The ME Association is very disappointed to learn that feedback from various sources to the guideline review process indicates that there is no need to carry out a three year review into a document that has been very heavily criticised by specialist organisations such as the British Psychological Society, neurologists, and most of the charities that represent patients with ME/CFS.
The MEA continues to believe that the current guideline on ME/CFS is skewed towards two largely psychiatric models of ME/CFS and three interventions based on these models. We also regard the recommendations regarding management as needlessly restrictive, and submit that the definition requires amendment. Our reasons have already been communicated to NICE in our previous submissions.
Focusing on both the need to provide practitioners with clear and evidence-based information, plus the obvious aim to improve patient care, it is of vital importance that the guideline recognises the heterogeneity of clinical presentations that make up ME/CFS and that the advice reflects this.
Previous submissions by ourselves and others, summarised in a report to you by Dr Ellen Goudsmit FBPsS, demonstrates quite clearly that there is now sufficient, good quality evidence for alternative approaches, and given that some of the relevant trials were published in journals cited by PubMed, we find it hard to understand why this information was not recognised by your experts.
The review should also take account of the growing evidence against the two protocols for cognitive behaviour therapy (CBT) and graded exercise therapy (GET) for everyone with mild to moderate ME/CFS. If the guideline is to be based on sound science, the existing recommendations must be amended. Moreover, the recommendations can no longer dismiss the consistent evidence from patients, obtained from surveys here in the UK (e.g The ME Association Management Report which contained feedback from over 4,000 respondents: www.meassociation.org.uk/?page_id=1345) and from the rest of the world, plus the independent audits, all of which indicate that these two forms of treatment are of limited efficacy or can even make the condition worse.
We are therefore calling for the guideline to be reviewed, and as set out in the points below we believe there is compelling new evidence which supports a more flexible approach involving other forms of management (i.e pacing) that are both effective and acceptable to people with this illness.
1 The information on pacing in the current guideline is inaccurate and vague (e.g what does balancing rest and activity entail?). It requires a science-based definition plus practical guidance based on evidence – so that pacing can be added as an additional option for therapists. Pacing is appropriate for the vast majority of patients, but may not be suitable for everyone who comes under the CFS umbrella. NICE needs an expert view of this to guide you through the literature.
2 There needs to be a review of the multidimensional programmes which have been assessed in controlled trials (e.g. Goudsmit et al, 2009), and two RCTs (e.g. Taylor et al, Jason et al, 2007), as these appear to be safe, acceptable and as ‘effective’ as the CBT programmes based on the Chalder and Vercoulen protocols. The NICE recommendations as they stand are unduly restrictive and do not take into account recent evidence on outcomes, e.g. Wiborg et al 2010 (CBT/GET does not increase activity levels).
3 The FINE trial has resulted in findings that are far from ‘inconclusive’ (as stated on p5 in the Centre for Clinical Practice review). This assessment is open to challenge. In fact 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 sheds considerable doubt on the effectiveness of managing ME/CFS in primary care, and must have implications for the future research agenda for ME/CFS. This is within the scope of the full NICE guideline.
We would also draw your attention to the literature on the CDC guidelines, which has attempted to address the flaws and which is therefore a significant improvement on earlier case definitions – as it reduces heterogeneity and therefore adds to diagnostic precision. We are sure that NICE is keen to promote the latter and thus increase the likelihood of better management and a reduction in the severity of ME/CFS. The latest paper on the revised Canadian criteria covers the inadequacies of earlier diagnostic criteria well and deserves serious consideration.
Finally, we note that NICE has not responded to new evidence of pathology related to post-exertional malaise, and we therefore feel that it would be hard to justify a blanket recommendation of the GET protocols that are currently described. GET may help some individuals, but equally, it makes others worse.
If the NICE guideline on ME/CFS is to be based on best evidence and rigour, then certain changes must be made.
The MEA is most disappointed with the document you sent us that was prepared by the Centre for Clinical Practice but we hope that we can engage in a constructive discussion to help not only those who manage patients with ME/CFS, but also the patients themselves.
We therefore urge you to reconsider the advice you are being given.
Background information can be found by entering ‘NICE’ into our SEARCH facility.
NB: This consultation process for NICE guideline stakeholders (eg other UK charities) closes on 14 November 2010.