PACE trial authors continue to ignore their own null effect

  title={PACE trial authors continue to ignore their own null effect},
  author={Mark Vink},
  journal={Journal of Health Psychology},
  pages={1134 - 1140}
  • M. Vink
  • Published 27 April 2017
  • Psychology, Medicine
  • Journal of Health Psychology
Protocols and outcomes for the PACE trial were changed after the start of the trial. These changes made substantial differences, leading to exaggerated claims for the efficacy of cognitive behavior therapy and graded exercise therapy in myalgic encephalomyelitis/chronic fatigue syndrome. The small, self-reported improvements in subjective measures cannot be used to say the interventions are effective, particularly in light of the absence of objective improvement. Geraghty’s criticism of the… 
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The effects of therapies for Myalgic Encephalomyelitis and chronic fatigue syndrome should be assessed using objective measures
Trials into proposed therapies for ME and CFS, including CBT, GET, rituximab and rintatolimod, should use objective measures to impartially assess the effectiveness.
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  • M. Scott
  • Psychology, Medicine
    Journal of health psychology
  • 2018
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The analysis of the objective outcomes in the trials provides sufficient evidence to conclude that graded exercise therapy is an ineffective treatment for myalgic encephalomyelitis/chronic fatigue syndrome.


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In this extraordinary case, patients discovered that the treatments tested had much lower efficacy after an information tribunal ordered the release of data from the PACE trial to a patient who had requested access using a freedom of information request.
The PACE Trial Invalidates the Use of Cognitive Behavioral and Graded Exercise Therapy in Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: A Review
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Graded exercise appears to be an effective treatment for CFS and it operates in part by reducing the degree to which patients focus on their symptoms.
Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial
The claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments.
Assessment of Individual PACE Trial Data: in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Cognitive Behavioral and Graded Exercise Therapy are Ineffective, Do Not Lead to Actual Recovery and Negative Outcomes may be Higher than Reported
Analysis of the individual participant PACE trial data has shown that CBT and GET are ineffective and (potentially) harmful, which invalidates the assumption and opinion-based biopsychosocial model.
When and How Can Endpoints Be Changed after Initiation of a Randomized Clinical Trial?
  • S. Evans
  • Psychology
    PLoS clinical trials
  • 2007
Some of the issues and decision-making processes that should be considered when evaluating whether to make changes to endpoints are discussed, and the documentation and reporting of clinical trials that have revised end points are discussed.
Recovery from chronic fatigue syndrome after treatments given in the PACE trial
This study confirms that recovery from CFS is possible, and that CBT and GET are the therapies most likely to lead to recovery.
How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity
The effect of CBT on fatigue in CFS is not mediated by a persistent increase in physical activity, and changes inPhysical activity were not related to changes in fatigue.