NICE 2021 ME/CFS guideline –
Doctors’ leaders reject ‘evidence based’ change, but many believe the guideline can be transformative
On the whole patients are relieved that the revised NICE guideline for ME/CFS has at last been published and are pleased with the change in direction it has taken i.e. that Post Exertional Malaise (PEM) is now a defining characteristic, and that Graded Exercise Therapy (GET) & Cognitive Behavioural Therapy (CBT) are no longer seen as curative treatments, with GET being recognised as having caused harm to patients. Some doctors, health professionals and researchers on the other hand have been vehement in their opposition to the changes.
NICE took unprecedented steps to accommodate health professionals who had difficulties with the final version of the guideline by: delaying publication; listening to their concerns in a ‘Roundtable’ discussion; and altering some of the language in the final guideline.
Medical leaders’ joint statement
This was not enough to appease them and following publication of the guideline a number of major UK medical organisations issued a scathing joint statement showing their lack of support for the guideline. The co-signatories of the statement represent thousands of medical personnel (though they were not consulted about the statement) and many CFS services that practise the discredited and now outlawed therapies of GET and CBT as treatments for ME/CFS.
The organisations opposed to the guideline are: Royal College of Physicians; Royal College of Physicians of Edinburgh; Royal College of General Practitioners; Royal College of Psychiatrists; Academy of Medical Royal Colleges; Faculty of Sport and Exercise Med
Their statement emphasises their belief that:
- activity and exercise are important in the management of ME/CFS i.e. personalised paced exercise programmes
- the phrase GET is unhelpful and this terminology should be dropped
- there is a connection between people’s mental and physical health – CBT remains a valuable treatment for alleviating symptoms in ME/CFS
- specialist rehabilitation medicine services and exercise medicine services should be able to provide services for people with ME/CFS
- the data and evidence had not been assessed correctly
They did not however produce any additional evidence at the Roundtable to support their claims and counteract the evidence underpinning the revised guideline. This was probably the reason their views did not alter the recommendations.
Expert comments
A number of researchers and doctors have been reported in the media to say the evidence supports GET and CBT as treatments, some of the statements coming from the Science Media Centre. Three of the eight professionals giving expert comment on the new guideline for the SMC are unwilling to accept the new narrower definition of ME/CFS or that there is evidence GET can cause harm.
“Researchers from different Institutions in different countries have found graded exercise therapy and cognitive behaviour therapy to be effective for some patients with CFS. Evidence has shown they reduce fatigue and improve functioning without harm, if delivered by trained therapists in specialist clinics. “ Prof Trudie Chalder
The other five professionals writing for the SMC however supported the guideline and believed it was evidence based and could improve care for people with ME/CFS: Caroline Kingdon; Prof Chris Ponting; Dr David Strain; Dr Karl Morten; Prof Kevin McConway.
“This is a transformative step for treatments offered to ME/CFS patients in the UK. I am hopeful that the move away from graded exercise to supporting patients in how they manage their daily activities will lead to more patients entering a recovery phase. It is important that the appropriate support from clinicians and healthcare professionals be put in place and this a key component of the new guidelines.” Dr Karl Morten
“The new NICE guidelines will improve the lives of people with ME worldwide, well beyond England and Wales. They will improve awareness that graded exercise often makes ME symptoms worse. NICE took due care and attention developing these guidelines, applying their rigorous methods and listening to highly regarded professionals and lay people. Low and very low quality scientific evidence was rightly discarded. Graded exercise therapy and cognitive behavioural therapy cannot now be offered as cures. The new guidelines vindicate the longstanding views of many people with ME, their carers and families.” Prof Chris Ponting
Applied statistics professor Kevin McConway examined the criticisms of NICE’s method of evaluating evidence and research, called GRADE, and explained on the SMC site that NICE had found numerous studies on illness definitions and treatments but concluded that many had “Very serious limitations” or “Serious limitations”. Based on the best evidence they could find they decided that GET and CBT were not safe curative treatments for a particular group of patients (those with PEM). They were unable to find evidence for a cure but stated that more research was needed to uncover whether this was the best definition of ME/CFS and what treatments were suitable for the condition.
“Of course, it would be really good news if there were a cure, of whatever sort, but the new guideline makes it very clear indeed that “ME/CFS symptoms can be managed but there is currently no cure (non-pharmacological or pharmacological) for ME/CFS.” Prof Kevin McConway
A Triumph of Science over Discrimination
Doctors leaders might be resisting the new guideline but but the campaign group Doctors with M.E. calls it a ‘triumph of science over discrimination’.
“Doctors with M.E. considers the launch of this guideline to be a watershed moment in the history of ME/CFS medical care in the UK, with implications that extend to those Long Covid (PASC) patients who also meet ME/CFS diagnostic criteria.”
Physiotherapists embrace change
Physiotherapists have been at the forefront of services using GET with people with CFS. Now the Chartered Society for Physiotherapists(CSP) has come out in support of the guideline:
” I expect all those physiotherapists working with people who have ME/CFS to read the document, reflect on what this means for their practice and make any changes to their practice in light of the revised guidelines.” Natalie Beswetherick, director CSP
The professional group Physios for ME have been active in researching care for patients with PEM and educating colleagues about ‘the known adverse physiological effects of exertion.’ They welcome the guideline.
The over-riding message for physiotherapists is:
“Do not offer people with ME/CFS physical activity or exercise programmes that use fixed incremental increases, based on deconditioning and exercise avoidance theories as perpetuating ME/CFS.”
They do have some concerns about how it will be implemented, believing the information is not just for practitioners specialising in treating people with ME/CFS.
“We feel that education for all physiotherapists needs to be improved regarding ME, in particular the ability to identify and manage post exertional malaise, so that all physiotherapy interventions can be adapted and made suitable for a person with ME.”
Is widespread support for the Guideline possible?
In delaying publication and organising a Roundtable discussion NICE had hoped to secure widespread support for the guideline and was pleased enough with how the discussions had gone to announce:
“We are now confident that the guideline can be effectively implemented across the system and we will discuss the input from the meeting at our Guidance Executive next week with a view to publication of the guideline.”
NICE must have been as disappointed as anyone that the Colleges continued to reject both the evidence base for the guideline and the warning that ‘any programme based on fixed incremental increases in physical activity or exercise, for example graded exercise therapy (GET), should not be offered for the treatment of ME/CFS’. Some commentators have cast doubt on the critics’ ability to recognise scientific evidence:
“As has been widely reported, no substantive concerns were raised at the roundtable. Instead, the Colleges chose to release a controversial joint statement criticising NICE after the guideline was published. It is somewhat peculiar that a group of self-styled “medical leaders” should claim to champion science-based medicine, while simultaneously lobbying NICE to allow patients to be treated using such practices as the Lightning Process.” Prof Brian Hughes quotes the colleges submissions to NICE re the draft guideline.
Prof Tuller has noted that GET researchers have relied on re-affirming the soundness of their own research, without clear evidence, as a strategy which has worked for many years to deflect, discredit and/or squelch legitimate criticism!
Maybe now is the time for the critics to ‘get over themselves’!
Maybe now is the time for the critics to ‘get over themselves’! Yes, it must be disappointing to have exerted so much time and effort ‘backing the wrong horse’ but if they are right and their graded exercise/ activity approach can help some people, then they need to do some work and prove, with high quality research, who those people are. Many in the ME community would say a separation between ME and CFS is long overdue. People with Post-Exertional Malaise would be only too grateful if exercise therapy enthusiasts would direct their attention elsewhere for a change!
Links to health related articles
Association of Paediatric Chartered Physiotherapists (APCP): NICE ME/CFS guideline outlines steps for better diagnosis and management
BMJ: ME/CFS: Exercise goals should be set by patients and not driven by treatment plan, says NICE
(Includes responses from doctors & researchers urging doctors to take the scientific evidence base seriously)
Nursing Times: Updated ME/CFS guidance finally published following controversy
“This severe, complex multisystem disease has long been misjudged by the healthcare profession. Educating nurses about the needs of people with ME/CFS will help drive the step change in understanding and belief, compassion and empathy required to care for all patients with ME/CFS.” Caroline Kingdon, research nurse
Pulse: Final ME/CFS NICE guideline recommends ‘personalised care and support plan’
GPonline: Reworked NICE advice on ME/CFS warns against ‘one-size-fits-all’ approach
Medscape: NICE publishes delayed ME/CFS guidance after summer controversy
NHE: Intense exercise therapy for ME sufferers abolished
BACME: BACME welcomes the new NICE Guidance on ME/CFS
Pharmacy Magazine: NICE publishes delayed guideline on ME/CFS
Pharmacy business: NICE myalgic encephalomyelitis guidance lists better diagnosis and management methods
Virology blog: Trial by error: Losers in NICE guideline fight remain defiant despite public repudiation of their claims
See also the reactions of the ME community:
NICE ME/CFS guideline – Cautious welcome from WAMES & the ME community
Add to that the inclusion of 
It is estimated that there are over 250,000 people in England and Wales with ME/CFS, with about 2.4 times as many women affected as men.
60 ME/CFS adults were studied: 30 patients had a normal heart rate and blood pressure response during the tilt test, 4 developed delayed orthostatic hypotension, and 26 developed postural orthostatic tachycardia syndrome (POTS) during the tilt. Cerebral blood flow measurements, using extracranial Doppler, were made in the supine position pre-tilt, at end-tilt, and in the supine position at 5 minutes post-tilt. Also, cardiac index measurements were performed, using suprasternal Doppler imaging, as well as end-tidal PCO2 measurements. The change in cerebral blood flow from supine to end-tilt was expressed as a percent reduction with mean and (SD). Disease severity was scored as mild (approximately 50% reduction in activity), moderate (mostly housebound), or severe (mostly bedbound).
(3) Results: thirty-six ME/CFS patients (age: 41.25 ± 12.14) completed all questionnaires (response rate 83.7%). Muscle pain and weakness, orthostatic intolerance and intolerance to extreme temperatures were experienced and fluctuated over time. Sleep disturbances were likely to present as severe. Work and household income were associated with worsened cognitive, gastrointestinal, body pain and sleep symptoms. Increased access to healthcare services was associated with improved symptom presentation;
We explored the role of the cortical autonomic network (CAN) involved in higher-order control of ANS functioning in 34 patients with ME/CFS and 34 healthy controls under task-free conditions. All participants underwent resting-state 
Yet, patients with severe or very severe ME/CFS struggle to receive appropriate medical care because they cannot travel to doctors’ offices and their doctors lack accurate information about the nature of this disease and how to diagnose and manage it.
NICE has today (20 October 2021) announced the next steps for publication of its updated guideline on the diagnosis and management of myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome (ME/CFS).
