I agree, absolute 0 chance of placebo. While I think the news we received is great and uplifting I think it will take positive news from the trial results to shutdown all of the placebo talk. Cheers till March and May.
It's not accurate to say there is no evidence.
Lol. I literally had to take a forum break because of this (and not having time for it anyway).
Too true. I think this time we can be more optimistic that FX-322 works due to positive results in the Phase 1B clinical trial. Past clinical trials were about getting rid of tinnitus whereas this time it's regrowing hair cells and synapses.
I've posted this here several times but I think it bears repeating, from the Hearing Health Foundation, a reliable source.
Don't worry, they're not going to shut down the trial based on one possible NDA violation. Millions of dollars spent on drug development in general and double- or gazillion-blinded studies specifically would never be risked if those investments could be sunk by one person over-sharing their experience.
I think there is more danger with "it didn't help me" anecdotes because it might deter recruitment (and delay the trial because recruitment can take as long or longer than the trial itself).
I agree with you, I should have said "poor" evidence instead. Of course I wish it works and I agree there is a possibility for that. I meant I read many people here who look to be so sure despite the fact it's still unsure to me, just a possibility, that I don't know what is going to happen to them if FX-322 is said to be ineffective in 2022 after all this wait.
The point is I read so many publications and each of them often say the opposite while demonstrating scientifically... I don't trust isolated publications anymore. Just like the scientific community, unless it's published in Nature magazine one thing needs to be supported by several studies and I need to read them (I mean the publications).
Excellent summation. It's simply the case that the treatment mechanism is completely different to the treatments in the past. Also treating auditory issues is probably dealing with the underlying cause.
Tinnitus improves with 83% of patients following tympanoplasty, a procedure which can restore function of the tympanic membrane and improve hearing. So yes neuroplasticity is reversible. Also, tinnitus outcomes in Phase 2a will likely fall short for subjects with bilateral hearing loss/tinnitus due to unilateral treatment. Considering the available evidence regarding hearing restoration and tinnitus it is no stretch to believe that this drug will demonstrate efficacy in the higher frequencies.
The difference is that in the hearing aid study, participants were told one was "new" and the other was "conventional." In the FX-322 trial, participants (and their doctors) have no idea if they're getting FX-322 or placebo.
Variations in susceptibility to tinnitus can certainly be attributed to sound processing variations among the population. An example would be tone deafness and the ability to recognize perfect pitch. Latest theories regarding tinnitus include the stochastic model of auditory central gain, of which there will be variations among the population.
Phase 2 can be divided into two parts. A "2a" focused on figuring out an optimal dose and 2b is more centered around efficacy at this optimal dose.
Dr. Will Sedley talks about this (as well as Dr. Thanos Tzounopoulos). That's two very well respected researchers and not "one off publications."
Thanks for the link, interesting abstract read.
Stress is definitely something to consider as we know how far our sympathetic nerve system can go when it comes to inflammation process (immune system at the front called by TNF cytokines, etc. that same TNF we try to fight in many auto immune diseases if not most of them). So of course at the time of natural healing, right after the accident, I guess stress won't help and will maintain inflammation, maybe long enough for the brain to build that specific plasticity which won't go away after a couple of days. That's... only me thinking out loud, sorry.
Unfortunately decades of mis-invested research have created this "status-quo" about tinnitus and hearing loss, that seems to be on-going. I've seen research as recent as 2019 that regurgitates basically the same findings as the decade prior on tinnitus. It's mildly infuriating the amount of resources wasted chasing a red-herring.
Honestly though this would actually make a lot of sense in my case lol. I had whiplash and shortly after a noise incident (100 dB alarm for 2-3 seconds). No issues however, until a few days later I had a major panic attack that lasted several days (from an earwax blocked ear)... and then the tinnitus came about. So I'm assuming this messy combination but especially the stress from the blocked ear (and that temporary muffled hearing) is what gave me tinnitus.
Not necessarily going to be longer. One thing that is believed to be happening is the Phase 2a trial might be determining whether FX-322 shows good enough results after 90 days to demonstrate appropriate benefit or whether they need to go the full 7 months.
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