VITAMIN C AND MAGNESIUM USED AS PLACEBO IN CHELATION STUDY
New
Study Based on Pauling/Rath Theory submitted to NIH
© Owen R. Fonorow 2002
Revision 43 01/18/03
“Would it surprise you to learn that
drug companies make their own placebo pills for research purposes? And that
THEY choose the ingredients? And sometimes they purposely put ingredients into
the placebos that match those in the drug and will affect the outcome of the
trial. And they are not required to disclose the ingredients they use.“ - Jenny Thompson, Health Sciences
Institute
See: http://www.hsibaltimore.com/ea2002/ea_020725.shtml
The Houston-based Vitamin C Foundation has
applied to the U. S. National Institutes of Health (NIH), National Center for
Complimentary and Alternative Medicine (NCCAM),for a grant to study 6 g vitamin
C and 6 g lysine as a therapy for heart disease. If funded, the study would be
the first-ever clinical trial in humans of the high oral vitamin C and lysine
intervention, first suggested by Linus Pauling in 1994.
The study design is somewhat unusual in that will
be one study group with elevated serum Lp(a), but there will be no placebo.
Because the Vitamin C Foundation and its investigators cannot deprive patients
of vitamin C for a lengthy period, the pilot study will first monitor Lp(a) and
other assessments for all study participants during a two-month baseline period
without any intervention. These two months will act as the control on which to
base the statistical analysis.
This method is designed to
overcome some of the more obvious objections to a long-term trial. These objections
include the subjects having to take a 'useless' placebo for 6 to 18
months. Also, this design overcomes many
of the problems that A. Hoffer and others have written – both ethical and
otherwise. These problems referred to are: The patient being deprived of a
therapy that may work; the difficulty of preparing a proper placebo for
megadose therapies; the fact that patients do not like to cooperate in
double-blind experiments leading to the high drop-out rates; the lack of
physician time to perform realistic monitoring; the fact that patients may
“switch” formulas with each other, etc.
Doctor A. Hoffer, one of the
pioneers of the double-blind method, having run one of the very first trials
beginning in 1953, wrote in Vitamin C and Cancer:
“In Sum, I believe
that the validity of the double-blind method has been grossly overvalued; iIt
has only limited utility. In my opinion it does not reliably prove that
effective treatments are effective or that ineffective ones are ineffective.
Elsewhere I have examined the reasons why it is such a limited method. The main
reason is that it violates the doctor-patient relationships and therefore
creates a model that is too far removed the real clinical relationships.”
We do not believe that the
lack of a "placebo controlled group" will lessen the value of the
Pauling therapy study. In the proposed study, serum Lp(a), homocysteine and
ordinary lipids will be monitored (as often as funds allow). Brachial arterial
stiffness (ASI) and blood pressure will be measured weekly using FDA-approved
CardioVision®. The Foundation has asked
the NIH/NCCAM to fund an 18 month pilot study of 30-40 subjects. More than 100
persons in Silver Springs, Florida, have already volunteered to participate.
The proposal can be read at http://vitamincfoundation.org/NCCAMgrant/
There is anecdotal evidence,
and thus some reason to believe, that the elevated Lp(a) levels in the Pauling
Therapy group can be lowered to zero (less than 3 mg/dl). A biochemist, Dr. R. F. (New Jersey)
reported to us regarding his personal experiment: He added 2 g lysine and .5 proline when a
blood test revealed elevated Lp(a). This
was the only change he made in his daily regimen, which already included
supplements and vitamin C. Doctor R.F. reported that after six months his Lp(a)
dropped by 40% and that after 14 months there was no detectable Lp(a) in his
blood serum.
Other physicians familiar
with the Pauling therapy, report similar effects. Warren Levin, MD, has written
a letter to the Journal of the American Medical Association (JAMA) about
lowering Lp(a) with high-doses of vitamin C, lysine and proline.
If this effect could be
monitored in a controlled setting, perhaps across some or most of the entire study
group, it would be an outstanding result which we hope would merit further
investigation by the National Institutes of Health (NIH) and other medical
authorities and researchers.
It is interesting that
organized medicine may have already run a similar trial on one-half of the
so-called Pauling Therapy, i.e., (5 g vitamin C). During this ‘placebo’
controlled trial, both groups were given IV vitamin C and
magnesium. While ethical, this approach
(giving multivitamins and the vitamin C IV to the placebo group) did
affect the conclusion.
The fact was obscured, evidently, that a statistically
significant result supporting the Pauling/Rath theory had been produced. This is not an argument for inert placebos
but one for making fully correct and less sweeping conclusions in papers.
In the JAMA study being
referred to (Chelation Therapy for Ischemic Heart
Disease: A Randomized Controlled Trial, Knudtson, et al. JAMA, Jan 23/30, 2002
- Vol. 287, No 4. pp. 481-486), 5 g
of vitamin C and 750 mg of magnesium were given intravenously to both
the EDTA and the control (placebo) groups.
The study paper, seemingly written to debunk EDTA chelation for heart
disease, concluded that there is “no benefit of EDTA chelation over
placebo”. Yet from the text in JAMA we
read that the sample size was chosen as follows:
“A sample size of 40 per group was chosen
to provide 90% power to detect a 60-second difference in mean change in
exercise time from the baseline to the 27-week follow-up.”
The study was designed to
detect a 60-second improvement in treadmill exercise time in a statistically
significant way.
Again from the paper, “The 500-ml. infusion solution of 5%
dextrose in water… Each treatment solution also contained 750 mg of
magnesium sulfate, 5 g of ascorbic acid, and 5 g of sodium bicarbonate…”
Vitamin C and magnesium were
given to both groups.
According to their own paper,
and I quote, “Both study groups were able to significantly (P<.001)
increase their exercise time to ischemia at the 27-week treadmill test.”
Thus, using vitamin C and
magnesium in the placebo obscured the statistically significant increase in
treadmill exercise time - in both groups, including the EDTA group. Unfortunately, the JAMA author’s conclusions
overlook this statistically significant benefit and called it a "placebo
effect." (The possibility that
it was a placebo effect is unlikely, based on a meta-review of other Time to
Ischemia treadmill studies in MEDLINE. See references.)
While I agree with Hoffer
that therapies and interventions are not “proven” by a double-blind placebo
controlled trial, on the basis of
generally accepted medical terminology, this trial “proves” the significant
value of vitamin C in heart patients.
As alternative doctors know,
“spontaneous remission” usually means that the patient did not tell the doctor
about the supplements that were taken. We now know that 5 g of vitamin C is
quite the "placebo" for ischemic heart disease. (Several drugs evaluated in a similar manner
showed no increase in Time to Ischemia.)
In my opinion, based on the JAMA study, which said little about the
value of EDTA for CVD (did the EDTA bind with something else given to both
groups inactivating it?) and said nothing about the long-term benefits of
EDTA, Chelation/ACAM doctors now have a moral obligation to add vitamin C and
magnesium to their EDTA (if not doing so already) based on this “proven” result
of the unified theory.
Not all ischemia is
calcium-based; however, EDTA has a proven affinity for calcium. If a patient receives the contents of an IV
bag for three hours, they ought to receive EDTA as well as ascorbate.
The air we breathe contains
lead; our teeth are full of mercury; our
foods and water contain aluminum and other metal and heavy metal toxins. EDTA detoxification has many proven
beneficial effects. We now know that EDTA is even a better idea for heart
patients when combined with supplements, especially vitamin C and
magnesium. (Maybe Knudtson, et al. can
be encouraged to add 5 g of lysine to the IV in their next study?)
For more information, or to
contribute to the Vitamin C Foundation’s sponsored clinical trial, please
contact:
|
OWEN FONOROW PO Box 73172 Houston,
Texas 77273 1-888-443-3634 Toll
Free 630-416-1438 Fax:
630-416-1309 fonorow@foxvalley.net www.vitaminCfoundation.org www.PaulingTherapy.com www.BolenReport.com |
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