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The PACE trial of treatments for chronic fatigue syndrome: a response to WILSHIRE et al

Published on Dec 1, 2019in BMC Psychology
· DOI :10.1186/s40359-019-0288-x
Michael Sharpe73
Estimated H-index: 73
(University of Oxford),
Kim Goldsmith2
Estimated H-index: 2
('KCL': King's College London),
Trudie Chalder53
Estimated H-index: 53
('KCL': King's College London)
Sources
Abstract
Chronic Fatigue Syndrome (CFS) is chronic disabling illness characterized by severe disabling fatigue, typically made worse by exertion. Myalgic Encephalomyelitis (ME) is thought by some to be the same disorder (then referred to as CFS/ME) and by others to be different. There is an urgent need to find effective treatments for CFS. The UK Medical Research Council PACE trial published in 2011 compared available treatments and concluded that when added to specialist medical care, cognitive behaviour therapy and graded exercise therapy were more effective in improving both fatigue and physical function in participants with CFS, than both adaptive pacing therapy and specialised medical care alone. In this paper, we respond to the methodological criticisms of the trial and a reanalysis of the trial data reported by Wilshire at al. We conclude that neither the criticisms nor the reanalysis offer any convincing reason to change the conclusions of the PACE trial.
  • References (22)
  • Citations (1)
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References22
Newest
#1Carolyn E. Wilshire (Victoria University of Wellington)H-Index: 14
#2Tom KindlonH-Index: 4
Last. Bruce Levin (Columbia University)H-Index: 51
view all 7 authors...
The PACE trial was a well-powered randomised trial designed to examine the efficacy of graded exercise therapy (GET) and cognitive behavioural therapy (CBT) for chronic fatigue syndrome. Reports concluded that both treatments were moderately effective, each leading to recovery in over a fifth of patients. However, the reported analyses did not consistently follow the procedures set out in the published protocol, and it is unclear whether the conclusions are fully justified by the evidence. Here,...
18 CitationsSource
#1A.L. Janse (UvA: University of Amsterdam)H-Index: 2
#2M.G.M. Worm-Smeitink (UvA: University of Amsterdam)H-Index: 1
Last. Hans Knoop (UvA: University of Amsterdam)H-Index: 27
view all 5 authors...
Background Face-to-face cognitive-behavioural therapy (CBT) leads to a reduction of fatigue in chronic fatigue syndrome (CFS). Aims To test the efficacy of internet-based CBT (iCBT) for adults with CFS. Method A total of 240 patients with CFS were randomised to either iCBT with protocol-driven therapist feedback or with therapist feedback on demand, or a waiting list. Primary outcome was fatigue severity assessed with the Checklist Individual Strength (Netherlands Trial Register: NTR4013). Resul...
8 CitationsSource
#1Federica Picariello ('KCL': King's College London)H-Index: 5
#2Sheila Ali (South London and Maudsley NHS Foundation Trust)H-Index: 5
Last. Trudie Chalder ('KCL': King's College London)H-Index: 53
view all 4 authors...
Objectives Cognitive behavioural therapy (CBT) is currently a first-line treatment for chronic fatigue syndrome (CFS). Even though the results from trials are promising, there is variability in patient outcomes. The aim of this study was to explore the experiences of patients with CFS who undertook CBT at a specialist service for CFS. Design This was a qualitative study. Methods Thirteen patients with CFS, approaching the end of CBT, participated in semi-structured interviews. In addition, parti...
4 CitationsSource
#1Helen Spandler (UCLan: University of Central Lancashire)H-Index: 19
#2Meg AllenH-Index: 1
ME/CFS is a medically contested illness and its understanding, framing and treatment has been the subject of heated debate. This paper examines why framing the condition as a psychiatric issue—what we refer to as ‘psychiatrisation’—has been so heavily contested by patients and activists. We argue that this contestation is not simply about stigmatising mental health conditions, as some have suggested, but relates to how people diagnosed with mental illness are treated in society, psychiatry and t...
3 CitationsSource
#1Lucy V Clark (QMUL: Queen Mary University of London)H-Index: 10
#2Francesca Pesola (QMUL: Queen Mary University of London)H-Index: 11
Last. Peter D White (QMUL: Queen Mary University of London)H-Index: 39
view all 6 authors...
Summary Background Graded exercise therapy is an effective and safe treatment for chronic fatigue syndrome, but it is therapist intensive and availability is limited. We aimed to test the efficacy and safety of graded exercise delivered as guided self-help. Methods In this pragmatic randomised controlled trial, we recruited adult patients (18 years and older) who met the UK National Institute for Health and Care Excellence criteria for chronic fatigue syndrome from two secondary-care clinics in ...
14 CitationsSource
#1Lillebeth Larun (FHI: Norwegian Institute of Public Health)H-Index: 8
#2Kjetil Gundro Brurberg (FHI: Norwegian Institute of Public Health)H-Index: 7
Last. Jonathan Price (University of Oxford)H-Index: 20
view all 4 authors...
Background Chronic fatigue syndrome (CFS) is characterised by persistent, medically unexplained fatigue, as well as symptoms such as musculoskeletal pain, sleep disturbance, headaches and impaired concentration and short-term memory. CFS presents as a common, debilitating and serious health problem. Treatment may include physical interventions, such as exercise therapy, which was last reviewed in 2004. Objectives The objective of this review was to determine the effects of exercise therapy (ET) ...
235 CitationsSource
#1Stephan P. Keijmel (Radboud University Nijmegen)H-Index: 7
#2Corine E. DelsingH-Index: 13
Last. Chantal P. Bleeker-Rovers (Radboud University Nijmegen)H-Index: 31
view all 12 authors...
Background.: Approximately 20% of patients with acute Q fever will develop chronic fatigue, referred to as Q fever fatigue syndrome (QFS). The objective of this randomized controlled clinical trial was to assess the efficacy of either long-term treatment with doxycycline or cognitive-behavioral therapy (CBT) in reducing fatigue severity in patients with QFS. Methods.: Adult patients were included who met the QFS criteria according to the Dutch guideline: a new onset of severe fatigue lasting >/=...
12 CitationsSource
#1Lv ClarkH-Index: 1
#2Francesca PesolaH-Index: 11
Last. Peter D WhiteH-Index: 39
view all 6 authors...
This paper presents independent research funded by the UK National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (grant reference number PB-PG-0610-22060). The views expressed are those of the authors and not necessarily those of the UK National Health Service (NHS), the NIHR, or the UK Department of Health. This study was also funded by the Sue Estermann Fund, a donor advised fund managed by The London Community Foundation. This study was supported...
1 Citations
#1Michael Sharpe (University of Oxford)H-Index: 73
#2Trudie Chalder ('KCL': King's College London)H-Index: 53
Last. Peter D White (QMUL: Queen Mary University of London)H-Index: 39
view all 5 authors...
ABSTRACTBackground: Wilshire et al. suggest that we have overestimated the number of patients that recover from chronic fatigue syndrome (CFS) after receiving a course of either cognitive behaviour therapy (CBT) or graded exercise therapy (GET), as reported in a secondary analysis of outcome data from the Pacing, graded Activity and Cognitive behavior therapy; a randomized Evaluation (PACE) trial. We provide counter-arguments to this view.Purpose: To provide an alternative view to that offered b...
4 CitationsSource
#1Carolina X. Sandler (UNSW: University of New South Wales)H-Index: 5
#2Blake A. Hamilton (UNSW: University of New South Wales)H-Index: 1
Last. Andrew R. Lloyd (UNSW: University of New South Wales)H-Index: 67
view all 7 authors...
Background Medically unexplained chronic fatigue states are prevalent and challenging to manage. Cognitive behavioural therapy (CBT) and graded exercise therapy (GET) are effective in clinical trials. The evaluation of delivery in a standard healthcare setting is rare. An integrated treatment programme with individualised allocation of resources to patients’ needs was developed and implemented through an academic outpatient clinic. It was hypothesised that the programme would result in similar r...
6 CitationsSource
Cited By1
Newest
#1Rosemary Twomey (U of C: University of Calgary)H-Index: 2
#2Samuel T. Yeung (U of C: University of Calgary)
Last. S. Nicole Culos-Reed (TBCC: Tom Baker Cancer Centre)H-Index: 18
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Abstract Context Cancer-related fatigue (CRF) is a distressing and persistent sense of tiredness or exhaustion that interferes with usual functioning. Chronic CRF continues for months after curative cancer treatment is complete. Post-exertional malaise (PEM) is a worsening of symptoms after physical or mental activity, with limited investigations in people with chronic CRF. Objectives The purpose of this study was to identify and describe self-reported incidences of PEM in people with chronic CR...
Source
#1Carolyn E. Wilshire (Victoria University of Wellington)H-Index: 14
#2Tom KindlonH-Index: 4
In a recent paper, we argued that the conclusions of the PACE trial of chronic fatigue syndrome are problematic because the pre-registered protocol was not adhered to. We showed that when the originally specific outcomes and analyses are used, the evidence for the effectiveness of CBT and graded exercise therapy is weak. In a companion paper to this article, Sharpe, Goldsmith and Chalder dismiss the concerns we raised and maintain that the original conclusions are robust. In this rejoinder, we c...
2 CitationsSource