Article abstract:
PACE trial claims for recovery in myalgic encephalomyelitis/chronic fatigue syndrome – true or false? It’s time for an independent review of the PACE Trial methods and results, by Charles Bernard Shepherd in Journal of Health Psychology, 10 April 2017
The PACE trial set out to discover whether cognitive behaviour therapy and graded exercise therapy are safe and effective forms of treatment for myalgic encephalomyelitis/ chronic fatigue syndrome.
It concluded that these interventions could even result in recovery. However, patient evidence has repeatedly found that cognitive behaviour therapy is ineffective and graded exercise therapy can make the condition worse.
The PACE trial methodology has been heavily criticised by clinicians, academics and patients. A re-analysis of the data has cast serious doubts on the recovery rates being claimed. The trust of patients has been lost. The medical profession must start listening to people with myalgic encephalomyelitis/chronic fatigue syndrome if trust is going to be restored.
Excerpt:
First, on behalf of all the journals that have so far published 16 papers from the trial, The Lancet must now set up an independent re-analysis of the PACE trial data, along with appropriate sensitivity analysis. This re-analysis should be carried out by well respected independent reviewers with expertise in statistics and study design. If any results are found to be significantly inaccurate or unreliable, the possibility of a retraction will have to be considered.
Second, if a drug treatment was found to be making a significant proportion of people worse, as is the case with patient evidence relating to the use of GET, the treatment would be withdrawn and would not form part of a NICE recommendation. As there is now both consistent and extensive patient evidence relating to the harmful effects of GET, the NICE guideline recommendation on GET must be reviewed as a matter of urgency. The generic prescribing of progressive and inflexible exercise programmes is not an acceptable form of treatment for people with ME/CFS.
Third, the enormous amount of public money spent by the Medical Research Council and Department of Work and Pensions on funding the PACE trial, along with legal costs met by Queen Mary University of London in appealing against the Freedom of Information requests, merits a formal inquiry, possibly at a parliamentary level.
Finally, there is a desperate need for clinical trials of activity management that examine the heterogeneity of ME/CFS, the fact that underlying disease processes involve both central and peripheral fatigue, and the consistent evidence from patients that inflexible or progressive exercise programmes aggravate symptoms in the majority of patients who come under the ME/CFS umbrella.
Link to other articles on the PACE trial in the Journal of Health Psychology:
PACE team response shows a disregard for the principles of science (Professor Jonathan Edwards)
The problem of bias in behavioural intervention studies: Lessons from the PACE trial (Carolyn Wilshire)
Do graded activity therapies cause harm in chronic fatigue syndrome? (Tom Kindlon)
Investigator bias and the PACE trial (Steven Lubet)
How have selection bias and disease misclassification undermined the validity of myalgic encephalomyelitis/chronic fatigue syndrome studies? (Dr Luis Nacul et al from the UK ME/CFS Biobank)
The PACE trial missteps on pacing and patient selection (Professor Leonard A Jason)
Response to the editorial by Dr Geraghty (Professor Peter D White, Professor Trudie Chalder, Professor Michael Sharpe et al)
