This is doing the rounds in NL. I don't have the spoons for a whole thread but I'll summarize the main points.
They tested lidocain with hydroxypropylbetacyclodextrine. This combo has not been evaluated before, not in vitro, in vivo or in volunteers. Open label study with 103 pwLC, who criteria (at least 2 months ill). Average was around 30 months.
Primary outcome measure: SF12 hrqol questionnaire. Small effect on physical functioning , moderate effect on mental functioning. Judge for yourself whether this is suitable in LC.
Secondary outcome measure. 30 symptoms scored daily on scale 1-7. Some significant improvements, but what do they mean? PEM goes from 5.5/7 to 3.5/7. Important: 37 people had not reached 36 weeks yet (but they mention n= 103 in all graphs...)
Important: 29%, 30 people stopped. (So I really don't understand n=103 in the graphs). They probably carried the last known value forward, but then I'd like to see a sensitivity analysis. 67/103 people may be missing... (Bc some people hadn't reached 36 weeks yet)
Reasons for stopping. 14 stopped due to non effect. Another 14 due to adverse events.
We need to talk about adverse events. The subc fibrosis is not mentioned as an adverse event in the national formulary. Its present in 63%! 33% accidentally injected intravascularly, which is dangerous. Authors say this decreased by 83% (of what) but it's still a major risk.
Authors do not think this is very serious. While the symptoms of intravascular admin they describe are indicative of CNS toxicity.
So, summary Rationale for the combo of lidocaine and hydroxypropylbetacyclodextrine unclear Modest effects Potential safety concerns Open label This is not the cure. Further research into alternative admin routes (transdermal? Sublingual?) could be interesting.
Link to the paper (open access yay) sciencedirect.com/science/articl…
(it did become a whole thread... I'm still very wired from the PAIS protest last Sunday, oops).
Adding that the trial was funded by the private clinic where the trial took place.