In 2011, following a randomised trial part-funded by the Department for Work and Pensions (DWP), researchers claimed that Cognitive Behaviour Therapy (CBT) and Graded Exercise Therapy (GET) “can safely be added to [specialist medical care] to moderately improve outcomes for chronic fatigue syndrome”.
What is CBT?
CBT is a talking therapy which focuses on how negative thoughts, beliefs and attitudes affect the way we feel both emotionally and physically in a particular situation and how we behave in that situation. Research has shown that CBT can be a highly effective treatment for certain conditions, for example depression and anxiety.
What is GET?
GET is a structured exercise programme often recommended to those with ME/CFS and other conditions of central sensitisation such as Fibromyalgia. The therapy is aimed at gradually increasing a person’s tolerance to a particular type or types of exercise such as walking or swimming.
PACE
The randomised trial mentioned above, which was known as the PACE trial, reported that 59% of patients receiving CBT and 61% of those who had received GET had experienced an overall improvement, compared with 45% in a control group. It also reported that 22% of patients in each of the CBT and GET groups had achieved a recovery.
Despite this, patient groups and clinicians were critical of both the conduct of the trial and the results reported. Their criticism was justified. Eventually, following a Freedom of Information request, data from the trial was released which was then independently re-analysed. The re-analysis, which was part-funded by the ME Association, established that improvement was found in just 20% of patients receiving CBT and 21% of those who had received GET, along with 10% in the control group. Further, in both groups, a recovery was found to have been achieved in only 8% of patients.
The results of the re-analysis have been published in the journal BMC Psychology. The new researchers say that “reanalyses of the trial data based on the published protocol generated some troubling findings”, saying that the measure of the success of the treatment was changed after the trial had begun, ie, the goalposts were moved.
The lead author, Dr Carolyn Wilshire, from the University of Wellington in New Zealand, said “until there is positive evidence to suggest otherwise, the conclusion we must draw is that PACE’s treatment effects are not sustained over the long term, not even on self-report measures.
“CBT and GET have no long-term benefits at all. Patients do just as well with good basic medical care.”
In response
In response, the authors of the original study have said that they stand firmly by their findings, suggesting that the new research was based upon only part of the data from the original trial. They also point to other research which they say supports their findings.
Despite that, in a recent parliamentary debate on PACE, one MP described the trial as “one of the greatest medical scandals of the 21st century”, which was “deliberately flawed to “remove people from long-term benefits and reduce the welfare bill.”
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