PACE trial claims for recovery in myalgic encephalomyelitis/chronic fatigue syndrome – true or false? It’s time for an independent review of the methodology and results

Shepherd, Charles

doi:10.1177/1359105317703786

Cited by 12 publications

(9 citation statements)

References 9 publications

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“…In addition, despite numerous approaches with various interventions, no definitively effective treatment has been approved for patients with CFS/ME [10]. Through a large-scale clinical study (called the PACE trial), cognitive behavior therapy (CBT) and graded exercise therapy (GET) were recommended as effective therapies for CFS/ ME; however, there is debate and criticism by both scientists and patients [11]. A recent trial using a monoclonal antibody, rituximab, also did not show promising results [12].…”

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confidence: 99%

Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)

et al. 2020

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Background: Although medical requirements are urgent, no effective intervention has been proven for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). To facilitate the development of new therapeutics, we systematically reviewed the randomized controlled trials (RCTs) for CFS/ME to date. Methods: RCTs targeting CFS/ME were surveyed using two electronic databases, PubMed and the Cochrane library, through April 2019. We included only RCTs that targeted fatigue-related symptoms, and we analyzed the data in terms of the characteristics of the participants, case definitions, primary measurements, and interventions with overall outcomes. Results: Among 513 potentially relevant articles, 55 RCTs met our inclusion criteria; these included 25 RCTs of 22 different pharmacological interventions, 28 RCTs of 18 non-pharmacological interventions and 2 RCTs of combined interventions. These studies accounted for a total of 6316 participants (1568 males and 4748 females, 5859 adults and 457 adolescents). CDC 1994 (Fukuda) criteria were mostly used for case definitions (42 RCTs, 76.4%), and the primary measurement tools included the Checklist Individual Strength (CIS, 36.4%) and the 36-item Short Form health survey (SF-36, 30.9%). Eight interventions showed statistical significance: 3 pharmacological (Staphypan Berna, Poly(I):poly(C 12 U) and CoQ 10 + NADH) and 5 non-pharmacological therapies (cognitive-behavior-therapy-related treatments, graded-exercise-related therapies, rehabilitation, acupuncture and abdominal tuina). However, there was no definitely effective intervention with coherence and reproducibility. Conclusions: This systematic review integrates the comprehensive features of previous RCTs for CFS/ME and reflects on their limitations and perspectives in the process of developing new interventions.

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confidence: 99%

Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)

et al. 2020

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“…PACE fails to demonstrate sizable improvements across objective tests of physical functioning (Kindlon, 2017; Shepherd, 2017; Tuller, 2017; Vink, 2017; Wilshire, 2017). Thus, what is ‘recovery’ if patients remain substantially functionally impaired?…”

Section: Recovery Measurementmentioning

confidence: 94%

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

Geraghty

2017

J Health Psychol

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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 data from the trial. The PACE authors offer a response, writing 'Dr Geraghty's views are based on misunderstandings and misrepresentations of the PACE trial'. This article draws on expert commentaries to further detail the critical methodological failures and biases identified in the PACE trial, which undermine the reliability and credibility of the major findings to emerge from this trial.

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“…Doubt has been cast on the methodology suggesting that the findings are not as conclusive as reported. [85][86][87][88] Many sufferers felt that these recommendations dismissed their experience of exacerbation of symptoms with exercise and disrespected their efforts to cope. Unfortunately, sensitivity to the fallout from the Royal Free experience has prejudiced cognitive behavior therapy's usefulness, and a more measured individualized approach Adolescent Health, Medicine and Therapeutics 2023:14 https://doi.org/10.2147/AHMT.S317314 DovePress 15 has been reported as more helpful.…”

Section: Interventionsmentioning

confidence: 99%

“…Although graded exercise therapy, as recommended from the PACE trial has been controversial due to the apparent disregard for post-exertional malaise, [84][85][86][87][88] some physical activity is required to prevent significant de-conditioning from lack of use because they are so unwell. Feeling weak and fatigued can result from post-exertional malaise, or from deconditioning, and learning to balance either activities of daily living or pleasurable activities with sufficient recovery time is a significant challenge.…”

Section: Self-management Plan Devised By the Young Personmentioning

confidence: 99%

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in Adolescents: Practical Guidance and Management Challenges

Rowe¹

2023

AHMT

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This paper reviews the current understanding of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), and whether any treatment strategies have been effective. ME/CFS is a condition of as yet unknown etiology that commonly follows an infective process. It includes a new onset of fatigue (of more than 3-6 month duration and not relieved by rest), post-exertional malaise, cognitive difficulties and unrefreshing sleep, and frequently orthostatic intolerance, somatic symptoms and pain. Long COVID has renewed interest in the condition and stimulated research with findings suggestive of a multisystem neuroimmune disease. There are no definitively effective treatments. Despite earlier recommendations regarding graded exercise therapy and cognitive behavior therapy, the current recommendations are managing symptoms, with lifestyle management and supportive care. This paper provides an outline of strategies that young people and their families have reported as helpful in managing a chronic illness that impacts their life socially, physically, emotionally, cognitively and educationally. As the illness frequently occurs at a time of rapid developmental changes, reducing these impacts is reported to be as important as managing the physical symptoms. Young people face a mean duration of 5 years illness (range 1-16 years) with a likely residual 20% having significant restrictions after 10 years. Their feedback has suggested that symptom management, selfmanagement strategies, advocacy and educational liaison have been the most helpful. They value professionals who will listen and take them seriously, and after excluding alternative diagnoses, they explain the diagnosis, are supportive and assist in monitoring their progress. Remaining engaged in education was the best predictor of later functioning. This allowed for social connections, as well as potential independence and fulfilling some aspirations. The need to consider the impact of this chronic illness on all aspects of adolescent development, as part of management, is highlighted.

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PACE trial claims for recovery in myalgic encephalomyelitis/chronic fatigue syndrome – true or false? It’s time for an independent review of the methodology and results

Cited by 12 publications

References 9 publications

Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)

Systematic review of randomized controlled trials for chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)

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

Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) in Adolescents: Practical Guidance and Management Challenges

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