Adam pwme
Senior Member (Voting Rights)
Half the research spending for ME in a 10 year period in the UK went on the widely discredited £5M PACE trial [1]. The trial is taught in textbooks [2] and universities [3] as an example of how not to conduct a clinical trial. Over 100 experts and 80 charities want an independent review [4] and 40 MPs want a public inquiry [5].
The authors had a strict plan which had been approved and published, but they decided to change that plan after the trial had started. The changes resulted in the publication of a study that was fundamentally flawed and uninterpretable. The main flaw is that the trial is unblinded and primarily relies on the results of patient questionnaires [6]. Students for best evidence, supported by Cochrane, state" If you are reading a study that is un-blinded, with subjective outcome measures, then you may as well stop reading it" and if a trial is unblinded the measures "must be objective!" [7]. Subjective measures like questionnaires are not reliable especially when the treatment encourages patients to think positively [8]. A freedom of information request of the trial steering committee minutes found that actimeters which objectively measure activity were dropped at the end of the trial because a Dutch study reported negative results [9] [10].
They also lowered their definition of improvement and recovery. Recovery was lowered to a level similar to patients with congestive heart failure [11]. The claim that patients can recover is not justified by the data and is highly misleading to clinicians and patients [12] [13]. Changes meant that 13% of participants were already recovered on a key measure before the trial had even started [14]. Ron Davis stated "I'm shocked that the Lancet published it... I don't understand how it got through any kind of peer review" [15].
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