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The effects of an intensive lifestyle modification program on carotid artery intima-media thickness: a randomized trial
Aldana SG, Greenlaw R, Salberg A, Merrill RM, Hager R, Jorgensen RB
American Journal of Health Promotion 2007 Jul-Aug;21(6):510-516
clinical trial
7/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

PURPOSE: This study evaluated the effect of the Dr Dean Ornish Program for Reversing Heart Disease on cardiovascular disease as measured by the intima-media thickness of the common carotid artery and compared this effect to outcomes from patients participating in traditional cardiac rehabilitation. DESIGN: Randomized clinical trial. SETTING: Swedish American Health System. SUBJECTS: Ninety three patients with clinically confirmed coronary artery disease were randomly assigned to the intervention (n = 46) or traditional cardiac rehabilitation (n = 47). INTERVENTION: Dr Dean Ornish Program for Reversing Heart Disease. Measures. Ultrasound of the carotid artery and other cardiovascular risk factors were measured at baseline, 6, and 12 months. ANALYSIS: Intent-to-treat analysis. RESULTS: There was no significant reduction in the carotid intima-media thickness of the carotid artery in the Ornish group or the cardiac rehabilitation group. Ornish Program participants had significantly improved dietary habits (p < 0.001), weight (p < 0.001), and body mass index (p < 0.001) as compared with the rehabilitation group. The decrease in the number of patients with angina from baseline to 12 months was 44% in Ornish and 12% in cardiac rehabilitation. CONCLUSIONS: The Ornish Program appears to causes improvements in cardiovascular risk factors but does not appear to change the atherosclerotic process as it affects the carotid artery.

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