Bioidentical Hormones versus HRT: Guest post from Compounding Pharmacist Peter Koshland

Posted by Liz on Mar 2, 2009 in bioidentical hormones | 5 comments

I’ve written  a number of posts lately about bioidentical and synthetic hormones. Hence, I am very happy to feature a guest post by compounding pharmacist and blogger Peter Kushland, on the distinction between the two.

Please welcome Peter. And stop by his blog – The Compounder’s Forum;  it’s terrific!

As a compounding pharmacist, I am often asked what is the difference between bioidentical hormone replacement (BHRT) and conventional hormone replacement (HRT).  BHRT, as described in my earlier post, is an approach to hormone replacement that has three key attributes:

1. All hormones used are chemically identical to human hormones
2. The dosage is individualized to a patent’s specific hormonal needs
3. The goal is to achieve a balance of activities of the hormones to improve quality of life

(See my post entitled ” Key Principles of Bioidentical Hormone Replacement Therapy (BHRT)” for a more detailed description)

Conventional HRT is best exemplified by the commercial drug Prempro.  Prempro is a combination drug that has both estrogens and a progestin.  The estrogens are derived from the urine from pregnant mares and the progestin is medroxyprogesterone, a synthetic hormone not found in nature.  Prempro comes in approx. 4 different dosages and is taken orally once daily.  It can be found at any pharmacy.

So let’s go down the list and talk about the differences between conventional hormone replacement (HRT) and bioidentical hormone replacement (BHRT):

• Hormones are identical to human hormones – HRT=no; BHRT=yes
• Dosage customized for individual patient – HRT=no; BHRT=yes
• Hormone balance goal of therapy – HRT=no; BHRT=yes
• Primary goal is improved quality of life – HRT=possibly; BHRT=yes
• Primary goal is to prevent disease – HRT=yes; BHRT=no

– there are some who claim that BHRT can prevent all types of diseases from osteoporosis to certain types of cancer, and although there is some scientific evidence supporting these statements, there is not enough good, solid research out there to back-up any definitive claim that BHRT prevents disease.

– Be very skeptical of anyone who claims that BHRT is going to prevent any type of disease.  With that said, there is lots of good evidence to support that BHRT is safe.

– furthermore, there is lots of good evidence that conventional HRT actually causes disease!

• close monitoring is regular part of treatment – HRT=no; BHRT=yes
• only available from a compounding pharmacist – HRT=no; BHRT=yes and no

– Here’s another area where people get confused.  BHRT does not necessarily have to be made by a compounding pharmacist.  Now, I don’t want to put myself out of a job and there are lots of reasons why a compounded product is superior to an off-the-shelf medication, but there are a handful of mass produced prescription drugs that are bioidentical.

There are various estradiol containing patches and an oral form of progesterone called Prometrium available.  Dosages and routes of administration (topical vs. oral) are limited, but these products are biologically identical to human hormones and therefore meet at least the first criteria of BHRT.

• The estrogen “estriol” is available – HRT=no; BHRT=yes

– I will discuss the specific hormones that are bioidentical in future posts

• Hormones can be given topically – HRT=sometimes (estradiol patches); BHRT=yes (any hormone)
• Drug manufactured with FDA oversight – HRT=yes; BHRT=no

– Here’s one of the areas that critics of BHRT pounce on.  Compounded bioidentical hormones are not regulated by the FDA.  This is true.  Compounding pharmacies are regulated by the state agencies that regulate retail pharmacies and for that reason the quality and potency of compounded medications can vary greatly.  With that said, a compounding pharmacy that is using the top of the line equipment and has the proper quality assurance procedures  in place will consistently exceed any standards the FDA might have for a mass produced medication.

It is important, however, to make sure you choose a compounding pharmacy that is using this equipment and has good quality assurance.  I will discuss specific questions to ask when evaluating a compounding pharmacy in future posts.

• Drugs covered by most insurance plans – HRT=usually; BHRT=sometimes

– in my experience practicing in Californa, about 25-30% if insurance plans will pay for compounded medications

• Clinical evidence to support its use – HRT=no; BHRT=yes

– This is where the critics get it wrong.  Many nay-sayers say that there is little scientific evidence to support the use of bioidentical hormones, when this couldn’t be further from the truth.  for example, the hormone progesterone has been available for almost 80 years now and there are reams of clinical trials that have looked at its efficacy and safety in a number of ways.  Also, estradiol, progesterone, and testosterone are available as mass produced pharmaceuticals and have passed the current FDA safety and efficacy standards.

Furthermore, there are good clinical trials that have studied HRT and they all show that it is dangerous, so the scientific evidence clearly does not support its use.