In February 2011, the Science Media Centre (SMC)
hosted a press conference for the publication in The
Lancet of the results of the PACE Trial research into
treatments for ME and CFS.   The research took 6 years and cost UK tax payers
£5 million. 640 Participants received either Cognitive
Behaviour Therapy (CBT); Graded Exercise Therapy
(GET);  Adaptive Pacing Therapy (APT) or Specialist
Medical Care (SMC – the Control Group).  Many people have submitted formal complaints about the flawed methodology of the £5 million publicly-funded PACE Trial; The PACE Trial results (The Lancet, Feb 2011) for
‘improved’ show that Graded Exercise Therapy (GET)
had an effect for 16% and Cognitive Behaviour
Therapy (CBT) for 14% compared to the control
group. The results for ‘normal ranges’ show that GET
had an effect for 13% and CBT for 15%. These results produce a ‘number needed to treat’
figure of 7. In other words, if 7 people are treated
with one of these therapies – one of them will
improve but the remaining 6 will not get any
significant benefit. 
All complaints and concerns have
been met with a  determined refusal to 
address the issues raised.
 
Professor White the chief investigator stated in
contradiction of the Trial Protocol and The Lancet
publication, that the PACE Trial was not studying
“CFS/ME”. He claims they were only studying people
with fatigue as a main symptom.
( http://bit.ly/kMqon8 ) The criteria of ‘fatigue’ does not define ME or CFS
according to the NICE Guidelines (2007), the CMO
Report (2002) and all other authorities on these
illnesses. The PACE Trial researchers were aware that using
lax criteria for CFS could improve the outcome of
their therapies. They reference Joyce, Hotopf and
Wessely who stated: “As the definition becomes
more stringent the prognosis appears to worsen.”
(PACE Protocol reference 9). The whole PACE Trial was based on the myth 
that ME is a behavioural disorder;
this myth continues to be condoned by 
the Medical Research Council (MRC).
 
 The FINE Trial published a year earlier, established
that rehabilitation therapies do not benefit severely
ill patients. Therefore if the PACE Trial had included
25% of severely ill patients to reflect the general
patient population it is reasonable to project that
the apparent treatment-effect in the PACE Trial
would only have occurred in 12%, instead of 15%;
and given the limitations of RCTs, a realistic ‘need to
treat’ figure in general medical practice would
probably be at least 10.  Studies suggest that ME costs the US
 economy at least  $26billion a year.
 People originally disqualified from participation were
later allowed to join the Trial. Patients with a
completely different illness from the target group
were allowed to join (fibromyalgia).

Because of moveable benchmarks, it was
possible for a participant to join the trial,
deteriorate, yet still fall within the modified
definition of ‘normal range’.
Improvements from GET and CBT were so small that
many patients that met the researcher’s chosen
definition of ‘normal functioning’ were still more
disabled than people with other serious diseases. The Trial Protocol stated that actigraphy
measurement would be used at the start and end of
treatment. The investigators cancelled this
objective test as an outcome measure, claiming it
was too much of an imposition even though all the
participants wore the monitor at the start of their
testing.
After CBT or GET, PACE Trial participants (whose
average age was under 40) did not even achieve a
six minute walking distance of 518 metres which is
lower than average scores for healthy people aged
50-85 years. Patients with Class III heart-failure
score higher than PACE Trial participants.
The PACE Trial did
 not return the participants to their
 health or even close to it The weak recovery protocol did not represent recovery by any rational means.  The weak recovery protocol did not represent recovery by any rational means. The PACE sister trial, the FINE TRial, which showed no significant findings on the fatigue and function scales was not mentioned in the PACE TRial.
Sources (links above):

Peter Kemp : Spinning out of Control
Tom Kindlon : Index of Harms
Professor Hooper : Update on the Pace Trial
David Tuller responds to the PACE investigators