20 Patients Reverse Heart Disease Without Drugs or Surgery

What was the purpose of this study?

“THE LIFESTYLE Heart Trial was the first randomized clinical trial to investigate whether ambulatory patients could be motivated to make and sustain comprehensive lifestyle changes and, if so, whether the progression of coronary atherosclerosis could be stopped or reversed without using lipid-lowering drugs as measured by computer-assisted quantitative coronary arteriography. This study derived from earlier studies that used noninvasive measures.

After 1 year, we found that experimental group participants were able to make and maintain intensive lifestyle changes and had a 37.2% reduction in low-density lipoprotein (LDL) cholesterol levels and a 91% reduction in the frequency of anginal episodes. Average percent diameter stenosis regressed from 40.0% at baseline to 37.8% 1 year later, a change that was correlated with the degree of lifestyle change. In contrast, patients in the usual-care control group made more moderate changes in lifestyle, reduced LDL cholesterol levels by 6%, and had a 165% increase in the frequency of reported anginal episodes. Average percent diameter stenosis progressed from 42.7% to 46.1%.

Given these encouraging findings, we extended the study for an additional 4 years to determine (1) the feasibility of patients sustaining intensive changes in diet and lifestyle for a much longer time, and (2) the effects of these changes on risk factors, coronary atherosclerosis, myocardial perfusion, and cardiac events after 4 additional years.”

Comments: Coronary atherosclerosis is the process that leads to heart disease, which is the number one cause of death in the whole world. In 2012, heart disease killed 7.4 million people. That’s more people than strokes, which claimed the lives of 6.7 million people, lung cancer, which claimed the lives of 1.6 million people, AIDS, which claimed the lives of 1.5 million people, and diabetes, which claimed the lives of 1.5 million people.

Coronary atherosclerosis is the narrowing, hardening, and clogging of the arteries due to cholesterol build up, which reduces and blocks the flow of oxygen-rich blood to the heart. This process is promoted by LDL, which is called the “bad” cholesterol because it’s the vehicle by which cholesterol is deposited into your arteries.

This process also leads to coronary artery disease, and a high level of LDL cholesterol is a risk factor for coronary artery disease. Coronary artery disease is also known as ischemic heart disease, which is the number one cause of death in the whole world.

Angina is chest pain that occurs when your heart muscle doesn’t get enough oxygen-rich blood, and is a symptom of coronary atherosclerosis.

Stenosis is an abnormal narrowing in a blood vessel such as an artery.

A randomized trial involves randomly allocating one group to a primary intervention – comprehensive lifestyle changes in this case – and comparing the results with those in a control group who receive a different intervention or none at all – moderate changes in lifestyle in this case. This is a type of experimental study to see whether people who get the primary intervention are better off than those who get the different intervention or none at all.

Randomized trials are considered the gold standard for evaluating interventions because the randomization process helps reduce the risk of other factors influencing the results.

Dr. Dean Ornish and his colleagues conducted a randomized trial called the Lifestyle Heart Trial. The purpose of this original trial was to see if comprehensive lifestyle changes alone – apart from drugs or surgery – could stop or even reverse the progression of heart disease, the number one cause of death in the whole world. After one year, risk factors improved, chest pain decreased in frequency, and arteries unclogged and opened up to allow more oxygen-rich blood to flow to the heart. Dr. Ornish is the author of several books, including Dr. Dean Ornish’s Program for Reversing Heart Disease: The Only System Scientifically Proven to Reverse Heart Disease Without Drugs or Surgery.

The purpose of this follow-up study was to see if the patients could stick to the lifestyle changes for four more years, and if so, to see the effects the changes would have on their risk factors, chest pain, and heart disease.

What changes did the experimental group make?

“Experimental group patients were prescribed an intensive lifestyle program that included a 10%-fat vegetarian diet, moderate aerobic exercise, stress management training, smoking cessation, and group psychosocial support previously described in detail. Patients were encouraged to avoid simple sugars and to emphasize the intake of complex carbohydrates and other whole foods.”

Comments: Vegetarians avoid meat, fish, and poultry, but may include dairy products and eggs in their diets.

Patients were asked to eat a low-fat diet made up of fruits, vegetables, grains, legumes, and soybean products without restriction. No animal products were allowed except egg white and one cup per day of non-fat milk or yogurt.

They were also asked to exercise, meditate to relax, stop smoking, and participate in group discussions. The purpose of the discussions was to express their feelings and receive support to help stick to the lifestyle changes.

How did they define moderate aerobic exercise?

“Walking was the recommended form of exercise, but some patients jogged or did more strenuous exercise.”

How did they measure whether or not the experimental group stuck to the diet and lifestyle changes?

“The adherence measure was a continuous score reflecting daily intake of cholesterol (in milligrams), fat (in grams), frequency and duration of exercise, frequency and duration of stress management techniques, and smoking. A score of 1.0 equalled 100% adherence but scores could be greater than 1.0 if participants exceeded the recommended intensive lifestyle changes.”

Comments: It was possible for the patients to make even greater changes than those that were already recommended by the authors of this study.

Did the experimental group stick to the advised diet and lifestyle changes?

“In the experimental group, adherence to all aspects of the program was excellent during the first year and good after 5 years, whereas control group patients maintained more moderate changes during the 5 years consistent with conventional guidelines (Table 2). The percentage of daily energy (calories) provided by fruits, vegetables, whole grains, soy, other legumes, nonfat dairy, and alcohol was comparable at 1 year and at 5 years. In the experimental group, fat intake decreased from approximately 30% to 8.5%, cholesterol from 211 to 18.6 mg/d, energy from 8159 to 7724 J (1950-1846 cal), protein from 17% to 15%, and carbohydrates increased from 53% to 76.5%. In the control group, fat intake decreased from 30% to 25%, cholesterol from 212.5 to 138.7 mg/d, energy from 5.49 to 3.59 J (1711-1573 cal), protein from 19% to 18%, and carbohydrates increased from 51% to 52%. Since patients volunteered originally only for a 1-year study, there was a significant decrease in meeting attendance after 1 year for 4 of the patients.”

“Although there was some reduction in adherence to the intensive lifestyle intervention between years 1 and 5 in the experimental group, long-term adherence remained remarkably high in this sample of self-selected patients. The level of lifestyle change, even at 5 years, is greater than in any other published study of ambulatory populations. These results are especially encouraging because these patients initially volunteered to participate for only 1 year when they entered the study.”

Comments: After one year, the experimental group achieved an adherence score of 1.29. After five years, the experimental group maintained an adherence score of 1.06. This shows that they stuck to the prescribed diet and lifestyle changes throughout the five-year study.

For optimum health and even lower disease risk, it may be even more beneficial to give up dairy, the only source of cholesterol in the diet of the experimental group. Here’s what the Institute of Medicine has to say about eating cholesterol: “A Tolerable Upper Intake Level is not set for cholesterol because any incremental increase in cholesterol intake increases CHD risk.”

Eating cholesterol increases CHD risk. CHD is also known as coronary heart disease, which is also known as coronary artery disease or ischemic heart disease. Ischemic heart disease is the number one cause of death in the whole world.

As for the egg white, which the patients in the experimental group were allowed to have, it is a source of animal protein. Here’s what Dr. T. Colin Campbell, author of The China Study, has to say about the dangers of animal protein:

“Several studies have now shown, in both experimental animals and in humans, that consuming animal-based protein increases blood cholesterol levels. Saturated fat and dietary cholesterol also raise blood cholesterol, although these nutrients are not as effective at doing this as is animal protein. In contrast, plant-based foods contain no cholesterol and, in various other ways, help to decrease the amount of cholesterol made by the body.”

Higher blood cholesterol increases your risk of developing heart disease.

What were the results of the study?

“Patients in the experimental group lost 10.9 kg (23.9 lbs) at 1 year and sustained a weight loss of 5.8 kg (12.8 lbs) at 5 years, whereas weight in the control group changed little from baseline. In the experimental group, LDL cholesterol levels decreased by 40% at 1 year and remained 20% below baseline at 5 years. In the control group, LDL cholesterol levels decreased by 1.2% at 1 year and by 19.3% at 5 years.”

Comments: The experimental group started at an average weight of 201 pounds, went down to 177 pounds after one year, and stayed at 188 pounds after five years. The control group started at an average weight of 167 pounds, and ended up at 170 pounds after five years.

At the end of the five years, the experimental group also had a lower level of LDL cholesterol than the control group. LDL cholesterol is the vehicle by which cholesterol is deposited into your arteries, which leads to heart disease.

“Experimental group patients had a 91% reduction in reported frequency of angina after 1 year and a 72% reduction after 5 years (Table 5). In contrast, control group patients had a 186% increase in reported frequency of angina after 1 year and a 36% decrease in frequency after 5 years. The decrease in angina in the control group after 5 years was in large part because 3 of the 5 patients who reported an increase in anginal episodes from baseline to 1 year underwent coronary angioplasty between years 1 and 5.”

Comments: The experimental group started with an average frequency of chest pain of 5.8 times per week, lowered the frequency to 0.5 times per week after one year, and stayed at 1.6 times per week after five years.

“The primary end point of this study, chosen a priori, was percent diameter stenosis. On average, there was more reduction (continued improvement) after 5 years than after 1 year in experimental group patients who were asked to make intensive lifestyle changes. In contrast, control group patients showed much more progression (continued worsening) in average percent diameter stenosis after 5 years than after 1 year, even though more than half of the control group patients were prescribed lipid-lowering medications during the course of the study. Although the sample size was relative small, these differences were statistically significant at both 1 year and 5 years.”

“In the experimental group, the average percent diameter stenosis at baseline decreased 1.75 absolute percentage points after 1 year (a 4.5% relative improvement) and by 3.1 absolute percentage points after 5 years (a 7.9% relative improvement). In contrast, the average percent diameter stenosis in the control group increased by 2.3 percentage points after 1 year (a 5.4% relative worsening) and by 11.8 percentage points after 5 years (a 27.7% relative worsening). These between-group differences were statistically significant after both 1 year and 5 years (P= .02 and P= .001, respectively, Figure 1).”

Comments: Stenosis is an abnormal narrowing in an artery. The experimental group achieved an opening and enlargement in the arteries that supply blood to their heart. The control group experienced greater narrowing and clogging of the arteries that supply blood to their heart.

“Figure 2 shows the experimental group changes in percent diameter stenosis from baseline to 5 years according to tertiles of adherence to the lifestyle intervention. As seen at 1 year, there was also a strong correlation between adherence and percent diameter stenosis after 5 years in a dose-response relationship; the tertile of patients that was most adherent to the program had the most regression, the tertile with intermediate adherence had less regression, and the tertile with the least adherence halted the progression of disease without regression (P= .04).”

Comments: The more the experimental group stuck to the advised diet and lifestyle changes over the five years, the more their arteries enlarged and healed. The experimental group that stuck to the changes the most enlarged their arteries twice as much as the group that stuck to the changes moderately. The experimental group that stuck to the changes the most also enlarged their arteries 18 times as much as the group that stuck to the changes the least.

“The experimental group reduced LDL cholesterol levels by 40% at 1 year and by 20% after 5 years; these reductions are comparable with those achieved with lipid-lowering drugs in an ambulatory population. In contrast, the Step II diet reduces LDL cholesterol by only 5% or less.”

Comments: The experimental group reduced their LDL cholesterol to levels comparable with those achieved with cholesterol-lowering drugs. But they achieved these results without drugs, using diet and lifestyle changes alone. A high level of LDL cholesterol is a risk factor for heart disease, which is the number one cause of death in the whole world.

“The experimental group’s marked reduction in frequency, severity, and duration of angina after 1 year was sustained at similar levels after 5 years. This long-term reduction in angina is comparable with that achieved following coronary artery bypass surgery or angioplasty and helps to maintain long-term adherence.”

Comments: The experimental group reduced the frequency, severity, and duration of their chest pain to levels comparable with that achieved using surgery. But they achieved these results without surgery, using diet and lifestyle changes alone. Chest pain that occurs when your heart muscle doesn’t get enough oxygen-rich blood is a symptom of coronary atherosclerosis.

Why didn’t the control group experience success, even after making changes to their diet and lifestyle?

“At 5 years, the differences between the experimental and control groups were statistically significant for both percent diameter stenosis and minimum diameter, even though control group patients reported risk reduction behavior consistent with a Step II diet of the National Cholesterol Education Program and the American Heart Association: they consumed an average of 25% of energy (calories) from fat and exercised an average of 3.5 times per week. These data are consistent with other studies indicating that moderate changes in diet and lifestyle may not be sufficient to stop the progression of coronary atherosclerosis unless combined with lipid-lowering drugs.”

Comments: The American Heart Association and the National Cholesterol Education Program both recommend eating between 25 and 35 percent of your total daily calories as fats. Although the control group lowered the amount of fat they ate to about 25 percent of their calories, this may still be too high, and it was not enough to stop the progression of coronary atherosclerosis in this study.

On the other hand, here’s the recommendation of Dr. T. Colin Campbell, author of Whole: Rethinking the Science of Nutrition. In the book, Dr. Campbell writes, “Aim to get 80 percent of your calories from carbohydrates, 10 percent from fat, and 10 percent from protein.”

What did the authors conclude from the results of the study?

“More regression of coronary atherosclerosis occurred after 5 years than after 1 year in the experimental group. In contrast, in the control group, coronary atherosclerosis continued to progress and more than twice as many cardiac events occurred.”

“These findings support the feasibility of intensive lifestyle changes in delaying, stopping, or reversing the progression of coronary artery disease in ambulatory patients over prolonged periods.”

Comments: The experimental group achieved even greater reversal of their heart disease as a result of sticking to the lifestyle changes for four more years. Intensive lifestyle changes are sustainable, and effective in reversing heart disease without using drugs or surgery.

References:

Ornish D, Scherwitz LW, Billings JH, Gould KL, Merritt TA, Sparler S, Armstrong WT, Ports TA, Kirkeeide RL, Hogeboom C, Brand RJ. Intensive lifestyle changes for reversal of coronary heart disease. JAMA. 1998 Dec 16;280(23):2001-7.

Dr. Dean Ornish’s Program for Reversing Heart Disease: The Only System Scientifically Proven to Reverse Heart Disease Without Drugs or Surgery by Dr. Dean Ornish

The top 10 causes of death in the world in 2012

The Institute of Medicine’s stance on cholesterol

The China Study by Dr. T. Colin Campbell

The American Heart Association’s recommendations on calories from fat

The National Cholesterol Education Program’s recommendations on calories from fat

Whole: Rethinking the Science of Nutrition by Dr. T. Colin Campbell



