NICE CFS / ME Guideline: Statement by the ME Association, 07 September 2007

Correction:

Journal of Psychosomatics: Issue November-December 2008

Error in URL

In the review article:

Customizing Treatment of Chronic Fatigue Syndrome and Fibromyalgia: The Role of Perpetuating Factors: Boudewijn Van Houdhove, M.D., Ph.D., and Patrick Luyten, Ph.D.

which was published in the November–December 2008 issue of the Journal of Psychosomatics, reference [14], a URL link to this posting and comments below had been incorrectly cited by the paper’s authors as:

http://meagenda.wordpress.com/2007/09/07/nice-cfs-me-guideline-statement-by-the-me-association-07-Sept-2007

which returns a “404 page not found” error.  The correct URL for this webpage is:

http://meagenda.wordpress.com/2007/09/07/nice-cfs-me-guideline-statement-by-the-me-association-07-september-2007/

The authors of the paper and the Journal of Psychosomatics have been informed. Senior Editor, Ms Elizabeth Stone, has confirmed that a data supplement has been added to the online version of the review article at:

http://psy.psychiatryonline.org/cgi/content/abstract/49/6/470

and that an Erratum notice will be published in the March-April print issue of the Journal.

************************************************************************************

Note: This press release can be read on the MEA website here

This press release is also supported by The 25% Group for severe ME sufferers and The Young ME Sufferers Trust.

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]  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.

b]  Too much reliance on research data that comes from psychiatrists and insufficient attention to evidence relating to fatigue in neurological disorders.

c] 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.

d] A failure to deal with many aspects of symptomatic relief – muscle, joint and neuropathic pain in particular.

e] 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.

f] A very inadequate guide to the management of relapses (or setbacks – the term used by NICE).

g] 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:

a] States that the symptoms can be as disabling as many other serious physical illnesses.
b] Emphasises the need for early diagnosis and management.
c] Makes it clear that patients must be fully informed about the type of treatments being proposed.
d] 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 on 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

ADDITIONAL NOTES

1] 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 on the MEA website (http://www.meassociation.org.uk) or in the July issue of ME Essential.

2] 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 the pdf literature order form on the MEA website

ENDS

 

2 Responses to NICE CFS / ME Guideline: Statement by the ME Association, 07 September 2007

  1. Hi,

    I’ve read the guideline, and as my personal view I fully support your comments. I find it very disturbing that NICE seems to have chosen to remain unaware of the biomedical research on ME of the past 70 years, and failed to follow the mandatory AGREE directive for medical guidelines.

    A Dutch guideline is expected to appear mid 2008. As a member of one of the workgroups, representing the patient organizations, I am at this time hopeful that we can do better. I’ll keep you informed.

    Regards,

    Guido den Broeder

  2. meagenda says:

    Thank you for your comments, Guido. If you have the time and the capacity to plough through them, as a patient representative you may be interested in accessing the Stakeholder Comments and Guideline Development Group (GDG) Responses documents. These are the comments made by registered stakeholders to the various draft documents with corresponding responses from the Guideline Development Group which followed the draft consultation process, last year, and which have now been published by NICE in association with the final NICE CG53 guidelines.

    There are ten Comment and GDG Response documents in all – several of considerable length, but they are well worth scrutinising.

    They are available for download from the NICE website:

    NICE Guideline CFS/ME Chronic fatigue syndrome / Myalgic encephalomyelitis: stakeholders comments and GDG responses, August 2007 Comments and GDG Responses

    A number of comments are still being held by the Institute and have not been included in the tables, these include comments submitted by Dr Derek Pheby, Project Co-ordinator, National CFS/ME Observatory who is challenging the Institute over this omission.

    Please note that in at least one document, the Comments made by one of the stakeholders and the corresponding GDG Responses appear to have been duplicated and attributed further on in the same document to another stakeholder. It has not yet been established whether or when NICE intend to correct this error and publish a revision.

    Many of the comments submitted by St Bartholomew’s Hospital Chronic Fatigue Services which are highlighted by Tom Kindlon, UK and are published on ME agenda in a posting directly below the ME Association’s statement and press release at:

    http://meagenda.wordpress.com/2007/09/06/a-selection-of-points-the-barts-cf-service-made-during-the-nice-guidelines-for-cfs-me-tom-kindlon/

    are chilling.

    Please do keep me updated on your own guideline development process.

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