Dr. Jim Smith's Center for Advance Medicine

Preliminary Results of Multi-Centered, Double Blind, Placebo Controlled, Cross-Over Study Evaluating Endogenous hGH Levels with Serial hGH Radio-Immunoassay Levels
After Trans-Dermal GH Releasing Hormone Analog (Trans-D Tropin®) Administration.

Rashid Buttar, DO, James Biddle, MD, Rajiv Chandra, MD, Terry Grossman, MD,
Clarence Norris, MD, James Smith, DO, Annette Stoesser, MD, Dean Viktora, PhD

Serial hGH radio-immunoassay testing has clearly established rapid and direct increases in ENDOGENOUS hGH levels with Trans-D Tropin® usage. This trans-dermal GH Releasing Hormone analog is the first hope of sustaining youthful and effective hGH levels naturally and conveniently.

The majority of published medical literature and current research have raised the question, if not definitively established the unreliability, of IGF-1 as an indicator of efficacy of hGH therapy. This study and clinical observations further indicate an actual inverse relationship between IGF-1 and effective hGH treatment, extensively supported by current medical research.

The only definitive method for precise evaluation of GH treatment is by DIRECT MEASUREMENT of ENDOGENOUS hGH. However, this test usually is not obtained by the clinician. One reason for this is, up until now, no generally available GH therapeutic modality has ever been shown to effectively increase ENDOGENOUS hGH levels in a sustainable manner. As a result, the testing of hGH has usually been reserved for evaluation in hGH deficiency and short stature syndromes.

Another major reason why hGH levels have not been measured as a standard is because natural physiological release of ENDOGENOUS hGH is pulsatile. Therefore, the very transitory nature of ENDOGENOUS hGH makes it difficult to measure.

Average levels of ENDOGENOUS hGH were measurably increased per radio-immunoassay by over 750% within 30 minutes of Trans-D Tropin® application. In some patients, there was even an increase in ENDOGENOUS hGH levels as early as 5 minutes post Trans-D Tropin application. The percent change in endogenous hGH levels were also measured in 117 patients from baseline to 90 minutes after Trans-D Tropin® administration.

There was an increase of 462% in ENDOGENOUS hGH levels from baseline to 90 minutes after using Trans-D Tropin® during first time usage. After 2 weeks, there was an increase of over 815% in ENDOGENOUS hGH levels from baseline to 90 minutes after using Trans-D Tropin®. At week 5, there was over a 1754% increase in ENDOGENOUS hGH levels within 90 minutes of using Trans-D Tropin®, compared to baseline.

In addition to increasing ENDOGENOUS levels of hGH, Trans-D Tropin® demonstrated changes not seen with hGH injection therapy. Consistent decrease in Cortisol, Insulin and IGF-1 levels were noted. Dramatic and rapid improvements in muscle strength, endurance, insomnia, anorexia, and sense of well-being were also noted. Trans-D Tropin® is not only more efficacious, but the safety, convenience, cost advantage, compliance and natural physiological emulation are factors which make it a far more preferable treatment modality than recombinant hGH injection therapy.