TransD-Tropin Study by liuhongmei


									                                                                        TransD-Tropin Study
Accelerated and efficacious results using variable somatotroph and hypothalamotroph
specific poly-peptide combinants utilizing a trans-dermal delivery mechanism (td-ghrh-a)
as an alternative to recombinant human growth hormone injection therapy
Rashid A. Buttar, DO, FAAPM, FACAM; Dean C. Viktora, PhD; Michael E. Quinn, EMT-P

Objective: A patient outcome based study was conducted to investigate the possible efficacy of certain somatotroph and
hypothalamotroph specific poly-peptide combinants which appear to emulate the action of GHRH resulting in a highly efficacious
release of endogenous GH.
Background: Although the GH injections and secretagogues do offer many benefits for the limitations of aging, the need for a
safer and more effective modality of therapy has long been warranted.
Methods: Of the 35 patients that were started on the study, 30 completed the full study. Groups were divided into sedentary
and athletic groups. A total of 22 subjective criteria were monitored including: sense of well being, overall energy, mental clarity,
emotional stability, memory improvement, mood improvement, skin thickness, skin elasticity, wrinkle disappearance, new hair
growth, skin texture, healing of old injuries, healing of overall injuries, range of motion, incidence of illness, body contour
change, facial contour change, sexual frequency, sexual stamina, libido, quality of erection/arousal, and change in nocturia.
Objective criteria measured were muscle strength, overall energy, exercise endurance and quality of sleep. Laboratory data
consisting of pre-and post- treatment IGF-1 levels and base line chemistries were also obtained. Changes were recorded by a
self-assessment methodology utilizing a scale of -5 to +5 with 0 as base line. This accepted modality of evaluation with previous
precedent having been set was chosen for this patient outcome based study.
Results: Within the first week, changes experienced were overwhelmingly positive. Improvements were reported of 282.98%
in the female subjects and 352.38% in male subjects. Muscle strength increased by 81.0%. Endurance increased by 60.0%.
Quality of sleep improved by 92.6%. Overall energy increased by 71.4%. Total mean improvement of all 4 objective criteria
increased by 76.6%. Interestingly, the 3 week post study IGF-1 levels dropped 20.39% within both athletic and sedentary
study groups with a 27.16% drop in IGF-1 levels in the female patients and a 14.61% drop in IGF-1 levels in the male patient
Conclusions: Efficacy based upon subjective criteria was far beyond expectation. Objectively measured increases in muscular
strength conclusively show this TD-GHRH-A (trans-dermal GHRH analog) to be clinically superior for resistance training
as compared to hGH injections. Simplicity of trans-dermal administration also appears to lead to a greater level of patient
compliance. Substantial improvements in all criteria are further validation of this TD-GHRH-A (brand name Trans-D Tropin® as
not only an effective alternative to hGH injections but perhaps a replacement of the more costly, potentially dangerous and less
compliant injection treatments. The lack of correlation between clinical improvement and increasing IGF-1 levels also warrants
re-evaluation of our currently accepted understanding of IGF-1. These results strongly warrant further clinical research of this

3505 Austin Bluffs Pkwy., Ste. 101                                                              Tel:800-888-9358/719-262-0022
Colorado Springs, Colorado 80918                                                                Fax:800-556-5893/719-262-0035
w w w. c o l l e g e p h a r m a c y. c o m                                           
                                                                        TransD-Tropin Study
ACCELERATED AND EFFICACIOUS RESULTS USING                           Although the GH injections and secretagogues do offer
VARIABLE SOMATOTROPH AND HYPOTHALAMOTROPH                           many benefits to counteract these limitations associated
SPECIFIC POLY-PEPTIDE COMBINANTS UTILIZING A                        with aging,3,48,57 the need for a safer and more effective
TRANS-DERMAL DELIVERY MECHANISM (TD-GHRH-A)                         modality of therapy has been warranted.1 The necessity for
AS AN ALTERNATIVE TO RECOMBINANT HUMAN                              a therapy offering a greater spectrum of results, providing
GROWTH HORMONE INJECTION THERAPY                                    an accelerated and rapid onset of subjective and objectively
Rashid A. Buttar, DO; Dean C. Viktora, PhD; Michael E. Quinn,       measurable efficacy, with a safer profile, a more efficient
EMT-P                                                               delivery mechanism, and an ease of administration leading
                                                                    to better patient compliance has led to the advent of Trans-D
Background: The advent of Anti-Aging Medicine and man's             Trans-D Tropin® is a unique combination of a number of various
long quest for the "Fountain of Youth" have propelled the           multi-chained somatotroph-specific and hypothalamotroph-
concept of Longevity from a figment of yesterday's fantasies        specific15 poly-peptide combinants, synthesized together with
into a viable and effective medical based science of today.1        an isolated complex of plant derived supporting precursors.
The age-reversal effects of GH (human growth hormone or             The active poly-peptide combinants are designed with the goal
hGH) injections have been conclusively shown in a number of         to mimic GHRH (GH releasing hormone) action.28,29 The result
published studies.1,2,3,28 Efficacy was evidenced by consistent     is a unique GHRH analog which results in potentiation and
improvement in a variety of subjective and objectively              release of endogenous GH.4,26,29 The final substance is then
measured factors.33,41,45 These included an increase in lean        synthesized into a proprietary base of essential fatty acids16
body mass, decrease in body fat, increase in stamina and            known as Evito®, a technologically advanced mechanism of
endurance, improved cognitive function, improvement in              trans-dermal delivery.25
libido, immune enhancement, faster resolution of injuries and
various other attributes of youth.46,47,48,57 However, there are    The trans-dermal delivery mechanism allows frequent dosing
numerous side effects with the injection therapies such as          up to 4 times daily21,61 without compliance being an issue. This
joint effusions, cardiomyopathy, peripheral edema, allergic         method of delivery allows for rapid onset of action and provides
reactions, and decrease in endogenous hGH production.1,2,29         a means by which the body's own natural response can be
In addition, the obvious lack of compliance as with any injection   mimicked. The small but frequent pulsatile stimulation by this
treatment and the high cost associated with treatments, led to      unique poly-peptide complex referred to as a GHRH analog
the advent and the rapid popularity of the oral growth hormone      (Trans-D Tropin®, imitates the body's natural mechanism
secretagogues. Although far safer than the injections, the          of releasing GHRH and results in an effective and superior
results of the secretagogues are less impressive and far more       release of endogenous GH.18,26,27
subtle, sometimes taking more than a few months before              Method:
changes are noted. Difficulty with achieving consistent results     The majority of patients on GH injections achieve a less than
with the secretagogues involve the immense vacillation in           satisfactory response to therapy within the first few months
gut absorption in our population as well as the necessity of        due to inhibition of GH responsiveness to GHRH.7,8,9,14,17,24
ingesting the secretagogues on a stomach empty for 4 hours.         As a result, a short duration study was determined to be
These issues lead to a great variability in absorption and          the most accurate method of ascertaining the rapid efficacy
compliance, and thus in efficacy of the secretagogues.              of this GHRH analog as compared to GH injection therapy
Purpose: The numerous potential benefits associated with GH         as well as the lesser effective and over sensationalized oral
(human growth hormone or hGH) treatment have generated              secretagogues.
a number of studies on variable anti-aging treatments and           The patients chosen for the study were divided into two groups.
extensive research to further the understanding of the aging        The first group was comprised of well trained, conditioned
process. Simply to extend life is no longer the challenge, but      athletes and the second comprised of average activity to
rather to improve the duration of life as well as the quality       sedentary individuals. Ages varied from 25 to 85 years of
of that extended life. The answer that we seek as clinicians        age. The well-conditioned athletic group was chosen based
is how to effectively inhibit, or at least slow down this aging     upon level of physical fitness and a history of consistently
process and thus prevent the associated debilitating limitations    high intensity athletic activity, for a minimum of 12 consecutive
which are accepted by society as being inevitable as we grow        months prior to onset of the study. All but two patients in this
older.1,3,6,48,57                                                   category were competitive power lifters, body builders, or
                                                                    professional athletes.

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                                                                         TransD-Tropin Study
All subjects had preliminary IGF-1 levels measured. Most were        disappearance, new hair growth, skin texture, healing of old
within the normal reference range for their respective ages but      injuries, healing of overall injuries, range of motion, incidence
a few were well below the normal values. In addition, baseline       of illness, body contour change, facial contour change, sexual
chemistries with liver functions, cholesterol and triglycerides      frequency, sexual stamina, libido, quality of erection/arousal,
were measured. The "n" number for this preliminary study was         and change in nighttime urination.3 The major objective
30 with a total of 14 men and 16 women. A multi-centered             criteria measured was muscle strength, but overall energy,
study with a much larger "n" has been initiated.                     exercise endurance and quality of sleep were also objectively
The athletic group was anticipated to be the least responsive        measured.
group since attaining a rapid response in a trained and              Lastly, to rule out or minimize placebo affect, the number
conditioned athlete is a significantly more difficult outcome        of repetitions of the last set during exercise was used as a
to achieve.5,6,10,52 This may be due to higher levels of             measurement of improvement as opposed to maximum lift
circulating GH found in athletes due to the exercise induced         capacity. Although all the study subjects dramatically increased
effects.5,6,10,48,52,57 The older group was selected since GH        their maximum lift capacities, the number of repetitions of the
levels begin decreasing noticeably as we age.6,7,8,10 The result     last set (performed at a higher weight) were deemed to be more
is 40% of all individuals over the age of 60 years are deficient     significant since placebo effects are usually not reproducible.
in GH33,58 and are suffering from various sequelae of GH             The logic used was that it would be difficult to attribute an
deficiency usually attributed to aging.2,3,29,41,42,43,44,49         increase in strength by 50 lbs. in a specific exercise to a
However, as previous studies have already established, the           placebo effect when the exercise was performed for 10 to 12
level of circulating GH may not be as important as establishing      repetitions.
GH responsiveness to GHRH.7,8,9,14,17,24 The decrease in             Results: The noticeable improvement in all criteria monitored
responsiveness of GH as we age may be due to insufficient            reveals the true benefits of increasing endogenous GH
GHRH secretion or possibly by a change in regulation of              production and its effect on increasing GH responsiveness to
somatostatin (a GH antagonist).13,15,19 It appears that this         GHRH.7,8,9,14,17,24 An important benefit associated with effective
dysfunction at the pituitary-hypothalamic axis is where the          increase in GH levels and the subsequent reversal of the aging
effects of this GHRH analog seems to be most apparent.9,17           process is actually a sequelae of the natural up-regulation of
All study subjects were provided with a detailed log sheet and       all the various hormonal levels.11,12,41,44 Clinical confirmation
required to document all changes for each criteria on a scale        was established during the study by changes in such criteria
of -5 to +5 with 0 being no change and +5 being maximum              as libido, sleep and stamina.
improvement. Since all study patients showed a net positive          Graph A indirectly depicts the improvement in many of these
effect, the negative scale on the graphs is not displayed.           secondary hormonal responses. All changes in subjective and
Baseline for all criteria was zero at the initiation of the study.   objective criteria that were monitored and measured in the
This methodology of assessment for a clinical study by               form of patient experience within the first 84 hours of treatment
ranking positive and negative changes on a +5 to -5 scale            are represented below with the plotted values detailed and
is an accepted modality of evaluation with previous studies          explained.
having set the precedent.20
Study subjects applied a specified number of drops 3 times
a day on the flexor surface of the forearms with a number of
days off per week.18,21,22,29,61 Times of application corresponded
to the natural release of GHRH in humans.21,22,29 The study
was designed to show the accelerated changes within the first
3 weeks of usage but due to the rapid results seen within just       Total improvement per patient was summed and negative
a few days, the study duration was changed. All subjective           changes subtracted from the total, per time period. This
data was recorded at 12 hour intervals with study duration           number represented the total sum of changes experienced
being 84 hours (7 data samplings).                                   by each individual study patient. The numbers generated
The subjective criteria that patients were required to record        (representing each patient’s total net improvement) were then
included the following: sense of well being, overall energy,         combined to obtain the mean of all study patients per time
mental clarity, emotional stability, memory improvement,             period with the calculated values plotted below by sex.
mood improvement, skin thickness, skin elasticity, wrinkle           The mean overall improvement measured by changes

3505 Austin Bluffs Pkwy., Ste. 101                                                               Tel:800-888-9358/719-262-0022
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                                                                        TransD-Tropin Study

                                                                    by 60.0%. Quality of sleep improved by 92.6%. Overall energy
                                                                    increased by 71.4%. Total mean improvement of all 4 objective
                                                                    criteria increased by 76.6%. It is important to note that this
                                                                    percent change (increase) does not reflect the initial changes
                                                                    that became evident within the first 12 hours of initiating
                                                                    Initial and three week post treatment IGF-1 levels and
                                                                    chemistries (comprehensive metabolic profile) were drawn
experienced by the study group from 12 hours post onset of          to assess improvements in glucose stabilization, as well as
study to 84 hours post onset of study increased substantially,      cholesterol / triglyceride levels to further delineate objective
with a 282.98 % change in female test subjects and 352.38 %         improvements. An interesting observation was noted in the
change in male test subjects. The change experienced was            pre-study IGF-1 levels obtained in the conditioned athletic
overwhelmingly positive.                                            group compared to the sedentary patient population,
Graph B depicts the sum totals for all four specific objective      contradicting the conventionally accepted principals regarding
criteria per 12 hour time period as represented by one data point   the interrelationship between GH and IGF-1 levels. This
per time period. Each data point represents two objectively         observation was further substantiated with the post study
measured quantitative criteria, specifically muscle strength        IGF-1 levels obtained 3 weeks after treatment was initiated.
and exercise endurance, as well as two qualitative objective        The oldest patient in the conditioned athletic group was 38
criteria, specifically quality of sleep and overall energy.         years old. All were in excellent health and medical condition.
                                                                    Conversely, the sedentary group ranged in ages from 32 to 85
                                                                    years old with variable health, some with extensive medical
                                                                    conditions. Yet, in overall comparison, the sedentary patient
                                                                    population had a statistically significant higher measurement
                                                                    of pre-study IGF-1 levels than the athletic group.

                                                                    The highest IGF-1 level measured in the athletic group was
                                                                    only 196 ng/ml. In comparison, a few patients in the sedentary
The data (plotted on Graph B) shows the mean improvement            group had IGF-1 levels in the 200 to 300 ng/ml levels with
measured from 12 hours to 84 hours post onset of study to           the highest measured at 304 ng/ml. Yet, the sedentary group
have also increased substantially. Changes were as follow:          represented a mean patient population far older than that of
Muscle strength increased by 81.0%. Endurance increased             the athletic group. In general, the female patients appeared

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                                                                          TransD-Tropin Study
to have a slightly higher mean IGF-1 level in both patient            male with severe atherosclerotic coronary artery disease and
populations.                                                          a history of multiple myocardial infarctions in the past. The
The 3 week post study IGF-1 levels, on the average, dropped           second patient, representing the trained, conditioned athletic
across the board in both the athletic and sedentary study             test group was a 30 year old male with no previous medical
groups. The female pre-study IGF-1 mean was 186.3 ng/ml               history and with a 15 year history of lifting weights. Further
and decreased to a post-study IGF-1 mean of 137.5 ng/ml,              review of the patient’s history revealed a use of amphetamines
representing a 27.16% drop in IGF-1 levels in approximately           to facilitate workouts and steroid use 2 years prior to the onset
a 3 week period. The same observation in the males of both            of the study.
study groups was also noted, with a pre-study IGF-1 mean of
159.7 ng/ml decreasing to a post-study IGF-1 mean of 136.3
ng/ml, representing a 14.61% drop in IGF-1 levels in the same
time period. The overall drop in IGF-1 levels was 20.39%
within both study groups.

The effects of GH do not appear to alter the pituitary-hypothalmic
axis at the blood chemistry level.40 The preliminary data
accumulated during this study further indicates the unreliability
of IGF-1 levels as a predictor of GH treatment efficacy.34,35,53,54
Further review of the literature supports an inverse correlation
between GH levels and IGF-1 levels.31,32,36,37,39 Only one
reference was found showing an increase in IGF-1 after GH
therapy but only after 6 to 12 months of treatment.60
A possible correlation between stress and lower levels of
IGF-1 became apparent as the data accumulated. Individuals
found to be under significant mental and emotional stress (life
style or vocational factors), who subjected their bodies to a
higher level of physical stress (athletes or body builders under
caloric restrictions) and those suffering from chronic pain or
depression, were noted to have the lowest measured IGF-1
levels. This observation is further evidenced and extensively
supported in the literature.30,43,44,50,51,55
The last set of graphs displayed in the next column represent
the changes in the objective criteria for a typical study patient
from each of the two test groups. The first patient, representing
the older, sedentary test group was a 65 year old, obese

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                                                                        TransD-Tropin Study
The information presented in the above graphs clearly displays      but an increased consumption of water was found to be the
an accelerated rate of response to Trans-D Tropin® in both          etiology of the polyuria. Virtually all patients described an
patient subjects. In addition, the recovery time post exercise      increased craving for water and protein within the first few
was substantially decreased in both patients, especially in the     days of treatment. In light of the increase in metabolism and
65 year old, obese male with a history of multiple myocardial       the decrease in body fat experienced by the study subjects,
infarctions. Prior to therapy, onset of angina occurred within      the increase in water and protein consumption is a logical
7 to 10 minutes of initiating exercise activity on a treadmill.     conclusion. Water is the most abundant substrate and protein
Within the first three weeks of treatment, exercise tolerance       is life’s building block, both found in all living organisms and
substantially increased to 35 minutes of the same type activity     essential for existence.
on the treadmill with no evidence of angina. This clinical          Conclusion: The physiological changes attained with Trans-D
observation attributed to increased GH levels was further           Tropin® up to this point, have been unprecedented. Efficacy
supported in the literature.46,47,56                                was far beyond expectation. Response was not secondary
In the “Overall Energy” graph, it should also be noted that the     to increase in sympathetic tone as evidenced by all patient’s
drop at 72 hours in the conditioned athlete was secondary           vital signs remaining well within normal range. Furthermore,
to the patient having missed three doses at the 72 hour time        although an increase in energy was noted, a marked
period (two doses before and one dose after). However, as           improvement in quality of sleep was experienced throughout
evident on the graph, recovery of overall energy was virtually      the study group, despite taking the last daily dose immediately
immediate once treatment was resumed.                               prior to bedtime, indicating that energy increase was not due
lthough of less significance from a medical standpoint, there       to sympatheto-mimetic changes.
were a number of aesthetic improvements noted among the             The significance of this study’s results become more dramatic
great majority of study subjects within the first 10 to 14 days     when the relatively short time period is considered in which the
after beginning treatment with this GHRH analog. Despite            levels of improvement were attained.21 In addition, it appears
one patient who had a noticeable change in facial wrinkles          that just the simplicity of trans-dermal administration would in
around the eyes within 3 days after initiating treatment, most      itself, lead to a greater compliance and improved treatment
physical changes were not evident within the first 84 hours by      efficacy.24
the majority of study subjects.                                     The preliminary results of this study warrant further research
However, almost all noted either a facial and/or body contour       to assess the various medical applications in which Trans-D
change within the first 21 days after initiating treatment . All    Tropin® administration may offer a greater benefit compared
subjects over the age of 25 noted some type of improvement          to GH injections. Further clinical trials are necessary to
in skin texture described either as “tightening” or a decrease      determine the efficacy of this GHRH analog in diabetes,
in “flabbiness” in areas such as the facial cheeks, under the       atherosclerosis3, HTN, chronic injuries41, GI disorders45,
chin, upper arms (older females especially), hips, thighs           obesity, cognitive dysfuntion58, compromised immunity33,44,
and abdominal areas. Within 30 days, all obese patients             chronic medial conditions1,2 and critically ill patients49.
experienced loss of inches in various areas without any             All patients experienced rapid improvements in a relatively
significant change in exercise routine or lifestyle modification.   short period of time. Yet, the unexpected and sustained
Other changes noted that were felt to be of significance            drop in IGF-1 levels in virtually all patients in the study was
included the resolution of chronic debilitating injuries such as    diametrically opposed to the generally expected increase
shoulder and low back injuries (in 3 cases the injuries were        in IGF-1 levels. The consistent lack of correlation between
refractory to multiple treatment modalities, each over a period     clinical improvement and increasing IGF-1 levels warrants
of 2 years or more). In addition, improvement in hormonal           further research and re-evaluation of our currently accepted
imbalances (hot flashes refractory to treatment), menstrual         understanding of IGF-1 levels.34,35,40,53,54
pain, libido, range of motion and accelerated healing of recent     The objectively measured increase in muscular strength
wounds with minimal scarring were noted.                            conclusively shows this GHRH analog to be clinically superior
No side effects were reported. However, onset of acne               in maximizing all aspects of resistance training (as in power
was noted in a number of patients which was attributed to           lifting and body building) as well as significantly improving
physiological changes consistent with reestablishing a              endurance and recovery time compared to hGH injections.
younger biological age closer to adolescence. An increase in        The rapid and substantial improvements in all other criteria are
nocturnal micturition was also noted in most study subjects         further validation of Trans-D Tropin® as not only an effective

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                                                                                         TransD-Tropin Study
alternative to hGH injections but perhaps a replacement of                          to 90 minutes post Trans-D Tropin® administration with
the more costly, potentially dangerous and less compliant                           interval measurements at 30 minutes and 60 minutes post
injection treatments.                                                               treatment. Measurements were taken at treatment initiation,
Post Study Follow Up: At the one year post study interval,                          with subsequent measurements at week 2, week 5 and week
nine of the original 30 patients were lost to follow-up. Of                         8. Control group was then crossed over into the experimental
the remaining 21 patients, 17 patients were found to have                           group.
continued using Trans-D Tropin®. All 17 patients reported                           An average increase of 462% in endogenous hGH levels
continued improvement in all subjective responses monitored.                        was noted at 90 minutes, compared to baseline during initial
All patients reported experiencing further changes which                            treatment. Within 5 weeks of treatment initiation, the response
included facial contour and body contour changes, as well as                        of endogenous hGH increased to 1754% at 90 minutes post
changes in skin, hair and peripheral adipose distribution. Of                       treatment, compared to baseline using this trans-dermal
these 17 patients who continued treatment, 11 still participated                    GHRH analog.
in a regular exercising regimen. Two of the patients reported                       Other interesting objective observations were also noted,
adverse outcomes consisting of comedogenic lesions and the                          indicating the need for revision of our current understanding
return of menstrual flow in a post-menopausal female patient.                       regarding GH replacement therapy. Cortisol levels and IGF-1
However, both findings are consistent with and indicative off a                     levels consistently dropped in the experimental (trans-dermal
reversion to that of a younger physiological state.                                 GHRH analog) group. The final results of this study will be
Preliminary results of a multi-centered, double blind, placebo                      released upon completion. Multiple other studies are already
controlled, cross-over study conclusively demonstrate the                           underway to further assess the efficacy of this trans-dermal
efficacy of this trans-dermal GHRH analog. Serial serum hGH                         GHRH analog, which shows promise as an effective method
radio-immuno assay levels were measured from baseline                               of increasing endogenous GH levels.

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3505 Austin Bluffs Pkwy., Ste. 101                                                                                    Tel:800-888-9358/719-262-0022
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w w w. c o l l e g e p h a r m a c y. c o m                                                                 
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3505 Austin Bluffs Pkwy., Ste. 101                                                                                     Tel:800-888-9358/719-262-0022
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3505 Austin Bluffs Pkwy., Ste. 101                                                                                    Tel:800-888-9358/719-262-0022
Colorado Springs, Colorado 80918                                                                                      Fax:800-556-5893/719-262-0035
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