Clinical Research

Mount Article
Abu Open Heart Trial

Regression of Coronary Atherosclerosis through Healthy Lifestyle in

Coronary Artery Disease Patients - Mount Abu Open Heart Trial.
1
Satish K. Gupta, 2Ramesh C. Sawhney, 3Lajpat Rai , 4V. D. Chavan, 5Sameer Dani,
6
Ramesh C. Arora, 2W. Selvamurthy, 7H. K. Chopra, 8Navin C. Nanda
1
J. Watumull Global Hospital & Research Centre, Mount Abu, Rajasthan, India
2
Defence Research & Development Organization, Ministry of Defence, New Delhi, India
3
Morarji Desai National Institute of Yoga, New Delhi, India
4
J. J. Group of Hospitals & Grant Medical College, Mumbai, Maharastra, India
5
U. N. Mehta Institute of Cardiology & Research Centre, Ahmedabad, Gujarat, India
6
G. B. Pant Hospital & Maulana Azad Medical College, New Delhi, India
7
Moolchand Medcity, New Delhi, India
8
Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, Alabama USA

Abstract
Aims: To evaluate the efficacy of a unique healthy and happy lifestyle (HLS) program in regression of coronary
atherosclerosis and reduction in cardiac events in an open trial.
Methods : One hundred and twenty three angiographically documented moderate to severe coronary artery disease
(CAD) patients were administered HLS comprising of low-fat, high-fiber vegetarian diet, moderate aerobic exercise
and stress-management through Rajyoga meditation. Its most salient feature was training in self-responsibility
(heal+thy) and self-empowerment through inner-self consciousness (swasth; swa=innerself, sth=consciousness)
approach using Rajyoga meditation. Following a seven day in-house sojourn, patients were invited for six month
follow-up for reassessment and advanced training. At the end of two years, all patients were asked to undergo repeat
angiography.
Results: Three hundred and sixty coronary lesions were analysed by two independent angiographers. In CAD
patients with most adherence, percent diameter stenosis regressed by 18.23 ± 12.04 absolute percentage points. 91%
patients showed a trend towards regression and 51.4% lesions regressed by more than 10 absolute percentage points.
The cardiac events in coronary artery disease patients were: 11 in most adherence, and 38 in least adherence over
a follow-up period of 6.48 yrs.(risk ratio; most vs least adherence: 4.32; 95% CI: 1.69-11.705; P<0.002).
Conclusion : Overall healthy changes in cardiovascular, metabolic and psychological parameters, decline in
absolute percent diameter coronary stenosis and cardiac events in patients of CAD were closely related to HLS
adherence. However, more than 50% adherence is essential to achieve a significant change.
Keywords: Healthy lifestyle, coronary artery disease, Rajyoga meditation, vegetarian diet

INTRODUCTION heart attacks8-10. In the lifestyle heart study8, a combination of

an extremely low fat diet, exercise, stress management and
Coronary artery disease(CAD) is a major cause of premature
yoga reduced progression of atherosclerosis, but the low fat
mortality and disability in both developing and developed
regime was unnecessarily very rigid and difficult to follow.
nations1,2. Over the last three decades, progress in coronary
Recent investigations have provided convincing evidence
artery bypass grafting (CABG) and percutaneous
interventions (PCI) has improved the prognosis of CAD3, but that the present prevalent outer self (body, role, material)
has not been able to address the basic issues of aetiopathology, conscious approach can lead to activation of psychosocial
providing merely palliative relief at a high cost4-6. CAD is factors like depression, anxiety, anger, hostility, isolation
now widely recognized as a lifestyle disease; hence its and chronic life stress which can contribute significantly
management should be lifestyle modification7. The lifestyle towards development and promotion of CAD by encouraging
intervention studies in small number of CAD patients have adoption of unhealthy lifestyle behaviours like smoking,
shown that dietary modifications, physical exercise and atherogenic diet and sedentary habits11-16. Besides activating
stress relaxation techniques can curtail progression of the sympatho-adreno-medullary system these psychological
coronary blockages and decrease the frequency of angina and factors can also activate endothelial dysfunction and platelet
Correspondence: Dr. Satish K. Gupta, J. Watumull Global Hospital & Research Center, Shantivan -307510, Abu Road, Rajasthan, India
E-mail: [email protected]

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Satish K Gupta et al.

activation and can become major impediment in modification The trial was initiated before the results of major statin trials
of the acquired aberrant lifestyle17-19. were published, and none of the patients was receiving lipid
The objective of the present study has been to develop a user lowering medications. One hundred and twenty one patients
friendly HLS program and to determine its efficacy in were on nitrates, 114 on anti-platelet agents, 78 on beta
regression of established CAD. The unique feature of this blockers, 56 on calcium channel blockers and 51 on ACE
program is that it focuses on self-responsibility and self- inhibitors.
empowerment as the basis for regression of coronary These patients served as their own control and their baseline
atherosclerosis and reduction in coronary events through characteristics are shown in Tables 1 & 2. Sixty seven percent
intensive information, education and counseling provided to patients had a documented history of myocardial infarction,
patients of CAD. The aim of this publication is to highlight 34% had diabetes mellitus, 60% had hypertension, 45% had
the features of the HLS program and to present the findings a history of dyslipidaemia, 40% had a history of smoking,
of this pilot study in angiographically documented CAD 53% had education up to high school or less and 50% patients
patients. were from the middle or low middle socio-economic group.
On coronary angiography, 49% had triple vessel disease,
MATERIALS AND METHODS 36% had double vessel disease and only 17% patients had
Two hundred and forty four angiographically documented single vessel disease. A total of 306 coronary lesions were
CAD patients were invited to participate in this study at taken at baseline for analysis. Average percent diameter
Global Hospital & Research Centre, Mount Abu, India. The stenosis at baseline was 65.40±14.11 (Mean ± SD) and the
inclusion criteria were: angiographically documented stable average number of lesions was 4.36±2.49.
CAD with more than 50% stenosis in at least one major Groups, limited to 10-20 patients and their spouses, stayed
epicardial vessel, coronary angiography having been in-house for seven days. On the first day, assessments were
performed within the last 6 months to one year; and patients made on baseline symptom score, drug score, exercise
for whom CABG or PCI were not considered due to poor tolerance, glycaemic status, lipid profile and psychological
anatomy, those unwilling to undergo CABG/PCI and left profile. The next step was detailed information, education,
ventricular ejection fraction(LVEF) >20% and without LVF. training and counseling about the aetiopathology of CAD and
The exclusion criteria were: another co-existent life- the importance of adopting and maintaining a healthy lifestyle.
threatening illness, acute coronary syndrome or significant Daily group support sessions encouraged patients to curtail
left main disease(e”50%). Of the 244 invitees, 123 CAD isolation and integrate happily with each other. The spouses
patients, 35-72 years, with chronic stable angina fulfilled all were also motivated to follow the HLS program as a moral
the criteria and were registered for the study. Out of 123, 2 support.
patients did not attend the first six-month follow-up On sixth day of training, the study parameters were reassessed.
study(Figure-1). Design of the Mount Abu Open Heart Each patient and spouse interacted with counselors: clinician,
Ttrial psychologist, Rajyoga meditation teacher, dietician, exercise
expert, ‘Dilwalas’ (CAD patients following HLS Program)
for overall risk factor modification and treatment advice.
They were provided with hand-outs, written material,
commentaries and cassettes about pathogenesis of CAD,
diet, exercise, Rajyoga meditation and the HLS Program
concept. Medications for angina, hypertension, diabetes,
antiplatelet agents, etc. were continued and modified as per
standard clinical guidelines. All volunteers received follow-
ups on intention-to-treat basis. After 7-day sojourn, subjects
were allocated to a Brahma Kumaris Rajyoga centre within
their vicinity for daily follow-up. Compliance to the program
was assessed using a 3 tier system. 1. Ten-point self –
assessment adherence chart. Each lifestyle related issue was
given a score of 0-10 to generate a quantitative score. A score
of 10 indicated 100% adherence while 0 indicated complete
lack of adherence. 2. Monthly report from the regional
coordinator and 3. Strict evaluation of each patient was

462 Indian Heart J. 2011; 63:461-469

 Mount Abu Open Heart Trial

individually done by the psychologist at 6 monthly follow- daily living.

ups. Patients were motivated to achieve at least 75% adherence The three major components of HLS program were:
to open their coronary blockages. The study protocol was i. ) Stress-management through Rajyoga meditation: Stress
approved by the Institute’s ethical committee, and written is defined as mental state in which the internal and
informed consent was obtained from every patient. An option external pressures exceed the inner strength (coping
for an angioplasty or bypass surgery was offered to all mechanism) leading to sympathetic over activity and
patients when required. release of stress hormones which in turn leads to vicious
cycle of mental dis-ease and physical dis-ease. Inner
HEALTHY LIFESTYLE - CONCEPT strength can be increased by Rajyoga. Rajyoga word has
Four principles, intrinsic to Rajyoga, which underlie the been derived from Raja meaning king and yoga meaning
program ethos are: union between Soul (spiritual energy) and Supreme
i.) Self-responsibility through self-empowerment: The Soul (ocean of spiritual energy). Rajyoga meditation
word ‘healthy’ is derived from two words; ‘heal’ + ’thy’ harmonizes spiritual, mental and physical energy, thereby
i.e., to heal yourself. To heal oneself, one needs to be increasing inner strength to lead a stress-free and healthy
empowered by appropriate and proper information about life. It enhances individual’s power of determination to
heart, mind-body connection, psychological and manage and practice positive thoughts, emotions,
conventional risk factors, stress-management, diet, attitudes, memories and adhere to healthy diet, exercise,
exercise, sleep, substance abuse and usual medical care. sleep, medication and cessation of smoking. Expert
ii.) Self-awareness: The Hindi word for healthy is ‘swasth’, Rajyoga teachers from Prajapita Brahma Kumaris
which consists of swa-, meaning ‘inner self’, and -sth, Ishwariya Vishwa Vidyalaya Mount Abu, taught Rajyoga
meaning ‘conscious’, so the word ‘healthy’ could also meditation in three different stages. During Stage-I (Inner
mean ‘inner self-conscious’. Outer self-consciousness self empowerment), patients were provided knowledge
(of body, role or material things, which are ever-changing about Soul and Supreme Soul and trained to forge a link
and mortal) leads to instability and insecurity, which in with the Supreme Soul to draw spiritual energy. This was
turn leads to anger, anxiety, depression, type A behaviour, followed by sessions of training in opening and healing
isolation and chronic life stresses. Conversely, inner the mind and opening the coronary blockages. In Stage-
self-consciousness (of spirit, which is enduring and II of opening and healing the mind, patients were made
immortal) leads to stability and security, which in turn to understand the role of non-physical factors like
leads to peace, love and happiness. So, by abstraction, depression, anger, cynicism, hostility, ego, jealousy,
a healthy lifestyle means an ‘inner self-conscious hurry, worry, anxiety, fear, isolation, lack of social and
lifestyle’; emotional support, job and family stress etc, in the
iii.) Multi-dimensionality: The current medical approach development of CAD; as these negative traits are acquired
addresses only one dimension, the physical body, which from the environment and are not part of the original
might explain why despite medical advancements the inner self. They were trained to inculcate the positive
epidemic of CAD has not been curbed. A human being mental energy thereby enhancing willpower to adhere to
is not one-dimensional. Therefore, a new model of healthy and happy lifestyle program. In stage-III of
health, ‘Soul-Mind-Body Medicine’ (three dimensional opening the coronary blockages by Rajyoga meditation,
healthcare) is called for. As per this new model, health is they were asked to focus the inner, radiant spiritual
a dynamic process of harmony in flow of spiritual energy energy on various organs of the body including the
(knowledge of truth, purity, peace, love, happiness, bliss stenosed arteries for regression of the disease. A
and power: of discretion, to judge, to withdraw, to pack meditation commentary was provided to guide the mind
up, to tolerate, to face, to accommodate, to cooperate), in a positive direction. They were encouraged to maintain
mental energy (Positive T.E.A.M.: thoughts, emotions, an inner self (soul) conscious mental state even while
attitudes and memories) and physical energy (healthy engaged in day-to-day work activities.
diet, exercise, sleep and medication). ii.) Low fat, high fiber vegetarian diet: The essential
iv.) Biological clock / circadian rhythm: When activities components of diet program were: what? (low fat, high
are in rhythm with one’s biological clock, they reduce fiber vegetarian), when? (as per biological clock) and
energy expense and stress, and prove beneficial for the how? (proper chewing in inner self conscious state). Diet
health of mind, intellect and body. consisted of low fat mostly PUFA and MUFA providing
All four principles should be sustained as far as possible in 15% of the calories, cholesterol intake restricted to less

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than 50mg/ day; soluble fiber about 50gms/ day, from were invited for follow-up and reassessment. The study
15gm psyllium husk/day, oat bran, fruits, vegetables, parameters were repeated at 6,12,18 and 24-month intervals,
sprouted seeds, beans, salads etc; complex carbohydrates and patients were advised to have repeat angiography after
providing about 65% of the calories; proteins 1gm/kg two years of follow-up. These patients were monitored for
body weight from soyabean and other vegetarian sources; cardiac events until 30 June, 2006.
antioxidants from sprouted seeds, fresh fruits, vegetables Psychological Status: Psychological tests were administered
and nuts.23 Beneficial effects of the prescribed diet were during the morning hours, using a battery of standardized
explained both to the patients as well as their spouses by psychological inventory. Anxiety was measured using the
audio-visual means and practical demonstration sessions IPAT Anxiety Scale questionnaire 21. Depression was
by the experts. The spouses were given the recipes of the evaluated using the Minnesota Multiphasic Personality
diet used and also taught the cooking methods. Smaller Inventory (MMPI) questionnaire22. Anger was measured by
and more frequent meals were provided. Diet was served MMPI-2 anger content scale.15 Well-being was evaluated
in silence with light music played to enhance the quality using a questionnaire on general health, quality of sleep,
of environmental ambience. Diet charts were also mental condition and feelings towards peers and superiors.
provided to each patient. The total score of subjective well-being was calculated using
iii.) Moderate aerobic exercise: Patients were individually a four-point scale.
prescribed brisk walk for 30-45 min in the morning after Blood biochemistry: Blood glucose, serum cholesterol,
the sun rise and 30 min of stroll during the evening before triglyceride and HDL-cholesterol were estimated using
sun set according to their baseline exercise tolerance. commercially available kits using RA 50, semiautomated
They were trained to reach a target heart rate of 60-70% clinical chemistry analyzer(Bayer Diagnostics, India).
of their maximum predicted heart rate(MPHR) based on Glucose kits were obtained from Bayer Diagnostics, India.
the level of physical conditioning.22 Initially all patients Total cholesterol, HDL cholesterol and triglyceride kits were
were made to walk to achieve 50% of MPHR and then obtained from M/S Ranbaxy Diagnostic, India. The LDL-
gradually build up over a period of one month or so to cholesterol and VLDL-cholesterol were calculated using
60% and then to 70% of MPHR, according to their health Fridewald’s formula.
status. In this study, (61%)patients had a history of Coronary angiography: Baseline and repeat coronary
documented myocardial infarction and many patients angiography reels/CD’s were coded to blind group allocation
had undergone baseline coronary angiography without a and to angiography sequencing (baseline or repeat). A panel
baseline stress test. Exercise tolerance was measured by of two independent angiographers analyzed the angiograms
requiring them to walk at a stretch to achieve 60-70% and selected the views in which the blockages were best seen.
MPHR or >110 steps/minute before developing All 100% occluded lesions, instent lesions and non-matching
symptoms, e.g. angina or dyspnea(observed and measured lesions were excluded. An electronic Digimatic Calliper
walk at baseline). The exercise routine included warming- (Mitutoyo, Japan) was used to quantitatively assess the
up period of 5 min, walking for 20-35 min, and cooling percent diameter stenosis. Trends towards regression/
down period of 5 min. They were advised to walk in progression were calculated by the percentage of patients
silence(inner self conscious state) and avoid walk after who showed overall regression/progression in repeat
the meals or during extreme cold or hot climatic angiographies as compared to baseline coronary
conditions. angiographies.
Statistical analysis: The data was analysed by an independent
FOLLOW-UP Biostatistician using SPSS 9 software. All data is presented
Patients participated in daily support sessions, of 30-45 as Mean±SD. To analyse changes in coronary lesions, percent
minutes, at their local Brahma Kumaris Rajyoga centers. To diameter stenosis was taken as the primary dependant variable.
ensure proper adherence, weekly group support sessions The mean and variance were calculated for quantitative
facilitated by Regional co-ordinators and Rajyoga teachers parameters and frequency with percentage for quantitative
addressed their day-to-day challenges. Every month the data. The comparison between two groups was done using
CAD project team visited three tertiary medical centers in paired ‘t’ and unpaired t-tests whereas for comparisons
Ahmedabad, Delhi and Mumbai for follow-up, assessment of between three groups ANOVA was used. To compare the
clinical status and program adherence. Those inaccessible proportions between different groups, the Chi square test was
were sent questionnaires with self-addressed, stamped used and to compare the scores, non-parametric tests were
envelopes. At 6-monthly intervals, patients and their spouses used. The baseline score data among three groups was

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 Mount Abu Open Heart Trial

analysed using the Kruskal Wallis test. To compare the 24 Table 1: Baseline characteristics of coronary artery disease (CAD)
months score data with the baseline in each group, the patients in Mount Abu Open Heart Trial (MAOHT)
Wilcoxon Signed Ranks test was used whereas for comparing
the improvement(change in score) between two groups, the
Mann-Whitney test was used. The univariate and multivariate
analyses determined the indicators and risk factors of the
outcome of CAD regression. Logistic regression was used to
calculate the Odds Ratio (OR) and 95% Confidence
Intervals(95%CI) for all efficacy parameters. Psychological
parameters were analysed by variance in the Kruskal Wallis
test. Significance was considered at p<0.05 levels for all the
parameters.
RESULTS Table 2: Baseline Socio-economic parameters in Mount Abu Open
Program adherence (Table 5) Heart Trial (MAOHT)

Patients were divided on the basis of adherence in three

categories: most adherence( 0.60-1.00 score, n=31), medium
adherence(0.50–0.60 score, n=36), least adherence(<0.50
score, n=54). All 31 patients with most adherence completed
two years of follow-up and 90.32% were still in the follow-
up after 8 years. In medium adherence, 36 patients completed
2 years of follow-up and 86.1% were still in follow-up at the
end of 8 years. In the least adherence group, 34 patients Table 3: Psychological, Metabolic & Clinical parameters of
completed two years of follow-up and 56% were in the Coronary Artery disease patients at baseline and after 24 months of
follow-up after 8 years. healthy and happy lifestyle. Values are Mean ± S D.
Adherence to all the components of HLS Program in patients
with most and medium adherence was significantly
higher(p<0.01) than the least adherence patients who had
very low adherence to Rajyoga(0.65 score in most adherence
Vs 0.15 score in least adherence; P=0.000). Patients with
most adherence had significantly higher adherence to the
prescribed diet regimen(0.76 score in most adherence vs 0.59
score in least adherence; P<0.0001) and exercise
schedule(0.74 score in most adherence vs 0.54 score in least
adherence, P<0.0001), thereby indicating that patients with
most and medium adherence were highly motivated to change
their diet and exercise habits compared to patients with least
adherence.
Psychological parameters
As is evident from Table 3, in all 121 patients, a significant
change in the various psychological parameters was observed
at two years of follow-up(P<0.0001). Patients with most
Metabolic profile
adherence showed a highly significant decrease in type A
behaviour score(P<0.001), anxiety score(P<0.005), Lipid profile: Total cholesterol decreased by 7% at day 7 and
depression score(P<0.023), anger score(P<0.0001), decreased further at 6 months(10.8%), 12 months(13.3%)
improvement in the lifestyle change(P 0.001) and in their and was maintained at 7.63% at 24 months(overall P<0.001).
overall sense of well-being(P<0.003) as compared to least A highly significant decrease(14.79%, P<0.0001) was
adherence. observed in patients with most adherence compared to an
insignificant decrease in patients with least adherence(most

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Satish K Gupta et al.

vs least adherence p<0.022). LDL cholesterol levels decreased respectively (overall p<0.001). Patients with most adherence
by 8.5% at day 7 and decreased further at 6 months (13.8%), registered 897.29% increase in exercise tolerance at the end
12 months (17.7%) and at 24 months (10.16%) of follow-up of 2 years (p<0.0001) compared to patients with least
(overall p<0.001). A highly significant decrease in LDL adherence where it increased by 212.50% (p=0.000).
levels was observed in patients with most adherence (16.87%, Left Ventricular Ejection Fraction(LVEF): The average LVEF
p<0.001) compared to an insignificant decrease in patients at baseline 46.51±11.94 did not change significantly at the
with least adherence (most vs least adherence p<0.041). end of 2 years, but in patients with most adherence the LVEF
HDL cholesterol levels increased by 3.6% at day 7 and 5.6% increased by 8.24% (p<0.021). In contrast, in patients with
at 2 years (p>0.05). Patients with most adherence recorded least adherence, the average LVEF reduced by 11.94%
6.4% (p>0.05) increase in HDL levels at 2 years compared to (p<0.009).
2.06% decrease in patients with least adherence( most vs Angiographic changes (Table 4)
least adherence p>0.05). Triglyceride levels decreased by
13.4% at day 7 and this decrease was maintained at 6 months Seventy three (76.04%) patients who had completed two
(14.1%), 12 months (15.6%) and at 24 months(13.07%) years of follow-up underwent check-angiography at the end
follow-up(overall p<0.001). A highly significant decrease of two years. A total of 306 out of 362 lesions (50 lesions
(30.1%, p<0.001) was observed in patients with most which were 100% occluded, and 6 instent lesions were
adherence at 2 years compared to insignificant decreases in excluded) were analysed. At baseline, there was no significant
patients with least adherence (11.29%) (p>0.05). The average difference in any measure of lesion severity amongst patients
LDL/HDL ratio decreased at 7 days(11.6%), which further with most, medium or least adherence.
decreased by the 6-month (16.3%), 12 month (21.4%) and The average percent diameter stenosis decreased by 6.10
24-month (16.4%) follow-ups(overall p< 0.001). A highly absolute percentage points at 2 years (p<0.003); i.e., a 7.06%
significant decrease (25.79%, p<0.002) was observed in relative improvement. Overall, HLS Program adherence was
patients with most adherence compared to an insignificant strongly related to changes in percent diameter stenosis of
decrease (2.14%) in patients with least adherence. coronary artery lesions in a “dose response manner”. In
Glycaemic control: Blood glucose and glycocylated patients with most adherence, average percent diameter
hemoglobin tended to decline but the change was not stenosis regressed from 70.06±8.09% to 50.00±13.84% i.e.
statistically significant (p>0.05). a regression of 18.23±12.04 absolute percentage
points(29.03% relative improvement; P<0.0001). In patients
Clinical parameters (Table 2) with medium adherence the average percent diameters stenosis
NYHA Functional Class (Symptom Score): The average regressed from 64.64±12.36 to 52.78±17.48% i.e. a regression
NYHA functional class significantly reduced by 28.3% by of 11.85±11.16 absolute percentage points(19.10% relative
day 7 of follow-up, and further reduced by 57.2% by 24- improvement; p<0.0001). In contrast, in patients with least
month of follow-up (overall p<0.001). Patients with most adherence, the average percent diameter stenosis progressed
adherence had a highly significant reduction by day 7 (28.07%, from 62.47±18.51 to 73.03±17.53 i.e. a progression of
p<0.01) itself whereas it took patients with least adherence 10.56±13.18 absolute percentage points (23.03% relative
two years to reach a reduction of 27.9% (p< 0.0001). worsening; p<0.0001). Overall, 63.01% patients showed
Drug score (Number. of 10mg nitrate tablets /day): The trends towards regression of coronary atherosclerosis. In
average drug score was reduced by 31.7%, at day 7 and patients with most adherence, 90.91% showed trends towards
58.2% by the 24-month follow-up(overall p<0.0001). A regression of coronary atherosclerosis. In contrast in patients
highly significant reduction in the drug score (35.37%, with least adherence, only 12% (3 out of 25) patients showed
p<0.0001) at day 7, and 89% reduction (p<0.0001) at two trends towards regression (p<0.0001)
years, compared to only 19.1% (p<0.004) reduction at two The change in lesion severity was classified into
years in the least adherence group (p<0.0001). 61.3% patients progression(percent diameter stenosis increased e•10 absolute
with most adherence were off the nitrate therapy at two years. percentage points), regression(percent diameter stenosis
Exercise tolerance: In this study, 81(66%) patients had a reduced e•10 absolute percentage points) or no significant
history of documented myocardial infarction, so many of change(percent diameter stenosis showing a change <10
them had undergone baseline coronary angiography without absolute percentage points). Overall, 37.4% lesions showed
a prior exercise stress test. The average exercise tolerance at regression of >10% absolute percentage points. In patients
baseline 0.36±0.46 km, increased by 210.80%, 378.37%, with most adherence, 51.4% lesions showed regression of
448.00% and 540.00% by day 7 and 6, 12 and 24-month >10% absolute percentage points as compared to only 6.12%

466 Indian Heart J. 2011; 63:461-469

 Mount Abu Open Heart Trial

lesions in patients with least adherence(overall Chi-square adherence (8 to most adherence and 6 to medium adherence).
102.57; p<0.001) After eight years follow-up, there were 31 patients with most
Table 4: Changes in coronary artery lesions as per program adherence, 31 patients with medium adherence and 16 patients
adherence. Value are Mean ± S D. with least adherence. Overall, it was observed that the number
of cardiovascular events were strongly related to HLS program
adherence in a “dose dependent manner”.
Table 6: Cardiac events over a mean followup period of 6.48 ±1.56
(range 0.35 - 8.34 yrs). Values are Mean± SD

Determinants of CAD regression (Table 5)

DISCUSSION
Univariate analysis showed significant correlation between
CAD regression and decrease in body weight(P<0.006), Results from the present study suggest that CAD patients can
triglycerides(p<0.03), exercise(p<0.007) and Rajyoga be motivated to adopt the HLS program for a fairly long
meditation (p<0.0001). On multivariate analysis changes in period of eight years of follow-up, while performing their
body weight and lipid parameters were not independent routine activities outside the hospital framework. This
predictors of CAD regression while management of program was found to be user-friendly, safe, flexible, and
psychosocial stressors through Rajyoga was found to be an compatible with other treatments in the setting of advanced
independent predictor of CAD regression (OR: 347.73; CAD, with a high degree of compliance. The primary end-
95%CI: 2.63-45,822; p<0.018). point of this study was change in percent diameter stenosis.
Table 5: Univariate and Multivariate analysis of various parameters In patients with most adherence the average percent diameter
in regression of CAD stenosis decreased by 18.23 absolute percentage points
(29.03% relative improvement), and in patients with medium
adherence it decreased by 11.85 absolute percentage points
(19.10% relative improvement), but it progressed in patients
with least adherence. Cardiac events were also markedly
decreased in patients with most adherence compared to
patients with least adherence. However, more than 50%
adherence to the prescribed HLS program is essential to
Cardiac events (Table 6) achieve significant regression in percent diameter stenosis
Data on cardiac events was obtained from all 121 patients and in the number of cardiac events. The HLS program could
over a mean follow-up period of 6.48±1.56 years (February modify psychosocial factors by significantly reducing anxiety,
1998 - June 2006). At about 8 years follow-up, there were depression, anger and type A behaviour scores, improvement
more events in the patients with least adherence (38 events in healthy lifestyle and overall sense of well-being. The
for 54 patients, 0.37% events per person over 334.58 person modification of psychosocial factors was reflected in better
years of observation; risk ratio least vs most: 4.32; 95%CI: adherence to healthy lifestyle behaviour like cessation of
1.69-11.05; p<0.002) compared to patients with most smoking, adherence to prescribed diet and exercise schedules.
adherence (11 events for 31 patients; 0.225 events per person Favourable highly significant changes were observed in
over 214.30 person years of observation). Patients with least NYHA function class, angina severity and frequency, drug
adherence were found to be more likely to have undergone score, and exercise tolerance by day 7 which were further
PCI (4 vs 2), CABG (10 vs 1) and to have been hospitalized favourably modified at different stages of follow up. The
for cardiovascular event (31 vs 5) than patients with most long-term reduction in NYHA functional class, nitrate
adherence. After eight years follow-up, all patients were requirement, and increased exercise tolerance is at par with
informed of the results of the trial. In response, of the 30 what is achieved following coronary angioplasty or bypass
patients with least adherence, 14 (47%) increased their surgery.

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Satish K Gupta et al.

The improvement in various metabolic parameters in these groups produced reductions in LDL by 25% to 53% or more
31,32
patients may be due to the low-cholesterol, high-fiber .
vegetarian diet, physical exercise or Rajyoga meditation In the control groups of various lifestyle trials, e.g Lifestyle
independently, or due to the synergistic effect of all three. An Heart trial8,9, Manchanda et al10, Yogendra et al 34, STARS 36,
improvement in the various metabolic parameters after the SCRIP37 and in patients with least adherence in our study, the
present program are consistent with results found by other average coronary lesion worsened at a rapid rate. In most of
investigators who observed that a diet rich in fruits, vegetables these trials, the treatment groups had no significant overall
and fiber can reduce the risk factors for CAD due to presence angiographic change, expressed in terms of percent diameter
of a variety of phytonutrients23-25. The beneficial effects of stenosis or minimum lumen diameter. In the SCRIP trial 37,
exercise on coronary heart disease may be mediated through the minimum lumen diameter worsened by 0.045mm per year
its effect on the cardiovascular system, on the musculoskeletal in the control group, a rate similar to that seen in the control
system and by modifying the various cardiovascular risk groups of lipid-lowering therapy trials 31,32. We recorded
factors 20,21. Exercise can also increase vasodilatory highly significant regression in coronary lesions with moderate
prostaglandin and decrease levels of plasma rennin activity reductions in LDL levels and a mild increase in HDL levels.
and blood viscosity26. Reductions in coronary atherosclerosis and cardiac events
The cardio-protective effects of Rajyoga meditation may be were strongly reflected in program adherence in a “dose
mediated through an interaction between the autonomic response manner”.
nervous system and the endocrine system27-29. In fact, in these The results of univariate analysis in these patients indicate
CAD patients the administration of HLS also enhanced alpha that the angiographic changes were attributable to the decrease
activity of EEG and caused shift of autonomic balance in weight, triglycerides, diet, exercise schedule and
towards relative parasympathetic predominance besides management of psychosocial stressors through Rajyoga
causing a marked reduction in secretion of stress hormones meditation. The multivariate analysis showed that change in
like epinephrine, nor-epinephrine and cortisol30. Rajyoga is weight and lipid parameters are not independent predictors of
also a training in awareness which produces definite changes CAD regression, but management of psychosocial stressors
in perception, attention and cognition. During Rajyoga through Rajyoga was an independent predictor of CAD
meditation, the practitioner remains awake and vigilant but regression. The Rajyoga meditation also motivated CAD
the body enters a state of deep muscle relaxation. It also helps patients to adhere more to the diet, exercise, treatment
in building strong will-power for compliance to HLS program; schedules and smoking cessation.
as it teaches a holistic lifestyle modification, the benefits of
which the participants begin to experience, within seven days LIMITATIONS OF THE STUDY
of the intervention. Since Rajyoga meditation also enhances The present investigation is a feasibility pilot study to
inner strength to lead a stress free and healthy life it might standardize the technique and determine its efficacy on
have caused marked reduction in psychological stressors and regression of CAD in limited numbers of subjects. (1.) The
favourably modified, unhealthy behavioural patterns which study could not be blinded because of the nature of program.
in turn may be responsible for regression in coronary Independent angiographers, blinded to the group allocation
atherosclerosis and reduction in coronary events. and angiography-sequencing (pre or post), analyzed the
During the last 15 years, a number of randomized clinical angiograms. Highly significant regression in coronary
trials using angiography have reported the effect of various atherosclerosis has been observed in this study but it is
interventions on the rate of progression/regression of coronary known that some lesions can regress & progress spontaneously,
atherosclerosis in CAD patients8-10,31-36 . In the REVERSAL hence to validate these findings, a randomized trial, ABU –
trial31 which focused primarily on effect of intensive compared Healthy Heart Trial was undertaken in May 2000. (2.) All the
with moderate lipid-lowering therapy and which used recruited patients were advised repeat angiogram after
intravascular ultrasound (IVUS) has revealed that progression completion of two years and followed up for clinical
(2.7%) occurred in the Pravastatin 40 mg/day group and parameters and coronary events up to eight years. 73 CAD
progression did not occur in the Atorvastatin 80 mg/day patients underwent repeat angiogram; rest did not have
group at 18 months. In the Asteroid trial32 Rosuvastatin 40 repeat angiography in spite of repeated request by the
mg/day for 24 months, significant reduction in percent investigators. Some of the patients with most and medium
atheroma volume (-0.79%) was observed using IVUS. Most adherence did not undergo repeat angiogram as they said
of these studies reported better angiographic outcomes with they’re already feeling better and hence were not interested
greater reduction in LDL cholesterol because their treatment in the same. Many patients with poor adherence refused

468 Indian Heart J. 2011; 63:461-469

 Mount Abu Open Heart Trial

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