NICE GUIDELINE ON ME/CFS – STATEMENT BY THE ME ASSOCIATION BOARD OF TRUSTEES
In September 2006, the National Institute for Health and Clinical Excellence (NICE) Guideline Development Group (GDG) published a draft of their proposed guidance on ME/CFS for consultation. This was the first opportunity for doctors, charities and other stakeholder organisations to read and comment on the proposed guidance.
The reaction from The ME Association, as well as many other ME/CFS charities, was that the proposed guidance was completely unfit for purpose. This was a view that was shared by a number of doctors involved in both clinical care and research into this illness, as well as politicians on the ME All Party Parliamentary Group at Westminster.
Our principal objection to the guidance related to the way in which NICE had failed to accept the conclusion of the World Health Organisation (WHO) that in our current state of knowledge ME/CFS is best classified as a neurological disorder. NICE also failed to refer to any research evidence that supports a neurological causation and they appeared to deliberately omit any of the more serious neurological symptoms that were noted in the Chief Medical Officer’s (CMO) report. In fact, any reference to neurological cause, neurological symptomatology, or neurological symptom relief appeared to be a no go area for NICE when it comes to ME/CFS.
As a result, their proposed guidance on management was dominated by the advice that everyone with mild or moderate ME/CFS should be offered cognitive behaviour therapy (CBT) or graded exercise therapy (GET)as a first choice treatment – regardless of their clinical presentation or the stage of their illness.
We pointed out at the time that the evidence base for both of these controversial and costly behavioural therapies remains weak with some published studies finding no benefits at all. We also pointed out that in evidence submitted by patients to the CMO report only 7% found CBT to be "helpful" whereas 67% found CBT had made "no change" and 26% reported that it made their condition "worse". And in the case of GET, 50% found that inappropriate exercise therapy had made their condition "worse". These are very worrying outcomes.
In addition, we pointed out that even if these therapies were anywhere near as successful as was being claimed by NICE, there was no money in the NHS pot to cover the cost of everyone with mild to moderate ME/CFS (a population of around 200,000 according to their own estimate) being treated with a course of 12 to 16 sessions. And where would all the extra properly trained therapists come from?
Our other key reasons for concluding that the draft guidance was unfit for purpose included:
- A failure to accept that ME/CFS is a very heterogeneous disorder in relation to both clinical presentation, causation and course – hence a ‘one size fits all’ approach to management is clearly inappropriate and may even be harmful.
- Too much reliance on research data that comes from psychiatrists and insufficient attention to evidence relating to fatigue in neurological disorders.
- A relaxation of the clinical criteria for defining the illness – the NICE redefinition requiring only one of the so-called minor symptoms with some characteristic ME/CFS symptoms not even appearing on the new list. The new NICE definition would bring in even more people with undiagnosed chronic fatigue under the ME/CFS umbrella. This would complicate the picture still further.
- A failure to deal with many aspects of symptomatic relief – muscle, joint and neuropathic pain in particular
- A failure to properly cover many key aspects of management – eg alternative therapies; benefits; occupational health; nutrition; pregnancy – that are not directly related to symptom control.
- A very inadequate guide to the management of relapses (or setbacks – the term used by NICE)
- The complexities and multiple problems faced by people with severe ME/CFS being largely ignored.
As a result of an unprecedented volume of critical responses from stakeholders, NICE were forced to abandon their decision to publish the final guidance in April 2007.
The MEA, along with other stakeholders, was informed that the final version would be published on August 22nd 2007. This would be without any further consultation or an opportunity to comment on the content prior to publication.
MEA trustees have now carefully considered the content of the final version.
We welcome some helpful new material at the front which:
- States that the symptoms can be as disabling as many other serious physical illnesses.
- Emphasises the need for early diagnosis and management.
- Makes it clear that patients must be fully informed about the type of treatments being proposed.
- States that there should be shared decision making and that patients should not be coerced into taking part in treatment programmes that they are not happy with.
However, the remainder of the guidance has seen very little significant change. And so our key objections remain:
- The guidance still fails to accept the WHO classification of ME/CFS as a neurological disorder – a classification that is also accepted by the Department of Health.
- The section of diagnostic assessment continues to use a much looser and unvalidated definition for considering a diagnosis of ME/CFS but fails to explain how this should then be narrowed down to confirm the diagnosis.
- The advice on management continues to be dominated by the recommendation that everyone with mild to moderate ME/CFS would benefit from trying a course of CBT and GET – which may well be based on the psychosomatic model of ME/CFS where it is maintained by abnormal illness beliefs and behaviour.
- There is still very little in the way of additional information on symptomatic relief – pain in particular.
- There is still a complete failure to address many key aspects of management.
- The key message in the BMJ review about management of a relapse: ‘…advise patients to maintain physical activity if possible’ is not evidence based and may well result in a further exacerbation of symptoms.
- The coverage of issues affecting the severely affected remains inadequate – in particular the provision of domiciliary services.
And the shortened version for patients, carers and families contains far too much repetitive waffle that is of little practical value.
NICE were presented with a unique opportunity to provide practical guidance that would help to ensure that people with ME/CFS were offered management advice covering all aspects of the illness that would be acceptable and beneficial. They have failed the task that was set.
People with ME/CFS in England, Wales, Scotland and Northern Ireland urgently require a network of physician led multidisciplinary services based on a biomedical model of causation. Where such services already exist they are much appreciated by patients – as was demonstrated at the July 2007 meeting of the ME All Party Parliamentary Group at Westminster. They do not want a network of services that offer little more than CBT and GET.
Overall, we must therefore conclude that the NICE guidance remains unfit for purpose. We call for the guidance to be withdrawn and rewritten by a group of health professionals who unambiguously accept that they are dealing with a physical rather than a psychosomatic illness.
The ME Association
7 September 2007
- The MEA has organised a public meeting on Saturday 15 September in Peterborough to discuss the NICE guideline. Taking part will be Professor Richard Baker, Chairman of the GDG and other officials from NICE. After the presentation there will be an opportunity to ask questions. Further details.
- The MEA has just published a fully updated 2007 edition of their own 36 page guidance on research, diagnosis and management. ‘ME/CFS/PVFS – An Exploration of the Key Clinical Issues’ is written by MEA Medical Adviser Dr Charles Shepherd and Consultant Neurologist Dr Abhijit Chaudhuri. Copies can be obtained using our pdf literature order form.
This statement is supported by:
The 25% Group for severe ME sufferers
The Young ME Sufferers Trust
East Kilbride ME Support Group
West Midlands ME Groups Consortium