Which is incredible given that this research cost UK Tax-payers £5 million and the TrialProtocol claimed: ‘
The main aim of this trial is to provide high qualityevidence to inform choices
made by patients, patient organisations, health servicesand health professionals about the relative benefits, cost-effectiveness, and cost-utility,as well as adverse effects, of the most widely advocated treatments for CFS/ME.’
Hooper observed: “…adverse event deemed by trial scrutinisers to be “non-serious” were CBT Group 89%; SMC and GET groups 93%; and APT Group 96%.” And: “… wehave no idea how many of the 3,002 adverse events that were deemed “non serious” may have been reactions to the trial interventions.”
Sir Michael Rawlins (as Chair of NICE) stated that, “we need a new approach toanalysing clinical evidence”. He observed that Randomised Controlled Trials, “are oftencarried out on specific types of patients for a relatively short period of time [snip]. Thereis a presumption that, in general, the benefits shown in an RCT can be extrapolated to awide population; but there is abundant evidence to show that the harmfulness of anintervention is often missed in RCTs.”
The PACE Trial relied almost entirely on subjective measures (questionnaires). This is acontradiction. The Trial treatments GET and CBT were based on theories thatparticipants are not physically ill but are incapable of accurately interpreting their ownsymptoms because of phobia and hysteria. Yet the opinions of these supposedlydelusional participants are considered reliable to provide data for a clinical trial.
The PACE Trial researchers modified benchmarks and entry criteria, cancelled or misappliedmeasures and changed scoring methods during the Trial. These changes had the effect of damaging generalizability, favoured the treatments being tested, eliminated objectivemeasurements and created ludicrous anomalies:
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 thetrial, deteriorate, yet still fall within the modified definition of ‘normal range’.
Improvements from GET and CBT were so small that many patients that met theresearcher’s chosen definition of ‘normal functioning’ were still more disabled thanpeople with other serious diseases.
The Trial Protocol stated that actigraphy measurement would be used at the start andend of treatment. The investigators cancelled this objective test as an outcomemeasure, claiming it was too much of an imposition even though all the participantswore the monitor at the start of their testing.
A 6 Minute Walk Test was the
objective measure used at the start and end of thetreatment. However,
the researchers did not follow the protocol for the 6 Minute