Caldwell B. Esselstyn, Jr, MD; Stephen G. Ellis, MD;
Sharon V. Medendorp, MPH; and Timothy D. Crowe
We studied the effect of a very low-fat diet and cholesterol- lowering drugs on the progression of coronary heart dis ease. All 11 participants were able to maintain a mean total serum cholesterol level of 132.4 mg/dL (3.42 mmol/L), which is the lowest level reported to date for patients such as ours. In addition, our data suggest that maintaining total cholesterol levels below 150 mg/dL (3.88 mmol/L) is associated with the arrest of coronary artery disease and appears to promote selective disease regression. This is the longest study of minimal fat nutri tion used in combination with cholesterol-lowering drugs conducted to date, and our finding of a mean decrease of arterial stenosis of 7.0% is greater than any reported in previous research.3--'3
Although the sample was small, self-selected, and not randomly assigned to treatment, careful angiographic analysis by the percent stenosis method documented ar rest in 100% and regression in 73% of patients. Analysis by the MLD method revealed that 20 of 24 arterial lesions (83%) remained stable or regressed, whereas 4 lesions barely progressed. No new infarctions or clinical evidence of progression has occurred in any participant as of 1995. In contrast, these 11 participants had experienced 37 car diovascular events in the 8 years before beginning the study, and the S dropouts who resumed their prestudy diet experienced an additional 10 cardiac events.
Although Ornish and colleagues6 have also reported successful arrest and reversal of coronary artery disease with lifestyle changes and less than 10% fat nutrition, others have analyzed more modest low-fat diets used in combination with drugs and achieved only partial sue cess.3-5~7-'5 If the ultimate goal of treatment is total arrest of heart disease, it appears that the combination of less than 10% fat nutrition and cholesterol-lowering drugs is most likely to achieve the greatest reduction in serum lipids. A recent report indicates that the lowest incidence of coronary events and mortality is associated with cho lesterol levels of 140 mg/dL (3.62 mmol/L) or below.33 Our participants lowered their total serum cholesterol by 46%, to a mean of 132.4 mg/dL (3.42 mmol/L), and their LDL to a mean of 71.6 mg/dL (1.85 mmol/L), values lower than previously reported, and, furthermore, participants experienced no new coronary events. The mean serum triglyceride level during the study period was 146.6%.
Gould33 and others34--36 recently emphasized the importance of lowering cholesterol levels to restore endothelial-mediated coronary vasodilation. These data confirm that low cholesterol levels are essential to restoring endothelial integrity over large and small plaques to protect against rupture, thrombosis, and infarction. The results of our study in achieving and maintaining a total serum choles terol level below 150 mg/dL (3.88 mmol/L) suggest that changes in the functional status of the arterial wall may be more important in decreasing coronary events than is reduc ing the degree of stenosis.
In a recent editorial, Roberts38 further emphasized the importance of maintaining serum cholesterol level below 150 mg/dL (3.88 mmol/L) because a high cho lesterol level is the single most important and perhaps the solitary risk factor in the genesis of coronary atheroscle rosis. Of additional interest is the average HDL value of 36.3 mg/dL (0.94 mmol/L) of our participants. Al- though this value is below the accepted normal range (45 to 55 mg/dL [1 .16 to 1.42 mmol/LI), it was sufficient to sustain these beneficial results. Because this report is the first on the effects of long-term diets containing less than 10% fat coupled with the use of cholesterol-lowering drugs, other studies are necessary to confirm these results.
Participants' Experience in Adopting the Diet
In general, participants were initially excited about a new form of therapy for which epidemiologic studies and re search indicated great promise. Their early difficulty rec ognizing acceptable no-fat foods and dealing with the constant challenge of redesigning most traditional choices at every meal was offset by their initial weight loss, improved feeling of well-being, and decreasing angina. At the time when "no fat" labeling was first permitted, pa tients began buying foods labeled "0 fat per serving." By law, such foods may, and most often do, contain just less than 0.5 g of fat per serving. Because this amount of hidden fat is still too much, these foods should be omitted from very low-fat diets. A list of fat-free recipes taken from low-fat cookbooks and other resources on weight loss, cardiac health, and healthy lifestyle changes'8--26 was given to each participant. In the early phases, the group support was especially helpful and solidified participants' resolve. For the initial several months, the constant chal lenge of shopping for appropriate foods and finding ap propriate menus was a major focus.
Factors Contributing to Patients' Long-term Success
Of the original 22 patients, 73% (16) continue to follow the nutritional guidelines. Therefore, we believe that pa tients with coronary artery disease are willing and able to follow a diet so devoid of fat, and some may become independent of assistance and surveillance once they have achieved the goal for cholesterol level. Evidence from the Monel Chemical Senses Center, which studied three groups of volunteers who consumed different levels of dietary fat,39 confirms our findings. In the Monel study, only the patients whose diet contained less than 15% of calories from fat lost their desire for fat after 90 days. Our patients received intense social support through the initial 90-day period, and they, too, lost their craving for fat. They can now travel away from home for weeks at a time while still adhering to the diet.
The participants' success in adhering to the dietary and pharmaceutical intervention can be also attributed to at least txvo other factors. First, the physician had also adopted the diet and was thus a consistent role model for the participants. He actively involved himself in their care through frequent personal contact over a period of years and through periodic semisocial meetings that centered around the treatment plan. His personal investment in the success of his participants was clear to them. He was a credible source of information and was supportive of their efforts, especially through the more difficult initial stages of the study.
Second, evidence suggests that interventions will be most effective when (1) the threat of death or major dis ability is high, (2) the participant is convinced that the threat is real and eminent, (3) the proposed intervention will remove the threat (response efficacy), and (4) the participant is capable of adopting the intervention (per sonal efficacy).40
The first two points, which are related to a high-risk and eminent threat of cardiac disease, were established by the time the participants entered the study. The third point, response efficacy, and the fourth, personal efficacy, were the purposes of the study. With time, participants became more comfortable with their diet and their symp toms improved, which provided evidence of both re sponse and personal efficacy. As the incidence of angina lessened, for example, participants became aware that they were feeling better for the first time in years, and they attributed this improvement to the treatment and their ability to stay with the treatment. For these patients, health became its own reward.
Implications of Our Findings
Our findings support studies that together suggest the need to reassess existing therapies for coronary artery dis ease and atherosclerosis 41,33 The present treatments of beta blockers, calcium channel blockers, pacemakers, thrombolytic therapy, atherectomy, angioplasty, stenting, and bypass surgery carry significant morbidity, mortality, and expense, and are essentially temporary "holding ac tions." Although further research is needed on minimal fat intake and cholesterol-lowering drugs, it would seem prudent to offer these modalities as an adjunct therapy for cardiac patients who are not enrolled in such studies. Patients incur little additional expense, except for the cholesterol-lowering agents. No known morbidity or mortality is associated with the decreased fat intake, al though the drugs may have side effects. We made no attempt to determine the contribution of the cholesterol- lowering medications to the total reduction of serum cho lesterol levels. All the participants continue to take these medications as well as to follow the diet.
Is there a need for aggressive cholesterol-lowering therapy? Gould33 notes that many cardiac patients are aware and desirous of such treatment but cannot find practitioners willing or able to provide it. It is difficult to know the number of patients in any individual practice who would qualify for such treatment. All patients with coronary artery disease are potential candidates and should be made aware of the opportunity for such ther apy. Patients with progressive but not immediately life threatening coronary artery disease are often very moti vated and make ideal candidates.
What components of this experience can be modified for application in other clinical practices? Of the four adherence strategies mentioned, the bimonthly evening phone call and group meetings could conceivably be ac complished by a physician assistant. Because the group meets only quarterly, many practitioners should, how ever, be able to attend. It is vital that the physician con duct the initial interview with the patient and spouse to explain the natural history of coronary artery disease, its epidemiology, and the animal and human research data confirming arrest and reversal, and to instill the idea that minimal fat nutrition is the hallmark of therapy. The bi monthly clinic visits to determine weight and blood pres sure, to review the diet diary, and to measure total serum cholesterol can be conducted by a nutritionist, nurse, or health care worker, with physician input in selective or challenging cases. These visits are more frequent than other treatment protocols, which are usually quarterly, but confirm for the patient that dietary adherence is the bedrock of success of this type of treatment and, also, its most vulnerable aspect. An authoritative, caring, yet un compromising figure regarding dietary adherence is vital at these visits. Creative appointment schedules that offer very early, very late, evening, or Saturday appointments will minimize absenteeism. The cost of total serum cho lesterol determinations can be reduced by employing a reproducible fingerstick method and extending visits to once a month for those whose cholesterol goals have been attained. Follow-up angiograms are probably unnecessary in stable patients.
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