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    2 Comments for this article
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    Study methodology likely to underestimate effect sizes of meditation studies
    Paul Grossman | University Hospital Basel, Switzerland
    The authors' decision to exclude RCT trials that only evaluate a waiting list or usual care control is inherently flawed with respect to behavioral intervention studies and is probably responsible for substantial underestimation of effect sizes: 1) In contrast to pharmacological experimental studies, active control procedures in behavioral intervention studies are never equivalent to an inert placebo; plausible active control interventions, therefore, are very likely to include therapeutic aspects that maintain patient motivation and participation across the treatment phase, and may consequently severely reduce the overall effect size of the experimental treatment. 2) Human beings have preferences when it comes to behavioral interventions—some clearly preferring meditation, others another program; using mere common sense, effects of preference are apparent (e.g. Linn et al, 2005) and to be expected in unblinded behavioral intervention trials (which all behavioral intervention trials in the current paper are), in which patients are aware of the treatment they are receiving and the outcome measures are subjective and typically self-reported by the patient. 3) Patients who have strong preferences may refuse to participate; the external validity will, thus, be adversely influenced in a trial in which strong preferences exist, and a large number of patients refuse enrolment and randomization. This will in turn lead to serious limitations of generalizability of the results to the general population. 4) Furthermore when patients who have strong preferences consent to randomization, this is likely also affect its internal validity (e.g. Schmoor et al, 1996). Those who receive preferred treatment are typically more motivated, comply better with treatment and report better outcomes (e.g. Linn et al, 2005; Preference Collaborative Review Group, 2008). Patients not receiving a preferred treatment may experience demoralisation, may be less motivated, may not comply with the treatment regimen, may not provide accurate self-report data during follow-up, and may even drop out of the study, contributing further bias to the internal validity of the trial (e.g. Howard &Thornicroft, 2006; Torgerson & Sibbald, 1998). 5) Demoralized patients who feel they are assigned to the wrong intervention can seriously disrupt the group dynamics of group interventions, such as mindfulness-based programs. These are serious issues that caste serious doubts upon the conclusions of Goyal et al. study. RCTs with waiting list as control procedure is, of course, also not the solution to the problems, but does counter many of the above objections: Humans are recognized as cognizant human beings who often have preferences about how they would like to spend their time and effort. The wait period is not sufficient as placebo but may, in fact, come closer to placebo than most active control programs. Perhaps separate evaluation of each of these types of RCT in a single study might provide a somewhat clearer picture. In any case, ignoring “no treatment” control procedures is just plain wrong. ReferencesLin P, Campbell DG, Chaney EF, Liu CF, Heagerty P, Felker BL, Hedrick SC. The influence of patient preference on depression treatment in primary care. Ann Behav Med. 2005, 30:164-73.Preference Collaborative Review Group. Patients' preferences within randomised trials: systematic review and patient level meta-analysis. BMJ 2008, 337:a1864. Schmoor C, Olschewski M, Schumacher M. Randomized and non-randomized patients in clinical trials: experiences with comprehensive cohort studies. Stat Med 1996 15:263-271. Torgerson DJ, Sibbald B. Understanding controlled trials. What is a patient preference trial? BMJ 1998, 316:360.
    CONFLICT OF INTEREST: None Reported
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    Mindfulness-based interventions in routine clinical care for stress-related ailments
    David S Black PhD MPH, Jeffrey M Greeson PhD | Keck School of Medicine University of Southern California, Perelman School of Medicine University of Pennsylvania
    The meta-analysis by Goyal et al. (1) appraises evidence on the efficacy of mainstreamed meditation programs that target stress-related outcomes in adult clinical populations. The authors concluded that mindfulness-based interventions (MBIs) (N=36 trials) showed statistically significant and clinically relevant effects for anxiety, depression, pain, stress/distress, and quality of life whereas other forms of meditation did not yield such effects. The observed effects support efforts that aim to integrate MBIs into routine healthcare recommendations made by clinicians, especially for patients who are interested in and receptive to the approach. We interpret the positive evidence from the review to indicate an opportunity for clinicians to recommend MBIs as a means to help patients engage in a participatory process of care. To support this recommendation, here we briefly compare effects sizes between MBIs and other commonly used clinical recommendations for stress-related ailments.According to Goyal, MBIs confer an average beneficial effect size of 0.30 on depressive symptoms at 8 weeks with effects lasting up to 6 months. For comparison, the overall mean effect size for commonly prescribed antidepressant medications for mild to moderate depression is 0.17 or below. (2) Further, based on trials that include active controls, MBIs can yield stronger effects on depression than the national recommended levels of physical activity, (3) and can yield comparable or stronger effects than relaxation training in head-to-head comparisons. (4) Similar comparisons can be made for anxiety, pain, and quality of life outcomes. (5) There were too few trials with active control groups in the Goyal et al. review to reliably determine effects on other important stress-related outcomes such as substance use, eating behavior, and sleep. Consequently, the evidence-base for MBIs is not developed enough at this time to make confident recommendations for these particular conditions. Recent special issues of other journals however, have made marked advances in elucidating the psychological, neurobiological, and behavioral pathways through which MBIs and mindfulness meditation practice can alleviate common stress-related symptoms such as smoking, unhealthy eating, and social anxiety, and can modulate brain structure, function, and connectivity. (6,7,8) Healthcare problems involving stress-related ailments are prevalent and costly, and it is essential that these ailments be adequately addressed to help patients move in the direction of taking personal accountability for pursuing optimal health. Where anxiety, depression, pain, stress/distress, and mental health-related quality of life appear relevant, clinicians should consider recommending MBIs to their patients along with other routine care recommendations. This approach is important considering that only 3% of primary care office visits include counseling on stress management, (9) presumably due to lack of time. Thus, MBIs offer patients the opportunity to be more proactive in their own health care by helping them make a persistent and sometimes daily effort in self-care and stress management, typically setting the intention for lasting lifestyle change. MBIs have a role in the future of medical care as they focus on putting day-to-day participation in health back in the hands of patients.References1. Goyal M, Singh S, Sibinga EMS, et al. Meditation Programs for Psychological Stress and Well-Being. JAMA Int Med. 2014;174:357-368.2. Fournier JC, DeRubeis RJ, Hollon SD, et al. Antidepressant drug effects and depression severity: a patient-level meta-analysis. JAMA. 2010;303:47-53.3. Cooney GM, Dwan K, Greig CA, et al. Exercise for depression. Cochrane Database of Syst Rev. 2013;9:CD004366.4. Jain S, Shapiro SL, Swanick S, et al. A randomized controlled trial of mindfulness meditation versus relaxation training: effects on distress, positive states of mind, rumination, and distraction. Ann Beh Med. 2007;33:11-21.5. Jensen MP, Day MA, Miró J. Neuromodulatory treatments for chronic pain: efficacy and mechanisms. Nat Rev Neurol. 2014;10:167-178.6. Black DS. Mindfulness-Based Interventions: An Antidote to Suffering in the Context of Substance Use, Misuse, and Addiction. Subst Use Misuse. 2014;49:487-491.7. Tang Y-Y, Posner MI. Special issue on mindfulness neuroscience. Soc Cogn Affect Neurosci. 2013;8:1.8. O'Reilly GA, Cook L, Spruijt-Metz D, Black DS. Mindfulness-based interventions for obesity-related eating behaviours: a literature review. Obesity Reviews. 2014;15:453-461.9. Nerurkar A, Bitton A, Davis RB, Phillips RS, Yeh G. When Physicians Counsel About Stress: Results of a National Study. JAMA Int Med. 2013;173:76-77.
    CONFLICT OF INTEREST: None Reported
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    Original Investigation
    March 2014

    Meditation Programs for Psychological Stress and Well-being: A Systematic Review and Meta-analysis

    Author Affiliations
    • 1Department of Medicine, The Johns Hopkins University, Baltimore, Maryland
    • 2Department of Pediatrics, The Johns Hopkins University, Baltimore, Maryland
    • 3Department of Psychiatry and Behavioral Services, The Johns Hopkins University, Baltimore, Maryland
    • 4Department of Health Policy and Management, Johns Hopkins School of Public Health, Baltimore, Maryland
    JAMA Intern Med. 2014;174(3):357-368. doi:10.1001/jamainternmed.2013.13018
    Abstract

    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.

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