PACE Trial & Reports

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PACE trial reanalysis, MEA 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.

The influential 2011 PACE trial has been heavily criticised by clinicians, researchers, statistical experts and patients.

We have also published other critical reviews of similar trials – namely the 2017 SMILE trial (Lightning Process) and 2017 GETSET trial (remote graded exercise therapy).

Leaflets explain Pacing and energy management (click)

Published trials, critical reanalysis, commentaries and patient evidence form the basis for our own recommendations on illness management.

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‘ (see also below).

Pacing remains the ME Association’s recommended approach to managing this debilitating disease.

The PACE Trial

1. Wilshire et al. (March 2018) Rethinking the treatment of chronic fatigue syndrome – a reanalysis and evaluation of findings from a recent major trial of graded exercise and CBT

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…”

2. Wilshire et al. (March 2017) 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 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.

3. Journal of Health Psychology (March 2017) 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. ME Association Patient Survey Report on CBT, GET and Pacing (2015) ‘No decision about me, without me.’ 

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.

2. ME Association Patient Survey Report on Illness Management (2010) ‘Managing my M.E.’

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.

3. October 2017 – The SMILE trial (Crawley, et al. Bristol University)

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.

4. June 2017 – The GETSET trial (Clark, et al. Queen Mary University Hospital)

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 Christmas Appeal

More research for M.E. in 2019

We believe that biomedical research offers the best hope. And we want to fund more research in 2019 than ever before. Please help us to build on our success and continue to expand our vital work.

If you would like to help our Christmas Appeal, please donate:

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