2021 NICE guideline for M.E.
The National Institute for Health and Care Excellence (NICE) provide national guidance on treatments and care for people using the NHS in England and Wales. In September 2017, NICE announced a full review of its 2007 guideline for M.E., following consultation with stakeholders including Action for M.E.
Peter Barry, Consultant Clinical Advisor for NICE and chair of the guideline committee, said:
“This guideline will provide clear support for people living with ME/CFS, their families and carers, and for clinicians. It recognises that ME/CFS is a complex, chronic medical condition that can have a significant effect on people's quality of life.”
As with all its guidance, NICE advises: "It is not mandatory to apply the recommendations, and the guideline does not override the responsibility to make decisions appropriate to the circumstances of the individual, in consultation with them and their families and carers or guardian"
In Scotland, health professionals refer to the 2010 Scottish Good Practice Statement on M.E./CFS. In 2020, the Scottish Government wrote to M.E. organisations to highlight its updated advice, cautioning against GET and CBT for M.E. Ministers committed to reviewing the statement following the publication of the NICE guideline; we are waiting for an update on this.
In Northern Ireland there are not only no specialist services for M.E. but still no Government guidance for healthcare professionals at all. Some refer to the NICE guideline, but there is no obligation to do this.
Key changes to the guideline
The 2021 NICE guideline says: “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.”
With regards to cognitive behaviour therapy *CBT, the guideline highlights that "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."
Additionally, it advises that professionals should:
"Recognise that people with M.E./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."
It continues: "Take into account the impact this may have on a child, young person or adult with ME/CFS; [and] that people with M.E./CFS may have lost trust in health and social care services and be hesitant about involving them."
Along with the guidance to "follow the principles on communication, information giving and shared decision making in the NICE guidelines on patient experience in adult NHS services, people's experience in adult social care services and shared decision making, it also recommends taking time "to build supportive, trusting and empathetic relationships [and] acknowledge to the person the reality of living with M.E./CFS and how symptoms could affect them."
We have reviewed the guideline and have created a guide to key differences between the 2007 and 2021 guidelines.
Prof Brian Hughes offers a useful overview of the why the changes to the guideline are so important on his blog, The Science Bit.
As a member of Forward-ME, we are working collaboratively to ensure the guideline is understood and implemented throughout the healthcare system and by all professionals working with children and adults with M.E. This includes:
- creating a template letter you can send to your GP, giving an essential overview of key changes
- producing a NICE guideline podcast special for our Learn about M.E. project, targeting GPs and other healthcare professionals.
Levels of severity
In its opening pages, the guideline defines the four levels of severity as follows:
- People with mild ME/CFS care for themselves and do some light domestic tasks (sometimes needing support) but may have difficulties with mobility. Most are still working or in education, but to do this they have probably stopped all leisure and social pursuits. They often have reduced hours, take days off and use the weekend to cope with the rest of the week.
- People with moderate ME/CFS have reduced mobility and are restricted in all activities of daily living, although they may have peaks and troughs in their level of symptoms and ability to do activities. They have usually stopped work or education, and need rest periods, often resting in the afternoon for 1 or 2 hours. Their sleep at night is generally poor quality and disturbed.
- People with severe ME/CFS are unable to do any activity for themselves or can carry out minimal daily tasks only (such as face washing or cleaning teeth). They have severe cognitive difficulties and may depend on a wheelchair for mobility. They are often unable to leave the house or have a severe and prolonged after-effect if they do so. They may also spend most of their time in bed and are often extremely sensitive to light and sound.
- People with very severe ME/CFS are in bed all day and dependent on care. They need help with personal hygiene and eating, and are very sensitive to sensory stimuli. Some people may not be able to swallow and may need to be tube fed.
Why is this update so important?
The 2007 NICE guideline recommended two treatment approaches: graded exercise therapy (GET) and cognitive behaviour therapy (CBT). However, patient evidence and experience repeatedly shows that GET and CBT are unhelpful and in many cases harmful.
Under-investment in research, and lack of rigour in applying appropriate research criteria to studies examining the efficacy of GET and CBT, mean that there is no reliable conclusive evidence base for treatments for M.E., including GET and CBT. This has led major international health agencies, including the Centers for Disease Control and Prevention in the US, to alter their guidance regarding CBT and GET.
Since work on this update began, we gathered the latest patient evidence and experience from children and adults, and shared this with NICE, to ensure the 2021 guideline is patient-led.
- In 2017, NICE proposed not updating the guideline, based on their surveillance review of evidence published since 2007. Based on consultation responses from Action for M.E. and others, they changed this position, and committed to a full review.
- We took part in workshops in January and May 2018 to inform the development of the guideline. In June 2018, we responded to NICE's consultation on the draft scope for the guideline on M.E.
- Our 2019 Big Survey of more than 4,000 children and adults with M.E. has informed all our submissions to NICE, including the October 2019 call for evidence.
- We took a leading role in developing and promoting Forward M.E.'s 2019 survey of GET and CBT, with responses from more than 2,270, shared with NICE.
- We worked with Oxfords Brooks University to gather the experiences of children and young people with M.E. for guideline-development focus groups.