CONTENT
Why Should I Read This Book ?............7
1. Consensus...........................................9
2. Calculation .........................................37
3. Conspiracy .........................................53
4. Cure ..............................................82
WHY SHOULD I READ THIS BOOK ?
To know why, attempt answering the following questions:
Q. 1) Which is correct ?
a) High Blood Pressure leads to Heart Disease
/Risk of Brain Stroke
b) Risk of Brain Stroke/Heart Disease leads to
High Blood Pressure
Q. 2) Is Mango good/ bad for diabetic patients?
a) Bad b) Good
"Mango is good for Diabetic Patients"
Q. 3) If your blood sugar reading (with glucometer) comes to about 250mg/dl consistently then
you are a diabetes patient ?
a) True b) False
Q. 4) The primary function of heart is to pump blood across the circulatory system?
a) True b) False
Correct Answers : All (b) options are correct.
If you are among 99% of doctors then chances are, you must have opted for option (a) as correct
answer.
Think again, it’s time to Unlearn and Relearn.. Read on!
Chapter 1 CONSENSUS
Get ready to be pleasantly shocked! The first chapter has the
potential for some amazing outcomes:
1. 100% of Diabetic patients will abandon their anti-diabetic pills...
permanently.
2.Up to 70% of Diabetic patients will come to know
that they are no more diabetic....
The Universal Consensus says that:
• The 10 year risk of cardiovascular diseases
(CVD) in a Diabetic population is just 2% higher
than in the non-diabetic population.
"The 10 year
risk of cardio
vascular
diseases
in case of
a person
suffering from
diabetes is
2% higher
than in the
non diabetic
population "
• Lifetime risk of Dialysis in case of a Diabetic patient is just 1.5% higher than the normal
population.
• Lifetime risk of blindness is 4% higher in case of Diabetes patients. [1]
It is clear from all the clinical studies specifically done on PIMA Indians (population with highest rate of Diabetes) that High Blood Sugar increases the risk of Cardio Vascular Disease (CVD),
Retinopathy, Neuropathy and Nephropathy.
Higher Blood Sugar = Higher risk of Diseases.
in other words
Lower Blood Sugar = Lower risk of Diseases
but, does that automatically mean lowering blood sugar with medication = Lower risk of diseases!
It seems obvious. But the reality is just the opposite!
It is Natural lowering of Blood Sugar = Lower risk of Diseases:
True
and
Lowering Blood Sugar with Medication = Lower risk of Diseases:
False
Let me prove my point by considering each group
of diabetes medication one by one, starting with
Metformin the highest prescribed pill among all.
Given in the next page is the meta-analysis of 13
Randomized Control Trial (RCT) - 9500
Metformin cases / 3500 Placebo for 5 years
(PLOS Medicine-2012). It can be clearly seen
that the Risk Ratio Interpretation (RRI) for all
the risk factors increase among patients on
Metformin.
"Lowering blood
sugar with
medication does
not lower the risk
of heart failure or
retinopathy "
Risk factor RRI
Cardio Vascular disease mortality 1.05
Heart Failure 1.03
Amputation 1.04
↑PLOS Medicine 2012
Conclusively, it means being on Metformin, one can lower the blood sugar level. But our prime aim is not just to target a particular blood sugar range rather, our aim is to reduce the risk of suffering from heart disease and other complication because of increased sugar levels in the blood.
What about the other class of diabetes medication?
To find an answer, a large study called ADOPT (A
Diabetes Outcome Progression Trial) blinded RCT
(Randomized Controlled Trial) in which 4360
patients were followed up to 4 years to compare
the effects of Glyburide, Metformin and Rosiglitazone.
The result showed that Glyburide and
Rosiglitazone performed worse than Metformin
with more mortality rate, more edema and more
weight gain.
Class of Drug Mortality Rate % Edema % Weight Gain %
Glyburide 2.2 8.5 3.3
Metformin 2.1 7.2 1.2
Rosiglitazone 2.3 14.10 6.9
With these heart breaking results of the above
class of glucose lowering agents, it is worth-
while to consider the performance of remaining
class of anti-diabetic medications such as GLPS,
Meglitinides and SGLT2.
"Risk ratio
interpretation
(RRI) for all
the risk factors
increase among
patients on
Metformin"
Upon searching the entire medical database, I
came across several research papers but the
most relevant research paper is as follows:
[[Diabetes Matab: 2014 Jan, 40(3):169-75 doi:10.1016/).diabet.2013.12.010. Epup 2014Feb3.
Effects of pharmacological treatments on micro and macro vascular complications of type 2 diabetes: what is the level of evidence?
BoussageonR1, GueyffierF2, Cornu C3.
Author Information
“In 2013, the level of evidence for the clinical efficacy of anti -diabetic drugs is disappointing
and does not support the millions of prescriptions being written for them”.]]
All the above reports conclude that although high blood sugar may be bad for your health, reducing the high blood sugar with medication is worst for your health and also a loss of significant
amount of wealth.
Here, we must understand that diabetes or high
blood sugar itself is not a disease, but a risk factor
for various diseases however, various developed
countries (under the influence of medical industry)
are irresponsibly propagating Diabetes as a
dreaded disease (learn more in 3rd Chapter - Conspiracy).
[[“Type 2 Diabetes is a Lifelong (chronic) disease.” -
A service of the U S National Library of
Medicine. National Institute of Health- USA
“Type 2 Diabetes is one of the fastest growing
diseases in Canada.” Government Of Canada ]]
The fundamental question here is, How high
should the sugar level be, to be called
Diabetes? The universal consensus or a
worldwide understanding is, ‘if your Random
Blood Glucose or Oral Glucose Tolerance Test
(OGTT) is more than 200 mg/dl, then you are
diagnosed as a diabetic patient. In simple words,
if in each litre of your blood there is more than
2gm of sugar (after 2 hrs of eating food) then
you are diagnosed as having diabetes or in other
words you have 2% higher chances of suffering
from CVD (Cardio Vascular Diseases) in next
10 years in comparison to the person with blood
glucose less than 200mg/dl.
"Glyburide and
Rosiglitazone
performed worse
than Metformin
with more
mortality rate ,
more edema and
more weight gain"
Here, the important point of consideration is, from where this number 200mg/dl arrived?
It all happened in 1979, when the expert committee of National Diabetes Data Group (NDDG) observed that the PIMA Indians (population with highest rate of diabetes) with higher blood
sugar levels were at higher risk of retinopathy. Here, it is important to note that if you go through the original trial (learn more in 2nd Chapter-Calculation) you will find that it was never 200mg/dl.
All the trials which were conducted to establish a cutoff point for Diabetes arrived at same conclusion i.e. 250 mg/dl as a threshold beyond which the risk of retinopathy and CVD increases
steeply.
Along with postprandial (PP/OGTT), other diagnostic parameters were also set such as:
• Fasting Plasma Glucose
• Intermediate Glucose Tolerance
• Impaired Fasting Glucose
• HbA1c
But the efficacy of these parameters were questioned from time to time and were considered only as a surrogate to PP/OGTT and not the main criteria to define or diagnose Diabetes.
My experience with more than 5000 Diabetic patients has shown that diabetic patients specially non-insulin dependent upon quitting their anti-diabetic medication are still able to maintain their blood sugar below 250 mg/dl. This means they were never diabetic patients but were falsely diagnosed as diabetic patients on the basis of the commercially promoted ( learn more in 3rd Chapter - Conspiracy) fasting blood glucose ≥ 100mg/dl or HbA1c ≥ 5.6% as a criteria to diagnose diabetes and had fallen in the trap of lifelong medication, diagnostics and doctors’ visits and ultimately ending up being a drug induced diabetic or hypertension patient (learn more in 4th Chapter-Cure).
“What you have just read may not only be an eye opener but also shocking and a matter of disbelief”. At this point you may have certain questions including, “if all kinds of anti-diabetes drugs do more harm and no good then why are millions of prescriptions being written for them?”
"Whole concept
of prescribing
Metformin is
based on
just one trial"
To answer your question let me start with Metformin, the first line of preferred drug for the newly diagnosed diabetes patients. The whole concept of prescribing Metformin is based on just one trial i.e. UKPDS (The United Kingdom Prospective Diabetes Study) where the number of patients on Metformin were followed up till the end of the trial were 136. Just 136! It is too small a number, to qualify for the world wide approval for prescription of Metformin as an anti-diabetic drug.
Here, it is important for us to understand that not all types of trials are same. Based on various factors, the trials are graded from highest to lowest level of importance. Refer to the table:
[[Hierarchy of Evidence2
Highest - ➤Meta-analysis of randomized controlled trial
➤Randomized Controlled trial
➤Non Randomized Controlled Trial
➤Cohort Studies
Lowest - ➤Case Reports ]]
"All the trials
to establish a
cut-off point for
diabetes arrived
at 250 mg/dl as a
threshold beyond
which the risk of
retinopathy and
CVD increases
steeply"
What is Meta-analysis of Randomized Controlled Trial?
Meta-analysis is a statistical technique for
combining the findings from independent
studies. Meta-analysis is most often used to
assess the clinical effectiveness of healthcare
interventions; it does this by combining data
from two or more randomized control trials.
What is Randomized Controlled Trial?
A Randomized Controlled Trial (RCT) is a type of
scientific (often medical) experiment, where the
people being studied are randomly allocated one
or other of the different treatments under study.
RCT is often considered the gold standard for a
clinical trial.
What is Non-Randomized Controlled Trial?
A study where participants have been assigned to
the treatment, procedure, or intervention
alternatives by a method that is not random. The
investigator defines and manages the alternatives.
What is Cohort Study?
Cohort Studies are a type of medical research used to investigate the causes of disease, establishing links between risk factors and health outcomes. Cohort studies are usually forward looking
- that is, they are “prospective” studies, or planned in advance and carried out over a period of time.
What is Case Report?
In medicine, a Case Report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the
patient, but usually describe an unusual or novel occurrence.
From here you can make out that the meta-analysis of RCT’s are the best evidence to understand the efficiency and effectiveness of a particular treatment protocol. But the problem
with meta-analysis is that it is possible only
when there are few RCTs already available.
Till that time the Medical Care has to rely on
Cohort Studies or Case Reports, which can be
misleading and even life threatening. Here is a
classic example of it.
“Should Oxygen therapy be given for acute Myocardial Infarction (heart attack patients)?”
The general consensus on the basis of various
Cohort Studies and Case Reports was that, “giving
oxygen therapy to heart attack patients, increases
the chances of survival,” till the meta-analysis
of Cochrane Database 2013 was published and
concluded that, ‘giving oxygen therapy to heart
attack patients doubles the chances of death.”
Sometimes the consensus is based on a weak
evidence and the public at large has to suffer.
Here is another example, “imagine all the
cardiologists of the world vanish for 3 days from
the world. What will happen to the heart patients
and the patients who arrive in the emergency
ward with heart attack?” General understanding
would be, ‘the patients would suffer and certainly
the mortality rate will drastically increase in the
absence of cardiac doctors in emergency units.’
"Up to 70% of
people were
falsely diagnosed
as diabetic
patients on the
basis of the
commercially
promoted fasting
blood glucose≥
100mg/dl or
HbA1c ≥ 5.6%
as a criteria to
diagnose diabetes"
Now, here is a jaw dropping surprise!
Every year National Cardiology Meeting is being organized by American Heart Association (AHA) and American College of Cardiology (ACC) in the month of March, where around 25000
Cardiologists participate in the conference leaving behind their hospitals for 3 days. In Dec 2014, a retrospective analysis was published in JAMA Internal Medicine with the objective to analyze
the mortality rate among the high risk patients with heart failure. The outcome was about 8% reduction in mortality during the cardiology meeting dates.
Sometimes the general consensus and expected outcome may be far from truth. Here, it is important to understand how to distinguish between the low quality & biased medical report from a true medical outcome.
"Meta-analysis
of RCT’s is
considered as the
highest level of
evidence"
As a trained medical analyst (trained at Penang Medical College, Malaysia) I follow 3 rules to identify the true picture of expected medical outcomes, which has also become the basis of my
writing this book:
1) If it is ‘industry-funded’ then ‘scrap it’.
To understand it, read the full story of Cholesterol Guidelines.
DECODING MEDICAL GUIDELINES
U.S. Department Of Health and Human Services
have projected themselves (successfully though)
as a self styled medical parameter and guidelines
deciding authority for rest of the world. Under it
is a department called National Institute of
Health, under National Institute of Health sits
National Heart Lung and Blood Institute
(NHLBI) which runs ‘National Cholesterol
Education Program (NCEP). An 8 member
committee of NCEP decides the Cholesterol
Guidelines ( similarly there are other department
in NIH, engaged in creating guidelines for
diabetes, hypertensions etc.) Now to decide the
Cholesterol Guidelines they refer to some of the
past trials related to cholesterol. In the present
case they referred to two major past trials,
1)” ALLHAT-LLT” and 2) “PROSPER”, and
concluded for “aggressive treatment for primary
prevention with Statin”, in patients with
cholesterol more than 200.
Please refer below:
{CHOLESTEROL}
U. S. Dept. of Health & Human Service;
⬇
National Institute of Health
⬇
National Heart, Lung and Blood Institute (NHLBI)
⬇
National Education
Cholesterol Program
⬇
2004 *
Aggressive treatment
for primary prevention
with statin
Cochrane Collaboration
⬇
University of British
Colombia
⬇
2005 *
Statin shows no health
benefit in primary of
prevention
* *ALLHAT-LLT PROSPER
Please refer below for profile of the 8 Members of
the Committee of NCEP.
[[ 1. Dr. Cleeman: (Chairman) has no financial relationships to
disclose.
2. Dr. Grundy: has received honoraria from Merck,
Pfizer, Sankyo, Bayer, Merck/Schering-Plough,
Kos, Abbott, Bristol-Myers Squibb, and Astra
Zeneca; he has received research grants from
Merck, Abbott, and Glaxo Smith Kline.
3. Dr. Bairey Merz: has received lecture honoraria
from Pfizer, Merck, and Kos; she has served as a
consultant for Pfizer, Bayer, and EHC (Merck );
she has received unrestricted institutional grants
for Continuing Medical Education from Pfizer,
Procter & Gamble, Novartis, Wyeth, Astra
Zeneca, and Bristol-Myers Squibb Medical
Imaging; she has received a research grant from
Merck; she has stock in Boston Scientific, IVAX,
Eli Lilly, Medtronic, Johnson & Johnson,
SCIPIE Insurance, ATS Medical, and Biosite.
4. Dr. Brewer: has received honoraria from AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/ Schering-Plough, Fournier, Tularik, Esperion, and Novartis ; he has served as a consultant for AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Sankyo, and Novartis.
5. Dr. Clark: has received honoraria for educational presentations from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer; he has received grant /research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer.
6. Dr. Pasternak: has served as a speaker for Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/ScheringPlough,
Sanofi, Pfizer Health Solutions, Johnson & Johnson -Merck, and. Johnson & Johnson.
7. Dr. Hunninghake: has received honoraria for consulting and speakers bureau from AstraZeneca, Merck, Merck/Schering-Plough, and Pfizer, and for consulting from Kos; he has received research grants from AstraZeneca, BristolMyers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, and Pfizer. Dr Pasternak: has served as a speaker for Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/Schering-Plough, Sanofi, Pfizer Health Solutions, Johnson & Johnson -Merck, and. Johnson & Johnson.
8. Dr. Stone: has received honoraria for
educational lectures from Abbott, AstraZeneca,
Bristol-Myers Squibb, Kos, Merck, Merck/
Schering-Plough, Novartis, Pfizer, Reliant, and
Sankyo; he has served as a consultant for Abbott,
Merck, Merck/ScheringPlough.]]
"Giving oxygen
therapy to heart
attack patients
doubles the
chances of death"
"Mortality rate
increases
considerably
by intensive
blood glucose
lowering among
the ICU patients
in comparison
to the standard
treatment "
It is now clear that these members can be greatly
influenced by the drug companies from whom they
receive regular grants /funding or have several
monetary tie-ups. So to understand the real picture
of cholesterol guidelines it is important to draw
your attention to Cochrane Collaboration, a highly
regarded medical organization being recognized
by and referred by all major medical agencies
across the world. They have branches in more
than 130 countries and are known for not accepting
any sponsorship or any kind of grant from any
pharmaceutical company. Under Cochrane
Collaboration, is University of British Columbia
who on the basis of same ‘ALLHAT -LLT’ and
‘PROSPER ‘ trial concluded that “Statin shows
no health benefit in primary prevention.” Even in
the past, several medical agencies proved beyond
doubts that lowering Cholesterol through drugs is
not only worthless but also injurious to human health.
Consider the following reference:
20 yrs (1960 to 1980) study by World Heath Organisation
Lowering Cholesterol with medication increased overall risk of death by 47%.
2010 British Medical Journal
Observational study of more than 2 million people treated with statin.
Result: Significantly increased risk of liver dysfunction, kidney failure and cataract.
Honolulu Heart Program
Low cholesterol had significant association with mortality, which was an increased risk of mortality by 64%.
The above conclusion was so clear that Pfizer, the largest manufacturer of Statin was forced to write a disclaimer for several years as below:
“Statins have not been shown to prevent
heart disease or heart attack”-Pfizer
On the other hand, it was observed that the residents of Rural China and Central Africa were always found to have cholesterol levels which were considered dangerously high by the present medical standards, but these residents are known to rarely suffer from heart diseases and often live beyond 100 years.
2) For the final verdict of any expected medical outcome, a given medical care protocol and pharmacology also relies on meta-analysis of randomized controlled trial. For this, ‘the most
preferred source is the Cochrane Database.
3) You should be able to ‘read between the lines’. Sometimes the final conclusion of a particular trial is too illusive and deceptive. It may mislead you in a direction which will in-fact harm
the patients.
To understand further, consider the following RCT of 11,140 patients with Type 2 Diabetes to undergo either standard glucose control or intensive glucose control. This widely quoted trial
ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Released Controlled Evaluation) Collaborative Group was published in New England Journal of Medicine June
12, 2008 .
The Final Conclusion of this trial is given below:
[[A strategy of intensive glucose control, involving gliclazide (modified release and other drugs as required), that lowered the glycated hemoglobin value to 6.5% yielded a 10% relative reduction in the combined outcome of major macrovascular
and micro-vascular events, primarily as a consequence of a 21% relative reduction in nephropathy. ClinicalTrials.gov number, NCT00145925]]
"Cochrane
Collaboration
2013 defines
the hypertension
guidelines as
having blood
pressure
more than
160/100 mmHg "
At the face of it, it is clear that the strategy of
intensive glucose control is a wiser decision for
the patients. However if you carefully read the
complete 13 page report, you will find a
contradictory (true) outcome.
Here in the box is given an extract from the ADVANCE trial:
Subgroup Intensive Control(N-5571) Standard
Control (N-5569)
All Cerebrovascular Events 6.3% 5.9%
All Cardiovascular Events 22.1% 22.4%
Visual Deterioration 54.4% 54.1%
New or Worsening Neuropathy 42.2% 41.5%
Dementia 1.1% 0.9%
When you compare various medical events /risk
factors of intensive control v/s standard control,
you can clearly see that there is more neuropathy,
more dementia, more visual deterioration and
more cerebrovascular events in intensive glucose
control group in comparison to the standard group
and only in cardiovascular event it is insignificantly
better than the standard group.
Reading, interpreting and implementing the out-
comes of a medical trial is far more important
than understanding the pharmacology. Our modern
doctors are not trained and are ill equipped to
interpret the outcomes of the medical trials. As a
result of this misinterpretation, sometimes the
mass popular practice by the doctors becomes a
harmful practice . For instance, it is a common
practice to tightly control the blood sugar level of
a patient, admitted in Medical ICU, whereas the
truth is, the mortality rate increases considerably
by intensive blood glucose lowering among the
ICU patients in comparison to the standard
treatment as reported in New England of
Journal of Medicines Feb 2, 2006. The
disparity in understanding of medical protocol
and medical diagnostic guidelines were clearly
demonstrated in 17th World Conference Of The
Hypertension League Council held in Montreal
in 1997 where 27 National Hypertension
Societies participated. Among them 14 used
140/90 mmHg as a threshold to diagnose
hypertension and 13 used 160/95 mmHg.
However, now 120/80 mmHg as a threshold is
prevailing globally as hypertension cutoff point.
Here as a medical doctor, your ability to identify
the right resources to find most reliable reference
to diagnose hypertension will play an important
role for the well being and safety of patients.
For that you can refer to the meta-analysis of
Cochrane Collaboration, 2013, which defines the
hypertension threshold as 160/100 mmHg
specially in case of diabetic patients.
Besides your ability to find a reliable source to
decide the protocol of your treatment and
diagnostic parameter, one more factor will help
patients to recover from the disease as it has helped
me to reverse diabetes of thousands of my patients.
And that is, ‘your understanding of making of the
diagnostic parameters.’ In the present context of
this book, let’s try to understand the making of
diagnostic parameter for diabetes.
"There was about
8% reduction in
mortality rates
during National
Cardiology
meeting dates"
It was somewhere between year 1965 and 1978,
an attempt was made to define the cutoff point for
the diagnosis of high blood sugar i.e. the amount
of sugar in the blood beyond which there is a steep
rise in the risk of retinopathy, nephropathy and
cardio vascular disease. For that PIMA Indians,
the population with highest prevalence of diabetes
was chosen. After 75 gm of oral glucose load,
blood sugar was measured after 2 hrs and the
results were plotted in histogram form as shown
below.
Fig A, Page 34. Blood glucose after 2hrs of OGTT
against % of population
Fig B, Page 35.
In figure B, a superimposed composite curve has
been drawn and there is a point where the 2 curves
meet and cross one another. This is called
Bi-modality, which separates the two populations.
Here the 2nd curve represents the diabetes
population and cutoff point is a little above 200
mg/dl somewhere near 225 mg/dl which can be
called as a threshold for the diagnosis of diabetes.
Bi-modality point
"Blood sample
taken from finger
tip (capillary
blood) always has
about 10% more
sugar level than
venous blood"
Here, we must note that the blood samples taken
here were venous blood samples whereas in home
set- up, the blood sample is taken from finger tip
(capillary blood) which always has about 10%
more sugar level.
In the light of the above factors, it is evident that
the well being of the patients depends on the
ability of the doctor to interpret the medical trial,
treatment protocol and diagnostic parameter.
References:
1. Cardiovascular risk factors and their effects on
the decision to treat hypertension: Evidence
Based Review. BMJ-2001.
2. Chalmers TC, Celano P, Sacks HS, Smith H Jr.
(1983) Bias in treatment assignment in controlled
clinical trials. New England Journal of Medicine.
Chapter 2 - CALCULATION
Are you a Diabetic Patient? How do you know
that you suffer from diabetes?
First of all we must remind ourselves that
diabetes is not a disease but a condition in which,
if sugar (glucose) concentration in the blood is
below or above a certain level, then the chances
of heart disease, kidney failure, blindness and
even death may increase substantially (it may be
noted that at any level of sugar, there still remains
about 20% chances of heart disease and
reasonable chances of blindness and kidney failure).
"Retinopathy
– a specific
micro-vascular
complication is a
basis for deciding
a cut-off point for
diabetes"
The basic question is how many grams of sugar
per litre of your blood is safe or will lead to risk
of dying from previously mentioned causes. Prior
to 1979, there were at least 6 different sets of
criteria to diagnose diabetes,[1] all of them
lacking evidence and standardization. In 1999,
the National Diabetes Data Group (NDDG)
attempted to resolve this issue by arriving at a
clear cut value of sugar level in the blood above
which the diabetes associated risk factors
increased steeply.[2]
Subsequently, the bimodal frequency distribution
of sugar concentration in the blood was suggested
which allowed a separation of the population in
two groups- Normal and Diabetic. This provided
a base for determining the degree of sugar level
in the blood that could be regarded as diabetes[3,4].
Out of all the complications that high level of
sugar may attract, they selected Retinopathya
specific micro-vascular complication as a basis
for deciding a cutoff point above which the
chances of retinopathy increases sharply. Three
major studies5,6,7 were available to the NDDG
on which they based their decision. A total of
1213 patients were followed up for 3 to 8 yrs after
Oral Glucose Tolerance Test (OGTT) and 77 of
them developed retinopathy.
Oral Glucose Tolerance Test (OGTT) was
conducted only at the beginning of the trial. It is
very likely that only these 77 patients with
increased glycemia (high sugar) in the years
between the Oral Glucose Tolerance Test (OGTT)
and the Onset of Retinopathy were considered by
NDDG (National Diabetes Data Group) to
establish the cut off point /diagnostic criteria.
So, on the basis of these 77 patients, the NDDG
(National Diabetes Data Group) defined that
anyone with blood glucose level above 200 mg/dl
(or 2 gm sugar per litre of blood) should be
recognized as diabetic. Thus, the gold standard
of blood sugar ≥200 mg/dl after 2hr of consuming
75 gm of glucose (OGTT), as a cut off point for
diagnosis of diabetes is actually based on results
from less than 100 individuals[8].
Adoption of similar guidelines by World Health Organization
(WHO) attracted a lot of worldwide criticism and dissatisfaction as
they seemed to be arbitrarily accepted as universal guidelines for
diagnosing diabetes5
. A Bimodal distribution method was applied
on two civilizations - PIMA Indians and Nauruans (Micronesian
https://www.biswaroop.com/9312286540.pdf
Why Should I Read This Book ?............7
1. Consensus...........................................9
2. Calculation .........................................37
3. Conspiracy .........................................53
4. Cure ..............................................82
WHY SHOULD I READ THIS BOOK ?
To know why, attempt answering the following questions:
Q. 1) Which is correct ?
a) High Blood Pressure leads to Heart Disease
/Risk of Brain Stroke
b) Risk of Brain Stroke/Heart Disease leads to
High Blood Pressure
Q. 2) Is Mango good/ bad for diabetic patients?
a) Bad b) Good
"Mango is good for Diabetic Patients"
Q. 3) If your blood sugar reading (with glucometer) comes to about 250mg/dl consistently then
you are a diabetes patient ?
a) True b) False
Q. 4) The primary function of heart is to pump blood across the circulatory system?
a) True b) False
Correct Answers : All (b) options are correct.
If you are among 99% of doctors then chances are, you must have opted for option (a) as correct
answer.
Think again, it’s time to Unlearn and Relearn.. Read on!
Chapter 1 CONSENSUS
Get ready to be pleasantly shocked! The first chapter has the
potential for some amazing outcomes:
1. 100% of Diabetic patients will abandon their anti-diabetic pills...
permanently.
2.Up to 70% of Diabetic patients will come to know
that they are no more diabetic....
The Universal Consensus says that:
• The 10 year risk of cardiovascular diseases
(CVD) in a Diabetic population is just 2% higher
than in the non-diabetic population.
"The 10 year
risk of cardio
vascular
diseases
in case of
a person
suffering from
diabetes is
2% higher
than in the
non diabetic
population "
• Lifetime risk of Dialysis in case of a Diabetic patient is just 1.5% higher than the normal
population.
• Lifetime risk of blindness is 4% higher in case of Diabetes patients. [1]
It is clear from all the clinical studies specifically done on PIMA Indians (population with highest rate of Diabetes) that High Blood Sugar increases the risk of Cardio Vascular Disease (CVD),
Retinopathy, Neuropathy and Nephropathy.
Higher Blood Sugar = Higher risk of Diseases.
in other words
Lower Blood Sugar = Lower risk of Diseases
but, does that automatically mean lowering blood sugar with medication = Lower risk of diseases!
It seems obvious. But the reality is just the opposite!
It is Natural lowering of Blood Sugar = Lower risk of Diseases:
True
and
Lowering Blood Sugar with Medication = Lower risk of Diseases:
False
Let me prove my point by considering each group
of diabetes medication one by one, starting with
Metformin the highest prescribed pill among all.
Given in the next page is the meta-analysis of 13
Randomized Control Trial (RCT) - 9500
Metformin cases / 3500 Placebo for 5 years
(PLOS Medicine-2012). It can be clearly seen
that the Risk Ratio Interpretation (RRI) for all
the risk factors increase among patients on
Metformin.
"Lowering blood
sugar with
medication does
not lower the risk
of heart failure or
retinopathy "
Risk factor RRI
Cardio Vascular disease mortality 1.05
Heart Failure 1.03
Amputation 1.04
↑PLOS Medicine 2012
Conclusively, it means being on Metformin, one can lower the blood sugar level. But our prime aim is not just to target a particular blood sugar range rather, our aim is to reduce the risk of suffering from heart disease and other complication because of increased sugar levels in the blood.
What about the other class of diabetes medication?
To find an answer, a large study called ADOPT (A
Diabetes Outcome Progression Trial) blinded RCT
(Randomized Controlled Trial) in which 4360
patients were followed up to 4 years to compare
the effects of Glyburide, Metformin and Rosiglitazone.
The result showed that Glyburide and
Rosiglitazone performed worse than Metformin
with more mortality rate, more edema and more
weight gain.
Class of Drug Mortality Rate % Edema % Weight Gain %
Glyburide 2.2 8.5 3.3
Metformin 2.1 7.2 1.2
Rosiglitazone 2.3 14.10 6.9
With these heart breaking results of the above
class of glucose lowering agents, it is worth-
while to consider the performance of remaining
class of anti-diabetic medications such as GLPS,
Meglitinides and SGLT2.
"Risk ratio
interpretation
(RRI) for all
the risk factors
increase among
patients on
Metformin"
Upon searching the entire medical database, I
came across several research papers but the
most relevant research paper is as follows:
[[Diabetes Matab: 2014 Jan, 40(3):169-75 doi:10.1016/).diabet.2013.12.010. Epup 2014Feb3.
Effects of pharmacological treatments on micro and macro vascular complications of type 2 diabetes: what is the level of evidence?
BoussageonR1, GueyffierF2, Cornu C3.
Author Information
“In 2013, the level of evidence for the clinical efficacy of anti -diabetic drugs is disappointing
and does not support the millions of prescriptions being written for them”.]]
All the above reports conclude that although high blood sugar may be bad for your health, reducing the high blood sugar with medication is worst for your health and also a loss of significant
amount of wealth.
Here, we must understand that diabetes or high
blood sugar itself is not a disease, but a risk factor
for various diseases however, various developed
countries (under the influence of medical industry)
are irresponsibly propagating Diabetes as a
dreaded disease (learn more in 3rd Chapter - Conspiracy).
[[“Type 2 Diabetes is a Lifelong (chronic) disease.” -
A service of the U S National Library of
Medicine. National Institute of Health- USA
“Type 2 Diabetes is one of the fastest growing
diseases in Canada.” Government Of Canada ]]
The fundamental question here is, How high
should the sugar level be, to be called
Diabetes? The universal consensus or a
worldwide understanding is, ‘if your Random
Blood Glucose or Oral Glucose Tolerance Test
(OGTT) is more than 200 mg/dl, then you are
diagnosed as a diabetic patient. In simple words,
if in each litre of your blood there is more than
2gm of sugar (after 2 hrs of eating food) then
you are diagnosed as having diabetes or in other
words you have 2% higher chances of suffering
from CVD (Cardio Vascular Diseases) in next
10 years in comparison to the person with blood
glucose less than 200mg/dl.
"Glyburide and
Rosiglitazone
performed worse
than Metformin
with more
mortality rate ,
more edema and
more weight gain"
Here, the important point of consideration is, from where this number 200mg/dl arrived?
It all happened in 1979, when the expert committee of National Diabetes Data Group (NDDG) observed that the PIMA Indians (population with highest rate of diabetes) with higher blood
sugar levels were at higher risk of retinopathy. Here, it is important to note that if you go through the original trial (learn more in 2nd Chapter-Calculation) you will find that it was never 200mg/dl.
All the trials which were conducted to establish a cutoff point for Diabetes arrived at same conclusion i.e. 250 mg/dl as a threshold beyond which the risk of retinopathy and CVD increases
steeply.
Along with postprandial (PP/OGTT), other diagnostic parameters were also set such as:
• Fasting Plasma Glucose
• Intermediate Glucose Tolerance
• Impaired Fasting Glucose
• HbA1c
But the efficacy of these parameters were questioned from time to time and were considered only as a surrogate to PP/OGTT and not the main criteria to define or diagnose Diabetes.
My experience with more than 5000 Diabetic patients has shown that diabetic patients specially non-insulin dependent upon quitting their anti-diabetic medication are still able to maintain their blood sugar below 250 mg/dl. This means they were never diabetic patients but were falsely diagnosed as diabetic patients on the basis of the commercially promoted ( learn more in 3rd Chapter - Conspiracy) fasting blood glucose ≥ 100mg/dl or HbA1c ≥ 5.6% as a criteria to diagnose diabetes and had fallen in the trap of lifelong medication, diagnostics and doctors’ visits and ultimately ending up being a drug induced diabetic or hypertension patient (learn more in 4th Chapter-Cure).
“What you have just read may not only be an eye opener but also shocking and a matter of disbelief”. At this point you may have certain questions including, “if all kinds of anti-diabetes drugs do more harm and no good then why are millions of prescriptions being written for them?”
"Whole concept
of prescribing
Metformin is
based on
just one trial"
To answer your question let me start with Metformin, the first line of preferred drug for the newly diagnosed diabetes patients. The whole concept of prescribing Metformin is based on just one trial i.e. UKPDS (The United Kingdom Prospective Diabetes Study) where the number of patients on Metformin were followed up till the end of the trial were 136. Just 136! It is too small a number, to qualify for the world wide approval for prescription of Metformin as an anti-diabetic drug.
Here, it is important for us to understand that not all types of trials are same. Based on various factors, the trials are graded from highest to lowest level of importance. Refer to the table:
[[Hierarchy of Evidence2
Highest - ➤Meta-analysis of randomized controlled trial
➤Randomized Controlled trial
➤Non Randomized Controlled Trial
➤Cohort Studies
Lowest - ➤Case Reports ]]
"All the trials
to establish a
cut-off point for
diabetes arrived
at 250 mg/dl as a
threshold beyond
which the risk of
retinopathy and
CVD increases
steeply"
What is Meta-analysis of Randomized Controlled Trial?
Meta-analysis is a statistical technique for
combining the findings from independent
studies. Meta-analysis is most often used to
assess the clinical effectiveness of healthcare
interventions; it does this by combining data
from two or more randomized control trials.
What is Randomized Controlled Trial?
A Randomized Controlled Trial (RCT) is a type of
scientific (often medical) experiment, where the
people being studied are randomly allocated one
or other of the different treatments under study.
RCT is often considered the gold standard for a
clinical trial.
What is Non-Randomized Controlled Trial?
A study where participants have been assigned to
the treatment, procedure, or intervention
alternatives by a method that is not random. The
investigator defines and manages the alternatives.
What is Cohort Study?
Cohort Studies are a type of medical research used to investigate the causes of disease, establishing links between risk factors and health outcomes. Cohort studies are usually forward looking
- that is, they are “prospective” studies, or planned in advance and carried out over a period of time.
What is Case Report?
In medicine, a Case Report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the
patient, but usually describe an unusual or novel occurrence.
From here you can make out that the meta-analysis of RCT’s are the best evidence to understand the efficiency and effectiveness of a particular treatment protocol. But the problem
with meta-analysis is that it is possible only
when there are few RCTs already available.
Till that time the Medical Care has to rely on
Cohort Studies or Case Reports, which can be
misleading and even life threatening. Here is a
classic example of it.
“Should Oxygen therapy be given for acute Myocardial Infarction (heart attack patients)?”
The general consensus on the basis of various
Cohort Studies and Case Reports was that, “giving
oxygen therapy to heart attack patients, increases
the chances of survival,” till the meta-analysis
of Cochrane Database 2013 was published and
concluded that, ‘giving oxygen therapy to heart
attack patients doubles the chances of death.”
Sometimes the consensus is based on a weak
evidence and the public at large has to suffer.
Here is another example, “imagine all the
cardiologists of the world vanish for 3 days from
the world. What will happen to the heart patients
and the patients who arrive in the emergency
ward with heart attack?” General understanding
would be, ‘the patients would suffer and certainly
the mortality rate will drastically increase in the
absence of cardiac doctors in emergency units.’
"Up to 70% of
people were
falsely diagnosed
as diabetic
patients on the
basis of the
commercially
promoted fasting
blood glucose≥
100mg/dl or
HbA1c ≥ 5.6%
as a criteria to
diagnose diabetes"
Now, here is a jaw dropping surprise!
Every year National Cardiology Meeting is being organized by American Heart Association (AHA) and American College of Cardiology (ACC) in the month of March, where around 25000
Cardiologists participate in the conference leaving behind their hospitals for 3 days. In Dec 2014, a retrospective analysis was published in JAMA Internal Medicine with the objective to analyze
the mortality rate among the high risk patients with heart failure. The outcome was about 8% reduction in mortality during the cardiology meeting dates.
Sometimes the general consensus and expected outcome may be far from truth. Here, it is important to understand how to distinguish between the low quality & biased medical report from a true medical outcome.
"Meta-analysis
of RCT’s is
considered as the
highest level of
evidence"
As a trained medical analyst (trained at Penang Medical College, Malaysia) I follow 3 rules to identify the true picture of expected medical outcomes, which has also become the basis of my
writing this book:
1) If it is ‘industry-funded’ then ‘scrap it’.
To understand it, read the full story of Cholesterol Guidelines.
DECODING MEDICAL GUIDELINES
U.S. Department Of Health and Human Services
have projected themselves (successfully though)
as a self styled medical parameter and guidelines
deciding authority for rest of the world. Under it
is a department called National Institute of
Health, under National Institute of Health sits
National Heart Lung and Blood Institute
(NHLBI) which runs ‘National Cholesterol
Education Program (NCEP). An 8 member
committee of NCEP decides the Cholesterol
Guidelines ( similarly there are other department
in NIH, engaged in creating guidelines for
diabetes, hypertensions etc.) Now to decide the
Cholesterol Guidelines they refer to some of the
past trials related to cholesterol. In the present
case they referred to two major past trials,
1)” ALLHAT-LLT” and 2) “PROSPER”, and
concluded for “aggressive treatment for primary
prevention with Statin”, in patients with
cholesterol more than 200.
Please refer below:
{CHOLESTEROL}
U. S. Dept. of Health & Human Service;
⬇
National Institute of Health
⬇
National Heart, Lung and Blood Institute (NHLBI)
⬇
National Education
Cholesterol Program
⬇
2004 *
Aggressive treatment
for primary prevention
with statin
Cochrane Collaboration
⬇
University of British
Colombia
⬇
2005 *
Statin shows no health
benefit in primary of
prevention
* *ALLHAT-LLT PROSPER
Please refer below for profile of the 8 Members of
the Committee of NCEP.
[[ 1. Dr. Cleeman: (Chairman) has no financial relationships to
disclose.
2. Dr. Grundy: has received honoraria from Merck,
Pfizer, Sankyo, Bayer, Merck/Schering-Plough,
Kos, Abbott, Bristol-Myers Squibb, and Astra
Zeneca; he has received research grants from
Merck, Abbott, and Glaxo Smith Kline.
3. Dr. Bairey Merz: has received lecture honoraria
from Pfizer, Merck, and Kos; she has served as a
consultant for Pfizer, Bayer, and EHC (Merck );
she has received unrestricted institutional grants
for Continuing Medical Education from Pfizer,
Procter & Gamble, Novartis, Wyeth, Astra
Zeneca, and Bristol-Myers Squibb Medical
Imaging; she has received a research grant from
Merck; she has stock in Boston Scientific, IVAX,
Eli Lilly, Medtronic, Johnson & Johnson,
SCIPIE Insurance, ATS Medical, and Biosite.
4. Dr. Brewer: has received honoraria from AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/ Schering-Plough, Fournier, Tularik, Esperion, and Novartis ; he has served as a consultant for AstraZeneca, Pfizer, Lipid Sciences, Merck, Merck/Schering-Plough, Fournier, Tularik, Sankyo, and Novartis.
5. Dr. Clark: has received honoraria for educational presentations from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer; he has received grant /research support from Abbott, AstraZeneca, Bristol-Myers Squibb, Merck, and Pfizer.
6. Dr. Pasternak: has served as a speaker for Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/ScheringPlough,
Sanofi, Pfizer Health Solutions, Johnson & Johnson -Merck, and. Johnson & Johnson.
7. Dr. Hunninghake: has received honoraria for consulting and speakers bureau from AstraZeneca, Merck, Merck/Schering-Plough, and Pfizer, and for consulting from Kos; he has received research grants from AstraZeneca, BristolMyers Squibb, Kos, Merck, Merck/Schering-Plough, Novartis, and Pfizer. Dr Pasternak: has served as a speaker for Pfizer, Merck, Merck/Schering-Plough, Takeda, Kos, BMS-Sanofi, and Novartis; he has served as a consultant for Merck, Merck/Schering-Plough, Sanofi, Pfizer Health Solutions, Johnson & Johnson -Merck, and. Johnson & Johnson.
8. Dr. Stone: has received honoraria for
educational lectures from Abbott, AstraZeneca,
Bristol-Myers Squibb, Kos, Merck, Merck/
Schering-Plough, Novartis, Pfizer, Reliant, and
Sankyo; he has served as a consultant for Abbott,
Merck, Merck/ScheringPlough.]]
"Giving oxygen
therapy to heart
attack patients
doubles the
chances of death"
"Mortality rate
increases
considerably
by intensive
blood glucose
lowering among
the ICU patients
in comparison
to the standard
treatment "
It is now clear that these members can be greatly
influenced by the drug companies from whom they
receive regular grants /funding or have several
monetary tie-ups. So to understand the real picture
of cholesterol guidelines it is important to draw
your attention to Cochrane Collaboration, a highly
regarded medical organization being recognized
by and referred by all major medical agencies
across the world. They have branches in more
than 130 countries and are known for not accepting
any sponsorship or any kind of grant from any
pharmaceutical company. Under Cochrane
Collaboration, is University of British Columbia
who on the basis of same ‘ALLHAT -LLT’ and
‘PROSPER ‘ trial concluded that “Statin shows
no health benefit in primary prevention.” Even in
the past, several medical agencies proved beyond
doubts that lowering Cholesterol through drugs is
not only worthless but also injurious to human health.
Consider the following reference:
20 yrs (1960 to 1980) study by World Heath Organisation
Lowering Cholesterol with medication increased overall risk of death by 47%.
2010 British Medical Journal
Observational study of more than 2 million people treated with statin.
Result: Significantly increased risk of liver dysfunction, kidney failure and cataract.
Honolulu Heart Program
Low cholesterol had significant association with mortality, which was an increased risk of mortality by 64%.
The above conclusion was so clear that Pfizer, the largest manufacturer of Statin was forced to write a disclaimer for several years as below:
“Statins have not been shown to prevent
heart disease or heart attack”-Pfizer
On the other hand, it was observed that the residents of Rural China and Central Africa were always found to have cholesterol levels which were considered dangerously high by the present medical standards, but these residents are known to rarely suffer from heart diseases and often live beyond 100 years.
2) For the final verdict of any expected medical outcome, a given medical care protocol and pharmacology also relies on meta-analysis of randomized controlled trial. For this, ‘the most
preferred source is the Cochrane Database.
3) You should be able to ‘read between the lines’. Sometimes the final conclusion of a particular trial is too illusive and deceptive. It may mislead you in a direction which will in-fact harm
the patients.
To understand further, consider the following RCT of 11,140 patients with Type 2 Diabetes to undergo either standard glucose control or intensive glucose control. This widely quoted trial
ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Released Controlled Evaluation) Collaborative Group was published in New England Journal of Medicine June
12, 2008 .
The Final Conclusion of this trial is given below:
[[A strategy of intensive glucose control, involving gliclazide (modified release and other drugs as required), that lowered the glycated hemoglobin value to 6.5% yielded a 10% relative reduction in the combined outcome of major macrovascular
and micro-vascular events, primarily as a consequence of a 21% relative reduction in nephropathy. ClinicalTrials.gov number, NCT00145925]]
"Cochrane
Collaboration
2013 defines
the hypertension
guidelines as
having blood
pressure
more than
160/100 mmHg "
At the face of it, it is clear that the strategy of
intensive glucose control is a wiser decision for
the patients. However if you carefully read the
complete 13 page report, you will find a
contradictory (true) outcome.
Here in the box is given an extract from the ADVANCE trial:
Subgroup Intensive Control(N-5571) Standard
Control (N-5569)
All Cerebrovascular Events 6.3% 5.9%
All Cardiovascular Events 22.1% 22.4%
Visual Deterioration 54.4% 54.1%
New or Worsening Neuropathy 42.2% 41.5%
Dementia 1.1% 0.9%
When you compare various medical events /risk
factors of intensive control v/s standard control,
you can clearly see that there is more neuropathy,
more dementia, more visual deterioration and
more cerebrovascular events in intensive glucose
control group in comparison to the standard group
and only in cardiovascular event it is insignificantly
better than the standard group.
Reading, interpreting and implementing the out-
comes of a medical trial is far more important
than understanding the pharmacology. Our modern
doctors are not trained and are ill equipped to
interpret the outcomes of the medical trials. As a
result of this misinterpretation, sometimes the
mass popular practice by the doctors becomes a
harmful practice . For instance, it is a common
practice to tightly control the blood sugar level of
a patient, admitted in Medical ICU, whereas the
truth is, the mortality rate increases considerably
by intensive blood glucose lowering among the
ICU patients in comparison to the standard
treatment as reported in New England of
Journal of Medicines Feb 2, 2006. The
disparity in understanding of medical protocol
and medical diagnostic guidelines were clearly
demonstrated in 17th World Conference Of The
Hypertension League Council held in Montreal
in 1997 where 27 National Hypertension
Societies participated. Among them 14 used
140/90 mmHg as a threshold to diagnose
hypertension and 13 used 160/95 mmHg.
However, now 120/80 mmHg as a threshold is
prevailing globally as hypertension cutoff point.
Here as a medical doctor, your ability to identify
the right resources to find most reliable reference
to diagnose hypertension will play an important
role for the well being and safety of patients.
For that you can refer to the meta-analysis of
Cochrane Collaboration, 2013, which defines the
hypertension threshold as 160/100 mmHg
specially in case of diabetic patients.
Besides your ability to find a reliable source to
decide the protocol of your treatment and
diagnostic parameter, one more factor will help
patients to recover from the disease as it has helped
me to reverse diabetes of thousands of my patients.
And that is, ‘your understanding of making of the
diagnostic parameters.’ In the present context of
this book, let’s try to understand the making of
diagnostic parameter for diabetes.
"There was about
8% reduction in
mortality rates
during National
Cardiology
meeting dates"
It was somewhere between year 1965 and 1978,
an attempt was made to define the cutoff point for
the diagnosis of high blood sugar i.e. the amount
of sugar in the blood beyond which there is a steep
rise in the risk of retinopathy, nephropathy and
cardio vascular disease. For that PIMA Indians,
the population with highest prevalence of diabetes
was chosen. After 75 gm of oral glucose load,
blood sugar was measured after 2 hrs and the
results were plotted in histogram form as shown
below.
Fig A, Page 34. Blood glucose after 2hrs of OGTT
against % of population
Fig B, Page 35.
In figure B, a superimposed composite curve has
been drawn and there is a point where the 2 curves
meet and cross one another. This is called
Bi-modality, which separates the two populations.
Here the 2nd curve represents the diabetes
population and cutoff point is a little above 200
mg/dl somewhere near 225 mg/dl which can be
called as a threshold for the diagnosis of diabetes.
Bi-modality point
"Blood sample
taken from finger
tip (capillary
blood) always has
about 10% more
sugar level than
venous blood"
Here, we must note that the blood samples taken
here were venous blood samples whereas in home
set- up, the blood sample is taken from finger tip
(capillary blood) which always has about 10%
more sugar level.
In the light of the above factors, it is evident that
the well being of the patients depends on the
ability of the doctor to interpret the medical trial,
treatment protocol and diagnostic parameter.
References:
1. Cardiovascular risk factors and their effects on
the decision to treat hypertension: Evidence
Based Review. BMJ-2001.
2. Chalmers TC, Celano P, Sacks HS, Smith H Jr.
(1983) Bias in treatment assignment in controlled
clinical trials. New England Journal of Medicine.
Chapter 2 - CALCULATION
Are you a Diabetic Patient? How do you know
that you suffer from diabetes?
First of all we must remind ourselves that
diabetes is not a disease but a condition in which,
if sugar (glucose) concentration in the blood is
below or above a certain level, then the chances
of heart disease, kidney failure, blindness and
even death may increase substantially (it may be
noted that at any level of sugar, there still remains
about 20% chances of heart disease and
reasonable chances of blindness and kidney failure).
"Retinopathy
– a specific
micro-vascular
complication is a
basis for deciding
a cut-off point for
diabetes"
The basic question is how many grams of sugar
per litre of your blood is safe or will lead to risk
of dying from previously mentioned causes. Prior
to 1979, there were at least 6 different sets of
criteria to diagnose diabetes,[1] all of them
lacking evidence and standardization. In 1999,
the National Diabetes Data Group (NDDG)
attempted to resolve this issue by arriving at a
clear cut value of sugar level in the blood above
which the diabetes associated risk factors
increased steeply.[2]
Subsequently, the bimodal frequency distribution
of sugar concentration in the blood was suggested
which allowed a separation of the population in
two groups- Normal and Diabetic. This provided
a base for determining the degree of sugar level
in the blood that could be regarded as diabetes[3,4].
Out of all the complications that high level of
sugar may attract, they selected Retinopathya
specific micro-vascular complication as a basis
for deciding a cutoff point above which the
chances of retinopathy increases sharply. Three
major studies5,6,7 were available to the NDDG
on which they based their decision. A total of
1213 patients were followed up for 3 to 8 yrs after
Oral Glucose Tolerance Test (OGTT) and 77 of
them developed retinopathy.
Oral Glucose Tolerance Test (OGTT) was
conducted only at the beginning of the trial. It is
very likely that only these 77 patients with
increased glycemia (high sugar) in the years
between the Oral Glucose Tolerance Test (OGTT)
and the Onset of Retinopathy were considered by
NDDG (National Diabetes Data Group) to
establish the cut off point /diagnostic criteria.
So, on the basis of these 77 patients, the NDDG
(National Diabetes Data Group) defined that
anyone with blood glucose level above 200 mg/dl
(or 2 gm sugar per litre of blood) should be
recognized as diabetic. Thus, the gold standard
of blood sugar ≥200 mg/dl after 2hr of consuming
75 gm of glucose (OGTT), as a cut off point for
diagnosis of diabetes is actually based on results
from less than 100 individuals[8].
Adoption of similar guidelines by World Health Organization
(WHO) attracted a lot of worldwide criticism and dissatisfaction as
they seemed to be arbitrarily accepted as universal guidelines for
diagnosing diabetes5
. A Bimodal distribution method was applied
on two civilizations - PIMA Indians and Nauruans (Micronesian
https://www.biswaroop.com/9312286540.pdf
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