Methods and Materials

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Effects of Magnesium Di-Potassium EDTA
suppositories on the symptoms of Diabetes
Mellitus Type One
Spencer Feldman and Boris Ljahnicki M.D. PhD.
April 2004
ABSTRACT: 29 adults both male and female with an average age of 50, diagnosed
with Diabetes Mellitus Type 1 with complications of the feet were divided into
three Groups. 11 were given 365 mg Magnesium Di-Potassium EDTA
suppositories in a cocoa butter base for one month then placebos for an additional
month, 12 were given Magnesium Di-Potassium EDTA suppositories for two
months, and 6 were given placebos from the beginning. While significant
improvements were seen in the first month in all measured parameters, for those
that continued for 2 months, glucose decreased 54%, pulse pressure decreased 34%
and the conditions of the diabetic foot improved as measured by a 37% decrease in
total score using the (S)AD system. In those subjects with significant hypertension,
systolic BP decreased 22% and diastolic BP decreased 12.6%. The study was
open label and placebo controlled. Subjects were told to refrain from taking long
acting insulin the night before any tests were to be performed.
Methods and Materials
29 subjects diagnosed with Diabetes Mellitus Type 1 were tested before, during and
after administration of 365 mg Magnesium Di-Potassium EDTA suppositories with
blood chemistries and assessed via the (S)AD System by Rosamund M. McFarlane
(The Diabetic Foot Journal, Vol. 2, No. 4, 123-131, 1999). The (S)AD
Classification has three grades, scoring affected area, depth, sepsis, arteriography,
and denervation. Also performed was the 6 stage Simple Staging System by Ali
Foster (The Diabetic Foot Journal, Vol. 3, No. 2, 56-62, 2000). 6 subjects were
also assessed pre and post with Doppler.
The subjects were divided into three Groups. Group one consisted of 12 subjects
who were instructed to take the suppositories as follows: one per day for 14 days,
one every other day for approximately 53 days. Group, consisting of 11 subjects
two were to take the suppositories as follows: one per day for 14 days, 1 every
other day for approximately 21 days, then placebo suppositories for approximately
30 days. Group three, consisting of six subjects only received placebo
suppositories throughout the entire study.
Two of the 12 subjects from Group one did not complete the study, two of the 11
subjects in Group two did not complete the study and four of the six subjects in
Group three (the placebo Group) did not complete the study. Those in Group two
were given placebo suppositories during the 31 st through the 60 th days. Days are
given as ~35 and ~67 in the charts since some subjects were tested a few days
before or after the target dates. 35 and 67 represent the average number of days
that passed between the initial baseline testing, and the two follow up
tests/assessments. Actual testing days for both dates of subjects in both Groups
one and two are days number (29,32,32,34,36,36,36,39,54) and
(59,63,63,64,67,67,70,70,82) respectively.
Data on the placebo-only subjects is not given, as the majority of them did not
complete the study. This is understandable since they did not show any
improvement, and without any improvement, who would want the inconvenience
of going to a medical office, taking blood tests and taking suppositories. Data on
the results of Group two following the first month, after which point they too were
on placebos, is also not given. As expected, many of the gains experienced by
Group two are lost when they began placebo.
Discussion
Glucose measurements at the onset of the study (Day 0) of Groups one, and Groups
one and two combined showed average glucose readings of 348 and 361mg/DL
respectively. After the first month the average glucose reading of Groups one and
two combined decreased to 231 a 36% decrease. By the end of the second month,
the average glucose reading of Group one subjects decreased again to 159 from
their initial 348, a 189-point drop. This represents a 54% decrease in blood
glucose for Group one.
The background represents Group one and two (G 1+2), and the foreground
represents only Group one (G1)
The average pulse pressure (systolic minus diastolic) of Group one (G1) and
Groups one and two combined (G 1+2) at the start of the study were 87 and 74
respectively. At the end of the first month, the average pulse pressure for G1 and G
1+2 respectively dropped to 62 and 61. This represents a 28% decrease for G1 and
a 17.5% decrease for G 1+2. By the end of the second month, the average pulse
pressure for G1 had dropped to 57, a 34% decrease from the beginning of the study.
From a cardiological perspective, this represents (for males) a drop in the
biological age of their hearts from 75+ to 55 years of age. 1 The drop in pulse
pressure is especially significant in the light of the fact that a pulse pressure of 65
or more triples the risk of heart attack. 2
The background represents Group one (G1) and the foreground represents Groups
one and two (G 1+2)
The average systolic and diastolic blood pressures those subjects in Group one with
significant hypertension (as defined as systolic readings greater than 150) was
198/101. By the end of the second month, the average systolic and diastolic blood
pressures for this group dropped to 140/83, a 29% drop of the systolic and an 18%
drop of the diastolic. Blood pressure control can reduce cardiovascular disease
(heart disease and stroke) by approximately 33% to 50% and can reduce
microvascular disease (eye, kidney, and nerve disease) by approximately 33%. In
general, for every 10 millimeters of mercury (mm Hg) reduction in systolic blood
pressure, the risk for any complication related to diabetes is reduced by 12% 3 ,
thus the 58 point drop in systolic pressure would represent a 70% decrease in any
diabetic complications.
The background represents systolic and the foreground represents diastolic
The condition of the feet was measured both by the (S)AD classification system as
shown in the table below, as well as in a few circumstances, by Doppler. “Score”
(which will show up in the chart on the following page represents the summation of
all these grade values across the symptom columns for any one date and can vary
from 0 to 15.
Area
Depth
Sepsis
Arteriopathy
Denervation
10 – 30 mm sq
Pinprick
Pedal pulses
sensation/VPT
Skin intact
No infection
palpable
normal
Skin and
Diminution of both Reduced or ab
subcutaneous
Superficial: slough pulses or absence of pinprick sensa
tissues
or exudate
one
VPT raised
Neuropathy
Tendon, joint,
Absence of both
dominant: pal
capsule periosteum Cellulitis
pedal pulses
pedal pulses
>30 mm sq
Bone and/or joint
spaces
Skin intact
<10 mm sq
Osteomyelitis
Gangrene
Charcot foot
The background represents the initial day 0 values for Groups one. The
foreground represents the values for day ~67 of Group one. Information on
Groups one and two combined for the first ~35 days is not included as it makes the
chart too complicated and adds no unexpected information. After ~67 days,
remarkable improvements were seen in all categories. The global (S)AD score
decreased 37% from 6.3 to 4. Among the 9 subjects who after the first ~37 days
received only placebo, 1 continued to improve, 6 maintained their gains and only
two regressed in their total score. Only six Doppler measurements could be made,
but among them, amplitude increases in the non-computerized Doppler's that did
not go off the top of the scale on the measurement paper after EDTA showed
increases of 175%, 200% and 260%.
66% of the subjects in Group one had the ‘Area' score drop by a full point
indicating that the affected area decreased from 10-30mm 2 to <10mm 2 . 77% of
subjects in Group one had their ‘Denervation' scores decreased by at least one full
point with 22% of Group one's subjects having the ‘Denervation' score decrease by
two full points.
Conclusion
Magnesium Di-Potassium EDTA in suppository form:
• Has significant effect in lowering high glucose readings.
• Has significant effect in lowering high blood pressure and high pulse pressures.
• Significantly decreases the biological age of the diabetic heart.
• Decreases the area, depth, septic condition, arteriopathy and denervation of the
diabetic foot.
• Increases blood flow to the diabetic foot.
• Represents a novel and important approach to the diabetic condition.
1 Biological Aging Measurement Clinical Applications, Ward Dean M.D. page
300, 1998.
2 Pulse Pressure: A predictor of Long-Term Cardiovascular Mortality in a
French Male Population. Institut Natinal de la Sante et de la Recherce Medicale.
Athanase Bentos MD, PhD.
3. Center for Disease control Diabetes website
http://www.cdc.gov/diabetes/pubs/general.htm
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