The American Study
Results of the Bio-Chelat™ Clinical Study
with Doctors Data Inc.
The clinical study was conducted over a 14 day-period, starting January 6, 2002 and ending April 18, 2002. Only 11 of the 20 participants fully complied with the experimental protocol and completed the Bio-Chelat™ clinical study. Due to the limited number of observations, David Quig Ph.D. of Doctors Data, was unable to perform the appropriate statistical analysis required for a legitimate evaluation of the trial results. The German Bio-Chelat™ study utilized blood, while the U.S. study made use of urine and fecal analysis. In retrospect, and on close review of all data, Target Your Health, Inc. noticeably sees, that the test design was not fully appropriate because of the specific pharmacokinetics of Bio-Chelat™. The decision was therefore made to revise the experimental design study, monitor patient compliance more closely, and conduct another clinical trial utilizing blood in conjunction with Doctors Data.
Nevertheless Dr. David Quig of Doctors Data stated: “Although the U.S. study sample was insufficient, it appears that the preliminary data that was collected show that Bio-Chelat™ brought about the elimination of heavy metals of the participants.”
To understand how the Bio-Chelat™ solution differs and works in comparison to other chelators i.e. (DMPS, DMSA, EDTA, etc), following is a summary description of the pharmacokinetics.
Clinic-Pharmacological Data of Bio-Chelat™.
Bio-Chelat™ contains a complex-forming agent (EDTA)
and an oxidative catalyst. The oxidative
catalyst has the following function:
1. To oxidize the SH-groups into SO3 2- groups or SH-ions into sulfate. SH-groups or SH-ions are ubiquitous in the GI tract and form very strong bonds with heavy metals. The bonds of the newly formed SO32-groups or sulfate groups are reduced, thus allowing this very low concentrated (homeopathic) dosage of EDTA to easily bind with the heavy metal ions. In an acidic environment (i.e. stomach, intestines etc), EDTA forms a high complex bond with mercury, cadmium and lead. Because of this, heavy metals coming from the food, teeth roots, bile etc. are chelated and excreted with the feces.
By decreasing the uptake of mercury ions into the blood stream and creating a high electric-magnetic gradient in the GI-tract, new heavy metal ions are pulled from the body into the blood stream and stomach/intestine and excreted (Law of Isotonicity).
One example: When
taking Bio-Chelat™, (DL) the urine clearly
showed an increased amount of Cadmium and
Nickel. On the other hand, fecal excretion of
Cadmium, Mercury, Lead decreased.
Analysis: When Bio-Chelat™ is absorbed into the GI tract, heavy metals are chelated and excreted with the feces. This “clean-up” of the GI tract can last between 24 hours to 1 week and depends on the patient. During this period higher values of excreted heavy metals can be seen. Once the “clean-up” is completed, a lower concentration of heavy metals is then found in the feces. Lesser heavy metals are now absorbed into the blood, creating an imbalance between the blood and the deposits, which then will pull new heavy metals into the blood stream from the deposits, which are then excreted via the urine and feces.
As formulated by Dr. Leman in the German study:
Bio-Chelat(TM) will indirectly intensify the body’s physiologic elimination mechanism of heavy metals. When comparing values prior to Bio-Chelat™ intake, due to the minimization of heavy metals into the blood (blood doesn’t receive anymore metals from the GI-tract), the balance between heavy metal depots and blood is disturbed, and heavy metals spill over (are pulled) into the blood, and are then discarded via the kidneys and intestines. An increase in the heavy metal concentration of the urine and feces should not be measurable, because even the blood level of heavy metals should now be inferior compared to the pre-therapeutic level. For long-term therapy, this physiological mechanism can be utilized to eliminate heavy metals.
value of Bio-Chelat™ in the context of chelators
currently on the market is seen as follows:
a) 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.
b) Bio-Chelat™ works much gentler and is easier as most common chelators.
c) Bio-Chelat™ is not suitable for acute care of heavy metal toxicity or a very high toxic ion loads.
d) Bio-Chelat™ has its greatest value as a middle and long-term therapy for chronic heavy metal toxicity and especially in preventing heavy metal toxicity through the today's overall heavy metal exposition. For this it is the optimal product.
e) 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™.
Because of this, Bio-Chelat™ is excellent in view of the numerous patients carrying a chronic heavy metal ion load. It is a necessary solution.
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Bio-Chelat™ Ecuador Clinical Trial
HYGIENE CARE FOR PEOPLE AT RISK OF LEAD CONTAMINATION.
(Lead Recycling Company (Foundry/Smelting), located in Guayaquil, Ecuador; South America.) Clinical trials
As a concern for the occupational health of the people working at the foundry we have implementing a Chelating treatment in order to drop the lead levels in blood to its normal parameter for people working in this kind of business.
26 Employees began treatment with
Bio-chelat, people with at least 40 u.g./dl. of lead
in blood. The patients began with the treatment as
First week at 15 drops daily
Second week at 30 drops daily
And Four weeks more at 60 drops daily.
Total weeks of treatment 6.
After finishing the 6 week treatment the patients had another blood test for lead, presenting a good decrease of lead in blood. The following chart has 15 of the 26 patients taking Bio-chelat.
Time @ Job
|Before||@ 6 Weeks|
|1||Arteaga Pareja Cideine||2 Years||36||61||40.35||-33.85%|
|2||Gonzabay Chavez Jose||10 Years||29||74||65.4||-11.62%|
|3||Navas Tinoco Fidel||3 Years||28||76||50.4||-33.68%|
|4||Retto Penafiel Vicente||7 Years||29||51.3||50.7||-1.17%|
|5||Suarez Suarez Vicente||10 Years||47||59||40.95||-30.59%|
|6||Villamar Reinoso Agustin||10 Years||31||44.1||34.6||-21.54%|
|7||Diaz Cornejo Johnson||7 Years||42||55.5||48.67||-12.31%|
|8||Munoz Cedeno Julio||1 Year||32||54.8||46.65||-14.87%|
|9||Jarna Pilay Bernardino||3 Years||27||70||55.65||-20.50%|
|10||Diaz Macias Raul||4 Years||31||52.8||44.77||-15.21%|
|11||Chila Perez Javier||4 Years||33||52.5||38.62||-26.44%|
|12||Preciado Tamayo Jose||1 Years||25||50.5||41.2||-18.42%|
|13||Santana Toro Johnny||5 Years||29||57.8||31.5||-45.50%|
|14||Cabezas Ramirez Xavier||6 Months||25||39.2||28.85||-26.40%|
|15||Danin Teran Carlos Luis||
As we can see patients have dropped their lead levels in an average of approximately 25% not considering patient number 4 because I think he did not follow the treatment at all. Also should be mentioned that no employee was off his job for this period, they all continued working in their usual area.
After this period of treatment looking the good results, I recommend to continue the use of Bio-chelat in order to prevent future toxicity with lead.
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Bio-Chelat™ German Clinical Trial
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).
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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