In the last newsletter, we worked through the anatomy of the heart — primarily to lay the groundwork for this issue. By using what we learned in the last issue, we can now explore:
Things that can go wrong with the heart.
Medical treatments.
Limitations that may be inherent in some of those treatments.
What you can do to change the equation.
Incidentally, if you haven’t read the previous newsletter, Anatomy of the Heart, you might want to do that now. It’s not absolutely necessary, but it will make for a more rewarding experience as you read this newsletter.
Problems of the epicardium
As you may remember, the epicardium is the lining that surrounds the heart muscle — inside and out. On the inside, it’s called the endocardium, and on the outside it’s called the pericardium. Let’s start our discussion of heart problems by looking at the epicardium — not because it’s the most important part of the heart, but because it’s a simple place to start and lets us dip our toes into the subject before plunging into deeper waters.
Problems that can occur with the heart lining pretty much fall into two categories
Physical damage.
Inflammation caused by infection.
Physical damage is easy to understand, and usually easy to repair. You’re driving in your car, you get into an accident. You’re slammed against the steering wheel or an airbag. Your body stops suddenly but your heart, powered by inertia (an object in motion tends to stay in motion) keeps moving forward and tears the pericardium that holds it in place before bouncing back and coming to rest. This causes bleeding in the pericardial sac, which serves as the buffer between the heart and the chest wall and lungs. The extra fluid (blood) pumps into the sac under pressure which expands the sac, thereby squeezing and constricting the heart. If the pressure isn’t relieved, it can build to the point where it constricts the heart so much that it prevents it from beating. Herbs and neutraceuticals are not much use here. Fortunately, medical intervention tends to be easy and effective in these situations. A catheter inserted into the sac to drain the excess blood and relieve the pressure will usually do the trick — along with stopping the bleeding.
Inflammation (known as “itis” in medical terminology) is a little more complex. The primary cause of inflammation of the heart lining is infection, both viral and bacterial. Depending on which part of the lining is affected, it will be called pericarditis, endocarditis, or epicarditis. The inflammation can cause chest pain, difficulty pumping, or fever. These symptoms can be mild, acute, or even chronic. Standard treatment includes the use of antibiotics and antivirals. These are “usually” effective unless the underlying infection is resistant to the arsenal of drugs at your doctor’s disposal, which is a growing problem. Fortunately, there are natural alternatives including garlic, olive leaf extract, oil of oregano, grapefruit seed extract, etc. that can work even in the case of drug resistant infections.
Problems with heart valves
Also, as we discussed last issue, your heart valves are constructed like parachutes with tendons or cords anchoring them to the heart muscle to keep them from opening too far. Their role is to allow blood to flow down from the atria into the ventricles, and then to seal shut when the ventricles pump so that blood doesn’t back up into the atria, but is instead forced out into the main pulmonary artery from the right ventricle or into the aorta from the left ventricle. Problems with the valves are easy to understand and fall generally into two categories.
Backflow, or regurgitation, is caused by misshapen or damaged valves or ruptures to the tendons that hold the valves in place. These things cause the valves to imperfectly seal with each heartbeat, thus allowing backflow into the atria.
Stenosis, or hardening of the valves, caused by disease or aging prevents the valves from fully opening. This limits the flow of blood into the ventricles so that they cannot fill completely in the fraction of a second the valves are open. Since the ventricle chamber is now partially empty when it pumps, it generates less pressure with each beat, which ultimately reduces the amount of blood that flows through the body.
There can be multiple causes for both problems.
- Either you were born with a problem. This can be genetic or it can be the result of nutritional problems in your parents’ diet (either before you were conceived or while you were gestating).
- Over time, as a result of aging and poor nutrition, the valves shrink and change shape.
- Infection has caused the valves to inflame so that they no longer seal perfectly.
- Diseases such as rheumatic fever and syphilis have scarred and hardened the valves.
- Valvular tissue can be damaged in the same way as heart muscle tissue as the result of a heart attack.
- Valve tendons may rupture, which means the valve no longer stays in place when backpressure is created by the squeezing of the ventricles.
The bottom line is that the pumping process becomes less efficient, and your heart has to pump harder and faster to compensate. Treatments can range from doing nothing, to using drugs to reduce infection and inflammation, to surgically replacing the damaged valves with artificial valves.
Doing nothing you might ask? Absolutely! In most cases, that’s what doctors do. Why? The heart has tremendous reserve capacity. Last issue we mentioned that you can have 70% blockage of your coronary arteries and never experience any outward symptoms. It doesn’t stop there. Your heart also has a tremendous reserve pumping capacity and when called upon can increase output 5-8 times if needed. For example, in mitral valve prolapse (a condition in which the mitral valve “falls down”, or prolapses too far into the left ventricle allowing for backflow into the right atrium), there are usually few symptoms or any problems. In most cases doctors will just make note of it and watch for any changes.
On the other hand, sometimes, there are symptoms. These can include:
- That old standby, chest pain.
- Fatigue and/or dizziness.
- Shortness of breath.
- Low or high blood pressure, depending on which valve is affected.
- Palpitations caused by irregular heartbeats.
- Even migraine headaches.
In those cases the valves are often replaced with mechanical valves. At one time, you could actually hear the mechanical valves make a slight clicking sound as they opened and closed 70-80 times a minute. This drove some people crazy when they tried to sleep at night. Newer models have overcome that problem and are silent.
Now you might think since problems with valves are mechanical in nature that nutrition and supplements would not play much of a role in resolving them. If so, you would be wrong. Most medical doctors are not aware of this fact, but there are numerous studies showing nutrients matter — and supplementation can actually change the mechanical aspects of valve function. For example, it has been shown that magnesium plays a role in mitral valve prolapse.
Therapeutic effect of a magnesium salt in patients suffering from mitral valvular prolapse and latent tetany.
Magnesium Deficiency in the Pathogenesis of Mitral Valve Prolapse.
This is just the tip of the iceberg. In fact, nutrition and supplementation can play a primary role in maintaining optimum heart health — and even reversing many chronic heart problems. We will talk more about this later; but for now let’s explore problems that happen within the coronary arteries.
Circulatory problems
The first blood vessels off the aorta are the two coronary arteries, which subsequently split off into numerous branches that feed the heart. Blockage of these arteries through the build up of arterial plaque is one of the most common causes of death. The net result is ischemia, which means a “reduced blood supply.” As I mentioned last issue, because there is so much redundancy in the branching of the coronary arteries, you can have up to 70% blockage and yet have no obvious symptoms. At some point, though, you will have a heart attack, also known as myocardial infarction. The myocardium is the name of the heart muscle, and infarction means the “death of tissue.” In other words, a heart attack is the result of loss of blood flow to the heart muscle, which causes death of heart muscle tissue. The severity of the attack is determined by:
Which part of the muscle is damaged. (Some parts are more critical than others.) How extensive the damage is.
In some cases, people do indeed die from their first heart attack. In most cases, though, the attacks are progressive — with each attack killing more and more tissue until the remaining heart muscle can no longer carry the load. Depending on the extent of the damage, standard medical treatments include:
Drugs, such as:
- Beta-blockers to slow heart rates and decrease blood pressure — thus lowering the heart’s demand for oxygen.
- Nitroglycerin to open coronary arteries and reduce the heart’s demand for oxygen.
- Calcium channel blockers to open coronary arteries to increase blood flow to the heart muscle.
- Angiotensin-converting enzyme to allow blood to flow from the heart more easily, decreasing the workload on the heart.
- Angioplasty uses a balloon inflated inside the blocked artery to press the plaque against the arterial wall, thus clearing the blockage — at least temporarily.
- Stents are like angioplasty on steroids. Instead of just pressing the plaque against the wall of the artery, the balloon is also used to also press a wire mesh against the arterial wall to hold the artery open.
- Bypass surgery involves using a vein (usually taken from the leg) to literally create a bypass around the clogged area of the coronary artery.
Heart transplants.
None of these options is perfect. Angioplasty and bypass surgery (even though they have been in use for years) are actually unproven (for those of you who think everything in medicine is backed by peer reviewed studies). In fact, recent studies indicate that they may actually give only slight temporary relief with no extension of life — not to mention an increased risk of stroke. Both stents and angioplasties (and bypasses too, for that matter) quickly re-plug, a problem called restenosis, and need to be periodically redone or replaced. New forms of stents are coated with drugs to slow down restenosis but come with their own set of problems. Bypass surgery produces a dramatically increased risk of stroke, infection and profound depression. And heart transplants force you to stay on immunosuppressant drugs for the rest of your life.
Far and away the biggest problem with all of these treatments, though, is that they only treat one manifestation of the problem, not the underlying cause — the fact that the arteries are blocking in the first place. It is here that alternative therapies excel — both short term, and long term. For example:
Dietary changes can have a profound impact in reversing coronary heart disease as can a number of supplements.
Shifting the balance of Omega-6 to Omega-3 fatty acids can eliminate a major source of heart attacks.
Hawthorne berries are tonic for the heart, working to support the relaxation and dilation of coronary arteries and increasing the flow of blood and oxygen to and from the heart. In effect, Hawthorne berries work much like prescription drugs, but without the side effects.
Blood Clots
Another aspect of coronary heart disease is the blood clot or thrombus. (If it becomes dislodged and floats free, it’s called an embolus.) In larger arteries, a clot will only impede the flow of blood. In smaller arteries, it can completely block it. Thrombi form most often in the veins of the leg, where they then float off (now called emboli) and end up lodging in and blocking the smaller arteries of the heart, lungs, and brain. There can be many triggers for the formation of clots and emboli, but one of the more interesting is deep vein thrombosis — the formation of blood clots as the result of prolonged sitting in airplanes and cars.
Preventing blood clots reduces the risk of stroke, heart attack and pulmonary embolism. The standard treatment for those at risk of embolisms involves the use of drugs such as Heparin or warfarin (a form of rat poison), which are anticoagulants used to inhibit the formation and growth of existing blood clots.
But these drugs are dangerous and require constant watching and regulating since they can cause internal bleeding. Far safer (and better since they also dissolve arterial plaque and help promote the repair of arterial tissue) are proteolytic enzyme formulations that incorporate specialized enzymes such as nattokinase.
Problems with the heart muscle — the myocardium
In the end, when you’re talking about the heart, it mostly comes down to the myocardium — the heart muscle. The danger of coronary heart disease, for example, is that it starves the myocardium of oxygen and kills it. The danger of a valve problem is that it forces the myocardium to work too hard. The danger of a bio-electrical/conductivity problem is that it throws the heart muscle out of rhythm and causes it to lose its beat, or to fibrillate. (Fibrillation occurs when a heart chamber “quivers” due to an abnormally fast rhythm and can no longer pump blood well. Fibrillation of the atrium is called atrial fibrillation; in the ventricle it’s called ventricular fibrillation. Ventricular fibrillation usually leads to death.) To paraphrase the Clinton campaign in the ‘90’s, “It’s all about the myocardium.”
Problems in the atria
For the most part, problems in the atria are not life threatening. Even if both atria totally lose their ability to pump or weaken and balloon out, you lose maybe 30% of your total heart function. Without pumping, gravity and suction will still bring most of the blood down into the ventricles. There are, of course, times your doctor will want to address problems, but for the most part, you can live for years with barely functioning atria.
Problems with the ventricles
Ah, but the ventricles are a different story. When the left ventricle goes into fibrillation, we’re talking cardiac arrest. It’s time to pull out the electric paddles. So what kinds of problems are we talking about?
Myocarditis, or inflammation of the heart, is a form of cardiomyopathy (which literally translates as “heart muscle disease”). The problem here is that blood flows more slowly through an enlarged heart, which increases the likelihood of blood clots. In addition, people with cardiomyopathy are often at risk of arrhythmia and/or sudden cardiac death. When cardiomyopathy results in a significantly enlarged heart, the mitral and tricuspid valves may not be able to close properly, resulting in murmurs. There may be multiple causes of myocarditis, including viral infection. Common culprits include: influenza, herpes, Epstein-Barr, hepatitis, and salmonella.
Ischemic cardiomyopathy is a weakness in the muscle of the heart due to inadequate oxygen delivery to the myocardium, with coronary artery disease being the most common cause. (Ischemia simply means “reduced blood flow.”) Anemia, sleep apnea, and hyperthyroidism can also contribute to ischemic myocardium.
Myocardial infarction literally means the “death of heart muscle tissue.” Since heart muscle does not grow back, this has a snowball effect. If you have a heart attack that starves part of the heart muscle of oxygen so that it dies, that scar tissue does not recover. You now have a weakened heart that is more likely to suffer a subsequent attack — leading to more heart muscle damage and increased chances for a third attack. And so on. It’s not too hard to see where this leads — to long-term loss of heart muscle activity and chronic heart failure.
Congestive heart failure (CHF) is a condition in which your weakened heart can no longer pump out all the blood that flows into it. CHF is the most common cause of hospitalization for people over age 65. It kills more than 50,000 people a year in the US and costs the health care system more than $50 billion per year. The heart is just like other muscles. When it is weakened, it becomes enlarged and inefficient. This leads to congestion and flaccid muscle tone. In fact, it can even lead to prolapse of the heart in which the heart literally “drops” from its original position in the chest. It is not unusual to require a stethoscope placement three to five inches below the normal area when listening to a weakened heart.
Unfortunately, modern medicine comes up short when it comes to problems of the myocardium. Mostly it just deals with the aftermath.
If the heart stops beating, use the electric paddles to get it going again.
If no paddles are near, pop a nitroglycerine tablet.
Perform a coronary bypass to try and prevent any further damage.
Use nitroglycerine tablets to open up the arteries in an emergency and prevent a heart attack.
When it comes to the muscle itself, nothing! But as luck would have it, here’s where alternative therapies shine.
- All of the B vitamins, but especially vitamin B4 are essential for heart health.
- Congestive heart failure has been strongly tied to significantly low blood and tissue levels of CoQ10.
- Supplementation with CoQ10 can literally change the size and shape of the heart.
- Studies have shown that high concentrations of heavy metals such as mercury directly correlate to higher incidences of acute coronary events. Regular heavy metal detoxing directly reduces and eventually eliminates that risk.
- Studies have also shown a direct connection between periodontal disease and acute coronary events. Regular use of avocado soy unsaponifiables, proteolytic enzymes, immune boosters, and pathogen destroyers can reduce the risk.
- Incidentally, electric paddles are not the only thing that can get a heart muscle going again. In an emergency cayenne pepper can do the trick too. A teaspoon of cayenne pepper in a glass of warm water taken every fifteen minutes can raise the dead.
- And in the end, the heart is a muscle, and like all muscles responds to exercise. Cardiovascular exercise, particularly interval training, can improve the efficiency and strength of your heart.
Heart rhythm disorders
The heart is an unusual organ. It has millions and millions of cells, and each cell has the potential for electrical activity. In the normal heart these electrical impulses occur in regular intervals. When something goes wrong with the heart’s electrical system, the heart does not beat regularly. Unlike most organs in the body, all the cells in the heart are wired together so that if a single cell fires prematurely or late, the neighboring cells will be activated and a mistimed wave will travel over the heart. The irregular beating results in a rhythm disorder, or arrhythmia.
To quickly review from last issue.
Every heart beat begins in the sinoatrial node (SA node) located in the right atrium. The SA node is “smart” and adapts to the body’s overall need for blood and increases the heart rate when necessary, such as during exercise.
Electrical impulses leave the SA node and travel through special conducting pathways in the heart to the atrioventricular node (AV, node). The purpose of the AV node is to provide a pathway for impulses from the atria to the ventricles. It also creates a delay in conduction from the atria to the ventricle. This delay allows the atria to contract first, allowing the ventricles to fill with blood before they contract themselves.
The delay ensures proper timing so that the lower chambers have time to fill completely before they contract.
From the AV node, the signal travels down through a group of fibers in the center of the heart called the bundle branch– and then to the ventricles.
So what can go wrong?
Due to natural aging or disease, the SA node starts losing function and no longer produces the right number of signals at the proper rate.
The AV node normally has one group of cells through which the electrical impulse can travel. However, due to aging or heart disease, it is possible for the AV node to develop two or more groups of conductive cells. Because of the extra conduction pathways, your heart can at times beat more quickly than normal.
The bundle branch (see above) becomes “blocked” as a result of a heart attack which damages the inner heart muscle and nerves. This stops the signal from traveling from the AV node to the ventricles. Left to their own devices, the ventricles establish their own rhythm of about 20-40 beats per minute. This is much too slow for health and results in weakness, fainting, and shortness of breath.
Valve stenosis (stiffness) causes increased pressure in the atria (since blood never fully clears) which causes ballooning of the walls of one or both of the atria (aka atrial dilation). Because the atrium is now bigger, it increases the distance signal has to travel. The increased distance means it takes longer for the signal to reach its final destination which throws off the pacing of the heartbeat.
Medical Treatments
Typical medical treatment involves drugs such as adenosine, calcium channel blockers (e.g., diltiazem, verapamil), short-acting beta-blockers (e.g., esmolol), and digitalis.
The other option, of course, is the pacemaker. The pacemaker uses electrodes attached to the heart that take over from the SA node to control the beating of the heart. The pacemaker is run by a small computer installed in the body. Modern pacemakers are externally programmable and allow for the selection of optimum pacing modes for individual patients. Some can even self-regulate and adapt to changing requirements such as stress or exertion. And some combine a pacemaker and defibrillator in a single device.
Drugs and pacemakers work reasonably well at keeping the heart going, but still address the problem after the fact. Keep in mind that in most cases the rhythm of the heart was lost through degradation based on nutrition or disease. Installing a pacemaker does not address that problem; it merely bypasses it. On the other hand, it is possible to reverse many of those conditions nutritionally and thus reverse many of the associated problems.
Alternatives
Mineral deficiencies particularly in calcium, sodium, magnesium, potassium, and many of the trace minerals can have a profound effect on the electrical efficiency of the heart since they are responsible for running it. Supplementing with minerals and liquid trace minerals can make a profound difference.
Supplementing with CoQ10 can significantly improve the energy level of each cell in the heart, thus improving its ability to respond to an electrical stimulus and pass the signal on to its neighbor in a timely manner.
Shifting the balance of Omega-6 to Omega-3 fatty acids can eliminate a major source of potassium imbalance which can trigger heart attacks.
Conclusion
Let’s take a break here, and next issue we’ll conclude our discussion of the heart by exploring what happens in your doctor’s office:
- What tests does your doctor run?
- What do they mean?
- What can you tell from them?
- What questions should you ask your doctor when viewing the results?
For now, though, it’s worth reviewing a key concept:
Although many problems with the heart may seem to be biomechanical in nature and beyond the purview of nutrition and supplements, that’s not necessarily true. As we’ve seen:
- Magnesium supplementation can change the shape and condition of heart valves.
- The B vitamins can help rebuild the heart.
- CoQ10 can reenergize every single cell in the heart and can literally remold the size and shape of the heart after the onset of congestive heart failure.
- The use of Omega-3 fatty acids can reverse damage caused by NEFAs.
- Proteolytic enzymes can provide nutritional support for your body as it works to clean out the coronary arteries and repair damage to epicardial tissue surrounding the heart.
- The use of heavy metal chelators such as cilantro and chlorella can reduce the risk of an acute coronary event.
- Regular supplementation of a tonic made with cayenne and Hawthorne berry can rebuild the strength of the heart.
- Proper dental care and the use of avocado soy unsaponifiables and proteolytic enzymes can reduce the incidence of periodontal disease, which reduces the chances of an acute coronary event.
- Regular use of immune enhancers and pathogen destroyers decreases the risk of most inflammatory heart disease and the incidence of viral and bacterial infections that can adversely affect the heart.
- And regular exercise can strengthen the heart and improve its efficiency even in your eighth and ninth decade of life.
As usual, it’s not just about pharmaceutical drugs and surgical procedures. Following the principles of the Baseline of Health Program can change your heart…and your prospects for long-term survival.
Most health professionals agree that heart disease, commonly also referred to as cardiovascular disease, is primarily a problem of blocked arteries or “pipes” as they are sometimes called. However, this is not the complete picture. There are many things which contribute to the development of heart disease and problems such as a heart attack. Some factors that have been implicated include:
- cholesterol and other blood fats (although this appears to have been over emphasized),
- coronary inflammation (homocysteine and C-reactive protein),
- blood clotting,
- excess body weight,
- blood pressure,
- diabetes,
- syndrome X (believed to be a product of insulin resistance),
- aerobic capacity,
- smoking and
- personality.
As well as these there are genetic factors. This is a variable over which we have no control. If you do have a family history of heart disease this does not necessarily mean that you will develop heart disease yourself. There are many factors, besides genetics, that go into the development of heart disease. It is these factors that can be changed and thereby reduce your risk of developing heart disease. Cholesterol and other blood fatsIn recent years cholesterol levels have become closely identified with heart disease. Too much cholesterol in the blood tends to clump together in the walls of arteries - combining with fibrous tissue to form a “bump” which thickens the artery walls and reduces the blood flow. However, cholesterol levels are not the be-all and end-all of heart disease. It is a natural, non toxic soft waxy substance that is in all cells and is necessary for good health. It is only when it is excessive that we have a problem. So how much cholesterol is too much? The National Cholesterol Education program in collaboration with the American Heart Association has provided the following guidelines for total cholesterol (milligrams of cholesterol in one deciliter (dl) of blood).
Below 200 - desirable
200 to 239 - borderline high
240 and above - high
If you have a total cholesterol above 200 you are not alone - the American Heart Association estimates that 98 million Americans have a high blood cholesterol level.
Total cholesterol, however, is not a single unit, it is made up of LDL (Low Density Lipoprotein) and HDL (High Density Lipoprotein). Cholesterol needs to be combined with fat and protein for it to be transported in the blood - the result is a lipoprotein. Various types of lipoproteins have different sizes, shapes and functions and are classified on the basis of their density (compactness).
LDL (Low Density Lipoprotein)
One of the most important is the LDL. It transports about 60 - 80 % of the cholesterol through the blood stream and it is taken up by the cells as a building block for hormones and cell parts. However the cells may not need all of the cholesterol that is produced and LDL is unstable and will “unravel”. It can penetrate the artery walls. LDL is sometimes referred to as “bad cholesterol” because of its role in the clogging of arteries. Because of this it is seen as a better marker of the potential for heart disease than total cholesterol levels. The higher your LDL levels the greater the risk of artery build up.
The National Cholesterol Education Program has created the following as a guideline of cardiac risk from LDL cholesterol (milligrams of LDL in one deciliter (dl) of blood).
Below 100 - optimal
100 to 129 - near optimal
130 to 159 - borderline high
160 - 189 - high
190 and above - very high
HDL (High Density Lipoprotein)
HDL is often known as the “good” cholesterol. It forms a stable package of cholesterol fats and proteins that do not unravel when it comes in contact with the artery wall and the cholesterol it carries does not deposit on the artery walls. HDL can also be used by the body to undo the damage that is caused by the LDL - it collects the unravelled LDL and transports it back to the liver for removal from the body. HDL is therefore considered to be cardio protective.
The National Cholesterol Education Program has created the following as a guideline of cardiac risk from HDL cholesterol (milligrams of HDL in one deciliter (dl) of blood).
60 and above - low
40 to 59 - moderate
below 40 - high
If your cholesterol levels are not what they should be then you need to take action - so that you don’t become another heart disease statistic.
If you smoke you need to stop. The quit smoking program at Growerz.com will take you through a quit smoking process and enable you to become smoke free. Take a tour at Growerz.com and see what they are able to do for you.
The national institutes of health sponsored the diet heart feasibility study to determine if it was possible to lower the blood cholesterol levels of Americans eating at home by changing the kind and amount of fat in their diet. About 1000 men aged 45 to 54 in five cities, all healthy volunteers, were assigned to one of three diets. Diets 1 and 2 were low in cholesterol and saturated fats but high in polyunsaturated fats; that is, they had a higher ratio of polyunsaturated to saturated fats, or P/S ratio. Diet 2 differed from diet 1 in that it contained more polyunsaturated fat and monounsaturated fat. The control diet (diet 3) was similar to a typical American diet, that is, high in cholesterol, total fat, and saturated fat but with low P/S ratio.
The men picked up all their food at special distribution centers. The food containers did not list the ingredients, and neither the participants nor the doctors who conducted the study knew who was assigned to which diet. This research design, called “double blind” is designed to reduce unintentional bias on the part of either the study subjects or the medical scientists, since neither knows who is in what program until the end of the study.
After one year on the assigned diets, the blood cholesterol levels fell between 11% & 12% in the men on diets 1 and 2. The average cholesterol level in the group on the typical American diet fell only 3%.
The next question was ” Will lowering blood cholesterol by diet in healthy Americans decrease the rate of coronary heart disease?” There were several problems in trying to answer this question. First, the symptoms of coronary heart disease usually take four or more decades to manifest themselves. Second, although coronary heart disease is the major cause of death and disability in this country, the actual rate of new cases per year in middle aged people is relatively low, about five to ten new cases per 1000 middle aged male adults. Third, what control group might such a study use?
Ideally, neither the participants nor the staff conducting the study should know which participants are in the treatment group and which are in the untreated control group. Diets that are high or low in animal fat and cholesterol are clearly different, and unless unlabeled foods were given out at a commissary, everyone would realize whether he was assigned to a diet low or high in cholesterol and saturated fat. Because 100,000 men were needed for a definitive diet heart study, it was not feasible to have a blind control group of the necessary size.
Because of these difficulties and a prospective price tag of about one billion dollars, another approach was taken. First, only patients with very high blood cholesterol levels were selected; second, a drug treatment was chosen that lowers the blood cholesterol level to a greater extent than diet alone. This approach reduces the number of participants needed to a manageable level. A drug trial can replace a diet trial, provided that the drug has a specific effect on lowering blood cholesterol (and LDL cholesterol). This permits a direct test of the hypothesis that a decrease in the blood cholesterol level reduces coronary heart disease. Further, a drug trial allows medical scientists to develop a suitable inactive medication or placebo that will not lower the blood cholesterol level, thus permitting the study to be double blind.
About 4,000 healthy middle aged men with high levels of blood total and LDL cholesterol were assigned to either a treatment group, which received an active medication called cholestyramine, or to a control group that received placebo. Cholestyramine was known to produce a significant decrease (10 to 20 percent) in the level of total and LDL cholesterol in the blood. Both the treatment and control groups were put on the same diet. Neither the participants nor the medical staff knew to which of the two groups a participant was assigned. Cholesterol levels were checked every other month. After one year the results of the study were as follows:
Man from group that took active drug: his cholesterol level at the beginning of the trial was 281, and at the end was 199. Man from group that was on placebo starting cholesterol level was 273, and at the end was 274. The men taking the cholestyramine had significantly greater decrease in there blood cholesterol than the men taking placebo. Therefore it is known that you can reduce the risk of coronary heart disease.
