...and not very impressive, on a skim-read...
http://www.cortjohnson.org/blog/201...hronic-fatigue-syndrome-study-results-are-in/
http://www.cortjohnson.org/blog/201...hronic-fatigue-syndrome-study-results-are-in/
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Cort Johnson said:But what does a 22% decline in a CIS score mean for a patient? The average beginning CIS score was about 110. A 22% decline in that score would put a patient at about 88. Seventy-six is considered the cutoff point for remaining in the workforce. Go above 76 and you’re probably going to drop out of the workforce. Go below 76 and you’re probably going to stay in the workforce.
The average response didn’t put the “average” patient back into the workforce but it put them within about 10 points of possibly entering it. That indicates that a significant increase in functionality occurred.
I would be pretty concerned if money goes to a Phase 3 trial for this - when major building block type research needs funding.
I had assumed it was industry-funded, but wasn't it?
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Wasn't it Wessely who claimed that the placebo rate in ME/CFS is very low? I really wonder what kind of patients they studied.
From a statistics point of view, the sample size is relatively small. A bigger study with a similar distribution of outcomes could easily lead to statistically significant results. The 9-point difference is quite large.
Exactly. The very best we can say is that maybe future research can determine if there's a subgroup who responds, or similar. To think that an insignificant result somehow suggests it's still worth trying is completely incorrect at this point.But the fact that it's not statistically significant is an indication that you can't trust that the 9-point difference is real. The lack of statistical significance indicates that in a larger population it could really be a 0-point difference.
I expected this intervention to make things worse relative to placebo so I am surprised by these results. Perhaps the follow-up was not long enough to detect the detrimental effects of exhaustion of already marginal dopamine stores in ME patients.
Still, the high placebo rate seems kinda odd. Wasn't it Wessely who claimed that the placebo rate in ME/CFS is very low? I really wonder what kind of patients they studied.
I think it also depends on the questionnaire. The more subjective it is, and less focused on specific physical activities, the less reliable it's going to be. It's a lot easier to fudge on "I feel like I can do things" than "I can walk up a flight of stairs without struggling". Though maybe that doesn't directly relate to the placebo response.I don't buy the argument at all. ME/CFS patients are just as suggestive as patients with other diseases when it comes to answering questionnaires.