WHY IS MY DOCTOR SO DOUBLE BLIND
Recently, there was a study done on Testosterone replacement in older men, the results of which, were reported in the "prestigious" JAMA (Journal of the American Medical Association). In this study, elderly men with clinically low Testosterone (TotalTestosterone less than 250 ng/dl and or Free less than 35 pg/dl). In this study ALL Men were given the same dose or a placebo). The study was a double-blind crossover design. Patients were all given a topical, commercially available formula. The average elevation in total Testosterone was a paltry 100 ng and the free elevation was proportionately even less. Therefore the patients that did manage to squeak by in to the "normal" ranges, were in the bottom 5% of normal.
Not surprisingly to the experts in the Clinical, Compounding arena, the patients reported little or no benefit >95% of the time. WOW WHAT A SHOCKER !!! You raise their levels from non-existent to "pathetic" and you are surprised that the didn't report any change......HOW SURPRISING !! How about setting a target range of that for a younger man in his 20's when he , undoubtedly, felt better. With the amount they administered, patients would benefit more from a glass of water and NO, I'M NOT KIDDING !!! Are these Practitioners REALLY this stupid or are the Naive and ignorant because it HAS to be one or the other.
In addition the poor study design, other essentials were ignored. I believe this is due to a complete lack of understanding of the Male endocrine pathways. In Men, Testosterone is metabolized to 2 potentially negative metabolic pathways. 1) is via Aromatase found in adipose (fatty tissues). This enzyme converts Testosterone to Estradiol (E2). In Men, high E2 can increase blood viscosity, cause weight-gain, and slow metabolism by increasing a substance called TBG (Thyroid Binding Globulin). Worst of all, and most relevant to this study, is that high E2 in the serum shuts down normal Testosterone production. This is because the Hypothalamus receives neuronal impulses directly from E2 receptors. In theory, this feedback mechanism would work fine since under normal circumstances only a small number of receptors are occupied. HOWEVER, age related over-induction and increased body fat drastically increase serum E2 thus "fooling" the body into thinking it has plenty of Testosterone.
So, why is all of this relevant ? 1) Physiologic response to Testosterone is dose-dependent and NO ATTENTION was given to this very simple and most basic fact and 2) No compensatory mechanism was considered in patients with higher levels of body fat so in these patients, administering Testosterone would be the equivalent of trying to fill a bottomless bucket with water !!!!!
THE MORAL OF THE STORY HERE IS....JUST BECAUSE THERE IS A DOUBLE BLING STUDY, DOESN'T MEAN THE RIGHT CONCLUSION IS REACHED ! i.e. GARBAGE IN = GARBAGE OUT.
Stay tuned, our next topic will be HRT, "The Women's Heath Initiative Study" and Breast Cancer. MISLEADING THE PUBLIC !!!!