The National Institute for Health and Clinical Excellence (NICE) has produced a draft guideline for ME/CFS which it has put out for comment.
With its emphasis on CBT and graded exercise as therapies of first choice, it will set the pattern for assessment, diagnosis and clinical management for years to come.
The ME Association says NICE has largely igored patient experience. It will be ‘a very sad day’ for people with ME/CFS if the document gets through in its present form.
MEA RESPONSE TO THE SEPTEMBER DRAFT
The ME Association (MEA) has carefully considered the contents of this draft. As a stakeholder in the guideline development process we have actively sought the views of our members as well. We have also taken note of the responses to our criticisms that were made at the meeting with NICE on Thursday 5 October.
The comments below represent the outcome of this extensive consultation process.
The MEA fully supports the view that a guideline on the assessment and management of ME/CFS should be prepared by NICE and made available to all health professionals in the UK.
A key feature of any such guideline is that it must reflect the wide variety of clinical presentations and pathophysiologica mechanisms that come under the ME/CFS umbrella. Equally, it must be acceptable to people who have this illness.
Overall, we feel that the current (ie September 2006) version of the guideline that has been prepared by NICE is unfit for purpose and we would not be willing to endorse it.
We have five major disagreements.
First involves the unbalanced coverage of CBT and GET.
Second is the failure to provide any meaningful advice on management during the acute and very early stages of the illness before a firm diagnosis of ME/CFS has been made.
Third is the failure to provide any meaningful advice on symptomatic management as the illness enters a more chronic stage.
Fourth is the way in which it deals with issues affecting the severely affected
Fifth is the failure to acknowledge the WHO classification of ME/CFS (and PVFS) as being neurological disorders (in section G93.3 of ICD 10) – a position that the Department of Health also accepts – and instead the NICE draft produces a new and much wider clinical definition of ME/CFS that includes almost anyone with chronic unexplained fatigue.
We will start by commenting on these five objections in more detail:
1 A VERY UNBALANCED ACCOUNT OF THE BENEFITS OF COGNITIVE BEHAVIOUR THERAPY (CBT) AND GRADED EXERCISE THERAPY (GET) in section 1.3.1
Our principal disagreement involves the way in which almost all of the management section is devoted to a manual-like approach that sets out how the authors believe that cognitive behaviour therapy (CBT) and graded exercise therapy (GET) should be used as an automatic first line treatment for almost everyone who has mild to moderate ME/CFS.
The sections on CBT and GET contain numerous recommendations on how to deal with specific management problems – most of which are based on opinion rather than the type of evidence-based medicine that normally dominates a NICE guideline.
Some of the advice on non-pharmacological management contains sensible and common sense suggestions. The ME Association already recommends some of these coping strategies in our own self-help literature. But there is no reason why this type of advice has to be given by specially trained behaviour therapists in hospital. Where the advice is sensible, and not based purely on the psychosocial model of abnormal illness beliefs and behaviour, it should form part of a self-help or Expert Patient management programme. This sort of advice could easily be given out in a primary care setting – where most people with ME/CFS are, and will continue to be managed.
However, much of the coverage here is seriously flawed because the opinions of those who are obviously very enthusiastic about the overall value of hospital-based CBT and GET are given undue emphasis whereas any form of critical opinion from people who have been treated with these approaches is simply ignored. The Chief Medical Officer's Report adopted a trident approach to deal with this difficult issue whereby it took note of opinion from clinicians and patients, as well as the results from published research studies, when it came to dealing with CBT and GET.
This point is crucial because patient opinion submitted to the CMO Report indicated that the results for CBT were not at all impressive with around 65% saying that this approach had not been helpful. And around 50% of people who had been placed on a graded exercise regime reported that this had made their condition ‘worse'.
NICE has clearly not grasped the fact that the treatment trials being quoted to support the use of CBT and GET have only used relatively small numbers of carefully selected patients, have generally been carried out in tertiary care centres that support the psychosocial model of ME/CFS causation, and in some cases have had quite high drop-out rates (eg 37% in the Manchester GET trial. Ref: Randomised, double-blind, placebo controlled treatment trial of fluoxetine and graded exercise for chronic fatigue syndrome. British Journal of Psychiatry 1998; 172: 485 – 490). Our feedback in relation to GET dropouts is that some of these people have gone on to relapse as a result of the exercise programme – but this is never made clear in published results.
Whilst preparing this response we have received feedback from someone who has recently been treated at an internationally recognised centre where this type of behavioural research is carried out. This person has stated that:
“When you cannot build up the exercises in the speed that xxx want you to, xxx tell you that you are not motivated enough to follow the programme. You get a last chance, but even then when you can't follow the programme they tell you to stop because of lack of motivation. Even when you do your best to keep up with longer walks and less rest, when you cannot do it, you are out.
“The psychologist really believes that when you are motivated enough you can keep up with the programme. They push you to do the activities, sometimes forcing it by manipulating the parents or school as well.
“Last year people were told that, when they have contact with other patients, they get the wrong signals and adopt a sick role. So they insist that there should be no contact with patient groups. Most patients follow this advice and so we don't have any contact with them. Patients who do stay in contact often drop out before ending the programme.”
We would be willing to forward the complete response to NICE if requested.
With regard to CBT (sections 184.108.40.206-13), we believe it is completely unacceptable to imply that everyone with mild to moderate ME/CFS needs to take part in a hospital-based CBT programme that includes an underlying assumption that symptoms are maintained by factors such as abnormal illness beliefs and behaviour. While a minority of people who come under the diagnostic umbrella of CFS do fit the psychosocial model of illness perpetuation, and would benefit from such an approach, the majority do not, have no significant psychiatric co-morbidity, are well motivated, and are doing everything they can to try and get better. They would, quite rightly, object to such an approach being taken to their management.
The Guideline Development Group (GDG) should also take note of the most recent research study on CBT. This found that CBT did not offer any significant overall benefit when compared to education and support and standard medical care (reference: Cognitive behaviour therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme. Health Technology Assessment. 2006 Oct; 10: number 37 – available on-line at: http://www.hta.ac.uk/fullmono/mon1037.pdf).
Neither does NICE appear to appreciate that counselling may well be just as effective, and cost effective, as CBT in some instances. Two relevant references here are:
Chronic fatigue in general practice: economic evaluation of counselling versus cognitive behaviour therapy. British Journal of General Practice 2001; 51: 15-18.
Chronic fatigue in general practice: is counselling as good as cognitive behaviour therapy? A UK randomised trial. British Journal of General Practice 2001; 51: 19-24.
We have a number of major concerns about the information being given on GET (sections 220.127.116.11 – 18).
Our first concern relates to the word exercise and the fact that most people – doctors, patients, the general public – take this to mean some form of short-lived and fairly intense physical activity.
Exercise is a completely misleading term for energy management in the severely affected group. It is also inappropriate for most people in the moderately affected group. It may or may not be appropriate in mild cases.
Furthermore, the guideline fails to put over the fact that energy management affects not only physical functioning in ME/CFS, and that inappropriate advice on energy management will also have an adverse effect on cognitive performance.
The unqualified and frequent use of the term exercise clearly implies that exercise is the key to recovery and that rest/relaxation is generally harmful.
NICE only have to look at the press coverage of the York systematic review in the Journal of the Royal Society of Medicine to see that this is how the media is already interpreting this type of advice. Exactly the same sort of over-simplistic interpretation of the term exercise will be made by most doctors who have no special interest in ME/CFS.
What is required is a name and a practical approach that advises people with ME/CFS on how to achieve a sensible and flexible balance between activity or energy management (not purely exercise) and rest. This will depend on the stage, severity and variability of their condition – as we point out in some detail in our own information literature. Some people may need to increase their activity levels whereas others may actually need to reduce them, especially in the early weeks and months following an acute onset – this is not what graded exercise implies.
Our second concern relates to the way in which the guideline appears to have dealt with energy/activity management during the very early stages of this illness (ie the first few weeks and months) before a firm diagnosis of ME/CFS has been made. At this stage we believe that a period of appropriate rest and convalescence is essential (we are not advocating that people go to bed and stay there) and that inappropriate exercise could well produce a further deterioration. Is NICE really advocating graded exercise during the very early stages of ME/CFS? This appears to be the case in section 18.104.22.168.
Our third concern relates to what is commonly referred to as the ‘glass ceiling' effect whereby people with ME/CFS often make a degree of improvement over the prolonged course of time, but then reach a point at which they are unable to increase their physical activity – despite high levels of motivation. The guideline does not even acknowledge that this situation exists – presumably on the assumption that graded exercise will eventually return almost everyone to normal health.
On this point we suggest that the Guideline Development Group reads the important study by Black et al (Increased daily physical activity and fatigue symptoms in chronic fatigue syndrome. Dynamic Medicine 2005; 4: 3 Electronic version available at: http://www.dynamic-med.com/content/4/1/3) that concluded:
‘CFS patients were able to increase their daily activity for a period of four weeks. In contrast to previous studies fatigue, muscle pain, and overall mood did not improve with increased activity. Increased activity was not presented as a treatment which may account for the differential findings between this and previous studies. The results suggest that a daily "activity limit" may exist in this population. Future studies on the impact of physical activity on the symptoms of CFS patients are needed'.
And in a further study (Time course of exercise induced alterations in daily activity in chronic fatigue syndrome. Dynamic Medicine 2005; 4: 10. Electronic version available at: http://www.dynamic-med.com/content/4/1/10) Black and McCully concluded:
‘Daily activity assessed via an accelometer worn at the hip was divided into sleep, active, and walking periods. Over the first 4 – 10 days of walking the subjects with CFS were able to reach the prescribed activity goals each day. After this time, walking and total activity counts decreased. Sedentary control subjects were able to maintain their daily walking and total activity goals throughout the four weeks. Unlike our previous interpretation of the data, we feel this new analysis suggests that CFS patients may develop exercise intolerance as demonstrated by reduced total activity after 4 – 10 days. The inability to sustain target activity levels, associated with pronounced worsening of symptomatology, suggests the subjects with CFS had reached their activity limit.'
Our fourth concern relates to the advice that activity levels should largely be maintained during a period of relapse or setback (section 22.214.171.124). We believe this advice is over simplistic and potentially dangerous, and is once again based on opinion rather than any sound evidence. We do not believe that spending a few days resting in bed during a significant relapse of symptoms, certainly one caused by an infection, is going to be harmful or result in deconditioning. This is the way in which many people with ME/CFS successfully cope with a relapse and we believe it would be irresponsible to ignore the views of patients yet again.
In relation to this we quote from what is very typical feedback on this particular aspect:
‘After reading the MEA summary of the October meeting on the draft NICE guidelines. I am very concerned about the emphasis on graded exercise.
‘I have had bouts of ME since 1991, when a run of flu-like illnesses was made worse by trying to carry on through them and indeed by trying to take exercise to ‘throw it off'.
‘During the last two years, when my problems have recurred, it has been necessary to dramatically scale back the previous routine of yoga and gentle swimming that was keeping me fit during the nine years or so of relative health that I enjoyed between xxxx and xxxx. In fact, Professor xxxx, who I am now seeing at xxxx Hospital, advised me that the muscle pains and recurrent fever which I was suffering last winter were probably not being helped by my constant attempts to tackle exercise and regain strength.
‘Very soon after stopping exercise, I found the muscle pains and weakness had lessened.
‘This leads me to conclude that forcing people to do exercise when they are actually ill, or pushing them too far when they are in recovery, could be really counter-productive. It will also, I expect, make patients feel disempowered and controlled by medics, which is extremely bad for self-respect and the self-confidence you need to cope with when recovering from such a challenging condition'.
Our fifth concern relates to the way in which NICE does not appear to have taken any notice of published evidence that contradicts the commonly held view that deconditioning is major factor in the perpetuation of symptoms. Key references here include:
1 A longitudinal study of physical activity and body mass index among persons with unexplained chronic fatigue. Journal of Psychosomatic Research 2005; 58: 375 – 381. Conclusion: These data do not support models that posit associations between CFS and deconditioning
2 Is physical deconditioning a perpetuating factor in chronic fatigue syndrome? A controlled study on maximal exercise performance and relations with fatigue, impairment and physical activity. Psychological Medicine 2001; 31: 107 – 114. Conclusion: Physical deconditioning does not seem a perpetuating factor in CFS.
Our sixth concern is that important evidence indicating that inappropriate exercise can be harmful also appears to have been ignored. For example, the Lapp exercise study (reference: Exercise limits in chronic fatigue syndrome. American Journal of Medicine 1997; 103: 83 – 84) found that:
In particular, 23 (74%) experienced worsening fatigue and 8 (26%) stayed about the same after maximum exercise. None improved. The average relapse lasted 8.82 days, although 12 subjects (22%) were still in relapse when the study ended at 12 days. Interestingly, we found similar changes in exercise in lymph pain, depression, abdominal pain, sleep quality, joint and muscle pain, headache, and sore throat.
The data would suggest that when PWCs (people with cfs) are pushed to maximal exertion, they frequently relapse for long periods of time.
CBT AND GET
The sections on CBT and GET are unbalanced, not properly researched, and contain advice that is potentially harmful for a significant proportion of people who come under the ME/CFS umbrella. We cannot therefore endorse them.
Instead, we would like to see a guideline that advocates the type of common sense, self-help strategies (ie pacing a person's activities according to stage and severity of their illness) that have been repeatedly endorsed by people with ME/CFS. This is an approach that could be incorporated into primary care management and/or an Expert Patient programme. And we find it strange that the Expert Patient Programme in relation to ME/CFS is not even mentioned in the shortened version, which will presumably form the basis for what is sent out to health professionals.
We also wonder whether NICE is living in the real world. The clear implication being given in this guideline (key priorities section on p6/48) is that if people with mild to moderate ME/CFS want to improve then they need to be referred by their GP to a multidisciplinary hospital-based ME/CFS service that has expertise in CBT and GET.
We agree with NICE that these services cannot be delivered by general practitioners. A relevant reference here is : Long-term efficacy of cognitive-behavioural therapy by general practitioners for fatigue. A four-year follow-up study. Journal of Psychosomatic Research 2006; 61: 601 – 607. Conclusion: CBT delivered by GPs is not effective in the long term.
So where is the money going to come from to assess and treat around 180,000 people with ME/CFS in the mild to moderate category? If a hospital-based assessment and course of CBT and/or GET costs around £1,000, the total cost to the NHS would be around £180 million.
Since NICE have not produced a cost-benefit analysis to support the CBT and GET recommendations, it must be assumed that no costing evaluation has taken place. Without this vital information the draft lacks an economic strategy. The Department of Health will surely want to know why.
And where are all the cognitive behaviour therapists going to come from? CBT services are already in a position where they cannot cope with a rapidly increasing referral rate for common psychiatric conditions such as anxiety and depression – a steadily worsening situation that NICE has been well aware of for some time.
2 A FAILURE TO PROVIDE INFORMATION ON THE VERY EARLY STAGES OF THE ILLNESS
Our second major disagreement concerns the way in which the guideline has almost completely ignored (apart from section 126.96.36.199) what happens in the first four months before a diagnosis of ME/CFS is confirmed. Whilst we agree that a period of time needs to elapse before the diagnostic label of ME/CFS is used, there are a number of crucial points that need to be discussed in relation to how these patients should be managed during the very early stages (ie the first few weeks and months).
On the question of labelling, the 2005 ME Alliance report into early diagnosis suggested that there are appropriate names that could be used while the diagnosis of ME/CFS is being considered – one example being a post-viral fatigue syndrome.
But what is far more important is the fact that advice on aspects such as sleep disturbance and energy management is likely to differ quite significantly from that offered once the illness enters a more chronic stage. In regard to sleep, excessive sleep (hypersomnia) is very common at this stage and may well form a crucial part of a natural recovery process. We know of no evidence to suggest that people who are needing to sleep for a long period of time at night following an acute infection should be coerced into adopting a more normal pattern of sleeping (as appears to be recommended in 188.8.131.52).
Anecdotal evidence is overwhelmingly in favour of a period of carefully monitored rest during the very early stages, something that may include a period of bed rest, followed by convalescence. Exercise in the normal sense of the word usually has little or no role to play during this very early stage. In fact, an inappropriate exercise programme is very likely to make the illness worse if introduced too early on.
3 A FAILURE TO PROVIDE AN ADEQUATE DESCRIPTION OF MANY IMPORTANT ASPECTS OF MANAGEMENT (mainly section 1.3.4)
Our third major disagreement is that, having spent most of the guideline recommending CBT and GET, the remainder contains a totally inadequate review of all the other aspects of management – many of which are extremely important to patients, and are likely to be dealt with in primary care rather than hospital-based services.
In particular, the almost non-existent coverage of pain, which for some people is the most disabling aspect of their illness, is extremely poor – especially when this is compared to the vast amount of space given to sleep disturbance.
In other words, there is very little of practical value in this guideline for general practitioners and members of the primary healthcare team – who are likely to remain the main source of information, advice and support for people with ME/CFS.
4 ISSUES AFFECTING THE SEVERELY AFFECTED (mainly section 1.4)
Although the guideline acknowledges that its recommendations regarding CBT and GET do not apply to the severely affected, we feel that the information that has been supplied does not take account of the enormous difficulties currently being experienced by many people in this group when it comes to accessing either hospital-based or domiciliary-delivered medical care, obtaining practical support, and being refused one or more component of the disability living allowance because both lay and medically qualified assessors have received misinformation about the cause and potential severity of this illness.
The description of severe ME/CFS (pp 4 – 5 of the short version) needs to include the type of more severe neurological symptoms – ie blackouts, atypical convulsions, loss of speech and swallowing necessitating tube feeding – that are prominently referred to in section 184.108.40.206 of the CMO report.
Of particular concern is the fact that during the preparation of our own response we have been told that PCTs are already using quotations from the draft guideline to prevent hospitalisation of severely affected patients. We assume that this probably refers to the following statement in 220.127.116.11: "The majority of adults and children with (severe) ME/CFS will not need hospital admission."
5 DIAGNOSTIC CRITERIA FOR ME/CFS (section 1.2)
We are very concerned at the way in which the guideline has modified the current Fukuda research criteria for CFS (section 18.104.22.168) to produce a new clinical criteria that extends the boundaries of what currently constitutes ME/CFS (ie chronic unexplained fatigue + one other symptom). Many clinicians and researchers believe that the existing research criteria are already far too wide and as a result CFS has become a dustbin diagnosis for anyone with unexplained chronic fatigue. The diagnostic criteria proposed by NICE means that almost anyone with unexplained chronic fatigue, or feeling ‘tired all the time' will now be diagnosed as having ME/CFS.
The practical result is that hospital-based services – which are still virtually non-existent in some parts of the UK, or are struggling to cope with their existing workload in others – will be flooded with referrals for people with unexplained chronic fatigue.
It makes no sense whatsoever to advocate what is basically a ‘one treatment fits all' approach to the extremely heterogeneous range of illness presentations that comes under the existing ME/CFS umbrella. To try and do this to everyone with unexplained chronic fatigue indicates a very serious lack of judgement.
And while we appreciate that the aetiology and pathogenesis of ME/CFS falls outside the NICE guideline remit, the situation regarding ME/CFS is unique in that a significant proportion of doctors still do not even accept that this illness exists as a distinct clinical entity (reference: Primary healthcare provision and Chronic Fatigue Syndrome: a survey of patients' and General Practitioner's beliefs. BMC Family Practice 2005; 6: 49; epublication: http://www.biomedcentral.com/content/6/1/49). So there must be reference to some of the important neuroradiological, neuroendocrine and neuro-immunological research findings that support the World Health Organisation classification of ME/CFS as a neurological disorder.
There should also be some reference to the important new research into gene expression that is being carried out in both the UK and the USA. Preliminary results have already identified abnormalities in gene expression that may be characteristic of ME/CFS – a finding that could, of course, lead to a diagnostic test and specific forms of treatment.
We are also very disappointed to find that the Guideline Development Group (GDG) appear to have totally rejected the way in which the Canadian Guidelines have, quite sensibly, moved towards a much tighter clinical definition that clearly recognises the importance of sub-grouping under the ME/CFS umbrella, and recommends that individual differences in symptoms and signs should play an important role in how an individual patient should be managed.
If NICE fails to take note of these crucial points relating to causation and subgrouping in formulating a new clinical criteria, ME/CFS will continue to be trivialised as a dustbin diagnosis with patients being incorrectly labelled as having some sort of psychosomatic or somatiform disorder.
As a result, people with ME/CFS will not receive the individual approach to management that they deserve and this will add to, rather than alleviate, the cost of health and social service provision.
We now move on to comment on some of the other conclusions and recommendations:
GENERAL PRINCIPLES OF CARE (section 1.1)
This is the one and only area where we find the content to be generally balanced, helpful and sensible – as it sets out the common sense protocols that should govern the management of any chronic disabling illness. We are particularly pleased to see that information regarding the issue of informed consent has been included here.
However, the value of the advice in this section is obviously going to be dependent on the quality of the advice that is contained elsewhere in the guideline.
CLINICAL ASSESSMENT (section 1.2)
The failure to include a comprehensive list of illnesses that ought to be considered before the diagnosis is confirmed is a serious omission – as is the failure to point out that there are important clinical and research findings that differentiate ME/CFS from depression.
Where symptoms are being discussed in relation to disease severity (eg on page 5 of the shortened version) it should be pointed out, as was done in section 22.214.171.124 of the CMO Report, that some people with more severe ME/CFS may have neurological symptoms and signs such as those already referred to.
With regard to the investigation of people with a possible diagnosis of ME/CFS:
Some of the recommendations regarding the investigation of people with a possible diagnosis of ME/CFS in section 1.2.2 suggest that the authors are not in touch with the sort of information and queries that patients are taking to their doctors regarding more speculative diagnostic tests. For example, having funded research into the value of investigations involving RNaseL (for antiviral activity) and chronic fatigue syndrome urinary markers (CSFUMs), The ME Association is surprised to find no mention of these tests.
We are also concerned at the lack of emphasis regarding the need to further investigate people who, while they fit the diagnosis of ME/CFS, still have a symptom or symptoms, which is/are more prominent than is normally found in this illness. For example, the need to exclude sarcoidosis or tuberculosis in someone who also has respiratory symptoms. Or systemic lupus and parvovirus infection in someone with joint pains. Or multiple sclerosis where neurological symptoms and signs are difficult to differentiate between the two – as does sometimes happen. Or an assessment for possible sleep apnoea, with an Epworth sleepiness score, where daytime sleepiness is excessive or comes on suddenly.
There also needs to be far more information on where extended investigation is required from points that are gathered during the routine history taking. For example, a positive response to a past history of blood transfusion prior to 1991 indicates the need to check hepatitis C status. Or a history with symptoms suggestive of more significant or widespread autonomic dysfunction would need to be assessed in hospital.
And why is the estimation of creatine kinase (section 126.96.36.199) only recommended in children when it may be a marker of a muscle disease in adults?
With regard to the physical examination of patients:
We are perplexed as to why there is no mention of clinical examination in the diagnostic assessment – in particular the assessment of problems such as dysequilibrium where a Romberg test or Fukuda test (for vestibular function) may demonstrate abnormal findings. Equally, people with symptoms suggesting postural hypotension should have their blood pressure checked lying and standing, and may in some circumstances require hospital based investigations. The various fibromyalgia trigger points need to be checked in those patients who have a fibromyalgic component.
The very short sections on prognosis (188.8.131.52 and 184.108.40.206) are inadequate and fail to provide an accurate overall picture of current research evidence on prognosis. While we accept that an approach of cautious optimism, especially early on, should be adopted, the overall impression being given of a generally good prognosis is not consistent with published evidence. We suggest that the Guideline Development Group refer to the information on prognosis that is provided in section 1.4.3 of the CMO report.
SETBACKS (section 220.127.116.11)
The term setback is a completely inappropriate way of describing the sort of relapses that quite frequently occur in ME/CFS. Although some relapses are relatively minor and short-lived, other people experience far more significant and long lasting relapses as a result of the sort of events that often trigger the illness to start with. We therefore believe that a red line should be placed through setback and the term relapse used instead.
The section covering relapse is curious in that, while it provides advice on how to cope with a relapse/setback, it fails to include a list of very common causes of a relapse (eg infections; over-exertion; temperature extremes; trauma; surgery and general anaesthetics; some types of vaccination – especially for hepatitis B). This is important information that doctors need to be aware of and informing their patients accordingly.
In particular, we are concerned about the lack of appreciation amongst many dentists and anaesthetists regarding the way in which both local anaesthetics and general anaesthetics can cause a relapse in symptoms. Advice such as using an adrenaline-free dental anaesthetic where appropriate, and the possible use of a shorter-acting general anaesthetic, ought to be included.
SYMPTOMATIC RELIEF AND PHARMACOLOGICAL TREATMENT (section 1.3.4)
This section is hopelessly inadequate because, for many people with ME/CFS, providing effective management for one or more of their symptoms can be far more important than the contribution of lifestyle management.
People with ME/CFS have a number of symptoms – pain, sleep disturbance, gastric symptoms – where a combination of self-help strategies and medication can often be very helpful. We do not understand why the guideline cannot provide more detailed information on the sort of approaches that can and should be given to patients. We have already referred to pain control, which for some is the most disabling aspect of having ME/CFS, but there are numerous other symptoms where symptomatic relief plays an important role in any management programme.
We enclose some examples of MEA self-help literature on pain relief and our ABC of symptomatic management to illustrate what could actually be done here.
DIET AND NUTRITION (section 1.3.5)
Again, this is hopelessly inadequate – especially in view of the fact that people with ME/CFS are very interested in dietary approaches and are going to ask questions about what may or may not be helpful. They clearly need straightforward and sensible advice that covers a wide area of dietary management, along with advice on the vitamins, minerals and supplements that are extensively used and recommended to people with ME/CFS.
Why, for example, is there no information about the reasons why some people (especially those with self-imposed dietary restrictions) with ME/CFS could be at increased risk of developing osteoporosis and how diet may be relevant here. Why is there no mention about the value of complex carbohydrates in helping to stabilise blood sugar levels? Why is there no mention of the importance of a good fluid intake? This is especially important in relation to those who have postural hypotension or orthostatic intolerance. Why is there no mention of simple self-help approaches that can help in the management of nausea (eg use of ginger) or the use of drugs such as ondansetron if this is more severe?
Why is there no discussion on the use of EPA supplements? These are probably the most popular supplement currently being used by people with ME/CFS, and while we accept that there have been no randomised controlled trials to support the use of EPA, it is untrue to say that there is ‘no evidence' in relation to this supplement (reference: The use of eicosapent-aenoic acid in the treatment of chronic fatigue syndrome. Prostaglandins, Leukotrines and Essential Fatty Acids 2004; 70: 399 – 401).
It is also 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 – where these occur in IBS. This section should also include advice about not going on a gluten-free diet before a screening test for coeliac disease has been carried out. We could go on.
ALTERNATIVE AND COMPLEMENTARY APPROACHES (section 1.3.6)
Again, this section is hopelessly inadequate. It also appears from the first sentence – ie ‘There are no complementary therapies that treat CFS/ME for adults and children and their use is not recommended' – to be very dismissive about any aspect of alternative medicine.
With the lack of recognition, or limited management input from many NHS practitioners, people with ME/CFS have been spending large amounts of time and money in the alternative health sector. So the pros and cons of the popular alternative treatments – eg anticandida regimes; dubious allergy tests and treatments, magnetic therapy, Reverse therapy – commonly aimed at people with ME/CFS must be properly reviewed, and where necessary criticised or discredited.
Approaches such as acupuncture for pain relief, which can be supported by some degree of clinical evidence, need to be included in a fair and balanced discussion.
As the CMO report acknowledged, the management of ME/CFS crosses many boundaries. It is not just dealing with a wide range of symptoms. The NICE guideline, while acknowledging that other management issues exist, almost completely ignores what could and should be done in these areas.
State sickness and disability benefits, for example, are a major source of anxiety for people with ME/CFS with many currently having to go to appeal in order to obtain benefits to which they should be entitled. (NB: In a House of Commons written answer dated 9 October 2006, the Minister of State at the Department of Constitutional Affairs, confirmed that 800 people with CFS successfully appealed against disqualification of their disability living allowance award in 2005) Any guideline on management must, therefore, contain a section on state benefits, and make it clear that where ME/CFS is concerned people should be entitled to Incapacity Benefit and Disability Living Allowance where there is a genuine need.
The guideline also needs to be point out that ME/CFS has been recognised as a disease that can be covered by the Disability Discrimination Act, and that this can be very useful in relation to employment and education. A useful reference here is the case of O'Neill v Symm and Company, details of which can be found at: www.outertemple.co.uk/cms/uploads/Disability%20Discrimination.pdf.
The medical defence organisations have repeatedly warned doctors that prescriptions for exercise must be given with exactly the same care as with a prescription drug. Failure to do so is likely to result in litigation if harm occurs as a result of inappropriate advice. The MEA continues to receive reports from people with ME/CFS whose condition has relapsed following inappropriate advice about exercise and we quote from one such response that was received during this consultation process:
‘I have been told by several doctors who don't have a clue about exercise. I went to see one while in a relapse, and hence was struggling to do even normal daily living stuff, without trying to add any more into my day. When I replied back to the doctor that I was working part time, doing gardening, doing too much and this exercise was making me worse, he told me this wasn't counted as exercise and that I need to do something like aerobics….'
As a result of the very disturbing accounts we continue to receive about completely inappropriate advice on exercise and activity management, we believe that the guideline must include a proper warning if it continues to use the term exercise – even when what is being referred to is activity or energy management. Otherwise, we have no doubt that someone will take a claim for negligent advice about exercise management to the courts.
UNHELPFUL OR INAPPROPRIATE LANGUAGE
Section 18.104.22.168 ‘Where the adult or child's main goal is to return to normal activities….' Many people will find this offensive as it implies that there is a substantial proportion of people who do not want to return to normal activities. This statement reinforces prejudices about sick role behaviour held by some health professionals.
Section 4.4 ‘It is not known how much improvement is important for patients with CFS/ME' Again, many people will find this offensive as it implies that some may not want to get better.
TWO FINAL POINTS
1 We welcome the inclusion of information about informed consent but feel that the guidance needs to make it clear, as did the CMO report in section 4.4.2, that benefit provision must not be made conditional on agreeing to participate in a particular form of treatment.
2 The guidance, certainly in the shortened version, repeats itself at times to no added effect. We feel that this will cause frustration to health professionals who are hard pressed for time and will consequently tend to skip read through this type of information.
In sending in this response as a stakeholder in the guideline development process, the MEA has consulted widely with its members and reflected their very strong views on the composition of the current draft.
We find it hard to imagine another situation where a group of people, many of whom have little or no direct experience in the clinical care of an illness they are advising on, have produced such a poor quality guideline.
We cannot understand why the views of people with ME/CFS and their charity representatives are not being listened to by NICE.
Unless NICE takes on board what the stakeholders representing patient opinion have to say, they will have failed the stakeholder principle – something that government continually tells us is at the heart of the consulting and listening process.
If this draft guidance becomes definitive guidance for health professionals in April 2007, it will be a very sad day for people with ME/CFS.
If you wish to send in your views on the current NICE draft, or this final draft draft of the MEA response, this can be done by emailing firstname.lastname@example.org