A Discussion About Bioidentical Hormones
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Bioidentical hormones or so-called “natural hormones” are plant-derived
hormones which are identical in structure to endogenous hormones produced by
the body. Because bioidentical hormones have low absorption with oral
administration, they are frequently formulated as a gel to be applied topically to
the skin. They include estradiol, estriol, estrone, and progesterone. They are
usually formulated by compounding pharmacies. Bioidentical hormone replacement
therapy (BHRPT) is typically used to relieve symptoms of menopause, but is also
prescribed for its alleged anti-aging effects. Bioidentical hormones have been
promoted usually, by people outside the conventional medical community, as a
safer alternative to traditional hormone replacement therapy. The US Food and
Drug Administration, however, has warned multiple compounding pharmacies that
the claims they make about the efficacy of bioidentical hormones are misleading
and are not supported by medical evidence. (The FDA letter can be read here.)
The Endocrine Society’s October 2006 Position Statement says, “…many
‘bioidentical hormone’ formulations are not subject to FDA oversight and can be
inconsistent in dose and purity. As a result of unfounded but highly publicized
claims, patients have received incomplete or incorrect information regarding the
relative safety and efficacy of hormone preparations that are referred to as
‘bioidentical.’” The American Association of Clinical Endocrinologists shares a similar
perspective, “…AACE believes that potentially serious dangers of BH [Bioidentical
Hormones] use have not been sufficiently exposed. The primary concern about
bioidentical hormone use is patient safety. These substances have not been
shown within the medical community to be clinically effective. In addition, utilization
of these formulations may be associated with various risks inherent in the
compounding process.”
Essentially, the assertions made by the scientific community about BHRT condense
into four criticisms: there is no medical evidence to support the claims about the
increased effectiveness and safety of BH; the majority of compounded products
have not undergone rigorous testing; there are significant concerns about the
purity, potency and quality of BH; and “hormone therapy does not belong to a
class of drugs with an indication for individualized dosing.” (Stephen Barret of
Pharmwatch.com). Unfortunately, clinical testing of bioidentical hormones may
never be done because the pharmaceutical industry has no economic interest in
their promotion. Since recent studies using traditional oral hormone replacement
therapy have shown negative consequences with long term use, it is reasonable
to further study bioidentical hormones in menopausal women to possibly make
them more generally available as prescription drugs.
(printer friendly page)
Bioidentical hormones or so-called “natural hormones” are plant-derived
hormones which are identical in structure to endogenous hormones produced by
the body. Because bioidentical hormones have low absorption with oral
administration, they are frequently formulated as a gel to be applied topically to
the skin. They include estradiol, estriol, estrone, and progesterone. They are
usually formulated by compounding pharmacies. Bioidentical hormone replacement
therapy (BHRPT) is typically used to relieve symptoms of menopause, but is also
prescribed for its alleged anti-aging effects. Bioidentical hormones have been
promoted usually, by people outside the conventional medical community, as a
safer alternative to traditional hormone replacement therapy. The US Food and
Drug Administration, however, has warned multiple compounding pharmacies that
the claims they make about the efficacy of bioidentical hormones are misleading
and are not supported by medical evidence. (The FDA letter can be read here.)
The Endocrine Society’s October 2006 Position Statement says, “…many
‘bioidentical hormone’ formulations are not subject to FDA oversight and can be
inconsistent in dose and purity. As a result of unfounded but highly publicized
claims, patients have received incomplete or incorrect information regarding the
relative safety and efficacy of hormone preparations that are referred to as
‘bioidentical.’” The American Association of Clinical Endocrinologists shares a similar
perspective, “…AACE believes that potentially serious dangers of BH [Bioidentical
Hormones] use have not been sufficiently exposed. The primary concern about
bioidentical hormone use is patient safety. These substances have not been
shown within the medical community to be clinically effective. In addition, utilization
of these formulations may be associated with various risks inherent in the
compounding process.”
Essentially, the assertions made by the scientific community about BHRT condense
into four criticisms: there is no medical evidence to support the claims about the
increased effectiveness and safety of BH; the majority of compounded products
have not undergone rigorous testing; there are significant concerns about the
purity, potency and quality of BH; and “hormone therapy does not belong to a
class of drugs with an indication for individualized dosing.” (Stephen Barret of
Pharmwatch.com). Unfortunately, clinical testing of bioidentical hormones may
never be done because the pharmaceutical industry has no economic interest in
their promotion. Since recent studies using traditional oral hormone replacement
therapy have shown negative consequences with long term use, it is reasonable
to further study bioidentical hormones in menopausal women to possibly make
them more generally available as prescription drugs.
Bioidentical Hormone Replacement Therapy
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