Effects of cardiac rehabilitation with and without meditation on myocardial blood flow using quantitative positron emission tomography: A pilot study.

BACKGROUND: Psychosocial stress is recognized as a risk factor for coronary heart disease (CHD). High rates of CHD in African-Americans may be related to psychosocial stress. However, standard cardiac rehabilitation (CR) usually does not include a systematic stress-reduction technique. Previous studies suggest that the Transcendental Meditation (TM) technique may reduce CHD risk factors and clinical events. This pilot study explored the effects of standard CR with and without TM on a measure of CHD in African-American patients. METHODS: Fifty-six CHD patients were assigned to CR, CR + TM, TM alone, or usual care. Testing was done at baseline and after 12 weeks. The primary outcome was myocardial flow reserve (MFR) assessed by 13N-ammonia positron emission tomography (PET). Secondary outcomes were CHD risk factors. Based on guidelines for analysis of small pilot studies, data were analyzed for effect size (ES). RESULTS: For 37 patients who completed posttesting, there were MFR improvements in the CR + TM group (+20.7%; ES = 0.64) and the TM group alone (+12.8%; ES = 0.36). By comparison, the CR-alone and usual care groups showed modest changes (+ 5.8%; ES = 0.17 and - 10.3%; ES = - 0.31), respectively. For the combined TM group, MFR increased (+ 14%, ES = 0.56) compared to the combined non-TM group (- 2.0%, ES = - 0.08). CONCLUSIONS: These pilot data suggest that adding the TM technique to standard cardiac rehabilitation or using TM alone may improve the myocardial flow reserve in African-American CHD patients. These results may be applied to the design of controlled clinical trials to definitively test these effects. TRIAL REGISTRATION: ClinicalTrials.gov registration # NCT01810029.

Stress Reduction in the Prevention of Left Ventricular Hypertrophy: A Randomized Controlled Trial of Transcendental Meditation and Health Education in Hypertensive African Americans.

Background: African Americans have disproportionately high rates of cardiovascular disease (CVD). Left ventricular hypertrophy (LVH) is an independent risk factor for CVD and may contribute to this disparity. Psychological stress contributes to LVH in African Americans and other populations. Objective: This study evaluated the effects of stress reduction with the Transcendental Meditation (TM) technique on preventing LVH in African American adults with hypertension. Setting: Martin Luther King Hospital - Charles R. Drew University of Medicine and Science, Los Angeles, CA. Method: In this trial, 85 African American adults (average 52.8 years) were randomly assigned to either TM program or health education (HE) control group and completed posttesting. Participants were tested at baseline and after six months for left ventricular mass index (LVMI) by M-mode echocardiography, blood pressure, psychosocial stress and behavioral factors. Change in outcomes was analyzed between groups by ANCOVA and within groups by paired t-test. Results: The TM group had significantly lower LVMI compared with the HE group (-7.55gm/m2, 95% CI -14.78 to -.34 gm/m2, P=.040). Both interventions showed significant within group reductions in BP, (SBP/DBP changes for TM: -5/ -3 mm Hg, and for HE: -7/-6 mm Hg, P=.028 to <.001) although between group changes were not significant. In addition, both groups showed significant reductions in anger (P=.002 to .001). There were no other changes in lifestyle factors. Conclusions: These findings indicate that stress reduction with TM was effective in preventing LVMI progression and thus may prevent LVH and associated CVD in high-risk African American patients.

Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: a randomised controlled trial.

BACKGROUND: Post-traumatic stress disorder (PTSD) is a complex and difficult-to-treat disorder, affecting 10-20% of military veterans. Previous research has raised the question of whether a non-trauma-focused treatment can be as effective as trauma exposure therapy in reducing PTSD symptoms. This study aimed to compare the non-trauma-focused practice of Transcendental Meditation (TM) with prolonged exposure therapy (PE) in a non-inferiority clinical trial, and to compare both therapies with a control of PTSD health education (HE). METHODS: We did a randomised controlled trial at the Department of Veterans Affairs San Diego Healthcare System in CA, USA. We included 203 veterans with a current diagnosis of PTSD resulting from active military service randomly assigned to a TM or PE group, or an active control group of HE, using stratified block randomisation. Each treatment provided 12 sessions over 12 weeks, with daily home practice. TM and HE were mainly given in a group setting and PE was given individually. The primary outcome was change in PTSD symptom severity over 3 months, assessed by the Clinician-Administered PTSD Scale (CAPS). Analysis was by intention to treat. We hypothesised that TM would show non-inferiority to PE in improvement of CAPS score (Δ=10), with TM and PE superior to PTSD HE. This study is registered with ClinicalTrials.gov, number NCT01865123. FINDINGS: Between June 10, 2013, and Oct 7, 2016, 203 veterans were randomly assigned to an intervention group (68 to the TM group, 68 to the PE group, and 67 to the PTSD HE group). TM was significantly non-inferior to PE on change in CAPS score from baseline to 3-month post-test (difference between groups in mean change -5·9, 95% CI -14·3 to 2·4, p=0·0002). In standard superiority comparisons, significant reductions in CAPS scores were found for TM versus PTSD HE (-14·6 95% CI, -23·3 to -5·9, p=0·0009), and PE versus PTSD HE (-8·7 95% CI, -17·0 to -0·32, p=0·041). 61% of those receiving TM, 42% of those receiving PE, and 32% of those receiving HE showed clinically significant improvements on the CAPS score. INTERPRETATION: A non-trauma-focused-therapy, TM, might be a viable option for decreasing the severity of PTSD symptoms in veterans and represents an efficacious alternative for veterans who prefer not to receive or who do not respond to traditional exposure-based treatments of PTSD. FUNDING: Department of Defense, US Army Medical Research.

Effects of Lifestyle Modification on Telomerase Gene Expression in Hypertensive Patients: A Pilot Trial of Stress Reduction and Health Education Programs in African Americans.

BACKGROUND: African Americans suffer from disproportionately high rates of hypertension and cardiovascular disease. Psychosocial stress, lifestyle and telomere dysfunction contribute to the pathogenesis of hypertension and cardiovascular disease. This study evaluated effects of stress reduction and lifestyle modification on blood pressure, telomerase gene expression and lifestyle factors in African Americans. METHODS: Forty-eight African American men and women with stage I hypertension who participated in a larger randomized controlled trial volunteered for this substudy. These subjects participated in either stress reduction with the Transcendental Meditation technique and a basic health education course (SR) or an extensive health education program (EHE) for 16 weeks. Primary outcomes were telomerase gene expression (hTERT and hTR) and clinic blood pressure. Secondary outcomes included lifestyle-related factors. Data were analyzed for within-group and between-group changes. RESULTS: Both groups showed increases in the two measures of telomerase gene expression, hTR mRNA levels (SR: p< 0.001; EHE: p< 0.001) and hTERT mRNA levels (SR: p = 0.055; EHE: p< 0.002). However, no statistically significant between-group changes were observed. Both groups showed reductions in systolic BP. Adjusted changes were SR = -5.7 mm Hg, p< 0.01; EHE = -9.0 mm Hg, p < 0.001 with no statistically significant difference between group difference. There was a significant reduction in diastolic BP in the EHE group (-5.3 mm Hg, p< 0.001) but not in SR (-1.2 mm Hg, p = 0.42); the between-group difference was significant (p = 0.04). The EHE group showed a greater number of changes in lifestyle behaviors. CONCLUSION: In this pilot trial, both stress reduction (Transcendental Meditation technique plus health education) and extensive health education groups demonstrated increased telomerase gene expression and reduced BP. The association between increased telomerase gene expression and reduced BP observed in this high-risk population suggest hypotheses that telomerase gene expression may either be a biomarker for reduced BP or a mechanism by which stress reduction and lifestyle modification reduces BP. TRIAL REGISTRATION: ClinicalTrials.gov NCT00681200.

Design and rationale of a comparative effectiveness trial evaluating transcendental meditation against established therapies for PTSD.

BACKGROUND: Although meditation therapies such as the Transcendental Meditation (TM) technique are commonly used to assist with stress and stress-related diseases, there remains a lack of rigorous clinical trial research establishing the relative efficacy of these treatments overall and for populations with psychiatric illness. This study uses a comparative effectiveness design to assess the relative benefits of TM to those obtained from a gold-standard cognitive behavioral therapy for posttraumatic stress disorder (PTSD) in a Veteran population. METHODS AND DESIGN: This paper describes the rationale and design of an in progress randomized controlled trial comparing TM to an established cognitive behavioral treatment - Prolonged Exposure (PE) - and an active control condition (health education [HE]) for PTSD. This trial will recruit 210 Veterans meeting DSM-IV criteria for PTSD, with testing conducted at 0 and 3 months for PTSD symptoms, depression, mood disturbance, quality of life, behavioral factors, and physiological/biochemical and gene expression mechanisms using validated measures. The study hypothesis is that TM will be noninferior to PE and superior to HE on changes in PTSD symptoms, using the Clinician Administered PTSD Scale (CAPS). DISCUSSION: The described study represents a methodologically rigorous protocol evaluating the benefits of TM for PTSD. The projected results will help to establish the overall efficacy of TM for PTSD among Veterans, identify bio-behavioral mechanisms through which TM and PE may improve PTSD symptoms, and will permit conclusions regarding the relative value of TM against currently established therapies for PTSD.

Stress reduction in the secondary prevention of cardiovascular disease: randomized, controlled trial of transcendental meditation and health education in Blacks.

BACKGROUND: Blacks have disproportionately high rates of cardiovascular disease. Psychosocial stress may contribute to this disparity. Previous trials on stress reduction with the Transcendental Meditation (TM) program have reported improvements in cardiovascular disease risk factors, surrogate end points, and mortality in blacks and other populations. METHODS AND RESULTS: This was a randomized, controlled trial of 201 black men and women with coronary heart disease who were randomized to the TM program or health education. The primary end point was the composite of all-cause mortality, myocardial infarction, or stroke. Secondary end points included the composite of cardiovascular mortality, revascularizations, and cardiovascular hospitalizations; blood pressure; psychosocial stress factors; and lifestyle behaviors. During an average follow-up of 5.4 years, there was a 48% risk reduction in the primary end point in the TM group (hazard ratio, 0.52; 95% confidence interval, 0.29-0.92; P=0.025). The TM group also showed a 24% risk reduction in the secondary end point (hazard ratio, 0.76; 95% confidence interval, 0.51-0.1.13; P=0.17). There were reductions of 4.9 mmHg in systolic blood pressure (95% confidence interval -8.3 to -1.5 mmHg; P=0.01) and anger expression (P<0.05 for all scales). Adherence was associated with survival. CONCLUSIONS: A selected mind-body intervention, the TM program, significantly reduced risk for mortality, myocardial infarction, and stroke in coronary heart disease 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. Clinical Trial Registration- URL: www.clinicaltrials.gov Unique identifier: NCT01299935.

Effects of the Transcendental Meditation Program on Substance Use among University Students.

A randomized wait-list controlled trial (N = 295 university students) of the effects of the Transcendental Meditation program was conducted in an urban setting. Substance use was assessed by self-report at baseline and 3 months later. For smoking and illicit drug use, there were no significant differences between conditions. For alcohol use, sex X intervention condition interactions were significant; TM instruction lowered drinking rates among male but not female students. TM instruction could play a valuable role in reducing alcohol use among male university students. Limitations are noted, along with suggestions for further research.

A self-referential default brain state: patterns of coherence, power, and eLORETA sources during eyes-closed rest and Transcendental Meditation practice.

Activation of a default mode network (DMN) including frontal and parietal midline structures varies with cognitive load, being more active during low-load tasks and less active during high-load tasks requiring executive control. Meditation practices entail various degrees of cognitive control. Thus, DMN activation patterns could give insight into the nature of meditation practices. This 10-week random assignment study compared theta2, alpha1, alpha2, beta1, beta2 and gamma EEG coherence, power, and eLORETA cortical sources during eyes-closed rest and Transcendental Meditation (TM) practice in 38 male and female college students, average age 23.7 years. Significant brainwave differences were seen between groups. Compared to eyes-closed rest, TM practice led to higher alpha1 frontal log-power, and lower beta1 and gamma frontal and parietal log-power; higher frontal and parietal alpha1 interhemispheric coherence and higher frontal and frontal-central beta2 intrahemispheric coherence. eLORETA analysis identified sources of alpha1 activity in midline cortical regions that overlapped with the DMN. Greater activation in areas that overlap the DMN during TM practice suggests that meditation practice may lead to a foundational or 'ground' state of cerebral functioning that may underlie eyes-closed rest and more focused cognitive processes.

A randomized controlled trial on effects of the Transcendental Meditation program on blood pressure, psychological distress, and coping in young adults.

BACKGROUND: Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind-body intervention on blood pressure (BP), psychological distress, and coping in college students. METHODS: This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. RESULTS: Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were -2.0/-1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were -5.0/-2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). CONCLUSIONS: This is the first RCT to demonstrate that a selected mind-body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind-body program may reduce the risk for future development of hypertension in young adults.

The effects of the transcendental meditation program on mindfulness.

Mindfulness is associated with low levels of neuroticism, anxiety, and depressive symptoms, as well as high levels of self-esteem and satisfaction with life (Brown & Ryan, 2003). As part of a 3-month randomized waitlist-controlled trial of the effects of the Transcendental Meditation (TM) program on university students (N=295), we examined the impact of TM practice on mindfulness as measured by the Kentucky Inventory of Mindfulness Skills (KIMS; Baer, Smith, & Allen, 2004). A repeated measures ANOVA on total KIMS scores showed a significant timextreatment interaction, with the TM participants reporting greater increases in mindfulness than the waitlist participants. All KIMS subscales were positively intercorrelated at pretreatment, and there were no differences over time or as a function of treatment condition in subscale intercorrelations. Therefore, previously published findings of a positive correlation between subscales measuring the skills of observing and accepting-without-judgment one's inner experiences only among those with meditation experience may have reflected a self-selection effect rather than a change in the relation of these mindfulness components resulting directly from meditation practice.

Effects of Transcendental Meditation practice on brain functioning and stress reactivity in college students.

This randomized controlled trial investigated effects of Transcendental Meditation (TM) practice on Brain Integration Scale scores (broadband frontal coherence, power ratios, and preparatory brain responses), electrodermal habituation to 85-dB tones, sleepiness, heart rate, respiratory sinus arrhythmia, and P300 latencies in 50 college students. After pretest, students were randomly assigned to learn TM immediately or learn after the 10-week posttest. There were no significant pretest group differences. A MANOVA of students with complete data (N=38) yielded significant group vs treatment interactions for Brain Integration Scale scores, sleepiness, and habituation rates (all p<.007). Post hoc analyses revealed significant increases in Brain Integration Scale scores for Immediate-start students but decreases in Delayed-start students; significant reductions in sleepiness in Immediate-start students with no change in Delayed-start students; and no changes in habituation rates in Immediate-start students, but significant increases in Delayed-start students. These data support the value of TM practice for college students.

Stress reduction programs in patients with elevated blood pressure: a systematic review and meta-analysis.

Substantial evidence indicates that psychosocial stress contributes to hypertension and cardiovascular disease (CVD). Previous meta-analyses of stress reduction and high blood pressure (BP) were outdated and/or methodologically limited. Therefore, we conducted an updated systematic review of the published literature and identified 107 studies on stress reduction and BP. Seventeen trials with 23 treatment comparisons and 960 participants with elevated BP met criteria for well-designed randomized controlled trials and were replicated within intervention categories. Meta-analysis was used to calculate BP changes for biofeedback, -0.8/-2.0 mm Hg (P = NS); relaxation-assisted biofeedback, +4.3/+2.4 mm Hg (P = NS); progressive muscle relaxation, -1.9/-1.4 mm Hg (P = NS); stress management training, -2.3/-1.3 mm (P = NS); and the Transcendental Meditation program, -5.0/-2.8 mm Hg (P = 0.002/0.02). Available evidence indicates that among stress reduction approaches, the Transcendental Meditation program is associated with significant reductions in BP. Related data suggest improvements in other CVD risk factors and clinical outcomes.