Treatment Options

Bioidentical Hormone Replacement Therapy (BHRT)

Possible Harm/No Value

This assessment does not address Hormone Replacement Therapy (HRT) – FDA approved manufactured products.  It is addressed in a separate assessment.

There has been a lot of media attention regarding bioidentical hormone replacement therapy (BHRT) – compounded.  There are advertisements that a drug can be created “just for you” to treat the symptoms of menopause.  Compounded bioidentical hormones are plant-derived - usually from soy or yams.   Compounded BHRT is achieved by the altering, mixing or combining of ingredients by a pharmacist to create a customized medication ordered by a licensed practitioner for a specific individual.  They're custom made for you, based on a test of your saliva to assess your unique hormonal needs. Unfortunately, however, the hormone levels in your saliva don't reflect the levels in your blood or correspond to menopause symptoms.  The compounded bioidentical hormones are then labeled as drugs. 

It is important to know that compounded BHRT is not recognized by the U.S. Food and Drug Administration (FDA).  It is also important to know that compounded BHRT is not approved by the FDA.

Menopause is sometimes called “the change of life.”  Natural menopause occurs when the ovaries gradually produce lower levels of estrogen and progesterone and the woman has her last menstrual period.  It is considered complete when menstruation has stopped for one year. Surgical menopause occurs when both ovaries are surgically removed, and the production of estrogen stops immediately.  Menopause may include symptoms such as hot flashes, night sweats, sleeplessness and vaginal dryness.  Conditions such as weak bones and heart disease are more common in women postmenopause.  Postmenopause is the term for all the years beyond menopause.

Things to Consider

  • This assessment does not address hormone replacement therapy (HRT) – FDA approved manufactured products.  It is addressed in a separate assessment.
  • Women are advised to discuss their options, as well as the risks, of BHRT with their health care provider.
  • February 2009: “In response to recent media attention being given to so-called bioidentical hormones, The American College of Obstetricians and Gynecologists (ACOG) reiterates its position that there is no scientific evidence supporting the safety or efficacy of compounded bioidentical hormones.”
  • The Endocrine Society “supports FDA regulation and oversight of all hormones—bioidentical and traditional—regardless of chemical structure or method of manufacture.”
  • According to the U.S. Food and Drug Administration (FDA):
    •  “BHRT is considered to be a marketing term not recognized by the FDA
    • The FDA has not approved compounded BHRT drugs and cannot assure their safety or effectiveness.”

 See also:

Results

Possible Harm/No Value

Will I live longer if I take compounded BHRT?

No. This treatment will not lengthen your life.  The risks involved with BHRT need to be discussed with your health care provider

Will taking compounded BHRT improve my quality of life?

Documented medical evidence is not available to access whether BHRT can approve the quality of your life.

Will taking compounded BHRT make my symptoms better?

Documented medical evidence is not available to access whether BHRT can improve menopausal symptoms.

Safety

Possible Harm/No Value

The American College of Obstetricians and Gynecologists (ACOG) released the following statement in February of 2009: “In response to recent media attention being given to so-called bioidentical hormones, The American College of Obstetricians and Gynecologists (ACOG) reiterates its position that there is no scientific evidence supporting the safety or efficacy of compounded bioidentical hormones.”

The Endocrine Society released the following statement in October of 2006: “The Endocrine Society is concerned that patients are receiving potentially misleading or false information about the benefits and risks of “bioidentical hormones.” Therefore, the Society supports FDA regulation and oversight of all hormones—bioidentical and traditional—regardless of chemical structure or method of manufacture.”

The FDA releases the following in January of 2008: “The U.S. Food and Drug Administration (FDA) sent letters warning seven pharmacy operations that the claims they make about the safety and effectiveness of their so-called "bio-identical hormone replacement therapy," or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the agency. FDA is concerned that unfounded claims like these mislead women and health care professionals…”  Also, “the FDA has not approved BHRT drugs and cannot assure their safety or effectiveness.”

Comparison

Possible Harm/No Value

This assessment does not address hormone replacement therapy (HRT) – FDA approved manufactured products.  It is addressed in a separate assessment.

Conservative treatments:

  • Avoid hot rooms, hot drinks, spicy food, caffeine, alcohol and stress
  • Wear layered lightweight clothing
  • Exercise
  • Eat a healthy diet
  • Increase dietary calcium and/or dietary calcium supplementation and vitamin D
  • Maintain appropriate weight for height
  • Maintain normal blood pressure, cholesterol and blood sugar
  • Avoid tobacco use
  • Use yoga or other meditation techniques
  • Have massages

Prescriptive medications are available for the treatment of hot flashes and the prevention of osteoporosis and heart disease. Over the counter preparations are available to help vaginal dryness.

Cost

Possible Harm/No Value

The cost of compounded BHRT depends on the compound that is requested.

Women are advised to discuss their treatment options as well as the risks of BHRT with their health care provider.

 

The cost may or may not be covered by your health benefits plan.

Sources

The following are off-site links off-site link :

American Congress of Obstetricians and Gynecologists. (2009, February). ACOG reiterates stance on so-called "bioidentical" hormones. Retrieved March 4, 2013 from http://abmed.wordpress.com/2009/02/04/acog-reiterates-stance-on-so-called-bioidentical-hormones/

Mayo Clinic. (2011). Are bioidentical hormones safer and more effective than hormones used in traditional hormone therapy for menopause symptoms? Retrieved March 18, 2014 from http://www.mayoclinic.org/diseases-conditions/menopause/expert-answers/bioidentical-hormones/faq-20058460?p=1.

National Institute of Aging. (2013, October).  Hormones and menopause. Retrieved March 18, 2014 from http://www.nia.nih.gov/health/publication/hormones-and-menopause

The Endocrine Society. (2009, February). The Endocrine Society re-issues position statement on bioidentical hormones.  Retrieved March 18, 2014 from https://www.endocrine.org/news-room/press-release-archives/2009/societyreissuespositionstatementonbioidenticalhormones.

Pharmatch. (2013, September). Steer clear of “bioidentical” hormone therapy. Retrieved March 18, 2014 from http://www.pharmwatch.org/strategy/bioidentical.shtml.

U. S. Food and Drug Administration. (2008, January). FDA takes action against compounded menopause hormone therapy drugs. Retrieved March 4, 2013 from http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116832.htm.

U. S. Food and Drug Administration. (2008, April). Bio-identicals: Sorting myths from facts. Retrieved March 18, 2014 from http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm049311.htm.

Next Review Date

3/27/2015

This document has been classified as public information.

Table of Findings

results:  possible harm / no value

safety:  possible harm / no value

comparison:  possible harm / no value

cost: possible harm / no value


total: possible harm / no value

legend

scale

Page modified:March 31, 2014