From: kingsley@hpwrce.mayfield.hp.com (Kingsley Morse)
Newsgroups: sci.med.nutrition
Subject: Re: Have you heard of this?????
Date: 6 Oct 92 20:02:11 GMT
Organization: HP Western Response Center

Chelation (EDTA) proponents have claimed that it is an effective treatment
for heart disease for 3 decades, but critics in the medical establishment have 
pointed out that chelation studies haven't included control groups. This is an 
important issue, because heart disease is America's #1 killer. Two little known
two double blind studies have been documented by Efrain Olszewer and 
James P. Carter, and another is in progress at American military hospitals. 
I will review the 3 studies here.                       




The first double blind chelation study is referenced in:

EDTA Chelation Therapy in Chronic Degenerative Disease, MEDICAL HYPOTHESES,
Efrain Olszewer and James P. Carter, (1988) 27, 41-49.

On page 46 the authors describe a double blind study. Here's what they said:

'The first and only double blind study on EDTA was funded by Thiemann       
Pharmaceuticals, manufacturers of the platelet inhibitor, Fludilat. It was
conducted by Schettler at al, in the clinics of the University Hospital in
Heidelberg, West Germany (5). It compared EDTA to Fludilat in a double blind 
study design. There were 48 patients in all; 24 in each group. EDTA, 2.5 gms
were administered in 1/2 L.N. Saline. Treatments were given for 5 days a week
for a total of 4 weeks. Each patient, therefore, received 20 infusions. The
age range of the patients was from 32-82 years. Only patients with 
peripheral vascular disease, Stage B LaFontaine, who could not walk more 
than 200 meters, without having intermittent claudication, were included in
the study. 

The results showed, initially, a 250% average increase in distance walked,
before the onset of claudication in the EDTA group. A 60% increase in the 
Fludilat group. However there were 4 patients in the EDTA group who got
over a 1000 meter increase in walking distance, at the end of thirty days
of treatment. The 4 patients were considered to be "unusual", and they were
eliminated from subsequent data analysis. The final analysis, therefore, showed
a 67% average increase in the EDTA group and nearly 8% had a "good 
improvement." That means that slightly more than 98% of the patients had a
"satisfactory recovery". 7 of 10 patients with gangene also made a 
"satisfactory recovery".

Here's the reference (5) cited above:

5. Poschal Johannes, Wilhelm Claudia. Verbal communication on the First
Double Blind Study of EDTA Chelation Therapy in Peripheral Vascular Disease;
done in Heidelberg, West Germany, and completed in 1985. Communicated in a 
Verbal Report given to and recorded by Dr. Charles Edmund Peres in New Orleans,
Saturday, August 10, 1985.




The second double blind test of EDTA was brought to my attention by Margot
Flowers. It is described in the following reference:

A Pilot Double-Blind Study of Sodium-Magnesium EDTA in Peripheral Vascular
Disease, by Efrain Olszewer, MD, Fuad Calil Sabbag, MD, and James P. Carter,
MD, DrPH New Orleans, Louisiana. Journal of the National Medical Association, 
1990 Mar, 82(3):173-7.

Here is the abstract from Margot's posting,

'Ten male patients with peripheral vascular disease, Type 2
(LaFontaine), were randomly assigned in a double-blind study to
receive either Na2 ethylene diamine tetra acetic acid (EDTA) plus
MgSO4, B complex, and vitamin C, or a placebo of MgSO4, B complex, and
vitamin C in Ringer's lactate solution. A total of 20 intravenous
infusions were planned for administration to each patient. Clinical
and laboratory (noninvasive) tests showed dramatic improvements after
10 infusions in some patients, and thus was broken the code indicating
who was receiving EDTA and who was receiving placebo. The group that
improved had been receiving EDTA; there was no change in the placebo
group. The trial was then completed in a single-blind fashion.
Patients originally assigned to receive placebo then received 10 EDTA
infusions, while the group originally assigned to EDTA received 20
EDTA infusions. The group that had formerly received placebo showed
improvements comparable to those seen in the first EDTA group after 10
treatments.'


The paper also has this table:

TABLE 2. OVERALL IMPROVEMENT RATIOS COMPARED WITH BASELINE VALUES
====================================================================
                       Group assigned to EDTA                           

  method            Rest to 10       10 to 20       Rest to 20
                    Treatments       Treatments     Treatments
------------------------------------------------------------------

Walking               2.65             1.42            3.76
Masters               1.86             1.07            2.00
Bicycle               2.10             1.44            3.04
Mean                  2.20             1.31            2.93

  
 
    Group assigned to Placebo (from Rest to 10 treatments, EDTA from 11 to
                  20 treatments)

  method            Rest to 10       10 Placebo     Rest to 10 EDTA
                    Sessions          to 10         Treatments after
                                  EDTA Treatments     10 Placebo
                                                      Treatments
------------------------------------------------------------------

Walking               1.1              2.08            2.30
Masters               1.02             1.94            2.00
Bicycle               1.01             1.60            1.60
Mean                  1.04             1.87            1.96


Later the authors summarize their data analysis with:                         
'These results suggest that EDTA had a significant impact in causing the
improvements seen in the patients' clinical status at the 0.05 level of
significance.'

At the risk of beating a dead horse, this study shows a huge difference between
EDTA and a placebo after 10 treatments. The guys getting the placebo improved 
4%, while the guys getting EDTA improved 120%.




Yet another EDTA double-blind study is in progress. It is described in:

Why M.D.'s Suddenly are taking a "Top 10 Health Fraud" Seriously, Longevity,
September 1990, p39-42.

Here's what the article says:

'a group of chelation proponents, led by Ross Gordon, M.D., president of the 
American Institute of Medical Preventics in Albany, CA, designed a protocol 
for a rigorously controlled double-blind test of chelation therapy with EDTA.
They then submitted that protocol to the FDA and the FDA approved it.

The trials themselves, coordinated by Oxford Research of Clifton, NJ, and
conducted at Walter Reed Army Hospital in Washington D.C. and Letterman 
Hospital in San Francisco, CA, began last year. In these trials, 40 patients
suffering from atherosclerosis in their legs are being treated by chelation
with low doses of EDTA for 15 weeks (and examined 3 months afterward), 
another 40 patients are receiving high doses and yet another getting 
placebos.  

The first stage of the test will not be completed until sometime next year.
"Right now," says Gordon. " all we can say is that the studies are under
way. But if chelation works as well as we think, it will cut down on 
coronary bypass surgery tremendously. If chelation does turn out to make a 
difference," Gordon adds, "then it should have been approved years ago.