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The results of the PACE Trial do not live up to the hype surrounding the PACE Trial

Posted by ZigZag on 14 May 2013 at 20:30 GMT

For CFS patients, McCrone et al. demonstrate that CBT and GET fail to significantly improve objectively measured endpoints for: working hours; welfare benefit claims; private financial claims; health care costs; lost employment costs; or lost production costs.

When measured using the only objective outcome measure of disability that was used in the PACE Trial (1), the six minute walking distance test, CBT and GET failed to significantly improve outcomes, beyond improvements seen in the standard medical care control group. Both CBT and GET left the average patient with severe disability. (Weber/NYHA)

The model of illness for CFS, that was tested by the PACE Trial, is not supported by the evidence of the PACE Trial, as so many patients failed to respond to treatment from CBT or GET, and all the objective measures failed to demonstrate any significant improvements.

The original PACE Trial paper (1), published in the Lancet, concludes:
"Our finding that studied treatments were only moderately effective also suggests research into more effective treatments is needed."

CBT and GET were found to be moderately effective, using subjective self-reported measures only. For all objectively measured endpoints, CBT and GET failed to improve outcomes.

Patient organisation surveys (2), also indicate that patients find CBT and GET of little value. The results of the PACE Trial verify patient organisations’ surveys of their members, in which patients express disappointment and concern towards CBT and GET. (2)

For subjective measures, the primary outcome results were as follows (the proportion of participants who achieved a minimal clinically useful outcome: difference from SMC) (see Table 3 in the original PACE Trial paper):

CBT physical function 13% (NNT = 1 in 8)
CBT fatigue 11% (NNT = 1 in 9)

GET physical function 12% (NNT = 1 in 8)
GET fatigue 15% (NNT = 1 in 7)





References:

1. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
P D White, K A Goldsmith, A L Johnson, L Potts, R Walwyn, J C DeCesare, H L Baber, M Burgess, L V Clark, D L Cox, J Bavinton, B J Angus, G Murphy, M Murphy, H O’Dowd, D Wilks, P McCrone, T Chalder, M Sharpe, on behalf of the PACE trial management group
5 March 2011
The Lancet, Volume 377, Issue 9768, Pages 823 - 836, 5 March 2011
doi:10.1016/S0140-6736(11)60096-2

2. Action for ME patient survey 2008:
http://www.actionforme.or...
Action for ME patient survey 2010:
http://www.actionforme.or...

No competing interests declared.