In a prospective, randomised, controlled trial to determine whether comprehensive lifestyle changes affect coronary atherosclerosis after 1 year, 28 patients were assigned to an experimental group (low-fat vegetarian diet, stopping smoking, stress management training, and moderate exercise) and 20 to a usual-care control group. 195 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 group yet progressed from 42-7 (15-5)% to 46-1 (18-5)% in the control group. When only lesions greater than 50% stenosed were analysed, the average percentage diameter stenosis regressed from 61-1 (8-8)% to 55-8 (11-0)% in the experimental group and progressed from 61-7 (9-5)% to 64-4 (16-3)% in the control group. Overall, 82% of experimental-group patients had an average change towards regression. 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. Lancet 1990; 336: 129-33.
The Lifestyle Heart Trial is the first randomised, controlled clinical trial to determine whether patients outside hospital can be motivated to make and sustain comprehensive lifestyle changes and, if so, whether regression of coronary atherosclerosis can occur as a result of lifestyle changes alone. Over twenty clinical trials are being carried out to determine whether the progression of coronary atherosclerosis can be modified; in all of these, cholesterol-lowering drugs, plasmapheresis, or partial ileal bypass surgery are the primary interventions.
We carried out trials in 1977 and 1980 to assess the short-term effects of lifestyle changes on coronary heart disease with non-invasive endpoint measures (improvements in cardiac risk factors, functional status, myocardial perfusion, and left ventricular function). However, the subjects of those studies were not living in the community during the trial, and we did not use angiography to assess changes in coronary atherosclerosis.
Patients and methods
Patients with angiographically documented coronary artery disease were randomly assigned to an experimental group or to a usual-care control group. Experimental-group patients were prescribed a lifestyle programme that included a low-fat vegetarian diet, moderate aerobic exercise, stress management training, stopping smoking, and group support. Control-group patients were not asked to make lifestyle changes, although they were free to do so. Progression or regression of coronary artery lesions was assessed in both groups by quantitative coronary angiography at baseline and after about a year.