochemical needs. It is usually recommended that progesterone cream be applied twice daily to different parts of the body.

As with estrogen therapy, the dose of progesterone can be adjusted depending on the individual’s symptoms and response to treatment. For a postmenopausal woman, a prescription for topical progesterone cream from a compounding pharmacy might be written as follows:

progesterone cream  

A prescription for a peri-menopausal woman might read as follows:

progesterone cream  

Compounded hormone formulas are applied via a syringe (with no needle) onto the skin or intravaginally, allowing for precise dosage adjustment. In some situations, a baseline blood test may be useful for determining doses of bioidentical hormones. A physician experienced in bioidentical hormone therapy may want to measure testosterone levels and prescribe bioidentical testosterone if needed (Davis 2008).

Since DHEA can be converted to testosterone in a woman’s body, a woman with low testosterone might be able to increase her level by taking up to 50 mg DHEA daily, which is available as a dietary supplement (Weiss 2009; Caufriez 2013).

Identifying High-Quality Compounding Pharmacies

Given the potential for error inherent in preparing individualized compounded products, it is important that the pharmacy with which you are working adheres to high quality and safety standards.

One way you can ensure your compounding facility adheres to high quality and safety standards is to inquire whether the facility is accredited by the Pharmacy Compounding Accreditation Board (PCAB) (ACHC 2017). More information and relevant directories of accredited facilities can be found at the following link: https://healthfinder.gov/FindServices/Organizations/Organization.aspx?code=HR3886

You can also ask your pharmacy directly whether the facility adheres to guidelines laid out by the United States Pharmacopeial Convention (USP). Specifically, USP General Chapter 795 identifies important standards relevant to bioidentical hormone compounding to which a compounding pharmacy should adhere to ensure safety and quality (USP 2014). Reputable pharmacies should be able to provide clear information regarding their adherence to USP guidance. One aspect of the PCAB accreditation mentioned previously is attestation to the accredited facility’s adherence to relevant USP guidelines.