15 November 2010
Action for M.E. stakeholder response on NICE review decision
A consultation by the National Institute for Health and Clinical Excellence (NICE), to consider whether Clinical Guideline 53 on CFS/M.E. should be updated, closed yesterday, 14 November.
Action for M.E. has submitted its response, based on our own consultation.
NICE had proposed that the guideline should not be reviewed, saying no conclusive evidence had yet been identified that would make it invalid.
The charity disagreed.
Our response said:
Action for M.E. is greatly concerned that there has long existed a discrepancy between evidence from comparative trials of the efficacy of physical rehabilitation therapies and accounts from patient groups and organisations. This is true above all in relation to the two treatments recommended by NICE for M.E.: Graded exercise therapy (GET) and Cognitive behavioural therapy (CBT). The treatments currently recommended are at best coping strategies, at worst make symptoms worse, and for many have no lasting benefits at all. A 2008 patient survey by Action for M.E. indicated that 34% of respondents reported having been made worse by GET, 21% reported no change, and only 45% found it helpful. The same survey indicated that CBT had been helpful to only 50% respondents, with 38% reporting no change and 12% made worse.
This highlights the case to incorporate a broader cross section of approaches until it has been determined why some treatments work for one patient, and not for another. We would also recommend that the revised guideline includes a statement that many patients have reported that graded exercise has made their symptoms worse. This advice has been incorporated into NHS Scotland’s Good Practice Statement for M.E./CFS which emphasises a patient centred approach.
Pacing has long been reported as the most effective management strategy by M.E. patients. It is not therefore clear why the review decision is being taken before the imminent dissemination of the findings of the PACE Trial.
Action for M.E. supports the need to ensure that any treatment made available to patients is safe and efficacious. On these grounds and in these exceptional circumstances we would urge NICE to reconsider the emphasis placed on randomised control trials, to seek to extend its scope beyond the usual hierarchy of evidence which does not adequately represent the treatment landscape for this diverse group, and to take into account patient feedback and other research which has been published in peer review journals.
We would suggest that rather than consider only whether new data contradicts any existing recommendations, it is important to consider also whether any new material, might enable the guideline to be updated. This applies both to studies which would not usually be viewed to have a direct implication for management such as studies which suggest that MLV-related retroviruses are associated with CFS, and to data such as patient feedback which does not feature highly on NICE’s hierarchy of evidence. Patient feedback is particularly significant in the case of M.E. which is so poorly understood medically, and where there is great variance in both the combinations of symptoms which patients experience, and in the efficacy of the treatments currently recommended by NICE.
We quote the views of Sir Michael Rawlins: “Randomised controlled trials (RCTs), long regarded at the ‘gold standard’ of evidence, have been put on an undeserved pedestal. Their appearance at the top of “hierarchies” of evidence is inappropriate; and hierarchies, themselves, are illusory tools for assessing evidence. They should be replaced by a diversity of approaches that involve analysing the totality of the evidence-base.”
The following points have been submitted by people with M.E. and their supporters during our consultation with them:
• Two books have been published since guideline 53 was issued that might be worth considering to see if the guideline could be strengthened in the area of pragmatic management of symptoms in mild, moderate and severe cases: Fighting Fatigue by Pemberton and Berry, and Severe ME/CFS: A Guide to Living by Collingridge. These resources could be said to embody a clinical consensus on management techniques, in areas where robust scientific evidence may be lacking, and as such, it would be desirable for NICE to consider them.
• Although the findings of the FINE trial have been deemed ‘inconclusive’ (page 5), it is noted that the FINE trial seemingly found that all of the arms of the trial – pragmatic rehabilitation, supportive listening or GP care - resulted in limited or no statistically significant benefit for patients. This may shed doubt on the effectiveness of managing CFS/ME in primary care, and must have implications for the future research agenda for CFS/ME.
• Brain studies in CFS/ME subjects: see the Gudrun Lange review: Brain Pathology in CFS/ME for an overview of some of the research in this field.
• The existing assessment of evidence is open to criticism since it is based on the 2006 York Review. Flaws in this review have since been identified. eg. the Powell papers of 2001 and 2004 were given a rating of 17 out of 20, despite the fact that patients were selected using the Oxford Criteria (too broad to be applied to CFS patients as currently understood via the Canadian and CDC/Fukuda definitions), there was a high drop-out rate in the 2001 treatment group, lack of objective medical criteria to support statements, etc. The weaknesses of the 2001 paper have been well documented in the pages of the BMJ.