Wednesday, July 29, 2009

Rapid Response re NICE

Thanks to Ellen Goudsmit for this one!
Online today (29th July 2009).

Whilst I respect the views of Rawlins and Littlejohns (1), I am not
persuaded that all the NICE guidelines can fairly be described as "robust".
I've worked on about five drafts in the past few years and one of these
included a surprising number of factual errors and demonstrated a distinct
lack of rigour.

The guideline in question concerns the management of chronic fatigue
syndrome (CFS). During the consultation phase, there were at least two
controlled studies supporting multi-component programmes (MCPs), thus
meeting the criteria for recommendation as outlined in the Guidelines Manual
2007. However, one of the trials had been classified under 'behavioural'
interventions although it bore little resemblance to the other studies in
the category (2), the RCT on pacing had been classified under graded
exercise therapy (3) and another study had been downgraded from showing a
positive overall effect to having 'no overall effect', although it still met
the criteria for the former (4).

Since my colleagues and I first alerted NICE to these 'errors', further
studies supporting the efficacy of MCPs have been published (e.g. 5). They
provide therapists with an alternative to the NICE preferred
cognitive-behaviour therapy-based programmes, all of which encourage a
graded increase in activity based on assumptions, not evidence, concerning
the role of deconditioning.
MCPs incorporate several elements of cognitive-behaviour therapy including
strategies to improve sleep and advice regarding diet, activity management
and stress reduction. However, they are more eclectic and make no
assumptions about deconditioning. For instance, graded activity is not
appropriate for 'high-functioning' patients and those with evidence of
ongoing infection (6-7). MCPs permit the practitioner to use pacing to
stabilise the condition and change to graded activity after a period of
sustained improvement. Effect size statistics for MCPs are similar to those
for CBT (4-5), but attrition rates tend to be lower (2 4) so these
programmes are likely to be more cost effective.

The response from NICE to a second request to correct the errors was
rejected as the latter were not considered "sufficiently serious". Space
does not permit me to elucidate further, but a meta-analysis, review,
various surveys and an independent audit have show that the outcomes related
to CBT tend to be modest and that many patients find graded activity
unhelpful (e.g. 8-9). In short, there is a clear need for additional,
evidence based therapeutic options.

One can describe the guideline for CFS in many ways, but robust it is not.

1. Rawlins M, Littlejohns P. NICE outraged by ousting of pain society
president. BMJ 2009, 339, b3028.
2. Taylor RR, Thanawala SG, Shiraishi Y, Schoeny ME. Long-term outcomes of
an integrative rehabilitation program on quality of life: A follow-up study.
J Psychsom Res 2006;61:835-9.
3. Wallman KE, Morton AR, Goodman C, Grove R, Guilfoyle AM. Randomised
controlled trial of graded exercise in chronic fatigue syndrome. Med J Aus
4. Goudsmit EM, Ho-Yen DO, Dancey, CP. Learning to cope with chronic
illness. Efficacy of a multi-component treatment for people with chronic
fatigue syndrome. Pat Educ Couns 2009, doi:10.1016/j.pec.2009.05.015.
5. Jason LA, Torres-Harding S, Friedberg F, Corradi K, Njoku MG, et al.
Non-pharmacologic interventions for CFS: A randomized trial. J Clin Psych
Med Settings 2007;14:275-96.
6. Chia JKS, Chia AY. Chronic fatigue syndrome is associated with chronic
enterovirus infection of the stomach. J Clin Pathol 2008;61:43- 8.
7. Friedberg F, Sohl S. Cognitive-behavior therapy in chronic fatigue
syndrome: is improvement related to increased physical activity? J Clin
Psychol 2009;65:423-42
8. Malouff JM, Thorsteinsson EB, Rooke SE, Bhullar N, Schutte NS. Efficacy
of cognitive behavioral therapy for chronic fatigue syndrome: a
meta-analysis. Clin Psychol Rev 2008;28: 736-45.
9. Nezu AM, Nezu CM, Lombardo ER. Cognitive-behavior therapy for medically
unexplained symptoms: a critical review of the treatment literature. Behav
Ther 2001;32:537-83.

Competing interests: None declared

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