Richard S. Tyler, Tinnitus Retraining Therapy, Where Are the Results?

[Markku]

Some $1.5M+ has been granted to the study of Tinnitus Retraining Therapy (TRT), lead by Richard S. Tyler.

(Source and above screenshot from Grantome)

The study was supposed to end in 2011. Yet, to this date, results have not been published.

(Source ClinicalTrials.gov)

We asked NIDCD for information on the results of the study after Richard S. Tyler didn't respond to our e-mail inquiries, however that yielded no result.

NIDCD just told us that the results of any study funded by them will be available on the study's page on ClinicalTrials.gov, and if they're not posted, they're not available. Figures.

It would be very interesting to get some actual data from this study, since Tinnitus Retraining Therapy is much discussed here, but with not too much evidence available as of this writing. Even the Cochrane concludes that evidence of Tinnitus Retraining Therapy is inconclusive and needs more research.

 

[Silvio Sabo]

Why are they wasting money on crap!!? Not a single penny should be spent on this kind of garbage!!

 

[Aussie Lea]

I've been to a few tinnitus groups and nobody has got their tinnitus reduced with TRT. We had several people start the usual nature and white noise therapy and one person doing TRT, with no difference in the end. Tinnitus is a brain disorder, and it needs to be looked that way. It isn't something a talking therapy or noise therapy helps. They can help cope but who wants to cope when that's still not the same as how you were before the hell started.

 

[Michael2013]

I've been to a few tinnitus groups and nobody has got their tinnitus reduced with TRT.

That doesn't surprise me, considering it's not supposed to reduce your tinnitus. It's supposed to help get you to the point where you don't care about it anymore.

-Mike

 

[Michael2013]

We asked NIDCD for information on the results of the study after Richard S. Tyler didn't respond to our e-mail inquiries, however that yielded no result.

I just received a response from Dr. Tyler and have obtained 11 attachments of various scanned copies of journal articles and research results. I'll dig through it later tonight after I get my kids in bed and see if I can post some of it.

-Mike

 

[Markku]

I just received a response from Dr. Tyler and have obtained 11 attachments of various scanned copies of journal articles and research results. I'll dig through it later tonight after I get my kids in bed and see if I can post some of it.

-Mike

Can you also ask him why the results haven't been published onto the ClinicalTrials.gov page relating to that study?

Additionally, on PubMed there's only one study on Tinnitus Retraining Therapy where Dr. Tyler has been attached to, and it's this one:
http://www.ncbi.nlm.nih.gov/pubmed/22609540

That study doesn't seem to be the same as the one discussed in the first post. The number of participants doesn't match, and study object is different.

Estimated enrollment was 180 in the one posted on ClinicalTrials, whilst the one posted on PubMed had only 48 participants.

Also, the PubMed study assigned participants to three sub-groups, whilst the one on ClinicalTrials lists six groups.

Thanks in advance!

 

[Aaron123]

Here's some further information:
1) In the acknowledgements to the article http://www.ncbi.nlm.nih.gov/pubmed/22609540, it says "This study was partially funded by a grant from the American Tinnitus Association and by the National Institutes of Health (Grant 5R01DC005972-02)."

2) That paper cites a paper from 2008: Tyler, R. S., Coelho, C., Tao, P., et al. (2008). Identifying tinnitus subgroups with cluster analysis. Am J Audiol, 17, S176–S184. In that paper, it says "This research was supported in part by National Institutes on Deafness and Other Communication Disorders Grant
R01 DC005972-01A1" In that paper, it also says "Disclosure Statement The first author is a consultant for Neuromonics, Inc."

So the R01 grant mentioned in the first post funded both of these studies even though neither of them looks like the study that was proposed. It is possible that more results could be forthcoming - the 2008 paper references funding from the first year of the grant (I believe the 01 at the end of the grant number indicates the first year) while the 2012 paper references funding from the second year (the 02 at the end of the grant number).

 

[Markku]

Here's some further information:
1) In the acknowledgements to the article http://www.ncbi.nlm.nih.gov/pubmed/22609540, it says "This study was partially funded by a grant from the American Tinnitus Association and by the National Institutes of Health (Grant 5R01DC005972-02)."

2) That paper cites a paper from 2008: Tyler, R. S., Coelho, C., Tao, P., et al. (2008). Identifying tinnitus subgroups with cluster analysis. Am J Audiol, 17, S176–S184. In that paper, it says "This research was supported in part by National Institutes on Deafness and Other Communication Disorders Grant
R01 DC005972-01A1" In that paper, it also says "Disclosure Statement The first author is a consultant for Neuromonics, Inc."

So the R01 grant mentioned in the first post funded both of these studies even though neither of them looks like the study that was proposed. It is possible that more results could be forthcoming - the 2008 paper references funding from the first year of the grant (I believe the 01 at the end of the grant number indicates the first year) while the 2012 paper references funding from the second year (the 02 at the end of the grant number).

Very interesting findings. Great work, @Aaron123.

So it may be possible that the big study - what I referred to in the first post - never happened exactly as proposed, but instead the NIDCD funds might have been used toward multiple separate TRT related studies.

That would be, in my opinion, a great shame, since the original proposal seems to be what TRT was lacking.

Although, of course, I think $1.5M+ would have been able to be better spent in any case, however that's my personal opinion. But, since NIDCD made the funding decision years ago and what's done is done, I would have much preferred to see the results to the proposed study as opposed to these separate smaller ones (unless all the smaller ones somehow added up make it whole, equal to the originally proposed study).

Maybe my conclusion above is wrong, let's wait what @Michael2013 shows us & if Dr. Tyler can provide any further insight.

 

[Michael2013]

So it may be possible that the big study - what I referred to in the first post - never happened exactly as proposed, but instead the NIDCD funds (and now it seems some ATA funds as well) might have been used toward multiple separate TRT related studies..

The paper found by @Aaron123 is actually one that Dr. Tyler sent to me. Unfortunately after looking through everything, there isn't anything here that provides any information about the study as initially proposed in @Markku's link. I am going to follow back up with him to see if I can hopefully get more details. It is possible that the study never really completed. If I get more details, I will share it back.

-Mike

 

[marqualler]

Hi @Markku--any update on this? Would be curious to see if there are any results to that study.

 

[Markku]

Hi @Markku--any update on this? Would be curious to see if there are any results to that study.

Nope.

However, I found something interesting, looking through Grantome.

There are a plethora of TRT trials funded (in addition to the ones by Dr. Tyler, which I've omitted from the below):

Dr. Craig Formby has received a total of...

...a whopping $3.7M+?

And Dr. Scherer approximately $2.2M?

I mean...

If this is true, then my mind is blown.

TRT would have received:

• ~$1.5M (Dr. Tyler)
• ~$2.2M (Dr. Scherer)
  
• ~$3.7M (Dr. Formby)

Totaling ~$7.4M.

And we don't have a high quality TRT trial for that money?

Now that seems very, very odd!

I'm not sure if the figures on Grantome's site are correct.

Needs some more looking into.

 

[Aaron123]

According to (US) federal law (https://www.gpo.gov/fdsys/pkg/PLAW-110publ85/pdf/PLAW-110publ85.pdf#page=82) results are supposed to be made available. See this article for information about the lack of reporting: http://www.statnews.com/2015/12/13/clinical-trials-investigation/
I found this information through the following NY times article: http://well.blogs.nytimes.com/2016/...roken-covenant-with-patients/?ref=health&_r=0

 

[Nucleo]

I'd like to see someone pro TRT try to defend this. I've only seen shady shit like this coming from TRT ''research''

TRT hasn't proven squat and yet is being sold as a premium preying on sufferers, praising some guy's model from 30 years ago. Later on, when a sufferer's tinnitus isn't getting any better they are told that TRT was never meant to do anything about the sound perception.

Quite convenient all this racket.

 

[Aaron123]

Needs some more looking into.

Happy to oblige.

There is a study, and it is on-going with an estimated completion date in 2017. It's a multi-site trial using US military personnel with a target enrollment of 228.

Here is the info at clinicaltrials.gov: https://clinicaltrials.gov/show/NCT01177137

There is information about the rationale and protocol at https://www.ncbi.nlm.nih.gov/pubmed/25319676?dopt=Abstract and https://www.ncbi.nlm.nih.gov/pubmed/23571304?dopt=Abstract

On clinicaltrials.gove, Dr. Formby is the "Study Chair" (presumably PI) and Dr. Scherer is the "Study Director". There's information about funding on the NIH web site that matches the above figures for Dr. Scherer. There is no mention on the NIH site about Dr. Formby. One of the pubmed articles lists the grants funding the study as

• U01 DC007411/DC/NIDCD NIH HHS/United States
• U01 DC007422/DC/NIDCD NIH HHS/United States

The second one (DC007422) is Dr. Scherer, and the first is Dr. Formby. I can't find any additional information about DC007411 on NIH's web site.

It might seem high at first glance, but ~ 6M for a study that has run from 2009 to 2015, has 6 sites and 44 collaborators at 9 institutions (see clinicaltrials.gov and the pubmed links for specifics) probably isn't unreasonable.

 

[Aussie Lea]

Millions of dollars of government's money for TRT research and no dollars for real research that can dampen our noise?

I don't know how to add a picture, excuse me if this doesn't work

 

[lymebite]

Here are some thoughts by Dr. Wilden on TRT:

http://www.dasgesundeohr.de/pdf/trt_critik_EN.pdf

 

[Nucleo]

TRT is a heap of dogshit.

I've ever seen TRT clinicians directing people away from the AM-101. Auris-Medical had contact this TRT clinic as well. After all, what better place to enroll tinnitus patients than a tinnitus clinic? Well they refused to hold the AM-101 trials and actively discouraged people from getting the AM-101 injections.

Instead they wanted to sell their stupid maskers for a thousand dollars a piece of course.

 

[Atlantis]

Instead they wanted to sell their stupid maskers for a thousand dollars a piece of course

Maskers can cost $3k or more. Equivalent of ripping off.

 

[Blackbird26]

Sad. I think it is clearly EVIDENT that TRT is placebo effect...Of course, which is to say, it still may work for some. However where these people are I have no clue. I don't know of ONE single individual. Not ONE.

 

[attheedgeofscience]

The monetary sums are quite interesting. As a comparison, one of the contacts of [USERGROUP=11]@Team Trobalt[/USERGROUP], Prof. Moore, was looking for funds of the order of $100k in order to run their worthwhile tinnitus research - a drop in the ocean compared with the +7 million dollars mentioned elsewhere within this thread.

Anyway, folks on this board might be interested to know that Team Trobalt had a research contact within the US armed forces. This person confirmed that their main focus is indeed so-called management therapies i.e. CBT and TRT.

The world is so full of mediocrity.

I wish the associated post on Facebook had gotten more "publicity":

 

[japongus]

Lol @ dis thread. emperor has no clothes indeed...

 

[Alue]

Anyway, folks on this board might be interested to know that Team Trobalt had a research contact within the US armed forces. This person confirmed that their main focus is indeed so-called management therapies i.e. CBT and TRT.

This irritates me to no end. If anyone has the funding to makes waves in tinnitus research it's the VA. I'm sure veterans with severe intrusive tinnitus would rather a cure.

 

[monacco]

Do You Know? I am not looking for these results at all because I know that it will never work on me

 

[Vaba]

Is there anything we can do about this? Is there some law that says that the results of clinical trials must be posted for the benefit of the investors?

Or, are researchers just allowed to take the funds and run away without ever proving they did any work?

If that's the case then I might work in research and just legally run off with millions of dollars every few months... seems lucrative!

 

[Dana]

I don't know how to add a picture, excuse me if this doesn't work

It worked, like, perfectly.

 

[Aaron123]

Yes, there is a law, but it is widely ignored: https://www.statnews.com/2015/12/13/clinical-trials-investigation/

 

[Mithrandir]

With this money we can heal hyperacusis and surely find something correlated with tinnitus !

 

[MikeP505]

The problem with research studies are they typically are not done with passion. Meaning they are usually carried out legally however those involved in the research can pay themselves what ever they want per hour or even a salary based pay scale, also write off tons of added expenses including fantastic trips around the world for "meetings" to discuss the research with others doing the same, pay those others by cheque as proof they had the meetings, enjoy the trip and eat at great restaurants and book class A rooms in 5 star hotels, and the list can go on and on. Once the research money has been accounted for after paying themselves say.... $150.00 per hour, and all added expenses, they simply publish a report no matter how conclusive it is, and BOOM!! Bob's Your Uncle!! Legal and useless.

Not to say researchers and research is a bad thing, but we as humans are pretty greedy and like to enjoy ourselves on other people's dime. History has proven this. Look at cancer research. Billions used on research that produced poor or no results. A few passionate research companies and individuals have made positive strides in some areas but not many. We do need research on Tinnitus. We do need more research and understanding on SSHL. How do we invest in this research properly feeling like we are not just making someone else wealthy for a year or more?

In short, I have begun to research Tinnitus and SSHL. I am documenting any and all findings by everyone I can. All of this in on MY dime. Should I find some positive ways to make changes or treatments available, and find a need for research money, then and only then will I apply for this. I would like the investors, be it taxpayers or private companies or individuals, to know what I am doing is well worth the money and not a cash grab for myself.

My ultimate goal is to have Hearing Health added to Elementary School Curriculum teaching along with Physical Education. Much like they way we were taught to brush our teeth or we COULD get cavities in the future. It needs to be reinforced for many years in children if ever we are going to be successful in lowering the numbers of sufferers like us in the future. A cure may or may not be possible but PREVENTION will defiantly have a strong impact.

 

[MikeP505]

@Markku

The possible reason the report on the study carried out by Richard S. Tyler not yet being published is there still may be funds unused and legally needed to be accounted for. So he MAY still continue to research until such time. What I would like to see in ALL studies done in every research capacity, is how much they paid themselves or how much the company charged for this, and exactly each and every added expense. He may also have simply run out of research funds and in need of more to complete his findings properly? I am only speculating here on the reason for the lack of publishing the report however history has proven that not all research has been worth the investment. Many research companies and individuals have become rich doing this without making a dent in progress for treatment or prevention in many many areas. However said, we cannot give up. Hopefully Richard S. Tyler will have made strides towards some good in Tinnitus treatments and/or prevention?? I am not holding by breath tho.

Regards and keep up the good work Markku!!

Mike

 

[Rings-a-Bell]

@MikeP505 You mention that PREVENTION will have an impact. Well here's something I always thought... certain decibel levels are proven to cause hearing damage right? Shouldn't there be a law as to how loud nightclubs and concerts should be allowed to go? And shouldn't that law actually be enforced? I mean if someone willfully and knowingly does something that is proven to cause people long term irreversible damage then they incur a legal liability. Perhaps we need some class action lawsuits by former clubbers how now have T and hearing loss against some big bars and concert venues to create some visibility and perhaps eventually change this.