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