PACE trial reanalyses, Illness management reports and Trial reviews
This page carries information relating to several illness management approaches that have been the subject of clinical trials and also evidence from patients collected via survey methods.
Most illness management for ME/CFS at present centres around activity management, pacing, cognitive behavioural therapy, and, most controversially, graded exercise therapy.
| “Pacing remains the ME Association's recommended approach to managing this debilitating disease. “We have not felt it necessary to change our position since it was last explained in the widely-cited 2015 report ‘No decision about me, without me‘ which was based on patient evidence. “From the medico-legal point of view, doctors who prescribe exercise programmes for ME/CFS patients must do so with just as much care as they would a prescription drug. “In our opinion GET is all too often applied in an inappropriate ‘one-size-fits-all’ generalised way, and delivered in a regimented and inflexible manner. It is based largely on the deconditioning theory for which there is now even less evidence. “A significant number of patients had been given advice on exercise and activity management that was judged harmful with symptoms becoming worse or much worse and leading to relapse. “And despite current NICE recommendations, a significant number of severe-to-very severe patients were recommended GET by practitioners and/or had taken part in GET courses. “We have concluded that GET should be withdrawn with immediate effect as a primary intervention for everyone with ME/CFS. “CBT courses, based on the model that abnormal beliefs and behaviours are responsible for maintaining the illness, have no role to play in the management of ME/CFS and increase the risk of symptoms becoming worse. “An appropriate model of CBT – one that helps patients learn practical coping skills and/or manage co-morbid issues such as those listed above – could be employed, where appropriate, for ME/CFS as it is for other chronic physical illnesses such as multiple sclerosis, Parkinson’s disease, cancer, heart disease, and arthritis etc. “We recommend all patients should have access to such courses as well as access to follow-up courses and/or consultations as and when required.” The ME Association. For additional and practical management information see our website. |
The influential 2011 PACE trial has been heavily criticised by clinicians, researchers, statistical experts and patients but is defended by its authors.
We have published other critical reviews of similar trials – namely the 2017 SMILE trial (Lightning Process) and 2017 GETSET trial (remote graded exercise therapy).
Published trials, critical reanalyses, commentaries and patient evidence form the basis for our own recommendations on illness management (see below).
The PACE Trial
1. The PACE Trial: How a Debate Over Science Empowered a Whole Community – Carolyn E. Wilshire 09 May 2019
There are few in the ME/CFS community who have not heard of the PACE Trial. This £5 million clinical trial was designed to test the effectiveness of cognitive behavioural therapy (CBT) and graded exercise therapy (GET) as treatments for people with “chronic fatigue syndrome” (CFS).
Publications from the trial claimed that CBT and GET could not only ease the symptoms of CFS but were enough to get over a fifth of patients back to normal. Here we tell the story of how a group of patients teamed up with researchers and statisticians to scrutinise these bold claims…
2. Rethinking the treatment of chronic fatigue syndrome – a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT (Wilshire et al. March 2018)
The ME Association was approached by the authors and agreed to cover the cost of publication of this important reanalysis of the PACE trial (payment was made from general funds).
The publication in BMC Psychology was accompanied by a ME Association press release, that included comment from the lead author, Carolyn Wilshire, and Dr Charles Shepherd:
| “The ME Association has always been very critical of the way in which the PACE trial was designed, especially the lack of any objective outcome measures. “And we have not been impressed by the way in which the results have been reported in medical journals, especially claims relating to recovery following CBT and GET. “So, it comes as no surprise to find that a very careful re-analysis of some of the PACE trial data by Carolyn Wilshire and colleagues has concluded that impressive claims for recovery following CBT and GET are not statistically reliable. “It is also very concerning to note that this data was only released through use of the Freedom of Information Act and a very costly Tribunal – which ordered the release of data…” |
3. 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 (Wilshire et al. March 2017)
The ME Association paid – from general funds – for a PACE Trial critique from ME/CFS patient advocates to be made open-access.
The commentary and preliminary reanalysis was authored by Carolyn Wilshire, Alem Matthees, Tom Kindlon and Simon McGrath and published in the journal ‘Fatigue'.
This has brought greater international attention to this important paper and helped many people, including patients, to read it for free and better appreciate the reasons why the Trial is considered by many – including the ME Association – to be unsound.
The authors concluded:
| “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.” |
A background article from the ME Association can be read, here.
4. Journal of Health Psychology PACE Trial Commentaries
In a further development, the Journal of Health Psychology, had published a PACE Trial critique from Dr Keith Geraghty in November 2016.
The Journal then featured additional commentaries from notable experts including Dr Charles Shepherd, Dr Leonard Jason, Dr Jonathan Edwards, the UK ME/CFS Biobank team, and others, which served to highlight concerns about the PACE trial.
The ME Association wrote to the Journal explaining the importance of easy access and were very pleased when it was agreed to make the commentaries open access, increasing audience reach.
It was also widely welcomed when the Journal's editor, David Marks, decided to make all the commentaries into a special edition on 31st July, 2017.
MEA Illness Management Reports and Trial Reviews
The following two main research reports were financed from ME Association general funds with data gathered from patients in the form of online and paper-based surveys that had been offered to both members of the ME Association and to non-members.
1. Forward ME and Oxford Brookes University Report on CBT/GET Patient Survey (April 2019)
This survey was commissioned by Forward ME following discussions between the Chair and Vice-Chair of the NICE Guideline Development Group, Members of Parliament and the Chair of Forward-ME.
It was designed by a steering group of Forward ME members and an independent research unit within Oxford Brookes University, Oxford Clinical Allied Technology and Trials Services Unit (OxCATTS), was engaged to undertake the survey, collate, analyse and report on the response.
The ME Association helped fund the cost of the report. See also: Blog Post.
2. ME Association Patient Survey Report on CBT, GET and Pacing ‘No decision about me, without me.' (May 2015)
Results and in-depth analysis of the 2012 ME Association extensive patient survey examining the acceptability, efficacy and safety of cognitive behaviour therapy, graded exercise therapy and pacing courses as interventions used as management strategies for ME/CFS.
The report demonstrated patient experiences of therapies prescribed by the National Institute for Health and Care Excellence (NICE) and endorsed by the PACE Trial, and has been used in the ME Association submissions to NICE and widely cited by many authors critiquing the PACE Trial.
You can download the 278-page report, here.
3. ME Association Patient Survey Report on Illness Management ‘Managing my M.E.' (May 2010)
Results and in-depth analysis of the 2008 survey into illness management.
Overall, 4,217 people took part – making this the largest ever survey of patient and carer evidence. A total of 3,494 people responded using an on-line version, and a further 723 completed a paper version.
The aim of the survey was to gather a wide range of patient and carer evidence including opinions relating to prescribed medications and illness management therapies.
You can download the 32-page report, here.
4. ME Association Review of The SMILE trial (Crawley, et al. Bristol University) (October 2017)
This randomised trial aimed to determine if young people with ME/CFS might benefit from standard medical care and the commercial Lightning Process.
We produced a damning review of both the research and the promoted results, explaining why the trial failed to deliver what it promised.
| “The SMILE trial is one of the worst examples of a clinical trial supposedly designed to assess the acceptability, effectiveness and safety of a treatment for ME/CFS that I have come across. “In fact, in several ways it is a lesson in how not to conduct a clinical trial in people who have ME/CFS….” Dr Charles Shepherd, Hon. Medical Adviser, ME Association. |
5. ME Association Review of The GETSET trial (Clark, et al. Queen Mary University Hospital) (June 2017)
This randomised controlled trial aimed to demonstrate that GET delivered remotely was able to improve physical function for people with ME/CFS.
We explain why it didn’t and why other aspects of this trial – and the therapy – should be treated with caution.
| “Our cautionary advice to anyone who is recommended graded exercise therapy (GET) – or its' derivatives – remains the same. “In our opinion GET is all too often applied in an inappropriate ‘one-size-fits-all' generalised way, and delivered in a regimented and inflexible manner. “It is based largely on the deconditioning theory for which there is now even less evidence. GES/GET in our opinion is an ineffective approach to management.” The ME Association. |
The ME Association
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Visit the other pages in this section:
- Published Research – Supported by the MEA Ramsay Research Fund
- Research Summaries – Lay summaries of interesting and important research
- PACE Trial Reanalysis and MEA Illness Management Reports
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