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Call to Action: Misleading Pace Claims Should Be Retracted

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Editor's Comment: The PACE Trial was a study sponsored by the UK government. The conclusion of the authors was that graded exercise (GET) and cognitive behavioral therapy (CBT) were effective treatments for ME/CFS. The study's results were taken to mean that exercise and therapy could cure the disease. As a consequence, the National Health Services (NHS) adopted these as first-line treatments for ME/CFS. The study has come under fire, most recently by David Tuller, for flawed methodologies, conflict of interest on the part of the authors, and conclusions that were not justified by the results.

Reprinted with the kind permission of #MEAction.

You can sign this petition HERE.


Given the weak and flawed methodologies of the PACE trial, which claims that CBT and GET led to the recovery of ME/CFS patients, we, the undersigned patients, doctors, scientists, parents, children, family, friends, caretakers and #MEAllies:

  • call upon The Lancet to retract the claim made in its February 2011 editorial [1] that 30% of patients, or indeed any patients at all, were said to have recovered in the accompanying Lancet paper on the PACE trial [2]; and retract from that paper all analyses and statements in relation to the absurd “normal ranges” for fatigue and physical function; (See: What's Wrong in the Lancet)

  • call upon Psychological Medicine to retract the claims in this paper [3] that 22% of patients in the CBT and GET groups recovered, based on recovery criteria that were weakened so far from their original form in the study protocol that they no longer represent recovery by any rational standard;?? (See: What's wrong in psychological medicine)

  • call upon the study authors to publish the recovery outcomes according to the analyses specified in the trial’s protocol [4] and to give independent researchers full access to the raw data (anonymised by removing trial identifiers and all other data superfluous to the calculation, such as age, sex or location). #MEAction undertakes to meet any reasonable cost of analysis or data preparation;

  • call upon all parties to reject the view that being as disabled as patients with congestive heart failure is a good recovery of physical function in CFS. (See: Why the PACE trial authors should publish the planned recovery analyses)

Why is this important?

The UK’s £5 million PACE trial has been hugely influential in bolstering the view that CFS (chronic fatigue syndrome) patients can recover if they gradually increase their activity, despite widespread reports of harm [5]. This view informs how patients around the world are treated in the media, in medical practice and by society. It is crucial that misleading claims of recovery do not stand.

"All the issues with the trial are extremely worrying, making interpretation of the clinical significance of the findings more or less impossible.” – Emeritus Professor Jonathan Edwards of University College London

Claims have been made in The Lancet and Psychological Medicine that a substantial proportion of CFS patients in the PACE trial recovered after a course of cognitive behavioural therapy (CBT) or graded exercise therapy (GET). However, the claims are based on criteria that were revised after the study was already underway. These new criteria included “normal ranges” for fatigue and physical function that are so broad that patients could at the end of the trial have physical function similar to someone with congestive heart failure — and yet be classed as “recovered”.

Being as disabled as patients with congestive heart failure [6] simply isn’t good enough to count as recovery of physical function for patients with chronic fatigue syndrome.


Backgound to the Petition

[1] Chronic fatigue syndrome: where to PACE from here? 
[2] Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial

[3] Recovery from chronic fatigue syndrome after treatments given in the PACE trial 
[4] Protocol for the PACE trial: A randomised controlled trial of adaptive pacing, cognitive behaviour therapy, and graded exercise as supplements to standardised specialist medical care versus standardised specialist medical care alone for patients with the chronic fatigue syndrome/myalgic encephalomyelitis or encephalopathy 

[5] ME Association Report on therapeutic approaches 

[6] Health related quality of life in patients with congestive heart failure: comparison with other chronic diseases and relation to functional variables 

Note: We use here the term "Chronic Fatigue Syndrome" (CFS) in line with the PACE trial authors' terminology and use of the Oxford Criteria.

You can sign this petition HERE.

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