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MEDICAL SCIENCE

Can lifestyle changes reverse coronary heart

disease?

The Lifestyle Heart Trial

In a prospective, randomised, controlled trial to We carried out trials in 1977 and 1980 to assess the
determine whether comprehensive lifestyle short-term effects of lifestyle changes on coronary heart
changes affect coronary atherosclerosis after 1 disease with non-invasive endpoint measures
year, 28 patients were assigned to an experimental (improvements in cardiac risk factors, functional status,
group (low-fat vegetarian diet, stopping smoking, myocardial perfusion,2 and left ventricular function3).
stress management training, and moderate However, the subjects of those studies were not living in the
exercise) and 20 to a usual-care control group. 195 community during the trial, and we did not use angiography
to assess changes in coronary atherosclerosis.
coronary artery lesions were analysed by
quantitative coronary angiography. The average
percentage diameter stenosis regressed from 40·0
(SD 16·9)% to 37·8 (16·5)% in the experimental Patients and methods
group yet progressed from 42·7 (15·5)% to 46·1 Patients with angiographically documented coronary artery disease
(18·5)% in the control group. When only lesions were randomly assigned to an experimental group or to a usual-care

greater than 50% stenosed were analysed, the control group. Experimental-group patients were prescribed a
average percentage diameter stenosis regressed lifestyle programme that included a low-fat vegetarian diet,
from 61·1 (8·8)% to 55·8 (11·0)% in the moderate aerobic exercise, stress management training, stopping
experimental group and progressed from 61·7 smoking, and group support. Control-group patients were not
asked to make lifestyle changes, although they were free to do so.
(9·5)% to 64·4 (16·3)% in the control group. Progression or regression of coronary artery lesions was assessed in
Overall, 82% of experimental-group patients had both groups by quantitative coronary angiography at baseline and
an average change towards regression. after about a year.
Comprehensive lifestyle changes may be able to
bring about regression of even severe coronary
atherosclerosis after only 1 year, without use of
lipid-lowering drugs. ADDRESSES: Pacific Presbyterian Medical Center, Preventive
Lancet 1990; Medicine Research Institute, and Departments of Medicine
and Psychology, University of California San Francisco School
Introduction of Medicine (D. Ornish, MD, S E. Brown, MD, J. H. Billings, PhD);
UCSF School of Dental Public Health and Hygiene (L. W.
The Lifestyle Heart Trial is the first randomised, controlled Scherwitz, PhD); Cardiac Catheterisation Laboratories, Pacific
clinical trial to determine whether patients outside hospital Presbyterian Medical Center (W. T. Armstrong, MD);
can be motivated to make and sustain comprehensive Cardiovascular Research Institute, UCSF School of Medicine
(T. A Ports, MD); Integral Health Services, Inc, Richmond,
lifestyle changes and, if so, whether regression of coronary Virginia (S. M. McLanahan, MD); Center for Cardiovascular and
atherosclerosis can occur as a result of lifestyle changes Imaging Research, University of Texas Medical School (R. L.
alone. Over twenty clinical trials are being carried out to Kirkeeide, PhD, Prof K. L. Gould, MD); and Department of
determine whether the progression of coronary Biomedical and Environmental Heath Science, University of
California School of Public Health, Berkeley, California, USA
atherosclerosis can be modified, in all of these, cholesterol-
(Prof R. J. Brand, PhD). Correspondence to Dr D. Ornish, Preventive
lowering drugs, plasmapheresis, or partial ileal bypass Medicine Research Institute, 1001 Bridgeway Box 305, Sausalito,
surgery are the primary interventions.1 California 94965, USA.
 130

Patients were recruited from Pacific Presbyterian Medical Center TABLE I-BASELINE CHARACTERISTICS OF EXPERIMENTAL
(PPMC) and from Moffitt Hospital of the UCSF School of AND CONTROL GROUPS
Medicine according to the following criteria: age 35-75 years, male
or female; residence in the greater San Francisco area; no other

life-threatening illnesses; no myocardial infarction during the

preceding 6 weeks, and no history of receiving streptokinase or
alteplase; not currently receiving lipid-lowering drugs; one, two, or
three vessel coronary artery disease (defined as any measurable
coronary atherosclerosis in a non-dilated or non-bypassed coronary
artery); left ventricular ejection fraction greater than 25%; not
scheduled to have coronary artery bypass grafting; and permission
granted by patient’s cardiologist and primary care physician. We
screened and recruited only patients who were having angiograms
for clinical reasons unrelated to this study so that only one additional
angiogram was needed for research purposes. out all medical tests remained unaware of both patient group
A total of 193 patients who met the first five entry criteria assignment and the order of the tests. Different people provided the
underwent quantitative coronary arteriography at UCSF and lifestyle intervention, carried out the tests, analysed the results, and
PPMC. 94 of these patients (49%) met the remaining entry criteria. carried out statistical analyses. Coronary arteriograms were
Of the 94 eligible patients, 53 were randomly assigned to the analysed without knowledge of sequence or of group assignment.
experimental group and 43 to the control group; 28 (53%) and 20 The intervention began with a week-long residential retreat at a
(42%), respectively, agreed to take part. All patients who were hotel to teach the lifestyle intervention to the experimental-group
eligible and volunteered were accepted into the study. These patients. Patients then attended regular group support meetings (4h
patients represented a cross-section of age, gender, race, ethnic twice a week).
group, socioeconomic status, and educational level. Each gave fully Experimental-group patients were asked to eat a low-fat
informed written consent and the study was approved by the vegetarian diet for at least a year. The diet included fruits,
relevant ethical committees. vegetables, grains, legumes, and soybean products without caloric
Follow-up angiographic data were not available for 7 patients: 1 restriction. Some take-home meals were provided for those who
control-group patient underwent emergency, non-quantitative wanted them. No animal products were allowed except egg white
angiography in another hospital; and of the 6 experimental-group and one cup per day of non-fat milk or yoghurt. The diet contained
patients, 1 died while greatly exceeding exercise recommendations approximately 10% of calories as fat (polyunsaturated/saturated
in an unsupervised gym, 1 could not be tested owing to a large ratio greater than 1), 15-20% protein, and 70-75% predominantly
unpaid hospital bill, 1 was a previously undiagnosed alcoholic who complex carbohydrates. Cholesterol intake was limited to 5 mg/day
or less. Salt was restricted only for hypertensive patients. Caffeine
dropped out, 1 patient’s preintervention angiogram was lost in
transit to Houston for quantitative analysis, and 2 patients’ was eliminated, and alcohol was limited to no more than 2 units per
angiographic views before and after intervention did not match day (alcohol was excluded for anyone with a history of alcoholism,
adequately owing to technical difficulties. and no one was encouraged to drink). The diet was nutritionally
Selective coronary angiography was done by the percutaneous adequate and met the recommended daily allowances for all
femoral technique. The two laboratories were calibrated at baseline nutrients except vitamin B12’ which was supplemented.
and every 6 months thereafter. Orthogonal views were obtained, The stress management techniques included stretching exercises,
and the angle, skew, rotation, table height, and type of catheter were breathing techniques, meditation, progressive relaxation, and
recorded during the baseline angiogram to allow these imagery.3,9-12 The purpose of each technique was to increase the
measurements to be reproduced during angiography about a year patient’s sense of relaxation, concentration, and awareness. Patients
were asked to practise these stress management techniques for at
(15 [SD 3] months) later. Baseline and follow-up measures were
identical in the view angles, their sequence, type of contrast dye, the least 1 h per day and were given a 1 h audiocassette tape to assist
angiographer, and the cine arteriographic equipment. Catheter tips them.
were saved and used as reference measures for quantitative analyses Only 1 patient in the experimental group was smoking at baseline,
of films. Cine arteriograms made in San Francisco were sent to the and she agreed to stop on entry.
University of Texas Medical School at Houston for quantitative Patients were individually prescribed exercise levels (typically
analyses by a protocol described elsewhere in detail.’4 walking) according to their baseline treadmill test results. Patients
Blood samples for measurement of serum lipids were drawn were asked to reach a target training heart rate of 50-80% of the

(after a 14 h fast) at baseline, after 6 months, and after a year. Total heart rate at which 1 mm ST depression occurred during baseline
cholesterol, HDL-cholesterol, and triglyceride concentrations were treadmill testing or, if not ischaemic, to 50-80% of their
measured by ’Astra’ enzymic assays (Beckman Instruments, Brea, age-adjusted maximum heart rate based on level of conditioning.
California). LDL was calculated as total cholesterol minus Patients were also trained to identify exertional levels by means of
HDL-cholesterol plus 0-16 x triglycerides. Apolipoproteins A-I the Borg rate of perceived exertion scale.13 Patients were asked to
and B were measured by disc gel electrophoresis and by isoelectric exercise for a minimum of 3 h per week and to spend a minimum of
focusing.6 30 min per session exercising within their target heart rates. A
To check adherence to the programme patients completed a defibrillator and emergency drugs were available at all times.
3-day diet diary at baseline and after a year to assess nutrient intake The twice-weekly group discussions provided social support to
and dietary adherence.7 These diaries were analysed by means of the help patients adhere to the lifestyle change programme.’" The
CBORD diet analyser based upon the USDA database (CBORD
Group Inc, Ithaca, New York, USA). Patients were asked to
TABLE II-MEAN LESION CHARACTERISTICS AT BASELINE
complete a questionnaire describing the type, frequency, and
duration of exercise and of each stress management technique.
Patients who said they had stopped smoking underwent random
tests of plasma cotinine.8 Information from the adherence
questionnaires was quantified by a formula determined before the
study. A total score of 1 indicated 100% adherence to the
recommended lifestyle change programme, and 0 indicated no
adherence. Patients who did more than we recommended achieved
a score greater than 1.
To reduce the possibility that knowledge of group assignment _ _ _ _ _ _ _ _! _ _
might bias the outcome measurements, the investigators carrying 195 lesions: 105 experimental, 90 control.
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TABLE III-COMPLIANCE WITH EXERCISE, STRESS MANAGEMENT, AND DIETARY CHANGES

*Percentage of minimum recommended level of combined lifestyle change; Includes all the above plus smoking cessation

TABLE IV-CHANGES IN RISK FACTORS

sessions were led by a clinical psychologist who facilitated atherosclerosis in these patients for the following reasons:
discussions of strategies for maintaining adherence to the quantitative analyses of coronary arteriograms tend to assess
programme, communication skills, and expression of feelings about stenoses as being less severe than do qualitative assessments;
relationships at work and at home. we analysed all detectable lesions, including minor ones; and
Differences in baseline characteristics of the two groups were
we excluded from analysis 33 lesions that were 100%
tested for statistical significance by conventional t tests.
occluded at baseline.
Comparisons of the two study groups’ baseline coronary artery
lesion characteristics (measured by quantitative coronary Adherence to the diet, exercise, and stress management
angiography) and changes in lesion characteristics after intervention components of the lifestyle programme in the experimental
were examined by a mixed-model analysis of variance.1S These group was excellent (table ill). Patients in the control group
analyses used lesion-specific data but allowed for the possibility that made more moderate changes in lifestyle consistent with
lesion data in a given subject could be statistically dependent. Mean more conventional recommendations.
changes in other endpoint measures were analysed for statistical Table IV summarises changes in risk factors during the
significance by repeated-measures analysis of variance. intervention period. In the experimental group, total
cholesterol fell by 24-3% and LDL-cholesterol by 37-4%.
Results These falls occurred even though patients had already
reduced fat consumption to 31 5% of calories and
At baseline, there were no significant differences between
the experimental and control groups in demographic TABLE V-CHANGES IN ANGINA SYMPTOMS
characteristics (table 1), diet and lifestyle characteristics,
functional status, cardiac history, or risk factors in the 41
subjects who completed angiography before and after the
intervention. The control group had significantly higher
levels of HDL-cholesterol (1-33 [SD 052] vs 1-02 [031]
mmol/1; p=0029) and apolipoprotein A-1 (156 (36) vs 133
(21) mg/dl; p 0-0155) than the experimental group, but the
=

ratios of total/HDL cholesterol and LDL/HDL cholesterol

did not differ significantly between the groups at baseline.
The experimental and control groups did not differ
significantly in disease severity at baseline. The mean values
in table n do not fully reflect the severity of coronary *Scale of 1 to 7, 1 least severe.
132

analysed, the average percentage diameter stenosis regressed

from 61-1(8-8)% to 55-8 (11 -0)% in the experimental group
but progressed from 61-7 (9-5)% to 64-4 (163)% in the
control group (p 0-03, two-tailed).
=

The average lesion change scores (% diameter stenosis

after intervention minus before intervention) in the
experimental group were in the direction of regression of
coronary atherosclerosis in 18 of the 22 patients (82%)
including the 1 woman, in the direction of slight progression
in 3 patients, and in the direction of substantial progression
in 1 patient with poor adherence. In contrast, in the control
group the average lesion change scores were in the direction
of progression of coronary atherosclerosis in 10 of 19 (53%),
in the direction of regression (including all 4 women) in 8,
and 1 showed no change.
In the experimental group and in the whole study group,
overall adherence to the lifestyle changes was strongly
related to changes in lesions in a "dose-response" manner,
suggesting that the relation was causal. The differences in
overall adherence are sufficient to explain the observed
differences in percentage diameter stenosis. To assess
whether programme adherence was related to lesion
changes, the experimental group and the combined study
group were divided into tertiles based on overall adherence
score. Degree of adherence was directly correlated with

changes in percentage diameter stenosis (see accompanying

figure).

Discussion
This clinical trial has shown that a heterogeneous group of
patients with coronary heart disease can be motivated to
make comprehensive changes in lifestyle for at least a year
outside hospital. The changes in serum lipid levels are
similar to those seen with cholesterol-lowering drugs. The
lifestyle intervention seems safe and compatible with other
treatments of coronary heart disease.
After a year, patients in the experimental group showed
Correlation of overall adherence score and changes in significant overall regression of coronary atherosclerosis as
percentage diameter stenosis in experimental group only (A) measured by quantitative coronary arteriography. Since
and in whole study group (B). coronary atherosclerosis occurs over a period of decades, one
A=7 subjects in each tertile; B = 13, 14. 13. would not expect to find larger changes in only a year.
Perfusion is a fourth-power function of coronary artery
cholesterol intake to 213 mg/day on average before baseline diameter, so even a small amount of regression in a critically
testing. HDL-cholesterol did not change significantly in stenosed artery has a large effect on myocardial perfusion
either group. Apolipoprotein B fell substantially in the and thus on functional status. In contrast, patients in the
experimental group but it did not change in the control usual-care control group who were making less
group. Neither group had significant changes in comprehensive changes in lifestyle showed significant
apolipoprotein A-1. overall progression of coronary atherosclerosis. This finding
Patients in the experimental group reported a 91 % suggests that conventional recommendations for patients
reduction in the frequency of angina, a 42% reduction in with coronary heart disease (such as a 30% fat diet) are not
duration of angina, and a 28% reduction in the severity of sufficient to bring about regression in many patients.
angina. In contrast, control-group patients reported a 165 % The strong relation between programme adherence and
rise in frequency, a 95% rise in duration, and a 39% rise in lesion changes showed that most patients needed to follow
severity of angina (table v). In previous studies,2,3 we found the lifestyle programme as prescribed to show regression.
that similar improvements in functional status occurred in Those who made the greatest changes showed the biggest
only 1 month, which suggests that improvements in angina improvement. Since degree of stenosis change was
may precede regression of coronary atherosclerosis, perhaps correlated with extent of lifestyle change across its whole
by changing platelet-endothelial interactions, vasomotor range, small changes in lifestyle may slow the progression of
tone, or other dynamic characteristics of stenoses. atherosclerosis, whereas substantial changes in lifestyle may
All 195 detectable lesions were included in the be required to halt or reverse coronary atherosclerosis.
quantitative analysis. The average percentage diameter The 5 women in our study (1experimental group, 4
stenosis decreased from 40-0 (SD 16-9)% to 37-8 (16-5)% in control group) were the notable exceptions. All 5 made only
the experimental group yet progressed from 42.7 (15 5)% to moderate lifestyle changes, yet all showed overall regression.
46.11 (18-5)% in the control group (p = 0-001, two-tailed). All 5 were postmenopausal, and none was taking exogenous
When only lesions greater than 50% stenosed were oestrogens. The 4 women in the control group showed more
 133

regression than any of the men in that group, even though analysers, Dale Jones, Yvonne Stuart; head angiography nurses, LaVeta
some men made greater lifestyle changes. Although the Luce, Geogie Hesse; angiographers, Craig Brandman, Bruce Brent, Ralph
Clark, Keith Cohn, James Cullen, Richard Francoz, Gabriel Gregoratos,
numbers are small, these findings suggest the possibility that Lester Jacobsen, Roy Meyer, Gene Shafton, Brian Strunk, Anne Thorson;
gender may affect progression and regression of radiologists Robert Bernstein, Myron Marx, Gerald Needleman, John Wack;
atherosclerosis. Futher studies may determine whether lipid laboratory directors, Washington Bums, John Kane, Steve Kunitake;
medical liaison, Patricia McKenna; research assistants, Patricia Chung,
women can reverse coronary atherosclerosis with more
Stephen Sparier; secretaries, Claire Finn, Kathy Rainbird.
moderate lifestyle changes than men.
5 men in the control group showed very slight regression
of atherosclerosis. These patients exercised more often, for
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