Hormone replacement therapy
Bioidentical hormones — a guide to your options and alternatives
by Marcy Holmes, NP, Certified Menopause Clinician
Topics covered in this article:
If you’ve been watching Oprah lately, you’ve seen the newfound interest
in hormone replacement therapy (HRT), particularly when it comes to bioidentical
hormones. But we hear from many women who are frustrated and confused about
the whole process of getting bioidentical hormone therapy (bHRT). Some have no access
to specialty providers, and think their provider will only offer up Premarin or
Prempro — which raises concerns about the health risks of synthetic hormones.
Others began using bioidentical hormones, but their provider retired or relocated,
or they just plain can’t afford it anymore. These women feel stuck, thinking
they can’t afford the time, effort, or expense of compounded bHRT, yet continuing
to suffer with perimenopause symptoms. And that’s just not necessary, since
there are so many wonderful options and alternatives available.
Why is there so much confusion about bHRT?
There’s a lot of misinformation out there about the availability of different
bioidentical hormone options. Many ad campaigns imply the only “real”
choice for severe menopause symptoms is between synthetic HRT and antidepressants.
There are also blogs and websites stating bHRT is illegal or banned by the FDA (which
it is not). No wonder women are confused!
The Pharmacy Compounding Accreditation Board (PCAB) is a nonprofit
organization created by eight pharmacy organizations to set standards for compounding
pharmacies in the United States.
To become accredited, a pharmacy must undergo a lengthy, rigorous process that includes
on-site quality assurance inspection and establishment of standard operating procedures
that are comparable to those used by pharmaceutical manufacturers.
Pharmacies can be accredited for either or both non-sterile (topical) or sterile
(ingested) medications.
To learn more about compounded medications and finding an accredited compounding
pharmacy, visit the PCAB
website.
So far the FDA has just wanted compounding pharmacies to refrain from making false
claims about bHRT that have not yet been proven in studies — I find that reasonable.
There are also concerns about consistency and quality in the products made, which
is why it’s so important to find a trustworthy provider. One of the best ways
to locate a compounding pharmacy is to look for one that’s accredited through
the Pharmacy Compounding
Accreditation Board (see box).
The FDA has approved many bHRT-based products from pharmaceutical companies, such
as estradiol products and Prometrium (progesterone). Many conventional practitioners
prefer to use the term “natural HRT” for those alternatives to Premarin
products, rather than “bioidentical,” since they do not involve compounding,
but they will prescribe many FDA-approved brand-name products that provide bioidentical
hormones if you ask for them by name.
What about avoiding HRT or getting off of HRT?
We have a wealth of natural alternatives to HRT, including a huge variety of herbs,
flax seed, soy, exercise, stress reduction, and optimal nutrition that can make
a huge impact when weaning off or trying to avoid HRT. Every one of these time-tested
measures can be used with or without HRT. Used alone, they work synergistically
to help relieve symptoms and balance your hormones yet pose a mere fraction of the
potential HRT risk. And when used alongside HRT, they allow for faster, better,
and more sustainable results, often using lower hormone doses. (Please see our article
about phytotherapy for more information,
and our article on what to expect when getting off HRT if appropriate.)
If bioidentical hormones are the next step
We want you to know that if you and your healthcare provider determine you need
hormone replacement therapy, there is a bioidentical option that will work well
for you. It may take a few tries, but you are worth the effort. Understanding
some basics will help you know what to ask for.
If you’re looking for bioidentical hormone replacement therapy but don’t
want or cannot access compounded bioidentical hormones, there are some simple statements
that can help you cue your practitioner toward alternative forms of hormonal support
rather than synthetics:
- Tell them you don’t want to take estrogen in conventional pill or capsule
(oral) form.
- Tell them you don’t want Premarin or Prempro — conjugated equine estrogens
or synthetic progesterone/progestin products — in any form.
- Ask them to stick with estradiol, a natural human estrogen, and Prometrium, which
is bioidentical progesterone, at least to start with. Both are available from ordinary
pharmacies, and there are several popular brands of estradiol to choose from (see
table). If you have your uterus, you will need to “oppose” the estrogen
with the progesterone. If you’ve had a hysterectomy, you likely won’t
need Prometrium.
Often it is usually best to schedule a special appointment for discussing hormone
therapy with your practitioner, so they allot enough time to answer all your questions
— rather than try to squeeze the topic in during a physical. (And before you
go, you may want to check out Dr. Dixie Mills’s guide on how to talk to your
doctor about bHRT.)
As shown in the table below, there are many forms of “natural” or bioidentical
HRT available. All of the non-compounded, brand-name hormone preparations
listed in the table are FDA-approved, legal, and available by prescription.
Table of natural hormone options for bHRT
|
Delivery methods
|
|
Topical/Transdermal
|
Oral
|
Transvaginal
|
|
Estrogens: E1 = estrone; E2 = estradiol; E3 = estriol
|
|
Brand-name choices available through regular pharmacies
|
Most of these products provide only E2 (estradiol)
The exception is Bezwecken E3 vaginal suppositories, which deliver 1 mg estriol
per suppository
|
Lotion
• Estrasorb
Gels
• Divigel
• Elestrin
• EstroGel
Spray
• Evamist
Patches
• Climara
• Vivelle
• Alora
• Menostar
|
|
Cream
• Estrace
Vaginal rings
• Estring (90-day vaginal ring – provides local delivery to vaginal tissues
only)
• Femring (90-day vaginal ring – provides systemic delivery)
Vaginal suppositories
• Vagifem vaginal insert
• Bezwecken E3 vaginal suppository (1 mg estriol)
|
|
Compounded bioidentical hormones available through compounding pharmacies
|
Primarily estradiol (E2), but depending upon a woman’s hormone panel, E1,
E3, or other hormones may also be included
|
• Liquid lotion in dropper bottle
|
• Sublingual (under the tongue) troches (tro’-keez)
• “Melts”
• Solution in dropper bottle
|
• Estriol vaginal cream in a pH-balanced base, concentrations of 0.6 mg/g
or 0.8 mg/g
|
|
P = Progesterone (P)
|
|
Brand-name choice available through regular pharmacies
|
|
|
Capsule:
• Prometrium (micronized progesterone in peanut oil)
|
Capsule can be placed in vagina (speak with your practitioner about this first)
|
|
Compounded bioidentical hormones available through compounding pharmacies
|
|
• Compounded topically-applied cream or lotion
|
• Capsules (micronized progesterone, usually in olive oil)
• Troches (lozenges)
• “Melts”
• Solution in dropper bottle
|
|
T = Testosterone
|
|
Compounded bioidentical hormones available through compounding pharmacies
|
|
• Compounded topically-applied cream, gel, or lotion
|
• Solution in dropper bottle
• “Melts”
• Troches (lozenges)
• Tablets of varying doses
|
|
|
Others
|
|
DHEA
|
A hormone precursor, sometimes prescribed in support of adrenal function
|
• Compounded topically-applied cream or lotion
|
• Solution in dropper bottle
• “Melts”
• Tablets
|
|
|
Pregnenolone
Cortisol
Thyroid hormones (T3 and T4)
|
Most women don’t think of these as forms of hormone replacement therapy, but
prescriptions are sometimes individualized and compounded for women. In particular,
many women do well on natural forms of thyroid hormone replacement.
|
|
• Solution in dropper bottle
• Tablets
• Capsules
|
|
Getting natural estrogen
It is easier nowadays to make it clear you want to avoid Premarin-based products.
Because Premarin is made from horse urine and has been implicated in the increased
health risks seen in studies such as the WHI — as exploited by the media —
there are many women in your position. Estradiol is bioidentical estrogen that is
now readily available in many forms (see table). Estradiol is the primary biologically
active estrogen that changes in menopause, and it’s the one that usually matters
most for estrogen replacement.
We do suggest you avoid estradiol in the pill forms that must be swallowed. We now
know that any form of estrogen taken orally, even bioidentical estrogen,
can induce the liver to make more blood-clotting factors and can increase the risk
of stroke. It also drives up a protein that binds up hormones over time, and can
disrupt blood sugar and triglycerides as well. That means that taking oral estrogen
pills of any kind can, over time, affect your body in ways that are problematic.
This does not include the sublingual (under the tongue) troches or “melt”
products, which pass directly into the blood stream through the thin membranes of
the mouth, bypassing the GI system and liver.
The latest evidence suggests that low-dose estrogen delivered by transdermal
(through the skin) methods, such as patches, creams, or sprays, is superior and
lacks the negative effects associated with oral formulas. Transdermal delivery should
be the first-line approach when using estrogen these days, but some conventional
practitioners may not be aware of these options. Often it’s worth bringing
the subject up yourself — you could say to your practitioner, “I’m
interested in estradiol in a form that goes through the skin. Have you read the
studies that suggest delivery of estradiol through the skin looks more desirable
than pill forms of estrogen?” There have been numerous studies pointing favorable
to the efficacy and relative safety of transdermal estradiol, so they should have
no problem with this request. (One important note: birth control patches such as
the one sold under the name Evra are not the same as transdermal estradiol.)
The FDA has approved many brands of estradiol patches for many years, and they are
a wonderful option that is usually well covered by insurance (see table). There
are even generic estradiol patches. Some types tend to be larger, thicker, or have
a more irritating adhesive. Estradiol patches also come in many doses, ranging from
0.014 mcg to 0.1 mcg per day, so I usually suggest starting in the middle (about
0.05 mcg per day) and adjusting up or down, based on response. Younger women usually
need the higher doses to begin with, while postmenopausal women often do well with
lower doses.
Patches are not for everyone, as skin sensitivities or hot humid climates can result
in irritation, but there are also gels, lotions, and even a topical spray for estradiol
(see table). These forms do tend to be more costly as they’re newer, but they
all deliver bioidentical estradiol through the skin.
There are also estradiol products that target the genital tissues directly, such
as the vaginal or urethral tissues where they are applied or worn, without exposing
the rest of your body to the hormones in the products (the exception is the brand-name
vaginal ring called Femring, which does deliver a systemic dose of estradiol).
Getting bioidentical progesterone
For most women — though not all — bioidentical progesterone has a calming,
mood-stabilizing, overall net positive for mood and well-being. Synthetic progestins,
on the other hand, such as medroxyprogesterone acetate (MPA) and norethindrone acetate,
tend to be associated with a set of net unpleasant effects. We rarely prescribe
synthetic progestins, but there are particular circumstances when certain women
can benefit from them, such as with uncontrolled heavy bleeding. This is one reason
having a full range of choices is to our advantage.
When progesterone therapy is called for, we do greatly favor the use of bioidentical
forms, whether in low-dose over-the-counter creams, compounded prescription-strength
preparations, such as creams, “melts” and troches (tro’-keez),
or in the sole brand-name, FDA-approved prescription-strength called Prometrium.
If you have a uterus, and you go on estradiol estrogen replacement, a prescription-strength
dose of oral progesterone (as in Prometrium) is needed to protect your uterus.
If you have had a hysterectomy, you may find that a low-dose, over-the-counter progesterone
cream is right for you. Other women who are post hysterectomy choose to complement
their estrogen replacement therapy with botanical support, such as chasteberry,
wild yam, and other herbs that mimic or complement natural progesterone, using it
instead of, or in addition to, bioidentical progesterone. (Chasteberry and wild
yam are two of the phytotherapeutic ingredients in our Herbal Equilibrium).
Oral progesterone doesn’t have the same risk profile as oral estrogen, by
the way; it has an entirely different set of molecular actions in the body. The
progesterone in Prometrium is derived in a laboratory setting from yams or soybeans,
then micronized in (peanut) oil, to allow for better absorption. (If you’re
allergic to peanuts, you should avoid Prometrium.) Because of its calming effects,
it’s best taken at night, and taking it with a bit of food also enhances absorption.
Troubleshooting and making adjustments
As explained above, you can obtain a prescription for bioidentical hormones by requesting
any one of the standard-dose, FDA-approved bHRT products listed below by name. If
you find that one brand of bHRT doesn’t work well for you, you can always
ask to try a different one, or even a different combination.
At our clinic, we even sometimes find a woman does best with a brand-name form of
bHRT used simultaneously, in combination with a compounded bioidentical cream, lotion,
gel, or lozenge. For example, she might use a trademark estradiol patch each week,
together with a compounded prescription-strength progesterone cream during the second
half of her cycle, mixed with a small amount of testosterone. She’s unique,
and so are you.
But there are situations where a bioidentical version from a compounding pharmacy
is more desirable. Among these are the following situations:
- Prometrium can be costly if not covered by insurance, and a bioidentical progesterone
from a compounding pharmacy can be a less expensive option. Even those practitioners
who don’t normally prescribe compounded hormones may be willing to do so when
cost is an issue, so be up-front with your provider if expense is a concern.
- If you are allergic or sensitive to peanuts, you would want to avoid Prometrium
altogether, so a compounded peanut-free version is the only other prescription-strength
option for bioidentical progesterone. (Many compounding pharmacies suspend the progesterone
in olive oil instead of peanut oil).
- For others, Prometrium taken orally is too sedating or has depressive side effects,
though that is rare. Cutting the dose, or adjusting the time you take it, can often
help. It’s also possible to insert the capsule into the vagina, to be more
directly absorbed, which can help eliminate these side effects (but talk to your
practitioner about that alternative). Sometimes women just do better if they have
their provider prescribe progesterone from a compounding pharmacy, in a similarly-dosed
capsule, troche, melt, or topically-applied cream.
These are all prime examples of why the service that compounding pharmacies provide
is essential to our well-being.
Things to avoid — combination patches or products
We generally don’t recommend combination patches such as Climara Pro or the
CombiPatch, because although the estrogen used in them is bioidentical estradiol,
the progestin agent is a synthetic rather than a bioidentical progesterone. If it
is the only choice because Prometrium is unavailable or you are allergic to it,
then it is reasonable to accept a combination patch, and it’s probably a better
choice than any combination oral formula.
We also do not suggest combination pills like Prempro, Premphase, Estratest, Activella,
FemHRT, and Angeliq due to concerns about side effects of oral estrogens and synthetic
hormones. Many women are, however, on a combination compounded bHRT pill or cream
with several hormones in it. At our clinic, we find that the decision on whether
to deliver hormones separately or in combination depends entirely on the individual
patient’s response — there’s no single regimen that fits everyone.
Starting with the ABC’s
When considering HRT for menopausal symptoms, here’s what we’ve learned
through working with thousands of women, one at a time, in our clinic and Personal
Program:
To fully heal hormonal imbalance, a woman needs a strong foundation of optimal nutrition
and the desire and ability to make healthy lifestyle choices.
The ABC’s of hormonal balance in menopause
- Adequate, healthy nutrition
- Begin healthy lifestyle changes
- Consider targeted phytotherapy
Eating right and taking care of yourself are needs that never go away, and when
honored, reap multiple benefits. This is the foundation encouraged at our clinic
as a must, before and during the use of any additional HRT. The next best step for
you is to layer targeted phytotherapy onto the foundation of core nutrition and
healthy living, for gentle upstream support of hormonal pathways.
With time and patience, this three-tiered natural approach allows many women to
avoid hormone replacement altogether; helps those women who need or desire HRT to
get the best results; and smoothes many women’s transition off HRT, when the
time comes for that.
We hope this article can help you get the results you want. For women who opt to
join the Personal Program, we offer one-on-one consultations with our Nurse–Educators
for in-depth discussion of these concerns. We can also help you learn to work in
full partnership with your practitioner, as we find once women understand key concepts,
they become their own best health advocates.
Our Personal Program is a great place to start
The Personal Program promotes natural hormonal balance with nutritional supplements,
our exclusive endocrine support formula, dietary and lifestyle guidance, and optional
phone consultations with our Nurse–Educators. It is a convenient, at-home
version of what we recommend to all our patients at the clinic.
If you have questions, don't hesitate to call us toll-free at
1-800-798-7902. We're here to listen and help.
Related to this article:
References & further reading for
bioHRT options & alternatives
Last Modified Date: 05/25/2011
Principal Author: Marcy Holmes, NP, Certified Menopause Clinician