PDF is a right PITA; this road-block to accessing and reviewing research papers comes up time and again. It would be most useful if anyone can recommend a free solution for accessing text from PDF files - or alternatively, I think the paid-for version of Acrobat Reader has that function so people with access to that software could rip the text from PDFs as a service to the rest of us. Maybe I'll look into it one day soon...but if anybody has a neat solution for us, do shout up...
Regarding this paper: first, it turns out to be important to have a basic definition of "QT" which is referred to throughout:
In medicine, specifically
cardiology, the
QT interval is a measure of the time between the start of the
Q wave and the end of the
T wave in the heart's
electrical cycle. The QT interval generally represents electrical depolarization and repolarization of the left and right ventricles.A prolonged QT interval is a biomarker for ventricular tachyarrhythmias like
torsades de pointes and a risk factor for sudden death.
So: QT interval is basically a measure of certain risk factors for heart disease, which is a leading cause of death in CFS patients.
The abstract of the study says it (AMP-516) is: "a double-blind placebo-controlled study in CFS patients to evaluate the effectiveness of rintatolimod (Ampligen (R))"...including "repeated QT interval measurements"
So yes, it is a double-blind placebo-controlled study of ampligen for CFS, basically.
Results: "
A greater proportion of the placebo patients were found to have significant QT prolongation, compared to patients receiving rintatolimod. The increase in QT in the placebo group was associated with continued use of concomitant medications known to prolong QT; patients randomised to receive rintatolimod were able to significantly reduce their dependance on these same medications".
"Reducing the risk of cardiac toxicity by reducing fatigue and the use of concomitant medications with serious side effects is an important clinical objective and underscores the seriousness of CFS."
"The increase in the placebo patients can be directly attributable to the use of concomitant medications known to prolong QT, coupled with a sedentary lifestyle known to be a risk factor for heart disease."
"
In both AMP-502 and AMP-516, rintatolimod resulted in a statistically significant (p < 0.05) increase in mobility and stamina (exercise tolerance)."
"Given more patients in the placebo group continue with their use of medications, compared to patients receiving rintatolimo, it is indeterminate as to the exact contribution the increase in exercise tolerance had on abrogating QT prolongation in the rintatolimod group."
SO: in short, this is a double-blind placebo controlled ampligen trial in CFS patients, which found
improvements in heart function for the patients receiving ampligen. Those patients reduced their use of other medications, some of which are known to cause QT prolongation. Those patients also benefited from increased mobility and improved exercise tolerance.
It wasn't clear how much of the improvement in QT measurements was due to direct benefits of ampligen, and how much was due to the indirect benefits of discontinuing other medications. But in either case, it's a double-blind placebo-controlled confirmation that Ampligen is beneficial to CFS patients. Sounds very significant to me.
Finally: ampligen is described as a "TLR3 agonist, which modulates innate and adoptive immunity". Given that this study shows that ampligen is beneficial to CFS patients, it seems to me that this might also be seen as strong evidence regarding what CFS actually is: it seems to imply that immune modulation is significant, which comes as no great surprise of course...