On 29th October 2021, GET was removed from NICE guidelines on ME/CFS. NICE is the National Institute for Health and Care Excellence. This is a short article which aims to give a snapshot of this recent news. It explains what GET is and why it is controversial. It then highlights the major changes in the new guideline. Finally we look at what could happen next.
What is GET?
GET stands for Graded Exercise Therapy, where physical activity gradually increases over time. It was one of only a few treatments recommended by NICE for ME/CFS. The other treatments are pacing and occupational therapy (often cognitive behavioural therapy).
GET’s inclusion in NICE guidelines was largely due to the 2011 PACE trial. Click here to view the PACE trial paper published in The Lancet. This publication has huge impact for clinical management of ME/CFS globally. The study outcomes, however, do not match widely reported patient experience. Many people with ME/CFS have said they get worse following GET, instead of better. Some of those patients are suffering severe relapses from which they are still not recovering. The PACE trial’s legitimacy has been called into question by scientists and doctors. They cite study design flaws, bias, that the trial was unblinded, authors’ conflicts of interest, and more.
The fight to independently re-evaluate PACE data
In 2015, an open letter signed by more than 40 scientists was sent to The Lancet asking for the data to be independently re-analysed.
The PACE authors continually resisted releasing the data despite countless requests from other scientists, patients and charity groups. The trial has been the subject of a number of parliamentary enquiries. The authors claim to have been harassed and threatened by militant members of the ME/CFS community. In 2017, patient protests took place in London on International ME Awareness day. If the authors have nothing to hide, why do they not allow their data to be scrutinised?
In 2014, a freedom of information request was made by Alem Matthees to QMUL. Matthees request was denied and he appealed to the Information Tribunal. The tribunal ruled in Matthees favour in 2015. The tribunal’s decision was appealed by QMUL later that same year. Matthees appealed the QMUL appeal. In August 2016, the tribunal upheld it’s original decision and ordered QMUL to release the anonymised data to Mr Matthees.
The results of the re-evaluated data
Re-analyses of the data have been published in on the virology blog and the journal Fatigue: Biomedicine, Health and Behaviour. Scientists conducting the reanalyses were unable to support the original findings of PACE. A couple of quotes:
“This re-analysis demonstrates that the previously reported recovery rates were inflated by an average of four-fold.”
“The claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments”
The PACE trial controversy is not over. A complaint is currently with the General Medical Council. A further Parliamentary debate took place in 2018, Carol Monaghan MP described the situation:
“I think that when the full details of the trial become known, it will be considered one of the biggest medical scandals of the 21st century.”
For further details of all aspects of the PACE trial, see this MEpedia post.
The NICE guidelines on ME/CFS were reviewed during 2017-2021. Out of 38 stakeholders, 32 wanted to update the guidelines (the Royal College of General Practitioners and 31 patient-representative bodies). Hours before the new guidelines were due to be published, NICE halted publication. This occurred as a result of several Royal Medical Colleges circumventing the guideline review process and demanding changes to the final, approved guideline. Following meetings with stakeholders, the new guidelines were finally published on 29th October 2021. You can find them on the NICE website or in pdf format.
GET Removed From NICE Guideline 2021
The major change in the new version is GET removed from NICE guidelines along with other similar physical activity programmes. Paragraph 1.11.14 states:
“Do not offer people with M.E./CFS:
- any therapy based on physical activity or exercise as a cure for M.E./CFS
- generalised physical activity or exercise programmes – this includes programmes developed for healthy people or people with other illnesses
- any programme that uses fixed incremental increases in physical activity or exercise, for example, graded exercise therapy (GET)
- physical activity or exercise programmes that are based on deconditioning and exercise intolerance theories as perpetuating.”
Other Significant Changes to NICE Guidelines for ME/CFS
Other significant changes to the guidelines relate to Cognitive Behavioural Therapy (CBT) and recognising the impact the illness has, especially in terms of stigma and prejudice.
In relation to CBT Box 5 states: “CBT has sometimes been assumed to be a cure for M.E./CFS. However, it should only be offered to support people who live with ME/CFS to manage their symptoms, improve their functioning and reduce the distress associated with having a chronic illness.”
With regard to patient experience and impact, paragraph 1.1.2 states:
“Recognise that people with ME/CFS may have experienced prejudice and disbelief and could feel stigmatised by people (including family, friends, health and social care professionals, and teachers) who do not understand their illness.
Take into account:
• the impact this may have on a child, young person or adult with ME/CFS
• that people with ME/CFS may have lost trust in health and social care services and be
hesitant about involving them.”
The changes have mainly involved the removal of GET and CBT being rescinded as a treatment and instead used as a possible coping mechanism. This means that treatment-wise there is less than there used to be. Whilst it’s good that harmful treatments have been removed – and therefore patients are forced to do things that will make them worse – it highlights that there isn’t anything significant which doctors can offer. Much more research is need to diagnose and treat ME/CFS, and to reveal long term outcomes, and links to other diseases.
The NICE guideline makes recommendations for research. These cover areas including: diagnostic tests and criteria, health outcome measures and management strategies (e.g. sleep, diet, self monitoring). here are many similarities in symptoms between Long Covid and ME/CFS. Just like Long Covid, ME/CFS can occur following an infection. So, many organisations and patient groups are calling for ME/CFS research to be conducted alongside research into Long Covid.