NICE draft guidance addresses the continuing debate about the best approach to the diagnosis and management of ME/CFS
NICE has today (10 November 2020) published its draft updated guideline on the diagnosis and management of myalgic encephalomyelitis (or encephalopathy)/chronic fatigue syndrome (ME/CFS).
It covers the identification and assessment of ME/CFS before and after diagnosis, its management, monitoring and review, information, education, and support for people with suspected or diagnosed ME/CFS and their families and carers, as well as information, education and support for health and social care professionals.
The draft guideline makes separate recommendations for children and for people with severe or very severe ME/CFS. It recognises that ME/CFS is a complex, multi-system, chronic medical condition where there is no ‘one size fits all’ approach to managing symptoms, particularly where there is the potential for an intervention to benefit some people but cause harm in others.
It stresses the need for a tailored, individualised approach to care based on establishing a partnership between the person with ME/CFS and those providing their care that allows joint decision making and informed choice.
The draft guideline also highlights the importance of ensuring that people remain in their ‘energy envelope’ when undertaking activity of any kind. It recommends that a physical activity programme, in particular, should only be considered in people with ME/CFS in specific circumstances.
The draft guideline says that any physical activity programme should begin by establishing the person’s physical activity capability at a level that does not worsen their symptoms. It also says a physical activity programme should only be offered on the basis that it is delivered or overseen by a physiotherapist or occupational therapist with training and expertise in ME/CFS and is regularly reviewed.
Because of the harms reported by people with ME/CFS, as well as the committee’s own experience of the effects when people exceed their energy limits, the draft guideline says 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.
Similarly, based on criticisms in the evidence from patient experience of CBT being used as a treatment for ME/CFS, the draft guideline emphasises that CBT is not a treatment or cure for the condition. However, as a supportive psychological therapy which aims to improve wellbeing and quality of life, the draft guideline says CBT may be useful in supporting people who live with ME/CFS to manage their symptoms. It should, therefore, only be offered in this context.
Paul Chrisp, director of the Centre for Guidelines at NICE, said:
ME/CFS can cause profound, long-term illness and disability, and much of the distress surrounding it is caused by difficulties in recognising, acknowledging and accepting the condition and its impact. This has been compounded further by a lack of effective treatments, wide variation in access to services, and by controversy over the use of graded exercise therapy and CBT that has served only to alienate many people with ME/CFS and in some cases undermine the confidence of those caring for them.
The recommendations in this draft guideline have been developed by an independent committee that was guided not just by the clinical evidence, but also by the experience and testimony of people with ME/CFS. The result is a guideline that will provide much needed clarity, set new standards for health professionals and ensure that people with ME/CFS have access to the right care and support.
Peter Barry, Consultant Paediatric Intensivist, University Hospitals of Leicester and chair of the guideline committee, said:
This guideline will provide clear support for people with ME/CFS, their families and carers, and for clinicians who may help to support them. It recognises that ME/CFS is a complex, chronic medical condition that can have a significant effect on people’s quality of life.
We know that people with ME/CFS have had difficulty in getting their illness acknowledged, and the draft guideline provides guidance for suspecting and diagnosing the condition, recognising that there is no specific test. The committee weren’t able to make any recommendations for treatments because of a lack of evidence of effectiveness. Instead it emphasises the importance of a personalised management plan for areas such as energy management (including the importance of rest and the concept of an energy envelope), the treatment of specific symptoms, and guidance on managing flares and exacerbations.
Baroness Finlay, Consultant in Palliative Medicine, Clinical Lead for Palliative Care for Wales, Velindre NHS Trust, and vice-chair of the guideline committee, said:
ME/CFS is a complex long-term condition that causes disordered energy metabolism and can be profoundly disabling. Those with ME/CFS need to be listened to, understood and supported to adapt their lives. Many have suffered stigmatisation and prejudicial attitudes in the past; this guideline should ensure they receive more empathetic care.
Adam Lowe, a lay member of the guideline committee, said:
ME/CFS patients have been voicing their concerns about graded exercise therapy for a long time, and the evidence presented to the committee supported these concerns.
One of the key points in the draft guideline is that exercise is not a treatment or cure for ME/CFS and should not be presumed to be safe for those with this disabling and often neglected illness. The approach it recommends is a pragmatic one which allows patients to self-manage themselves, within their daily limits, while using readily available interventions to address the most serious of their symptoms first.
Caroline Kingdon, Research Nurse, London School of Hygiene and Tropical Medicine and member of the guideline committee, said:
This draft guideline reinforces the legitimacy of this biomedical disease and aims to reduce the disbelief and stigma felt by people with ME/CFS. It recognises the pressing need for training and education for health and social care practitioners in this neglected field.
The draft guideline highlights post-exertional symptom exacerbation, including debilitating fatigue, as core to ME/CFS, so critically it recommends that graded exercise therapy should not be offered as a treatment.
It acknowledges the profound needs of people with severe ME/CFS and their carers whose lives are hugely impacted by ME/CFS, and states that this unique patient group should be treated with respect, dignity, and empathy.
The draft guideline recommends reducing the time from 4 months to 3 months that a person needs to have persistent symptoms before a diagnosis of ME/CFS can be confirmed. It says that people should then be directed to a specialist team (in the case of children this should be a paediatric specialist team) experienced in the management of ME/CFS to confirm their diagnosis and develop a personalised management plan. This will enable people to access care earlier and could potentially improve longer term outcomes.
A key component of a personalised management plan highlighted in the draft guideline is energy management. This is a self-management strategy led by the person themselves with support from a healthcare professional that can be applied to any type of activity (cognitive, physical, emotional or social). Reviewed regularly, it is designed to help people understand their energy envelope so they can reduce the risk of overexertion worsening their symptoms.
Other components of a personalised management plan recommended in the draft guideline include symptom management, managing flares and relapse, support for activities of daily living and education, training or employment support needs.
- The draft clinical guideline on the diagnosis and management of ME/CFS will be available on the NICE website at https://www.nice.org.uk/guidance/indevelopment/gid-ng10091/documents from 00:01 on Tuesday, 10 November 2020. Embargoed copies are available on request from the NICE press office.
- Recent data from the UK Biobank suggests 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.
- ME/CFS is a complex, multi-system, chronic medical condition that has considerable personal, social and economic consequences and a significant impact on a person’s emotional wellbeing and quality of life.
- Everyday life for people with ME/CFS, their family and carers is disrupted and unpredictable. Many people with the condition are unemployed, and less than a fifth work full-time. Approximately 25% have severe disease and are house- or bed-bound.
- It is not clear what causes ME/CFS. In many cases, symptoms are thought to have been triggered by an infection but it is not simple post-illness fatigue. It lasts longer and even minimal mental or physical activity can make symptoms worse.
- There is no diagnostic test or universally accepted definition for ME/CFS. People with the condition report delays in diagnosis, and many healthcare professionals lack the confidence and knowledge to recognise, diagnose and manage it.