Saturday, June 15, 2013

All About Bioidentical Hormone Replacement Therapy Including Compounding


Until recently, traditional hormone replacement therapy (HRT) was the treatment of choice for menopause related symptoms, but this changed once the serious risks of long term HRT use were exposed. Bioidentical hormone replacement therapy (BHRT) has become the default treatment of choice for women who consider the risks of HRT to be too great. BHRT is a plant based product that chemically matches natural hormone produced in the body while traditional HRT is made from the urine of pregnant horses and wasn't an exact chemical match. Obviously this makes BHRT sound very attractive, but BHRT isn't without controversy. The FDA has approved many BHRT drugs for menopause treatment, but doesn't endorse or recognize the term "bioidentical" as anything other than a marketing term. The process of compounding is the biggest controversy in the production of BHRT drugs and one we'll discuss at length.

Why BHRT?

The surge in popularity of BHRT corresponds exactly with the fall of HRT which started in 2002 with the halting of ground breaking study conducted by the Women's Health Initiative. This study was a 15 year study on estrogen and estrogen and progestin combined, the common hormone treatment used to treat menopause related symptoms. This study was halted prematurely when serious health risks such as heart attacks, strokes, breast cancer and blood clots were found to be associated with both types of long term HRT use.

Not too surprisingly, once these risks were exposed, both doctors and women quickly moved away from HRT and were left looking for effective safer options; this is where BHRT steps in to fill the void.

Potential Risks of Compounding

Compounding - a compounding pharmacist mixes up a hormone blend of "bioidentical" hormones according to an individual woman's needs, which is indicated by a blood or saliva test done by a doctor.

There are several reasons that detractors say compounded bioidentical hormone therapy (CHRT) may not be the best option including:

  • The reliability of saliva testing is unproven

  • CHRT is not FDA approved

  • There has not been significant long term testing on BHRT showing that it's any safer than HRT

  • The term "bioidentical hormone replacement therapy" is nothing but a marketing term

  • A lot of false and misleading claims have been made about both CHRT and BHRT

  • Unlike with commercially prepared medications, the compounding process may increase the risk of human error in the compounding process

Although the FDA has approved BHRT drug for use, CHRT drugs are not FDA approved. This is due to the fact that these compounded medications are made on a case by case basis so each blend is different; this makes the standardized scientific testing required for FDA approval impossible, so it's unlikely that CHRT will ever get FDA approval.

In addition, in an effort to educate the public, the FDA has started cracking down on false or misleading claims. Manufacturers and suppliers of traditional HRT medications obviously don't like the fact that CHRT and BHRT are being touted as safer alternatives when actually no evidence suggests that this is true. The truth is that there is simply not enough information available at this time to say the BHRT is any safer than HRT; unfortunately a lot of people are overlooking this important fact. When you consider how long the hazards of HRT were hidden or overlooked, this is a significant oversight.

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