What are bioidentical hormones?

Bioidentical hormones, also called natural hormones are derived from plant extracts that are processed to modify their chemical structure to make it identical to human hormones. Hormones such as progesterone, estriol, and estradiol are commonly available as bio-identical hormones. Many of the bio-identical hormones used are derived from soybeans and wild yams. They provide a cost-effective option. Bioidentical hormones containing preparations have been used since several years in many countries. However, in the United States predominantly, non-bioidentical hormones are used. FDA has approved conventional hormone therapies (CHTs) containing bio-identical hormones. Other regulated pharmaceutically manufactured and branded CHTs also employ bio-identical hormones.


How are bio-identical different from synthetic hormones?

Bio-identical hormones are compounds that have identical chemical and molecular structure as that of human hormones. Synthetic hormones on the other hand have different chemical structures and can include medications such as conjugated equine estrogens (CEE), medroxyprogesterone acetate (MPA), and other synthetic progestins. This difference translates in differences in the way these hormones act in our body leading to differences in side effects, interaction, potency, and elimination of the hormones.


What is hormone replacement therapy?

Hormone replacement therapy (HRT) is a type of medical treatment where the patient is given hormones to prevent or treat certain medical conditions like symptomatic treatment of menopause. The hormones used in HRT are synthetic hormones that make up for the decline or lack of hormones produced in our body.

Estrogen plus progestin (synthetic progesterone), and testosterone are the commonly used female hormones for HRT. HRT is commonly used to treat the symptoms of menopause, such as hot flashes, vaginal dryness, mood swings, sleep disorders, and decreased sexual desire.


What is bio-identical hormone replacement therapy?

Bio-identical hormone replacement therapy is a medical treatment that utilizes hormone supplements that have an identical chemical structure to that of human hormones such as progesterone, estriol, and estradiol.


What is the use of bio-identical hormone replacement therapy?

Bio-identical hormone replacement therapy is used to treat the symptoms of menopause, perimenopause and postmenopause. Bio-identical hormone replacement therapy may be effective in improving symptoms of menopause. A wide range of dose and delivery systems are available that can be used for individualization of the therapy depending on the needs and preferences of patients.


How are bio-identical hormone replacement therapies available?

Two main types of Bio-identical hormones are available

  1. Commercially available with a prescription is approved by the FDA
  2. Compounded based on individual requirement for women in compounding pharmacies these are not approved by the FDA

Bio-identical hormone replacement therapies are commercially available in fixed dose or can be compounded depending on the patient’s dosage requirement and the route of administration as determined by the doctor. Compounded preparations of bio-identical hormone may include estriol, estrone, estradiol, testosterone, micronized progesterone, and occasionally dehydroepiandrosterone (DHEA). Usually the formulation contains different hormones depending on the need of individual patients.


What is bioidentical hormone replacement therapy for menopause treatment like?

If the doctor determines that a patient is having hormonal deficiency, there is a need to administer fixed dose of hormones. In women with active menstrual cycles three main forms of estrogen are produced that includes estrone, estradiol, and estriol. Estradiol is converted to estrone and estriol. After examining the hormone levels the dose of estradiol to be administered is determined that has to be administered every day of the month. On days 18 to 28, a fixed dose of progesterone may be prescribed to simulate what the body made previously. In a cyclic regimen estradiol is given daily for 23 consecutive days, followed by 5 days of no medication, after which the cycle resumes.


What are the different forms of dosing for bioidentical hormone replacement therapy?


Bioidentical hormone replacement therapy can be administered in fixed doses or in rhythmic cycling. Rhythmic cycling is based on the menstruation cycles and is meant to mimic the time during which women are at their reproductive peak.


What are the different dosage forms of bioidentical hormone replacement therapy?

Bioidentical hormones are applied via a cream, a suppository, taken orally or are injected.


What are the concerns of with bioidentical hormone replacement therapy?

The US Food and Drug Administration and The Endocrine Society say that there is a lack of evidence that supports improved safety and efficacy of bioidentical hormones compared with conventional HRT.

Bioidentical hormone replacement therapy should be used for short-term (maximum use 4 years). Bio-identical hormone replacement therapy is recommended only for symptomatic relief of menopausal symptoms and is not recommended for the prevention of chronic diseases. Bio-identical hormone replacement therapy may be associated with difference in bioavailability. This is a concern as this may have a negative effect on the safety and efficacy of compounded bioidentical hormone replacement therapy products. It is necessary to carefully monitor the hormone levels in patients receiving the appropriate dose considering the fact that sub-therapeutic levels of levels could increase the risk of serious adverse effects. This may involve serum testing or saliva testing. However, evidences suggest that saliva testing used to monitor hormone levels have a poor correlation between saliva progesterone levels and plasma progesterone levels.


What are the potential risks of hormone replacement therapy?


The use of bioidentical hormone therapy is generally well tolerated, is effective in providing symptomatic relief, and allows for individualization of treatment in based on the preferences of menopausal and perimenopausal women and the doctors presription. However, the use of bio-identical hormone replacement therapy is associated with potential risks of hormone replacement like increased incidence of heart and blood disorders, stroke and breast cancer. It is recommended that hormone therapy safe for breast cancer risk when taken for up to 5 years.

Estrogen can increase the risk for blood clots. The risk for endometrial cancer is more than five times higher in women who take estrogen therapy alone, compared with those who do not. However, taking progesterone with estrogen seems to protect against this cancer. Women who take estrogen/progestin therapy have an increased risk for developing gallstones.

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