Cochrane Database of Systematic Reviews

Meditation for the primary and secondary prevention of

cardiovascular disease (Protocol)

Rees K, Court R, Takeda A, Ernst E

Rees K, Court R, Takeda A, Ernst E.

Meditation for the primary and secondary prevention of cardiovascular disease.
Cochrane Database of Systematic Reviews 2019, Issue 6. Art. No.: CD013358.
DOI: 10.1002/14651858.CD013358.

www.cochranelibrary.com

Meditation for the primary and secondary prevention of cardiovascular disease (Protocol)
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
ADDITIONAL TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
NOTES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Meditation for the primary and secondary prevention of cardiovascular disease (Protocol) i
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]

Meditation for the primary and secondary prevention of

cardiovascular disease

Karen Rees1 , Rachel Court1 , Andrea Takeda2 , Edzard Ernst3

1 Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK. 2 Institute of Health Informatics
Research, University College London, London, UK. 3 Complementary Medicine Department, Peninsula Medical School, University
of Exeter, Exeter, UK

Contact address: Karen Rees, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
karen.rees@warwick.ac.uk, rees_karen@yahoo.co.uk.

Editorial group: Cochrane Heart Group.

Publication status and date: New, published in Issue 6, 2019.

Citation: Rees K, Court R, Takeda A, Ernst E. Meditation for the primary and secondary prevention of cardiovascular disease. Cochrane
Database of Systematic Reviews 2019, Issue 6. Art. No.: CD013358. DOI: 10.1002/14651858.CD013358.

Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

To determine the effectiveness of meditation techniques, primarily MBIs and TM, for the primary and secondary prevention of CVD
in adults at high risk and with established CVD.

BACKGROUND
Description of the condition
Cardiovascular diseases (CVDs) are a group of disorders of the
heart and blood vessels, which include CVDs due to atheroscle-
rosis (coronary heart disease (CHD), cerebrovascular disease, and
peripheral vascular disease) and other CVDs (rheumatic heart dis-
ease, congenital heart disease, cardiomyopathies, and cardiac ar-
rhythmias). Atherosclerosis is a complex process that occurs in the
walls of blood vessels over many years, where fatty material and
cholesterol deposit and form plaques, which narrow and stiffen
arteries and reduce blood flow. Ruptured plaques can cause the
formation of blood clots, which trigger heart attacks if they de-
velop in the coronary arteries and strokes if clots develop in the
brain (WHO 2011).
Meditation for the primary and secondary prevention of cardiovascular disease (Protocol)
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CVDs are the world’s leading cause of death and caused 17.7 mil-
lion deaths in 2015; this represented 31% of all global deaths that
year, over three-quarters of which occurred in low- and middle-
income countries (WHO 2017). Of these 17.7 million deaths,
7.4 million were due to CHD and 6.7 million were due to stroke
(WHO 2017).
Many CVDs are preventable by addressing behavioural cardio-
vascular risk factors, the most important of which are unhealthy
diet, physical inactivity, tobacco use, and harmful use of alcohol
which in turn can affect markers of increased CVD risk such as
raised blood pressure, raised blood glucose, raised blood lipids,
and overweight and obesity (WHO 2017). Population-wide strate-
gies to address these behavioural risk factors and health policies
to create environments where healthy options are available and
affordable are recommended (WHO 2017). Other determinants
of atherosclerotic CVD include advancing age, hereditary factors,
gender, poverty, and psychological factors including stress and de-
1
pression (WHO 2011). Psychosocial stress has been shown to be
a risk factor for CVD (Dimsdale 2008; Merz 2002; O’Donnell
2010; Rosengren 2004; Yusuf 2004), and clusters with other be-
havioural risk factors such as smoking and increased consumption
of alcohol and unhealthy foods. As many of these risk factors are
related to lifestyle choices and are modifiable, they have become
the focus of CVD prevention strategies. It is estimated that as
much as 90% of the population-attributable risk for CHD (specif-
ically myocardial infarction) and stroke worldwide is accounted
for by contributions from nine modifiable risk factors: abnormal
cholesterol, raised blood pressure, diabetes mellitus, smoking, ex-
cessive alcohol intake, unhealthy diet, psychosocial stress, abdom-
inal obesity, and lack of physical activity (O’Donnell 2010; Yusuf
2004).
CHD, high blood pressure, and diabetes mellitus are also major
risk factors for heart failure. Heart failure occurs when there is
insufficient oxygen to meet the metabolic demands of the body,
resulting from a reduced ability of the heart to pump or fill with
blood, or both (DHDSP 2016; Fox 2001). Heart failure is a grow-
ing public health burden, where it is estimated that over 26 mil-
lion people worldwide are affected and the prevalence is increasing
(Savarese 2017). Mortality and morbidity associated with heart
failure are high even with advances in treatment and prevention,
and quality of life is poor (Savarese 2017). Reducing cardiovascu-
lar risk thus also impacts the numbers affected by heart failure.
Description of the intervention
Interventions incorporating meditation to address stress, anxiety,
and depression, and self management of chronic conditions, are
becoming popular for many health complaints and to enhance
wellbeing, yet the benefits of meditation were understood thou-
sands of years ago. Meditation is a contemplative practice that
originates from the world’s wisdom traditions, but interventions
are now commonly delivered in a secular context. There are many
types of meditation practice, but the most researched interventions
are mindfulness-based interventions (MBIs) and transcendental
meditation (TM).
MBIs in healthcare originate from the work of Jon Kabat Zinn
in the late 1970s and the development of his eight-week pro-
gramme of mindfulness-based stress reduction (MBSR) (Kabat-
Zinn 1990). This programme has been evaluated for a number of
conditions, for example chronic pain (Kabat-Zinn 1986) and anx-
iety (Kabat-Zinn 1992). MBSR has been informed by Buddhist
teachings but is taught in a secular context. MBSR has also in-
formed another well-researched intervention, mindfulness-based
cognitive therapy (MBCT) developed by Segal 2013 for the treat-
ment of depression. Mindfulness is most commonly defined as
“paying attention, in a particular way, on purpose, in the present
moment and non-judgementally” (Kabat-Zinn 1994). Mindful-
ness has also been described by a UK Mindfulness All Party Parlia-
mentary Group in the following way: “Mindfulness is best consid-
Meditation for the primary and secondary prevention of cardiovascular disease (Protocol)
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ered an inherent human capacity akin to language acquisition; a
capacity that enables people to focus on what they experience in the
moment, inside themselves as well as in their environment, with
an attitude of openness, curiosity and care” and has been defined as
“live in the moment, notice what is happening and make choices
in how you respond to your experience rather than being driven
by habitual reactions” (Breathworks 2019). Simply it means being
aware of our experience moment to moment, and with this aware-
ness comes choice. Other key aspects of many MBIs are compas-
sion practices for self and others, and in this respect mindfulness
has also been described as heartfulness: it is as much of the heart as
it is of the mind (Kabat-Zinn 1994; Williams 2007). Mindfulness
courses are typically eight weeks long, delivered by trained teach-
ers from their own mindfulness practice, and cover a series of for-
mal mediation practices including body scanning, mindfulness of
breathing, compassion practices, and informal practices of mind-
fulness of daily living including mindful movement (Burch 2013;
Hennessey 2016; Kabat-Zinn 1990; Segal 2013). The essential
components of MBIs, including teachers’ training and character-
istics, have been recently reviewed (Crane 2017). The expectation
of participants is home practice daily starting at a minimum of 10
minutes twice a day, which increases over the course of eight-week
programmes, with continued practice thereafter.
TM is described as a technique for inner peace and wellness, an
effortless practice which enables the mind and body to access a
special quality of rest (Transcendental Meditation® 2018). Tran-
scending means to go beyond the steps of the meditation practice
itself to an inner stillness. The technique is delivered by certified
teachers, trained in the techniques of the founder Maharishi Ma-
hesh. It is based on ancient Vedic teachings from India, which
were popularised and brought to the west by Maharishi Mahesh
in the late 1950s. Practitioners receive a personal mantra to repeat
silently to settle the mind inward, this is practiced for 15 or 20
minutes twice a day. Training in TM takes four days, personal in-
struction on day one and small group sessions days two to four to
consolidate the practice. TM distinguishes itself from other forms
of meditation that train the mind in some way, for example, in the
case of mindfulness, to be in the present moment. TM liberates
rather than trains the mind, allowing it to settle effortlessly into
a silence more profound than the present moment (Meditation
Trust). There is a considerable volume of research on the potential
benefits of TM and its standardised format has allowed compar-
isons between studies. A meta-analysis for example found benefi-
cial effects of TM for trait anxiety compared to alternative treat-
ments and care as usual, with larger effect sizes for those with
higher levels of anxiety at baseline (Orme-Johnson 2014).
How the intervention might work
There is extensive evidence to show a link between psychosocial
stress and CVD. Whilst psychosocial stress clusters with other
behavioural risk factors for CVD, independent associations are
2
seen for perceived stress (Richardson 2012), stress at work (general
work stress (Rosengren 2004), specifically job strain (Kuper 2003),
and an imbalance between effort and reward (Dragano 2017)),
stress at home, financial stress, stressful life events, and depression
(Rosengren 2004). Rosengren 2004 was a case control study con-
ducted over 52 countries and found that these differences were
consistent across different regions, in different ethnic groups, and
in both men and women. It is clear that stress is a trigger for CVD,
but less clear are the mechanisms by which this operates and these
may be complex and multifactorial (Dimsdale 2008; Merz 2002;
Rozanski 1999; Vale 2005).
There is evidence from systematic reviews to show that MBIs are
effective at reducing stress, anxiety, and depression (Fjorback 2011;
Janssen 2018; Khoury 2013; Khoury 2015), with modest results
for studies employing active control groups (Goyal 2014). There is
also a developing body of research demonstrating that MBIs could
have beneficial effects on other CVD risk factors (Fulwiler 2015).
For example, mindfulness training has been used for smoking ces-
sation (Brewer 2011), weight loss (Fulwiler 2015), and to reduce
blood pressure (Blom 2014). The possible mechanisms by which
MBIs could influence cardiovascular risk include attention con-
trol, emotional regulation, and self awareness (Fulwiler 2015). Few
studies have been conducted in patients with established CVD.
The effects of MBSR and MBCT have been examined in a system-
atic review of patients with vascular disease including hyperten-
sion, heart disease, and stroke. Some improvements were seen in
psychological outcomes in vascular disease patients but the effects
on physical outcomes were mixed (Abbott 2014). Another review
of MBIs in patients following transient ischaemic attack (TIA) or
stroke found very few studies and could draw no firm conclusions
(Lawrence 2013).
Similarly, there is evidence of beneficial effects of TM on psy-
chological distress (Orme-Johnson 2014), but positive effects are
less apparent in studies using active control groups (Goyal 2014).
There are a large number of studies looking at the effects of TM
on blood pressure. Overall beneficial effects have been seen in sys-
tematic reviews (e.g. Anderson 2008) but positive effects of TM
on blood pressure have been attributed to important methodolog-
ical weaknesses and bias (Canter 2004). A recent overview of eight
systematic reviews and meta-analyses finds a clear trend of increas-
ing evidence to support reductions in blood pressure with TM
but cautions that there are some conflicting findings and potential
risk of bias in many of the included RCTs (Ooi 2017). The ef-
fects of ambulatory blood pressure monitoring (ABPM) and non-
ABPM have been examined in response to both TM and other
forms of meditation (non-TM) where both interventions showed
reductions in blood pressure and smaller effect sizes with ABPM
(Shi 2017). Components of the metabolic syndrome, including
blood pressure, have been examined in a trial of TM compared
to health education as an active control in patients with stable
CHD. TM was found to have beneficial changes on systolic blood
pressure, insulin resistance, and heart rate variability compared to
Meditation for the primary and secondary prevention of cardiovascular disease (Protocol)
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
health education (Paul-Labrador 2006). A trial with long term
follow-up has shown reduced CVD clinical events and improve-
ments in psychological outcomes compared to health education
in Black patients with CHD (subjects were identified from the
African American Heart Health Registry) (Schneider 2012).
Two recent Cochrane Reviews have examined a range of psycho-
logical interventions for CHD (Richards 2017) and for diabetes
distress in adults with type 2 diabetes (Chew 2017). Richards 2017
looked at psychological interventions compared to usual care, de-
livered by trained staff and with a minimum follow-up of six
months. Only two of the 35 included studies examined medita-
tion. Chew 2017 looked at a range of psychological interventions,
and none of these focused on meditation (Chew 2017). Two fur-
ther systematic reviews have looked at mixed mind-body inter-
ventions for cardiac disease, including meditation. Younge 2015
found promising results in quality of life measures, psychological
measures, and blood pressure but reported overall low quality stud-
ies. Similarly, in heart failure patients, small to moderate effects
were seen in quality of life, exercise capacity, anxiety, depression,
blood pressure, and heart rate variability (Gok Metin 2018). Anx-
iety and depression often co-exist with long-term conditions such
as CVD, type 2 diabetes, and heart failure. Meditation could be
effective in addressing these co-morbidities, as well as potentially
affecting risk factors for CVD.
Why it is important to do this review
The 2017 scientific statement from the American Heart Associ-
ation (AHA) highlights the potential benefits of meditation on
CVD risk factors including psychosocial stress, blood pressure,
smoking, insulin resistance and the metabolic syndrome, subclin-
ical atherosclerosis, endothelial function, exercise capacity, and
the primary and secondary prevention of CVD (AHA 2017).
Their findings suggest possible benefits of meditation, although
the overall quality and sometimes quantity of studies is poor. Re-
search recommendations include use of randomised controlled tri-
als (RCTs), blinded outcome assessment, adequate power of stud-
ies, longer and more complete follow-up, and studies performed
by investigators without financial or intellectual bias (AHA 2017).
This Cochrane Review will update these findings, and will focus
on evidence from RCTs and assess risk of bias and overall quality
of contributing research.This is a rapidly expanding field and it
is important to synthesise the evidence of these potentially useful
interventions in a format that can be updated to further inform
guideline development and end user choice.
OBJECTIVES
To determine the effectiveness of meditation techniques, primarily
MBIs and TM, for the primary and secondary prevention of CVD
in adults at high risk and with established CVD.
3
METHODS
Criteria for considering studies for this review
Types of studies
We will include parallel-arm and cluster-RCTs. We will also in-
clude cross-over RCTs but will analyse only the first phase as a
parallel group design. We will include studies reported as full-text,
those published as abstract only, and unpublished data.
Types of participants
We will include adults (defined as ≥ 18 years of age) both at high
risk of, and with established CVD, to examine both primary and
secondary prevention.
form of meditation or different levels of intensity of the inter-
vention of interest will be excluded. We will exclude trials where
meditation is delivered alongside co-interventions unless the com-
parison group also receives the co-intervention, so the effects of
meditation alone can be determined.
We will not combine different meditation interventions and com-
parators in the main analysis as this will make interpretation of the
results difficult due to heterogeneity. Instead we plan to undertake
four main analyses:
• MBIs versus active comparators.
• MBIs versus non-active comparators.
• TM versus active comparators.
• TM versus non-active comparators.
Other meditation interventions that meet the inclusion criteria
but do not fit the above categories will be described narratively.
Types of outcome measures

Primary prevention
Adults identified as being at increased risk of CVD will exhibit Primary outcomes
one or more of the following risk factors as defined by the trial
authors: hypertension, abnormal cholesterol levels, overweight/ • CVD clinical events
obesity, smoking, impaired glucose control/type 2 diabetes. ◦ cardiovascular mortality
◦ myocardial infarction
◦ CABG
Secondary prevention ◦ PCI
Adults diagnosed with CVD as defined by the trial authors in- ◦ angina
cluding the following: experienced a myocardial infarction (MI); ◦ angiographically defined CHD
undergone a revascularisation procedure (coronary artery bypass ◦ stroke
graft (CABG) or percutaneous coronary intervention (PCI)); peo- ◦ TIA
ple with angina; people with angiographically defined CHD, cere- ◦ PVD.
brovascular disease including stroke and TIA, or peripheral vascu- • Blood pressure
lar disease (PVD). We will also include patients with heart failure ◦ systolic blood pressure
that has developed as a consequence of CVD where these can be ◦ diastolic blood pressure.
identified from other forms of heart failure, or form the majority • Validated measures of psychological distress (e.g. Beck
in mixed populations. Anxiety Inventory (Beck 1988) and Beck Depression Inventory
We will explore the effects of different populations on outcomes (Beck 1996), Centre for Epidemiological Studies - Depression
in subgroup analyses. Scale (CES-D; Radloff 1977), Patient Health Questionnaire-9
(PHQ-9; Spitzer 1999), Hospital Anxiety and Depression Scale
(HADS; Zigmond 1983), Generalized Anxiety Disorder 7
Types of interventions (GAD-7; Spitzer 2006)) and wellbeing (e.g. the Warwick-
We will include trials of meditation interventions, predominantly Edinburgh Mental Well-being Scale (WEMWBS; Tennant
MBIs and TM. We will also include other types of meditation 2007).
where the methods are adequately described. Multifactorial inter- • Adverse events (number of patients affected).
ventions will only be included where meditation is the main focus.
We will exclude interventions that comprise predominantly phys-
ical practices as well as meditation such as yoga, tai chi, and qigong Secondary outcomes
to avoid the confounding effects of physical activity on CVD out- • Individual CVD risk factors other than blood pressure
comes. We will include trials with any comparison group, for ex- including:
ample no intervention/wait list, usual care, attention control, or ◦ lipid levels (total cholesterol, LDL and HDL
alternative interventions. Trials where the comparison is another cholesterol, triglycerides, measured separately)

Meditation for the primary and secondary prevention of cardiovascular disease (Protocol) 4
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 ◦ glycaemic control (measures such as fasting blood
glucose and HbA1c, and the incidence of type 2 diabetes)
◦ body weight or body mass index (BMI), or both
◦ smoking rates.
• Validated measures of Quality of Life (QoL) (e.g. 36-item
short-form health survey (SF-36; Ware 1992)).
• Validated measures of coping, resilience, mastery (e.g. the
Self-Efficacy Scale (Sherer 1982), and self-management (e.g.
Self-Management Screening (SeMaS) tool (Eikelenboom 2015)).
Failure to report one or more of the outcomes listed here in the
trial is not an exclusion criterion for the review. Where a published
report does not appear to report one of these outcomes, we will
access the trial protocol and contact the trial authors to ascertain
whether the outcomes were measured but not reported. We will
include relevant trials that measure these outcomes but did not
report the data at all, or not in a usable format, in the review as
part of the narrative.
Search methods for identification of studies
Electronic searches
We will identify trials through systematic searches of the following
bibliographic databases:
• Cochrane Central Register of Controlled Trials
(CENTRAL) in the Cochrane Library.
• MEDLINE (Ovid, from 1946 onwards).
• Embase (Ovid, from 1980 onwards).
• PsycINFO (Ovid, 1806 onwards).
• CINAHL (Cumulative Index to Nursing and Allied Health
Literature) (EBSCO, 1937 onwards).
• AMED (Allied and Complementary Medicine Database)
(EBSCO, from inception onwards).
The preliminary search strategy for MEDLINE (Ovid) (Appendix
1) will be adapted for use in the other databases. The Cochrane
sensitivity-maximising RCT filter (Lefebvre 2011) will be applied
to MEDLINE (Ovid) and adaptations of it to the other databases,
except CENTRAL.
We will also conduct a search of ClinicalTrials.gov (
www.ClinicalTrials.gov) and the WHO International Clinical
Trials Registry Platform ( ICTRP) Search Portal ( http://
apps.who.int/trialsearch/) for ongoing or unpublished trials.
We will search all databases from their inception to the present,
and we will impose no restriction on language of publication or
publication status.
We will not perform a separate search for adverse effects of inter-
ventions. We will consider adverse effects described in included
studies only.
Meditation for the primary and secondary prevention of cardiovascular disease (Protocol)
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Searching other resources
We will check reference lists of all included studies and any relevant
systematic reviews identified for additional references to trials. We
will also examine any relevant retraction statements and errata for
included studies. We will contact authors for missing information
and details of ongoing trials.
Data collection and analysis
Selection of studies
Two review authors (of KR, RC, AT) will independently screen
titles and abstracts of all the potential studies we identify as a re-
sult of the search and will code them as either ‘retrieve’ (eligible
or potentially eligible/unclear) or ‘do not retrieve’. If there are any
disagreements, a third review author will arbitrate (EE). We will
retrieve the full-text study reports/publication and two review au-
thors (of KR, RC, AT) will independently screen the full-text and
identify studies for inclusion, and identify and record reasons for
exclusion of the ineligible studies. We will resolve any disagree-
ment through discussion or, if required, we will consult a third
review author (EE). We will identify and exclude duplicates and
collate multiple reports of the same study so that each study, rather
than each report, is the unit of interest in the review. We will record
the selection process in sufficient detail to complete a PRISMA
flow diagram and ‘Characteristics of excluded studies’ table.
Data extraction and management
We will use a data collection form for study characteristics and
outcome data which we will pilot on at least one study included in
the review. Two review authors (of KR, RC, AT) will extract study
characteristics from included studies. We will extract the following
study characteristics:
• Methods: study design, total duration of study, number of
study centres and location, study setting, and date of study.
• Participants: N randomised, N lost to follow-up/
withdrawn, N analysed, mean age, age range, gender, primary or
secondary prevention (at increased risk of CVD, or established
CVD), inclusion criteria, and exclusion criteria.
• Interventions: intervention, comparison, concomitant
treatments/medications.
• Outcomes: primary and secondary outcomes specified and
collected, and time points reported.
• Notes: funding for trial, and notable conflicts of interest of
trial authors.
Two review authors (of KR, RC, AT) will independently extract
outcome data from included studies. We will resolve disagreements
by consensus or by involving a third review author (EE). One
review author (KR) will transfer data into the Review Manager
5
5 file (RevMan 2014). We will double-check that data is entered
correctly by comparing the data presented in the systematic review
with the data extraction form. A second review author (RC or AT)
will spot-check study characteristics for accuracy against the trial
report.
Assessment of risk of bias in included studies
Two review authors (of KR, RC, AT) will independently asses the
risk of bias for each included study using the criteria outlined
in the Cochrane Handbook for Systematic Reviews of Interventions
(Higgins 2011). We will resolve any disagreements by discussion
or by involving another review author (EE). We will assess the risk
of bias according to the following domains.
• Random sequence generation.
• Allocation concealment.
• Blinding of participants and personnel.
• Blinding of outcome assessment.
• Incomplete outcome data.
• Selective outcome reporting.
• Other bias.
We will assess each potential source of bias as either high, low, or
unclear and will provide a quote from the study report together
with a justification for our judgment in the ‘Risk of bias’ table.
We will summarise the ‘Risk of bias’ judgements across different
studies for each of the domains listed. We expect blinding of par-
ticipants and personnel to be difficult to achieve and unlikely for
trials of meditation interventions. Where information on risk of
bias relates to unpublished data or correspondence with a trial au-
thor, we will note this in the ‘Risk of bias’ table.
Where we find cluster-randomised trials that meet the inclusion
criteria, we will follow the guidance in Section 16.3.2 of the
Cochrane Handbook for Systematic Reviews of Interventions (Higgins
2011), and will explore the following: recruitment bias, baseline
imbalance, loss of clusters, incorrect analysis, and comparability
with individually randomised trials.
When considering treatment effects, we will take into account the
risk of bias for the studies that contribute to that outcome.
Assessment of bias in conducting the systematic
review
We will conduct the review according to this published protocol
and report any deviations from it in the ‘Differences between pro-
tocol and review’ section of the systematic review.
Measures of treatment effect
We will analyse dichotomous data as risk ratios with 95% confi-
dence intervals (CIs). For continuous variables, we will compare
net changes (i.e. intervention group minus control group differ-
ences) and calculate mean differences (MD) and 95% CIs for each
Meditation for the primary and secondary prevention of cardiovascular disease (Protocol)
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
study. We will use the standardised mean difference (SMD) where
different scales have been used to measure the same outcome e.g.
quality of life, and test the robustness of using this and MD using
sensitivity analyses. Where possible, we will calculate the number
needed to treat for an additional beneficial or harmful outcome
(NNTB or NNTH) to aid the interpretation of findings. We will
enter data presented as a scale with a consistent direction of effect.
We will narratively describe skewed data reported as medians and
interquartile ranges.
Unit of analysis issues
Where we find cluster-randomised trials that meet the inclusion
criteria of the review, we will analyse these in accordance with
guidance in Section 16.3.2 of the Cochrane Handbook for System-
atic Reviews of Interventions (Higgins 2011). For trials with mul-
tiple arms we will divide the control group N by the number of
intervention arms to avoid double counting in meta-analyses. We
will analyse outcomes at the longest period of follow-up where
multiple measurements have been taken unless there is significant
(> 30%) attrition. We will explore the effects of very short (less
than 3 months), short term (3 to 6 months), and longer term
(greater than 6 months) follow-up in subgroup analyses if there
are sufficient data.
Dealing with missing data
We will contact investigators or study sponsors in order to verify
key study characteristics and obtain missing numerical outcome
data where possible (e.g. when a study is identified as abstract
only). Where standard deviations (SD) for outcomes are not re-
ported; other variance measures, such as standard errors and CIs,
are unavailable to derive SDs from; and we are unable to obtain
information from study authors; we will impute these following
the methods presented in the Cochrane Handbook for Systematic
Reviews of Interventions (Higgins 2011). Where studies do not re-
port results as change from baseline for continuous outcomes, we
will calculate this and the SD differences following the methods
presented in the Cochrane Handbook for Systematic Reviews of Inter-
ventions for imputing these (Section 16.1.3.2 Imputing standard
deviations for changes from baseline; Higgins 2011), and assume
a correlation of 0.5 between baseline and follow-up measures, as
suggested by Follman 1992.
Assessment of heterogeneity
We will use the I² statistic to measure heterogeneity among the tri-
als in each analysis. If we identify substantial heterogeneity (50%
to 90%), we will report it and explore possible causes by prespec-
ified subgroup analysis.
6
Assessment of reporting biases
If we are able to pool more than 10 trials, we will create and
examine a funnel plot to explore possible small study biases for
the primary outcomes.
Data synthesis
We will undertake meta-analyses only where this is meaningful i.e.
if the treatments, participants, and the underlying clinical question
are similar enough for pooling to make sense.
We will use a random-effects model as we cannot assume that all
studies in the meta-analysis are estimating the same intervention
effect, but rather are estimating intervention effects that follow a
distribution across studies.
‘Summary of findings’ table
We will create ‘Summary of findings’ tables using the following
outcomes: primary outcomes - CVD clinical events (cardiovascu-
lar mortality and non-fatal endpoints reported separately and de-
scribed in a narrative synthesis); systolic and diastolic blood pres-
sure; validated measures of psychological distress and wellbeing;
adverse events; and smoking rates. We will use the five GRADE
considerations (study limitations, consistency of effect, impreci-
sion, indirectness, and publication bias) to assess the quality of a
body of evidence as it relates to the studies that contribute data to
the meta-analyses for the prespecified outcomes. We will use meth-
ods and recommendations described in Section 8.5 and Chapter
12 of the Cochrane Handbook for Systematic Reviews of Interventions
(Higgins 2011), and will use GRADEpro software (GRADEPro
GDT 2015). We will create a separate ‘Summary of findings’ table
for each comparison (MBI vs active control, MBI vs non-active
control, TM vs active control, TM vs non-active control). We will
justify all decisions to downgrade the quality of the evidence using
footnotes and we will make comments to aid reader’s understand-
ing of the review where necessary.
Two review authors (KR, RC, or AT) will independently assess the
quality of the evidence. We will resolve any disagreements through
discussion or by consulting a third review author (EE). Judgements
will be justified, documented, and incorporated into reporting of
results for each outcome.
We plan to extract study data, format our comparisons in data
tables, and prepare a ‘Summary of findings’ table before writing
the results and conclusions of our review. A template ‘Summary
of findings’ table of one of our four main comparisons is in Table
1.
Subgroup analysis and investigation of heterogeneity
We plan to undertake the following subgroup analyses.
• By patient population: primary prevention (those at high
risk of CVD) and secondary prevention (those with established
CVD).
Meditation for the primary and secondary prevention of cardiovascular disease (Protocol)
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
• Nature and intensity of the meditation intervention.
• Nature and intensity of the comparator.
• Length of follow-up (less than 3 months, 3 to 6 months,
and greater than 6 months).
• Setting of the intervention (e.g. group, individual, online,
community, inpatient).
We will use the following outcomes in subgroup analyses.
• Blood pressure.
• Validated measures of psychological distress and wellbeing.
If there are sufficient studies we will explore heterogeneity for other
outcome measures.
We will use the formal test for subgroup interactions in Review
Manager 5 (RevMan 2014).
Sensitivity analysis
We plan to carry out the following sensitivity analyses.
• Only including studies with a low risk of bias. We will
define this as: low risk in at least four domains, but will not
include blinding of participants and personnel which is difficult
and therefore unlikely in the trials of interest. For most outcomes
of interest, important domains are adequate randomisation and
concealment, blinding of outcome assessors, attrition, and
selective reporting.
• Only including studies where there are no conflicts of
interest e.g. funding source of trials.
• Testing the robustness of using SMD or MD where
appropriate.
• Testing the robustness of the results by repeating the
analyses using different statistical models (fixed-effect and
random-effects models).
• Restricting the analyses to published peer reviewed trials.
Reaching conclusions
We will base our conclusions only on findings from the quantita-
tive or narrative synthesis of included studies for this review. We
will avoid making recommendations for practice and our impli-
cations for research will suggest priorities for future research and
outline what the remaining uncertainties are in the area.
ACKNOWLEDGEMENTS
This is a new review and supersedes a Cochrane Review on TM
for the primary prevention of cardiovascular disease. The scope of
this new review has broadened considerably and will include other
meditation interventions, notably MBIs, and will also examine
the effects of these interventions in those with established heart
disease and those at risk.
7
We acknowledge the contributions of Louise Hartley, Angelique
Mavrodaris and Nadine Flowers, who were authors on the original
review team.
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∗
Indicates the major publication for the study

ADDITIONAL TABLES
Table 1. ’Summary of findings’ table

For example: mindfulness compared with active control for the primary and secondary prevention of CVD (there will be a
separate table for each of the 4 main comparisons)

Patient or population: participants at high risk or with established CVD

Settings: community
Intervention: mindfulness
Comparison: active control

Outcomes Illustrative comparative risks* (95% CI) Relative effect No of Participants Quality of the evi-
(95% CI) (studies) dence
(GRADE)
Assumed risk Corresponding
risk

Active control mindfulness

CVD clinical end- Narrative summary ⊕

points very low
(reported separately ⊕⊕
and described in a low
narrative synthesis) ⊕⊕⊕
(median/range of moderate
follow-up) ⊕⊕⊕⊕
high

Systolic blood pres- The mean [out- The mean [out- [value] ⊕
sure (mmHg) come] ranged across come] in the inter- ([value]) very low
, change from base- control groups from vention groups was ⊕⊕
line [value][measure] [value] [lower/ low
(median/range of

Meditation for the primary and secondary prevention of cardiovascular disease (Protocol) 11
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 1. ’Summary of findings’ table (Continued)

follow-up) higher] ⊕⊕⊕

[(value to value moderate
lower/higher)] ⊕⊕⊕⊕
high

Diastolic blood The mean [out- The mean [out- [value] ⊕

pressure (mmHg), come] ranged across come] in the inter- ([value]) very low
change from base- control groups from vention groups was ⊕⊕
line [value][measure] [value] [lower/ low
(median/range of higher] ⊕⊕⊕
follow-up) [(value to value moderate
lower/higher)] ⊕⊕⊕⊕
high

Validated measures The mean [out- The mean [out- [value] ⊕

of psychological dis- come] ranged across come] in the inter- ([value]) very low
tress, change from control groups from vention groups was ⊕⊕
baseline [value][measure] [value] [lower/ low
(median/range of higher] ⊕⊕⊕
follow-up) [(value to value moderate
lower/higher)] ⊕⊕⊕⊕
high

Val- The mean [out- The mean [out- [value] ⊕

idated measures of come] ranged across come] in the inter- ([value]) very low
psychological well- control groups from vention groups was ⊕⊕
being, change from [value][measure] [value] [lower/ low
baseline higher] ⊕⊕⊕
(median/range of [(value to value moderate
follow-up) lower/higher)] ⊕⊕⊕⊕
high

Adverse events [value] per 1000 [value] per 1000 RR (95% CI) [value] ⊕
(number of partici- ([value] to [value]) ([value]) very low
pants affected) ⊕⊕
(median/range of low
follow-up) ⊕⊕⊕
moderate
⊕⊕⊕⊕
high

Smoking rates [value] per 1000 [value] per 1000 RR (95% CI) [value] ⊕
(median/range of ([value] to [value]) ([value]) very low
follow-up) ⊕⊕
low
⊕⊕⊕
moderate
⊕⊕⊕⊕
high

Meditation for the primary and secondary prevention of cardiovascular disease (Protocol) 12
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Table 1. ’Summary of findings’ table (Continued)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk
(and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
Abbreviations: CI: confidence interval; CVD: cardiovascular disease; RR: risk ratio

GRADE Working Group grades of evidence

High quality: further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: further research is likely to have an important impact on our confidence in the estimate of effect and may change
the estimate.
Low quality: further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to
change the estimate.
Very low quality: we are very uncertain about the estimate.

APPENDICES

Appendix 1. Preliminary MEDLINE (Ovid) search strategy

1 Meditation/
2 meditat*.ti,ab,kf.
3 Mindfulness/
4 mindful*.ti,ab,kf.
5 (MBCT or MBSR).ti,ab,kf.
6 1 or 2 or 3 or 4 or 5
7 exp Cardiovascular Diseases/
8 exp Pulmonary Embolism/
9 cardio*.ti,ab,kf.
10 cardia*.ti,ab,kf.
11 heart*.ti,ab,kf.
12 coronary*.ti,ab,kf.
13 angina*.ti,ab,kf.
14 ventric*.ti,ab,kf.
15 myocard*.ti,ab,kf.
16 pericard*.ti,ab,kf.
17 (ischaem* or ischem*).ti,ab,kf.
18 emboli*.ti,ab,kf.
19 arrhythmi*.ti,ab,kf.
20 thrombo*.ti,ab,kf.
21 atrial fibrillat*.ti,ab,kf.
22 tachycardi*.ti,ab,kf.
23 endocardi*.ti,ab,kf.
24 (sick adj sinus).ti,ab,kf.
25 exp Stroke/
26 (stroke or stokes).ti,ab,kf.
27 cerebrovasc*.ti,ab,kf.
28 cerebral vascular.ti,ab,kf.
Meditation for the primary and secondary prevention of cardiovascular disease (Protocol) 13
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
29 apoplexy.ti,ab,kf.
30 (brain adj2 accident*).ti,ab,kf.
31 ((brain* or cerebral or lacunar) adj2 infarct*).ti,ab,kf.
32 exp Hypertension/
33 hypertensi*.ti,ab,kf.
34 peripheral arter* disease*.ti,ab,kf.
35 exp Vascular Stiffness/
36 exp Plaque, Atherosclerotic/
37 ((high or increased or elevated) adj2 blood pressure).ti,ab,kf.
38 exp Hyperlipidemias/
39 hyperlipid*.ti,ab,kf.
40 (hyperlipaemia* or hyperlipemia*).ti,ab,kf.
41 hypercholesterol*.ti,ab,kf.
42 (hypercholesteraemia* or hypercholesteremia*).ti,ab,kf.
43 (hyperlipoproteinaemia* or hyperlipoproteinemia*).ti,ab,kf.
44 (hypertriglyceridaemia* or hypertriglyceridemia*).ti,ab,kf.
45 exp Arteriosclerosis/
46 exp Cholesterol/
47 cholesterol.ti,ab,kf.
48 coronary risk factor*.ti,ab,kf.
49 Blood Pressure/
50 blood pressure.ti,ab,kf.
51 ((blood or venous or arterial) adj2 (clot* or emboli* or thrombo*)).ti,ab,kf.
52 exp Diabetes Mellitus/
53 diabet*.ti,ab,kf.
54 exp Hyperglycemia/
55 (hyperglycaemi* or hyperglycemi*).ti,ab,kf.
56 (glucose adj2 intoleran*).ti,ab,kf.
57 Insulin Resistance/
58 insulin resistan*.ti,ab,kf.
59 (metabolic adj3 syndrome).ti,ab,kf.
60 (dysmetabolic adj3 syndrome).ti,ab,kf.
61 or/7-60
62 6 and 61
63 randomized controlled trial.pt.
64 controlled clinical trial.pt.
65 randomized.ab.
66 placebo.ab.
67 drug therapy.fs.
68 randomly.ab.
69 trial.ab.
70 groups.ab.
71 63 or 64 or 65 or 66 or 67 or 68 or 69 or 70
72 exp animals/ not humans.sh.
73 71 not 72
74 62 and 73

Meditation for the primary and secondary prevention of cardiovascular disease (Protocol) 14
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
CONTRIBUTIONS OF AUTHORS
We have discussed the scope of the review extensively with the Cochrane Heart Group editorial team and this protocol has been
externally peer reviewed.
Karen Rees wrote the protocol following a template provided by the Cochrane Heart Group to adhere to MECIR standards.
Rachel Court performed an initial scoping exercise to inform the Background of the protocol, developed the search strategy, and
provided critical comments on the draft protocol.
Andrea Takeda provided critical comments on the draft protocol.
Edzard Ernst provided critical comments on the draft protocol.

DECLARATIONS OF INTEREST
Karen Rees is an accredited Breathworks mindfulness teacher, as well as a methodologist. This provides additional subject expertise and
is not regarded as a conflict of interest (no benefits in cash or kind), but is declared here in the interests of transparency.
Rachel Court has no known conflicts of interest.
Andrea Takeda has no known conflicts of interest.
Edzard Ernst has no known conflicts of interest.

SOURCES OF SUPPORT

Internal sources
• Warwick Medical School, University of Warwick, UK.
• Complementary Medicine, Peninsula Medical School, Exeter, UK.

External sources
• This project was supported by the National Institute for Health Research (NIHR), via Cochrane Infrastructure funding to the
Cochrane Heart Group. The views and opinions expressed therein are those of the review authors and do not necessarily reflect those
of the Systematic Reviews Programme, the NIHR, the NHS or the Department of Health, UK.

NOTES
This is a protocol to a new Cochrane Review, which supersedes the Cochrane Review on TM for the primary prevention of cardiovascular
disease. The scope of this new review has broadened considerably and will include other meditation interventions, notably MBIs, and
will also examine the effects of these interventions in those with established heart disease and those at risk.

Meditation for the primary and secondary prevention of cardiovascular disease (Protocol) 15
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