Lloyd’s university responds: CBT/GET training trial for chronic fatigue syndrome

By Sasha Nimmo

Prof Rodney Phillips, Dean of  Medicine at the University of New South Wales (UNSW) denies that Prof Lloyd’s trial would cause harm to participants and refuses to stop the trial or amend it in any way. The university says the people who are protesting harbour ‘resentment against the notion that CFS may have psychological causes’, while there is no evidence for their argument.

The letter from Prof Phillips was in response to the petition protesting a trial of a training module of graded exercise therapy (CBT) and cognitive behaviour therapy (GET) for health professionals. The petition was sent to UNSW’s Vice Chancellor Prof Ian Jacobs; the Mason Foundation; the federal health minister and the National Health and Medical Research Council (NHMRC). It asked them to stop UNSW’s trial of an education module for health professionals which treats chronic fatigue syndrome patients with GET/CBT, despite the evidence showing these therapies have no benefit and often cause permanent harm.

The trial registration says “despite GET and CBT being widely acknowledged as best-practice interventions for CFS, the great majority of patients in Australia are not receiving these appropriate evidence-based interventions. Recent studies have demonstrated that the reason for this documented gap between research and practice is largely due to practicing health professionals lacking the knowledge and skills to provide appropriate care.”

The letter from UNSW explains that the dean believes chronic fatigue syndrome (CFS) to be a subjective diagnosis of exclusion; going against researchers at ANU, Melbourne University, Griffith University and overseas at Stanford University and other leading universities, who use the Canadian or International Consenus criteria and have made significant medical progress. The World Health Organisation also classify it as neurological, not psychological.

“This is a difficult, and often controversial, clinical syndrome featuring disabling subjective fatigue,” said Prof Phillips

“The diagnosis is made after careful exclusion of alternative medical and psychiatric explanations for the fatigue state. The controversy typically relates to the validity of the illness as a separable diagnostic entity, and also whether the illness has a purely ‘psychological’ basis. I do not propose getting into those arguments here.”

It appears that UNSW do not have a clear grasp of the illness in the group of people they are aiming to treat.

“Since listing the trial on the register, the study investigators and the UNSW HREC have been receiving correspondence from critics requesting the trial not go ahead. This response essentially reflects resentment against the notion that CFS may have psychological causes.”

It poses an international risk, as UNSW plan to “disseminate the treatment to other centers nationally and internationally”, according to information the University provided to the National Health and Medical Research Council.

“The scientific evidence base for CBT and GET patients with CFS both individually and combined is very strong,” argued Prof Phillips.

However Geraghty 2016 found “re-analysis showed that the levels of improvement and recovery observed in the released data were much lower than the levels reported in the published report (White et al., 2011a) and other related publications. The released data showed that the effectiveness of cognitive behavioural therapy (CBT) and graded exercise therapy (GET), in comparison to standard medical care (SMC) and adaptive pacing therapy (APT), fell by almost two-thirds.

The New York TimesGetting It Wrong on Chronic Fatigue Syndrome‘ pointed out “when the study’s findings were first published, patients and some scientists noted a stunning problem: The investigators had weakened their outcome measures from their trial protocol so much that participants could actually deteriorate on physical function and still qualify as “recovered.” Thirteen percent entered the trial already having met the definition of “recovered” on that measure.”

Even the head of the USA’s National Institute of Health recognises that reconditioning is not the answer, writing about in the Director’s Blog this month.

“Any exertion just makes you worse,” said Dr. Walter Koroshetz and Dr. Francis Collins.

“A number of studies suggest that abnormalities in cellular metabolism, a complex biological process that the body uses to create energy [3][4][5], may underlie ME/CFS. A recent study of metabolite pathways in blood samples from people with ME/CFS reported a signature suggestive of a hypometabolic condition, similar to a phenomenon biologists have studied in other organisms and refer to by the term “dauer” (a hibernation-like state) [5]. A number of other studies have suggested that changes in the immune system may play a causal role in ME/CFS [6][7][8], either due to a post-infectious autoimmune process or due to a unknown chronic infection.”

It is incomprehensible that UNSW continue to defend the PACE trial, going against more than 120 of the world’s leading researchers and clinicians in the field as well as patient organisations from around the world, who signed an open letter asking for the study to be retracted.

The letter said the PACE trial had null results for recovery, according to the protocol definition selected by the authors themselves. Besides the inflated recovery results reported in Psychological Medicine, the study suffered from a host of other problems, which are too numerous to list in this article.

“The PACE investigators have published analyses refuting all of these concerns,” was the response from the UNSW dean.

Wilshire, Kindlon and McGrath 2017 were clear in the rejoinder after reading the PACE investiagators re-analysis: “the PACE trial provides no evidence that CBT and GET can lead to recovery from CFS. The recovery claims made in the PACE trial are therefore misleading for patients and clinicians.”

Screen Shot 2017-03-30 at 3.23.02 pm

Figure 1 from Matthees, Kindlon, Maryhew, Stark & Levin 2016.

Sense about Science wrote about the problems. “The fundamental [issue], which is that the way PACE was designed and redesigned means it cannot provide reliable answers to the questions it asked. There is really not a lot that can be said to mitigate that; it’s a terminal prognosis.”

“The conclusion of Rebecca Goldin’s 7,000-word analysis on PACE’s design is this: “The best we can glean from PACE,” concludes Goldin, “is that study design is essential to good science, the flaws in this design were enough to doom its results from the start.””

UNSW not only accept this flawed science, but are promoting it.

“There is clear level one evidence for both cognitive behavioural therapy (CBT) and graded exercise therapy (GET), both from the Cochran collaboration and from a recent NIH expert workshop,” said Prof Phillips.

“It is important to emphasise that this trial is not an evaluation of the effectiveness of the CBT/GET intervention but a trial of education for healthcare practitioners on how to conduct CBT/GET intervention for patients with CFS.”

Prof Phillips insisted that there was no risk of harm, despite the petition pointing out that the ME Association found that 74% of people were worse after graded exercise therapy.

He said that the training would safeguard them against any notional risk of harm.

“The concern of harm from GET is not supported by the systematic reviews which state no evidence suggests that exercise therapy may worsen outcomes,” said Prof Phillips.

How can UNSW base their research on the results of a trial with “flaws are so egregious that it would serve well in an undergraduate textbook as an object lesson in how not to design a trial,” Edwards 2017?

“His [Lloyd’s] approach combining pathophysiological research and treatment research underpins his NHMRC practitioner fellowship as it seeks to improve the care of patients with CFS.”

Here in Australia, news.com.au reported that “incorrectly claiming that a significant number of CFS patients can actually recover from a treatment can cause real harm”.

“Based on the evidence I have outlined above I’m not prepared to require that the study be suspended or abandoned. It is in fact nearly complete in any case,” said Prof Phillips.

“I do not accept that there is any reason to accede to your request.”

Read the full letter: Letter DM0797 – Sasha Nimmo – 22 March 2017-3 .

18 thoughts on “Lloyd’s university responds: CBT/GET training trial for chronic fatigue syndrome

  1. Just makes you want to weep. Very very disappointing response based on outdated information…Hickie et al 2006? No mention of ICC or even CCC diagnostic criteria and repeated reference to “fatigue”. And insulting comment about people objecting to CBT/GET are resentful of suggestion the CFS is psychological. Shame on the Dean of Medicine and shame on UNSW for not even doing their basic homework properly.

  2. With all the impressive, progressive research coming out of Australia I was proud of the leading role Australian medicine was taking.

    The last response says it all. They’ve almost spent all the money so they are going to continue anyway.

  3. Very disappointing, did Prof Rodney Phillips, Dean of Medicine at the UNSW actually read the latest research or did he just sign off on what he was told? He totally misses the point about the dangers of uncontrolled exercise and the wealth of research finding biomedical markers at Monash, Bio21, NCNED and the USA. Patients want the facts and appropriate medical research and treatment for decades claims of “its psychological” have been used to deny biomedical research. Patients wish it was true then we wouldn’t have to force ourselves to rest, to recover to not over exert ourselves. The disease can be easily measured by 2 day CPET tests, heart rate monitoring shows abnormalities, orthostatic intolerance can be measured, abnormal heart rate response to exertion can be seen using standard heart rate montiors, heart rate variability can be measured. Why isn’t physiological research being carried out at UNSW? Where is the objective science at UNSW? Prof Phillips, please reference the location of the ” sound evidence” that GET and CBT are appropriate “treatments” for people with ME/CFS? PS – I just want to get well. The cause of the disease is immaterial to me, but touting out treatments that are harmful is NOT the way to help patients get their lives back.

  4. So why can’t we give blood? If ME, OR CFS AS YOU LIKE TO CALL IT =THAT TRIVIALIS THE ILLNESS / DISEASES . I am damage from following the NICE GUIDELINES 💔 GET MADE ME WORSE! That is “FACT ” NOT FICTION! I AM NOW SEVERE WITH ME. With “NO RECOVERY IN SITES FOR MY ILLNESS. So PLEASE STOP THIS HARMFUL EFFECTS ON ME PEOPLE + CHILDREN.

  5. CFS , mental disorder, chronic pain , etc. may be easy and perfect and instantly cure.

    Our body have 5 major control system(immune, nervous, circular, muscle, digest) for keep alive.

    If nervous control system may sleep or turn off, we have mental ill.

    If digest control system is blocked, we will have digest disease.

    If 5 major control system turn off or sleep down, we have chronic fatigue syndrome.

    CFS fatigue cure may simple,,,

    Turn on the control system and remove the negative charge source

    (negative source make sleep or turn off our control system)..

    I can read the negative charge and tune up for turn on.

    I am a biologist(50 years experience). and live in carol stream il.

    Some invisible disease need breakthrough idea, treatment,,,

    Some of chronic fatigue syndrome may cure easy and simple(1-2days)..

    Most of people think the cfs is invisible disease, but I can see and feel and I know why, how to treat..

    Our body consists of 5 major systems that work together to keep we alive.

    Circular, nervous system, digest system, respiration system, Musculoskeletal system.
    The 5 major system control by special systems.
    If one control system weak or sleep(same like low charge) , a major system related disease are expressed.
    If 5 major control system are weak or sleep, Fatigue condition may come…Cure may easy. wake up the sleep control system and remove the sleep source

    CFS means 5 of our major control system are not normal.

    Our body charged with positive electron and control system work normally.

    If our body contact with negative charge, Our body may get negative electron.

    If our body charged with negative electron, our control system(gene expression or control)

    may changed and abnormal condition.

    High uric acid, infection, emotional extremes, toxic bra, toxic cloth, toxic bedding(negative electron)

    may block the control system.

    If negative charged part is partially charged, mental disorder or digest problem or immune problem

    etc.. If most of our body charged with negative charged, several disorder occur and CFS.

    I can read the positive charge and negative charge from people, material, photo, earth, sound etc..

    Gene expression or body control signal may alter or change with negative charge.

    The CFS cure may easy and simple.

    2 steps.

    1. Remove the negative charged source

    —water veins above bed or chair, toxic bra, glass, cloth, bedding, phone etc..

    2. massage with positive hand or contact with strong positive charged source or cupping.

    (body tune up may turn the negative body to positive body)

    It need 20-30 minutes

    No drug, No acupuncture, No medical treatment.

    Cures seems magic and amazing and unbelievable

    Use hand massage and cupping and sticker or peddle(positive charged) —-very very safe

    Remove negative source—moving sleep site, change cloth, bra, girdle, shoes, glass etc.

    Prevent method for mental disorder, chronic fatigue, chronic respiration disease, chronic pain etc

    —1)escape from water vein above bed

    2) new commercial product quality( positive electron charged cloth, bedding, glass, car, chair, bra, cosmentic

    3) Flavored water for water hate people(high uric acid)

    1. What a load of incoherent crap!! Let me just get rid of my toxic bra and I’ll be cured – yay!! Do you have any idea what a despicable moron you are peddling this bullshit to CFS sufferers – many of whom are desperate and willing to try anything to get better?
      There’s a special place in hell for people like you – and that also goes for the UNSW people who persist in insisting that CFS is a “psychological illness” despite all evidence to the contrary, and want to mistreat sufferers with GET accordingly.
      #CFSsufferersickofthiscrap

  6. this is an evil line of research that can only further entrench negative stereotypes that people have of patients with this illness. i would like to know from this prof at unsw, whether the university and the staff running the perverse research project, are going to assume full responsibility for patients whose health deteriorates??

  7. “Truth to Power: New York Native 1980-1997
    by Charles Ortleb

    Charles Ortleb’s *Truth to Power* takes you inside the New York Native, one of the most unique and consequential newspapers of the twentieth century.

    Shortly after starting his small gay New York City newspaper in late 1980, one of the biggest scientific and political stories of our time, fell into his lap in the form of the AIDS and Chronic Fatigue Syndrome epidemic.

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