Bio-Chelat™
Clinical Trial
German
Study
This investigation was done according to the
recommendation of 83/571 EWG, Part IV, dated
11/28/1983 (EG#L332).
Planning, methodology, completion, evaluation and
documentation went according to the appropriate
principles for clinical drug testing, dated
12/09/1987 (Banz. Page 16-617).
Pharmacological Data
1.
Pharmacological Dynamics
For this clinical evaluation, a standard dose of
3x20 drops was used and well tolerated by most
patients. We recommend taking the solution before
meals. With associated dryness of the mouth, follow
the solution with water. We also recommended
decreasing the dosage to 3x15 or a minimum of 3x10
or 2x15 drops per day when a decrease of saliva was
noted. Dryness of the mouth was rarely experienced
with the reduced dose and whenever it was an issue,
most symptoms disappeared 3-4 weeks after taking the
Bio-Chelat™.
There was an obvious connection between the release
of mercury ions from amalgam fillings by Bio-Chelat™,
and the subsequent depressive effect of this release
on the salivary glands. It turns out that the amount
of liquid taken by the participant is of particular
importance. Participants were instructed to drink a
minimum of 2 liters of water per day to ensure
adequate mercury excretion by the kidneys. However,
not all participants followed the recommendation.
Those participants, who drank less increasingly
complained of mouth dryness.
The
time-relationship-effect concludes that Bio-Chelat™
is fast absorbed and its’ maximum effect occurs
during the first 1-3 hours when the most excretion
takes place. Because of this, it is necessary and
indicated to take the solution 3 times per day. The
increased digestibility after a few weeks concludes
that either a tolerance occurs or that the mercury
elimination is sufficiently advanced.
To
see the effect on the body, blood panels must be
assessed (especially calcium, magnesium, zinc as
well as heavy metals), to check for toxic
consequences within the kidneys and to determine
mercury excretion. Also, liver panels to determine
metabolic performance and evaluate possible
hepatotoxic action of Bio-Chelat™. According to the
published data, there were no negative responses
when observing blood count; life essential mineral
concentration also did not change. Only zinc was
significantly decreased, and therefore, zinc
supplementation should be considered whenever
necessary. Thrombocyte count also decreased
slightly, while leucocytes increased minimally. On
the other hand, mercury levels decreased, as well as
other heavy metal ions (lead, cadmium), which is
seen as a positive finding.
Specific kidney parameters showed no negative
consequences to the kidneys. In regards to the liver
panel, we recognized a small insignificant increase
of gamma-GT-values. The observed changes in LDH and
GOT are not significant. This is most likely because
of the increased demand placed on this organ with
the excretion of toxic metal ions.
2. Pharmacokinetics and Bio-availability
A
pharmacological determination of absorption,
distribution, change, and excretion of Bio-Chelat™
or its by-products did not occur. This is unusual
with homeopathic diluted agents. The optimum dose is
a compromise between desired effect on one hand and
side effects on the other. Here it was a minimal
dose of 3x10 drops and an optimal dose of 3x20
drops. The maximal dose should not be strived for.
3. Effect with continued use
The
therapeutic goal of mercury elimination can't be
achieved in a short time because mercury is either
deposited or bound to various organs. A fast
mobilization by chelators can bring considerable
side effects.
Because of this it is normal and appropriate to take
Bio-Chelat™ over at least a 3-month time span.
Longer time periods are only indicated when, for
example, there are mercury extractions, removal of
amalgam fillings or new fillings are being placed.
We
know that Bio-Chelat™ is an excellent solution as
long as the mercury concentration in the serum,
urine or sputum continues to be high, and there are
occasionally new chemical exposures that would make
it useful to continue taking the solution daily.
4. Side effects
None are known. In this study, no patient gave such
an indication, although it should be mentioned that
all participants had a naturopathic medical
orientation and do not take pharmaceuticals.
Clinical Therapeutic Data
The
results of this study was based on 74 participants
and was documented statistically, including side
effects. Each patient was questioned about side
effects during the exit interview. Questions
centered on how the solution was taken, as well as
how they felt during the trial and how they
tolerated the solution. This information is given
whenever known.
·
All users were clients from the HG Homeopathic
Clinic, which is the practices of Drs.
Pieper/Bender, Hautzel, Rebien and Schneider, as
well as from the dental practices of Drs. Obermayer
and Obreschko.
·
Testing Method
More than 60 participants were examined, all having
mercury-amalgam-fillings; their mercury and heavy
metal load was checked and the effects of the Bio-Chelat™
on this heavy metal burden.
·
Hypothesis Will
Bio-Chelat™ reduce this load significantly after
taking it for 3 months? For verification and
documentation, blood, urine, and sputum examination
was used, as demonstrated on the enclosed table.
Absorption spectrometry, done at the Diagnostic
Center for Mineral Analysis and Spectroscopy (Lowensteinst.
9, Michelrieth), was the specific method used to
measure these metals within the serum.
·
The company Hormonology produced Bio-Chelat™ (a
liquid solution enriched with minerals in addition
to 100 ml of oxygen). The standard dose recommended
by the manufacturing company was 3 x 20 drops/day.
It was recommended to take a teaspoon of Bio-Chelat™
before meals, followed with water. The dose was
modified when necessary for the participant.
·
Testing Period
The test was done over a 3-month period. Because it
took 3 months to find appropriate test participants,
the complete study lasted from January 1, 1995 until
July 31, 1995.
·
No additional therapies were done or recommended.
·
Test Results
The desired effect was a decrease of the serum
mercury, lead, cadmium, and palladium concentrations
upon completion of the program.
·
Undesirable effects were any associated dryness of
the mouth, stomach problems and occasional nausea.
These were present in a few cases and Bio-Chelat™
was discontinued. Those problems generally decreased
after 3-4 weeks. Nevertheless, in a few cases an
adjustment of the dosage was necessary. Side effects
were generally only noted for 1-2 hours and did not
cause any further problems.
The therapeutic value of the Bio-Chelat™ in the
context of other chelators that are currently on the
market is seen as follows:
Chelators work relatively fast, but they are also
very strong with a relative high washout of
important trace elements and a high degree of
specific side effects.
Bio-Chelat™ works much gentler than most common
chelators. Although during the treatment a
significant decrease of the body's heavy metal ion
load was seen, this is accomplished without greatly
disturbing the mineral and trace element
relationships. The reduction of zinc should be
looked at with caution and may easily be corrected
throughout the treatment.
A
small increase in the liver panel is, as mentioned
earlier, partly due to the increased load on the
liver while eliminating heavy metal ions. In a few
isolated cases, it was observed that those values
completely approached normal levels within a few
days or weeks, particularly when liver supportive
and excreting therapies were simultaneously
administered. All liver panel values were normal
upon completion of the Bio-Chelat™ study.
Should a patient have liver damage, and have for
example an increased transaminase value, Bio-Chelat™
should be given very carefully while evaluating the
risks.
Bio-Chelat™ is not suitable for acute mercury
poisoning or very high new toxic ion loads. Bio-Chelat™
has its greatest value as a middle and long-term
therapy for sub-acute or chronic mercury toxicity.
For this it is the optimal product.
The
side effects of Bio-Chelat™ are minimal when
compared to the overall effect. Those side effects
can be totally eliminated through a modification of
intake and dose. No associated risks are connected
with the use of Bio-Chelat™. After discontinuance of
the Bio-Chelat™, any effects disappear within hours.
Because of this, Bio-Chelat™ is an excellent therapy
that will fill today's market niche, in view of the
numerous patients carrying a chronic toxic mercury
and heavy metal ion load. It is a necessary solution
for that particular market.
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