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Trial By Error: The Surprising New BMJ Best Practice Guide



By Steven Lubet, JD, and David Tuller, DrPH

Something has changed. 
 
That’s the only explanation for the recent publication of a “Best Practice” guide for “chronic fatigue syndrome” (behind a paywall, unfortunately) from the BMJ Publishing Group. This thing is good. It’s very good, in fact. One bottom line at this stage for any treatment guide is the following: Would it lead a clinician to prescribe cognitive behavior therapy or graded exercise therapy for patients with ME, as opposed to those suffering from a vague fatiguing illness? The answer here is an unequivocal no.
 
The guide doesn’t refute the PACE trial by name. It doesn’t have to. With its strong emphasis on the many physiological dysfunctions that characterize the illness, the guide represents a refutation not only of PACE itself but of the deconditioning/fear-of-exercise hypothesis—the foundational myth of the CBT/GET cult. It is hard to imagine that any organization associated with the British medical and academic establishment would have published this document just two years ago, before patients’ concerns about the PACE trial mushroomed into an international scientific scandal. Someone over at BMJ obviously understands that the field has moved beyond the simplistic and unproven claims of the biopsychosocial field.
 
The author, Dr. James Baraniuk, is an immunologist at Georgetown University and an expert on ME/CFS as well as Gulf War Illness. (Just this month, in a study in the journal Scientific Reports, he and a colleague reported distinctive molecular patterns in the cerebrospinal fluid of chronic fatigue syndrome patients, Gulf War Illness patients, and healthy controls after a round of exercise.) The best practice guide’s peer reviewers were Rosamund Vallings (Howick Health and Medical Centre, New Zealand), Abhijit Chaudhuri (Queen’s Hospital, Essex, UK), and, surprisingly, PACE lead investigator Peter White. Recommending an article for publication does not necessarily indicate agreement with its conclusions, but Professor White still deserves some credit for apparently approving this document, since it essentially demolishes the claims he and his colleagues have made for decades. 
 
Let’s be clear: While it was The Lancet that published the first PACE results, The BMJ has also failed to distinguish itself in the debate. Just one example: When the first PACE results were published, The BMJ stated in a news report that 30 percent of the participants receiving CBT and GET had been “cured”—an obvious misinterpretation of the trial’s findings that BMJ editors have never bothered to correct.

In the best practice guide, Dr. Baraniuk repeatedly makes the following salient points: 
 
*”Post-exertional malaise” or “exertional exhaustion” is the distinguishing characteristic of the disease; as noted in the guide’s summary, this symptom is a possible result of “autoimmune and metabolomic dysfunction that reduces mitochondrial ATP production.” 
 
*Oxford criteria studies should not be used to determine treatment approaches to patients identified by more narrow case definitions, such as for ME, that require post-exertional malaise and other core symptoms.
 
*Cognitive behavior therapy and graded exercise therapy are not indicated for patients with narrowly defined illness, whether or not these treatments might be indicated for patients with idiopathic chronic fatigue or fatigue arising from psychological causes. 

Dr. Baraniuk’s report therefore rejects CBT and GET as effective therapies for appropriately diagnosed ME/CFS patients, as the following quotes indicate:

*[T]he prospect that CBT can change the illness beliefs of a patient, and that graded activity can reverse or cure CFS, is not supported by post-intervention outcome data.

*There is widespread concern among CFS physicians that mandated exercise programmes can cause significant patient deterioration because of the exercise-induced musculoskeletal pain, neurocognitive impairment, weakness, and prolonged bed rest patients may require to recover from them.

*[I]n routine medical practice CBT has not yielded clinically significant long-term benefits in CFS.

This report puts the National Institute for Health and Care Exellence (NICE) to shame. NICE develops clinical guidelines that are widely followed in the U.K, and in other countries as well. A NICE surveillance team had the opportunity to review the same recent literature available to Dr. Baraniuk and recommended in June that the agency should make no changes to its 2007 guidance—which of course highlights CBT and GET as effective treatments.

In September, after patient organizations expressed overwhelming opposition to this recommendation, NICE rejected it and announced that the 2007 guidance would instead undergo a complete overhaul. The new NICE committee that will be tasked with developing fresh guidelines should thank Dr. Baraniuk for providing them with a pretty good road map.

It would be fascinating to learn the back-story of this report. What did the BMJ Publishing Group expect when Dr. Baraniuk took on this assignment? What did Professor White really think during his peer-review of a document that inflicts such serious damage on his legacy? Do Professor White and his colleagues finally recognize that the larger scientific community has rejected their flawed trial and that their long reign over this domain of research is finally coming to an end?

It is too soon to tell whether Dr. Baraniuk’s report will turn out to be an inflection point in the British understanding and treatment of ME/CFS. Old prejudices (and paradigms) die hard, and the PACE-influenced U.K. medical and academic establishment is deeply entrenched. Nonetheless, it may soon become impossible for anyone to continue to argue that valid research can be based on the Oxford criteria or that “best practices” can embrace the discredited CBT/GET model.



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