The Endocrine Society cautious physicians against the use of
compounded hormone for treatment of menopausal symptoms, female sexual
dysfunction, and thyroid disorders in a scientific statement issued at Endo 16,
the Annual Meeting at Boston
from April 1-4, 2016.
The Society supported
the use of FDA approved therapies and
asserted that custom compounded Hormone formulations should only be used when
the patient is allergic or does not tolerate
the FDA approved drugs and treatment is cardinal to his/her health.
“By no means do I wish to disparage the practice of
pharmacists who are measuring hormones and providing them to patients,” Nanette
Santoro, MD, professor and chair of reproductive endocrinology and
infertility, department of obstetrics and gynecology at the University of Colorado
Denver, said during a press conference discussing
the recommendations. “Where we get into scientific trouble ... is as soon as
something is being custom compounded, it’s being measured out and added to a
variety of agents and diluters that will make it into a pill or a gel. ... How
these excipients influence how these hormones get into a person, and what that
hormone does, is essentially unknown.”
She also opined that one third to one quarter of all the
drugs prescribed for menopausal hormone therapy are custom compounds as
observed in a recent survey. She was also appalled at the large amount
bioidentical and formulations available in the market that are similar to FDA
approved therapies. “It is also a perversion of the intent of the practice of
custom compounding,” She added.
This statement is also endorsed by a number of other
societies like American College of Obstetricians and Gynecologists and the North American Menopause Society; nonetheless almost
60% of clinicians prescribe so-called bioidentical compounded menopausal
hormone therapy, against recommendations from major medical societies,
according to a new survey.
Custom compound hormone is a big business, with annual sales
of $ 1 billion, and are largely popular
among patients as many clinicians prescribe them telling they are without any
side effects. But, the reality is the side effects have never been tested.
“What has happened is the absence of evidence of harm is taken as proof of
safety,” Santoro said. “This is very illogical, yet it pervades the media and
the popular press. You see happy people with anecdotes ... what we don’t know
are how much they’re getting and what are the biological endpoints?”
Currently, the only indication for prescribing compounding
therapy is in a woman who needs testosterone since there is no good commercially
available drug in market added Dr Sklar, who is an assistant professor of medicine and endocrinology at
Georgetown University Medical Center and George Washington University
Medical Center, Washington, DC.
The endocrine society new document provides detailed review
of many FDA approved hormonal products:
- No randomized, double-blind, placebo-controlled trials demonstrating efficacy of compounded bioidentical drugs in relieving menopausal symptoms exists as also no trials comparing FDA approved therapy vs. compounding formulations could be found.
- For Menopausal Hormone therapy, non oral formulations are associated with reduced risk of venous thromboembolism and stroke.
- Micronized Progesterone is a treatment of choice opted by some physician, and is considered safe biochemically, but evidence is lacking regarding benefit on clinical front.
- Transdermal patches, gels, and intramuscular preparations of bioidentical testosterone are available and FDA approved for use in men with hypogonadism, but no FDA approved testosterone preparation for women.
- There are currently no FDA approved preparations available for dehydroepiandrosterone (DHEA), no indication for prescribing it except in few patients with low libido. The bioidentical preparations come with all the drawbacks of dosing, absorption and safety as estrogen and progesterone.
- Vaginal formulation is currently undergoing trial for vaginal atrophy, but no FDA approved preparation is available in the market.
- Levothyroxine (LT4) is bioidentical, and is a highly effective therapy in patients with hypothyroidism. It is converted to T3 at tissue level and acts on all the target receptors in the body. Some patients may still exhibit symptoms of hypothyroidism; inspite adequate dosing and the clinician should investigate them for other causes. Compounded hormone therapy can be used in such patients with close monitoring of TSH and free T4.
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