I just had another look at Fluge and Mella's 2011 paper, to see if I'd interpreted it wrongly.
(I haven't seen the results of their unpublished latest study.)
When compared to the placebo group, 8 out of 15 (53%) extra patients responded to treatment. These were all defined as a 'major' response to treatment. The average response duration was 25 weeks.
However, I am unable to work out exactly what a 'major' response meant, as their primary outcome scale is an average of four other outcome scales, and I can't find how they calculated their scores.
A 'major' response was defined as a Fatigue score ≥4.5 for at least six consecutive weeks (
"also demanding recordings of some fatigue symptoms as major improvement (value 6) during the response period"), but I can't find the Fatigue scores at baseline for comparison, and I can't work out what a Fatigue score of 4.5 actually means, in terms of function.
I don't fully understand the way results have been presented, but a brief calculation suggests to me that
average SF-36 physical function scores increased as follows...
Average SF-36 physical function scores in treatment group:
Baseline = 34 points
change (increase) = 13 points after treatment (this is the average
maximum increase in scores)
End = 47 points
Or, if taking the placebo group into account the changes are as follows, for the treatment group:
Baseline = 34 points
change (increase) = 4 points as a result of placebo
End, after increase as a result of placebo = 38 points (when improvements as a result of placebo are added)
change (increase) = 9 points as a result of treatment *
End = 47 points
* This compares with an increase of 9.4 points for GET in the PACE trial.
(I might have got my calculations wrong)
There are 3 or 4 patients in full remission, as far as I understand (but I might have this wrong), and I thought there was talk about the effects not being long lasting in all the patients who experienced full remission (again, I might have this wrong). These are certainly promising results, but 3 out of 30 patients in full remission means that 90% (27 out of 30) of patients are
potentially going to be disappointed.
If anyone can explain what I've not understood, then I'd be grateful.
Full paper:
http://www.plosone.org/article/info:doi/10.1371/journal.pone.0026358