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

[David S]

Before we all get our hopes up, this paper was written by a private clinic's owner (and family members I assume, based on the last names.) I didn't come across any other publications under these names.

It seems they may have a large financial benefit from patients coming to their clinic for this treatment.

I have to agree very much. This might be too good to be true. But also the study is quite well written. It might be too much of a risk to have something injected close to the facial nerve? Could be quite drastic consequences of that.

 

[David S]

I am not sure but yesterday I emailed one of the researchers who was given as a point of contact. I asked if they are implementing this practice in their clinics and what would be the cost. I am currently awaiting for a response.

Thanks for doing that. Let us know once they reply.

 

[buttercake]

@urgentresearch, any thoughts on this one?

 

[Reed19]

Thanks. The inclusion and exclusion is confusing. I think it might refer to muscular tinnitus, something I recently had surgery for, but I have ordinary tinnitus too.

Either way, hopefully this procedure is rolled out globally as soon as practically possible!

Pity more controlled trials are needed. Hopefully they might be global though.

Yeah, it is confusing. I would take it as they don't want people with a very obvious root cause and fixable somatic tinnitus like someone whose tinnitus stops and starts because of grinding teeth or sleeping with bad neck posture. It doesn't make sense to exclude 70 percent of people who have tinnitus.

 

[justguts]

i need this right now.

 

[Chinmoku]

Before we all get our hopes up, this paper was written by a private clinic's owner (and family members I assume, based on the last names.) I didn't come across any other publications under these names.

It seems they may have a large financial benefit from patients coming to their clinic for this treatment.

It's not university/pharmaceutical company research.

This would not be the first time hopeful results might be debunked later on...

It is a little suspicious but you can find other publications from Heon Man Sirh, for example:

The effect of integrated injection techniques for the serratus posterior superior muscle on interscapular pain, upper extremity pain, and paresthesia

He is also patenting a new type of needle he used in the tinnitus treatment. It doesn't mean much per se but we should also recall the paper was peer reviewed and Dr. Will Sedley, who is a strong researcher, was involved in the review, so I wouldn't discount it necessarily. However I agree we need to tread carefully.

P.S. The email address given for correspondence is not a professional one, but something like a Korean GMail or Yahoo. This is also a little suspicious.

 

[Padraigh Griffin]

We need Western academics and practicing surgeons to consider this. I emailed the link through to one of the UK's top Neurotologists. I'm a patient of his.

I hope he reads it and circles it around academic/surgical circles. The best way to get a practicing trial up and running in my opinion.

I've also sent the trial results to Dr. Shore and the secretary of Professor Dirk De Ridder.

This needs full investigation. If results are as good as those published, we have pretty much got a cure.

Circulate the article as much as possible.

The results are startling and it was reviewed by Dr. Will Sedley.

A number of board members participated in Dr. Sedley's recent sound therapy trial, therefore some on here have a contact line to him or at least his student who was posting here looking for volunteers. Maybe we can get more information from that point of contact.

 

[Markku]

The results are startling and it was reviewed by Dr. Will Sedley.

A number of board members participated in Dr. Sedley's recent sound therapy trial, therefore some on here have a contact line to him or at least his student who was posting here looking for volunteers. Maybe we can get more information from that point of contact.

Yes, and we also had Dr. Sedley in Tinnitus Talk Podcast. That episode was received very well by our community.

I have now reached out to him if he has any comments to provide. Seeing he was, indeed, part of the peer review of this study (Dr. Roland Schaette was the other one, who is also well known in the tinnitus research circles), I'm not sure if there are any restrictions on what he can - or wants to - say.

I will update as soon as I hear something.

And thanks @David S for finding and posting this! My initial reaction was "this looks too good to be true", but at the same time hope dies last. The authors do go over study limitations in the "Discussion" section.

@Padraigh Griffin, please let us know if you get some impressions out of your contacts as well!

 

[Padraigh Griffin]

Re: limitations... The lack of placebo is something to take into account BUT (and a big but) the patient paid for each procedure. Why pay continuously for a treatment that did not work?

Some chronic sufferers needed 18 treatments.

 

[Padraigh Griffin]

Dr. Shore is amazing to contact and she replied very quickly. She has given it short shrift based on lack of control and placebo.

Dear Padraigh,

Thank you for forwarding. It is hard to evaluate trials that do not have a placebo control nor a washout or crossover design.

Best wishes,
Susan Shore

Thank you Dr. Shore,

I totally get your point (hence why my faith in Lenire Bimodal is zero), BUT one thing that gives me hope is that the patients paid for each and every treatment in this trial.
Some paid for 18 treatments and results were a very dramatic reduction in VAS. (TFI and THI not used). Why pay if it is not very effective?

Results were maintained 1 year post treatment and the publication was reviewed by Dr. Wil Sedley and Dr. Roland Schaette, both well respected European tinnitus researchers.

I really think it is something that could be very positive for the Tinnitus community and severe sufferers like myself.

Fingers crossed!

Again thanks for your reply.

Kind regards,
Padraigh

If patients pay for each treatment it is not a proper trial. Paying can contribute to placebo effect. That is why a control is essential.

 

[David S]

This seems to be without electric stimulation. Forgive me if I was wrong in my initial posts. It's just injections of Lidocaine close to different nerves.

 

[DocTors_94]

Dr. Shore is amazing to contact and she replied very quickly. She has given it short shrift based on lack of control and placebo.

I understand her point. Although paying can't make 85% patients have a placebo effect on tinnitus, and some patients going from 10 to 0. That's basically impossible... How many people paid for stem cells yet they didn't work at all, or only slightly. Stem cells haven't had these amazing results...

 

[Chinmoku]

Placebo control with needle-placement is tricky. How do you do it? Place the needle wrong?

Also, it's not so much that they paid for it, how many people paid for useless treatments hoping in results down the line, but more that they took only cases above 5 on a scale 0-10. There is no way tinnitus goes from 8 to 3 due to placebo. Maybe from 3 to 2 or 4 to 2 but a reduction from severe to mild is hard to accept as placebo. If my tinnitus went down to 4, I would be sure there is no placebo.

I understand Dr. Shore's sceptical approach and prudence but I think we shouldn't dismiss this study on the basis of no placebo.

Edit @DocTors_94 anticipated me

 

[Markku]

Yes, and we also had Dr. Sedley in Tinnitus Talk Podcast. That episode was received very well by our community.

I have now reached out to him if he has any comments to provide. Seeing he was, indeed, part of the peer review of this study (Dr. Roland Schaette was the other one, who is also well known in the tinnitus research circles), I'm not sure if there are any restrictions on what he can - or wants to - say.

Update: In the coming week, Dr. Sedley is going to come here and provide some thoughts.

 

[Padraigh Griffin]

I understand her point. Although paying can't make 85% patients have a placebo effect on tinnitus, and some patients going from 10 to 0. That's basically impossible... How many people paid for stem cells yet they didn't work at all, or only slightly. Stem cells haven't had these amazing results...

Exactly. The results are too dramatic to account for 'placebo effect' from my point of view.

I have been a harsh critic of Lenire (who had no control group) but Lenire only achieved 12 pt reduction in TFI. That result certainly is something that could be accounted for by incorporating placebo effect. Going from 10 to zero is a totally different story as you well say!

I do know Susan Shore is a fan of proper science so a properly constructed study would be something that is a priority for her.

 

[UKBloke]

This seems to be without electric stimulation. Forgive me if I was wrong in my initial posts. It's just injections of Lidocaine close to different nerves.

From what I understood reading the study, the needle is inserted for a couple of centimetres behind the ear lobe and left in-situ for a circa 60 min period.

During that period the clinician moves the needle (I'm thinking this is something akin to a kind of deep-tissue acupuncture) presumably to innervate the nerve.

So the protocol seems to be a mixture of Lidocaine injection together with physical movement of the needle.

 

[Ben Johnson]

With all due respect to Dr. Shore, it wouldn't be in her best interest for a procedure to come out that has very positive results. Assuming her device is successful, this South Korean procedure could potentially knock a huge dent in what she is working on.

While I'm sure she has the best of intentions, it is human nature to want your creation to be the "winner". I don't give a damn which one works. I would pay anything to anyone to get lasting relief.

I do believe she makes a good point regarding placebo but so do posters on this board regarding paying for something if it's not working. As soon as I find out a $10 supplement isn't working, I'm done with it. Damn sure wouldn't pay for continuous $$$ shots if they weren't helping.

 

[StoneInFocus]

Dr. Shore is amazing to contact and she replied very quickly. She has given it short shrift based on lack of control and placebo.

I am a bit out of the loop on this, but isn't Dr. Shore developing a treatment for tinnitus herself?

She sounds very quick to throw the baby out with the bathwater, not to sound disrespectful, but maybe she is afraid of the competition?

Not trying to offend anyone.

 

[Padraigh Griffin]

With all due respect to Dr. Shore, it wouldn't be in her best interest for a procedure to come out that has very positive results. Assuming her device is successful, this South Korean procedure could potentially knock a huge dent in what she is working on.

While I'm sure she has the best of intentions, it is human nature to want your creation to be the "winner". I don't give a damn which one works. I would pay anything to anyone to get lasting relief.

I do believe she makes a good point regarding placebo but so do posters on this board regarding paying for something if it's not working. As soon as I find out a $10 supplement isn't working, I'm done with it. Damn sure wouldn't pay for continuous $$$ shots if they weren't helping.

Yes I do think my second reply somewhat 'hit a nerve'

Sincerely hope Dr. Shore's trial comes out good though. She deserves it and it probably would serve a different market. Less expensive plus accommodates more moderate sufferers + treatment at home.

I hope it will be good for severe tinnitus sufferers but the results from Trial 1 were not exactly spectacular from a TFI reduction perspective.

2022 is proving interesting so far!

 

[Gb3]

If paying for a treatment increased the effectiveness, then everyone who bought Lenire and Desyncra would say they worked.

 

[Will Sedley]

I thought it would be a good idea to post on here briefly, as this is clearly a very interesting study, and it is understandable that this should generate a lot of interest... and questions.

I was a reviewer on the study, meaning I had no hand in any aspect of it, and also have no current or prior connection with the team conducting the research.

The fact that the study appears in a scientific journal indicates that I, and the other reviewer, felt that it contained findings that would be of interest to the tinnitus research community, and had no obvious flaws that clearly undermined its findings and needed to be addressed before publishing the work.

Like many of you, I found the apparent benefits to tinnitus symptoms quite astonishing. Particularly as this technique appears 'brand new' almost, being first published in a fully functioning form, rather than from a gradual series of studies and techniques each making advances on the last.

I would consider that it is, however, very premature to be making any recommendations about this being adopted into routine medical practice, or indeed any practice outside of a research setting. Firstly, it absolutely must be tested in a randomised controlled clinical trial, against a sham or placebo treatment. I do very much accept that the apparent responses obtained seem beyond that which we would expect for a placebo treatment, but the size of placebo effects can vary with many factors, including the methods of response recording, and socio-cultural factors. Ideally, this trial would be first conducted by the team leading this research, as it does seem a highly specialised method, rather than something that other medical specialists in related areas would simply be able to perform from their existing skills. If this showed a similar benefit, then larger-scale trials in different locations would be needed to inform decisions about when/how/whether to fund the technique, and training for specialists in order to be able to perform it. There are also considerations of safety, particularly as some of the injections involve placing needles very close to delicate and easily damaged nerve structures. There is a lot involved in any new treatment's journey from initial development to widespread use, and in this case it seems particularly complicated.

That said, if the technique does prove successful in robustly conducted trials, then it would obviously become a huge priority to try and get it into widespread use. The desperate need for effective tinnitus treatments is well-recognised.

Will Sedley

 

[UKBloke]

I thought it would be a good idea to post on here briefly, as this is clearly a very interesting study, and it is understandable that this should generate a lot of interest... and questions.

I was a reviewer on the study, meaning I had no hand in any aspect of it, and also have no current or prior connection with the team conducting the research.

The fact that the study appears in a scientific journal indicates that I, and the other reviewer, felt that it contained findings that would be of interest to the tinnitus research community, and had no obvious flaws that clearly undermined its findings and needed to be addressed before publishing the work.

Like many of you, I found the apparent benefits to tinnitus symptoms quite astonishing. Particularly as this technique appears 'brand new' almost, being first published in a fully functioning form, rather than from a gradual series of studies and techniques each making advances on the last.

I would consider that it is, however, very premature to be making any recommendations about this being adopted into routine medical practice, or indeed any practice outside of a research setting. Firstly, it absolutely must be tested in a randomised controlled clinical trial, against a sham or placebo treatment. I do very much accept that the apparent responses obtained seem beyond that which we would expect for a placebo treatment, but the size of placebo effects can vary with many factors, including the methods of response recording, and socio-cultural factors. Ideally, this trial would be first conducted by the team leading this research, as it does seem a highly specialised method, rather than something that other medical specialists in related areas would simply be able to perform from their existing skills. If this showed a similar benefit, then larger-scale trials in different locations would be needed to inform decisions about when/how/whether to fund the technique, and training for specialists in order to be able to perform it. There are also considerations of safety, particularly as some of the injections involve placing needles very close to delicate and easily damaged nerve structures. There is a lot involved in any new treatment's journey from initial development to widespread use, and in this case it seems particularly complicated.

That said, if the technique does prove successful in robustly conducted trials, then it would obviously become a huge priority to try and get it into widespread use. The desperate need for effective tinnitus treatments is well-recognised.

Will Sedley

Great to have your input here at such an early stage of the process, Will. Many thanks.

 

[Padraigh Griffin]

Thanks for the reply Will.

Maybe some of the performing Neurotologist's in the UK where there are some excellent world renowned surgeons might be interested in supervising a local trial here.

The procedure would become pretty routine quickly for some of these excellent surgeons and trained juniors. It does not seem difficult compared to complex ear surgery (speaking as someone who recently had bilateral sectioning of the Tensor Tympani and Stapedius performed in Cambdridge).

It may be worth reaching out to some of those with a tinnitus specific focus?

I have sent it to my surgeon and hopefully he might take an interest. I have sent it my contact in the BTA as well. This is definitely worth funding allocation.

We can't let potential huge breakthroughs like this 'sit on the shelf' for too long.

The tinnitus community should be all over it like a rash

The results are too good to be placebo and South Korea are well advanced in tinnitus research. Best papers I could find online on my condition of Middle Ear Myoclonus all came from South Korea.

Appreciate your continued efforts.

 

[Bambam0]

Cannot seem to find Sirh's Private Pain Clinic online...

 

[ajc]

Cannot seem to find Sirh's Private Pain Clinic online...

The doctor is Heon Man Sirh, MD (Dr. Sirh's Pain Clinic, 44 Seocho-daero 78-gil, Seocho-gu, Seoul 06626, Korea)

I found Dr. Sirh's YouTube channel, the videos show how his needle is used.

Can't find a website.

 

[ThomasC]

The doctor is Heon Man Sirh, MD (Dr. Sirh's Pain Clinic, 44 Seocho-daero 78-gil, Seocho-gu, Seoul 06626, Korea)

I found Dr. Sirh's YouTube channel, the videos show how his needle is used.

Can't find a website.

Doesn't look very convincing. Anyone know the educational background of these guys?

 

[Padraigh Griffin]

It's a well written study confirming astounding results. It needs to be investigated by all tinnitus researchers.

This is always how I thought a cure/treatment would come about. A kind of Eureka moment/treatment.

As I am Irish I am going to try and make an appointment with Dr. Brendan Conlon of Lenire to try and get him to bring this to Ireland. I am an optimist despite having very pessimistic tinnitus.

I have also circulated the research to as many neurotologists and academics as I could yesterday and will continue to do so.

Are there any Korean nationals on this board that could possibly make contact with the performing doctor themselves? We surely must have members from South Korea?

 

[Uklawyer]

@David S, well done for providing this. @Padraigh Griffin, thank you for the being so proactive in corresponding with surgeons and the wider tinnitus community. Please keep pushing forward with this one.

 

[Padraigh Griffin]

Reply from Professor De Ridder's secretary.

Hi Griffin
Thanks , i already sended it to Dr. De Ridder.

Kind regards,
Tina Maheux

Medisch secretariaat​

I am very happy that Professor De Ridder has his hands on this now. He has close research links with South Korea, and Seoul based South Korean academics from my reading.

 

[Ed209]

It's very encouraging; some good news for a change.