NICE guideline publication awaited

When the National Institute for Health and Care Excellence (NICE) announced on 20th September 2017 that it was planning a full update of its guideline on the diagnosis and management of CFS/ME ME Research UK did not think that almost 4 years later the process would be incomplete.  The review was welcomed as many, in particular, rightly questioned the 2007 guideline’s value to patients as its main treatment recommendations were for psychosocial management and coping strategies such as cognitive behavioural therapy (CBT) and graded exercise therapy (GET) which surveys (such as Forward-ME’s (co funded by ME Research UK and the ME Association) later showed were either ineffective or inappropriate for most ME patients. Next week, on 18th August 2021, the oft-delayed replacement for the 2007 NICE guideline is due to published and a process marked by COVID interruptions and extended evidence gathering and consultation will be at an end. The draft Guidance has been available since November 2020 and despite limitations and caveats, has been broadly welcomed (at least) as an improvement upon the 2007 version.

Much discussion has centred around NICE’s shift in its stance on CBT and GET. The 2007 version (s presently guides healthcare professionals as follows “Cognitive behavioural therapy (CBT) and/or graded exercise therapy (GET) should be offered to people with mild or moderate CFS/ME and provided to those who choose these approaches, because currently these are the interventions for which there is the clearest research evidence of benefit.”

Scroll forward 14 years and the draft (s1.1.15 – 16) evidences as stark reversal in advice –

“Do not advise people with ME/CFS to undertake unstructured exercise  that is not part of a supervised programme, such as telling them to go to  the gym or exercise more, because this may worsen their symptoms.

Do not offer people with ME/CFS:
• any therapy based on physical activity or exercise as a treatment or cure for ME/CFS

• generalised physical activity or exercise programmes – this includes programmes developed for healthy people or people with other illnesses

• any programme based on fixed incremental increases in physical activity or exercise, for example graded exercise therapy

• structured activity or exercise programmes that are based on deconditioning as the cause of ME/CFS”

And (s1.11.43)

“Only offer cognitive behavioural therapy (CBT) to people with ME/CFS 3 who would like to use it to support them in managing their symptoms of  ME/CFS and to reduce the psychological distress associated with having  a chronic illness. Do not offer CBT as a treatment or cure for ME/CFS.”

If the provisions in the draft are implemented in the finalised guideline then the implications for specialists centres for the ‘treatment’ of ME/CFS – such as exist – will be nothing more than a complete reformulation of what they offer and this will entail a degree of upheaval for staff as well as a hoped for improvement in support for patients.

One recent development which was not expected was the departure of four members of the guideline committee. Reported in The BMJ (paywall) on 3 August 2021 under the heading “Exclusive: Four Members of NICE’s guideline committee stand down” was the departure of Dr Charles Shepherd (ME Association trustee and Hon Medical Advisor) who had the day before announced that he had “now been ‘stood down’ from the NICE guideline committee” after discussions over conflict of interest having been “thanked for my hard work and contribution to the committee over the past three years” and that of Dr Michael BJ Beadsworth (clinical lead for an ME/CFS regional service, Dr Gabrielle Murphy (clinical lead of Royal Free London’s fatigue service) and Joanne Bond-Kendall (senior physiotherapist, Bristol).

To the BMJ reporter the “departures suggest divisions within the committee over the guideline’s final content, which is an update on 2007 guidance on diagnosing and managing ME/CFS. Three have resigned, and one has been removed by NICE.”

Brian Hughes in his ‘The Science Bit’ blog “Is it just me, or is the BMJ’s take on those NICE guideline committee resignations maybe a little biased?” deftly dissects the language used in the article and the fact that, due to confidentiality restrictions, no-one (including The BMJ) ought to know the reasons or motivations for the departures.

To The BMJ the sea-change in GET/CBT advice by NICE and stated to be due to the ‘lack of evidence for the effectiveness of these interventions’ is followed immediately by a query as to “It is unclear, however, how the evidence became unsupportive.” This ignores all the evidence published by NICE on what research and submissions they had considered in arriving at their recommendations and, let us not forget that

NICE is far from the only healthcare institution that downgraded the quality of evidence for GET or CBT. The Health Council of both Belgium and the Netherlands recently came to similar conclusions. In the US, the website of the Centers for Disease Control and Prevention (CDC) no longer recommends GET or CBT for patients with ME/CFS. Cochrane is currently updating its review on GET for ME/CFS after an internal review clarified that the evidence has multiple limitations.” Michiel Thack

The BMJ’s reporter stated that the ‘significantly’ higher’ than usual (4000) responses to the consultation meant that NICE was “forced to delay publication of the final guidance by several months”. As stakeholders in the process, ME Research UK submitted both independently and as part of Forward-ME, comments to the committee which we knew would be given due consideration and were given in light of the research which existed and which had evolved since 2007. It is odd to imply criticism of participation in a process which was actively encouraged and which was available to all irrespective of whether they viewed NICE’s recommendations positively or negatively. 

Further, the article points out that the 21 member committee had 5 lay members “rather than usual 2” plus a co-opted member from the ME Association. Could the charge being levelled was that the outcome of the NICE process was skewed by the minority despite the new guideline being a product of the whole committee and of the NICE infrastructure? Also, were the 6 supposedly of one mind whereas the non-lay members were wholly unencumbered by any external considerations?

In fact, in October 2018, on our website we stated that “ME Research UK wishes to express its disappointment with the current appointment of a comparatively small number of members of the ME/CFS Guideline Committee who have expertise on the biomedical basis of ME/CFS when compared to those whose background appears to favour the bio psychosocial model. Given the increasing evidence of a biomedical origin of the illness and the current uncertainty, for example, of the soundness of the PACE trial, this is to be regretted. “

Change would appear to be coming in the attitude of NICE towards ME/CFS and GET/CBT in particular. This will necessarily impact not just practices but challenge attitudes – and not just at The BMJ – but in doctor’s surgeries, clinics, and (hopefully) funders. What NICE implements has repercussions for all professionals who are supposed to care and support those with ME/CFS. NICE guidelines are also looked to beyond the shores of the UK and so the stakes are high – and, what is more to the point, people know it.

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