Artem,
It sounds very interesting! As you say (and Indeed the Clarke article, I think, says) there has been a very unusual reticence for a Randomised double-blind Clinical Trial to be undertaken. The Clarke article is interesting in its explanation of the history here.
I guess the key question is, do you have a TNFα presence in your body, such that taking a drug such as this, perispinally might benefit you? How many of the other criteria used in the trial can you check off as well?
The trial group was necessarily very small and quite short (due to a lack of funding) so is difficult to attribute a statistical significance to (my very rudimentary statistical knowledge tells me that you need a “sample size” of something like 25-30 to get towards a 95% confidence rating, and I think there were perhaps only 22 persons in this trial, being then split into two groups, so you’d need about three times the number of participants to start to ascribe some statistical significance to the patient outcomes). I know the individual measures of pain differential are statistically sufficiently different, but the limited number of patients means that (to my mind) there is still work to do to make this demonstrated to a good confidence.
It does seem independent of Tobinick, which is good. And it does support the outcomes he has for some time cited. I think both articles are very interesting in explaining how the treatment works, so even I understand why it would seem to be a treatment that would have some value.
How many of the criteria do you think you could check off?
The success rate appears to be quite poor. I don’t remember the figures but did it effectively translate into maybe three or four of the group of 10 or 11 Etanercept recipients actually seeing a decent reduction in pain? And the Clarke article I think said that it is still unknown why it is not effective for more cases.
… so those are my thoughts. I have to say that reading through these articles is never very easy: it helps if you believe the treatment could be completely relevant to you, so I can see how you have managed to fight your way through them! Very interesting, though.
Somehow, we need the relevant pharmaceutical companies to suddenly be keen on a decent sized RCT.
Hope this helps. I hope others might knuckle down and try to read the articles.
Very best wishes,
Richard