Trial By Error: The Surprising New BMJ Best Practice Guide

By Steven Lubet, JD, and David Tuller, DrPH

Update: Nov 13th

We wrote this post based on a version of the guide that appeared recently and had been updated on July 31, 2017. That version lists Peter White as among three peer-reviewers. As commenters pointed out soon after the post went up, however, Peter White’s name is no longer on the peer-review list in the currently posted version of the guide, which indicates that it was updated this month. We are trying to determine when and why this change occurred.

**********

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.

Comments on this entry are closed.

  • Brenda Vreeswijk

    Would it be that “someone” finally comes to terms that the “false illness believes” were not in the patients heads?? Is “someone” trying to swing to the other side to create a smokescreen of some sort…or trying damage control??

  • Lisa Petrison

    Bravo David, well done!

  • Peter Trewhitt

    Fantastic news. It is a big step forward for us here in the UK. It will be interesting to see if the SMC responds to this and how the PACE appologists as a whole respond.

    It sounds like it does not even leave Esther Crawley wiggle room with her unsupported claim that ME/CFS is a biomedical condition but that it can be cured by CBT and GET.

  • Paul_Watton

    It looks like Prof. Peter White’s name has been removed from the list of peer reviewers: http://bestpractice.bmj.com/topics/en-gb/277

  • Wendy Boutilier

    Creepy may end up as the scape goat

  • Tina Marie Miller Tidmore

    I agree with the author putting “CFS” and “ME” into the category of a physiological illness, where the CBT is unproven and GET can be harmful, because of the post-exercise sickness symptoms. Then, on the other hand, you have chronic fatigue of unknown reason, idiopathic chronic fatigue or undiagnosed chronic fatigue. Whether CBT or GET, because it may be psychological, is unknown.

    Some put CFS with ICF saying those may be psychological. Then put ME in the physiological.
    But I think it’s more appropriate, as this study does, put CFS with ME.

    We all may be trying to say the same thing, just differing on the definition or name to use to make the distinction. I like the way this paper makes the distinction (as you report on it here).

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  • Peter Trewhitt

    Let’s hope that this is an indication of how the future rewritten NICE guidelines for ME/CFS might pan out.

  • Geoffrey Hallmann

    Indeed it has … but that’s okay … the copy I gave David certainly has it in there

  • Paul_Watton

    That’s intriguing. I wonder what’s going on?

  • Olivia Beatty

    Now we need Prof Baraniauk on the review panel. Are there enough UK physicians with the correct knowledge to lead the review? We don’t want 3 psychiatrists again.

  • mesupport

    Are BPS lobby a step ahead and putting CFS into the MUS (medically unexplained symptoms) category with the intention of holding onto anyone that cannot get an ME diagnosis.

  • Jo Best

    I would be interested in the back-story. IiMER posted that the BMJ Best Practice update was on the agenda of the IiMER Biomedical Research into ME Colloquium in 2016 and that Dr. Baraniuk sought input from all of the participants during the discussion. http://www.investinme.eu/BRMEC%20Colloquiums.shtml#brmec6

  • Erik Johnson

    Peter White did a presentation years ago where he admitted that his profession was responsible for the confusion, as they had accepted the way the meanings of ME and CFS had diverged from their original purpose.
    I take this as Dr. White “saw the writing on the wall” and made some effort to leave traces that protect his PERSONAL legacy.

  • Margaret Smith

    We don’t want or need ANY psychiatrists on the review panel. Nothing against psychiatrists per se, just don’t see the relevance of them being on a panel reviewing treatment options for what is clearly a physical condition.

    I’m sure there must be at least 3 physicians that could qualify. I suspect it’s possibly more a case of will they feel safe enough to put themselves forward given the likely backlash from certain quarters desperate to save face.

  • Tina Rodwell

    I have just read the treatment on this journal and I have to say I am concerned. Rehabilitation with the term Body awareness therapy fills me with the collywobbles and the fact it is coached by a physiotherapist. The paper Ref [212] is https://www.ncbi.nlm.nih.gov/pubmed/26306716 The second treatment is CBT.

    Multidisciplinary rehabilitation treatment is more effective at reducing long-term fatigue severity than CBT in patients with CFS. [212] Body awareness therapy, coached by a physiotherapist, aims to establish an increased awareness and consciousness of healthy bodily symptoms and their relation to physical function, psychological wellbeing, and social interaction. Unlike conventional CBT, immediate feedback is provided. The intent is to increase self-awareness and self-acceptance, reduce reactivity to passing thoughts and emotions, and improve the ability to make adaptive choices.

    In patients who have been chronically ill, mindfulness skills have a positive effect on depression, mood, and activity level.

    Normalisation of the sleep/wake rhythm begins by stopping daytime napping, and proceeds to improving the quality of sleep through relaxation therapy.

    Occupational therapists and social workers supervise social reintegration by making plans to return to work or school, and to increase social activities. Instruction is provided to prevent relapse.

  • Kat

    Amazing, thanks for reporting on this!

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  • Betty

    The UK is starting to look to the science!! Yeah.

  • Joan Byrne

    I have to agree with Tina here. I’ve only started to go through the document but it’s riddled with the bps double speak and the treatment options are extremely worrying. I would urge people to read it extremely carefully

  • disqus_joh5XNAv6w
  • Peter Trewhitt

    Yes, I too was wondering whether guides like this and the future NICE guidelines, if appropriately modified, will be of any help for people with the assorted MUS diagnosises. I have a long standing ME/CFS diagnosis where as a neighbour has a recent diagnosis of a functional neurological condition.

    It may be even if we escape the psychosocial model of ME/CFS sidetrack here in the UK over the next few years, there will still be a significant number of people trapped with unhelpful and misleading ‘psychiatric’ diagnoses being excluded from appropriate medical interventions.

  • Steve Hawkins

    Peter White himself disproved the ‘fear of exercise/deconditioning model’ in a paper of 2005. I’ve pointed this out before:

    It’s another amazing case where the results cry out that his theory is wrong, so he just moves the goalposts and carries on!

    “Graded exercise therapy (GET) has been advocated for CFS, on the basis that CFS is maintained by both the avoidance of activity and deconditioning. Two systematic reviews have concluded that there is high quality evidence of efficacy of GET in adult outpatients. Yet, many patients can drop out of GET or not even start it.  This may be related to a *fear of exercise, which is reported by the majority of CFS patients*.

    [He is interpreting an ME patient survey showing patient *knowledge* of the effects of exercise, as their ‘reporting of fear’. Outrageous! ]

    Fifty percent of 2338 members of an ME self-help charity held the belief that GET was damaging. Of 105 patients reporting their experience of exercise, 55% believed that their recovery would be facilitated by limiting their physical activity.  Even some doctors have deep concerns over the current application of graded exercise programmes…

    …The lack of a significant difference in physical activity in anticipation of the exercise test, both on the day of and the day before the test, suggests that there was no more anticipatory avoidant behaviour in CFS patients compared with healthy controls. However, there was a trend for the CFS group to have a shorter time on the treadmill, consistent with their perceived exertion being significantly higher at all three stages. This indicates that *the CFS group found the exercise more of an effort than the controls; a consistent finding in past studies. This was not associated with excessive physiological arousal, and therefore, we would conclude that it does not support the presence of an exercise phobia*. Because patients with comorbid psychiatric disorders were excluded, it is still possible that kinesiophobia is important in comorbid patients. This might explain why kinesiophobia, as measured purely by self-reported questionnaires, was found to be important in two previous studies that did include comorbid patients. The close correlation reported by Silver et al. between the kinesiophobia questionnaire score and the HADS depression and anxiety scores would suggest that the kinesiophobia maybe primarily related to comorbid mood disorders, rather than CFS itself. *Our data suggest exercise phobia is unlikely to be a maintaining factor in CFS alone, without the presence of a comorbid disorder.* The other contrast with previous work is that we used objective rather than subjective measures of avoidance and arousal…

     …As both groups were equally sedentary and inactive, this suggests that fatigue was not caused by current levels of inactivity.  The results from the psychological measures lend support to some of the perpetuating factors suggested by the cognitive–behavioural model for CFS being related to mood and somatic focusing.  Avoidance of exercise maybe caused by beliefs (or cognitions) that, in their current state of health, exercise is damaging or could exacerbate illness, rather than a phobia itself. CFS patients had a lower exercise tolerance than did the controls, although they were no more deconditioned than were the sedentary controls. Somatic focusing and sensitisation are more likely explanations for the excessive perception of effort.  *We conclude that CFS, without a comorbid psychiatric disorder, probably is not an exercise phobia, and fear avoidance is perhaps less important in CFS than chronic pain disorders.*  The cognitive behaviour model may need to be adapted to include beliefs and interoceptive sensitivity for avoiding activity.”

    Thus he starts off by offering up the fact that members of M.E self help groups ‘believe’ [on the evidence] that exercise may be harmful, as his starting FACT that most M.E patients are *afraid* of exercise!

    Then, when he finds that ‘CFS’ patients had lower skin resistance than controls [which he doesn’t mention] and this proves they are not afraid, he says ‘this must be because this time we used objective measures rather than subjective’ questionnaires; and, instead of concluding that the questionnaires are wrong, and saying so, he, presumably, just makes a mental note not to use objective measures next time! 🙂

    He actually finds that ‘CFS’ patients do perform worse in the exercise test, AND that it’s not due to deconditioning, even though they are matched with controls and less scared than them, and had no pre test anxiety the previous day: yet, instead of concluding this is the illness *actually being measured*, he just says they only ‘perceive’ they are fatigued: which is back where we started!

    Then he finishes by saying, essentially, they ought to drop the fear of exercise mainstay of their theory, and replace it with the idea that we are ill because we believe what the help groups tell us, instead of what he tells us!   By this reckoning, M.E could not have occurred before the charities were set up to help those suffering from it!!!

    I also might add, that they say they excluded one person because he had a ‘fatigue score of 0’. This highlights another often forgotten point: people with M.E are often people who were high end exercisers, who found their abilities failing dramatically for no good reason. They would be disbelieved and turned away from help until their ‘fatigue score’ rose above zero too. By which time they could–and do–suffer years of misery and patronising disrespect from the medical profession. Trial by questionnaire is a bloody outrage that should not be allowed.”

    https://www.ncbi.nlm.nih.gov/pubmed/15992572

    It’s also a surprise to see that Chaudhuri was a reviewer on this new guidance too, because I waited years to get a referral to his clinic, only to have him ridicule my attempts to explain my illness to him in barely any time while only being allowed to ‘choose three symptoms’. Then he wrote a scornful letter to my GP, with instructions that it wasn’t to be shown to me even though I have a legal right to see it.

    You might say, I found his attitude less than helpful.

  • Lolly

    Thank you for the important work!

  • Lolly

    thanks for the heads up on this Joan.

  • Lolly

    It took me a lot of years to figure out that attempting to push through got me into more and more trouble, as opposed to learning my own body signals to pause, rest or shift, that allowed me to do more things and spend more time in between crashes. I wish I had figured this out earlier in my illness although I expect there was time where it would not have made any difference. I have yet to meet a patient who did not tend to push through as a standard MO.

  • Fiona

    This is fantastic news! These guidelines MUST be presented to the NICE review.

  • It would be nice to have open peer review, and then we would have a better idea.

  • Thanks and well done for saving a copy!

  • Jenny Horner

    Great progress. Something to point medics to while the 3 year NICE review grinds along.
    BTW you can get a free trial of the BMJ best practice guides here http://bestpractice.bmj.com/info/subscribe/free-trial/

  • disqus_joh5XNAv6w

    Barb Robinson – a personal comment regarding a posting elsewhere.

    The question should be, why, in October was this released with PW
    acknowledged and re issued AGAIN without PW as a named Peer Reviewer?

    Either he did, or he did not?

    Surely this may bring the BMJ process into question? Surely, some
    statement needs to be issued formally by them about the changes, as both
    versions are available electronically.

    If there are differing
    views between the peer reviews, at the end of the day it was signed off
    and published. So one would presume there a consensus agreed prior to
    release or not?

    I presume the content reflects the peer reviewers
    opinion. If one is removed, what of the original text was he
    responsible for? Has the text within changed?

  • disqus_joh5XNAv6w

    There are some excellent psychiatrist who help,
    Dr Adrian Winbow MB BS, FRCPsych, DPM and Professor Basant Puri to name two who as psychiatrist can sort sheep from goats, unlike PW and SW

    ( ME from mental health conditions)

  • disqus_joh5XNAv6w

    BMJ,……. “best practice guide” three versions and counting…….?

    https://www.youtube.com/watch?v=rY0WxgSXdEE

    “Best Practice’ but not as we know it Jim” …..

  • Marija Miosic

    After the recent CDC changes, several good articles, and now BMJ best practice guide, I am cautiously optimistic that things are finally changing for ME/CFS. But being burned many times in the past let’s add _very_ cautiously optimistic.

    Thank you Mr. Tuller for keeping on top of things.

  • Eilidh Hewitt

    This article is wonderful news and shows that progress is being made but like you Tina I will be watching out for the chameleon like technique use by the BPS group as they change and shift to accommodate and slither out of trouble whilst holding on to power. I expect the sections on therapies have most likely been entered by PW thus accounting for his taking part as a reviewer.

    These two therapies are just GET by other names:

    Normalisation of the sleep/wake rhythm begins by stopping daytime
    napping, and proceeds to improving the quality of sleep through
    relaxation therapy.

    Why exchange a restorative nap with a therapy it makes no sense at
    all. Naps in ME most often enhance night time sleep rather than damage it.

    Occupational therapists and social workers
    supervise social reintegration by making plans to return to work or
    school, and to increase social activities. Instruction is provided to prevent relapse.

    This quote gives Esther a get out clause I think she has used similar wording recently.

  • 1SarahL1

    Here’s the whole document, so people can read for themselves what great progress this is… it is a disaster, imo and will do nothing to alleviate our suffering. It appears to be a damage limitation exercise – limiting damage to the psyche profession, not to folk with ME: https://drive.google.com/file/d/0B57eLIp17Q8MNEtlV2RnSG54N28/view

  • anniekim

    I am just skim reading it now and will try to read properly. I have to say on reading so far I still have many concerns. Yes, the guide does point out there is research coming out that shows metabolic dysfunction and graded exercise can make many worse, which on the surface is some progress. Yet the treatment recommendations are still focused on rehabilitation and CBT. Also the document rightly says Oxford and NICE criteria should not be used but still wrongly recommends Fukuda as a valid criteria. It also criticises ICC criteria.

    Also says the CFS definitions require PEM. Yet fails (purposely?) to point out that PEM is not essential under the Fukuda CFS defintion for a CFS diagnosis. Are they still wanting to include studies using Fukuda which we know uses mixed patient cohorts making the results dubious. A lot of the assertions use studies using Oxford and Fukuda criteria as evidence for them, even cites PACE as a reference for a claim.

    To me, the BPS lot have their finger prints all over the document and I am not surprised until this month Peter White was listed as one of the peer reviewers. It’s a mish mash of a guide in my opinion.

  • Christine Fenton
  • Alex Young

    Often reviewers may make comments on what changes they would like. I wondered from the start if there were any changes recommended by reviewers or editors. Also its possible that PDWs comments were minimised by the other two reviewers.

  • CureCFS

    This is a step but what needs to be updated is UpToDate. That is what all the doctors I know look up and send me info from. It is still recommending CBT and GET. Therefore, my own sister, a doctor, is still telling me to do that even after informing her of newer research. They don’t look up chronic fatigue syndrome at the CDC, BMJ, nor IOM report and probably don’t even know of the existence of that info, and likely aren’t going to look there even if told. Actual doctors in practice are going to ignore all the other information until UpToDate gets updated.
    https://www.uptodate.com/contents/treatment-of-chronic-fatigue-syndrome-systemic-exertion-intolerance-disease

  • acacia1

    Thank you David. I still have an uneasiness about the biopsychosocial assumptions inherent in this document. Judging by the contradictions, I can only imagine the authors went for an incremental approach in introducing some of the realities about ME/CFS and GET and that there must have been some horse-trading necessitated by the involvement of White (and who else?, from that ideology)

    Also, now that White has been removed form the list of peer-reviewers, is the responsibility for these biopsychosocial assumptions being transferred to the other authors? Do they agree with this?

    Will you explore this consideration please, David? (As far as possible)

  • anniekim

    Yes, very possible Alex.

  • anniekim

    I agree definition/criteria as opposed to the name is key. As pem in Fukuda is not mandatory, some diagnosed with Fukuda CFS will have something different – idiopathic chronic fatigue – to all those who have post exertional symptom flare up. My take always is many of those diagnosed with CFS will have the same illness as those whose symptoms map onto ME defiintions, but crucially not all.

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  • Ian Howe

    Very interesting and certainly a step in the right direction…but as it states in the last paragraph …..’the die hard, and PACE influenced UK medical and academic establishment is deeply entrenched’…..so I won’t hold my breath…..just yet!

  • Minuet

    UpToDate relies on publications from high-impact journals (they’re silly enough to think that citation count of articles in the journal generally is a meaningful indicator of the likely article quality of each and every article published in it), so this BMJ publication should improve the UpToDate article. Well, improve except where it just rewords bad ideas.

  • It is good to see progress. It is bad when they try to sneak it in without a decent explanation of the change. What? Do they think nobody pays attention? All we see is something that isn’t really cleanly separated – and too many egos which should be repudiated are being cossetted instead.

    Without removal of the bad science, the future science is tainted. Some researchers will still believe things that haven’t been thoroughly debunked publicly. To say nothing of the ‘scientists’ who remain at their posts, able to do more damage.

    May I please have some good science that tells me what to do to remove a disease that has lasted almost three decades? And some accountability for the monies spent on bad science?

    Science isn’t that delicate. It can take having the bad weeded out.

  • Margaret Smith

    I dare say they do. Like I said I have nothing against psychiatrists per se. I just don’t see the relevance of having psychiatrists on the review panel for drawing up guide lines on treatments for a physical illness.