NICE

By David Tuller, DrPH

Professor Trudie Chalder, Professor Peter White and like-minded members of the CBT/GET ideological brigades have appeared desperate in the last year to promote their favored interventions, publishing one shoddy paper after another. This stream of sewage has seemed intended  to influence the new ME/CFS clinical guidelines that Britain’s National Institute for Health and Care Excellence (NICE) has been developing since 2017. NICE called off the scheduled August 18^th publication of the new guidelines, which formally reject the longstanding treatment paradigm for ME/CFS, because of fierce objections from the cabal of CBT/GET true believers.

High-profile researchers like Professor Chalder and Professor White continue to mislead readers and tart up pathetic findings from both randomized trials and clinical services. Patients long ago recognized that this research base is a mountain of hooey. In recent years, that clear-eyed perspective has become more widely adopted. It is not surprising that NICE now finds itself squeezed between the actual evidence on one side and the braying of eminent pooh-bahs on the other–that’s what happens when paradigms undergo major shifts.

Those on the losing end of the scientific argument–in this case the CBT/GET cabal–are exquisitely aware of their deteriorating position. They know that the new NICE guidelines will have a negative impact on their reputations and ambitions. It is easy to understand why they are so motivated to prevent NICE from publishing the guidelines in their current form.

The new guidelines, for example, could hamper ongoing efforts to extend these psychological and behavioral treatments to all forms of so-called “medically unexplained symptom”–whether through the National Health Service’s metastasizing Improving Access to Psychological Therapies program or through other means. The guidelines will also impair the ability of the CBT/GET cabal to colonize long COVID as yet another category of MUS requiring their forms of rehabilitation rather than a biomedical approach. Just this week, the British Psychological Society proposed the creation of screening tools to identify people suffering from “perfectionism” and other unfortunate personality traits that are purported risk factors for developing long COVID. (I gather this proposal has now been rescinded.)

Perhaps Professor Chalder and her colleagues believe that the volume of studies confers some sort of credibility on the content. That strategy might work in some cases, but not when the research is as misleading as the GET propaganda Professor Chalder and colleagues published in July in the journal Disability and Rehabilitation. (This publication comes after, among other instances, Professor Chalder’s misleading CBT paper last fall in the Journal of the Royal Society of Medicine, to which Professor Brian Hughes and I published a rejoinder; and Professor White’s misleading GET paper in the Journal of Psychosomatic Research, which was corrected to make it clear that the study had null results.)

The Disability and Rehabilitation paper is called “Graded exercise therapy for patients with chronic fatigue syndrome in secondary care: a benchmarking study.” The authors investigated clinic data from 92 attendees who had filled in questionnaires at baseline. The participants were asked to fill out the same questionnaires at multiple subsequent timepoints. The authors compared pre- and post-treatment assessments on a range of measures, including fatigue and physical function.

The abstract presents the positive conclusion that GET is “effective” while leaving out significant amounts of information–in particular, that the number of those responding to the various questionnaires post-treatment ranged from 32 to 67 of the 92 who provided baseline data. Those are pretty big drop-off numbers. It is difficult to interpret findings with confidence when little information is known or provided about why participants failed to respond to questionnaires.

**********

Conflation of association and causation

Beyond that, the paper is fraught with sloppy argumentation and apparent confusion over the difference between association and causation. It is sad that some people seem to learn nothing despite their many years of experience. The thinking behind GET in the new paper is stale. It could have been written three decades ago:

“Fatigue symptoms experienced by patients with CFS/ME lead to a general decrease in activity which over time causes the body to become weaker and deconditioned. The graded exercise programme aims to reverse this, so the body becomes stronger and reconditioned, thereby reducing symptoms. Core aims of GET are to increase muscle flexibility, muscle strength, and fitness levels so that activities that may be difficult at the start of treatment can be carried out more comfortably in the future.”

Despite no reliable evidence that ME/CFS symptoms have any relationship to the supposed presence of “deconditioning,” Professor Chalder and her colleagues parrot this argument as if it is acknowledged fact–not an unproven and widely rejected theory. This is akin to Trump’s repeated claims that he won the presidential election. Trump did not win the election, and ME/CFS patients do not need treatments premised on the need to reverse deconditioning.

This is 2021, not 1991 or even 2011, when Professor Chalder and colleagues published their first PACE results in The Lancet and could still earn praise and plaudits for their prattle. Deconditioning? Really? I am embarrassed for Professor Chalder; it is cringe-inducing that she and her colleagues have nothing to resort to here but this debunked rationale for GET.

The GET approach is at the core of an international medical controversy. The US Centers for Disease and Control and Prevention, for example, changed its mind on the issue and removed its recommendations for GET several years ago. Yet Professor Chalder and her colleagues have preferred to “disappear” the opposing views. They of course have an obligation to readers and to the medical literature to acknowledge rather than ignore the ongoing dispute.

The new study was not a clinical trial, and there was no control group. In the limitations section, the authors noted that “the lack of a controlled comparison group limits our ability to propose causal explanations about our patient outcomes.”

Exactly. This study can demonstrate at best that patients reported improvements following a course of GET. Because of its design, it cannot demonstrate a causal relationship–specifically, that the intervention itself rather than one or many extraneous factors was responsible for any reported changes.

Yet here is how the authors described what they did: “We investigated the effectiveness of graded exercise therapy (GET) delivered to patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) in a routine, specialist clinic.”

And here’s what they conclude: “GET is an effective treatment for CFS/ME within clinical practice.”

This is bullshit. The study documented a chronological association between treatment and outcomes. It is unwarranted to argue that the measured changes demonstrated that the intervention was “effective.” Declaring something to be “effective” is making a causal statement–and the authors have already noted that the study design limits their ability to do any such thing.

This sort of over-interpretation is expected from Professor Chalder, given her past record. In the paper published by the Journal of the Royal Society of Medicine, she and her co-authors similarly made causal assertions while disclaiming the possibility of doing so. It is disturbing that peer reviewers for Disability and Rehabilitation and the Journal of the Royal Society of Medicine overlooked these unjustified exaggerations. First-year epidemiology students at Berkeley know better than to commit such a basic offense against scientific reasoning.