So it is possible that the study failed to show efficacy not because of the science, but, because of the study design.
Those who pay attention will notice that the info-sheet was downloaded an incredible +50,000 times. Compare that with the average attachment which typically is downloaded - on average - 10, 20, 30, or perhaps 50 times. Suppose back then that every person who downloaded the info sheet had also clicked our Trobalt campaign (which I was very much part of devising) or some other initiative - think about the massive amount of awareness there would now be. Well, opportunities come and go. And for the tinnitus community, they seem to mostly go.
All the best to everyone. And, on a very final note: many many thanks to Auris Medical for being a pioneer in the emerging field of inner ear otology.
That could be part of it. I would have been ready for my injections 1 week after onset but I had to wait 1 month.
But I have a different problem with the study and at least one of the 2 doctors that performed the injections revealed at a visit during my open label round that they at least had similar discussions internally and worries about the use of Lidocaine as a numbing agent.
It's not supposed to penetrate the ear drum, but in my case all signs point to this taking place. After having continuous T for the month leading up to the injections, I experienced silence immediately after the numbing agent and suctioning, on all 3 consecutive days of injections. However within just 15 minutes of the Lidocaine, I was in complete silence, so it's hard to toss that up to some coincidence.
Now if AM-101 did not work, then it must mean my improvement and my T definitely became intermittent on its own over time - or perhaps as I had previously thought before, the Lidocaine triggered this - since I did end up with days of silence long after the injections and I still experience this. Having said that, the Lidocaine did have an immediate effect during the procedure and who knows how long after it continued to have an affect. My first couple of weeks of the first trial showed continuous improvement.
What made little sense to me is that if they are very worried about us even doing something like using white noise to get temporary relief, I do not understand the use of Lidocaine as a numbing agent. It's been well documented as a temporary T suppressor. So it makes you wonder how many other people got some benefit initially from Lidocaine immediately after injections which later wore off.
Lidocaine has a healing benefit over the other agent and I am grateful they gave it to me but I do wonder how much it affected at least a portion of the study group that were given this. If there was any risk of it interfering with study results, I do not believe they should have used it.
Another thing worth noting. The research assistant revealed to me that Auris provides absolutely everything for the study, even vials for blood tests, they are labeled, numbered, and even the empty boxes have to be returned. I found this out because the vials used for my first blood test were expired, and had to do it again.
So if they are so careful with everything, why allow 2 different numbing agents, one known to be a temporary T suppressor? Makes you wonder if there was also an additional internal research taking place at Auris or something else. You would think they would also send all trial centers one single numbing agent, and probably should not have been Lidocaine.
It's also worth noting this effect also did not happen during my open label injections when I was ~4 months in and I experienced pain overnight which I did not during the first round.
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