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Meditation Programs for Psychological Stress and Well-being A Systematic Review and Meta-analysis Madhav Goyal, MD, MPH; Sonal Singh, MD, MPH; Erica M. S. Sibinga, MD, MHS; Neda F. Gould, PhD; Anastasia Rowland-Seymour, MD; Ritu Sharma, BSc; Zackary Berger, MD, PhD; Dana Sleicher, MS, MPH; David D. Maron, MHS; Hasan M. Shihab, MBChB, MPH; Padmini D. Ranasinghe, MD, MPH; Shauna Linn, BA; Shonali Saha, MD; Eric B. Bass, MD, MPH; Jennifer A. Haythornthwaite, PhD

IMPORTANCE Many people meditate to reduce psychological stress and stress-related health problems. To counsel people appropriately, clinicians need to know what the evidence says about the health benefits of meditation.

OBJECTIVE To determine the efficacy of meditation programs in improving stress-related outcomes (anxiety, depression, stress/distress, positive mood, mental health–related quality of life, attention, substance use, eating habits, sleep, pain, and weight) in diverse adult clinical populations.

EVIDENCE REVIEW We identified randomized clinical trials with active controls for placebo effects through November 2012 from MEDLINE, PsycINFO, EMBASE, PsycArticles, Scopus, CINAHL, AMED, the Cochrane Library, and hand searches. Two independent reviewers screened citations and extracted data. We graded the strength of evidence using 4 domains (risk of bias, precision, directness, and consistency) and determined the magnitude and direction of effect by calculating the relative difference between groups in change from baseline. When possible, we conducted meta-analyses using standardized mean differences to obtain aggregate estimates of effect size with 95% confidence intervals.

FINDINGS After reviewing 18 753 citations, we included 47 trials with 3515 participants. Mindfulness meditation programs had moderate evidence of improved anxiety (effect size, 0.38 [95% CI, 0.12-0.64] at 8 weeks and 0.22 [0.02-0.43] at 3-6 months), depression (0.30 [0.00-0.59] at 8 weeks and 0.23 [0.05-0.42] at 3-6 months), and pain (0.33 [0.03- 0.62]) and low evidence of improved stress/distress and mental health–related quality of life. We found low evidence of no effect or insufficient evidence of any effect of meditation programs on positive mood, attention, substance use, eating habits, sleep, and weight. We found no evidence that meditation programs were better than any active treatment (ie, drugs, exercise, and other behavioral therapies).

CONCLUSIONS AND RELEVANCE Clinicians should be aware that meditation programs can result in small to moderate reductions of multiple negative dimensions of psychological stress. Thus, clinicians should be prepared to talk with their patients about the role that a meditation program could have in addressing psychological stress. Stronger study designs are needed to determine the effects of meditation programs in improving the positive dimensions of mental health and stress-related behavior.

JAMA Intern Med. 2014;174(3):357-368. doi:10.1001/jamainternmed.2013.13018 Published online January 6, 2014.

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Author Affiliations: Department of Medicine, The Johns Hopkins University, Baltimore, Maryland (Goyal, Singh, Rowland-Seymour, Berger, Ranasinghe, Bass); Department of Pediatrics, The Johns Hopkins University, Baltimore, Maryland (Sibinga, Saha); Department of Psychiatry and Behavioral Services, The Johns Hopkins University, Baltimore, Maryland (Gould, Sleicher, Haythornthwaite); Department of Health Policy and Management, Johns Hopkins School of Public Health, Baltimore, Maryland (Sharma, Maron, Shihab, Linn, Bass).

Corresponding Author: Madhav Goyal, MD, MPH, Department of Medicine, The Johns Hopkins University, 2024 E Monument St, Ste 1-500W, Baltimore, MD 21287 ([email protected]).

Research

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M any people use meditation to treat stress and stress-related conditions and to promote general health.1,2To counsel patients appropriately, clinicians need to know more about meditation programs and how they can affect health outcomes. Meditation training programs vary in sev- eral ways, including the type of mental activity promoted, the amount of training recommended, the use and qualifications of an instructor, and the degree of emphasis on religion or spiri- tuality. Some meditative techniques are integrated into a broader alternative approach that includes dietary and/or movement therapies (eg, ayurveda or yoga).

Meditative techniques are categorized as emphasizing mindfulness, concentration, and automatic self-transcen- dence. Popular techniques, such as transcendental medita- tion, emphasize the use of a mantra in such a way that it tran- scends one to an effortless state where focused attention is absent.3-5 Other popular techniques, such as mindfulness- based stress reduction, emphasize training in present- focused awareness or mindfulness. Uncertainty remains about what these distinctions mean and the extent to which these distinctions actually influence psychosocial stress outcomes.5,6

Reviews to date report a small to moderate effect of mind- fulness and mantra meditation techniques in reducing emo- tional symptoms (eg, anxiety, depression, and stress) and im- proving physical symptoms (eg, pain).7-26 These reviews have largely included uncontrolled and controlled studies, and many of the controlled studies did not adequately control for pla- cebo effects (eg, waiting list– or usual care–controlled stud- ies). Observational studies have a high risk of bias owing to problems such as self-selection of interventions (people who believe in the benefits of meditation or who have prior expe- rience with meditation are more likely to enroll in a medita- tion program and report that they benefited from one) and use of outcome measures that can be easily biased by partici- pants’ beliefs in the benefits of meditation. Clinicians need to know whether meditation training has beneficial effects be- yond self-selection biases and the nonspecific effects of time, attention, and expectations for improvement.27,28

An informative analogy is the use of placebos in pharma- ceutical trials. A placebo is typically designed to match non- specific aspects of the “active” intervention and thereby elicit the same expectations of benefit on the part of the provider and patient in the absence of the active ingredient. Office vis- its and patient-provider interactions, all of which influence ex- pectations for outcome, are particularly important to control when the evaluation of outcome relies on patient reporting. In the situation when double-blinding has not been feasible, the challenge to execute studies that are not biased by these nonspecific factors is more pressing.28 To develop evidence- based guidance on the use of meditation programs, we need to examine the specific effects of meditation in randomized clinical trials (RCTs) in which the nonspecific aspects of the in- tervention are controlled.

The objective of this systematic review is to evaluate the effects of meditation programs on negative affect (eg, anxi- ety, stress), positive affect (eg, well-being), the mental com- ponent of health-related quality of life, attention, health- related behaviors affected by stress (eg, substance use, sleep,

eating habits), pain, and weight among persons with a clini- cal condition. We include only RCTs that used 1 or more con- trol groups in which the amount of time and attention pro- vided by the control intervention was comparable to that of the meditation program.

Methods Study Selection We searched the following databases for primary studies: MEDLINE, PsycINFO, EMBASE, PsycArticles, Scopus, CINAHL, AMED, and the Cochrane Library through June 2013. We de- veloped a MEDLINE search strategy using PubMed medical subject heading terms and the text words of key articles that we identified a priori. We used a similar strategy in the other electronic sources. We reviewed the reference lists of in- cluded articles, relevant review articles, and related system- atic reviews to identify articles missed in the database searches. We did not impose any limits based on language or date of pub- lication. The protocol for this systematic review is publicly available.29

Two trained investigators independently screened titles and abstracts, excluding those that both investigators agreed met at least 1 of the exclusion criteria (Table 1). For those stud- ies included after the first review, a second dual independent review of the full-text article occurred, and differences regard- ing article inclusion were resolved through consensus.

We included RCTs in which the control group was matched in time and attention to the intervention group. We also re- quired that studies include participants with a clinical condi- tion. We defined a clinical condition broadly to include men- tal health/psychiatric conditions (eg, anxiety or stress) and physical conditions (eg, lower back pain, heart disease, or ad- vanced age). In addition, because stress is of particular inter- est in meditation studies, we also included trials that studied stressed populations, although they may not have had a de- fined medical or psychiatric diagnosis.

Data Abstraction and Data Management We used systemic review software (DistillerSR, 2010; Evi- dence Partners) to manage the screening process. For each meditation program, we extracted information on measures of intervention fidelity, including dose, training, and receipt of intervention. We recorded the duration and maximal hours of structured training in meditation, the amount of home prac- tice recommended, description of instructor qualifications, and description of participant adherence, if any. Because numer- ous scales measured negative or positive affect, we chose scales that were common to the other trials and the most clinically relevant to make comparisons more meaningful.

To display outcome data, we calculated the relative dif- ference in change scores (ie, the change from baseline in the treatment group minus the change from baseline in the con- trol group, divided by the baseline score in the treatment group). We used the relative difference in change scores to es- timate the direction and approximate magnitude of effect for all outcomes. We were unable to calculate a relative differ-

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ence in change score for 6 outcomes owing to incompletely re- ported data for statistically insignificant findings. We consid- ered a 5% relative difference in change score to be potentially clinically significant because these studies examined short- term interventions and relatively low doses of meditation.

For the purpose of generating an aggregate quantitative es- timate of the effect of an intervention and the associated 95% confidence interval, we performed random-effects meta- analyses using standardized mean differences (effect size [ES]; Cohen d). We also used these analyses to assess the precision of individual studies, which we factored into the overall strength of evidence. For each outcome, ES estimates are dis- played according to the type of control group and the dura- tion of follow-up. Trials did not give enough information to con- duct a meta-analysis on 16 outcomes. We display the relative difference in change scores along with the ES estimates from the meta-analysis so that readers can see the full extent of the available data (Figure 1 and Supplement [eFigures 1 to 34]).

We classified the type of control group as a nonspecific ac- tive or specific active control (Table 1). The nonspecific active comparison conditions (eg, education or attention control) con- trol for the nonspecific effects of time, attention, and expec- tation. Comparisons against these controls allow for assess- ments of the specific effectiveness of the meditation program beyond the nonspecific effects of time, attention, and expec- tation. This comparison is similar to a comparison against a pla- cebo pill in a drug trial. Specific active controls are therapies (eg, exercise or progressive muscle relaxation) known or ex- pected to change clinical outcomes. Comparisons against these controls allow for assessments of comparative effectiveness similar to those of drug trials that compare one drug against another known drug. Because these study designs are ex- pected to yield different conclusions (efficacy vs compara- tive effectiveness), we separated them in our analyses.

Strength of the Body of Evidence We assessed the quality of the trials independently and in du- plicate based on the recommendations in the Methods Guide for Conducting Comparative Effectiveness Reviews.30 We supple- mented these tools with additional assessment questions based on the Cochrane Collaboration’s risk-of-bias tool.31,32 Two re- viewers graded the strength of evidence for each outcome using the grading scheme recommended by the Methods Guide for Conducting Comparative Effectiveness Reviews.33 This grad- ing was followed by a discussion to review and achieve con- sensus on the assigned grades. In assigning evidence grades, we considered the following 4 domains: risk of bias, direct- ness, consistency, and precision. We classified evidence into the following 4 basic categories: (1) high grade (indicating high confidence that the evidence reflects the true effect and that further research is very unlikely to change our confidence in the estimate of the effect), (2) moderate grade (indicating mod- erate confidence that the evidence reflects the true effect and that further research may change our confidence in the esti- mate of the effect and may change the estimate), (3) low grade (indicating low confidence that the evidence reflects the true effect and that further research is likely to change our confi- dence in the estimate of the effect and is likely to change the estimate), and (4) insufficient grade (indicating that evi- dence is unavailable or inadequate to draw a conclusion).

Results We screened 18 753 unique citations (Figure 2) and 1651 full-text articles. Forty seven trials met our inclusion criteria.34-80

Most trials were short-term but ranged from 3 weeks to 5.4 years in duration (Table 2). Not all trials reported the amount

Table 1. Study Inclusion and Exclusion Criteria

Inclusion Criteria Exclusion Criteriaa

Population and condition of interest

Adult populations (≥18 y); clinical (medical or psychiatric) diagnosis, defined as any condition (eg, high blood pressure, anxiety) including a stressor

Studies of children (type and nature of meditation received may be significantly different from that of adults); studies of otherwise healthy individuals

Interventions Structured meditation programs (any systematic or protocol meditation programs that follow predetermined curricula) consisting of, at a minimum, ≥4 h of training with instructions to practice outside the training session, including mindfulness-based programs (ie, MBSR, MBCT, vipassana, Zen, and other mindfulness meditation), mantra-based programs (ie, TM, other mantra meditation), and other meditation programs

Meditation programs in which the meditation is not the foundation and most of the intervention, including DBT; ACT; any of the movement-based meditations, such as yoga (eg, Iyengar, Hatha, shavasana), tai chi, and qi gong (chi kung); aromatherapy; biofeedback; neurofeedback; hypnosis; autogenic training; psychotherapy; laughter therapy; therapeutic touch; eye movement desensitization reprocessing; relaxation therapy; spiritual therapy; breathing exercise; pranayama exercise; any intervention that is given remotely or only by video or audio to an individual without the involvement of a meditation teacher physically present

Comparisons of interest

Active control is defined as a program that is matched in time and attention to the intervention group for the purpose of matching expectations of benefit (examples include attention control, educational control, or another therapy, such as progressive muscle relaxation, that the study compares with the intervention; nonspecific active control only matches time and attention and is not a known therapy); specific active control compares the intervention with another known therapy, such as progressive muscle relaxation

Studies that only evaluate a waiting list or usual care control or do not include a comparison group

Study design RCTs with an active control Nonrandomized designs, such as observational studies

Timing and setting Longitudinal studies that occur in general and clinical settings None

Abbreviations: ACT, acceptance and commitment therapy; DBT, dialectical behavioral therapy; MBCT, mindfulness-based cognitive therapy; MBSR, mindfulness-based stress reduction; RCTs, randomized clinical trials; TM, transcendental meditation. a We excluded articles with no original data (reviews, editorials, and comments), studies published in abstract form only, and dissertations.

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Figure 1. Strength of Evidence on the Trial Outcomes

Outcome

Anxiety

Depression

Stress/Distress

Negative Affect

Positive Affect

Quality of Life

Attention

Sleep

Substance Use

Pain

Weight

Meditation Program

Comparisons of Meditation Programs With Nonspecific Active Controls (Efficacy)

Comparisons of Meditation Programs With Specific Active Controls (Comparative Effectiveness)

Mindfulness

Mantra

Mindfulness

Mantra

Mindfulness

Mantra

Mindfulness

Mantra

Mindfulness

TM (mantra)

Mindfulness

TM (mantra)

Clinical Population

Various (n = 647)

Various (n = 237)

Various (n = 806)

Various (n = 440)

Various (n = 735)a

Select (n = 239)

Various (n = 1140)b

Various (n = 438)c

Various (n = 293)

CHF (n = 23)

Various (n = 346)

Caregivers (n = 21)

Various (n = 578)

CAD (n = 201)

Select (n = 341)

CHF (n = 23)

Select (n = 297)

No. of Trials, Total (PO); PA (MA)

8 (3); 7 (7)

3 (2); 3 (3)

10 (4); 9 (8)

5 (1); 5 (3)

9 (4); 8 (7)

4 (2); 4 (2)

14 (5); 12 (11)

5 (2); 5 (0)

4 (0); 4 (4)

1 (0); 1 (0)

4 (2); 4 (3)

1 (0); 1 (0)

6 (2); 4 (4)

1 (0); 0 (0)

4 (2); 4 (4)

1 (0); 1 (0)

3 (0); 2 (0)

Strength of Evidence

Moderate for improvement

Low for no effect

Moderate for improvement

Insufficient

Low for improvement

Low for no effect

Low for improvement

Insufficient

Low for improvement

Insufficient

Moderate for improvement

Low for no effect

–1 10

d Statistic (95% CI)

Favors Mediation

Favors Control

Direction (Magnitude) of Effect

Ø (–3% to +6%)

↑(–5% to +52%)

↑↓(–19% to +46%)

↑(+1% to +21%)

Ø (–6% to +1%)

↑(–1% to +44%)

↑↓(–3% to +46%)

↑(+1% to +55%)

Ø (+2%)

↑(+5% to +28%)

↑(+15% to +81%)

↑↓(–3% to +24%)

↑(+5% to +31%)

Ø (–2%)

Ø (–1% to +2%)

↑(0% to +44%)

Outcome

Anxiety

Depression

Stress/Distress

Quality of Life

Eating

Positive Affect

Sleep

Smoking/Alcohol

Alcohol only

Pain

Weight

Meditation Program

Mindfulness

CSM (mantra)

Mindfulness

CSM (mantra)

Mindfulness

Mantra

Mindfulness

Clinical Population

Various (n = 691)

Anxiety (n = 42)

Various (n = 986)

Anxiety (n = 42)

Various (n = 523)

Various (n = 297)

Various (n = 472)

Various (n = 311)

Select (n = 158)

Substance abuse (n = 95)

Alcoholic (n = 145)

Select (n = 410)

Select (n = 151)

No. of Trials, Total (PO); PA (MA)

11 (6); 11 (10)

1 (1); 1 (0)

13 (6); 13 (11)

1 (1); 1 (0)

7 (5); 7 (6)

4 (2); 4 (4)

6 (1); 6 (5)

3 (1); 3 (2)

2 (1); 2 (0)

2 (2); 1 (0)

2 (2); 2 (0)

4 (2); 4 (4)

2 (2); 2 (0)

Strength of Evidence

Insufficient

Low for no effect

–1 10

d Statistic (95% CI)

Favors Mediation

Favors Control

Direction (Magnitude) of Effect

↓(–6%)

↑↓(–32% to +23%)

↓(–28%)

↑↓(–24% to +18%)

↑↓(–45% to +10%)

↑↓(–23% to +9%)

↑↓(–2% to +15%)

↓(–6% to –15%)

↑(Ø to +21%)

Ø (–5% to –36%)

Ø (–1% to –32%)

Ø (–2% to +1%)

↑↓(–39% to +8%)

Summary across measurement domains of comparisons of meditation programs with nonspecific active controls (efficacy analysis) (A) and specific active controls (comparative effectiveness analysis) (B). CAD indicates coronary artery disease; CHF, congestive heart failure; CSM, clinically standardized meditation (a mantra meditation program); MA, meta-analysis; PA, primary analysis; PO, number of trials in which this was a primary outcome for the trial; and TM, transcendental meditation (a mantra meditation program). Direction is based on the relative difference in change analysis. ↑ Indicates the meditation group improved relative to the control group (with a relative difference generally �5% across trials); ↓, the meditation group worsened relative to the control group (with a relative difference generally ±5% across trials); Ø, a null effect (with a relative difference generally <5% across trials); and ↑↓, inconsistent findings (some trials reported improvement with meditation [relative to control], whereas others showed no improvement or improvement in the control group [relative to meditation]). Magnitude is based on the relative difference in the change score, a relative percent difference, using the baseline mean in the meditation group as the denominator. For example, if the

meditation group improves from 10 to 19 on a mental health scale and the control group improves from 11 to 16 on the same scale, the relative difference between groups in the change score is: {[(19 − 10) − (16 − 11)]/10} × 100 = 40%. The interpretation is a 40% relative improvement on the mental health scale in the meditation group compared with the control group. Improvement in all scales is indicated in the positive direction. A positive relative percent difference means that the score improved more in the intervention group than in the control group. The meta-analysis figure (far right) shows the Cohen d statistic with the 95% CI. aSummary effect size is not shown owing to concern about publication bias for this outcome. bNegative affect combines the outcomes of anxiety, depression, and stress/distress and is thus duplicative of those outcomes. cWe did not perform an MA on this outcome because it would duplicate the anxiety MA for mantra. Anxiety and depression are indirect measures of negative affect and therefore resulted in a lower strength of evidence than that for the outcome of mantra on anxiety.

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of training or home practice recommended. Mindfulness- based stress reduction programs typically provided 20 to 27.5 hours of training during 8 weeks. The other mindfulness medi- tation trials provided about half this amount. Transcendental meditation trials were estimated to provide 16 to 39 hours in 3 to 12 months, whereas other mantra meditation programs pro- vided about half this amount. Only 5 of the trials reported the trainers’ actual meditation experience (ranging from 4 months to 25 years), and 6 reported the trainers’ actual teaching ex- perience (ranging from 0-15.7 years). Fifteen trials studied psy- chiatric populations, including those with anxiety, depres- sion, stress, chronic worry, and insomnia. Five trials studied smokers and alcoholics, 5 studied populations with chronic pain, and 16 studied populations with diverse medical prob- lems, including those with heart disease, lung disease, breast cancer, diabetes mellitus, hypertension, and human immu- nodeficiency virus infection.

The strength of evidence concerning the outcomes is shown in Figure 1. We found it difficult to draw comparative effectiveness conclusions owing to the large heterogeneity of type and strength of the many comparators. Therefore, we pre- sent our results first for all the comparisons with nonspecific active controls (efficacy) and then for those with specific ac- tive controls (comparative effectiveness).

The direction and magnitude of effect is derived from the relative difference between groups in the change score. In our efficacy analysis (Figure 1A), we found low evidence of no ef- fect or insufficient evidence that mantra meditation pro- grams had an effect on any of the psychological stress and well- being outcomes we examined. Mindfulness meditation programs had moderate evidence of improved anxiety (ES, 0.38

[95% CI, 0.12- 0.64] at 8 weeks and 0.22 [0.02-0.43] at 3-6 months), depression (0.30 [0.00-0.59] at 8 weeks and 0.23 [0.05-0.42] at 3-6 months), and pain (0.33 [0.03-0.62]) and low evidence of improved stress/distress and mental health– related quality of life. We found low evidence of no effect or insufficient evidence of an effect of meditation programs on positive mood, attention, sleep, and weight. We also found in- sufficient evidence that meditation programs had an effect on health-related behaviors affected by stress, including sub- stance use and sleep.

In our comparative effectiveness analyses (Figure 1B), we found low evidence of no effect or insufficient evidence that any of the meditation programs were more effective than ex- ercise, progressive muscle relaxation, cognitive-behavioral group therapy, or other specific comparators in changing any outcomes of interest. Few trials reported on potential harms of meditation programs. Of the 9 trials reporting this informa- tion, none reported any harms of the intervention.

We could not conduct any quantitative tests (eg, funnel plots) for publication bias because few studies were available for most outcomes, and many were excluded from the meta- analysis owing to missing data. We reviewed the clinicaltrials .gov registration database to identify trials completed 3 or more years ago that prespecified our outcomes of interest and did not publish at all or did not publish all prespecified out- comes. We found 5 trials that appeared to have been com- pleted before January 1, 2010, that did not publish all the out- comes they had prespecified and 9 trials for which we could not find an associated publication. Because only 6 outcomes were excluded from the analyses of the relative difference in change scores between groups, whereas 16 outcomes were

Figure 2. Summary of the Literature Search

47 Included articles

Studies retrieved from electronic database searches 7532 MEDLINE 1195 Cochrane Library 3369 CINAHL 4054 PsycINFO

200 PsycArticles 8285 Scopus 2723 EMBASE 1200 AMED

30 206 Retrieved

11 453 Duplicates

17 102 Excluded

1604 Excluded

1648 From hand searching

18 753 Undergo title-abstract review

1651 Undergo article review

Reasons for exclusion at title-abstract review levela 8526 With no original data

353 With other meditation form 459 Only included children or adolescents (0-18 y)

1922 With no control group 2177 Not randomized

10 446 Not relevant to key questions 772 Other

Reasons for exclusion at article review levela 183 With no original data

70 With meeting abstracts 454 With movement-based meditation forms

18 With other excluded meditation forms 11 Only included children or adolescents (0-18 y) 84 With no active control group

360 Not randomized 54 With only healthy populations

250 Not relevant to key questions 460 Other

aTotal exceeds the number in the exclusion box because reviewers were allowed to mark more than 1 reason for exclusion.

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Table 2. Study Descriptions

Source Meditation Program

Type of Active Control

Study Quality

No. of Hours Program Duration/Study Duration

Outcomes (End of Treatment/End of Study) Population

No. of Patients

Program Training Homework

Henderson et al,68 2012

MBSR NSAC Fair 25 UC 8 wk/24 mo Anxiety (NS/NS), depression (+/↑), positive affect (+/Ø)

Breast cancer 100

Gaylord et al,43 2011

MBSR NSAC Fair 23a Y-NS 8 wk/3 mo Anxiety (Ø/+), depression (Ø/Ø), stress/distress (Ø/+), pain (+/+)

IBS 75

Schmidt et al,64 2011

MBSR NSAC Fair 27 42 8 wk/4 mo Anxiety (Ø/+), depression (Ø/↑), sleep (Ø/Ø), pain (↑/Ø)

Fibromyalgia 109

Gross et al,44 2010

MBSR NSAC Fair 27 Y-NS 8 wk/6 mo Anxiety (↑/↑), depression (↑/↑), positive affect (Ø/↑), mental QOL (Ø/Ø), sleep (↑/+), pain (Ø/Ø)

Organ transplant

137

Morone et al,55 2009

MBSR NSAC Good 12 42 8 wk/6 mo Pain (↑/Ø) Low back pain 35

Whitebird et al,72 2013

MBSR NSAC Fair 25 26.7 8 wk/6 mo Anxiety (Ø/Ø), depression (+/↑), stress/distress (+/+), mental QOL (+/+)

Dementia caregivers

SeyedAlinaghi et al,67 2012

MBSR NSAC Poor 25a Y-NS 8 wk/14 mo Stress/distress (↑/↓) HIV 171

Pbert et al,60 2012

MBSR NSAC Good 26 24 8 wk/10 mo Stress/distress (↑/+), mental QOL (↑/+)

Asthma 82

Oken et al,58 2010

MM NSAC Fair 9 Y-NS 7 wk/NA Depression (↑/NA), stress/distress (↑ /NA), sleep (Ø/NA)

Dementia caregivers

Garland et al,42 2010

MM NSAC Fair UC 17.5 10 wk/NA Stress/distress (+/NA) Alcoholism 37

Mularski et al,56 2009

MM NSAC Poor 8 Y-NS 8 wk/NA Stress/distress (Ø /NA), mental QOL (↑/NA)

COPD 49

Lee et al,50 2007

MM NSAC Fair 8 Y-NS 8 wk/NA Anxiety (+/NA), depression (↑/NA)

Anxiety 41

Malarkey et al,52 2013

MM NSAC Good 9 18.5 8 h/NA Depression (NS/NA), stress/distress (NS /NA), sleep (NS/NA)

CRP level >3.0 mg/L

186

Chiesa et al,39 2012

MBCT NSAC Fair 16 UC 8 wk/NA Anxiety (↑/NA), depression (+/NA), positive affect (+/NA)

Depression 18

Hoge et al,78 2013

MBSR NSAC Fair 20 18.7 8 wk/NA Anxiety (+/NA), sleep (+/NA)

Anxiety 89

Nakamura et al,79 2013

MM NSAC Fair 6 UC 3 wk/3 mo Depression (Ø/↑), stress/distress (↑/↑), positive affect (Ø/Ø), sleep (↑/↑)

Cancer and insomnia

Wong et al,74 2011

MBSR Pain AC Good 27 Y-NS 8 wk/6 mo Anxiety (Ø/Ø), depression (Ø/Ø), mental QOL (Ø/Ø), pain (Ø/Ø)

Chronic pain 99

Gross et al,45 2011

MBSR Drug Fair 26 36 8 wk/5 mo Anxiety (Ø/↑), depression (↓/↓), mental QOL (Ø/NA), sleep (↑/Ø)

Insomnia 27

Koszycki et al,71 2007

MBSR CBGT Poor 27.5 28 8 wk/NA Anxiety (↓/NA), depression (Ø/NA)

Anxiety 53

Barrett et al,34 2012

MBSR Exercise Fair 20 42 8 wk/5 mo Anxiety (Ø/Ø), stress/distress (Ø/Ø), positive affect (Ø/Ø), mental QOL (Ø/Ø), sleep (Ø/Ø)

Cold/URI in past year

(continued)

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Table 2. Study Descriptions (continued)

Source Meditation Program

Type of Active Control

Study Quality

No. of Hours Program Duration/Study Duration

Outcomes (End of Treatment/End of Study) Population

No. of Patients

Program Training Homework

Jazaieri et al,48 2012

MBSR Exercise Poor 25 28.3 8 wk/5 mo Anxiety (↑/Ø), depression (↑/↑), stress/distress (↑ /NA), positive affect (↑/NA)

Social anxiety disorder

Moritz et al,54 2006

MBSR Spirituality Good 12a Y-NS 8 wk/3 mo Anxiety (−/NA), depression (↓/NA), stress/distress (−/↓), positive affect (− /NA), mental QOL (−/↓), pain (↓/NA)

Mood distur- bance (POMS)

110

Plews-Ogan et al,63 2005

MBSR Massage Poor 20 Y-NS 8 wk/3 mo Mental QOL (↓/↑), pain (↓/↓)

Chronic pain 23

Hebert et al,46 2001

MBSR Nutrition education

Fair 45a UC 15 wk/12 mo Eating habits (Ø/Ø), weight (Ø/Ø)

Breast cancer 106

Philippot et al,61 2012

MBCT Relaxation Fair 13.5 Y-NS 6 wk/3 mo Anxiety (↑/↑), depression (↑/Ø)

Tinnitus 25

Segal et al,66 2010

MBCT Drug Good 23a Y-NS 8 wk/20 mo Depression (NA/↑) Depression 84

Kuyken et al,49 2008

MBCT Drug Good 24a 37.5 8 wk/15 mo Depression (↓/NA), mental QOL (+/+)

Depression 123

Piet et al,62 2010

MBCT CBGT Fair 16 28 8 wk/NA Anxiety (↓/NA), depression (↓/NA), stress/distress (↓/NA)

Social phobia 26

Delgado et al,40 2010

MM PMR Fair 10 Y-NS 5 wk/NA Anxiety (Ø/NA), depression (↑/NA), stress/distress (Ø /NA), positive affect (Ø/NA)

Worriers 32

Wolever et al,73 2012

MM Viniyoga Fair 14 UC 12 wk/NA Depression (↑/NA), stress/distress (Ø /NA), sleep (Ø/NA), pain (↓/NA)

Stressed employees

186

Miller et al,53 2012

MM Smart Choices

Poor 25 Y-NS 12 wk/6 mo Eating (↓/↓), weight (Ø/Ø)

Diabetes mellitus

Brewer et al,37 2011

MM Lung Asso- ciation FFS

Poor 12 Y-NS 4 wk/4 mo Smoking (↑/+) Smokers 71

Brewer et al,36 2009

MM CBT Poor 9 UC 9 wk/NA Alcohol abuse (Ø/NA) Alcoholism 118

Arch et al,75 2013

MM CBT Fair 18 29.2 10 wk/6 mo Anxiety (Ø/↑), depression (↑/Ø)

Anxiety 105

Omidi et al,80 2013

MBCT CBT Poor 16 56 8 wk/NA Anxiety (↓/NA), depression (↓/NA)

Depression 60

Ferraioli and Harris,77 2013

MM SBPT Poor 16 UC 8 wk/5 mo Stress/distress (+/+) Stressed parents

Paul-Labrador et al,59 2006

TM NSAC Good 39 Y-NS 16 wk/NA Anxiety (Ø/NA), depression (↓/NA), stress/distress (↓/NA)

CAD 103

Jayadevappa et al,47 2007

TM NSAC Good 22.5a 90 12 wk/6 mo Depression (↓/NA), stress/distress (Ø/Ø), positive affect (Ø/Ø), pain (Ø/↑)

CHF 23

Schneider et al,65 2012

TM NSAC Good 78a 1310 12 wk/5.4 y Depression (NA/↑), weight (NA/NS)

CAD 201

Smith,69 1976 TM NSAC Poor UC 87.5 4 wk/6 mo Anxiety (NA/Ø) Anxiety 41

Elder et al,41 2006

TM NSAC Fair UC 90 UC Weight (Ø/NA) Diabetes mellitus

Castillo-Rich- mond et al,38 2000

TM NSAC Poor UC 120.6 12 wk/NA Weight (Ø/NA) AA with hypertension

Chhatre et al,76 2013

TM NSAC Fair 24 112 12 wk/6 mo Depression (NA/↑), stress/distress (NA/↑)

HIV 20

(continued)

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excluded from the meta-analyses, our findings from the pri- mary analyses are less likely than the meta-analyses to be affected by publication bias.

Discussion Our review indicates that meditation programs can reduce the negative dimensions of psychological stress. Mindfulness meditation programs, in particular, show small improve- ments in anxiety, depression, and pain with moderate evi- dence and small improvements in stress/distress and the men- tal health component of health-related quality of life with low evidence when compared with nonspecific active controls. Mantra meditation programs did not improve any of the out- comes examined, but the strength of this evidence varied from low to insufficient. Although meditation programs generally seek to improve the positive dimensions of health, the evi- dence from a small number of studies did not show any ef- fects on positive affect or well-being for any meditation pro- gram. We found no evidence of any harms of meditation programs, although few trials reported on harms. One strength of our review is the focus on RCTs with active controls, which should give clinicians greater confidence that the reported ben- efits are not the result of nonspecific effects (eg, attention and expectations) that are seen in trials using a waiting list or usual- care control condition.

Anxiety, depression, and stress/distress are different components of negative affect. When we combined each component of negative affect, we saw a small and consis- tent signal that any domain of negative affect is improved in mindfulness programs when compared with a nonspecific active control. The ESs were small but significant for some of these individual outcomes and were seen across a broad range of clinical conditions (Table 2). During the course of 2 to 6 months, the mindfulness meditation program ES esti- mates ranged from 0.22 to 0.38 for anxiety symptoms and

0.23 to 0.30 for depressive symptoms. These small effects are comparable with what would be expected from the use of an antidepressant in a primary care population but with- out the associated toxicities. In a study using patient-level meta-analysis, Fournier et al81 found that for patients with mild to moderate depressive symptoms, antidepressants had an ES of 0.11 (95% CI, −0.18 to 0.41), whereas for those with severe depression, antidepressants had an ES of 0.17 (−0.08 to 0.43) compared with placebo.

Among the 9 RCTs* evaluating the effect on pain, we found moderate evidence that mindfulness-based stress reduction reduces pain severity to a small degree when compared with a nonspecific active control, yielding an ES of 0.33 from the meta-analysis. This effect is variable across painful condi- tions and is based on the results of 4 trials, of which 2 were con- ducted in patients with musculoskeletal pain,55,64 1 trial in pa- tients with irritable bowel syndrome,43 and 1 trial in a population without pain.44 Visceral pain had a large and sta- tistically significant relative 30% improvement in pain sever- ity, whereas musculoskeletal pain showed 5% to 8% improve- ments that were considered nonsignificant.

Overall, the evidence was insufficient to indicate that medi- tation programs alter health-related behaviors affected by stress, and low-grade evidence suggested that meditation programs do not influence weight. Although uncontrolled studies have usu- ally found a benefit of meditation, very few controlled studies have found a similar benefit for the effects of meditation pro- grams on health-related behaviors affected by stress.17-19

In the 20 RCTs examining comparative effectiveness,† mindfulness and mantra programs did not show significant ef- fects when the comparator was a known treatment or therapy. A lack of statistically significant superiority compared with a specific active control (eg, exercise) only addresses the ques- tion of equivalency or noninferiority if the trial is suitably pow-

*References 43, 44, 47, 54, 55, 63, 64, 73, 74 †References 34, 36, 37, 40, 45, 46, 48, 49, 51, 53, 54, 57, 61-63, 66, 70, 71, 73-75, 77, 80

Table 2. Study Descriptions (continued)

Source Meditation Program

Type of Active Control

Study Quality

No. of Hours Program Duration/Study Duration

Outcomes (End of Treatment/End of Study) Population

No. of Patients

Program Training Homework

Bormann et al,35 2006

Mantra NSAC Fair 7.5 Y-NS 10 wk/6 mo Anxiety (↑/Ø), depression (Ø/↓), stress/distress (Ø/Ø)

HIV 93

Taub et al,70 1994

TM Biofeedback Fair 19 UC 4 wk/NA Alcohol (Ø/NA) Alcoholism 118

Lehrer et al,51 1983

CSM PMR Fair 7.5 Y-NS 5 wk/6 mo Anxiety (Ø/NA), depression (↓/↓)

Anxiety 42

Murphy et al,57 1986

CSM Running Poor 8 37.5 8 wk/NA Alcohol (−/NA) Alcoholism 27

Abbreviations: AA, African American; AC, active control; CAD, coronary artery disease; CBGT, cognitive behavioral group therapy; CBT, cognitive behavioral therapy; CHF, congestive heart failure; COPD, chronic obstructive pulmonary disease; CRP, C-reactive protein; CSM, clinically standardized meditation; FFS, Freedom From Smoking program; HIV, human immunodeficiency virus; IBS, irritable bowel syndrome; MBCT, mindfulness-based cognitive therapy; MBSR, mindfulness-based stress reduction; mental QOL, mental component of health-related quality of life; MM, mindfulness meditation; NA, not available; NS, not significant; NSAC, nonspecific active control; PMR, progressive muscle

relaxation; POMS, Profile of Mood States; SBPT, skills-based parent training program; TM, transcendental meditation; UC, unclear; URI, upper respiratory tract infection; Y-NS, homework was prescribed but amount not specified; Ø, no effect (within ±5%); +improved and statistically significant; ↑favors meditation (>5% but nonsignificant); ↓favors control (>5% but nonsignificant); −, worsened and statistically significant.

SI conversion factor: To convert CRP to nanomoles per liter, multiply by 9.524. a Indicates estimated.

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ered to detect any difference. Sample sizes in the compara- tive effectiveness trials were small (mean size of 37 per group), and none appeared adequately powered to assess noninferi- ority or equivalence.

A number of observations provide context to our conclu- sions. First, very few mantra meditation programs met our in- clusion criteria. This lack significantly limited our ability to draw inferences about the effects of mantra meditation pro- grams on psychological stress–related outcomes, which did not change when we evaluated transcendental meditation sepa- rately from other mantra training.

Second, differences may exist between trials for which the outcomes are a primary vs a secondary focus, although we did not find any evidence of this. The samples included in these trials resembled a general primary care population, and there may not be room to measure an effect if symptom levels of the outcomes are low to start with (ie, a floor effect). This limita- tion may explain the null results for mantra meditation pro- grams because 3 transcendental meditation trials47,59,65 en- rolled patients with cardiac disease, whereas only 1 enrolled patients with anxiety.69

Third, the lack of effect on stress-related outcomes may relate to the way the research community conceptualizes medi- tation programs, the challenges in acquiring such skills or medi- tative states, and the limited duration of RCTs. Historically, meditation was not conceptualized as an expedient therapy for health problems.3,6,82 Meditation was a skill or state one learned and practiced over time to increase one’s awareness and through this awareness to gain insight and understand- ing into the various subtleties of one’s existence. Training the mind in awareness, in nonjudgmental states, or in the ability to become completely free of thoughts or other activity are daunting accomplishments. The interest in meditation that has grown during the past 30 years in Western cultures comes from Eastern traditions that emphasize lifelong growth. The trans- lation of these traditions into research studies remains chal- lenging. Long-term trials may be optimal to examine the ef- fect of meditation on many health outcomes, such as those trials that have evaluated mortality.65 However, many of the studies included in this review were short term (eg, 2.5 h/wk for 8 weeks), and the participants likely did not achieve a level of expertise needed to improve outcomes that depend on mas- tery of mental and emotional processes.

Finally, none of our conclusions yielded a high strength- of-evidence grade for a positive or null effect. Thus, further studies in primary care and disease-specific populations are indicated to address uncertainties caused by inconsis- tencies in the body of evidence, deficiencies in power, and risk of bias.

Limitations Some of the trials we reviewed were implemented before mod- ern standards for clinical trials were established. Thus, many did not report key design characteristics to enable an accu-

rate assessment of the risk of bias. Most trials were not regis- tered, did not standardize training using trainers who met specified criteria, did not specify primary and secondary out- comes a priori, did not power the trial based on the primary outcomes, did not use CONSORT recommendations for report- ing results, or did not operationalize and measure the prac- tice of meditation by study participants.83

We could not draw definitive conclusions about effect modifiers, such as dose and duration of training, because of the limited details provided in the publications of the trials. Despite our focus on RCTs using active controls, we were un- able to detect a specific effect of meditation on most out- comes, with the majority of our evidence grades being insuf- ficient or low. These evidence grades were mostly driven by 2 important evaluation criteria: the quality of the trial and in- consistencies in the body of evidence. Trials primarily had the following 4 biases: lack of blinding of outcome assessment, high attrition, lack of allocation concealment, and lack of intention- to-treat analysis. The reasons for inconsistencies in the body of evidence may have included the differences in the par- ticular clinical conditions and the type of control groups the studies used. Another possibility is that the programs had no real effect on many of the outcomes that had inconsis- tent findings.

Clinical Implications and Future Directions Despite the limitations of the literature, the evidence sug- gests that mindfulness meditation programs could help re- duce anxiety, depression, and pain in some clinical popula- tions. Thus, clinicians should be prepared to talk with their patients about the role that a meditation program could have in addressing psychological stress.

Future research in meditation would benefit by address- ing the remaining methodological and conceptual issues. All forms of meditation, including mindfulness and mantra, im- ply that more time spent meditating will yield larger effects. Most forms, but not all, present meditation as a skill that re- quires expert instruction and time dedicated to practice. Thus, more training with an expert and practice in daily life should lead to greater competency in the skill or practice, and greater competency or practice would presumably lead to better out- comes. However, when compared with other skills that re- quire training, such as writing, the amount of training or the dose afforded in the trials was quite small, and generally the training was offered during a fairly short period. These 3 com- ponents—trainer expertise, amount of practice, and skill— require further investigation. We were unable to examine the extent to which trainer expertise influences clinical outcome because teacher qualifications were not reported in detail in most trials. Trials need to document the amount of training instructors provide and patients receive and the amount of home practice patients complete. These measures will allow future investigators to examine questions about dosing re- lated to outcome.

ARTICLE INFORMATION

Accepted for Publication: October 4, 2013.

Published Online: January 6, 2014. doi:10.1001/jamainternmed.2013.13018.

Author Contributions: Dr Goyal had full access to all the data and takes full responsibility for the completeness and integrity of the data.

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Study concept and design: Goyal, Singh, Sibinga, Rowland-Seymour, Sharma, Berger, Ranasinghe, Bass, Haythornthwaite. Acquisition of data: Goyal, Singh, Sibinga, Gould, Rowland-Seymour, Sharma, Berger, Maron, Shihab, Ranasinghe, Linn. Analysis and interpretation of data: Goyal, Sibinga, Gould, Rowland-Seymour, Berger, Sleicher, Shihab, Ranasinghe, Linn, Saha, Bass, Haythornthwaite. Drafting of the manuscript: Goyal, Singh, Sibinga, Gould, Rowland-Seymour, Sharma, Berger, Sleicher, Maron, Ranasinghe, Haythornthwaite. Critical revision of the manuscript for important intellectual content: Goyal, Sibinga, Rowland-Seymour, Berger, Shihab, Ranasinghe, Linn, Saha, Bass, Haythornthwaite. Statistical analysis: Goyal, Singh, Berger, Saha. Obtained funding: Goyal, Bass. Administrative, technical, and material support: Goyal, Gould, Sharma, Maron, Shihab, Linn, Bass. Study supervision: Goyal, Sharma, Bass.

Conflict of Interest Disclosures: None reported.

Funding/Support: This study was supported by grant HHSA 290 2007 10061 from the Agency for Healthcare Research and Quality (AHRQ).

Role of the Sponsor: The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication. The funding source approved assertion of copyright by the authors, as noted in a letter from the AHRQ Contracting Officer.

Disclaimer: The authors are responsible for the contents, including any clinical or treatment recommendations. No statement in this article should be construed as an official position of AHRQ or of the US Department of Health and Human Services.

Additional Contributions: Shilpa H. Amin, MD, provided support for this review in her capacity as the Task Order Officer assigned by the AHRQ for the work done under this task order. We received thoughtful advice and input from our key informants and members of a technical expert panel, who were offered a small honorarium in appreciation of their time. Swaroop Vedula, MBBS, PhD, helped to conduct the meta-analysis and was compensated for his time. Manisha Reuben, BS, Deepa Pawar, MD, MPH, Oluwaseun Shogbesan, MBBS, MPH, and Yohalakshmi Chelladurai, MBBS, MPH, helped to review studies included in the review and were compensated for their time.

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66. Segal ZV, Bieling P, Young T, et al. Antidepressant monotherapy vs sequential pharmacotherapy and mindfulness-based cognitive therapy, or placebo, for relapse prophylaxis in recurrent depression. Arch Gen Psychiatry. 2010;67(12):1256-1264.

67. SeyedAlinaghi S, Jam S, Foroughi M, et al. Randomized controlled trial of mindfulness-based stress reduction delivered to HIV+ patients in Iran: effects on CD4+ T lymphocyte count and medical and psychological symptoms. Psychosom Med. 2012;74(6):620-627.

68. Henderson VP, Clemow L, Massion AO, Hurley TG, Druker S, Hebert JR. The effects of mindfulness-based stress reduction on psychosocial outcomes and quality of life in early-stage breast cancer patients: a randomized trial. Breast Cancer Res Treat. 2012;131(1):99-109.

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Invited Commentary

Moving Toward Evidence-Based Complementary Care Allan H. Goroll, MD

Therapies that lie outside the spectrum of traditional, science- based clinical medicine and surgery are often labeled as comple- mentary or alternative. These therapies range from herbal rem- edies and dietary supplements to meditation and acupuncture, and they derive from Eastern and Western traditions. Use is widespread and often promoted by commercial interests and practitioners, with prevalence estimates exceeding 50%.1 Their popularity derives in part from being available without pre- scription and the supposition that the label of natural makes them safe and preferable to pharmacologic and surgical treatments.2 Despite widespread use, many complementary therapies still lack a rigorous evidence base.3

The relative scarcity of scientifically derived data on effi- cacy and safety stems from a number of factors, ranging from a lack of financial incentives for practitioners and suppliers (why study something that is already profitable and accepted by patients?) to difficulty measuring outcomes.3 This unac- ceptable state of affairs for treatments that consume billions of health care dollars annually in the United States alone1 pro-

vided the stimulus for estab- lishing at the National Insti- tutes of Health a National

Center for Complementary and Alternative Medicine in 1991. Its mission is “to define, through rigorous scientific investi- gation, the usefulness and safety of complementary and alternative medic ine inter ventions and their roles in improving health and health care.”4 The Agency for Health- care Research and Quality shares this mission. Their spon- sorship and funding have begun to generate and make avail- able scientific evidence on a wide variety of complementary therapies.

Among complementary measures, meditation has occu- pied a special position, revered in religious circles and East- ern societies for centuries and rediscovered in the West in the mid-20th century by psychologists such as Abraham Maslow who were interested in its potential for enhancing human con- sciousness and experience. Widespread medical application followed about 10 years later, popularized by such best- selling books as The Relaxation Response by Herbert Benson.5

Mindfulness techniques, which seek to enhance self- awareness, and mantra methods, which aim for transcen-

dence, have been applied widely to treat stress and stress- related conditions1,6 and are becoming popular for use in everyday life by a public that finds itself increasingly dis- tracted and disrupted by endless interruptions and stressors.7

In this issue, Goyal and colleagues8 from The Johns Hop- kins University report on their examination of best available evidence for the efficacy and comparative effectiveness of meditation. In their Agency for Healthcare Research and Quality–sponsored systematic review and meta-analysis of methodologically sound studies of mindful and transcenden- tal forms of meditation, they attempt to address efficacy and comparative effectiveness with regard to psychological stress and well-being. They focus their review on best evidence, derived from randomized clinical trials involving patients with a mental health or physical condition and using active controls for determination of efficacy and comparative effec- tiveness. The active control studies are subcategorized by whether the control involves a nonspecific measure, such as education (which helps determine efficacy by controlling for time, attention, and expectation), or a specific intervention, such as exercise or progressive muscle relaxation (which pro- vides for a comparative effectiveness assessment). They also grade studies for strength of evidence based on assessments for risk of bias, directness, consistency, and precision and categorized according to degree of confidence in the results by likelihood that further research would change the level of confidence.

Only 3% of published trials examined met their inclusion criteria, making for a review of 47 trials of mindfulness-based stress reduction (MBSR) or transcendental (mantra-based) meditation. With the exception of MBSR studies providing moderate evidence of improvement in anxiety, depression, and pain and low evidence of improvement in stress/distress and mental health–related quality of life, the investigators found low levels of evidence of no effect or insufficient evidence of effect for improvements by MBSR or transcendental medita- tion in any of the other variables of psychological stress or well- being examined. In the comparative-effectiveness analysis, they found little evidence of any benefit compared with spe- cific active measures, such as exercise, progressive muscle re- laxation, or cognitive behavioral therapy.8