MAGICAL MEDICINE: HOW TO MAKE AN ILLNESS ... - Invest in ME

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patients do not know which group they are in. CBT was found to produce better results than the other treatments
with which they were compared”.
The trials mentioned by Burgess and Chalder are the same trials upon which the PACE Trial Principal
Investigators relied for justification of the trial, all of which have been shown to have serious methodological
flaws (S Butler, T Chalder, M Ron, S Wessely, JNNP 1991:54:153‐158; Sharpe M et al, BMJ 1996:312:22‐26;
Deale A, Chalder T, Marks I, Wessely S, Am J Psychiat 1997:154:3:408‐414).
On 6 th January 2006 a severely affected ME sufferer wrote to Dr Burgess about the three trials referred to in
their book: “I can well understand that it must be crucially important that participating patients do not know which
group they are in, and I am wondering if you can tell me how that was achieved in the three trials you refer to?”
When the error in their book (ie. that in the three trials in question, “participating patients do not know which
group they are in”) was brought to her attention, on 9 th January 2006 Dr Burgess’ reply was notable: “The
paragraph to which you refer is a mistake that I had unfortunately not noticed before it went to print.
Patients did know the group to which they had been allocated because they would have had to know about the
different treatments before consenting to the trial”.
That was a remarkable mistake not to have noticed.
When the same person wrote again to Dr Burgess enquiring if there had been any critical commentaries
about the three trials relied upon in their book, the enquiry was ignored.
It was in fact the case that numerous criticisms of those studies existed. For example, Friedberg and Jason’s
book “Understanding Chronic Fatigue Syndrome” (American Psychological Association, 1998) was explicit
about two of the three studies that underpinned the Burgess and Chalder book (Deale A, Wessely S et al
1997 and Sharpe et al 1996):
“It is possible that psychiatric morbidity rather than a CFS disease process maintained disability and
symptoms status…a near‐complete resolution of the illness, as reported in Sharpe et al (1996) suggests the
presence in many patients of primary psychiatric illness with prominent fatigue symptoms, rather than
CFS”.
“The heterogeneity of the CFS population may be another factor that is related to clinical outcome”.
“…patients…showed a high degree of psychiatric morbidity”.
Further criticisms had been noted by others: in the Deale and Wessely et al study of 60 patients, half
received CBT in the form of “graded activity and cognitive restructuring” and half received “relaxation”. Three
subjects withdrew from the CBT group and four withdrew from the relaxation group. No details were
given by the authors of any symptoms apart from “fatigue”. Half the participants did not think that they
had a physical illness; there was about a seven year age gap between the two groups (the CBT group being
the younger group); it seems that there were no proper controls; there was no placebo arm and no non‐
treatment arm (both required); there was no blinding; there were no independent assessors; and it was the
same individual therapist on both arms of the trial. The authors stated that at final follow‐up (six months
after the course of CBT and relaxation was completed), 19 patients “achieved good outcomes compared with 5
patients in the relaxation group”. Somatisation disorder and severe depression were cited as exclusion
criteria, yet nine participants were described as having ‘major depression’ and there were high levels of
existing psychiatric morbidity in the study cohort.
Outcome measures were said to relate to “subjectively experienced fatigue and mood disturbance, which
are the areas of interest in chronic fatigue syndrome”. This statement alone indicates that the study cannot
have been considering people with ME/CFS because neither “fatigue” nor mood disturbance is a