I would like to draw your attention to an error in the rapid response from Chalder et al (1), most of whom were also authors of the original PACE Trial paper. They wrongly stated that PACE was a “randomised, controlled trial”.
The title of the PACE Trial, “Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial” clearly and correctly describes it as just a “randomised trial” not as a "randomised, controlled trial" (2)
This is reiterated under “Method, study design” where it states “PACE was a parallel, four group, multicentre, randomised trial”(2).
As has been explained here in several of the rapid responses, in common with most cognitive behavioural therapy research, the PACE trial failed methodologically to attain the gold standard of a randomised, controlled trial (3-5).
For example, Robert Courtney points out:
“Although it was a large and expensive government-funded trial, the PACE trial, as with most cognitive-behavioural research, was open-label and failed to control for placebo effects and biases such as response bias [24,25]. CBT and GET changed the way that a minority of patients interpreted their illness and responded to self-report questionnaires, as demonstrated by the 11-15% self-report clinical response rate to CBT/GET, but as placebo effects and response bias were not controlled for in this open-label study, it is possible that the self-reported effects could be explained by weaknesses of the trial methodology [24-28].” (3)
May I suggest this significant error is corrected to ensure accuracy and avoid further confusion.
1. Trudie Chalder, Kimberley Goldsmith, Peter White, Michael Sharpe, Andrew Pickles. “Mediators of response to behavioural treatments in CFS”. http://www.bmj.com/content/350/bmj.h227/rr-24
2. White PD, Goldsmith KA, Johnson AL et al. (2011) Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial. Lancet 377:823-36 http://dx.doi.org/10.1016/S0140-6736(11)60096-2
3. Robert Courtney, “The cognitive-behavioural model of illness for chronic fatigue syndrome and myalgic encephalomyelitis is not supported by the outcomes of the PACE” trial.” http://www.bmj.com/content/350/bmj.h227/rr-20
4. Carolyn E Wilshire, “Re: Tackling fears about exercise is important for ME treatment, analysis indicates”. http://www.bmj.com/content/350/bmj.h227/rr-7
5. Professor Jonathan CW Edwards, “Re: Tackling fears about exercise is important for ME treatment”. http://www.bmj.com/content/350/bmj.h227/rr-9
Competing interests: No competing interests