Smoke and Mirrors — ME/CFS NICE Guideline
King Lear
Poor naked wretches, whereso’er you are,
That bide the pelting of this pitiless storm,
How shall your houseless heads and unfed sides,
Your loop’d and window’d raggedness, defend you
From seasons such as these?…
(King Lear, Act 3, Scene 4)
The publication of the ME/CFS Guideline Draft For Consultation by the National Institute for Clinical Excellence (NICE) has energised patient support groups and ME/CFS charities like nothing in recent memory. Their response has been overwhelmingly hostile, and those which are Registered Stakeholders have registered their protest by supplying detailed critiques of the document (we have added our own voice to the clamour). Nothing new in that, you might say: as Polly Toynbee’s defence of NICE over its refusal to approve the cancer drug Velcade pointed out, “Patient groups understandably want everything for their sufferers.
”
The role of NICE and the controversies surrounding its decisions are well known (see the article, ‘Debate — National Institute for Clinical Excellence’); the Institute expects to come under fire, and probably treats its wounds as badges of honour. Yet, there is something unusual — unique, in fact — about the current uproar. Today, almost certainly for the first time since it started work in April 1999, the Institute is faced with a united body of patient-based opinion which does NOT want the guideline it has produced, certainly not in its current form, and if push comes to shove would rather have a non-guideline on ME/CFS (the first Clinical Guidance with a minus number) than the one on offer. Restlessness in the natives is one thing, but a full-scale rebellion by deeply ungrateful wretches — poor mostly, and certainly naked of the kind of randomised clinical trial evidence recognised by the Institute — is quite another. What’s it all about?
Well, it’s simple really. The draft produced by the Guideline Development Group (GDG) is unfit for purpose — i.e., for informing the diagnosis and management of ME/CFS patients, primarily because it flags up as treatments for the illness psychosocial management and coping strategies that at best have an adjunctive role to play. Patient-based charities and self-help groups (and there are around 20,000 members of these in the UK alone) recognise this, and can foresee that the major recommendations of the guideline will not, unfortunately, solve the problem on the ground.
Essentially, the Institute has not got to grips with core issues surrounding ME/CFS. These are explored in depth in our submission, but can be briefly stated. The first, and most central, is the problem of diagnosis: whichever definition is used, ME/CFS is widely recognised to be an impossibly wide diagnostic marquis and to contain different patient groups; the formation of clinical guidance inevitable raises the question of guidance for what and for whom. The second problem concerns the randomised controlled trial (RCT) evidence upon which NICE puts a premium, and the devaluation of evidence from scientific studies and surveys. This is a continuing area of controversy for the Institute, but it has a particular poignancy in the case of ME/CFS since the evidence-base is skewed towards a small group of mildly positive RCTs on psychosocial strategies; thus, instead of finding the ‘best’ evidence garnered from the work of a range of biomedical and biopsychosocial scientists working on a level playing field, what is found is quite modest evidence in a forgotten field put there by proponents of psychosocial strategies. Multiple sclerosis with the formal evidence-base that currently exists for ME/CFS would be no less a physical illness, and the non-specific management and coping strategies would be no more specifically effective for the underlying disease, yet these adjunctive strategies have an unduly prominent role in the Institute’s draft guideline… This can be nicely illustrated by the Table below in which the ME/CFS NICE Guideline Draft is placed side by side with other Clinical Guidelines in the NICE pantheon, representing 19 different clinical conditions.
| Clinical Guideline (number) | A | B | C | D |
|---|---|---|---|---|
| Anxiety (22) | Yes | …Any of the following types of intervention should be offered and the preference of the person should be taken into account. psychological therapy (cognitive behavioural therapy [CBT])… The choice of treatment will be a consequence of the assessment process and shared decision-making. | — | No |
| Bipolar disorder (38) | Yes | …The following treatments should be considered, in discussion with the patient, for people who have an established diagnosis of bipolar disorder and chronic or recurrent depressive symptoms, but who are not taking prophylactic medication and have not had a recent manic or hypomanic episode… cognitive behavioural therapy (16–20 sessions) in combination with prophylactic medication. | — | No |
| Depression (23) | Yes | …When considering individual psychological treatments for moderate, severe and treatment-resistant depression, the treatment of choice is CBT. | — | No |
| Eating disorders (9) | Yes | …Specifically adapted forms of CBT are offered to adults with bulimia nervosa, binge eating disorder… | — | No |
| Obsessive-compulsive disorder (31) | Yes | In the initial treatment of adults with OCD, low intensity psychological treatments… should be offered… cognitive behavioural therapy (CBT)… | — | No |
| Schizophrenia (1) | Yes | CBT is offered to any individual with schizophrenia, and especially to the individual who is experiencing persistent psychotic symptoms. The notes should indicate that the clinician responsible for treatment has discussed the process and benefits of CBT… | — | No |
| Chronic obstructive pulmonary disease (12) | No | — | Pulmonary rehabilitation programmes should include multicomponent, multidisciplinary interventions, which are tailored to the individual patient’s needs. The rehabilitation process should incorporate… psychological and behavioural intervention. | No |
| Dementia (42) | No | — | …Comorbid emotional disorders — For people with dementia who have depression and/or anxiety, cognitive behavioural therapy, which may involve the active participation of their carers, may be considered as part of treatment. | No |
| Dyspepsia (17) | No | — | …Psychological therapies, such as cognitive behavioural therapy and psychotherapy, may reduce dyspeptic symptoms in the short term in individual patients. Given the intensive and relatively costly nature of such interventions, routine provision by primary care teams is not currently recommended. | No |
| Type 1 diabetes (15) | No | — | …psychosocial support for psychological and psychosocial difficulties. | No |
| Hypertension (34) | No | — | Relaxation therapies […cognitive therapies, muscle relaxation and biofeedback…] can reduce blood pressure and individual patients may wish to pursue these as part of their treatment. However, routine provision by primary care teams is not currently recommended. | No |
| Lung cancer (24) | No | — | Non-drug interventions based on psychosocial support, breathing control and coping strategies should be considered for patients with breathlessness… | No |
| Multiple sclerosis (8) | No | — | a) …Cognitive behavioural and imagery treatment methods should be considered in a person with MS who has musculoskeletal pain only if the person has sufficiently well-preserved cognition to participate actively. b) …Specific antidepressant medication, or psychological treatments such as cognitive behavioural therapy, should be considered, but only as part of an overall programme of depression management… |
No |
| The epilepsies (20) | No | — | Psychological interventions (relaxation, cognitive behaviour therapy, biofeedback) may be used in conjunction with AED therapy in adults where either the individual or the specialist considers seizure control to be inadequate with optimal AED therapy. This approach may be associated with an improved quality of life in some individuals. | No |
| Parkinson’s disease (35) | No | — | No | No |
| Familial breast cancer (41) | No | — | No | No |
| Tuberculosis (33) | No | — | No | No |
| Chronic heart failure (5) | No | — | No | No |
| Chronic fatigue syndrome/ myalgic encephalo-myelitis (or encephal-opathy): NICE guideline Draft for consultation, Sept 2006 | Yes | …CBT is an evidence based treatment for CFS/ME… When the adult or child’s main goal is to return to normal activities then the therapies of first choice should be CBT… programme of CBT should include… explanation of the CBT model for CFS/ME and therapy rationale, for example, the relationship between thoughts, feelings, behaviours and symptoms, and the distinction between causal and perpetuating factors… discussion of the patient’s attitudes and expectations. | — | Yes |
The Table above shows that cognitive behavioural therapy (CBT) is postulated to be a specific treatment for Anxiety, Bipolar disorder, Depression, Eating disorders, Obsessive-compulsive disorder, and Schizophrenia; this is an unsurprising finding since a psychological therapy surely has some utility for some psychological disorders. It also shows that in none of the remaining 12 conditions, all primarily physical in origin, is CBT proposed as a treatment for the illness or disease; where CBT is mentioned, its role is clearly constrained, for example to co-morbid emotional disorders, for rehabilitation programmes or psychosocial support. Only in the case of the physical illness ME/CFS is CBT proposed as a specific treatment; moreover, only in the case of ME/CFS is the basis of CBT — “relationship between thoughts, feelings, behaviours”, “discussion of the patient’s attitudes and expectations”, etc. — described in the NICE guideline outside of the standard glossary. This is a strange development, even stranger given that the Institute’s Full Draft Guideline on ME/CFS, page 203, says: “…The GDG did not regard CBT or other behavioural treatments as curative or directed at the underlying disease process, which remains unknown. Rather, such treatments can help some patients cope with the condition and consequently experience a improved quality of life.”
Indeed, organisations representing people with the physical illness ME/CFS are marvelling why the Institute has delivered a draft guideline that is unique even in its own pantheon, as well as being inappropriate for their needs. While everyone recognises that psychiatry has been desirous of a greater role in physical illness for over a decade — a thrust nicely expressed by Jeremy Couper (Australian and New Zealand Journal of Psychiatry 2000; 34: 762–9), “…chronic fatigue syndrome can be seen as a potential Trojan horse for psychiatry, enabling psychiatry to perform a broader role in medical research and a more truly integrated role in the health system
” — it had been assumed that the Institute valued its independence too much to be fooled by smoke and mirrors.
The unfitness of this guideline draft is a terrible blow to people with ME/CFS who already exist in a pelting storm of disbelief and sometimes professional distain. Clinical guidelines are routinely circulated to all NHS primary care trusts, strategic health authorities, GPs and practice nurses in England and Wales, and representative bodies for health services, professional organisations and statutory bodies, so there could be severe consequences for patients — particularly negative effects in the form of the denial of other treatment options — if the draft guideline was published in its present form. Rather than incorporate an inadequate and skewed evidence-base into established guidelines which feed into clinical care and government policy, the Institute should withdraw the draft pending a complete overhaul to reflect the simple truth: that specific, rigorous, evidence-based recommendations for treatment of people falling under the diagnostic marquis ME/CFS probably cannot be made at present, but that (as in other physical illnesses) psychosocial coping and management strategies, such as CBT, may be an option for symptom management or comorbid anxiety or depression.
Cartoon by Trish Campbell of the Warwickshire Network for ME
