Traditional risk factors for cardiovascular disease can only assess risks for groups of people. New parameters of arterial stiffness are more reliable for predicting cardiovascular outcomes for individuals with and without a cardiovascular history. The objective of this study was to assess the effects of Magnesium-EDTA chelation therapy using new methods and parameters such as pulse wave velocity (PWV), central blood pressure (SBPao) and endothelial function (Aix). We followed 43 patients with an abnormal PWV and SBPao, setting them up in two groups. The 21 patients in Group A had already been diagnosed with cardiovascular disease. The other 22 patients in Group B also showed abnormal PWV, SBPao and Aix, but showed no cardiovascular symptoms. Each patient in Groups A and B received one Mg-EDTA treatment per week. The total treatment plan consisted of 25 Mg-EDTA chelation treatments according to the standard protocol of IBCMT. After 25 Mg-EDTA chelation sessions, PWV and SBPao improved significantly in all patients of Groups A and B. In addition, Aix improved significantly in these patients, but remained abnormal. Group C included 18 asymptomatic patients with normal PWV or SBPao. Aix was abnormal in this group, but to a much lesser extent than Groups A and B. The 18 asymptomatic patients of Group C did not receive Mg-EDTA treatment. Observation showed no significant changes in all three parameters of arterial stiffness. The results of this study indicate that a course of treatment with Magnesium-EDTA chelation therapy significantly lowers cardiovascular risks. We conclude that Mg-EDTA chelation therapy improves PWV as an indicator of arterial stiffness, SBPao (central blood pressure) as an indicator of aortic elasticity and Aix (augmented aortic index) as an indicator of endothelial functioning. These improvements in PWV, SBPao and Aix demonstrate that atherosclerosis is a dynamic and (partially) reversible process.
Intravenous chelation therapy with Magnesium-EDTA (Mg-EDTA) for cardiovascular disease has been controversial for decades until recently when the randomized double-blind TACT study revealed that treatment with Mg-EDTA reduces risks for cardiac death, hospitalization and invasive cardiac procedures compared to placebo [
Standard risk factors for cardiovascular disease have prognostic value for a large population, but little prognostic value for an individual. Although several scoring systems for cardiovascular risk prediction are valuable in the assessment and management of asymptomatic individuals, differences between predicted and actual events do exist. The concept of vascular aging as a cumulative measure of the impact of cardiovascular risk factors on the arterial wall has the potential to assess an individual’s overall cardiovascular risk. In this context, candidate arterial biomarkers, apart from proving an incremental predictive value over and above traditional risk factors, must fulfill stringent criteria in order to be integrated into clinical practice. In 2000, L. Terry Chappell et al. concluded that brachial artery stiffness testing appeared to be a good outcome measurement for patients treated with EDTA-chelation therapy [
Arterial stiffness measured as pulse wave velocity (PWV) is highly correlated with coronary atherosclerosis in asymptomatic patients [
Central pressure has been shown to relate more strongly to vascular disease and outcome than traditional upper arm blood pressure. Central pressure can also distinguish between the effects of different hypertension medications when upper arm blood pressure and pulse wave velocity do not [
Up until recently, the effects of Mg-EDTA could only be evaluated by subjectively assessing patient’s complaints and by increased walking distance or improved exercise tolerance during stress-testing. The parameters used in the TACT study were also an approximation of what actually happened in the patient’s vascular system. Iron (Fe) chelation already has shown to improve endothelial functioning as assessed by the augmented aortic index (Aix) [
We established a pilot study to investigate how Mg-EDTA chelation therapy influences these new and more objective cardiovascular risk factors: Aix, SBPao and PWV.
1) Patient selection
We followed 43 patients with an abnormal PWV and Aix. Of these, 21 patients in Group A had already been diagnosed with cardiovascular disease. The other 22 patients in Group B also showed elevated AIX and PWV, but were cardiovascular asymptomatic. Group B was considered at high risk for developing cardiovascular disease.
All 43 individuals (Groups A and B) were treated 25 times with Mg-EDTA chelation therapy in weekly sessions according to the standard protocol of IBCMT. After 25 chelation sessions the Aix, SBPao and PWV were determined again.
The control group (Group C), consisted of 18 patients with a normal PWV. Aix was abnormal in this group, but to a much lesser extent than Groups A and B. Group C patients were without cardiovascular disease and did not receive Mg-EDTA treatment. It was our aim to find out if risk factors would change in Group C compared to patients with known cardiovascular disease.
2) Testing methods
PWV (arterial stiffness analysis), Aix (endothelial function) and SBPao (central blood pressure) were performed with the Tensiomed® [
3) Treatment method
3 gr of disodium-EDTA and 5 gr of magnesium sulfate were added to 500 ml of a 0.9% saline solution along with 1.49 gr potassium chloride, 20 mg thiamine, 100 mg pyridoxine, 0.5 mg hydrocobalamin and 5000 IU heparin. This “Mg-EDTA solution” was infused slowly over 3 hrs according to IBCMT Protocol [
Reference ranges:
PWV (aortic stiffness) improved significantly after 25 treatments with Mg-EDTA chelation therapy in all (N = 43) treated patients (
SBPao (central blood pressure) improved significantly after 25 Mg-EDTA chelation therapies in all (N = 43) treated patients from 148.3 mm Hg to 131.6 mm Hg.
Aix (endothelial function) improved significantly after 25 Mg-EDTA chelation therapies in all (N = 43) treated patients, but was still abnormal. It decreased from 26.8% to 11.5%.
When differentiating between patients with (Group A) and without (Group B) a prior cardiovascular history, we obtained the following results:
Group A
PWV (aortic stiffness) improved significantly after 25 treatments with Mg-EDTA chelation therapy in all (N = 21) treated patients with known cardiovascular disease and with an initially abnormal PWV (Group A;
SBPao (central blood pressure) improved significantly after 25 Mg-EDTA chelation therapies in all (N = 21) treated patients with cardiovascular disease from 146.3 mm Hg to 133.9 mm Hg.
Aix (endothelial function) improved significantly after 25 Mg-EDTA chelation therapies in all (N = 21) treated patients with cardiovascular disease, but was still abnormal. It decreased from 31.2% to 12.2%.
Group B
PWV (aortic stiffness) improved significantly after 25 treatments with Mg-EDTA chelation therapy in all (N = 22) treated patients without prior cardiovascular disease but with an initial, abnormal PWV (Group B;
SBPao (central blood pressure) improved significantly after 25 Mg-EDTA chelation therapies in all (N = 22) treated patients without known cardiovascular disease but with an initially abnormal PWV. SBPao decreased from 148.3 to 129.8.
Aix (endothelial function) improved significantly after 25 Mg-EDTA chelation therapies in all (N = 22) treated patients with cardiovascular disease. The risk category of the Aix in Group B went from category IV (abnormal) to III (increased). Aix decreased from 21.6% to 4.4%.
Control Group C
The control group of 18 asymptomatic patients with a normal PWV (Group C,
Mg-EDTA chelation therapy is a treatment used for cardiovascular disease. Worldwide, physicians are using
Risk category | Aortic Augmentation Index (Aix) | ||
---|---|---|---|
I | Optimal | Aix < 30% | No signs of endothelial dysfunction |
II | Normal | −30% < Aix < −10% | No signs of endothelial dysfunction |
III | Increased | −10% < Aix < 10% | Signs of endothelial dysfunction |
IV | Abnormal | Aix > 10% | Clearly endothelial dysfunction |
Risk category | Puls wave velocity (PWV) | ||
---|---|---|---|
I | Optimal | PWV < 7.0 ms−1 | No signs of aortic stiffness |
II | Normal | 7.0 < PWV < 9.7 ms−1 | No signs of aortic stiffness |
III | Increased | 9.7 < PWV < 12.0 ms−1 | Signs of aortic stiffness |
IV | Abnormal | PWV > 12.0 ms−1 | Clear signs of aortic stiffness |
N = 43 | Before Mg-EDTA | After Mg-EDTA | Significance | Correlation |
---|---|---|---|---|
PWV (ms−1) | 11.7 | 9.0 | <0.001 | 0.64 |
SBPao (mm Hg) | 148.3 | 131.6 | <0.001 | 0.71 |
Aix (%) | 26.8 | 11.5 | <0.001 | 0.78 |
N = 21 | Before Mg-EDTA | After Mg-EDTA | Significance | Correlation |
---|---|---|---|---|
PWV (ms−1) | 12.4 | 10.1 | 0.004 | 0.66 |
SBPao (mm Hg) | 146.3 | 133.9 | 0.011 | 0.87 |
Aix (%) | 31.2 | 12.2 | 0.007 | 0.84 |
N = 22 | Before Mg-EDTA | After Mg-EDTA | Significance | Correlation |
---|---|---|---|---|
PWV (ms−1) | 11.2 | 8.4 | <0.001 | 0.57 |
SBPao (mm Hg) | 148.3 | 129.8 | <0.001 | 0.74 |
Aix (%) | 21.6 | 4.4 | <0.001 | 0.70 |
N = 18 | First measurement | After 1 year | Significance |
---|---|---|---|
PWV (ms−1) | 9.7 | 9.5 | 0.74 |
SBPao (mm Hg) | 139.9 | 138.9 | 0.86 |
Aix (%) | 10.9 | 3.7 | 0.19 |
Mg-EDTA for the treatment of cardiovascular disease, and have done so for several decades. In the UK, Mg-EDTA is used since 1985, in the USA since the 1950s.
Most of the research published in the early and middle 1950s, relates to aspects of EDTA’s treatment of arterial disease. The most recent study, financed by the National Institute of Health (NIH) was a Trial to Assess Chelation Therapy (TACT). The purpose of this randomized, double blind, placebo-controlled, 2 × 2 factorial clinical trial was to assess the benefits and risks of EDTA chelation. TACT followed 1708 patients for an average of approximately 4 years. The study was published in 2013, and concluded EDTA’s safety and effectiveness for individuals that have been diagnosed with coronary artery disease [
According to IBCMT protocol, a course of treatment consists of a series of intravenous infusions of a solution containing the synthetic chelating agent EDTA (Ethylene-Diamin-Tetraacetic Acid) combined with magnesium. Each infusion takes about 3 hours and depending on the patient’s condition, infusions are repeated weekly for a series of treatments. In this case, Groups A and B patients each received a total of 25 infusions. Group C did not receive Mg-EDTA.
All Mg-EDTA treated patients with an initially abnormal PWV showed significant improvement of the PWV. In Group A patients (
Mg-EDTA treatment lowered central blood pressure in Groups A and B, which is indicative of better aortic elasticity [
Endothelial function (Aix) improved significantly in Groups A and B. This improvement was clearly more pronounced in Group B, yet another indication that arterial stiffening or in this case, endothelial stiffening, was not as advanced as in Group A. It should be pointed out however, that of the three parameters PWV, SBPao and Aix, endothelial function (Aix) improved the least.
Control Group C, which had not received Mg-EDTA treatments, showed no significant changes in arterial stiffness parameters within one year follow-up.
Mg-EDTA chelation therapy improves parameters of arterial stiffness: Pulse Wave Velocity as an indicator of arterial stiffness; central blood pressure (SBPao) as an indicator of aortic elasticity and endothelial functioning (augmented aortic index: Aix). These improvements in PWV, SBPao and Aix indicate that atherosclerosis is a dynamic and (partially) reversible process.
This supports the concept that maintenance treatment with Mg-EDTA minimizes risk factors leading to cardiovascular events. As in the TACT trial, we recommend that Magnesium-EDTA treatments are initially administered once a week. Depending on patient symptoms and response, the frequency can gradually be decreased to monthly intervals. In future work we plan to demonstrate how these individual cardiovascular parameters uphold when the frequency of treatment with Magnesium-EDTA has been maintained once a month for at least one year.
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