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Concerns Raised by Professional Bodies over NICE Guideline on ME/CFS

Posted Mar 14 2009 3:14pm
Permission to Repost

http://www.meactionuk.org.uk


Examples of concerns raised by professional bodies about the NICE (draft) Guideline CG53 on “CFS/ME”

Margaret Williams 13th March 2009

In his Approved Judgment in the Judicial Review of the NICE Clinical Guideline 53 on “CFS/ME” released today, the Judge (Mr Justice Simon) stated:
“The circumstances are not such as to lead a fair minded and informed observer to conclude that there was a real risk of bias among the members of the GDG…” .

Commenting on today’s Judgment, NICE’s Press Statement says: “Professor Peter Littlejohns, NICE Clinical and Public Health Director, responded to the High Court judgment saying….We are pleased that all members of the GDG and those involved in selecting the GDG were totally exonerated from the unfounded claims made against them”
( http://www.nice.org.uk/media/001/6F/CFSMEJRJudgementStatement130309.pdf ).

Stakeholder submissions and comments on the various chapters of the NICE draft Guideline quoted below can be accessed in full at:
http://www.nice.org.uk/guidance/index.jsp?action=folder&o=36179. Although some changes were made in the final Guideline in response to some of the objections raised by these professional bodies, they were mostly superficial alterations and the recommendation for behavioural interventions as the primary management strategy for “CFS/ME” remained.

Association of British Neurologists: “it almost seems that a select group of psychiatrists with a polarised view of this complex condition is directing the development of the guideline from ‘behind the scene’ ”

Association for Psychoanalytic Psychotherapy in the NHS :“It is highly misleading to state that CBT is the therapy of first choice, since the only relative efficacy RCT quoted in the Guideline shows that counselling has better outcomes than CBT.”

British Association for Counselling and Psychotherapy (BACP): “responses to the Action for ME Membership Survey rate CBT and GET as the least helpful of a range of interventions...”

British Dietetic Association: “It is unhelpful to simply state that ‘Exclusion diets are not generally recommended for the management of CFS/ME’ when irritable bowel symptomatology is quite common in this illness.”

Chartered Society of Physiotherapy: “If 50% get worse with GET, why suggest it as first line of treatment?”

College of Occupational Therapists: “The College has serious reservations about the suitability of this Guideline.”

ME Research UK: (Commenting on “…CBT is an evidence-based treatment for CFS/ME…). It is not. The evidence base consists of only five trials which have a validity score of less than 10.”

National CFS/ME Observatory: “The belief that evidence-based guidelines can be constructed on such an inadequate evidence base is, in our opinion, misguided.”

National Coordinating Centre for Health Technology Assessment: “NICE largely pays lip service to the principle of consensus, with patient evidence being viewed as biased and virtually ignored”.

NHS Fife: “as is common practice sale technique, the ‘customer’ is gently led into a corner by a set of very cleverly designed questions aimed at achieving agreement on everything the salesman offers.”

NHS Plus: “the advice given to maintain exercise even when there is an increase in symptoms is potentially harmful and dangerous, and the supposed negative effects of deconditioning would be negligible in comparison”

Royal College of Paediatrics and Child Health: “There is a danger in relying solely on information from systematic reviews of clinical and randomised trial reports for non-pharmaceutical treatments that are not easily defined or replicated, such as CBT and GET.”

Royal College of Physicians of London: “We think that this is a potentially dangerous statement (ie.) that with increases in CFS/ME symptoms, exercise or physical activity should be maintained to avoid the negative effects of deconditioning. We are not aware of any clinician who would make this recommendation, except in a very mildly affected patient.”

Sheffield South West Primary Care Trust: “The narrow focus of the NICE Guideline may lead to helpful approaches being undermined and patient preference / clinical judgment being undervalued. All clinicians do not subscribe to the ‘CBT model of CFS/ME’, and (it) does not seem to be well received by many ME Support Groups either”.




DETAILED ILLUSTRATIONS

Association of British Neurologists

“The draft guideline is fundamentally flawed because it presupposes certain interventions (CBT and GET) to be highly effective in CFS/ME for routine clinical use despite lack of adequate evidence”

“The Guideline is also selective in its review of existing literature and is heavily influenced by (the) psychiatric view of the condition. Indeed, it almost seems that a select group of psychiatrists with a polarised view of this complex condition is directing the development of the guideline from ‘behind the scene’ ”

“There has been no review of general and post-exercise pain”

“The draft guideline reflects an incomplete and psychiatrically polarised view of CFS/ME”

“The importance of appropriate diagnosis of CFS/ME from common psychiatric conditions has not been mentioned even once”

“No-where in this guideline have the exclusion criteria for CFS/ME (eg. generalised anxiety disorder, somatisation) been adequately defined and properly discussed”

“ The guideline needs to be thoroughly revised to reflect our current understanding of this condition rather than the supposition of the psychiatrists”

“It would be immoral for NICE not to recognise the huge dissatisfaction about this draft guideline amongst most patients, carers and clinicians”

“The guideline should not re-define CFS/ME to ‘fit in’ CBT and GET as the recommended treatment options. Listen to patients”.


A further submission from the Association of British Neurologists said the following:

“The GDG is neither competent nor empowered to redefine CFS/ME by using only one of all the minor criteria: by doing so, the Group is tactically promoting the Oxford (ie. Wessely School) criteria over the more widely used and recognised international CDC criteria – again, a clear evidence of psychiatrists’ influence on this group”

“This paragraph deals with a publication (Wessely et al, Lancet 1999) which was published as a HYPOTHESIS and which remains to be proven. However, the GDG seems to have taken it as a matter of fact. Please refer to the criticisms of this article in the Lancet. Being only a hypothesis, (it) is totally irrelevant for the purpose of a dedicated guideline on CFS/ME”

“The GDG should also be criticised for its total lack of reference to the neurological aspect of fatigue and its overemphasis and over-reliance on the psychiatric literature from a group of psychiatrists”

“With the possible exception of some psychiatrists, most specialists prefer the international criteria to diagnose CFS/ME”.

“Clearly there is very little compelling evidence at present that these patients benefit from CBT and GET” and the GDG recommendations for CBT and GET are “both unsubstantiated and unjustified”

“There is selective omission of research literature on reproducible neuroendocrine tests, with an overemphasis on research data from certain psychiatrists”.


Association for Psychoanalytic Psychotherapy in the NHS

"We are concerned that NICE is misleading patients and health professionals on the question of CBT as the treatment of choice (for) patients who suffer from CFS ... it is clearly unhelpful for people to be given misleading advice or to have their expectations raised on a false basis………….there is also evidence that many CFS sufferers do not find CBT suitable as a treatment"

"It is highly misleading for this to be the main recommendation"

“It is highly misleading to state that CBT is the therapy of first choice, since the only relative efficacy RCT quoted in the Guideline (Ridsdale et al, Br J Gen Pract 2001:51:462:19-24) shows that counselling has better outcomes than CBT. This recommendation seriously conflicts with the recommendation that patient choice and preference need to be uppermost in the collaborative approach to care, and the finding that 45% of patients report either being made worse or not helped at all by CBT and, elsewhere, only 7% of patients surveyed report being helped by CBT. Why is a misleading recommendation being made?”

With reference to Ridsdale et al. (Chronic fatigue in general practice: is counselling as good as cognitive behaviour therapy? A UK randomised trial. Br J Gen Pract 2001): "the main findings of this study are reported - that counselling is more cost effective than CBT, and that counselling has better outcomes than CBT - followed by tortuous, vague and perverse reasons given for why this guideline then chooses to ignore these studies - nor is any explanation offered why they do not appear in the list of RCTs reviewed - this seems to be a result of bias in the GDG, What is the reason for ignoring the findings of this study in the recommendations?"

“Despite….good evidence for homeopathy from a high quality RCT, there is no place in the recommendations for alternative therapy --- this contradicts the general principle that patient preference should be given due respect”.





British Association for Counselling and Psychotherapy (BACP)

“We see responses to the Action for ME Membership Survey rate CBT and GET as the least helpful of a range of interventions……..It would be a shame to antagonise patient groups, which are often not convinced by the benefits of CBT as demonstrated in clinical studies”.


British Dietetic Association

“We wish to highlight the importance of optimum vitamin D status not only for vulnerable groups of CFS patients…….More evidence is appearing linking low vitamin D status to lower extremity muscle weakness and immunity. We would recommend the use of vitamin D supplementation of at least 10mcg. The patient surveys indicate that dietary change helped 59 – 73% of patients”

“Many patients experience food intolerances and find a clinically supervised exclusion diet a helpful tool in identifying those symptoms which may be related to foods. We feel that this should be reflected here. People with ME/CFS….clearly need straightforward and sensible advice that covers a wide range of dietary management along with advice on the vitamins, minerals and supplements that are extensively used and recommended to people with ME/CFS”

“There is no discussion on the use of EPA supplements which are probably the most popular supplement currently being used by people with ME/CFS”

“It is unhelpful to simply state that ‘Exclusion diets are not generally recommended for the management of CFS/ME’ when irritable bowel symptomatology is quite common in this illness and there is good evidence to show that exclusion diets can be helpful in identifying food intolerances”

“We note the discrepancy between the results of the surveys of patient groups showing that a large number have found dietary change helpful (59% in one survey and 65% in the other) and the final recommendations in the Guideline”

(It should be noted that the stakeholder comments from psychiatrist Professor Peter White’s Chronic Fatigue Services at St Bartholomew’s Hospital dismisses the evidence of bowel problems in ME/CFS: “bowel symptoms are not part of CFS/ME” ---stakeholder comments on chapter 6, page 143.

It should also be noted that the final Guideline does not recommend testing for vitamin levels (even vitamin D, which is known to be very low in ME/CFS) and supplementation specifically is not recommended).


British Infection Society

“Second line tests should include autoimmune serology”.

(The Final Guideline does not mention testing for autoimmune serology).

Chartered Society of Physiotherapy

(Note that GDG member Ms Jessica Bavinton was nominated by The Chartered Society of Physiotherapy).

“Can we clarify which name is preferable to use and identify that CFS/ME falls within the umbrella of neurological conditions?”

“If 50% get worse with GET, why suggest it as first line of treatment?”

“Do not agree that the evidence-base is strong enough for GET”

“Are five reviews enough to describe a strong evidence-base?”

“Was the GET definition / criteria the same in all five studies?”

“GET is dangerous without activity management first”

“Does not take individual reactions into account enough”.


College of Occupational Therapists

“The College has serious reservations about the suitability of this Guideline. Furthermore, the College believes that its implementation would compromise essential services in this client group”

“It is disappointing that all the personal testimonies give negative feedback about services”

“Are we now saying that all patients have chronic fatigue rather than chronic fatigue syndrome?”

“The therapeutic relationship may be compromised if the patient refuses an intervention because there may be no other intervention on offer and the therapeutic relationship ends”.


Counselling and Psychotherapy Trust

“We feel that it is restrictive and artificial to try to define approaches such as GET (which is essentially a behavioural therapy programme) separately, when (it) is frequently delivered as a component within an integrated CBT framework. The real danger lies in the fact that definition of GET as a separate area could well lead to any number of ‘lay’ practitioners offering support, without adequate knowledge or skills (and) errors can have severe detrimental effects”.


Maidstone and Tunbridge Wells NHS Trust

“The warning about lower tolerances and more adverse effects from medication certainly concurs with patient experience and is both welcome and important”

“Whilst thyroid hormone may appear normal on laboratory tests, the patient may actually be clinically hypothyroid. It must be recognised that the thyroid test has required updating numerous times”.

ME Research UK

"The draft produced by the Guideline Development Group (GDG) is unsafe and unsatisfactory (“unfit for purpose”) because it does not engage with key issues involved in the diagnosis and management of ME/CFS”

“Core areas of difficulty can be divided into the following: (i) the problem of the diagnostic rubric and the need for research-based subsets (ii) the skewing of the RCT evidence-base examined by the GDG, and the devaluation of evidence from scientific studies and surveys (iii) the limitations of the evidence-base for non-specific management”

“The WHO ICD has, since 1969, classified ME separately as a neurological problem (G93.3), with ‘CFS’ incorporated into the current ICD as a sometime synonym for ME. The chronic fatigue states per se are listed under mental and behavioural disorders (F48.0), a category which specifically excludes ME/PVFS/CFS”

"Our key point is that CFS/ME or ME/CFS is a wide umbrella term recognised by clinical champions, patient charities, leaders of ME/CFS support groups, and scientific researchers to contain many different patient groups. Without addressing this core issue, the efforts of the GDG to give diagnostic and management guidance that goes beyond the recommendation of anodyne, non-specific interventions will be inadequate and probably constitute misguidance”

“The experiences of patients and the professional judgments of doctors are important. It is not a simple battle between evidence and anecdote... NICE needs to do more than just look at published science. It needs to start listening to people, patients and doctors”

"It would be preferable for NICE and the GDG to recognise that specific, rigorous, evidence-based recommendations for treatment cannot be made at present than to incorporate an inadequate evidence-base into established guidelines which feed into clinical care and government policy to the detriment of people with ME/CFS"

(Commenting on “….like other chronic illnesses with no certain disease process…) This leaves open the possibility that there might not be a disease process at all, when there are thousands of people with a physical illness”

(Commenting on “…CBT is an evidence-based treatment for CFS/ME…) It is not. The evidence base consists of only five trials which have a validity score of less than 10. We note that the most recently published RCT on CBT (O’Dowd 2006) states: ‘there was, however, no evidence that the treatment restored normal levels of function for the majority of patients’ ”

“the rationale for using CBT in ME/CFS is that inaccurate beliefs / ineffective coping maintain and perpetuate the illness, but it has never been proven that these illness beliefs have caused or maintain the illness, and correlations (where they exist) might just as well have arisen from the valid belief that the illness does have a physical cause, and that activity avoidance is the correct course of action”

(Commenting on “…GET is an evidence-based self-management approach to CFS/ME…) It is not. The evidence base consists of only three RCTs with a validity score of less than 10. Given that all three trials recruited patients on the basis of the Oxford criteria which selects an over-broad group of patients including those with idiopathic chronic fatigue…..this management approach cannot be properly called evidence-based or cost-effective in ME/CFS”

(Commenting on “…Healthcare professionals should be proactive in advising about fitness for work and education…) This is not a standard phrase used in NICE Guidelines for other chronic conditions (and) there is a suspicion that this phrase would not be written of patients with other illnesses. What evidence is there that people with ME/CFS need unusual prompting from healthcare professionals to return to their pre-illness lives and jobs?”

“This attempt by the GDG to define a clinical definition makes the situation far worse. It introduces diagnosis based on ‘fatigue’ plus one of nine vague, ill-defined symptoms shared with many other illnesses. The widened diagnosis would include many thousands of patients currently diagnosed with idiopathic fatigue (and) it would lead to significantly increased heterogeneity within the diagnostic category and it would not be taken seriously because it flies in the face of other expert opinion. Furthermore, the experts devising the Canadian Consensus Document (Carruthers 2003) derived a rubric based on characteristic symptom patterns which reflect specific areas of pathogenesis”

“There is a clear mismatch between the recommendations of the GDG and the routine examinations recommended by ME/CFS clinicians across the world”

(Commenting on “…When a diagnosis is made, a prognosis of cautious optimism should be conveyed. With appropriate management, most children and adults, but not all, will have some improvement and some will fully recover….) This is not true. Two separate recent reviews have concluded that ‘Substantial improvement is uncommon and is less than 6%’ (Andersen 2004) and ‘Full recovery …is rare’ (Cairns and Hotopf, 2006)”

“Neither CBT (a form of psychotherapy designed to manage dysfunctional illness beliefs) nor GET (which is used as part of a biopsychosocial programme predicated on a model of physical deconditioning) are evidence-based to a level that would allow NICE to recommend that these management strategies be rolled out to the 120,000 – 240,000 people with ME/CFS in the UK”

“Evidence from formal RCTs is opposed by evidence from patient surveys which overwhelmingly find against the usefulness of these strategies. Accordingly, the emphasis on these strategies in the NICE Guideline is misplaced”

(Commenting on “…A programme of CBT should include…explanation of the CBT model for CFS/ME…) There is no CBT model for ME/CFS. Rather there is CBT, a form of psychotherapy, which can be applied to all illnesses through the supposed biopsychosocial model”

(Commenting on “…discussion of the patient’s attitudes and expectations….developing awareness of thoughts or expectations…or beliefs….challenging cognitions which may adversely affect rehabilitation or symptoms management, for example fear of activity and perfectionist beliefs….addressing symptom over-vigilance….) Such sentences, characteristic of the biopsychosocial model, have been given undue prominence by the GDG. There is a suspicion that they would not be so prominently displayed in NICE guidelines for other illnesses; indeed, we note that they do not appear in (the NICE Clinical Guideline on multiple sclerosis) despite the fact that fatigue is one of the dominant symptoms of most people with MS”

“The Analysis Report (2004) by the 25% ME Group for Severe Sufferers which was submitted to the GDG is not mentioned in either the FULL or the NICE guidance. This reported that 93% of respondents found CBT unhelpful and that GET was found to be unhelpful by 95%. It may be, as the FULL Guideline says ‘surveys from self-selected respondents are subject to bias’. But this report is still valuable and full of meaning and does not deserve to drop off the edge of the evidential world”.


National CFS/ME Observatory

“Given our misgivings about the inadequacy of the evidence base pertaining to CFS/ME, we are concerned that the current draft is premature. The belief that evidence-based guidelines can be constructed on such an inadequate evidence base is, in our opinion, misguided. Indeed, many of the recommendations in the draft guideline appear not to be evidence-based at all…. (and) reflect what limited research was carried out in the 1990s and before”

“If promulgated, even if subject to subsequent review, the guidelines are likely to be in force for at least five years, during which time people with ME receiving NHS care will be unable to benefit from whatever scientific advances may be made”

“It also implies that, of a range of possible therapeutic approaches, CBT and GET are the two which emerge as being the most effective, whereas the reality is that there has been very little clinical trial activity involving other treatment”

“ The statement is also misleading because it does not consider at all the extent to which outcomes of trials of CBT and GET …… do not appear representative of the population with CFS/ME as a whole, are generalisable, and applicable to that whole population”

“The diagnostic criteria detailed in paragraph 1.2.1.2 do not conform to any existing clinical case definition for CFS/ME and appear to be based on poor evidence”

“We do not consider that CBT and GET have been evaluated sufficiently for this blanket claim as to their effectiveness to be justified”

“CBT and GET….. should not be regarded as the first choice of treatment or as providing a cure. To put rehabilitation before prevention or early intervention falls short of the patient-centred approach which the draft guidelines claim to be advocating”

“Greater evidence should be placed on medical interventions, including symptom control and improved access by patients to services, information and resources

“…promoting the use of CBT and GET in severely affected people (is) extremely dubious, since there is a dearth of evidence supporting the use of these approaches in such patients, and plenty of anecdotal evidence, as well as evidence from surveys conducted by patients organisations, of these methods being at best of limited value and at worst damaging. (In relation to the use of CBT and GET in children and the severely affected, the draft guideline) states that ‘There is no evidence for the use or effectiveness of these strategies in these two patient groups’, and yet the guideline recommends that they may be used in such cases”

“The (draft Guideline), as it stands, has obvious defects, which make it unsuitable for general application throughout the NHS”

“It demonstrates lack of understanding of CFS/ME (and) the evidence-base is inadequate to support the conclusions and recommendations made”

“The review claims to be evidence-based but in fact is mostly based on expert opinion, rather than on evidence”

“ There is no indication that the document reflects a balanced view of expert opinion on CFS/ME”

“ The report gives the erroneous impression that the role of these management options has been satisfactorily evidenced and widely agreed by professional and lay groups involved in this field”

“The recommendations serve only to underline the extent to which the existing evidence base is inadequate”

“We strongly recommend that the draft be rewritten to reflect more accurately the current state of scientific knowledge, and also the views of stakeholders (and) patients’ organisations, which do not appear to have been taken much into account. NICE guidance is of such importance in the NHS, and has such huge repercussions on patterns of treatment and care. It therefore needs to be accurate. Where there are differences of opinion among experts, such differences should be reflected in the document”.


National Coordinating Centre for Health Technology Assessment

“NICE acknowledges that there is at present little good research evidence for most aspects of ME/CFS and acknowledged the need for consensus methods. However, NICE largely pays lip service to the principle of consensus, with patient evidence being viewed as biased and virtually ignored”.


Newcastle Primary Care Trust
“As many key questions did not progress to the wider group, we wonder to what extent the stakeholder principle is being upheld".

Newport Pharamaceuticals Ltd

“Diagnostic Recommendations: this is a curious paragraph in a number of respects: ME is a neurological illness (ref. The WHO classification), so why would patients with neurological signs be excluded from diagnosis?”

“Cardiovascular abnormalities have been found in patients with ME (ref. Human Tragedy and the Heart of the Matter – vascular research by ME Research UK)”

“Surely anxiety and depression indicate anxiety and depression, rather than acting as markers for some ‘seriously underlying pathology’. Of course anxiety and depression should be treated in their own right if present. More generally, the implication is that a diagnosis of ME/ICD CFS does not in itself indicate a likelihood of ‘serious underlying pathology’. Even if ‘serious’ is intended to be read as ‘life-threatening’, fatalities, though rare, do occur (ref. Carruthers 2003, page 34), and the documented deaths”.


NHS Fife

“The biomedical research evidence suggests it cannot be safely assumed that negative effected reported by patients following exercise are attributable to inappropriate application of what we are told is an intrinsically helpful approach. However as is common practice sale techniques, the ‘customer’ is gently led into a corner by a set of very cleverly designed questions aimed at achieving agreement on everything the salesman offers. One system is known as the Hierarchy of Effects model and is a marketing behavioural response model. It is highly probable that participation in GET programmes evokes a similar behavioural response from patients, thereby discouraging disagreements with most statements made by the professional”.

NHS Plus

“It is essential that this issue of deconditioning and exercise / rest is resolved, since the advice given to maintain exercise even when there is an increase in symptoms is potentially harmful and dangerous, and the supposed negative effects of deconditioing would be negligible in comparison”

“Some research should be done on thyroid function. Levels of T3 and T4 and TSH should be measured at times in all patients and readings scrutinised to see if many are at the bottom end of the normal range. There is also evidence to suggest that there may be some ‘peripheral resistance’ to thyroid hormone in CFS/ME”.


NHS Quality Improvement Scotland

“Supplements: again there is inconsistency: (NICE states)‘There is no evidence for the use of supplements’, whereas the Full Guideline details that there is some evidence for Essential Fatty Acids and magnesium. The statement in NICE is misleading and potentially prevents many patients deriving benefit from certain supplements. Another failing of the strictly ‘evidence-based’ approach”.


North Bristol NHS Trust

“There is enormous concern amongst patients about who is doing the training and what exactly they are being taught”.


North Eastern Derbyshire Primary Care Trust

“This is another example of the GDG ignoring the consensus of the wider group. The wider group actually agreed that a clinically supervised exclusion diet followed by food challenges is appropriate where there are bowel symptoms, however the NICE is worded such as to discourage this and takes no account of the practical experiences of large numbers of people with ME/CFS who often derive benefit from excluding certain foods”.


PRIME (Partnership for Research in ME/CFS)
PRIME noted the GDG’s acknowledgement that there are insufficient studies using outcomes that are important to patients and that most studies often assess only fatigue and sleep, and that few studies include outcome measures that explore the wider impact of ME/CFS.


Royal College of General Practitioners (Wales)

“A guideline based on dysfunction and disability will inevitably remain focused on rehabilitation rather than on cure and prevention”.


Royal College of Nursing

“The current order seems to imply that CBT and GET are the most important factors and this could be a source of upset with service users”

“Diagnosis to be considered if fatigue plus one additional symptom – what sort of impact will this have on the number of patients being referred to the CFS/ME services?”

“Not sure that this conceptual framework is helpful, nor does it help clarify what CFS/ME is”.


Royal College of Paediatrics and Child Health

“We note that only 63 / 219 participants in the consensus process were healthcare professionals and it is unclear how many of these 63 had any experience of managing children and young people with this condition”

“Further to the email sent to NICE on the 4th September (copy attached with this response), we have the following concerns regarding the consensus methodology process: The methodology is difficult / impossible to interpret from the information given. Clearly this needs to be clarified as it seriously undermines the document in its current form. For example, there are several occurrences where a consensus appears to have been reached in one round but the question has gone on to the next round. In at least one situation it appears that a statement reached an agree consensus in the first round but then continued to the second round where it reached a disagree consensus”

“For many interventions there is a lack of evidence of efficacy”

“There is a danger in relying solely on information from systematic reviews of clinical and randomised trial reports for non-pharmaceutical treatments that are not easily defined or replicated, such as CBT and GET. It is only by reading the actual paper describing the RCT does one see how the approach described as CBT and GET differs from study to study”

“(NICE) says practitioners are advised to provide information on the aetiology of CFS/ME – but where is the information to assist them in doing so?”

“At a minimum could we have a reference here to the NSF (National Service Framework, which includes ME/CFS as a chronic neurological disorder) for CFS/ME?”

“NICE recommends assessment of mental health is carried out before a diagnosis is made. This does not appear to be evidence based and could appear threatening in some situations”

“We are concerned that doctors reading this Guideline might interpret this Guideline as that (sic) anxiety and depression are primary causes of CFS/ME for which, as far as we are aware, there is no evidence”.


Royal College of Physicians of London

“Unlike other NICE Guidelines, this document is a consensus document, with evidence base limited to CBT and GET. It is important that the ‘consensus’ nature of this document is highlighted, as it may be used in its own right as a source of evidence base, ie. in the diagnostic, health planning or medico-legal arenas”

“The consensus Guideline Development Group, with one exception, did not include any single expert in major aspects of CFS, ie. clinical aspects or research”

“We do not believe that an acceptable definition of CFS/ME has been adhered to”

“The consensus group here have presented their own definition, which really describes fatigue for four months with one of a limited number of other symptoms. This opens up the diagnosis from CFS/ME into a wider remit of fatigue disorders”

“If the consensus group are confident in this new classification, then this should be emphasised and stated that the remit of these guidelines extends to ‘virtually any intrusive prolonged fatigue state’ ”

“Clinical evidence and patient experience suggest strongly that some patients may be worsened by GET”

“We think that this is a potentially dangerous statement (ie.) that with increases in CFS/ME symptoms, exercise or physical activity should be maintained to avoid the negative effects of deconditioning. We are not aware of any clinician who would make this recommendation, except in a very mildly affected patient”

“There are many reasons for setbacks in CFS, including excess physical activity or stress. If this is the case, and activity levels remain unchanged, the patient is at risk of having a more major or serious relapse. This needs to be emphasised”

“The Implementation Group expressed concern that…..the wholesale recommendation of CBT would not be practical in any ‘reasonable timescale’ ”

“1.3.4.1. states ‘there is no pharmacological treatment or cure for CFS/ME’. This is ostensibly true, but misses the point that…..most patients have additional symptoms, eg. sleep disturbance, pain, anxiety, mood changes, new onset headache, bowel symptoms, allergies, vertigo etc. Without management of these symptoms the individual is unlikely to improve easily”

“It is stated that GET may be an appropriate addition to help patients develop their physical capacity and functioning. GET in its traditional form is not applicable, and not possible in the very severe dependent patients”.


Sheffield South West Primary Care Trust

“CBT and GET are mentioned several times. However, there may be other approaches which are more helpful. Lack of evidence does not necessarily mean lack of effectiveness for these approaches”.

“The narrow focus of the NICE Guideline may lead to helpful approaches being undermined and patient preference / clinical judgment being undervalued. All clinicians do not subscribe to the ‘CBT model of CFS/ME’, and (it) does not seem to be well received by many ME Support Groups either”.
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