Let's not get too far ahead of ourselves. I just hope I would be among the possibly 50% (maybe less) of people who receive a clinically significant reduction in tinnitus volume using the device and that it's meaningful for me personally. Anything more will be a bonus.
It's an interesting question. You would think so with continued damage to the inner ear. Once the device is on the market, we can be sure the limits are going to get pushed and tested in every way. Sure as hell not by me.
65% had a clinically significant reduction and the rest had a reduction as well.
It's also possible the other 35% could have had a significant reduction as well if they could have used the device longer. It will be nice when we no longer need to speculate.
It's clear to me that the device will help the majority of patients with somatic tinnitus which again is the majority of tinnitus patients overall.
Combining Dr. Shore's device with XEN1101 should potentiate its effects.
We need to factor in 20% in the placebo arm had a clinically significant reduction.
It was actually 53% of the full group of 99 participants, and that's before discounting that 20% of the placebo/control group had clinically significant reduction. So, that's a 33% points difference better than placebo. That doesn't look nearly like 65%. Subtract for the placebo effect, and you're going to see a lower number for effectiveness who were truly helped by the device.
Exactly!
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It doesn't sound too promising. This is all that was mentioned in the Q&A:
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Dr. Shore said:
Yes, we need to be happy a treatment is coming to market but we also need to temper expectations, I think. It will be interesting to see how TU Delft goes as it may be a more expedient way to access treatment for the 97% of us who live outside America.
A few of us are aiming to attend a tinnitus symposium that will be hosted by TU Delft in February.
I agree with the positivity but also I think it's a good idea for us to keep pragmatic in our approach to the Michigan device. I think it's a lot safer mentally for everyone to be cautious and to follow the data to make a call on whether it will work or not. A blanket approach of predicting it works for everyone will see some people here devastated when the device is launched and if unfortunately, it doesn't work.
It's going to take more than one person saying it worked to feel like a victory. We've had that with Lenire.
Is 65% that low? Seems high to me.
As I mentioned a few posts back, the results of 65% (PP) and 53% (ITT) for clinically significant reduction were only 40% and 33% points better than a placebo / control group for the PP group and ITT group (all 99 participants) respectively, despite the selective criteria of the study, and that's ignoring the second half of the study. So, keep your expectations in check while maintaining optimism.
As with any treatment, results are mixed with different people. Hopefully future treatments will be more successful. At least it's a start we can learn from while benefiting possibly up to half of sufferers.
Not gonna happen. After waiting x amount of years and spending $5k or whatever this device is going to run, there will be zero chance of keeping expectations in check. I'm sure most here feel the same.
Yes, I have been wondering about this as well. They are both bimodal approaches; however,
Perhaps this has already been looked out, but if the study followed the participants for a longer time, one would expect most of the placebo group to eventually revert back to baseline, BUT the treatment group might retain the improvement. Just a thought.
Right, as long as treatment continued. That's why I mentioned a couple posts back that the early feedback may be more positive due to the placebo effect being stronger then, so I would like to see a higher percentage of success to feel the device is really working beyond a placebo effect. And, if someone maintains that improvement over time, it's more convincing the device really helped. I think this happened early on with Lenire where people thought it was helping and later came to the conclusion it wasn't - possibly just an early placebo effect.
Agreed. All guessing aside though, and with the risk of sounding judgemental towards Dr. Shore - it's just somehow baffling to me that one can spend 20 years of their life researching something and have the pivotal results be "meh". Like... how? Why?
A more positive yet still logically consistent take on this kind of placebo-arithmetic might be to consider that in an actual therapeutic setting, no one will know whether any effect is from placebo or not. One might speculate that the placebo effect will be more transient in some way, but there really isn't any evidence of that one way or another.
I'd argue that can be blamed on how little we understand the human brain. This approach is in line with the idea that tinnitus is caused by the brain being hyperactive. There's a few examples of treatments having positive results with this understanding. Deep Brain Stimulation, the Kv7 modulators, and Neromodulation like the Auricle device all follow those lines of logic. The brain is a confusing and fragile organ that has to be approached with caution. Which 20 years of research is both cautious and thorough. It doesn't make it a silver bullet, but it adds to the pile of research that will be used to find a cure one day.
Great find! I guess the PDF slides are interesting to see how the software GUI works.
Why do you think it's a bit of a mess? The setup steps in the slides looks quite thorough and it's obviously designed to be run with specific hardware to generate calibrated tones.
65% is aiming high. The 65% includes only the PP group receiving active treatment before the crossover, which is only 30 participants, after excluding those getting worse tinnitus or receiving no benefit and not figured in the analysis. Add back in those 5 excluded participants, you're closer to 54% of 35 analyzed who received clinical meaningful improvement when receiving the active treatment. But as mentioned, 25% could be placebo effect as that is what the control side of the study showed. Also keep in mind that some people were not allowed to participate in the study as they were expected to have less positive outcomes, so those figures for tinnitus improvement would have likely been lower with more patients from the broader public who want to use the equipment who couldn't have qualified for the study, like some members here.
So, without the placebo effect, it's bound to be about 20%-25% less who truly benefit rather than 54%, but hopefully not too low so that we can chalk it up to the device actually working effectively for a substantial percentage of people rather than just the placebo effect benefit, which isn't likely to last long term for many. Personally, the placebo effect hasn't helped me with quite a few different things I've tried, so I want to see real lasting reduction in tinnitus for 50% of users, which may be too optimistic. 50% including those with the placebo effect is a lower bar to reach.
I'm not going to dig back through the study, I'm kind of at the whatever will be will be with the state of Auricle, but I wonder what you think about the noise reduction numbers?
The placebo/control effect on volume reduction was shown in the results just as it showed a reduction in the TFI scores from baseline for placebo/control, so placebo shows up in both metrics.
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