Stress Reduction in the Secondary Prevention of Cardiovascular Disease: Randomized, Controlled Trial of Transcendental Meditation and Health Education in Blacks

Study Questions:

Psychosocial stress may contribute to the disproportionately high rates of cardiovascular disease in blacks. What is the effect of stress reduction with the Transcendental Meditation (TM) program on cardiovascular events and mortality in blacks with coronary heart disease (CHD)?

Methods:

A randomized, single-blind, controlled trial was conducted in 201 black men and women with CHD, defined as angiographic evidence of at least one coronary artery with >50% stenosis. Exclusion criteria were acute myocardial infarction (MI), stroke, or coronary revascularization within the previous 3 months, chronic heart failure with ejection fraction <20%, cognitive impairment, and noncardiac life-threatening illness. Subjects were randomized to a TM program or health education, and continued usual medical care throughout the study. The primary endpoint was the composite of all-cause mortality, MI, or stroke. Secondary endpoints included the composite of cardiovascular mortality, revascularizations, and cardiovascular hospitalizations; blood pressure; psychosocial stress factors; and lifestyle behaviors.

Results:

There was no difference between groups for mean age of 59 years, 42% were women, about 50% had incomes of <$10,000/year, 60% were on lipid-lowering medications, 45% angiotensin-converting enzyme inhibitors, 35% aspirin, or clinical variables, but for a lower depression score in the TM group. Nonparticipation (<1 session per day) occurred in 19% of the TM and 10% of the health education group (p = 0.07). During an average follow-up of 5.4 ± 2.5 years (maximum 9.3), there was a 48% risk reduction in the primary endpoint in the TM group (hazard ratio, 0.52; 95% confidence interval [CI], 0.29-0.92; p = 0.025). The TM group also showed a 24% risk reduction in the secondary endpoint (hazard ratio, 0.76; 95% CI, 0.51-0.1.13; p = 0.17). TM was associated with a net reduction of 4.9 mm Hg in systolic blood pressure (95% CI interval, −8.3 to –1.5 mm Hg; p = 0.01) and reduced anger expression (p < 0.05 for all scales), but no difference in depression or hostility. Subjects practiced the assigned technique an average of 8.5 times/week. Adherence was associated with survival.

Conclusions:

A selected mind–body intervention, the TM program, significantly reduced risk for mortality, MI, and stroke in CHD patients. These changes were associated with lower blood pressure and psychosocial stress factors. Therefore, this practice may be clinically useful in the secondary prevention of cardiovascular disease.

Perspective:

The nearly 50% reduction in hard cardiovascular events with TM in blacks with CHD is a remarkably robust finding. Caution is needed prior to widespread application of TM based on this study, which was stopped and restarted following interim analysis, which demonstrated that an additional 5 years of outcome (initial cohort 1998-2003) would have an 80% power to detect a 50% risk reduction of the primary outcome.

Clinical Topics: Prevention

Keywords: Coronary Artery Disease, Myocardial Infarction, Stroke, Secondary Prevention, Health Education, Single-Blind Method


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