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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 substantial increases in ENDOGENOUS hGH levels with Trans-D Tropin usage. This trans-dermal GH Releasing Hormone analog offers the first hope of naturally and conveniently sustaining youthful levels of hGH.
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.
The preliminary results of a double blind study demonstrated measurably increased levels of ENDOGENOUS hGH per radio-immunoassay in 117 patients using Trans-D Tropin. Serum hGH levels were drawn at baseline, followed by a dose of Trans-D Tropin (experimental group) or placebo (control group) with subsequent serum levels drawn at 30, 60 and 90 minutes post treatment. Average levels increased over 750% within 30 minutes of Trans-D Tropin application.
ENDOGENOUS hGH levels increased 462% from baseline to 90 minutes after Trans-D Tropin administration during first time use. At 2 weeks, over 815% increase in ENDOGENOUS hGH levels were recorded from baseline to 90 minutes post Trans-D Tropin application. By week 5, a 1754% increase in ENDOGENOUS hGH levels were achieved within 90 minutes of using Trans-D Tropin, compared to baseline. Although every patient did not respond (93.16% response rate), the data was statistically significant (P<0.001).
In addition to increasing ENDOGENOUS hGH levels, Trans-D Tropin demonstrated changes not generally associated with hGH injection therapy. Consistent decrease in Cortisol, Insulin and IGF-1 levels were noted. The majority of published medical literature and current research have definitively established the unreliability of IGF-1 as an indicator of hGH therapy efficacy. This study further supports existing research and indicates a possibility of an inverse relationship.
Rapid and dramatic improvements in muscle strength, endurance, insomnia and recovery were also noted in certain patient populations. Same subjective changes were noted in placebo group after cross-over. Trans-D Tropin appears to be not only more efficacious, but the safety, convenience, cost advantage, compliance and natural physiological emulation of GH release are factors indicating it to be a much more preferable modality of treatment than the far more expensive recombinant, synthetic hGH injection therapy.
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 substantial increases in ENDOGENOUS hGH levels with Trans-D Tropin usage. This trans-dermal GH Releasing Hormone analog offers the first hope of naturally and conveniently sustaining youthful levels of hGH.
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.
The preliminary results of a double blind study demonstrated measurably increased levels of ENDOGENOUS hGH per radio-immunoassay in 117 patients using Trans-D Tropin. Serum hGH levels were drawn at baseline, followed by a dose of Trans-D Tropin (experimental group) or placebo (control group) with subsequent serum levels drawn at 30, 60 and 90 minutes post treatment. Average levels increased over 750% within 30 minutes of Trans-D Tropin application.
ENDOGENOUS hGH levels increased 462% from baseline to 90 minutes after Trans-D Tropin administration during first time use. At 2 weeks, over 815% increase in ENDOGENOUS hGH levels were recorded from baseline to 90 minutes post Trans-D Tropin application. By week 5, a 1754% increase in ENDOGENOUS hGH levels were achieved within 90 minutes of using Trans-D Tropin, compared to baseline. Although every patient did not respond (93.16% response rate), the data was statistically significant (P<0.001).
In addition to increasing ENDOGENOUS hGH levels, Trans-D Tropin demonstrated changes not generally associated with hGH injection therapy. Consistent decrease in Cortisol, Insulin and IGF-1 levels were noted. The majority of published medical literature and current research have definitively established the unreliability of IGF-1 as an indicator of hGH therapy efficacy. This study further supports existing research and indicates a possibility of an inverse relationship.
Rapid and dramatic improvements in muscle strength, endurance, insomnia and recovery were also noted in certain patient populations. Same subjective changes were noted in placebo group after cross-over. Trans-D Tropin appears to be not only more efficacious, but the safety, convenience, cost advantage, compliance and natural physiological emulation of GH release are factors indicating it to be a much more preferable modality of treatment than the far more expensive recombinant, synthetic hGH injection therapy.
