The PACE Trial continues to unravel …

A major study has been released today (22nd March) which again looks at the PACE Trial, and this in turn has led to a lot of coverage in the media.

 
“The message is clear – CBT and GET are not effective ways of treating a serious neuroimmune disease. The sooner this message gets across to health professionals the better.” (Dr Charles Shepherd, The ME Association).
 
The study –
 
Rethinking the treatment of chronic fatigue syndrome—a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT
https://bmcpsychology.biomedcentral.com/articles/10.1186/s40359-018-0218-3
 
PDF download: 
https://bmcpsychology.biomedcentral.com/track/pdf/10.1186/s40359-018-0218-3?site=bmcpsychology.biomedcentral.com
 
Some of the media coverage –
 
BBC
 
Chronic fatigue trial results ‘not robust’, new study says
http://www.bbc.co.uk/news/health-43490335
 
Belfast Telegraph
 
Findings of chronic fatigue study ‘not reliable’
The study faced intense criticism from patients and charities
https://www.belfasttelegraph.co.uk/news/uk/findings-of-chronic-fatigue-study-not-reliable-36733161.html
 
Daily Mail
 
Findings of chronic fatigue study `not reliable´
http://www.dailymail.co.uk/wires/pa/article-5532233/Findings-chronic-fatigue-study-not-reliable.html
 
The Canary
 
The mainstream medical community just declared war on people living with ME
https://www.thecanary.co/discovery/analysis-discovery/2018/03/22/the-mainstream-medical-community-just-declared-war-on-people-living-with-me/
 
The Times
 
Findings of £5m ME chronic fatigue study ‘worthless’
https://www.thetimes.co.uk/article/findings-of-5m-me-chronic-fatigue-study-worthless-89z8x0xzr
 
 
The ME Association’s response
 
Reanalysis of the PACE trial finds impressive claims for recovery following CBT and GET are ‘not statistically reliable’
http://www.meassociation.org.uk/2018/03/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).
 
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”.
 
After a long legal battle, unpublished data from the trial was released and has now been independently reanalysed. The paper, published in the journal BMC Psychology, has found that the benefits reported for psychotherapy and exercise therapy are modest and not statistically reliable.
 
Lead author Carolyn Wilshire, said:
 
“Our reanalysis was designed to explore how the PACE trial outcomes would have looked if the investigators had adhered to the primary outcome they described in their original published protocol.
 
“We also looked into the published data on long-term outcomes to examine whether they had been influenced by the treatments patients had received after the trial had ended.
 
“We found that the groups receiving CBT or GET did not significantly outperform the control group after correcting for the number of comparisons specified in the trial protocol. Rates of recovery were consistently low and not significantly different across treatment groups.”
 
In surveys carried out by the ME Association, more than half of patients who had followed the recommended graded exercise programme saw a worsening in their symptoms.
 
Dr Charles Shepherd, Honorary Medical Adviser to the ME Association, today said:
 
“The ME Association has always been very critical of the way in which the PACE trial was designed, especially the lack of any objective outcome measures.
 
“And we have not been impressed by the way in which the results have been reported in medical journals, especially claims relating to recovery following CBT and GET.
 
“So, it comes as no surprise to find that a very careful re-analysis of some of the PACE trial data by Carolyn Wilshire and colleagues has concluded that impressive claims for recovery following CBT and GET are not statistically reliable.
 
“It is also very concerning to note that this data was only released through use of the Freedom of Information Act and a very costly Tribunal – which ordered the release of data.
 
“This sends a powerful message to the research community that they must be willing to share data where there are serious concerns about protocols or the reliability of results from a clinical trial.
 
“The ME Association believes that it is very important to encourage research data sharing and, where appropriate, independent reanalysis – which is why we made a significant financial contribution towards the processing fee for publication of this paper.
 
“The message is clear – CBT and GET are not effective ways of treating a serious neuroimmune disease. The sooner this message gets across to health professionals the better.”
 
The PACE trial data was used justify NHS recommendations of exercise and cognitive behaviour therapy and no changes were made as a result.
 

But a patient revolt has forced the government and NICE (the National Institute of Clinical Excellence) to review the guidelines used by UK doctors. That review may not be completed before 2020.


Forward ME Letter to The Times: Patients with ME/CFS ‘are not simply “deconditioned” as claimed by many psychiatrists’ | 23 March 2018

http://www.meassociation.org.uk/2018/03/forward-me-letter-to-the-times-patients-with-me-cfs-are-not-simply-deconditioned-as-claimed-by-many-psychiatrists-23-march-2018/

Letter to The Times, 23rd March, 2018.

Treatment for patients with M.E.

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.

Signatures

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

 

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