By Tom Whipple, Science Editor, The Times, 25 September 2017.
A patient revolt in collaboration with MPs and academics has led to a major review of NHS guidelines on the treatment of ME.
The reassessment of recommendations for the condition will consider the validity of a £5 million taxpayer-funded trial that claimed sufferers could be helped by simple lifestyle intervention.
About 200,000 people in the UK suffer from myalgic encephalomyelitis (ME), also sometimes known as chronic fatigue syndrome (CFS). Its symptoms include debilitating tiredness, joint pain and concentration problems, and its causes are poorly understood.
In 2011 a UK study published in The Lancet found that patients could experience significant improvements through exercise and cognitive behavioural therapy. Its findings have since formed the basis of treatment in the UK and abroad.
However, patient groups claimed that the interventions made them worse and argued that the treatment wrongly implied it was a psychological, rather than biological, illness. Some academics agreed.
In an open letter to The Lancet, more than 40 academics from UCL, Stanford, Columbia and University of California, Berkeley, among others, argued that the trial had “major flaws”, which included changing its criteria for patient improvement midway through.
They said that this was of particular concern “because of its significant impact on government policy, public health practice, clinical care and decisions about disability insurance and other social benefits”.
The severity of CFS means people are often unable to hold down jobs or live normal lives.
Keith Geraghty, from the University of Manchester, said that the apparent improvements in some patients could be better explained by initial misdiagnosis, and that the benefits were marginal. “The problem is, if you look at patients when you do nothing there is a similar level of recovery,” he said.
Because the criteria for measuring recovery was changed, it was also not clear what recovery even meant, he said. “It became farcical because once they did that patients who began the trial as sick could have been deemed recovered when they started.”
The debate about the trial has become one of the most acrimonious in science, with both sides claiming they have been abused by the other. The US has now changed its recommendations.
The National Institute for Health and Care Excellence (Nice) has been receiving strenuous lobbying to do the same, and this month pressure was increased when 30 MPs signed an early day motion urging a review.
This week Sir Andrew Dillon, chief executive of Nice, said that it would carry out a full review, expected to report back after 2020.
Trudie Chalder, professor of cognitive behavioural psychotherapy at King’s College London, was one of the authors of the original 2011 Lancet paper. She welcomed the review and said that subsequent trials showed that exercise and cognitive behavioural therapy remained the best treatment.
“There have been several well conducted trials from independent researchers showing that rehabilitative treatments such as cognitive behavioural therapy and graded exercise therapy improve people’s lives,” she said. “Professionals who provide evidence-based treatments need an update on the state of play.”
Read the article in The Times.