Patients with chronic fatigue syndrome could be "harmed rather than helped" by a "flawed" review which concluded that graded exercise therapy was unsafe, according to researchers.

A new evaluation has re-opened a long-running controversy over what interventions doctors should prescribe for patients suffering from chronic fatigue syndrome, also known as ME.

Landmark guidance published in 2021 by NICE - the body which advises on clinical practice for England and Wales - said graded exercise therapy (GET) should no longer be recommended.

It also revised its position on cognitive behavioural therapy (CBT), saying it should only be used to manage symptoms and distress - not to aid recovery.

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Instead, NICE recommended energy management - known as "pacing" - which advises patients on how to best to ration activity levels in order not to aggravate symptoms.

The U-turn - reversing 2007 guidance - was hailed as a victory by campaigners who warned that it was dangerous for a majority of patients and had caused symptoms to worsen, instead of improve.

In February this year, the Scottish Government partially incorporated the NICE update into its own policy document for ME-CFS treatment, known as the Scottish Good Practice Statement.

However, the row has been reignited by a new review of the 2021 NICE guidance, published in the Journal of Neurology, Neurosurgery and Psychiatry.

The Herald:

The study, co-led by researchers from the Institute of Psychiatry, Psychology & Neuroscience at King’s College London with input from more than 50 international specialists - including academics from Edinburgh University's Centre for Clinical Brain Sciences - described the 2021 guidance as "problematic".

They state: "It is difficult to understand the disconnect between the initial 2007 guideline that recommended CBT and GET, for which the research evidence has strengthened over the following decade, and the recent guideline that removes GET, qualifies CBT and replaces them with ‘energy management’, for which there is little evidence.

"We are concerned that this new guideline will effectively deny clinicians the ability to offer GET and evidence based CBT to those patients who want them and risks perpetuating chronic ill health and disability."

NICE has rejected the findings and promises a "detailed response".

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It is estimated that there are around 20,000 people in Scotland living with ME/CFS, a post-viral condition which is characterised by chronic long-term symptoms including debilitating fatigue, muscle pain, brain fog, and insomnia.

Although symptoms can fluctuate over time, there is no cure and many patients are bedbound.

The new analysis claims that the 2021 NICE review was riddled with flaws.

These include using a definition of ME/CFS - as "post-exertional symptom exacerbation" - which had not been mandatory in previous studies, and "ignoring" treatment outcomes from some previous trials.

In addition, the researchers said that the 2021 review "prioritised evidence from qualitative studies and patient organised surveys" to conclude that GET causes harm.

The Herald: The onset of ME/CFS typically follows a viral infection, but the exact mechanism behind the condition is still unclearThe onset of ME/CFS typically follows a viral infection, but the exact mechanism behind the condition is still unclear (Image: PA)

However, they state that "rigorously conducted systematic reviews, which included gold standard randomised controlled trials, found no evidence that GET caused harm".

They add: "Having downgraded the evidence for trials of CBT and GET, NICE recommended the use of 'energy management', in which patients are encouraged to stay within the energy limits imposed by their illness, also known as pacing.

"But there is little or no evidence to support such an approach.

"The only substantial trial of pacing for CFS/ME published to date showed that such an approach was no more effective than specialist medical care alone and less effective than either CBT or GET."

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Paul Garner, a co-author on the review and professor emeritus of evidence synthesis in global health at the Liverpool School of Tropical Medicine, said: “Taking all these errors leads to one conclusion: that NICE has not followed international standards for guideline development, which has led to guidance that could harm rather than help patients.

"The implications of this are complicated.

"The flaws really do shake the credibility of this 2021 update of the NICE guideline for CFS/ME”.

The Herald: Campaigners for MEAction Scotland outside the Scottish Parliament protesting against graded exercise therapy as part of the #MissingMillions campaign, raising awareness of those housebound due to the conditionCampaigners for MEAction Scotland outside the Scottish Parliament protesting against graded exercise therapy as part of the #MissingMillions campaign, raising awareness of those housebound due to the condition (Image: MEAction)

A spokesman for NICE said: “We reject entirely the conclusions drawn by the authors of this analysis, and in particular their conclusion that NICE has not followed international standards for guideline development which has led to guidance that could harm rather than help patients.

"In developing our guideline, as well as bringing together the best available scientific evidence, we also listened to the real, lived experience and testimony of people with ME/CFS to produce a balanced guideline which has their wellbeing at its heart.

"We will provide a detailed response to this analysis and in the meantime we are confident that system partners and the ME/CFS community will continue to work together to make sure the important recommendations in our guideline are implemented.”