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
(For a full selection of options, see natural treatments for vaginal dryness.) |
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) |
These are not generally regarded as, or categorized as forms of hormone replacement therapy, but prescriptions are sometimes individualized and compounded for individuals |
|
• Solution in dropper bottle |
|
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). For an overview of these products, their pros and cons, and typical uses, see our table of treatments for vaginal dryness.
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.
We’re always happy to welcome new patients to our medical clinic in Yarmouth, Maine, for those who can make the trip. Click here for information about making an appointment.
Related to this article:
References & further reading for bioHRT options & alternatives
Original Publication Date: 03/02/2009
Last Modified: 08/17/2009
Principal Author: Marcy Holmes, NP, Certified Menopause Clinician