Is All Bioidentical Hormone Therapy The Same? Not Exactly!

Is All Bioidentical Hormone Therapy The Same? Not Exactly!
6
Aug

In my best selling book, The Estrogen Fix, there is a long discussion of bioidentical hormones for menopause symptoms. Bioidentical hormones are manufactured to be chemically identical to the naturally occurring hormones your ovaries produce during the reproductive years. Those include estradiol, progesterone, and testosterone.

 

Are Bioidentical Hormones Natural?

For many people, bioidentical hormones has come to mean natural because they are typically made from natural sources, including yams or soy. But as the North American Menopause Society (NAMS) points out in a recent MenoNote, the term bioidentical hormones is often used to refer to these identical copies of natural hormones (typically prescribed as custom mixes or compounds for an individual woman). But the fact is, the term bioidentical hormones was invented by marketers and has no clear scientific meaning.

 

First of all, they aren’t natural; they are all manufactured in a chemical plant. They are not necessarily safer. They are also not any more effective than other forms of estrogen and progestogen. What they are is identical in structure to the hormones that your ovaries made when you were younger. So they are “bio-identical.”

 

Are Compounding Pharmacies The Only Place to Get Bioidentical Hormones?

Many women and some doctors don’t realize that bioidentical hormones are not only available from compounding pharmacies, but also from traditional drugstores. NAMS recommends that, “If you prefer to treat your bothersome menopause symptoms with hormones that are chemically identical to those you produced naturally before menopause, ask your healthcare provider to prescribe estradiol and progesterone products that are scientifically tested and government approved.”

 

That quote is underscoring that estradiol found in compounding pharmacies is the same estradiol available as an oral tablet, skin patch, topical gel, topical spray, and vaginal ring in traditional chain store drug stores. They are exactly the same molecule. Chain drugstores also offer low doses of estradiol used in the vagina (to treat vaginal dryness and painful intercourse but not hot flashes). They are sold as vaginal tablets, cream, and rings. As you’ll see in the table below, bioidentical progesterone is also available as an oral capsule.

 

Does it Matter Where You Buy Bioidentical Hormones?

The one big difference between the bioidentical custom-compounded hormones and the ones sold in chain drug stores is this: the ones sold in chain drug stores are FDA regulated and each dose contains exactly the amount your doctor ordered; the custom-compounded hormones are not FDA regulated and may not contain the exact amount your doctor ordered.  Sometimes they contain more and sometimes they contain less.

 

But there is one situation where custom-compounded hormones are a real advantage. If your healthcare provider prescribes custom-mixed (custom-compounded) bioidentical hormones containing one or more natural hormones mixed in differing amounts, or if there isn’t an FDA product available for a particular hormone. So if your provider believes you need a specific mixture of hormones, or a unique dosage, or you need a hormone and there isn’t an FDA approved one available, a compounding pharmacy can create that for you because they compound them one at a time. The downside to that is the individually mixed recipes are not tested to verify they contain the right amount of hormone to be absorbed or to provide predictable hormone levels in blood and tissue.

 

Are Bioidentical Hormones Safer or Slow Aging?

Healthcare providers who prescribe bioidentical hormones often claim that custom-compounded products are safer and more effective than clinically tested and government-approved hormones produced by large pharmaceutical companies. Some also claim that bioidentical hormones slow the aging process. According to NAMS, there is no scientific evidence to support any of these claims. Government-approved hormone products are required by law to come with a package insert that describes possible risks and side effects. Custom-compounded hormones are not required to come with this information, but this does not mean they are safer. They contain the same active hormones (such as estradiol and progesterone), so they share the same risks.

 

What’s One Potential Risk of Bioidentical Hormones I Must Know?

There is one potential risk from compounded estrogen and progesterone that in particular needs more attention. If you have a uterus, you have to take both estrogen and progesterone to protect the uterine lining from developing uterine cancer. But there are no studies showing that the amount of progesterone in these custom-mixed hormones is enough to protect you from developing uterine cancer. In fact, there are several reports of women taking custom-compounded hormones developing uterine cancer. That isn’t happening in women taking FDA approved estrogen and progesterone products.

 

Also, preparation methods vary from one pharmacist to another and between pharmacies, so NAMS cautions that you may receive different amounts of active medication every time you fill the prescription. Inactive ingredients may vary from batch to batch as well. Sterile production technique and freedom from undesired contaminants are additional concerns. Cost is another issue. Most custom-compounded preparations are treated as experimental drugs and are not covered by insurance plans. Most FDA approved hormones are covered by insurance.

 

So if you want to use bioidentical hormones to control your menopause symptoms, major medical societies are suggesting you ask your healthcare provider for government-approved products containing estradiol and progesterone. There is no benefit to using custom-compounded hormones, and there may be additional risks.

 

Government-Approved Natural Hormone Therapy Products

Chart from NAMS

Systemic doses of estradiol/progesterone for treatment of hot flashes

  • Estradiol oral tablet: Estrace, generics
  • Estradiol skin patch: Alora, Climara, Esclim, Menostar, Vivelle (Dot), Estraderm, generics
  • Estradiol skin gel/cream: EstroGel, Elestrin, Divigel, Estrasorb
  • Estradiol skin spray: Evamist
  • Estradiol vaginal ring: Femring
  • Progesterone oral tablet: Prometrium, generics
  • Estradiol plus progesterone combined oral capsule: Bijuva

Low doses of vaginal estradiol for treatment of vaginal dryness and pain with intercourse

  • Vaginal cream: Estrace vaginal cream
  • Vaginal ring: Estring
  • Vaginal tablet: Vagifem
  • Vaginal insert: Imvexxy

For more information on estrogen and progesterone and menopause, read the Estrogen Fix and become a partner in your healthcare.

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