Tom Kindlon
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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.
“ 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.
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.
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”.
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?
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