Comment on the NICE draft guidelines (Nov. 2006)

We think the comments made by Dr Charles Shepherd are very good and we are happy to endorse them. We will try to avoid too much repetition and concentrate on the points we would like to add.

Good Points

• p2 that care should be tailored to the individual and take into account individual preferences. p12 also refers to an individual management plan.
• p2 that support and information should also be provided to carers and relatives
• p6 (and p17-18) that a patient has the right to refuse any component of a care plan without detriment to other aspects of care. However we are deeply concerned that this may not be interpreted as without detriment at all; to benefit entitlement or social care for example. If people refuse part of a care plan will this be deemed refusal to co-operate with planning for a return to work under the coming Welfare Reform bill?
• p6 (and elsewhere) that GPs should give the patient information on support groups. This is very good, as some official guidance lately (Department of Health “Occupational Aspects of the Management of CFS”) has contained unsubstantiated claims that membership of support groups is a “predictor of poor outcome” in relation to a GET programme.
• p7 that a firm diagnosis may be made after 4 months in adults (previously 6 months?) and that management advice should not be delayed while waiting for a firm diagnosis or for referral. It should be made clear, however, that management advice should be given immediately the patient presents with suspected ME symptoms in an attempt to prevent the illness developing further.
• p7 the principal that the severely affected should have the same access to care as anyone else is a good one (this is not the current situation) so long as it is recognised that the details of that care may be different. p12 that care should be provided regardless of ability to travel. The severely affected may find hospital or clinic based care impossible to access and need care to be provided at home. Here is one member’s experience:

I had great help from my local Primary Care Trust who provided me with occupational therapy, physiotherapy and disability counselling at home. I am much improved from these interventions. For severely ill people I feel it is a mistake to provide concentrated “packs” of care and much more helpful to provide one service at a time, introduced slowly and over a long period of time (3-4 years in my case.)

• p12 helping people negotiate the healthcare, benefits and social services systems – this is excellent and, should it actually be carried out, would be a huge improvement on the current situation.
• P33 that there should be regular review of the management plan. Feedback from our members suggests that at present patients often feel abandoned after initial GP contact.
• p35 that a summary of each consultation should be provided for the severely affected. Considering how common cognitive problems are this is an idea we would like to see extended beyond the severely affected.

Bad Points

• p6 (and elsewhere) we strongly agree with others that to use the phrase “where the [patient’s] main goal is to return to normal activities….” is grossly insulting in its implication that some people desire otherwise. Equally the statement (p38) “it is not known how much improvement is important for people with ME/CFS”
• p7 (and elsewhere) we also agree with others who have suggested that the emphasis in the early stages should strongly be on rest (and explaining just what this means in practise.) The experience of our members shows that there are greater dangers from over- than under-activity at this stage (as well as throughout the illness).
• The tone taken by much of this document is that people with ME do not want to undertake activity and have to be coerced into it. This is insulting and inaccurate. We think it far more common that the reverse is true i.e. that patients push themselves beyond their capabilities and become more ill as a result. We think that practitioners should be warned, especially in relation to GET, about the risk of relapse caused by encouraging the patient to undertake too much too quickly.
• Overall the document seems to have completely disregarded the more balanced position to be found in the Chief Medical Officer working group report of 2002 which presented the biopsychosocial model of the illness as only one of several as yet unproven theories. This document arose from wide consultation and contained information from the patient and carer perspective (as well as diverse specialist medical opinion) which seems entirely absent in the NICE draft guidelines; the second chapter opens “During the Working Group process, the strongest message received was that patients’ voices are not being listened to and understood.” It is depressing that, instead of building on this work as we hoped and expected, this continues to be the case.

Omissions

• p7 the implication here is that ME only follows an acute infection. There is no mention of slow onset with no definable cause or of other possible triggers such as immunisations or chemical exposure.
• p38 the first item on any list of research priorities should be what actually causes the illness and what is going wrong. Does this omission mean that NICE takes the “biopsychosocial” view of this condition? We also think a priority for research should be identifying sub-groups.
• There is no mention of light or noise sensitivity as symptoms
• There is hardly any mention of pain control
• There is no mention of commonly associated conditions such as fibromyalgia, irritable bowel syndrome/gut disbiosis, multiple chemical sensitivities, food allergies and intolerances. Many of our members suffer from one or several of these.
• We are very concerned that many ME/CFS patients are having difficulty in accessing the services currently on offer. We feel that some kind of outreach work to contact hard-to-reach patients is urgently needed.
• Pacing (is this the same as “activity management”?) is the intervention most commonly reported to be helpful by patients.
• p31 There is some mention of potentially increased sensitivity to drugs, but we believe this should be worded much more strongly, including a warning about the danger of relapse, and examples given of the sort of fraction of a normal dose that should be used. One member’s experience was so extreme as to be life-threatening:

The first time I was prescribed an anti-depressant (Prozac) was when I was first ill by a doctor who did not believe in ME. On this occasion, fortunately, it did me no harm although it certainly made no difference to my ME. Some years later, when prescribed a course of CBT, I was told that the therapy demanded I take a course of anti-depressants (Sertraline) for a year before commencing treatment although I was not depressed. On this occasion I rapidly developed a strongly adverse reaction, relapsing badly. I only suspected the drug (having no warning this reaction was possible) after two weeks and recovered fairly quickly when I decided to stop taking it. On the third occasion I was depressed. I explained my previous drug reaction to my GP who prescribed the “lowest” dose of Prozac. On this occasion I had a major ME relapse, developed a rash and my depression worsened dramatically to the point I became suicidal in just a few days. On this occasion it took longer for symptoms to subside after discontinuing the drug.

General comments about CBT and GET
We have no difficulty with the appropriate use of CBT and GET as these therapies clearly do help some people. However we would like to make the following points:

• Our evidence suggests that they definitely do not help everyone and indeed make some people worse. We strongly object to their use across the board. The emphasis given to these therapies in the document gives a skewed impression of their potential use.
• One of our members has just finished a successful course of CBT but had to wait 3 yrs to commence treatment
• We see no need for CBT and GET to be used together, at the same time.
• We strongly object to the underlying assumption with these therapies that the illness is perpetuated by deconditioning and abnormal illness beliefs. Although (p3) there is an initial explanation that the use of CBT does not mean that the patients symptoms are psychological, this appears to be contradicted by implication on p20 and 21.
• We believe it should be made plain that these therapies (along with activity management) are management strategies, and not treatment which will cure the patient.
• Consultation with our members shows that patients want better choice and a range of options open to them (see below)

We cannot comment on the quick reference guide (p38) as there appears to be no web access to it.

Previous consultation with our members
We previously conducted a survey amongst our membership (autumn '03) which included questions about people's experiences of treatment for ME on the NHS and another (Apr.'04) asking specifically for members' views of the therapies GET, CBT and Graded Activity Management.

Our most striking finding was that patients frequently feel they have been badly treated, let down or abandoned by the NHS and are suspicious of many of the treatments currently on offer, particularly those seen to be 'imposed' without respect for the patient's individual experience (GET comes in for the greatest criticism in this respect.) It is very apparent that a great deal of trust needs to be rebuilt between patients and practitioners and that little progress will be made in the treatment of this illness without it. We cannot stress too strongly that, for many patients, the knowledge that they are believed, listened to, respected and supported can be as important as the treatment on offer. Until this issue is adequately addressed many patients will continue to by-pass NHS services altogether, instead turning to private practitioners who may charge large fees for unregulated therapies of dubious benefit. Unfortunately the draft NICE guidelines as they stand only serve to exacerbate this very poor situation. Here is a summary of our findings:

- The attitude of NHS staff has a profound effect on patients. Patients expect practitioners to be open-minded, respectful and flexible; to listen to them and treat them as an equal partner in the management of their illness.

- People want to know that their condition is being monitored regularly.

- Access to services is a great problem for many, if not most, of the members surveyed and the NHS needs to be more flexible in this regard e.g. by providing:
- a range of domiciliary care
- services within the community, not just in hospitals
- care and advice via the telephone

- Patients do not want to be forced into accepting CBT, GET or GAT as the only therapies on offer; they want a range of treatment options as provided, for example, by The Royal Homeopathic Hospital, London. This service combines specialist care with pacing and activity management, pain management, stress management, advice from a dietician and a range of complimentary medicine. We are concerned that these guidelines will threaten such programmes.

The answers which come up most often in our membership surveys in response to our question "what medical treatments and services would you ideally like to see provided for people with ME on the NHS?" are:

• specialist consultant/support centres, knowledgeable about ME, able to keep them informed of the latest research and pioneering treatments. These centres were (and are) in existence; this answer seems to reflect the fact that few people had received referral to them. This strengthens our belief that outreach and advocacy work is necessary.
• more tests to rule out other conditions and/or to treat co-existing problems
• psychological support/counselling: many of our members recognise that this could be helpful to them and would like to have a range of options e.g. counselling and psychotherapy as well as CBT.
• 'alternative' therapies (various people cited massage, homeopathy, acupuncture and other forms of therapy.)
• suitable recuperative residential care for the severely affected and for respite breaks.