Efficacy of Bioidentical Hormone Replacement

I have been questioned by many patients whether hormone replacement therapy is safe or not.  This is a very good question, as I don't personally believe we know the true answer to that question.  Based on the Women's Health Intiative study that came out in 1996, hormone replacement therapy (HRT) is a bad thing.  That study revealed that the combination of Prover and Premarin led to things such as breast cancer, blood clots, and more.  After that time, many women were taken off of their HRT. Well, it is no surprise that women did not like to be off of their HRT, as their menopausal symptoms returned.

Bioidential hormone replacement therapy (BHRT) then came in to play.  BHRT claims to give women chemically identical hormones to the ones that naturally exist in their bodies at younger ages. These hormones are compunded in yams or soy.  The HRT study done in the 90s was based on hormones that were not biochemically identical to our naturally occurring hormones, such as horse estrogens (those found in Premarin).  Many physicians now prescribe BHRT, while other physicians continue to believe that all HRT is bad, no matter where it comes from.

There are not many studies dedicated to BHRT for women.  In fact, most physicians who prescribe BHRT claim that there are no studies with adverse effects of BHRT, and they use this as a reason to prescribe BHRT and label it as "safe"

I elected to find at least one decent study on BHRT to properly assess the actual risk versus benefit of BHRT for women.  I actually only found one study that was adequate to even consider putting it into Treatment Scores.  However, when I began to put this study into the STAR blocks, I immediately realized that this study was going to get an "F" grade.

This study compared topical BHRT to sublingual.  It claimed the "Wilcoxon signed-rank test" as the main statistic to compare menopausal symptom improvement in women.  However, the complete article was not available to read, and the abstract did not even mention results of their main statistic. Additionally, the main outcome that they measured is a way to see if 2 means differ, it does not actually evaluate and measure treatment outcomes! In order for a study to even begin to allow us to evaluate and grade it, it must be looking at treatment outcomes. The treatment outcomes in this study are things like hot flashes, night sweats, irritability, anxiety, fatigue, emotional lability, sleep disturbances, memory loss, fatigue, and libido. What they really needed to do is combine all those symptoms into a questionnaire and develop a symptom score for menopausal symptoms that is on a 100 point scale.

Again, the scientific research and it's availability to the public needs to be altered.  We need clear and concise information as physicians in order to get the best outcomes when treating our patients. Additionally, patients need to have access to the ever changing recommendations of medicine that exists today.  


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  1. So many women taking BHRT and we have no idea how its risks compare to HRT. NIH, or someone, really needs to be tracking epidemiological data.