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… 

Further commentary on the PACE trial: Biased methods and unreliable outcomes

Geraghty in the year 2016, outlines a range of controversies surrounding publication of results from the PACE trial and discusses a freedom of information case brought by a patient refused access to

Graded exercise therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective and unsafe. Re-analysis of a Cochrane review

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.

Graded exercise therapy doesn't restore the ability to work in ME/CFS. Rethinking of a Cochrane review.

Get not only fails to objectively improve function significantly or to restore the ability to work, but it's also detrimental to the health of≥50% of patients, according to a multitude of patient surveys, and should not be recommended.

Cognitive behavioural therapy for myalgic encephalomyelitis/chronic fatigue syndrome is not effective. Re-analysis of a Cochrane review

Cognitive behavioural therapy should be downgrade to an adjunct support-level therapy, rather than a treatment for chronic fatigue syndrome, because it is not matched by an objective improvement of physical fitness or employment and illness benefit status.

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.

The Impact of a Structured Exercise Programme upon Cognitive Function in Chronic Fatigue Syndrome Patients

ME/CFS patients able to complete the SEP showed improved visual attention both in terms of reaction time and correctness of responses and processing speed of simple visual stimuli.

Improving Access to Psychological Therapies (IAPT) - The Need for Radical Reform

  • M. Scott
  • Psychology, Medicine
    Journal of health psychology
  • 2018
The results suggest that only the tip of the iceberg fully recovers from their disorderWhether or not they were treated before or after a personal injury claim, there is a pressing need to re-examine the modus operandi of the service.

Moving Sport and Exercise Science Forward: A Call for the Adoption of More Transparent Research Practices

The primary means of disseminating sport and exercise science research is currently through journal articles. However, not all studies, especially those with null findings, make it to formal

The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial

The hypothesis that Myelophil can be a therapeutic candidate to manage CFS is supported and the rationale for its progression to a phase 3 clinical trial is provided.

Multidisciplinary rehabilitation treatment is not effective for myalgic encephalomyelitis/chronic fatigue syndrome: A review of the FatiGo trial

FatiGo’s claims of efficacy of multidisciplinary rehabilitation treatment and cognitive behaviour therapy for chronic fatigue syndrome/myalgic encephalomyelitis are misleading and not justified by their results.



‘PACE-Gate’: When clinical trial evidence meets open data access

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

The discovery that an increase in exercise tolerance did not lead to a increase in fitness means that an underlying physical problem prevented this; validates that ME/CFS is a physical disease and that none of the treatments studied addressed this issue.

Response to the editorial by Dr Geraghty

This article is written in response to the linked editorial by Dr Geraghty about the adaptive Pacing, graded Activity and Cognitive behaviour therapy; a randomised Evaluation (PACE) trial, which we

A Randomized Controlled Graded Exercise Trial for Chronic Fatigue Syndrome: Outcomes and Mechanisms of Change

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.

Reporting of Harms Associated with Graded Exercise Therapy and Cognitive Behavioural Therapy in Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

This paper identifies problems with the reporting of harms in previous RCTs and suggests potential strategies for improvement and issues involving the heterogeneity of subjects and interventions, tracking of adverse events, trial participants' compliance to therapies, and measurement of harms using patient-oriented and objective outcome measures are discussed.

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.