David Orme-Johnson, Ph.D.
This is a critique of a comparative effectiveness review entitled “Meditation Programs for Stress and Well-being,” which was prepared for the U.S. Government's Agency for Healthcare Research and Quality (AHRQ) and posted on their website from December 4, 2012 through January 2, 2013 (1).
The AHRQ’s non-scientific process
The main problem with this report (“Meditation Programs for Stress and Well-being,”) is that the AHRQ review process does not adhere to even the minimal standards of science that any professional journal requires.
Peer-reviewed journals send submitted papers to independent outside reviewers to critique, and the authors of the submission must address the weaknesses and flaws identified by the reviewers and incorporate changes into the submission to the satisfaction of the reviewers before the paper is published in the journal. AHRQ does invite outside professional as well as public reviews. However, study authors are not required to make changes that satisfy the reviewers’ criticisms before they publish their reports. They only promise to make revisions, “as appropriate” through some opaque internal process to be posted three months after the review is finalized. In any journal review, the researchers may even have to go back and do more research and analyses and completely revise the paper, with the reviewer’s final signing off on it before it is acceptable for publication. The AHRQ reviews do not have such a transparent process of interaction with the reviewers in place, and consequently, there is no real accountability to the scientific community (2). As a scientist and taxpayer who has paid for this report, as well as paid for all the salaries of the AHRQ personnel, I have to say that the AHRQ review process is a sham, blatantly ignoring the most basic tenets of the scientific process, making it completely open to bias and vulnerable to the agendas of special interest groups.
Bias in the inclusion criteria
Meta-analysis is a completely objective process, as far as the mathematics of quantifying the effects of a body of studies is concerned. There are indeed many choices and decisions on how to conduct it, but these are explicitly stated and transparent. Where subjectivity and bias can creep in is in the selection of what studies to include (3, 4).
The guiding principle for what studies to include should be the best controlled and most relevant ones for addressing the major question being posed by the analysis: “This report reviews the efficacy of meditation programs on stress-related outcomes among those with a clinical condition.” Yet this report excludes meditation studies on hypertension, chronic heart failure, arterial sclerosis and other aspects of cardiovascular disease, which are arguably the conditions most well-documented to be stress-related (5-7). The omitted meditation studies in this area used highly objective outcome measures, such as decreased blood pressure in hypertensive patients (8-13), arterial blockage in patients with blocked arteries (14), decreased mortality due to cardiovascular disease and by all causes in hypertensive patients over an 18-year period (13, 15, 16), reduction of enlarged hearts in patients with left ventricular hypertrophy (17, 18), and decreased strokes, heart attacks and death due to all causes over a ten-year period in patients with at least 50% blockage of one or more of the major arteries to their heart (19).
All these studies used active treatment control groups to control non-specific effects, such as expectation, attention, social support, amount of contact time with the instructors, and other factors. All were on the Transcendental Meditation technique (TM) and there are no such studies on mindfulness. Yet, studies on mindfulness on much more subjective outcomes, such as pain perception, were included. The selection process of what studies to include in this AHRQ report suggests a bias that is not in the national interest. The review was initially presented as being on all types of meditation, yet the name given in the download of the preliminary report is simply “Mindfulness Meditation.”
Another exclusion criterion not favorable to the TM technique but favorable to mindfulness techniques was excluding studies on adolescents, who are not “children” using different techniques, as the report asserts. Learning to meditate in early adulthood could potentially reduce stress-related problems and diseases and increase the quality of life across the lifespan (6, 17, 20-22). The report also misclassifies the TM technique as “concentration” meditation, even though it is consistently characterized as an effortless technique requiring no concentration (23, 24), and recently as automatic self-transcending (25).
The advantages and limitations of active controls in behavioral research and using cross-validation to solve the problem. The AHRQ report only included studies that used active control groups to control for non-specific effects, which is good. But there can be problems interpreting such studies. For example, in a study on anxiety prominently cited in the review as evidence that TM does not work, Smith (1976) carefully constructed a control group that had received all same the expectation fostering features and procedural details as the TM program and found that both TM and the control group reduced anxiety (26). Does this mean that TM is just a placebo? Not necessarily. TM’s reduction of anxiety is cross-validated by studies showing it reduces autonomic correlates of anxiety, such as respiratory rate, skin resistance, and plasma lactate, compared to sitting comfortably with eyes closed as is done in TM practice (27). It also reduces cortisol, a major stress hormone in humans (28), and reduces stress reactivity (22, 29, 30). Coronary heart disease is a correlate of anxiety (31, 32) and TM practice reduces coronary heart disease (5). Physiological cross-validating evidence should be included in evaluating outcomes such as Smith’s. The abstract of the AHRQ report states: “We need more research using adequately powered high-quality randomized controlled trials that address the effects of meditation programs on stress and its correlates (emphasis added).” Yet, the review ignored precisely that information, the physiological and medical correlates of stress.
The review should also be broadened to take into account the results of previous meta-analyses. To continue with the example of Smith’s study, it is relevant that a recent meta-analysis, conducted by researchers at Chemnitz University in Germany, who are completely independent of any TM organization, found that TM practice reduces anxiety more than mindfulness and other meditation techniques (33). The studies included were not limited to randomized controlled trails (RCTs), but they do replicate an earlier meta-analysis, which also found that TM practice reduced anxiety more than other meditation and relaxation techniques, even when only RTC’s conducted by researchers who were neutral or negative towards the TM technique were included (34). The other meditation and relaxation treatments that the TM technique has been compared with in these meta-analyses provides a wide range of controls for attention, expectation, social support, etc. that support the conclusion that TM has non-specific effects on reducing anxiety, regardless of the conclusions from Smith’s study.
Tunnel vision
This AHRQ report used a set of exclusion/inclusion criteria that severely limited its perspective on the current status of meditation research on stress and well-being, which led to highly distorted conclusions. I was invited to be a key informant at the beginning of this study, and I emphasized to the study group that they needed to include studies on objective outcomes on stress and its correlates, such as cardiovascular disease, and that they needed to examine cross-validating physiological evidence of stress reduction. Apparently, they had another agenda than to provide a balanced picture of the evidence.
References:
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