Repeated Modified Nerve Blocks and Auditory and Non-Auditory Nerve Stimulation

I also don’t believe in this treatment. For me it looks like super acupuncture, which usually has no effect on tinnitus. Especially for chronic cases.

 

A massive shout out to those that went through the trouble to get the treatment.

Looks like a dud but at least we know.

 

Yea, absolutely fair play to everyone that went, did the treatment and reported back. Truly full of admiration.

Hoping Tom gets relief. I know what it’s like to have a young child and be struck down with this condition. The frustration that the joy of seeing a child grow is taken away from you by severe tinnitus.

Wishing you well @Tom Parijs.

Please update us with your progress.

 

Hey guys.

Sorry for my late response! It was a rollercoaster mentally and emotionally.

Today I stopped the treatment. I've done 19 in total. Before starting the treatment I had a T-VAS score of 8 in both ears. Normally I would fill in a 10 but, because my friend has it even worse than me, I couldn't do that.

If I now have to fill in a score, the left ear is still an 8 and the right ear is an 8. It seemed as if the right ear was going to respond to the treatment, but in the end, after 19 treatments, it is still the same as it was in the Netherlands.

My friend's tinnitus dropped considerably after every treatment, but then later on the same or the next day it goes back up. But in 10 years of trying everything, nothing has before made his tinnitus better even temporarily, so he wants to stay in South Korea until October 18th.

I am flying home next week, September 23rd. Back to Hell. I had it so bad in the Netherlands last year that I'm very scared going back and winter is coming...

What should I do? Go to the Brai3n clinic? Wait for FX-322? Or Dr. Susan Shore's device... I am a hopeless piece of grief.

I cannot recommend this treatment to anyone. It is a very hard journey and time here in a busy city. It is a waste of money. And the results of the research are completely wrong. I mean 52 million people live here, 10% of who have tinnitus on average, and of those 10% have extreme problems with tinnitus. We don't see any Koreans or Western people doing the treatment here at all. If the treatment was that successful, it would have to be super busy here with Koreans. And the references we have so far are 5 Western people with 0 result.

Next week back to my wife and 2-year-old son. Hopefully I can stay strong until there is something that can help me and you too.

Greetings,
Tom

 

That's what hurts me the most. Seeing my kid grow up true hell... big mistake from me not to take care of my ears. I cannot forgive myself. I had never heard of tinnitus before... but I should have known better.

 

Thanks for getting back to us brother Tom.

I am sorry it didn't work, we were all cheering for you to have some improvements.

Take one day at a time and be kind to yourself.

Big hug,
Daniel

 

I can only empathise. The stress of the birth of my 23+3 twins caused mine. There is nothing worse than having suicidal thoughts when you only want to allowed to be a loving father. I hope the treatment is working. Please God.

 

I would try the Brai3n clinic. They won't cure you but may be able to offer some relief via neuromodulation.

 

Bro, it might work for those with skeletomuscular origins of tinnitus or cervical instability. Noise induced tinnitus might be different. I’m sorry it didn’t work for you. Meditate, focus on good healthy living and distracting yourself by staying busy. Try acupuncture, massage therapy, wait for OTO-413, FX-322, Dr. Susan Shore’s device, etc.

Just because it doesn’t work for noise induced tinnitus, doesn’t mean it won’t work for another type of tinnitus.

 

Officially a scam.

 

How are you my friend? Is the worsening from South Korea still the same?

We have another Dutch guy here. He has had 9 treatments now, and he says he has worsening from treatment number 9. I told him your story - and warning to us - and advised him to stop the treatment.

He asked me if your tinnitus is still the same after the worsening in South Korea?

Greetings,
Tom

 

Hi Tom, the worsening never reverted, sadly. I'm struggling a lot these days, to put it mildly. I am sorry it didn't work for you but at least it hasn't made you worse. Overall, with all the feedback we have, I would conclude the study has some kind of bias and results in real life are not as good as in the paper. We haven't seen a single successful case from the west.

So I cannot recommend this treatment. Best avoided. Not that there weren't any red flags, we discussed them early on, but I decided to try it anyway on a balance of probabilities.

 

I just wonder if the published results were fabricated.

 

Thanks for your comment, my friend. The other Dutch boy will immediately stop the treatment. It's unbelievable that a treatment like this can be published with such high positive results in 2022 but then turn out to be a serious scam.

Hope you can keep it up until the seriously researched treatments come on the market, my friend.

You deserve better! Stay strong.

 

No placebo, no blinding = no evidence!

 

Response from my email explaining disappointment.

 

I'm going to have to agree. Statistically I don't see how it's possible to reconcile the 5 (or is it 6 of us now) experiencing no effect/worsening, with the results of the published study. I believe the study must have been fabricated. Which makes me feel even more betrayed, because the people at the clinic seemed genuinely nice and caring. It's odd to think they would do this to people, but the math simply doesn't add up.

 

Calling the clinic a scam is as extremist and unproductive as claiming it has a cure. No, we can not jump to conclusions because 5 members here didn't get any relief. Just statistically alone, it could be explained by bad luck. The chance is really small (about 0.003%), but it is still possible. More realistically, though, many other things could have happened, other than "the clinic forged the initial results".

People in this thread don't seem to understand what the placebo effect really means either. If a treatment got 95% success with no placebo group, it doesn't mean that either it worked, or placebo effect had a miraculous 95% remission rate. It could be a lot of different things. For example, perhaps the group that did the treatment on the initial trial had a specific kind of tinnitus that is different from people flying to the clinic oversea. That is very likely actually; it would be surprising if they managed to locally select a group that was representative of the overall population. Perhaps they changed staff and the new doctors are applying the method with some slight variation that is making it ineffective. Perhaps the equipment changed, or the drug provider changed, or the local diet has some key nutrient that synergies with the treatment. Perhaps the form for reporting the outcome was written in such a way that participants felt bad if they'd not answer "yes I'm feeling better", and that doesn't necessarily imply malice. Who knows? There are countless sensible explanations that aren't "the clinic is definitely a scam that forged the data". Jumping to this conclusion because of 5 patients didn't get a remission, with no additional evidence, is as absurd as claiming they have a cure.

The proposal is solid and makes perfect sense. In fact, I'd be surprised if it did **not** work for at least some forms of tinnitus. At this point, we know with almost certainty that there is a very direct link between hair cell damage and tinnitus. Blocking the nerves that come out of these hair cells is such a direct on-point intervention that it is very likely that, if done properly, it will have some effect (which may be good or bad) for most tinnitus sufferers. And if that's not the case, then this is still a very good research as it would add evidence that the ear isn't as important as we think, and a more central approach should have priority. Either way this is a great line of research and if the clinic is not a scam, we have a lot of valuable knowledge to extract from it.

 

Exactly. 0.003%. You can always calculate a % that says it's possible, but when it gets to percentages like 0.003% I believe eyebrows should be raised.

There were other issues with the study that I chose to ignore because I didn't want to doubt it. For example the study includes this paragraph:

How is anything less than a 70% improvement considered unsatisfactory? The T-VAS score is a 0-10 scale, and the paragraph literally cites 4 patients - one that went from from an 8 to a 3, one that went from a 10 to a 5, one that went from a 10 to a 4, and one that went from a 10 to a 3, and cites them all as 'unsatisfactory' results. Imagine having 10/10 tinnitus and having it reduced to a 3/10.

I remember reading that and being concerned, because any other treatment method would consider that a giant success, no?

Re: your theory of changing clinicians - while there, I was told by the doctor that her and her father had done all the tinnitus treatments in the clinic thus far.

Re: your theory of equipment changes - the only equipment used was a proprietary needle that was literally created by the doctor.

Re: your theory of all previous patients having a different type of tinnitus - the doctors spoke at length with us about the different types of tinnitus and assured us that our types were similar to those of previous patients, and that they expected us to respond similarly to the previous patients to the treatment.

Re: the drug - it was standard Lidocaine.

I spent 2 months in South Korea and a good deal of money - so yes I may have some emotional bias. But initially when it didn't work for me I believed I was an outlier. But which each successive story of a non-responder I am more and more skeptical.

You have to remember that the study showed an AVERAGE reduction from 7.73 to 1.53 in the chronic group (40 patients) and an average reduction of 7.13 to 0.60 (15 patients) in the subacute group. These are massive reductions. Yet all 5 of us experienced no reduction at all. Zero.

I possibly wouldn't have used the word 'scam' myself, but I fully understand @BrysonKingMe's frustration because he went through the same thing as me. And when I read about the others after us, my heart went out to them.

Maybe you are right, and hopefully you are, but unfortunately my gut says something isn't right. I suppose more people will need to go and we'll see what happens.

Is there a certain point (# of non-responders) where you personally would also start to be skeptical?

 

I mean, I do understand your frustration and don't think it is unjustified. But calling the clinic a scam is a strong accusation, that one shouldn't make without conclusive evidence. Moreover, the method itself could still have value even if it turns out the clinic is not legit. The things I cited are just a few, among an ocean of possible explanations you'd get different results compared to the initial trial, that don't involve malice. That doesn't mean they're clean either, it just means we don't have enough information.

I am skeptical. And I believe it is justifiable to question and investigate them.

 

If it worked, we would know by now.

 

I will double down on my scam comment.

It's a total scam. There were no Koreans going there for tinnitus treatment.

It definitely does affect tinnitus though -- it spiked mine to 11/10 levels every time! Fortunately the spikes all died down by the next day.

Every session it was usually me and 1 or 2 Koreans there for pain management. The clinic would have a line out the door if it worked. It doesn't. Sorry.

 

I know it’s not much consolation , but I just wanted, like others, to add my thanks to all the people who took the risk of trying this. Very brave of you, and sorry it didn’t work.

I wonder if one the reasons for such discrepancy in results is due to cultural factors (I think this was discussed a while back), with Korean patients there being uneasy being frank with the lack of results, and pretending there was some improvement when there was none.

Or it could be a real scam, yes. But I’m not entirely convinced by the idea that these guys could think they could completely fabricate a study and get away with it.

 

What makes me skeptical of this and Lenire is that they obviously have the money to do rigorous studies, but aren't doing them.

From an outside perspective, there doesn't seem to be a legitimate reason that this clinic couldn't throw together a study with better sampling methods.

 

How can someone be this naive, especially in 2022? If you want to believe in a noble government nanny who keeps your money safe, by all means, you're free to do so. I hope you're prepared for a rude awakening one day. Just consider for 1 second what it would take to sue a company such as this over some non-harmful service. You'd basically have to conduct trials by yourself to prove that it doesn't work - for anyone! Unless you happen to get friendly with an ex-employee who has managed to collect evidence of their scheme. In most cases, this might not be enough, because a bad study =\= a fraudulent study. And then if you can't prove it doesn't work, you've gotta pay all the expenses. I don't know about investors, but it hardly takes any balls to deceive potential customers in Korea.

 

I mean, if you are so certain it is scam, it might be. My point is that 4 failed treatments do not imply that the idea is necessarily bad. That's not how stats work. You seem to have a bunch of additional reasons to believe it is a scam after having visited the clinic, which, fine, I can't dispute. Just wish we had some good news for once.

 

There were several red flags. I had noticed them myself in the early discussion in this thread, possible cultural differences, possible biases in the study, poor testimonials in the Korean forums, etc.

I balanced this with the positive reviews of Sedley and Schaette, who accepted the article for publication, and took a risk, because the mechanism of action looked plausible.

However, once you see the clinic, its size, the type of clients, how many doctors are working there and in which conditions, the lack of a proper database, the fact they were insisting to continue my treatment after severe worsening, one of the doctors telling me not to think too much about my tinnitus, etc, well, you ask yourself what's going on here. Everyone is kind and exquisite but this is not a valid treatment in my view. Perhaps it can help a few special cases but I'm sorry to say, based on a combination of elements, I believe the study is affected by bias at the very least.

I'd like to know how they really selected the 57 patients of the study. My experience was never recorded for example, no exit interview or assessment, so my failure and worsening are not in their database. But they don't seem to have a database to start with, everything is embedded in a general Korean healthcare database that would require some extraction to a dedicated database. Apparently, the clinic does not have the resources for that. If I had known all this in advance I would have obviously avoided.