February 11th and 12th 2009 marked the failure of the legal challenge to the National Institute for Clinical Excellence (NICE) Guideline on CFS/ME (Clinical Guideline 53, pdf 847 KB) at the High Court in London, with Professor Littlejohns of NICE commenting, “We’re delighted that this issue is now closed” (read a report on the BBC News website).

The judgment marks the end of a long, intricate and (for the patient–claimants) exhausting process which began with the publication of the Guideline Draft in August 2007. This draft energised patient support groups and ME/CFS charities like nothing in recent memory; their responses were predominantly negative, and most Registered Stakeholders supplied their own detailed critiques of the document (read ME Research UK’s own critique here, pdf 205 KB). These critiques were considered by NICE which, to its credit, made some key alterations to the Guideline in response to them. Yet the final NICE Guideline failed to satisfy a large section of opinion — hence the High Court appeal — and concerns still remain about its real usefulness to patients, estimated by the guideline itself to average 193,000 in the UK.

These concerns can be simply put. First, there is the problem of diagnosis: whichever definition is used, “CFS/ME” is widely recognised to be a very wide diagnostic marquis and to contain different patient groups — and the formation of clinical guidance inevitably raises the question of guidance for what and for whom. Second, because the randomised controlled trial (RCT) evidence upon which NICE puts a premium consists of a small group of mildly positive RCTs on cognitive behavioural therapy (CBT) and graded exercise, the Guideline’s main treatment recommendations concern psychosocial management and coping strategies widely believed to have an adjunctive role to play at best. The view of ME Research UK is that conclusions about efficacy one could draw from this small group of trials are limited (see “The NICE Clinical Guideline: convincing evidence?” in the Spring 2009 issue of Breakthrough, pdf 48 KB).

For these reasons alone, it is entirely possible that the major recommendations of the guideline will not, unfortunately, solve the clinical problem on the ground. Indeed, when Clinical Guideline 53 is placed side by side with other Clinical Guidelines in the NICE pantheon, representing 19 different clinical conditions (see the table in “The NICE Guideline: what’s the problem?” in the Spring 2008 issue of Breakthrough, pdf 53 KB), it can be seen that while CBT is postulated to be a main intervention for a range of psychological conditions, ME/CFS is the only physical condition in this list for which the therapy is flagged up as a primary specialist management approach in a NICE guideline. This is a rum business, particularly since Clinical Guideline 53 (full version, page 252) is clear in stating: “The [Guideline Development Group] did not regard CBT or other behavioural therapies as curative or directed at the underlying disease process, which remains unknown. Rather, such interventions can help some patients cope with the condition and experience improved functioning, and consequently a improved quality of life.

For the moment at least, arguments over the content of Clinical Guideline 53 are stilled while attention moves to its operational use at the surgery and the clinic. 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 will be opportunities to examine (in the fullness of time, through audit and outcome studies) the true effectiveness of Clinical Guideline 53, and whether or not it is achieving its stated aims of helping people manage the condition and maintain and extend their capacities.

Cartoon by Trish Campbell of the Warwickshire Network for ME

Cartoon by Trish Campbell of the Warwickshire Network for ME