Following the publication of David Tuller’s damning critique of the PACE trial (Oct 21-23)and then further conclusions from the PACE trial team (Oct 27) the media debate has raged on. There has been much criticism of how the media has overstated the results of the trial and continued accusations that the researchers haven’t acknowledged glaring flaws in trial methodology.
Virology blog: Trial By Error, Continued: Did the PACE Study Really Adopt a ‘Strict Criterion’ for Recovery? by David Tuller [4 Nov 2015] This includes a discussion of what constitutes ‘normal ranges of recovery’. He concludes:
Given that relapsing after too much exertion is a core symptom of the illness, it is impossible to calculate the possible harms that could have arisen from this widespread dissemination of misinformation to health care professionals—all based on the flawed claim from the comment that 30 percent of participants had recovered according to the PACE study’s “strict criterion for recovery.”
And that “strict criterion,” it should be remembered, allowed participants to get worse and still be counted as better.
Guardian: Chronic fatigue sufferers need help and more research – not misleading headlines [Suzanne O’Sullivan Oct 29] A study in Lancet Psychiatry this week was reported as if exercise and counselling are magic cures for CFS. A closer reading of this timely research is required.
ME Research UK: Media ballyhoo over PACE by Dr Neil Abbot Oct 28 2015]
The real findings are unremarkable; as the authors themselves say, “There was little evidence of differences between the four groups in fatigue or in physical functioning at long-term follow-up”.
PLOS blog: Uninterpretable: Fatal flaws in PACE Chronic Fatigue Syndrome follow-up study [James Coyne Oct 29 2015]
…we should reject some of the interpretations offered by the PACE investigators as unfairly spun to fit what has already a distorted positive interpretation of the results.
Mental elf: The PACE Trial for chronic fatigue syndrome: choppy seas but a prosperous voyage [Simon Wessely Nov 4] A defence of the trial results concluding:
I think this trial is the best evidence we have so far that there are two treatments that can provide some hope for improvement for people with chronic fatigue syndrome. Furthermore the treatments are safe, so long as they are provided by trained appropriate therapists who are properly supervised and in a way that is appropriate to each patient. These treatments are not “exercise and positive thinking” as one newspaper unfortunately termed it; these are sophisticated, collaborative therapies between a patient and a professional. Having said that, there were a significant number of patients who did not improve with these treatments. Some patients deteriorated, but this seems to be the nature of the illness, rather than related to a particular treatment.
The authors suggest that it is the CBT and GET after APT and specialist medical care alone that is the reason the differences between the groups disappeared. However the table doesn’t bear this out.
Indeed those that had 10 or more sessions of CBT and GET tended to have the lowest improvements of the three groups.
BMJ: Tackling fear about exercise produces long term benefit in chronic fatigue syndrome [Ingrid Torjesen Oct 28]
…the follow-up findings were complicated by the fact that some of the patients who were randomly assigned to specific treatments in the PACE trial went on to undergo additional treatments…
At the end of the follow-up period, which was a median of 31 months after randomisation, there was little difference in outcomes among patients in any of the original four treatment groups. There was also no significant difference between the original four groups in the proportions of patients reporting a long term deterioration in their general health.
Spectator: The ME lobby is just a symptom of our stupidity about mental illness [Rod Liddle Nov 7] The poisonous emails, the threats, the rage – it’s all rooted in our crude attitude to psychiatric suffering Rod Liddle compares ME and FM to a turn of the century fad, Morgellons disease.