Meditation Intervention Reviews

Abstract

A recent publication on the effects of Meditation programs against stress reviews rigorously randomized clinical trials (RCTs) with active control groups. We would like to point out a couple of unsolved issues that may arise when discussing the impact of these findings.
The review has only collated evidence from RCTs with active control groups. Randomized clinical trials can only be done, by definition, with patients and individuals who are willing to
be randomized. Thereby such trials are excluding the potentially most beneficial therapeutic agent: conscious choice and active engagement. Thus, by default, RCTs can only test and describe what is the minimum effect on people who use a certain intervention, as if it were delivered to them as a passive recipient, like a medication. But meditation is no medication. It requires active involvement and the decision to dedicate regularly a specific amount of time, over a larger period in order to change one's habits and attitudes. This can only be assessed in long-term comparative cohort studies that in other conditions and occasions have shown reliable results comparable toRCTs. Against active treatments this meta-analysis showed no effect. We find that this part of the analysis did not represent studies adequately. For instance, two studies regarding mindfulness-based cognitive therapy for depression relapse prevention were not included, likely because they used treatment as usual as a control, which was an exclusion criterion. Why should, in a condition like recurrent depression, where any treatment is very difficult and has in fact not worked, be treatment as usual be an inadequate control and hence studies be excluded?
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4. Bank AJ, Obetz C, Konrardy A, et al. Impact of scribes on patient interaction,
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COMMENT & RESPONSE
Meditation Intervention Reviews
To the Editor We appreciated the meta-analysis by Goyal and
colleagues
1
concerning the benefits of meditation for psycho-
logical health. This review reflects a growing scientific inter-
est in health applications for meditation therapies. As au-
thors active in National Institutes of Health– and Department
of Defense–sponsored meditation research, we offer several
observations that may assist readers in placing these results
into a broader context.
We commend the authors’ inclusion of only randomized
clinical trials (RCTs) with active controls. However, the re-
view by Goyal et al
1
demonstrates the profound effect of rela-
tively subtle decisions about study inclusion criteria for par-
ticipants with “a clinical condition” or “stressed populations.”
1
In contrast, a 2013 meta-analysis of transcendental medita-
tion (TM)
2
identified 10 RCTs on anxiety with active controls
(vs 3 in the review by Goyal et al
1
), with results showing sig-
nificant effects of TM on anxiety that were not found by Goyal
et al. This suggests that different meta-analyses of high-
quality studies can arrive at different conclusions based on au-
thors’ selection of studies (see also the meditation review by
Sedlmeier et al,
3
2012).
Goyal et al
1
restricted their review to psychological out-
comes and did not include other important clinical out-
comes. Given their inclusion criteria, we find this a major limi-
tation in design. The American Heart Association (AHA)
published in 2013 its systematic review of RCTs of meditation
for high blood pressure and reported that “TM may be con-
sidered in clinical practice to lower BP,” and because of nega-
tive or insufficient studies, “other meditation techniques are
not recommended in clinical practice to lower BP at this
time.”
4(p1365)
The AHA statement also reports RCT data show-
ing reduced rates of mortality and cardiovascular disease events
associated with TM practice.
5
We would like to reinforce the authors’ limitations con-
cerning the mixed design quality of the meditation trials. Fu-
ture meditation research would benefit from a systematic cat-
egorization of meditation techniques, taking into account the
distinctiveness of widely used techniques, quality assurance
(certification) of treatment providers, and the regularity of prac-
tice by participants.
The authors refer to the important question of noninferi-
ority of meditation to standard treatments.We believe that this
is a critical direction for future meditation research. Studies
investigating the comparative effectiveness of meditation
therapies to more established treatments are crucial next steps
for establishing meditation as bona fide treatments.
Thomas Rutledge, PhD
Paul Mills, PhD
Robert Schneider, MD
Author Affiliations: Psychology Service, Department of Veterans Affairs San
Diego Healthcare System, San Diego (Rutledge); Department of Psychiatry,
University of California, San Diego (Rutledge, Mills); Maharishi University of
Management, Institute for Natural Medicine and Prevention, Maharishi Vedic
City,Iowa (Schneider).
Corresponding Author: Thomas Rutledge, PhD, ABPP, Psychology Service, Mail
Code 116B, VA San Diego Healthcare System, 3350 La Jolla Village Dr, San Diego,
CA 92161 (thomas.rutledge@va.gov).
Conflict of Interest Disclosures: None reported.
1. Goyal M, Singh S, Sibinga EM, et al. Meditation programs for psychological
stress and well-being: a systematic review and meta-analysis. JAMA Intern Med.
2014;174(3):357-368.
2. Orme-Johnson DW, Barnes VA. Effects of the transcendental meditation
technique on trait anxiety: a meta-analysis of randomized controlled trials.
J Altern Complement Med. 2013;19(10):1-12.
3. Sedlmeier P, Eberth J, Schwarz M, et al. The psychological effects of
meditation: a meta-analysis. Psychol Bull. 2012;138(6):1139-1171.
4. Brook RD, Appel LJ, Rubenfire M, et al; American Heart Association
Professional Education Committee of the Council for High Blood Pressure
Research, Council on Cardiovascular and Stroke Nursing, Council on
Epidemiology and Prevention, and Council on Nutrition, Physical Activity.
Beyond medications and diet: alternative approaches to lowering blood
pressure: a scientific statement from the American Heart Association.
Hypertension. 2013;61(6):1360-1383.
5. Schneider RH, Grim CE, Rainforth MV, et al. Stress reduction in the secondary
prevention of cardiovascular disease: randomized, controlled trial of
transcendental meditation and health education in Blacks. Circ Cardiovasc Qual
Outcomes. 2012;5(6):750-758.
To the Editor A recent publication on the effects of meditation
programs against stress
1
reviews rigorously randomized clini-
cal trials (RCTs) with active control groups. We would like to
point out a couple of unsolved issues that may arise when dis-
cussing the impact of these findings.
The review has only collated evidence from RCTs with ac-
tive control groups. Randomized clinical trials can only be done,
by definition, with patients and individuals who are willing to
be randomized. Thereby such trials are excluding the poten-
tially most beneficial therapeutic agent: conscious choice and
active engagement. Thus, bydef ault, RCTs can only test and de-
scribe what is the minimum effect on people who use a certain
intervention, as if it were delivered to them as a passive recipi-
ent, like a medication. But meditation is no medication. It re-
quires active involvement and the decision to dedicate regu-
larly a specific amount of time, over a larger period in order to
change one's habits and attitudes. This can only be assessed in
long-term comparative cohort studies that in other conditions
and occasions have shown reliable results comparable to RCTs.
2
Against active treatments this meta-analysis showed no
effect. We find that this part of the analysis did not represent
studies adequately. For instance, 2 studies regarding mindful-
ness-based cognitive therapy for depression relapse
prevention
3,4
were not included, likely because they used treat-
ment as usual as a control, which was an exclusion criterion.
Why should, in a condition like recurrent depression, where
any treatment is very difficult and has in fact not worked, be
treatment as usual be an inadequate control and hence stud-
ies be excluded?
Letters
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In another actively controlled trial of mindfulness-based
stress reduction,
5
the control was designed to match the treat-
ment. It was equal in dose and time spent and included in-
tense teaching and practicing of progressive muscle relax-
ation and special stretching exercises. The authors rated this
as “nonspecific attention control” not as an “active control,”
although they give progressive muscle relaxation as one ex-
ample what would qualify as an “active control.”
The methodological quality of studies was rated accord-
ing to standard criteria, which also included allocation con-
cealment. Thereby the highest level can only be achieved by
blinding the meditating patients toward the fact that they are
meditating. This is of course impossible and shows once more
that what makes sense from a pharmacological point of view
does not necessarily apply to trials where patients are seen as
active motivated agents with respect to their health.
Harald Walach, PhD
Stefan Schmidt, PhD
Tobias Esch, MD
Author Affiliations: Institute for TransculturalHealth Studies, European
University Viadrina, Frankfurt (Oder), Germany (Walach, Schmidt); Department
for Psychosomatic Medicine and Psychotherapy, University Medical Center
Freiburg, Freiburg, Germany (Schmidt); Division of GeneralMedicine and
Primary Care, Beth Israel Deaconess Medical Center, Harvard Medical School,
Boston, Massachusetts (Esch); Neuroscience Research Institute, State
University of New York College at Old Westbury, Old Westbury (Esch); Division
of Integrative Health Promotion, Coburg University of Applied Sciences,
Coburg, Germany (Esch).
Corresponding Author: Stefan Schmidt, PhD, Department of Psychosomatic
Medicine and Psychotherapy, University Medical Center Freiburg, Hauptstr 8,
79104 Freiburg, Germany (stefan.schmidt@uniklinik-freiburg.de).
Conflict of Interest Disclosures: None reported.
Additional Contribution: We acknowledge Martin Offenbächer,MD,
Ludwigs-Maximilians University Munich, Munich, Germany, who gave the first
impulse for this letter, and NikoKohls, PhD, Coburg University of Applied
Sciences, Coburg, Germany, who contributed to an earlier draft.
1. Goyal M, Singh S, Sibinga EM, et al. Meditation programs for psychological
stress and well-being: a systematic review and meta-analysis. JAMA Intern Med.
2014;174(3):357-368.
2. Concato J. Is it time for medicine-based evidence? JAMA. 2012;307(15):1641-
1643.
3. Teasdale JD, Segal ZV, Williams JMG, Ridgeway VA, Soulsby JM, Lau MA.
Prevention of relapse/recurrence in major depression by mindfulness-based
cognitive therapy. J Consult Clin Psychol. 2000;68(4):615-623.
4. Ma SH, Teasdale JD. Mindfulness-based cognitive therapy for depression:
replication and exploration of differential relapse prevention effects. J Consult
Clin Psychol. 2004;72(1):31-40.
5. Schmidt S, Grossman P, Schwarzer B, Jena S, Naumann J, Walach H. Treating
fibromyalgia with mindfulness-based stress reduction: results from a 3-armed
randomized controlled trial. Pain. 2011;152(2):361-369.
Tothe Editor I read with appreciation the meta-analysis by Goyal
et al
1
that summarized evidence for effects of meditation pro-
grams on psychological stress and well-being. It restricted stud-
ies to randomized clinical trials that used active control groups.
The review was nicely done; however, I am concerned it ex-
cluded studies with certain types of existing practice control
groups such as usual care control groups. This decision was
in juxtaposition to the 2009 Institute of Medicine report, titled
“Initial National Priorities for Comparative Effectiveness
Research,”
2(p6)
that recommended to “Compare the effective-
ness of mindfulness-based interventions (eg, yoga, medita-
tion, deep breathing training) and usual care in treating anxi-
ety and depression, pain, cardiovascular risk factors, and
chronic diseases.”
Goyal et al
1(p358)
stated that “clinicians need to know
whether meditation training has beneficial effects beyond self-
selection biases and the nonspecific effects of time, attention
and expectations for improvement.” Controlling for attention
is done in explanatory trials to evaluate if effects of interven-
tions occur over and above the attention that participants re-
ceive from meditation intervention providers or fellow group
members. However, for pragmatic trials on meditation inter-
ventions (and many other types of behavioral interventions),
attention and its related social support may not be a rival ex-
planation for effects of meditation programs. Attention and
group support within meditation practice groups may be im-
portant components of meditation training and for providing
continued meditation practice support afterwards, similar to
behavioral change programs for alcohol abstinence (eg, Alco-
holics Anonymous) and weight loss (eg, Weight Watchers).
3
Freedland et al
4(p331)
stated the following:
The assumption that it is always necessary to control for at-
tention in psychotherapy or behavioral intervention trials rests
on the questionable premise that attention is always a threat to
internal validity. It is a genuine threat to the internal validity
of standard drug trials because they are designed to answer ques-
tions about chemical compounds, not about their clinical deliv-
ery. Psychotherapy differs from pharmacotherapy in that clini-
cal attention is an integral component of psychotherapy, not
something that is coadministered with it.
It is important to show results for trials that have usual care
control groups, in addition to nonspecific and specific active
control groups, because this provides pragmatic evidence on
whether meditation interventions in their entirety are useful
compared with the care that community members typically
receive. This is what was recommended by the aforemen-
tioned Institute of Medicine report.
2
It is a question that many
community members have, and may ask for advice on from
physicians.
Eric B. Loucks, PhD
Author Affiliation: Department of Epidemiology, Brown University School of
Public Health, Providence, Rhode Island.
Corresponding Author: Eric B. Loucks, PhD, Department of Epidemiology,
Brown University School of Public Health, 121 S Main St, Providence, RI 02906
(eric.loucks@brown.edu).
Conflict of Interest Disclosures: None reported.
1. Goyal M, Singh S, Sibinga EM, et al. Meditation programs for psychological
stress and well-being: a systematic review and meta-analysis. JAMA Intern Med.
2014;174(3):357-368.
2. Institute of Medicine, Committee on Comparative Effectiveness Research
Prioritization. Initial National Priorities for Comparative EffectivenessResearch.
Washington, DC: The National Academies Press; 2009.
3. Mantzios M, Giannou K. Group vs single mindfulness meditation: exploring
avoidance, impulsivity,and weight management in two separate mindfulness
meditation settings [published online February 28, 2014]. Appl Psychol Health
Well Being. doi:10.1111/aphw.12023.
Letters
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4. Freedland KE, Mohr DC, Davidson KW,Schwartz JE. Usual and unusual care:
existing practice control groups in randomized controlled trials of behavioral
interventions. Psychosom Med. 2011;73(4):323-335.
In Reply Walach et al suggest that randomized clinical trials
(RCTs) should not be used to evaluate meditation programs.
While we agree that cohort studies provide valuable informa-
tion, we disagree with the rationale that conscious choice and
active engagement are eliminated in RCTs. Individuals make
a conscious choice to join meditation trials, and since medi-
tation requires engagement by the participant, it cannot be-
come a passive activity merely by the act of randomization any
more than exercise could. Both cohort studies and RCTs
have inherent strengths and weaknesses in terms of gener-
alizability and the extent to which “causal” conclusions can
be drawn. Cohort studies are useful early in establishing
short- and long-term outcomes of a risk or risk reduction
factor. Randomized clinical trials then provide evidence as
to the “causal” role of this factor through manipulating, ide-
ally, only the factor of interest. The Institute of Medicine
report cited by Dr Loucks makes a point of this value of
RCTs.
1
Following high-quality RCTs, cohort studies can fur-
ther establish the circumstances that optimize and promote
engagement over long periods.
Our review only included trials with an “active control.”
The main purpose of nonspecific active controls (Figure 1A in
our article
2
) is to control for nonspecific effects. Specific ac-
tive controls (Figure 1B in our article
2
) are comparisons with a
known therapy. Schmidt et al,
3(p362)
while using some progres-
sive muscle relaxation, described the control as “an active con-
trol intervention aimed at equating the nonspecific features
of MBSR [mindfulness-based stress reduction],” rather than as
a specific comparison with progressive muscle relaxation it-
self. Therefore we categorized it as a nonspecific (but active)
control.
A clarification: Allocation concealment refers to the pro-
tection of the randomization process, can be accomplished in
unblinded trials, and should not be confused with blinding.
4,5
Our rating criteria did not assess double blinding but did
assess single blinding of outcome assessors as a quality
criterion.
Regarding usual care controls, many of the outcomes of
interest were symptoms such as anxiety that are not rou-
tinely addressed in usual care in the same manner that blood
pressure or cholesterol are managed. Therefore, relying on
usual care as a benchmark may not provide a rigorous test of
an intervention, particularly when the outcomes are self-
reported. The choice of control also depends on the question
one is trying to answer. Numerous reviews have already shown
the positive effects of meditation programs compared with
usual care, and we did not wish to replicate these. Instead, we
sought to understand the effects of these programs beyond
nonspecific effects such as time and attention. These are im-
portant questions to answer if we wish to know the extent and
mechanisms through which meditation operates. While at-
tention and group support may be important components of
any behavioral intervention, they have not been advocated as
a primary means by which meditation programs work.
6
We agree with Rutledgeet al that different meta-analyses
with different inclusion criteria can lead to different conclu-
sions. We also agree itis important to perform a systematic re-
view of biological outcomes of meditation programs, which
would require much additional effort beyond what was pos-
sible within the scope of our funded project.
Madhav Goyal, MD, MPH
Eric B. Bass, MD, MPH
Jennifer A. Haythornthwaite, PhD
Author Affiliations: Department of Medicine, Johns Hopkins University,
Baltimore, Maryland (Goyal, Bass); Department of Health Policy and
Management, Johns Hopkins School of Public Health, Baltimore, Maryland
(Bass); Department of Psychiatry and Behavioral Services, Johns Hopkins
University,Baltimore, Maryland (Haythornthwaite).
Corresponding Author: Madhav Goyal, MD, MPH, Department of Medicine,
Johns Hopkins University,2024 E Monument St, Ste 1-500W, Baltimore, MD
21287 (madhav@jhmi.edu).
Conflict of Interest Disclosures: None reported.
1. Institute of Medicine, Committee on Comparative Effectiveness Research
Prioritization. Initial National Priorities for Comparative EffectivenessResearch.
Washington, DC: National Academies Press; 2009.
2. Goyal M, Singh S, Sibinga EM, et al. Meditation programs for psychological
stress and well-being: a systematic review and meta-analysis. JAMA Intern Med.
2014;174(3):357-368.
3. Schmidt S, Grossman P, Schwarzer B, Jena S, Naumann J, Walach H. Treating
fibromyalgia with mindfulness-based stress reduction: results from a 3-armed
randomized controlled trial. Pain. 2011;152(2):361-369.
4. Sedgwick P.Allocation concealment. BMJ. 2012;344:e156.
5. Viera AJ, Bangdiwala SI. Eliminating bias in randomizedcontrolled trials:
importance of allocation concealment and masking. Fam Med. 2007;39(2):132-
137.
6. MacCoon DG, Imel ZE, Rosenkranz MA, et al. The validation of an active
control intervention for mindfulness based stress reduction (MBSR). Behav Res
Ther. 2012;50(1):3-12.
Assessing the Clinical Impact
of Appropriate Echocardiograms
Tothe Editor Appropriate use criteria (AUC) were created by the
American College of Cardiology and subspecialty societies with
the goal of providing health care practitioners and reimburse-
ment agencies a rational approach to the use of diagnostic
imaging in the delivery of high-quality care.
1
In a recent issue
of JAMA Internal Medicine, Matulevicius and colleagues
2
pre-
sent novel data regarding the association of AUC classifica-
tion and clinical impact of transthoracic echocardiography
(TTE). They conclude that despite a high prevalence of appro-
priate TTEs (approximately 92%), only one-third of TTEs re-
sulted in an active change in clinical care. Findings from this
study have generated discussion in the echocardiography com-
munity and resulted in a response statement from the Ameri-
can Society of Echocardiography.
3
We agree thatattempting to identify the clinical impact of
appropriate vs inappropriate TTEs is of great importance and
may help validate—or fail to validate—the use of AUC. How-
ever, a retrospective review of the electronic medical record
is limited by the challenge of distinguishing whether TTE re-
sults did not affect care or whether a lack of determination in
the electronic medical record made that appear to be the case.
Letters
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