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Dean Ornish, MD; Larry W. Scherwitz, PhD; James H. Billings, PhD, MPH; K. Lance Gould, MD; Terri A. Merritt, MS; Stephen Sparler, MA; William T. Armstrong, MD; Thomas A. Ports, MD; Richard L. Kirkeeide, PhD; Charissa Hogeboom, PhD; Richard J. Brand, PhD

JAMA. 1998;280:2001-2007.

Context.— The Lifestyle Heart Trial demonstrated that intensive lifestyle changes may lead to regression of coronary atherosclerosis after 1 year.

Objectives.— To determine the feasibility of patients to sustain intensive lifestyle changes for a total of 5 years and the effects of these lifestyle changes (without lipid-lowering drugs) on coronary heart disease.

Design.— Randomized controlled trial conducted from 1986 to 1992 using a randomized invitational design.

Patients.— Forty-eight patients with moderate to severe coronary heart disease were randomized to an intensive lifestyle change group or to a usual-care control group, and 35 completed the 5-year follow-up quantitative coronary arteriography.

Setting.— Two tertiary care university medical centers.

Intervention.— Intensive lifestyle changes (10% fat whole foods vegetarian diet, aerobic exercise, stress management training, smoking cessation, group psychosocial support) for 5 years.

Main Outcome Measures.— Adherence to intensive lifestyle changes, changes in coronary artery percent diameter stenosis, and cardiac events.

Results.— Experimental group patients (20 [71%] of 28 patients completed 5-year follow-up) made and maintained comprehensive lifestyle changes for 5 years, whereas control group patients (15 [75%] of 20 patients completed 5-year follow-up) made more moderate changes. 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) (P=.001 between groups. Twenty-five cardiac events occurred in 28 experimental group patients vs 45 events in 20 control group patients during the 5-year follow-up (risk ratio for any event for the control group, 2.47 [95% confidence interval, 1.48-4.20]).

Conclusions.— 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.

From the Department of Medicine (Dr Ornish), and the Division of Cardiology (Dr Armstrong), California Pacific Medical Center, San Francisco; the Department of Medicine (Dr Ornish), the Division of Cardiology, Cardiac Catheterization Laboratory, Cardiovascular Research Institute (Dr Ports), and the Division of Biostatistics (Drs Brand and Hogeboom), School of Medicine, University of California, San Francisco; the Division of Cardiology, University of Texas Medical School, Houston (Drs Gould and Kirkeeide); and the Preventive Medicine Research Institue, Sausalito, Calif (Drs Ornish Scherwitz, and Billings, Mr Sparler, and Ms Merritt).

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