What the Loprinzi study really says
I get the idea that this board thinks that the study was a randomized trial - it was not.
I followed Vaffan's link to NIH clintrials website. Correct me if I am wrong, but the study is a single arm study. For the first day, the patient receives a sham treatment. They then receive ten days of calmare treatment.
There is no follow up on the sham treatment to see if there is any prolonged impact because the patient goes to calmare treatment the next day.
A success is an improvement of 50% or greater in any of one of 12 criteria. So, 6 of 10 reported an improvement in at least one of the criteria. Interesting criteria (not really) but I wouldn't be excited if my pain got worse and numbness in my foot went away - yet that is called a success. A 40% improvement in all 12 criteria would be a failure.
It looks like outcomes measures are taken at the end of treatment and then at 10 weeks.
The 60% and 50% question is after one day of sham and after one day of calmare. Calmare is not a one day treatment. (outcome at day 2 or one treatment). While this is outcome criteria one, I dont consider this interesting.
So, this is not a sham trial - nor is it evidence of a calmare failure. But it is not evidence of a similar success to Smith's trial either. There were strong benefits in tingling and numbness and minor improvements in pain at 10 weeks. Again, there is no sham comparison.
