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

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David S

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Dec 1, 2013
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10/2013
#1
Quite amazing results. What are your thoughts?

Integrative Treatment for Tinnitus Combining Repeated Facial and Auriculotemporal Nerve Blocks With Stimulation of Auditory and Non-auditory Nerves
Methods: This retrospective chart review study included 55 patients with tinnitus (subacute, n = 15; chronic, n = 40) who underwent repeated nerve blocks after stimulation of the trigeminal (V) and facial (VII) nerves to modulate the auditory and non-auditory nervous systems via the vestibulocochlear (VIII) cranial nerve pathways. We used a simplified smiley tinnitus-visual analog scale (T-VAS) with scores ranging from 0 to 10 combining the effect of tinnitus loudness, distress, and quality of life as the outcome measure to evaluate the efficacy of our treatment method. Statistical analyses were performed using SPSS (version 18.0, SPSS Inc., Chicago, IL, United States), one-way and two-way analysis of variance.
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Results: In more than 87.5% of patients (14/15 subacute, 35/40 chronic), tinnitus disappeared or had significantly reduced by the end of the treatment. The mean T-VAS score reduced significantly from 7.13 to 0.60 in the subacute group and from 7.73 to 1.53 in the chronic group by the end of treatment (p < 0.05). The benefits were maintained after treatment cessation and at the 1-year follow-up. The average number of treatment procedures was 9.8 ± 3.589 (range, 5–15) in the subacute group and 9.775 ± 3.717 (range, 5–18) in the chronic group.
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#3
This is quite big! I can't understand from the article though, if they found it works on most tinnitus vs. only on some subset.
 
#5
Lidocaine is well known to suppress tinnitus temporarily via blood infusions. This is a much more direct approach. Also electric stimulation aimed at the cochlea suppress tinnitus. It is much easier to get close to any of the binding nerves.

I like this approach a lot.
 
#8
Even without a control group, the effects are quite impressive. I doubt that someone could report such big improvement due to the placebo effect.

Does it need to go through a series of clinical trials? If I understand correctly, this is a combination of methods we already have.
 
#9
grayfox00 said:
Even without a control group, the effects are quite impressive. I doubt that someone could report such big improvement due to the placebo effect.

Does it need to go through a series of clinical trials? If I understand correctly, this is a combination of methods we already have.
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I very much agree with @grayfox00. The results are SPECTACULAR to say the least. It's just impossible to get VAS score down 7 points (from severe to mild) in so many patients by placebo effect... I would fly to South Korea right now if this could be done by compassion.
 
#10
grayfox00 said:
Even without a control group, the effects are quite impressive. I doubt that someone could report such big improvement due to the placebo effect.

Does it need to go through a series of clinical trials? If I understand correctly, this is a combination of methods we already have.
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Yes, everything is very well known. The new approach is that you guide the needle very precise to get close to the nerve that you want to block or stimulate. You guide with low radiation CT (similar as pictures that you take at the dentist) or with ultrasonic.
 
#12
DimLeb said:
This is quite big! I can't understand from the article though, if they found it works on most tinnitus vs. only on some subset.
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You got to start somewhere. Also this is a quite expensive treatment. Every injection would be somewhere around $500-1000 per occasion. Chronic tinnitus might need 15 or more treatments. Need to be done by very skilled doctors to not hurt the nerves.

Not a pill or a device the big pharma can earn any money out of.
 
#13
Wow, even the effects were still ongoing after 1 year. Well, is this procedure to be used in other countries as well? What do you think? If it is indeed so successful, maybe it will be implemented at ENT practices and for once they will be useful for us.
 
#14
David S said:
this is a quite expensive treatment. Every injection would be somewhere around $500-1000 per occasion. Chronic tinnitus might need 15 or more treatments. Need to be done by very skilled doctors to not hurt the nerves.

Not a pill or a device the big pharma can earn any money out of.
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Don't any of you people have health insurance?
 
#15
David S said:
You got to start somewhere. Also this is a quite expensive treatment. Every injection would be somewhere around $500-1000 per occasion. Chronic tinnitus might need 15 or more treatments. Need to be done by very skilled doctors to not hurt the nerves.

Not a pill or a device the big pharma can earn any money out of.
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Oh, I see. It still looks like a lot more viable treatment than stem cells, for example, which cost just about the same. I believe it's very promising that these news keep popping up and something is finally moving in the right direction!
 
#16
DocTors_94 said:
I very much agree with @grayfox00. The results are SPECTACULAR to say the least. It's just impossible to get VAS score down 7 points (from severe to mild) in so many patients by placebo effect... I would fly to South Korea right now if this could be done by compassion.
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Very much agree. No way a placebo effect cloud knock out my chronic tinnitus.
 
#19
Are there people on Tinnitus Talk who can push this study to the front and center of the medical community?

The study sounds very hopeful and I would hate to see red tape and regulations drag it to a snail's pace.
 
#20
Ben Johnson said:
Are there people on Tinnitus Talk who can push this study to the front and center of the medical community?

The study sounds very hopeful and I would hate to see red tape and regulations drag it to a snail's pace.
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Correct me if I'm wrong. All of these drugs are approved so there are no trials to conduct. How does a potential treatment become a standard of care?

Example: Steroids are given to people with hearing loss but from my understanding there is no evidence that they help at all but that is the standard of care.
 
#23
Nice. I wonder how they will move forward with the treatment. I'm guessing more people to test it on. We will find out soon since it's a new article.
 
#24
David S said:
Yes I know, but double blinded. Phase 1/2, Phase 2, Phase 3 trials will take 5-10 years.

I feel we need more hope for the short term.
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This actually seems like a Phase 1/2 combined study already. Phase 1 is for safety Phase 2 is for efficiency. It is clearly not but i doubt this has to run through a Phase 1/2/3.

Placebo seems quite risky since this is quite a risky procedure. You don't want to end up giving someone permanent facial damage by applying placebo needling in their face..
 
#26
This sounds too good to be true. Why are we not doing this right now?
 
#27
Was I correct in seeing 'somatic tinnitus' as an exclusion criteria?

Also, as it is a new surgical approach, not a drug or medical device, I presume clinical trials are not necessary?

For those of us in Europe/UK it is interesting to see Dr. Will Sedley as a peer reviewer.

The results are amazing.
 
#28
Padraigh Griffin said:
Was I correct in seeing 'somatic tinnitus' as an exclusion criteria?
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Inclusion criteria included:

6. subjective tinnitus regardless of whether accompanied by sensorineural hearing loss, objective or somatic tinnitus, or unidentified brain diseases.

Exclusion criteria included:

5. purely objective or somatic tinnitus.

So nothing to worry about. Most people with subjective tinnitus have some somatic tinnitus. And those people are eligible. I'm not sure what "purely somatic tinnitus" is, maybe it means there's like a tumor or some actual identifiable somatic issue causing the tinnitus.
 
#29
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...
 
#30
ajc said:
Inclusion criteria included:

6. subjective tinnitus regardless of whether accompanied by sensorineural hearing loss, objective or somatic tinnitus, or unidentified brain diseases.

Exclusion criteria included:

5. purely objective or somatic tinnitus.

So nothing to worry about. Most people with subjective tinnitus have some somatic tinnitus. And those people are eligible. I'm not sure what "purely somatic tinnitus" is, maybe it means there's like a tumor or some actual identifiable somatic issue causing the tinnitus.
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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.
 

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