From Psychological Medicine, January 2013 (click link for pdf download of full text).
Recovery from chronic fatigue syndrome after treatments given in the PACE trial
P. D. White(1), K. Goldsmith(2), A. L. Johnson(3,4), T. Chalder(5) and M. Sharpe(6) ; PACE Trial Management Group#
(1) Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK
(2) Biostatistics Department, Institute of Psychiatry, King’s College London, UK
(3) MRC Biostatistics Unit, Institute of Public Health, University of Cambridge, UK
(4) MRC Clinical Trials Unit, London, UK
(5) Academic Department of Psychological Medicine, King’s College London, UK
(6) Department of Psychiatry, University of Oxford, UK
Abstract
background
A multi-centre, four-arm trial (the PACE trial) found that rehabilitative cognitive behaviour therapy (CBT) and graded exercise therapy (GET) were more effective treatments for chronic fatigue syndrome (CFS) than specialist medical care (SMC) alone, when each was added to SMC, and more effective than adaptive pacing therapy (APT) when added to SMC.
In this study we compared how many participants recovered after each treatment.
METHOD
We defined recovery operationally using multiple criteria, and compared the proportions of participants meeting each individual criterion along with two composite criteria, defined as (a) recovery in the context of the trial and (b) clinical recovery from the current episode of the illness, however defined, 52 weeks after randomization. We used logistic regression modelling to compare treatments.
RESULTS
The percentages (number/total) meeting trial criteria for recovery were 22% (32/143) after CBT, 22% (32/143) after GET, 8% (12/149) after APT and 7% (11/150) after SMC. Similar proportions met criteria for clinical recovery.
The odds ratio (OR) for trial recovery after CBT was 3.36 [95% confidence interval (CI) 1.64–6.88] and for GET 3.38 (95% CI 1.65–6.93), when compared to APT, and after CBT 3.69 (95% CI 1.77–7.69) and GET 3.71 (95% CI 1.78–7.74), when compared to SMC (p values f0.001 for all comparisons). There was no significant difference between APT and SMC.
Similar proportions recovered in trial subgroups meeting different definitions of the illness.
CONCLUSIONS
This study confirms that recovery from CFS is possible, and that CBT and GET are the therapies most likely to lead to recovery.
Press release issued by Queen Mary College, University of London today
Recovered people are well. Yet the PACE trial authors have redefined the term in several different ways for interpreting the PACE trial data. None of which has any meaning. Despite this the results still show that CBT and GET don’t work. CBT conferrred no obecively measurable benefits whatsoever. Thus the NICE CFS/ME guidelines are invalidated, as patients were still profoundly disabled at the end of the trial, as they were at the start.
A couple more concerns have been raised by this study, which was published in Psychological Medicine. A journal whose editorial board includes PACE trial authors Simon Wessely and Michael Sharpe
Firstly the authors state that:
“The prevalence of the case-level International (CDC) definition of CFS may have been inaccurate because we only examined for accompanying symptoms in the previous week, not the previous 6 months.”
If symptoms have only been examined over the course of one week, then by definition, the patients cannot have been assessed using the Fukuda or London criteria’s, which both require six months.
The primary screening criteria used in the study were in fact the Oxford criteria, which excludes organic brain diseases. This would include Myalgic Encephalomyelitis (G93.3), which is classified by the WHO as an organic brain disease. This was also confirmed by PACE trial author Peter’s White:
“The PACE trial paper refers to chronic fatigue syndrome (CFS) which is operationally defined; it does not purport to be studying CFS/ME”
http://www.meactionuk.org.uk/Hoopers-initial-response-to-PDW-letter.htm
Therefore, there simply is no scientific evidence that supports continued use of the NICE guidelines. And it would be incorrect for more taxpayer funds to go to further research into the failed pet theories of the Wessely school.