The NICE Guidelines for ME/CFS - Reasons for Rejection

Translated with permission from the Norway’s ME Forening (

On the 22 August 2007 The National Institute of Health and Clinical Excellence (NICE) published guidelines for doctors, titled: Chronic Fatigue Syndrome / myalgic encephalomyelitis (or encephalopathy) - Diagnosis and management for CFS/ME in adults and children.

Eight of the biggest ME organisations and more in the UK are strongly critical of the NICE guidelines and have declared them ’unfit for purpose’. They demand a considerable rewrite of the guidelines. We think, as they do, that the NICE guidelines will make the situation even worse for ME patients than it is at present.

Some of the critical points include:

Cognitive behavioural therapy (CBT) and graded/graduated exercise therapy (GET) are recommended as first line treatments for mild or moderate CFS/ME, and ‘Activity Management strategy’, which has elements of CBT and GET, for the most severely ill. These therapies have shown to have little effect (CBT) or are potentially harmful (GET). Large scale patient surveys in the UK show opposite results to the NICE guidelines. Apart from the outlined concerns, the key psychiatrists themselves, who actively promote these approaches say that CBT and GET cannot be described as ‘curative’ and/or have only a short term effect. ( Michael Sharp, AACFS, (now IACFS/ME) ) International CFS Conference, Cambridge, Mass., 10.-11. oktober 1998. S. Wessely, Editorial, JAMA 19.9.2001:286:11), Marcus JH Huibers + S. Wessely, Psychological Medicine, 2006:36(7):895-900).

CBT and GET are not specific methods for ME/CFS because the cause is unknown. Many have been made worse by these therapies. (Devanur & Kerr 2006):

The NICE Guidelines did not want to include or concentrate on research which actually documents the claims of the users.

Results of cognitive behavioural therapy and graded excercise therapy from large scale patient surveys

* 3074 patients (Jones, 2003)

  • - CBT made no difference 55 %
  • - CBT made worse 22 %
  • - GET made no difference 16 %
  • - GET made worse 48 %
  • - Pacing activity with rest was the most helpful 90 %
  • - Bed rest the most helpful 89 %

* 2338 patients (Afme, 2001)

  • - CBT helpful 7 %
  • - CBT not helpful 67 %
  • - CBT made worse 50 %
  • - Activity managment most favourable 89 %
  • - Rest most favourable 91 %

* 437 patients (25 % M.E. Group, 2004)

  • - CBT helpful 7 %
  • - CBT not helpful 93 %
  • - GET helpful 5 %
  • - GET not helpful 95 %
  • - Psychotherapy helpful 10 %
  • - Psychotherapy not helpful 90 %
  • - The most helpful was activity managment and symptom control respct. 70 % - 75 %

At a conference in Fort Lauderdale, January 2007, Professor Fred Friedberg talked about a two year study in which patients used an actigraph ( pedometer) to register their activity level. The patients reported subjectively increased activity levels, but at the same time the actigraph showed that the number of steps taken sank drastically. The results showed that graded excercise therapy did not lead to improvement in relation to increased total activity level (Friedberg 2002).

Physical activity exceeding ”limit/ceiling effect” leads to increased symptoms and deterioration of the condition (Black & McCully 2005):

Patients can develop training intolerance, and this is shown by reduced activity level after 4-10 days. The inability to maintain an activity level, caused by worsening of symptoms, suggests that patients have reached an activity threshold. See also a more recent study by Yoshiuchi et. al (2007) which documents increased symptoms following graded excercise

It has been shown that patients with ME have increased oxidative stress during excercise, and this increase continues even after the the excercise has been stopped(Kennedy et al. 2005):

It is important to note that patients do not protest about treatments which make them better, but they do protest against treatments which either do not work or make them worse.

Jones DM. Some facts and figures on CBT, GET and other approaches, 2003.

25 % M.E. Group. Severely Affected ME (Myalgic Encephalomyelitis) Report on Questionnaire, Issued January 2004.

VanNess JM, Snell CR. Stevens SR, Bateman L, Keller BA. FACSM. Using Serial Cardiopulmonary Exercise Tests to Support a Diagnosis of Chronic Fatigue Syndrome. Medicine & Science in Sports & Exercise: Volume 38(5) Supplement May 2006 p S85;jsessionid=HV9HJwhtvwtNlGyB7vvTzBpDQt0xbKl87pnqpqrSnCTT9QlWCNXx!65375592!181195628!8091!-1?nav=search&fullimage=true

VanNess and his coworkers (2006) have written the following:

“Reduced functional capacity and post-exertional malaise following physical activity are hallmark symptoms of Chronic Fatigue Syndrome (CFS). That these symptoms are often delayed may explain the equivocal results for clinical cardiopulmonary exercise testing (GXT) with CFS patients. The reproducibility of VO max in healthy subjects is well documented. This may not be the case with CFS due to delayed recovery symptoms. Conclusion: In the absence of a second exercise test, the lack of any significant differences for the first test would appear to suggest no functional impairment in CFS patients. However, the results from the second test indicate the presence of a CFS related post-exertional malaise. It might be concluded then that a single exercise test is insufficient to demonstrate functional impairment in CFS patients. A second test may be necessary to document the atypical recovery response and protracted malaise unique to CFS.”

Both the Association of British Neurologists and The British Psychological Society have criticised the NICE guidelines.

Much of the research referred to, has been done on patients with fatigue, but who do not have ME.

The project has not been a cooperation where professionals and carers have taken part as it is described in the NICE guidelines. It is written that there was cooperation but the ones who have been involved as user representatives feel it was not real cooperation, but a form of masquerade. Considerable and documented contributions from users and experts who support the physical/organic cause of the illness have been ignored in a great degree. This and lack of real user contribution has also been confirmed in personal communication between organisations and Norway’s ME Association. The documents have been delivered to Competence Network co/Cecilie Daae.

The NICE guideline’s definition of the illness is so wide that it includes almost everyone with unexplained fatigue, and not ME, diagnostic code G93.3. There is a clear need to subgroup patients who fall under the umbrella term CF (fatique syndromes). The use of overview articles as research methods, have clear weaknesses when studies of heterogeneous populations are included - the methodology critique doesn’t focus on the fact that the evidence base is very weak and the dropout analysis cannot find out who, and why, the dropout rate in a few studies is very high. See also the critique the Association has produced in relation to the Knowledge centre’s report.

A lot of information on the physiological abnormalities was presented, but NICE has ignored this for the benefit of the ”biopsychosocial model” of the illness. This is a clear action which favours political strategies instead of medical and scientific evidence. The urgent need for biomedical research to uncover the underlying cause(s) have not been taken onboard. NICE has failed on several “Key Items” (Key Items 3, 5, 8, 10 and 20) in the use of AGREE INSTRUMENT (Appraisal of Guidelines Research and Evaluation, the AGREE Collaboration, Sept. 2001).

Costing report

The cost of these treatment strategies is based on assumptions, which the costing report says in the introduction. In addition the report comments on excisting uncertainties in the diagnosis and treatment of patients with CFS/ME. The high costs are expected to become even higher than estimated. The British organisations are questioning these costs for interventions which don’t have documented effect, and which the ptients themselves don’t want, at the same time when official bodies don’t prioritise biomedical research.

Legal evaluation

The critique of the NICE guidelines for ME/CFS was taken to High Court in the Royal Courts of Justice on June 17 2008. Two named persons act as litigants. The judge concluded that there are grounds for a full hearing. It is estimated that the hearing will take at least two days. The date has not determined, but expected soon. (Editor: the date is set for 11 and 12 February 2009)

There is diminishing trust in NICE within the British population because its decisions are constantly criticised and challenged. One questions its evaluation process and whether some distinct groups are disadvantaged by the process. There is a separate report where a wide range of patient organisations, among others cancer and multiple sclerosis organisations, Alzheimer’s Society and many other organisations for neurological and autoimmune conditions, have come forward with searing critique of NICE’s conduct and evaluations process. (House of Commons Health Committee: National Institute for Health and Clinical Excellence (NICE). Written evidence. HC 503-II. 17. May 2007).

Last Update 26/01/2009