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New CBT and GET threat for Aust CFS patients

UNSW chronic fatigue syndrome studies use 'potentially harmful guidelines'

Australian CFS researcher, Prof Andrew Lloyd last year explained that he was working on an online program of graded exercise therapy (GET) and cognitive behavior therapy (CBT) at the University of NSW’s Fatigue Clinic.

Prof Lloyd described the PACE trial, which evaluated these therapies, as having ‘reasonably solid data’.

The UNSW has now registered a trial to ‘investigate the efficacy of online continuing education for health professionals to improve the management of chronic fatigue syndrome’.

The study is designed to educate medical professionals. Prof Lloyd said it would ‘protocolise the intervention’ and that he had a grant to turn it into an online module and evaluate it.

The study isn’t evaluating CBT and GET, it already accepts those as ‘widely acknowledged as best-practice interventions for CFS’, it is training health professionals in:

  1. Psychoeducation
  2. Activity pacing and graded exercise therapy
  3. Interventions for sleep-wake cycle disturbance
  4. Interventions of neurocognitive functioning in CFS
  5. Interventions for mood disturbance
  6. Interventions for anxiety
  7. Interventions for coping

This study is funded by the Mason Foundation.

Modafinil study

The second study Prof Lloyd mentioned was the trial for a brain stimulant called Modafinil. He received a grant for this work and is accessing the drug directly from the manufacturer.

“It changes the perception of fatigue and lengthens time to exhaustion,” Prof Lloyd said.

Modafinil is used to treat idiopathic somnolence (excessive sleepiness) and the US National Library of Medicine warns: “Modafinil may be habit-forming. Modafinil may decrease your sleepiness, but it will not cure your sleep disorder. Modafinil should not be used in place of getting enough sleep.”

Why Lloyd’s involvement is a concern

Prof Lloyd is one of the authors of the 2002 Australian criteria and also sits on NHMRC grant review committees.

The Australian set of criteria states chronic fatigue syndrome overlaps with the psychiatric condition, neurasthenia, that it is on the spectrum of fatigue so it is not its own ‘entity’ and apart from minor, non-specific signs of illness, the physical examination in people with CFS is normal.  Prof Lloyd doesn’t believe these criteria need updating.

Here are extracts from the 2002 Australian criteria:

“Graded exercise programs have been shown to be beneficial for some people with CFS, and can improve functional status.

[Patients] may have been led to believe that any physical activity at all could be harmful. Unwarranted concerns of this kind may lead to maladaptive attitudes and behaviours that may increase disability and retard recovery.

Doctors should avoid simplistic attributions of CFS to “chronic infection”, “immune dysfunction”, “malingering”, or “mere depression”. Instead, it should be recognised that the illness is likely to be multifactorial in origin. A broad perspective that encompasses medical, psychological, and social aspects is more appropriate.

“Concurrent psychological disorder, somatic symptoms, high levels of fatigue and a low sense of control over symptoms are associated with poorer outcomes.

Neurasthenia (literally meaning “nervous exhaustion”) is a diagnosis included in the International classification of diseases (ICD-10) to describe a syndrome of mental and physical fatigue of at least three months’ duration. The term has a long tradition of use in psychiatric classification, but the extent of its overlap with CFS, and with common psychological disorders such as anxiety and depression, remains to be determined.

Perhaps the most difficult diagnostic uncertainty between CFS and psychological illness is in relation to “somatoform” disorders (DSM-IV107). In these disorders, people present with medically inexplicable physical symptoms that are hypothesised to be the result of underlying psychological processes. As the causes of CFS are “unexplained”, there is an obvious overlap between the diagnostic criteria for the somatoform disorders and CFS.

The mental state examination of people with prolonged fatigue should focus on the observed behavioural features rather than simply those reported by the person. These include psychomotor slowing (which may suggest a serious depressive disorder), demonstrable cognitive impairment (suggesting intoxication, delirium or a dementia syndrome), odd or bizarre interpersonal behaviour (suggesting a psychosis), and hostile, angry or excessively irritable responses (suggesting a personality disorder).

Diagnostic labelling of patients with fatigue

In the general population, fatigue states form a continuum in terms of severity and duration, and it is only in those with the most severe and persistent symptoms that a diagnosis of ‘CFS’ may be appropriate. Although the internationally accepted CFS case definition remains the “gold standard” for diagnosis, it is necessarily arbitrary, having been developed for the purpose of making valid comparisons between research studies carried out in different settings. As such, it creates an artificial boundary within the clinical continuum of fatigue states, giving the false impression that a specific clinical “entity” has thereby been delineated.

In the absence of a clear understanding of aetiology and pathogenesis, the term CFS should be regarded as a descriptive label only. Diagnostic boundaries are further blurred by the clinical overlap with other conditions such as fibromyalgia, irritable bowel syndrome, neurasthenia, anxiety and depression, in each of which fatigue can occur as a major symptom. In each person with chronic fatigue the doctor must exercise clinical judgement in deciding whether CFS is an appropriate diagnostic label.

And this…

Apart from minor, non-specific signs of illness, the physical examination in people with CFS is normal.

2002 Australian chronic fatigue syndrome criteria

What needs to be done

The 2002 Australian criteria need replacing, for the purposes of the NHMRC and other bodies evaluating grants, as well as for the Australian Medical Association (AMA) and the Royal Australian College of General Practitioners (RACGP) to distribute to their members, who are our GPs.

In research, Griffith University already uses the International Consensus Criteria (ICC) and they are the some of the authors of this Primer for Medical Practitioners.

Other reputable researchers, such as the Murdoch Childrens’ Research Institute, the Australian National University and the CFS Discovery Clinic use an earlier version of the ICC, the Canadian Consensus Criteria.

The majority of the Australian patient organisations endorse the ICC: Emerge Australia (who represent Victoria, Tasmania, NT and others), ME/CFS Australia (South Australia), the ACT ME/chronic fatigue syndrome society (Canberra) and ME/CFS NSW (NSW).

Western Australia’s society endorse the earlier version, the Canadian Consensus Criteria and Queensland doesn’t make mention on their website. (to be updated with information from them once provided)

The South Australian society’s chairman, Simon R. Molesworth AM, QC, has issued two written complaints to the AMA’s Dr Martin Van Der Weyden about the 2002 Australian criteria, here and here, which are worth reading. The letters say the guidelines will result in misdiagnosis, inappropriate and inadequate medical care and the promotion of widespread misconceptions about the illness.

“Evidence is not good enough for the Guidelines to be called ‘evidence-based,’ the assessment and presentation of the evidence has not been objective, the Working Group was not truly representative and so the end product is unreliable. The document provides potentially harmful management suggestions with insufficient supporting evidence.”

Simon R. Molesworth AM, QC, Chairman, ME/CFS Australia (South Australia)

Emerge Australia has made its views on CBT and GET quite clear: “There is no good evidence to support the use of graded exercise therapy or cognitive behaviour therapy and there is important emerging evidence on genetic and immune markers for the condition, so we ask the Department of Health not to waste precious research dollars on those studies.”

In an interview, Senator Ludlam said Australia should not be funding research into totally inappropriate exercise regimes or therapy, as ‘these remedies are actually counter-productive and dangerous’.

Australia needs to adopt the International Consensus Criteria for Myalgic Encephalomyelitis, which does not recommend these therapies and has a much higher standard, providing much more evidence of the biological processes of a disease.

What you can do

As well as writing to the UNSW and Mason Foundation, we should urge our representatives at the state and territory societies to endorse the International Consensus Criteria and commend the ICC Medical Primer to the National Medical Health Research Council (NHMRC), the AMA and the RACGP. Write to them, call them and let them know this is the time to act.

As authors of the Canadian and International Consensus Criteria, the National Centre for Neuroimmunology (NCNED) at Griffith University should also be commending this criteria to the NHMRC, ask NCNED to recommend it formally.

If the NHMRC has the International Consensus Criteria, we can point to it as an authoritative source and say, “This is not how the government recognises this disease should be treated.”

It has become urgent, now is the time to act. Our representative bodies are already supportive – now is the time to ask them, the NHMRC, the AMA and the RACGP to make the change from the potentially dangerous 2002 Australian criteria to the 2012 International Consensus Criteria.

FEATURE PHOTO: mirroring by Lauren Anderson

This article was first published by ME Australia

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Written by Sasha Nimmo

Sasha Nimmo

Sasha Nimmo suffers from ME. She lives in Australia. In a previous life she was a journalist and media adviser. Her expressive Twitter bio states: 'Thwart institutional cowardice. Carry bolt cutters everywhere - Werner Hertzog. Also, medical research for Myalgic Encephalomyelitis.'

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  1. Great article Sasha. Good to see a considered analysis of the Australian CFS and ME scene. Prof Lloyd is a big problem for us since he has the ear of the govt. It is a shame that as patients push for greater funding, with Sen Scott Ludlam’s support, researchers like Lloyd are positioning themselves for a large slice of the pie.

  2. So frustrating to hear that CBT & GET are being pursued world over as “effective” treatments for ME.

    Did they not read about the null findings of the follow up PACE study?
    Have they not heard of the patient surveys showing how damaging these treatments can be?
    Do they not follow any of the current articles questioning PACE methods and conclusions?
    Why have they put their heads in the sand like this?

    Meh…. Frustrated here in Northern Ireland too. 🙁

    Well said Sasha. This really is a global issue now. xx

  3. Thank you Russell, I appreciate you publishing it.

    Sally, thank you! In some ways I thought Australia was ahead but I fear we are so, so behind in some influential and well-funded circles.

  4. “The study isn’t evaluating CBT and GET, it already accepts those as “widely acknowledged as best-practice interventions for CFS”, it is training health professionals in:

    [..]

    Activity pacing and graded exercise therapy”

    Given that the PACE Trial is mentioned, this may not be to recommend pacing but in fact contrast pacing with graded exercise and say that graded exercise is better.

  5. Thanks for outlining it so beautifully for us that want to write but have limited time or energy. I have shared it with my community and encouraged them to write. I have already written to Sophie Li expressing my dismay. I work extensively supporting people with cfs (I have cfs) and I have shared it with my tribe on facebook. Thankyou.

  6. And studies that show a largely abnormal immune response (among others) to the effort, whether physical or cognitive, what think about that this dear sir ?

    Fortunately Australia has REAL Researchers in M.E, because if all patients with ME know that the effort will worsen them, then make them agonize, and finaly kill them, it does not seem to be the same with some ” self-declared experts “. Shameful. I can not imagine that they are not aware about that. Not in 2016. Not with the thousands of publlished studies on ME. We are suffering from the only one (to my knowledge) serious neuro-immune disease aggravated by exertion. And I really can not imagine that this man did not have the curiosity to read one of the thousands of studies on ME, and can not know that. Preconize efforts, whether cognitive or physical , as a treatment of ME ,is seriously hurting. It’s kill. No more no less.

  7. Patients need to call for objective data collection. Heart rest monitors quantify and illustrate pwME’s abnormal reaction. Minimal exertion = extraordinary rise in resting heart rate for hours.
    Heart rates that rise way above 60 percent of our age predicted maximum on exertion.
    Low anerobic thresholds an disability verified by VO2 max tests…
    The basics of what is going on with our hearts which appear to be a window into the impact of this disease on our heart rate/health.

  8. I want to make you aware of an article published today. April 5, 2016, in Counterpunch online – http://www.counterpunch.org, by Julian Vigo, entitled “Science Deniers in the Twenty-First Century”,
    http://www.counterpunch.org/2016/04/05/science-deniers-in-the-twenty-first-century/
    which equates the skepticism of the psycho-genic nature of ME with climate-change deniers and accuses the CFS/ME community of engaging in threatening and harassing behavior to researchers who advocate a psycho-genic cause for, and graded exercise therapies as a succesful treatment fo, ME.

    Julian Vigo bills herself as:

    ” a scholar, film-maker and human rights consultant. Her latest book is Earthquake in Haiti: The Pornography of Poverty and the Politics of Development (2015). She can be reached at: julian.vigo@gmail.com

    From her listed professional areas, it is oh so obvious she is a credible commenter on the etiology of CFS/ME and the current state of CFS/ME research.

    She begins with the worst form of sophstry: that psycho-genic advocates of CFS/ME etiology are akin to persecuted visionaries such as Galileo and Darwin and continues with lauding as well-founded the controversial research results concerning the benefits of graded exercise therapies.

    From her article:

    “In recent years, science has been up for debate, a position that was not unfamiliar to the likes of Galileo and Darwin. But who would have thought that in the twenty-first century scientific evidence would usher forth death threats and even violence to the transmitters of certain lines of scientific inquiry?

    Take for instance Chronic Fatigue Syndrome (also known as Myalgic Encephalomyelitis) whereby researchers into this condition have been regularly harassed and threatened should the research suggest that cognitive behavioural therapy or exercise therapy be effective in treating CFS, a fact demonstrated by research. Simon Wessely, professor of epidemiological and liaison psychiatry at King’s College School of Medicine in London, has been under attack for many years by those in the CFS community who decry any psychiatric approach to this condition. Even though last year in the USA a panel made the claim that CFS is physical and not psychological, there is no international consensus on this matter. In fact, there is much evidence to show that many illnesses such as CFS—even when primarily physical—respond well to changes in the psychological state of the patient. Hence, there has been much advocacy to remove the stigma of CFS as psychological even before any evidence to the contrary. The resistance to the idea that CFS has a psychological component was met with outrage despite evidence that shows that wellness measures such as graded exercise therapy (GET) and cognitive behaviour therapy (CBT) are two of the most effective treatments for the condition.”

    Despite Ms. Vigo’s claims she offers no references to credible research to back up the notion that CFS/ME “responds\ well to changes in the psychological state of the patient”, nor that pyschological state is a cause of the physical limitations inflicted by CFS/ME, assertings later
    “Hence, there has been much advocacy to remove the stigma of CFS as psychological even before any evidence to the contrary.” simply ignoring all the present evidence “to the contrary”.

    Please disseminate links to this article to the CFS/ME advocacy and research community. I had antipated a semi-productive day here trying to do some constructive work on my property before the torrid rainy season hits the tropics, but instead I find myself stalled by the need to respond to Ms. Vigo. Unfortunately, I know I don’t have all the facts handily available, especially the scientific critiques of the PACE study, to mount a credible critique quickly. I trust you and the wider CFS/ME community do, and will be able to do so.

    Mike Aliotta

  9. Aerobic exercise had been shown to be harmful. Maybe Andrew Lloyd can explain why the PACE trial findings in their follow up paper stated that GET and CBT were ineffective.
    Maybe Andrew Lloyd csn explain why the walking test data from the PACE trial finds people severely ill at the start and yes severely ill at the end- pretty solid data of ineffectiveness.
    Andrew has 2 clinics for people with medically unexplained symptoms. He accepts all people with fatigue into his clinic – that’s fine but these people aren’t the same subset as those wiht ICC or CCC diagnosed ME//CFS. Years of these clinics yet NO objective data on results. Since the 8 million dollar PACE trail found GET and CBT don’t work??? Why??? Are there any links to insurance companies??? Aerobic exercise harms people with ME/CFs.

  10. Lloyd when asked how the model at his clinics compare to the PACE model, he said:
    “No substantive difference except that we integrate the pacing, GET and CBT elements.”
    GP’s referring people to the clinic, just tick a box that says : CF
    You are most likely to benefit if you are at 30-40% of your pre illness capacity.
    You also need to be well enough to cope with 2 hours at the clinic and getting there and back, thats pretty much a 1/2 day outing.
    Hence there are an awful lot of people with ME/CFS, that are nowhere near well enough to attend but then again this clinic isn’t actually for people with ME/CFS.
    ME/CFS is not even on the referral form that the GP’s fill in.
    So who are attending the clinics? People who are fatigued- post cancer fatigue (known to have a different cytotoxin profile from people with ME/CFS, people who are depressed (don’t have the core ME/CFS symptom of post exertional exacerbation of symptoms).
    Do any of these people have post orthostatic tachycardia syndrome? – may be people with ME/CFS do?

    The International Consensus Criteria and IAMECFS recommend pacing with heart rate monitoring, and staying under your anerobic threshold, as do the Workwell Foundation, Bateman Horne, Dr. Nancy Klimas…. Patients find this approach works. It’s not anti-exercise its finding safe limits and staying within them. Exercise and activity and rest managed in by patients in a controlled manner that enables them to avoid crashing, relapsing, cumulative harm and deterioration. NICE guidelines recommend heart rate monitors ……why isn’t this simple management tool introduced?

    Why is it so hard for the biopsychosocial researchers to tag the patients surveyed and identify, those, who meet the ICC and the CCC criteria, so it is clear whether or not his clinics help these patients?
    Why no objective data?
    Why no heart rate monitoring?
    Why no HRV monitoring?

    If the claims that ME/CFS fits the biopsychosocial model, then why do the researchers supporting this model choose broad entry criteria, vague statistical outcomes? If they are confident that their model is accurate why aren’t they clearly defining the subsets of patients? Their studies would start to have some meaning for people with ME/CFS, if the researchers identified this cohort of patients.
    Why is physical functioning that is extremely easy to measure objectively, not measured?

    The biomedical researchers are looking at a neurological disease: strictly defined, clear physiological signs.

    The biopsychosocial “researchers” mix together a large cohort of people that have various medical issues.

    Who benefits from keeping the waters muddy?

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