Saturday, April 01, 2006

Bio-Chelat: Chelation Therapy Clinical Trial - US Study

Clinical Investigation of Bio-Chelat(TM) Chelation Therapy

Results of the Bio-Chelat(TM) 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(TM) 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(TM) 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(TM). 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(TM), chelation therapy, brought about elimination of heavy metals of the participants."
To understand how the Bio-Chelat(TM) 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(TM).
Pharmacokinetics: Bio-Chelat(TM) 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(TM), (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(TM) 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), chelation therapy, will indirectly intensify the body's physiologic elimination mechanism of heavy metals. When comparing values prior to Bio-Chelat(TM) 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.

Final Conclusion
The therapeutic value of Bio-Chelat(TM) 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(TM), chelation therapy, works much gentler and is easier as most common chelators.

c) Bio-Chelat(TM) is not suitable for acute care of heavy metal toxicity or a very high toxic ion loads.

d) Bio-Chelat(TM) 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(TM) 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(TM).
Because of this, Bio-Chelat(TM), chelation therapy, is excellent in view of the numerous patients carrying a chronic heavy metal ion load.
It is a necessary solution.

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