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Rethinking the treatment of CFS—a reanalysis and evaluation of findings from a recent major trial

Tom Kindlon

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Free full text:
https://bmcpsychology.biomedcentral.com/articles/10.1186/s40359-018-0218-3
Wilshire et al header.png

Wilshire et al abstract.png
 

Countrygirl

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you are here: science media centre > roundups for journalists > expert reaction to reanalysis of the pace trial for chronic fatigue syndrome (cfs) treatments
MARCH 22, 2018
expert reaction to reanalysis of the PACE trial for chronic fatigue syndrome (CFS) treatments


A reanalysis of the PACE trial is published in BMC Psychology.

A Before the Headlines analysis accompanied this roundup.



Dr Jon Stone, Consultant Neurologist and Honorary Senior Lecturer, Western General Hospital, Edinburgh, said:

“This reanalysis of data from the PACE trial shows that using more stringent outcome measures, patients with CFS/ME had a better outcome at one year with Cognitive Behavioural Therapy(CBT), Graded Exercise Therapy (GET) than the control group, but the proportion improved was not as large as in the original report (20%/21% vs 10% in this reanalysis). This is not a surprising result. That would be the expected effect of using more restrictive criteria in any similar trial. The apparent benefit will be reduced for those undergoing the intervention, and also for the controls.


“The PACE Trial has been subject to an extraordinary degree of hostility. On the basis of this reanalysis, this was not warranted – the basic difference in outcomes are still present.


Prof Chris Ponting, Professor of Medical Bioinformatics, University of Edinburgh, said:

“ Wilshire and coauthors report on a new analysis of the PACE trial’s data. This reanalysis was required in part because the trial group had revised their analysis from the plan published in their protocol. This revision meant that, in theory, some trial participants nonsensically could be accepted on to the trial as patients, yet then be considered to have recovered by the trial’s end despite their symptoms not improving, or even deteriorating. Wilshire et al. provide evidence that “the effects of CBT and GET were very modest – and not statistically reliable overall if we apply procedures very close to those specified in the original published protocol”. Their analysis also revealed that recovery rates according to the protocol definition were much lower than previously published and that CBT and GET did not lead to recovery.

Importantly, Wilshire et al. provide a plausible explanation even of these modest effects. Specifically, they argue that they are explicable simply from the raised expectations of CBT and/or GET participants that their treatments would be effective.

The absence of meaningful gains in objective outcome measures such as fitness indicates that gains on self-report measures may well be unreliable. This could largely explain both the modest effects seen after 1 year and the disappearance of these effects subsequently.


Comment from three authors of the original PACE trial


We note that most of the analyses they report have already been published, either in peer reviewed journals or by ourselves on the PACE trial website (https://www.qmul.ac.uk/wolfson/research-projects-a-z/current-projects/pace-trial/).


“In conclusion we find little of substance in this critique and stand by our original reports.


* ‘Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT’ by Wiltshire et al. published in BMC Psychology on Thursday 22 March.


All our previous output on this subject can be seen at this weblink: http://www.sciencemediacentre.org/?s=CHRONIC FATIGUE SYNDROME&cat



The SMC also produced a Factsheet on CFS/ME which is attached and available here: http://www.sciencemediacentre.org/cfsme-the-illness-and-the-controversy/



 
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Countrygirl

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http://www.meassociation.org.uk/201...are-not-statistically-reliable-22-march-2018/

Reanalysis of the PACE trial finds impressive claims for recovery following CBT and GET are ‘not statistically reliable’ | 22 March 2018


ME Association Press Release, 21st March 2018

Benefits reported in a controversial medical trial part-funded by the Department of Work of Pensions were “not reliable,” a major study has found.

A large-scale, government-funded trial, known as PACE, claimed psychotherapy and exercise helped the estimated 250,000 sufferers of the devastating illness, M.E. (myalgic encephalomyelitis).


“We found that the groups receiving CBT or GET did not significantly outperform the control group…” Carolyne Wilshire.

Manifesting as unrelenting fatigue and profound pain, the condition, also known as chronic fatigue syndrome, has no known cure and is made worse by exertion.

Sufferers are often confined to their beds, unable to walk, and need help even to shower – an action that could then lay them low for hours, days, weeks or longer.

When the results of the five-year PACE trial were published in 2011, researchers claimed that graded exercise therapy (GET) and cognitive behaviour therapy (CBT) were “moderately effective” forms of treatment.

The trial concluded that both treatments led to recovery in over a fifth of patients.

But PACE has since faced intense criticism from patients and charities, such as the ME Association, over how the results were obtained, analysed and presented.

Parliament has previously heard claims that the data was deliberately flawed to “remove people from long-term benefits and reduce the welfare bill”.
 

Countrygirl

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David Tuller has somethimg to say about the SMC's pre-emptive strike yesterday:




David Tuller
·
In a preemptive strike against the new reanalysis of the PACE data released today, the Anti-Science Media Centre in London yesterday published a laughable "fact sheet"--a desperation move to protect the collapsing CBT/GET paradigm and the reputations of the CBT/GET ideological brigades. Here's just one of the many offensive statements from the fact sheet"--a desperation move to protect the collapsing CBT/GET paradigm and the reputations of the CBT/GET ideological brigades. : "After sustained pressure from activists the CDC has removed mention of CBT and GET from its website and currently states that there is no approved treatment for CFS/ME despite evidence to the contrary." It's certainly true that this change occurred after "sustain pressure from activists." But the implication that this was why the change was made--rather than that PACE is a likely case of research misconduct whose positive findings were based on unacceptable data manipulation--is absurd.
 

Countrygirl

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Another comment from David:



David Tuller

I found Professor Chris Ponting's statement about the new study on the website of the ASMC (Anti-Science Media Centre) to be quite heartening. I wrote to him earlier to thank him for this straightforward and honest comment. It makes me wonder if it's possible that the leadership change at the CFS/ME Research Collaborative could actually be real rather than decorative. So does the fact that he responded quickly and thanked me for my note.

From the ASMC website:

Prof Chris Ponting, Professor of Medical Bioinformatics, University of Edinburgh, said:

“In 2011 the PACE group interpreted their randomised trial data to mean that cognitive behaviour therapy (CBT) and graded exercise therapy (GET) “can safely be added to [specialist medical care] to moderately improve outcomes for chronic fatigue syndrome [CFS, or M.E./CFS]”. Now Wilshire and coauthors report on a new analysis of the PACE trial’s data. This reanalysis was required in part because the trial group had revised their analysis from the plan published in their protocol. This revision meant that, in theory, some trial participants nonsensically could be accepted on to the trial as patients, yet then be considered to have recovered by the trial’s end despite their symptoms not improving, or even deteriorating. Wilshire et al. provide evidence that “the effects of CBT and GET were very modest – and not statistically reliable overall if we apply procedures very close to those specified in the original published protocol”. Their analysis also revealed that recovery rates according to the protocol definition were much lower than previously published and that CBT and GET did not lead to recovery.

Importantly, Wilshire et al. provide a plausible explanation even of these modest effects. Specifically, they argue that they are explicable simply from the raised expectations of CBT and/or GET participants that their treatments would be effective. Expectations are heightened, they argue, when participants are not blinded to their treatment and are assured that their treatment is effective, as was the case for the PACE trial. The absence of meaningful gains in objective outcome measures such as fitness indicates that gains on self-report measures may well be unreliable. This could largely explain both the modest effects seen after 1 year and the disappearance of these effects subsequently. The authors also make the case that the lack of substantial and enduring effects of CBT and/or GET seen from a trial of the size of PACE implies that these therapies are unlikely to be commonly effective.”
 

Countrygirl

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https://www.thecanary.co/discovery/...y-just-declared-war-on-people-living-with-me/

ME-CFS-PACE-Trial-770x403.jpg



The publication of a study into what an MP called one of the “biggest medical scandals of the 21st century” has sparked a war of words between areas of the medical and science communities. Caught in the crossfire are between 17 and 24 million disabled people worldwide, on whom critics of this latest research are effectively declaring war if they dare to question current mainstream treatment.

PACE Trials: controversial from the start
The PACE Trials were a study into treatment for people living with myalgic encephalomyelitis/chronic fatigue syndrome, commonly referred to as ME/CFS. The research has also been applied to people living with fibromyalgia and Ehlers-Danlos syndromes (EDS), among other illnesses. The PACE Trials claim that people living with ME/CFS can improve their illnesses, and sometimes recover, by having cognitive behavioural therapy (CBT) and by using graded exercise therapy (GET).

The results of the £5m trial, part-funded by the UK Department for Work and Pensions (DWP), were originally published in The Lancet in 2011. But they have been dismissed by many medical professionals and disabled people alike as damaging and ineffective. In the US in 2016, the federal Agency for Healthcare Research and Quality (AHRQ) downgraded the reliability of GET for ME/CFS patients, saying there was “insufficient evidence of effectiveness of GET on any outcome”. It also saidthere was “low strength” or “insufficient” evidence about the effectiveness of CBT. In 2017, the US Center for Disease Control (CDC) also removed CBT and GET as recommended treatments.

In the UK CBT and GET are still the NHS’s approved treatment under guidelines from the National Institute for Health and Care Excellence (NICE). But NICE is undertakinga review of this.

Now, a new study into the PACE Trials’ original research has been released. Its evidence completely contradicts the results of the original study, and to cast even more doubt over the PACE Trials’ findings, the study has used the trials’ original data to prove its point.

But some in the mainstream medical and scientific community have already hit back.


Patients: trying to “disrupt” research?


Oh, what a tangled web we weave…
The impartiality of the SMC is questionable in this instance, and it’s these questions of impartiality which lie at the heart of disabled people’s concerns over the PACE Trials.

For example, sitting on the SMC governance committee is Sir Simon Wessely, whom Brea refers to as “one of the architects of the biopsychosocial school as applied to ME”. As The Canary previously reported, a group of 60 leading professionals and campaigners criticised the UK government’s appointment of Wessley as lead on the review into the Mental Health Act. They said that:

Wessely’s body of work on ME… demonstrates his lack of honesty, care and compassion for patients. His unsubstantiated claim that ME is driven by ‘false illness beliefs’ has led to patients being labelled as hypochondriacs, treated with contempt by some in the medical profession and stigmatised by society. His recommended treatment regime of Graded Exercise Therapy caused deterioration in function for nearly 50% of ME patients surveyed, yet he dismisses their evidence as unreliable and labels all critics of this work as irrational and extremist.

But he stood by his claims, telling The Canary he still supports GET as a treatment for ME/CFS, and that he still regards the PACE Trials as “well conducted”. But Wessley’s role in ME/CFS treatments, and the SMC’s “factsheet” underscore the concerns about the PACE Trials.

Conflicts of interest?
 

Countrygirl

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Here is a letter in response to The Times article above (you may find the names familiar :))


TREATMENT FOR PATIENTS WITH ME

Sir, The article by Tom Whipple, (“Findings of £5m ME chronic fatigue study ‘worthless’,” Mar 22) highlights a long-standing problem.

The National Institute for Health and Care Excellence (Nice) is in the process of replacing its guideline for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), but this will take time.

Patients with ME/CFS in this country continue to receive damaging treatment in the form of graded exercise therapy (GET). Despite evidence of disabling metabolic abnormalities in their muscles, patients are advised to “exercise back to fitness”. They are not simply “deconditioned” as claimed by many psychiatrists. Forced exercise above very low levels characteristically incapacitates most patients. The “exercise will make you better doctrine” applied to ME/CFS is profoundly incorrect and has no scientific evidence base.

The human cost is enormous, with many sufferers from ME/CFS rendered worse by inappropriate medical management. Even worse, such management is inflicted compulsorily on some patients, both adults and children, with their informed consent being bypassed via
the use of mental health and child protection legislation.

Countess of Mar, Forward-ME; Dr William Weir, infectious disease consultant; Dr Nigel Speight, paediatrician; Dr Charles Shepherd, ME association; Dr Vance Spence, ME research UK; Jonathan Davies, ME research UK; Dr Gareth Tuckwell, ME trust; Dr Paul Worthley, ME trust; Jane Colby, Tymes trust; Helen Brownlie, 25 per cent ME group; Tanya and Christine Harrison, Brame; William and Janice Kent, Remember; Hannah Clifton, ME trust; Clare Ogden, Action for ME
 

Countrygirl

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As we are on the subject of a certain 'thing of beauty' :rolleyes: Sir Prof Wesselly who had absolutely nothing to do with it seems for have forgotten this:

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