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

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than giving actual numbers of patients. The authors acknowledged that: “The data from all the outcome
measures were skewed and not normally distributed, with varying distributions at each measurement point”. In such
circumstances, merely providing “average” figures is not the most appropriate illustration of findings. In
summary, this RCT has little relevance in general and none whatever to people with ME/CFS (with grateful
acknowledgement to ScotME for this analysis).
In 2001, Trudie Chalder and Simon Wessely et al published their 5‐year follow‐up of their 1997 paper (Am J
Psychiat 2001:158:2038‐2042). The original 1997 study had 60 patients, whilst the 2001 follow‐up study had
53 patients. Significantly, this study suffered from corrupt data: the authors themselves stated: “56% of the
patients undergoing CBT reported receiving further treatments for their chronic fatigue symptoms; other treatments
used were antidepressants, counselling, physiotherapy and complementary medicine”. Over the course of the five
year follow‐up, treatment of many patients had deviated from the trial protocol, rendering the outcome
measures meaningless.
It is worth noting that in the NICE Guideline (CG53, 2007) that recommended CBT for “CFS/ME”, ten
studies were identified (including the two mentioned above) and in most of the ten identified trials of CBT
the methodology does not meet even the most minimally acceptable standards. Five out of the ten trials
registered no overall effect, yet the Guideline states on page 198: “Eight of the studies reported beneficial effects
of CBT”, which seems to indicate a determination on the part of those advising NICE to use CBT whatever
the evidence.
Three studies in particular by two of the PACE Trial Principal Investigators deserve attention (the Fulcher
and White study of 1997; the Sharpe et al study of 1996 and the White et al study of 2001).
The Fulcher and White study (BMJ 1997:314:1647‐1652) specifically states: “If patients complained of increased
fatigue they were advised to continue at the same level of exercise”, which should be borne in mind when noting
that the PACE Trial literature states that the undeniable adverse effects of previous GET interventions were
likely to be due to improperly administered therapy (see below).
It is notable that at least 40% of White’s participants were working at the time of the study; all were capable
of at least 15 minutes of intense aerobic activity, and 30% of patients enrolled were receiving concurrent
antidepressant therapy or hypnotic medication, yet the authors stated that patients with psychiatric
disorders were intentionally excluded.
As Mike Sadler, Consultant in public health medicine, commented in the BMJ: “Fulcher and White conclude
that their findings support the use of graded exercise in the management of CFS…Given that this is already a subgroup
selected by their referral to psychiatric outpatient departments, to select out those with a current psychiatric disorder
makes them an unusual group indeed” (BMJ 1997:315:947‐948).
There is evidence that Peter White is fully aware that his 1997 study did not look at people with ME/CFS.
That study excluded people with sleep disturbance, which means that they excluded people with ME/CFS,
since a diagnostic feature of ME/CFS is sleep disturbance. When this anomaly was pointed out in person to
Professor White by a senior NHS Consultant Physician, Professor White shrugged his shoulders and said:
(verbatim): “So what?”. This response by Professor White must surely cast doubt on his credibility and upon
the value of the RCT in question as being “the best available evidence”.
Equally, the Sharpe et al study of 1996 merits comment (BMJ 1996:312:22‐26). This was a small study of just
60 patients, of which only 30 patients received CBT (the other 30 being controls). Sharpe et al concluded:
“CBT was both acceptable and more effective than medical care alone (but) few patients reported complete resolution of
symptoms and not all improved”.
At the time, the study received much media publicity, with inflated claims of success. When countered by
informed ME/CFS patients, The Independent published a hostile article by Rob Stepney (26 th March 1996)