At our Lexington Meeting in Spring of 2012, Terry Chappell MD created an innovative workshop called "Saving a Million
Hearts." This was an intense series of panel discussions on the iconic red couch, which were based around the following article published in the Townsend Letter. Vidoe recordings of these detailed conversations are available by contacting wendy@icimed.com.
By L. Terry Chappell
Introduction
In
September of 2011, the Department of Health and Human Services (DHHS), the
Centers for Disease Control(CDC), and the Centers for Medicare and Medicaid
Services(CMS) jointly announced the
Million Hearts Initiative(1,2). The goal
is to prevent 1 million heart attacks and strokes over the next five
years. Other groups such as the American
Heart Association, the American College of Cardiology, the American Pharmacy
Association, and Walgreen drug stores quickly joined the effort.
Unfortunately,
the action plan to achieve this lofty goal as published is likely to fail. Nevertheless, those of us in Integrative
Medicine should embrace the overall goal and use all of our skills to formulate
a plan to prevent even more heart attacks and strokes than the efforts put
forth by these prestigious organizations.
This article analyzes the strengths and weaknesses of the Million Hearts
Initiative(MHI) and shows how we can make it dramatically better.
Cardiovascular
Disease as the Leading Cause of Death
In the
United States there are about 2 million heart attacks and strokes each year
with 800,000 fatalities. Not only is
this the leading cause of death, but also the overall medical cost of these
diseases is estimated to be $450 billion per year. From 1980 to 2000 there was a significant
reduction in the death rate from cardiovascular disease, most of which was due
to lifestyle changes and preventive medicine.
Yet cardiovascular disease is still by far the leading cause of death. HHS Secretary, Kathleen Sebelius, states that
heart disease is responsible for one of every three deaths in the U.S.
The MHI Plan to
Prevent Heart Attacks and Strokes
The
clinical interventions put forth by the MHI consist of four potential categories
of drugs. The treatment acronym is the
ABC’S of prevention: aspirin for high-risk
patients, medications to control blood pressure, cholesterol management, and
smoking cessation if needed (varenicline, nicotine patches, etc.). In addition, the MHI calls for improved
nutrition through a reduction in the intake of sodium and trans-fats. The MHI hopes to coordinate activities with
Obama’s Affordable Care Act. Electronic
health records and quality recognition programs offered by both the government
and various private insurance plans should also be useful for recruitment of
patients to participate.
At present,
only 47% of patients at risk take aspirin, 46% have blood pressure under
control, and 33% have LDLs below 100. The
specific goals of the MHI are to increase all of these numbers to 65% by
2017. A fourth clinical goal is to
reduce smoking prevalence from 19% to 17%(1).
Emphasizing
four interventions that might require drug therapy certainly makes one wonder
about the influence of the pharmaceutical industry in this effort. There are at
least 30 million people in the U.S. whose blood pressure and/or cholesterol are
not under control. That is a pretty
large target population, just with these two factors. Overall, Forbes
estimates that the MHI seeks to put half of our adult population on drugs
prescribed by doctors.
One of the strengths of the MHI
plan is that it does not depend on intensive care by cardiologists and vascular
surgeons. In fact, several popular blogs
written by these specialists have complained that cardiologists are being left
out of the campaign. Perhaps there is a
reason for this omission. The OAT
trial(3) in 2006 demonstrated that opening totally occluded arteries with
stents after uncomplicated myocardial infarctions involving those vessels
actually increased the mortality rate when compared to medical management. Soon
afterwards, the COURAGE trial(4) showed that angioplasty and stents for stable
coronary artery disease were no more effective than proper medical management. Before the COURAGE trial, 85% of all stents
in the U.S. were surgically placed in patients with stable coronary artery
disease. Both of these important studies have been virtually ignored in clinical
practice. Vascular specialists continue
to place unnecessary stents in many patients each year. A recent JAMA editorial(5) described this
practice as an “expensive placebo”. The
authors further commented that “some entire medical subspecialties (might be)
based on little evidence”. No doubt
there are valid indications for revascularization procedures and complex drug
therapy. Cardiologists are necessary. Many of them would be more effective,
however, if they focused more on nutritional biochemistry.
Of great interest is the study by
Canto and associates(6) that analyzed 542,008 patients who had heart attacks
from 1994 to 2006. For those patients
who suffered their first heart attack, the in-hospital mortality was inversely proportional to the number of
traditional risk factors that were identified.
The risk factors they examined were hypertension, smoking, dyslipidemia,
diabetes, and family history of heart disease.
Obviously, other factors were contributing to the increased mortality
for these patients. If we are to
succeed, we must do a more thorough job of identifying risk factors and
modifying them safely.
Criticism of the MHI
Plan
The most
obvious deficit in the MHI plan is that it does not include three commonly
recognized lifestyle factors for the prevention of cardiovascular disease:
regular exercise, stress coping measures, and weight reduction if needed. Exercise alone is probably more effective
than any drug one can take. By excluding
these important lifestyle factors it becomes highly unlikely that the MHI will
succeed in real life.
The MHI appropriately
states that we must reduce trans-fats and sodium in our diets, but it could do
much more. At the very least, patients
at risk should avoid foods that are high in the glycemic index, aspartame,
high-fructose corn syrup, processed foods, and fried foods. We also could eat organic raw veggies as much
as possible. The use of unrefined salt
would add beneficial trace minerals. Not
surprisingly, the potential benefits of nutritional and herbal supplements are
not mentioned in the MHI.
Diabetes is
another prominent risk factor for cardiovascular disease. Weight control and low carbohydrate diets are
important for prevention and treatment of diabetes. Diet, exercise and supplements are often sufficient
to achieve control of Type 2 disease without medications.
Poverty and
inequality are factors that have been shown to increase cardiovascular
disease. Not only do these factors cause
economic stress, but they also result in poor quality food and increased
smoking as a stress-coping measure. Such
socioeconomic factors make it more difficult for the ABC’S of the MHI to
succeed. A more comprehensive approach
as I describe is required to overcome the twin risk factors of poverty and
inequality.
The MHI is
careful to note that aspirin and statin drugs for cholesterol management are to
be used only for high-risk patients.
However, that might serve to be the “fine print” that nobody reads. Recent reports show that for primary
prevention of cardiovascular disease the “number needed to treat” to prevent
one heart attack with aspirin is 163 and for statin drugs is 200(7). The “number needed to harm” for both of these
interventions is much lower. Thus the
use of these drugs for primary prevention is highly questionable. However, many physicians still prescribe them
when not indicated, which is a waste of resources and the potential source of serious
complications.
If we are
going to succeed in saving a million hearts with our current socioeconomic and
lifestyle stresses and our failure to change our therapies in response to
definitive evidence, we should look at additional risk factors, especially ones
whose remedies are much less likely to cause complications than the proposed
drugs. We should emphasize powerful
lifestyle changes and safe, optimal supplements instead of diverting our
attention toward aspirin, anti-hypertensive drugs, and statins. For this, we can
rely on and offer our patients the insights and experience of integrative
medicine.
Let’s Get Serious
About Saving a Million Hearts
Obviously,
we cannot save a million hearts and strokes all by ourselves. But we can save way more than our share. First, we should identify the hearts that
need saving (although the case can be made that all hearts need saving). We can determine if patients’ hearts are at
risk mostly by performing a history and physical exam and gathering basic lab
and other tests, some of which might have been previously been performed. If patients have a history of documented
vascular disease, hypertension, hyperlipidemia, diabetes, smoking in the
previous 5 years, or a family history of heart attacks or strokes, they
automatically qualify.
Computerized risk assessments, usually
based on the Framingham Risk Assessment, might or might not be helpful. They provide striking graphic displays that
demonstrate the effect of improving basic risk factors. However, they don’t include the cumulative
effect of a comprehensive risk factor plan like we are discussing. If patients are at least 50 years old or the
physician suspects high-risk lifestyles, one or more screening tests to
determine if they are beginning to develop plaque in their arteries is
indicated. If a resting EKG has non-specific
ST/T-wave changes, their heart might be at risk. A stress EKG can have false positives and
false negatives, especially in women. A
stress echocardiogram is more accurate in females. An ultra-fast CT scan for calcium score is a
good screening test. A carotid intima
media thickness(CIMT) ultrasound test by CardioRisk(www.cardiorisk.us) is also
a very sensitive screening test that can be done by that company periodically
in your office. The ankle/brachial index
is a reasonable screen for peripheral artery disease, although not very
sensitive, in my experience. If
positive, however, there is an increased risk for heart attacks and strokes.
If we determine that a patient is
at risk, a comprehensive cardiovascular risk factor evaluation is indicated. For our patients who join the MHI, we often
recommend a VAP cholesterol panel, including Lp(a)(8), HbA1C, ferritin,
fibrinogen, CRPsensitive, red cell magnesium, 25 [OH] vitamin D3(9), and homocysteine
test. Virtually all of these tests and
more are included in a comprehensive cardiovascular blood panel. Two companies that offer such panels are
Doctors Data(www.doctorsdata.com) and
Atherotech(www.Atherotech.com). We also do a EDTA challenge test for heavy
metals, with special attention to lead(10).
If available, heart rate variability testing frequently detects high
sympathetic activity that is not balanced by parasympathetic output, even when
the patient is unaware of excessive stress. A saliva test strip for nitric oxide (www.advancedbionutritionals.com)
can detect low NO levels, which theoretically at least, can be improved with
nutritional support. Other tests for
nutritional factors can certainly be ordered, but they are beyond the scope of
this article.
In our report of findings, we estimate how much risk we think each
patient has and how we feel we can improve that risk with various
interventions. Our individual patient
data base is considerably larger than that of the MHI. Our recommended treatment interventions include
more aggressive lifestyle measures, nutritional supplements, herbal therapies,
and other treatments as indicated.
Integrative Treatment
Plan
Start with the ABC’S. Instead of or in addition to aspirin, to
reduce platelet aggregation, we can use fish oils, garlic, vitamin E (mixed
tocopherols especially gamma), nattokinase, and/or lumbokinase. Donating blood several times a year is another
way to decrease blood viscosity. One
study showed an 88% reduction in the risk for myocardial infarction for 153
middle-aged men who donated blood in the previous 24 months(11) That study has been criticized, but a more
recent study(12) delineated a more complex mechanism and confirmed that blood
donation might reduce the risk of vascular disease. In addition to reduced blood viscosity, the
resulting decrease in elevated ferritins substantially lowered free radical
activity. Rheologics (610-524-5427)
makes a machine that measures blood viscosity.
The blood pressure might respond to
garlic, potassium, magnesium, and other phytonutrients. I have found rauwolfia with sandalwood and
other herbs(BP Natural Relief) to be particularly effective(www.natrelief.com).
Weight loss can often lower the blood
pressure significantly. These measures might be sufficient by themselves, or
they can be used in conjunction with medications to achieve good control.
For cholesterol, HDL, and LDL
management, low carbs appears to be the most effective diet(13), especially if
the triglycerides are high. But this
remains controversial. The DASH, LEARN,
Ornish and Mediterranean diets are alternatives. Red yeast is a natural statin that can
effectively lower cholesterol and LDL, with much fewer side effects than the
drugs. As with statin drugs, the main
beneficial effect from red yeast rice might be to reduce arterial inflammation
rather than to reduce LDL. Always
replace coenzymeQ10 when prescribing any kind of statin. Both muscle inflammation and congestive heart
failure have been attributed to low levels of coQ10, which is depleted by the
statins. Fish oils can help reduce
cholesterol and so can cinnamon, niacin, berberine, and lecithin. Intravenous essential phospholipids from lecithin
have been used in Europe to treat coronary artery disease. Proteolytic enzymes might also be effective to
reduce inflammation. Food allergies can
be important, especially gluten and casein sensitivity. A therapeutic trial of an elimination diet
can be very helpful.
To stop smoking, hypnosis and
acupuncture are somewhat effective. The medication varenicline(Chantix) might
have its place, but the incidence of side effects is troubling.
For better
fitness compliance an exercise prescription is mandatory, depending on the
physical capacities of patients. People
often need to have specific goals to get the best results. Al Sears’ PACE program with brief periods of
intense exercise makes sense to me. It
is backed by the Harvard Professional Lifestyle Study(14). Adequate fitness, however, can usually be
achieved by walking for 30 minutes 5 days per week.
Always be aware of how important
stress can be for cardiovascular disease.
One of the best-documented treatment programs is Heart Math(15),
which is a home tutorial using biofeedback.
Yoga, meditation, progressive relaxation, visualization, deep breathing,
emotional freedom technique, prayer and acupressure are procedures that can be
utilized. All patients in the MHI should
form a plan to improve their stress-coping activities, especially if their
heart rate variability results are abnormal.
Nutrient deficiencies are
frequently detected with the comprehensive cardiovascular risk profile,
particularly magnesium. Antioxidants are
indicated if an increased amount of oxidized LDL is detected. Linus Pauling’s admonition to treat patients
who have elevated Lp(a) levels with vitamin C, proline, and lysine still rings
true. The optimal level of 25 [OH]
Vitamin D3 is 60-100 ng/ml, although the listed normal is usually as low as 30
ng/ml. Calcium might be given to lower
the risk of osteoporosis or colon cancer, but always balance it with at least
half of the milligram dose of magnesium.
Do not prescribe the ultra-high doses of 1500-2000 mg of calcium a
day. Studies have shown that high-dose
calcium can lead to calcification of the arteries. Coenzyme Q10, d-ribose, and l-carnitine are
helpful adjuncts, especially for congestive heart failure and fatigue. Medium chain triglycerides from coconut oil
are useful to preserve brain function. The herb, apoaequorin(Prevagen) is particularly
good to preserve memory, in my experience.
The physician formulation of apoaequorin is four times as strong as the
product available over-the-counter.
For many years, integrative
physicians have found intravenous EDTA chelation therapy to be very effective
in treating and preventing cardiovascular disease. This is especially true if a build-up of
toxic metals is detected. Lead is the best-documented
toxic heavy metal(10). It has been
linked to heart disease, cancer and autoimmune problems. If mercury is found, DMPS or DMSA might be
needed in addition to EDTA. The
published intravenous EDTA protocol appears to be effective, even if heavy
metals are not found. The author and
associates demonstrated a dramatic decrease in subsequent cardiac events in
high-risk patients who had received chelation therapy(16). The results of the Trial to Assess Chelation
Therapy (TACT) are due to be published this summer.
An under-appreciated advantage of
enrolling a patient in a course of chelation therapy is that the treatments are
given once or twice a week during the basic course. That means that each week, the nurse has a teaching
opportunity to reinforce diet, exercise, stress-coping, supplement compliance,
and habit control, all of which are important for saving hearts. Our staff helps the patient set goals and
identify barriers to reaching the goals. As with any class or program, repetition is
key. It often helps to bring a
friend. When patients share their
experiences and goals with others, results can be better than trying to follow
the program by themselves. Group visits
to deal with risk factors and lifestyle might be a useful service to offer.
Monitoring and maintenance are two
key concepts for a successful program.
The risk factors identified must be monitored often enough to assure
that interventions are effective. Too
often the patient and the physician identify risk factors, correct them
temporarily, but fail to be sure that the factors remain under control. Non-invasive vascular tests should be
repeated to monitor progress. Lab
biomarkers should be repeated at specified intervals. The CIMT and the heart rate variability are particularly
good monitoring tests. However, the
ultra-fast CT scan is not.
A summary of the integrative
approach in seven steps is outlined in Table 1.
Research and New
Frontiers
Several avenues of research are
currently taking place, including genomics, molecular targeting, stem cell
biology, and regenerative medicine(17).
Both conventional and integrative medicine are active in these areas of
interest. Progress is anticipated within
the five-year target period of the MHI.
For example, stem cells harvested from autologous bone marrow are being
tested to treat myocardial infarction(18).
Initial results were not impressive, but the authors were optimistic
that revisions in protocol might yield better results. Mikirova and associates(19) recently showed
that chelation of heavy metals improved the number of stem/progenitor cells in
circulation. Our version of the MHI
should be a fluid plan that can be improved as new evidence emerges.
One criticism of integrative
medicine is that there are few large clinical trials to support the therapies
that are utilized. Harvard professors
Groopman and Hartzband in their book, Your
Medical Mind (7), point out that too often the larger the clinical trial,
the less significant the results. Their
reason is that it takes a large study to have sufficient statistical
significance to prove a minimal effect. Smaller
studies with larger effects are often more useful.
On March 31, 2012 in Lexington,
Kentucky, the International College of Integrative Medicine will hold a forum
on the Million Hearts Initiative for clinicians experienced in the use of
chelation therapy and other integrative techniques. Round table discussions by the experts will
explore further the ideas presented in this article. Readers are invited to attend. The proceedings will be published in the Townsend Letter.
Conclusion
How
much effort is required to prevent a heart attack or a stroke? How about a million heart attacks and strokes? We applaud the conventional medical community
and government for setting the MHI as a lofty goal. Unfortunately, it is unlikely that goal will
be reached with the plan that has been put forth. On the other hand, utilizing a comprehensive,
integrative approach, we can make a huge impact for those one million
individual hearts and brains that we want to save. Not infrequently, hypertension and
hyperlipidemia can be controlled by detoxification of heavy metals, exercise, a
healthy diet and stress management without the use of medications that might
cause more adverse affects than beneficial ones. Nutritional and herbal supplements, as needed,
can be added with greater safety than many medications, with similar
benefits.
Patients must be presented with all
the evidence in an unbiased manner. Then
it is their responsibility to choose the therapies that suit them best. Individual
treatment plans are more effective than rigid guidelines. Our goal is to reduce their chances of having
heart attacks or strokes over the long term to the lowest incidence
possible. With this effort, I am
confident that we will prevent many heart attacks and strokes, while helping
patients live longer. Many patients will
have a better quality of life as well. Let’s
start immediately, by providing comprehensive plans for our patients and letting
the word spread, wide and far.
References
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