The most interesting things to be learned from a recent clinical trial of mindfulness-based stress reduction to cognitive behavior therapy for chronic back pain are not what the authors intend.

Noticing that some key information is missing from the study illustrates why we don’t need more studies like it.

We need more studies of mindfulness-based therapies with meaningful comparison/control groups.

We need evidence that patients assigned to mindfulness-based treatments actually practice mindfulness in their everyday lives.

We need to demonstrate that any efficacy of mindfulness depends upon patients assigned to it actually showing up.

We need to be alert how boundaries of the concept of mindfulness-based therapies are expanding. Reviewers should be cautious in integrating results from different studies claiming to evaluate “mindfulness.” There is growing clinical heterogeneity – different interventions, sometimes with very different components–that should be distinguished.

For only the second time in its history, the flagship journal of the American Medical Association, JAMA has published a clinical trial of mindfulness. .

The importance of this study was underscored by (1) an accompanying editorial commentary, (2) free access and continue education credit for reading it, and (3) three multimedia links –a JAMA Report on the study, and audio in video interviews with the author.

Cherkin DC, Sherman KJ, Balderson BH, Cook AJ, Anderson ML, Hawkes RJ, Hansen KE, Turner JA. Effect of Mindfulness-Based Stress Reduction vs Cognitive Behavioral Therapy or Usual Care on Back Pain and Functional Limitations in Adults With Chronic Low Back Pain: A Randomized Clinical Trial. JAMA. 2016 Mar 22;315(12):1240-9.

The trial registration is Comparison of CAM and Conventional Mind-Body Therapies for Chronic Back Pain.

The protocol is available here.

The editorial commentary by Madhav Goyal and Jennifer Haythornthwaite JA asked:

Is It Time to Make Mind-Body Approaches Available for Chronic Low Back Pain?

My recent discussions of articles in JAMA network journals that are accompanied by editorial commentaries have contemplated why particular studies were chosen for JAMA journals and the conflicts of interest that characterize editorial commentaries. This discussion will be somewhat different.

This commentary is definitely written by authors who have reasons to promote mindfulness. The commentary ends with a predictable non sequitur:

High-quality studies such as the clinical trial by Cherkin et al create a compelling argument for ensuring that an evidence-based health care system should provide access to affordable mind-body therapies.

Not exactly, if you stick to the evidence.

I will eventually comment on my usual questions of:

Why was this article published in a prestigious, generalist medical journal?

Why was it accompanied by an invited editorial commentary?

Why were the particular authors chosen for the commentary?

But the commentary isn’t that bad. It makes some reasonable points that might be overlooked. I will mainly focus on the article itself.

Abstract

Importance. Mindfulness-based stress reduction (MBSR) has not been rigorously evaluated for young and middle-aged adults with chronic low back pain.

Objective. To evaluate the effectiveness for chronic low back pain of MBSR vs cognitive behavioral therapy (CBT) or usual care.

Design, Setting, and Participants. Randomized, interviewer-blind, clinical trial in an integrated health care system in Washington State of 342 adults aged 20 to 70 years with chronic low back pain enrolled between September 2012 and April 2014 and randomly assigned to receive MBSR (n = 116), CBT (n = 113), or usual care (n = 113).

Interventions. CBT (training to change pain-related thoughts and behaviors) and MBSR (training in mindfulness meditation and yoga) were delivered in 8 weekly 2-hour groups. Usual care included whatever care participants received.

Main Outcomes and Measures. Coprimary outcomes were the percentages of participants with clinically meaningful (≥30%) improvement from baseline in functional limitations (modified Roland Disability Questionnaire ; range, 0-23) and in self-reported back pain bothersomeness (scale, 0-10) at 26 weeks. Outcomes were also assessed at 4, 8, and 52 weeks.

Results. There were 342 randomized participants, the mean (SD) ). Findings for MBSR persisted with little change at 52 weeks for both primary outcomes.

Conclusions and Relevance Among adults with chronic low back pain, treatment with MBSR or CBT, compared with usual care, resulted in greater improvement in back pain and functional limitations at 26 weeks, with no significant differences in outcomes between MBSR and CBT. These findings suggest that MBSR may be an effective treatment option for patients with chronic low back pain.

Among the interesting things to note in the abstract is that there were only modest (p <.04) differences between either MBSR or CBT and usual care, which was described as “whatever participants received.” The MBSR was augmented by yoga. We cannot distinguish the effects of mindfulness from this added component.

Unfortunately, if you do a search for “usual care” or “yoga” in the article itself or in the trial registration or protocol, you won’t learn about what the nature of the usual care or yoga. You will learn, however, in the article that:

Thirty of the 103 (29%) participants attending at least 1 MBSR session reported an adverse event (mostly temporarily increased pain with yoga). Ten of the 100 (10%) participants who attended at least 1 CBT session reported an adverse event (mostly temporarily increased pain with progressive muscle relaxation). No serious adverse events were reported.

Secondary outcomes

Some outcomes that would be of interest to policy makers, clinicians, in patients are relegated to a secondary status: whether medication was used in the past week, whether back exercises were done for at least three days, and whether there was general exercise for more than three days.

There were no consistent effects of these interventions versus routine care for these variables.

Intensity of treatment

Unless a study is focusing simply on differences in intensity of treatment, comparisons of treatments should ensure that the conditions being compared are equivalent in the intensity and frequency of clinical contact. In this trial:

The interventions were comparable in format (group), duration (2 hours/week for 8 weeks, although the MBSR program also included an optional 6-hour retreat), frequency (weekly), and number of participants per group.

Only about a quarter of the patients assigned to MBSR attended the six hour retreat, compounding the problems of adherence (around half of patients assigned to either to MBSR or CBT attended at least six group sessions), which also suggests that the 20% of patients lost to follow-up may not be random. That poses issues for the fancy statistical techniques used to compensate for attrition, which assume the missing data are random.

But the bigger issue is that the interventions provide a lot more contact than is typically available in routine care for chronic pain. There are lots of opportunities for important differences between the interventions and control group in nonspecific factors, like supportive accountability.

More contact communicates the patients that they matter more. Getting more interaction with providers means patients have more of a sense that their adherence matters (i.e., they are accountable) to someone besides themselves for activities like daily back exercises. The more intensive treatment also influences self-reported subjective outcomes, even when effects are not shown for other important variables, like decreased use of medication.

Distinguishing MBSR from CBT

MBSR was modeled closely after the original MBSR program—adapted from the 2009 MBSR instructor’s manual by a senior MBSR instructor. The MBSR program does not focus specifically on a particular condition such as pain. All classes included didactic content and mindfulness practice (body scan, yoga, meditation ).

The original manual that is cited comes from the University of Massachusetts Medical School. If you go the website you can find Mindfulness-Based Stress Reduction (MBSR): Standards of Practice .

The standards describe the yoga component as

“Formal” Mindfulness Meditation Methods

Body Scan Meditation – a supine meditation

Gentle Hatha Yoga – practiced with mindful awareness of the body

Sitting Meditation – mindfulness of breath, body, feelings, thoughts, emotions, and choiceless awareness

Walking Meditation

My concern is that an RCT has been published in JAMA concludes that a combined mindfulness and yoga treatment “may be an effective treatment option for patients with chronic low back pain.” Past research by some of the authors this JAMA article suggests that yoga by itself provides only short-term benefits for patients with chronic pain. This particular study had worrisome adverse effect from the yoga component. Why add something unnecessary to treatments if they may have adverse effects?

Although the providers of MBSR are described as having training in MBSR, there is no mention of training specifically for yoga for patients with chronic back pain.

Practitioners of yoga who have intermittent chronic pain tell me that it has been very important for them to find yoga instructors who are competent to deal with pain. A single, ill-chosen exercise can inflict long-term damage on patient who already has chronic back pain.

The CBT protocol included CBT techniques most commonly applied and studied for chronic low back pain. The intervention included (1) education about chronic pain, relationships between thoughts and emotional and physical reactions, sleep hygiene, relapse prevention, and maintenance of gains; and (2) instruction and practice in changing dysfunctional thoughts, setting and working toward behavioral goals, relaxation skills (abdominal breathing, progressive muscle relaxation, and guided imagery), activity pacing, and pain-coping strategies. Between-session activities included reading chapters of The Pain Survival Guide: How to Reclaim Your Life. Mindfulness, meditation, and yoga techniques were proscribed in CBT; methods to challenge dysfunctional thoughts were proscribed in MBSR.

Many stripped-down versions of CBT offered in primary care do not have all these components, leaving out the abdominal breathing, progressive muscle relaxation, and guided imagery. Many eclectic versions of mindfulness training incorporate progressive muscle relaxation.

Given the about 50% attendance to at least six sessions in the modest uptake of the mindfulness retreat, I’m not sure that that these two interventions often distinctly different experiences. It’s doubtful that questions of whether these two treatments are characterized by distinctly different mechanisms could be addressed in this trial.

Routine Care for Chronic Pain in the US

Routine care for chronic back pain differs widely in the United States. Episodes of care – a clustering of visits around a complaint – do not typically occur beyond a month or couple of visits.

Routine care can be no care at all after initial evaluation in which diagnosis of chronic back pain is recorded.

But routine care for chronic back pain that is guideline-congruent can ironically prove iatrogenic. It can involve overtreatment, unnecessary exposure to opioids and antidepressants without adequate evaluation or follow up, and unnecessary surgeries.

We are living in the aftermath of pain being identified as the Fifth Vital Sign. In some settings, every patient has to be assessed with a simple rating scale of pain, regardless of the reason for visit. Providers have to document that they asked about pain and what procedures or referrals they provided if the patient reported other than “no pain.” Providers are penalized for not recording interventions when there is any pain indicated. They may lose insurance reimbursement for the visit.

There is currently a campaign to overturn these ridiculous and harmful guidelines, which are not evidence-based. The effect of the guidelines having that prescribed opioid pain medications rivaled heroin in terms of its negative public health impact. There is also been an epidemic of unnecessary back surgery, sometimes with crippling adverse effects.

But the guidelines have also induced despair and an unwillingness to address a condition that often must be endured with minimal intervention, rather than burdening clinicians and patients with the unrealistic expectation that it will be cured or eliminated. Clinicians are not good at dealing with conditions for which they do not have solutions.

I suspect that many of the patients in this study who remained assigned to routine care were getting minimal or no care. They were being provided little or no monitoring or reassessment of pain medications; little encouragement to engage in back exercises with regularity needed for them to be effective; and little support in the face of success and failures of getting on with their life in the face of chronic back pain.

Once again, we have an expensive study of mindfulness that does not address the question of whether any apparent effectiveness is simply due to increased intensity and frequency contact with the medical system and support.

We don’t know if the intervention is simply correcting the inadequacies or lack of routine care.

We cannot determine whether a better use of funds would be to improve the overall quality of routine care for chronic pain, including for the bulk of patients who have no interest in devoting the necessary time in the daily lives to practicing mindfulness.

The editorial commentary

The intended answer to the question posed by the title is obviously yes: Is It Time to Make Mind-Body Approaches Available for Chronic Low Back Pain?

The assessment provided by the commentary is:

A compelling argument for ensuring that an evidence-based health care system should provide access to affordable mind-body therapies.

Like the authors of the trial itself, the commentators are trying to get reimbursement for treatment that is provided through a designated mind-body center. Whether or not mind-body centers improve patient outcomes, they are useful for the intensive competitive marketing of medical centers.

Like the authors, the commentators are not only competing for funds from the National Center for Complementary and Integrative Health , they hoping to get more funds to this National Institute of Health.

The authors of the trial are connected. They have previously co-authored a study of acupuncture for chronic back pain with NCCAM program officers who are listed in the article as influencing and revising interpretations of the data. We have ample evidence acupuncture is not a science based medicine intervention chronic back pain. Any apparent effects are nonspecific. An illusion of effectiveness is likely to emerge in a comparison with routine care that lacks these nonspecific effects. I can’t believe the authors don’t know that.

So we’ve come in another route, but we’ve arrived at the same old story.

Authors with connections get their articles into prestigious, generalist medical journals.

Even though the evidence does not report the strong claims that are made, they are amplified with goodies like the article been freely available, having free continuing education, and other promotions like audio and video links.

Authors of the invited commentaries are written by persons with similar connections and similar vested interest.

I don’t think this article should have made it into JAMA. I don’t think it deserved an editorial commentary. If one were nonetheless provided, it should interpret for a general medical audience issues of the inadequacies of routine care, and inadequacy of routine care as a comparison group, and the practical issues of allocating scarce resources. An accompanying editorial should be reserved for articles more special than this one, and should offer a more detached, objective assessment of the strengths and weaknesses of a study and their implications.

MBSR spans New Age religious and science, as well as, evidence-based versus alternative, non-evidence-based treatments. The new agey aspect is emphasized in the titling of the trial registration including a designation as “CAM and Conventional Mind-Body Therapies.”

We must be alert to MBSR being hyped, promoted beyond what is justified by available evidence, – and now – it leading the charge of non-evidence-based treatments into reimbursement and competition for scarce resources in an already overexpensive and malfunctioning health system.

by James Coyne For Plos