Low-Level Laser Therapy (LLLT) for Tinnitus — Efficacy Debate

[dboy]

The only "implication" I care about is whether or not LLLT does what its advocates claim it does for tinnitus. How it gets there is of no concern to me.

Dr. Stephen Nagler

But surely you can see my point? If LLLT is a scam for tinnitus but possibly not for hearing thresholds then it must hold that improving hearing thresholds will not improve tinnitus?

You value science very highly but is not science founded on logical inference as well as observation?

 

[Dr. Nagler]

But surely you can see my point? If LLLT is a scam for tinnitus but possibly not for hearing thresholds then it must hold that improving hearing thresholds will not improve tinnitus?

I don't have an opinion about LLLT for hearing thresholds.

You value science very highly but is not science founded on logical inference as well as observation?

Why in the world do you care about what I personally value highly? I surely don't care about what you value.

Look, either LLLT works for tinnitus or it doesn't. That is a FACT.

And here's another FACT: What I happen to personally think about LLLT cannot possibly affect whether or not LLLT does indeed work for tinnitus. They are totally independent variables.

Now I do not let that reality bother me one bit. And I find the fact that it bothers you and one or two others here so much to be incredibly bizarre. But that's your problem - not mine.

Either I am right or I am wrong about LLLT. Personally, I'd love to be wrong about it. But either way, my opinion about LLLT does not affect the reality in the least.

There was a terrible tragedy today in Paris. THAT bothers me. It bothers me a lot. But what you think about what I think regarding LLLT, or anything else for that matter? That doesn't bother me in the slightest.

I hope you are finished with this ridiculous line of questioning. Because I sure am.

stephen nagler

 

[dboy]

I don't have an opinion about LLLT for hearing thresholds.



Why in the world do you care about what I personally value highly? I surely don't care about what you value.

Look, either LLLT works for tinnitus or it doesn't. That is a FACT.

And here's another FACT: What I happen to personally think about LLLT cannot possibly affect whether or not LLLT does indeed work for tinnitus. They are totally independent variables.

Now I do not let that reality bother me one bit. And I find the fact that it bothers you and one or two others here so much to be incredibly bizarre. But that's your problem - not mine.

Either I am right or I am wrong about LLLT. Personally, I'd love to be wrong about it. But wither way, my opinion about LLLT does not affect the reality in the least.

There was a terrible tragedy today in Paris. THAT bothers me. It bothers me a lot. But what you think about what I think regarding LLLT? That doesn't bother me in the slightest.

I hope you are finished with this ridiculous line of questioning. Because I sure am.

stephen nagler

Crikey! You have made a lot of very strident assertions about LLLT. All I (and others) have done is to hold your assertions up to examination to see where they lead and whether they hold water. It is a valid form of debate and I think your response speaks volumes. You post very aggressively and seem to expect nobody to even query things you say. If you do not enjoy disagreement then it would be easy to not court controversy quite so ardently!

From Wikipedia:
Socratic method (also known as method of elenchus, elenctic method, or Socratic debate), named after the classical Greek philosopher Socrates, is a form of inquiry and discussion between individuals, based on asking and answering questions to stimulate critical thinking and to illuminate ideas.

 

[Dr. Nagler]

You have made a lot of very strident assertions about LLLT.

Right. And I would absolutely love to be wrong about every single one of them. Moreover, you would absolutely love me to be wrong about every single one of them. So we agree!

I'm happy leaving it at that. If you wish to carry on alone, be my guest.

stephen nagler

 

[dboy]

I'm happy leaving it at that. If you wish to carry on alone, be my guest.

Good night & no hard feelings.

 

[Michael2013]

But surely you can see my point? If LLLT is a scam for tinnitus but possibly not for hearing thresholds then it must hold that improving hearing thresholds will not improve tinnitus?

And that is why it is futile to try and limit the discussion of LLLT to only tinnitus. The whole idea behind why it would potentially work is because it is improving your hearing, is it not? If it doesn't do a thing for improving hearing thresholds or repairing the cochlea then it's certainly not going to help T.

-Mike

 

[dboy]

And that is why it is futile to try and limit the discussion of LLLT to only tinnitus. The whole idea behind why it would potentially work is because it is improving your hearing, is it not? If it doesn't do a thing for improving hearing thresholds or repairing the cochlea then it's certainly not going to help T.

-Mike

In the case of LLLT I believe that is correct, although there are treatments that aim to treat T in the brain without correcting hearing loss (eg. neuromodulation, Autifony's upcoming drug, etc.).

 

[Michael2013]

In the case of LLLT I believe that is correct, although there are treatments that aim to treat T in the brain without correcting hearing loss (eg. neuromodulation, Autifony's upcoming drug, etc.).

Agreed. It will be interesting to see how those turn out, that's for sure.

 

[Dr. Nagler]

Bad hair day ...

Guys, I sorta had a bad hair day today, which if you check out my photo to the left is definitely not a good thing at all. Anyway, I hope I didn't offend anybody with my responses in this thread. We might see things differently - but in the final analysis we are on the same side of this thing. Anyway, my apologies to all.

stephen nagler

 

[dboy]

Bad hair day ...

Guys, I sorta had a bad hair day today, which if you check out my photo to the left is definitely not a good thing at all. Anyway, I hope I didn't offend anybody with my responses in this thread. We might see things differently - but in the final analysis we are on the same side of this thing. Anyway, my apologies to all.

stephen nagler

Hi @Dr. Nagler, if I am included in that apology then no worries & thanks. I can see how it might have felt that folks were ganging up on you, and that my question was annoying to you. The point felt (feels) important and worth making, which was why I repeated it when you dodged it. But yes, we are all on the same side and maybe you and I could both be gentler in how we express ourselves. I will try.

 

[dboy]

P.S. I was wrong when I referred to Autifony's drug as not intended to improve hearing. It is.

In the case of LLLT I believe that is correct, although there are treatments that aim to treat T in the brain without correcting hearing loss (eg. neuromodulation, Autifony's upcoming drug, etc.).

 

[Zechariah]

And that is why it is futile to try and limit the discussion of LLLT to only tinnitus. The whole idea behind why it would potentially work is because it is improving your hearing, is it not? If it doesn't do a thing for improving hearing thresholds or repairing the cochlea then it's certainly not going to help T.

-Mike

This is exactly the thing I've been thinking about why LLLT could work on T. Improving hearing thresholds and repairing damage is the main purpose. T getting better is only preferred "by-product".

 

[Dr. Nagler]

The point felt (feels) important and worth making, which was why I repeated it when you dodged it.

Well, in addition to expressing myself inelegantly, I likely didn't express myself clearly.

There are two things that I feel are incumbent upon me as a person with strong opinions posting on a board such as this. The first is that when I am wrong, I need to be prepared to acknowledge that fact. I have never had a problem with that. (See, for instance, Post #260 in this thread.) The second is that the fact that I am opinionated does not require me to have an opinion about everything, even though some might expect me to. And I simply do not have an opinion about whether or not LLLT can affect hearing thresholds.

stephen nagler

 

[Zechariah]

Well, in addition to expressing myself inelegantly, I likely didn't express myself clearly.

There are two things that I feel are incumbent upon me as a person with strong opinions posting on a board such as this. The first is that when I am wrong, I need to be prepared to acknowledge that fact. I have never had a problem with that. (See, for instance, Post #260 in this thread.) The second is that the fact that I am opinionated does not require me to have an opinion about everything, even though some might expect me to. And I simply do not have an opinion about whether or not LLLT can affect hearing thresholds.

stephen nagler

Well my guess is that people expect you to have an opinion (obviously) and if you don't - people expect you to look into studies/facts and form one. After all, you are the health professional at TT-forum and your opinion on some study/assumption is more valuable than Average Joe's because you can make more reliable conclusions based on your experience and education. Maybe this is the reason why ppl are wondering this "no opinion"-aspect. Needless to say, being the Doctor on the forum, doesn't obligate you to answer to everything.

Of course the turn side is that you have already greatly contributed to this forum and this all is your free time so maybe people should consider this as well when asking (or demanding) for your opinion. After all no professional wants to give an inaccurate opinion and forming an accurate/valid/"correct" opinion may require quite a bit of time. But that's another story.

I guess my point is here that Give Dr. Nagler some time and if he chooses too, he may (or may not) look into LLLT more closely and form an opinion about LLLT affecting the hearing tresholds

This may be a bit offtopic but: @Dr. Nagler , you keep telling "My opinion doesn't change the reality". Well, that is true, but your opinion may guide people to right direction while pursuing relief for T and that may lead to real positive changes in their life. So in some loose way your opinion may have some impact to reality in someones life, which again, may be a reason why people are so eager to know your opinion. Of course we could debate what "reality" actually is but I think you got my point here

 

[Dr. Nagler]

Well my guess is that people expect you to have an opinion (obviously) and if you don't - people expect you to look into studies/facts and form one.

I think in general it would be far better if they expected less of me and demanded more from themselves.

This may be a bit offtopic but: @Dr. Nagler , you keep telling "My opinion doesn't change the reality". Well, that is true, but your opinion may guide people to right direction while pursuing relief for T and that may lead to real positive changes in their life.

What I really want to do is give tinnitus sufferers the tools to think critically so that they will be in a better position to make responsible healthcare decisions for themselves based upon the criteria that they themselves feel is important.

As an example, it should be obvious to all that I have no plans to travel to Germany to become Dr. Wilden's LLLT patient. But if LLLT were an option for me back in 1994, that is precisely what I would have done.

Dr. Stephen Nagler

 

[attheedgeofscience]

P.S. I was wrong when I referred to Autifony's drug as not intended to improve hearing. It is.

I agree. However, while I do not have expert commentary on this part of the trial, I understand from my own basic reading that AUT-63 intends to target improved hearing in terms of "auditory processing". What is known is that some people, in particular the elderly, may have good hearing thresholds (as per audiograms) but still experience difficulty with interpretation of speech. To my knowledge, AUT-63 will not improve hearing thresholds, as such. It seems to me, therefore, that they are targeting a fairly specific hearing loss condition, rather than the more general one of cochlear hearing loss.

 

[dboy]

Maybe this is the reason why ppl are wondering this "no opinion"-aspect.

Just to clarify, I was rather inferring from the 'no opinion' on hearing thresholds (in contrast to 'strong opinion' w.r.t. tinnitus) that Dr. Nagler considered the efficacy of LLLT for hearing thresholds a possibility. Maybe to do so was incorrect but since I posed it as a question seeking an answer I do not think I was being unreasonable.

If LLLT is possibly efficacious for hearing loss then most people would consider that it might also work for tinnitus, therefore the matter is central to the debate. However if Dr. Nagler chooses to abstain on the matter then that is his right and I see little point debating it further.

What I really want to do is give tinnitus sufferers the tools to think critically

With sincere apologies if this seems argumentative as my intention is genuinely not to cause offence, thinking critically is exactly what myself, @FERNANDO GIL and @attheedgeofscience were doing. We just happened to be thinking critically about your own arguments.

 

[Dr. Nagler]

With sincere apologies if this seems argumentative as my intention is genuinely not to cause offence, thinking critically is exactly what myself, @FERNANDO GIL and @attheedgeofscience were doing. We just happened to be thinking critically about your own arguments.

My interest is in having folks think critically about the healthcare choices they make.

As far as thinking critically about what I might post on this subject or that, that can be a good thing as well. But if I do not have an opinion on a particular topic, trying to force the issue or put words in my mouth really doesn't get anybody anywhere.

Just to clarify, I was rather inferring from the 'no opinion' on hearing thresholds (in contrast to 'strong opinion' w.r.t. tinnitus) that Dr. Nagler considered the efficacy of LLLT for hearing thresholds a possibility.

Probably best not to infer anything in that regard. No opinion means no opinion.

stephen nagler

 

[Michael2013]

As far as thinking critically about what I might post on this subject or that, that can be a good thing as well. But if I do not have an opinion on a particular topic, trying to force the issue or put words in my mouth really doesn't get anybody anywhere.

I think what people might be getting at is that if you don't have an opinion on how LLLT affects hearing, then it lessens the value of any thoughts you might have about LLLT for tinnitus. Again, the idea is that if LLLT improves hearing or repairs hair cells, that gives credence to the possibility that it could improve tinnitus since tinnitus is often the result of damaged hearing.

Of course I'm extremely skeptical that it works effectively for either one of those.

-Mike

 

[Dr. Nagler]

I think what people might be getting at is that if you don't have an opinion on how LLLT affects hearing, then it lessens the value of any thoughts you might have about LLLT for tinnitus.

I have very clearly stated the rationale behind my opinion about LLLT for tinnitus - and it has absolutely nothing to do with whether or not LLLT affects hearing.

I am getting rather dizzy from going around and around in circles over this - so I'm going to excuse myself from this discussion.

Best to all -

Dr. Stephen Nagler

 

[Michael2013]

I have very clearly stated the rationale behind my opinion about LLLT for tinnitus - and it has absolutely nothing to do with whether or not LLLT affects hearing.

I am getting rather dizzy from going around and around in circles over this - so I'm going to excuse myself from this discussion.

Best to all -

Dr. Stephen Nagler

Yes, you keep going in circles. I was just trying to help explain why that was, as you seemed to be missing everyone's point but your own. Don't worry about it.

-Mike

 

[Dr. Nagler]

Yes, you keep going in circles. I was just trying to help explain why that was, as you seemed to be missing everyone's point but your own.

That can happen on a message board.

Don't worry about it.

I'll try not to. Thanks!

stephen nagler

 

[dboy]

A bit of an experiment that may or may not be useful:

I thought maybe it might help with that going around in circles thing if we made a list of what the clearly stated points refuting the efficacy of LLLT for tinnitus are, and what objections have been put forward against those points. Maybe even objections to those objections, but lets keep it in concise/summary format otherwise this will not work. Anybody who wants to add to the list could simply copy the list whole into their post and then add their contribution. Explanations or rationales could be posted separately from the list itself if anyone wants to.

This does not need to dominate the thread, it could just recur when a relevant new point or argument emerges. I'll start but this is from memory (not great) so feel free to correct any points. Although we all have our own personal opinions lets make a stab at impartiality if updating the list. This should not take the life out of the debate, just be an occasional aid to clarity (and cooperation).

1 - There are several studies showing no efficacy for LLLT in treating tinnitus.
BUT - These studies use very low doses and seem designed to fail. ATEOS has demonstrated a clear link from at least one such study to a hearing aid company, which seems to support claims of bad faith.

2 - Dr Wilden (or other practitioner) has not conducted a double blind, randomised clinical trial.
BUT - Such a trial costs a lot of money. Dr Nagler suggested ATA funding may be available but in reality this seems unlikely. Dr Wilden has published a trial but this fails to meet the 'gold standard'.

3 - If LLLT worked for tinnitus then it would be more well known and used.
BUT - It takes a big commitment of time, effort and money to get results and these are not guaranteed.

[Old arguments discarded: Light cannot reach the cochlea (now accepted that it can); Dr Wilden would have a Nobel Prize if it worked (specious, probably not actually true?).]

 

[Dr. Nagler]

1 - There are several studies showing no efficacy for LLLT in treating tinnitus.
BUT - These studies use very low doses and seem designed to fail. ATEOS has demonstrated a clear link from at least one such study to a hearing aid company, which seems to support claims of bad faith.

The studies were not designed to fail. That's is just the claim of LLLT advocates. Jack Vernon and Mary Meikle were co-investigators on the Nakashima study. Those two tinnitus research superstars do not participate in studies designed to fail.

2 - Dr Wilden (or other practitioner) has not conducted a double blind, randomised clinical trial.
BUT - Such a trial costs a lot of money. Dr Nagler suggested ATA funding may be available but in reality this seems unlikely.

Unlikely? ATA and NIH fund studies all the time.

Dr Wilden has published a trial but this fails to meet the 'gold standard'.

Right. But I think you are suggesting that this standard is difficult to achieve, when in point of fact such studies are commonplace.

3 - If LLLT worked for tinnitus then it would be more well known and used.
BUT - It takes a big commitment of time, effort and money to get results and these are not guaranteed.

NO! The results of a reliable and verifiable double blind randomized prospective LLLT tinnitus study would be absolutely guaranteed. That's the point of doing the study in the first place. It is how science is done and how real progress is made. What would not be guaranteed is that the results of such study would be to Dr. Wilden's liking. He is far better off raking in the $$ and leaving the question unanswered. Otherwise, he'd have to find a whole new scam.

If it looks like a duck, walks like a duck, and quacks like a duck ... then it's a duck until proven otherwise.

Dr. Stephen Nagler

 

[dboy]

OK. It was only an idea. I'm off to bed.

 

[attheedgeofscience]

The studies were not designed to fail. That's is just the claim of LLLT advocates. Jack Vernon and Mary Meikle were co-investigators on the Nakashima study. Those two tinnitus research superstars do not participate in studies designed to fail.

Dr. Nagler, I was wondering if the study you mention is the following one? Thanks.

Transmeatal low-power laser irradiation for tinnitus.
Nakashima T1, Ueda H, Misawa H, Suzuki T, Tominaga M, Ito A, Numata S, Kasai S, Asahi K, Vernon JA, Meikle MB.
Author information

• 1Department of Otorhinolaryngology, Nagoya University School of Medicine, 65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan.

Abstract
OBJECTIVE:
To evaluate effectiveness of 60-mW laser irradiation in the treatment of tinnitus.
STUDY DESIGN:
Prospective, randomized double-blind study.
METHODS:
This investigation included 68 ears in 45 patients with disabling unilateral or bilateral tinnitus. The active or placebo laser treatment was administered transmeatally once a week for 6 minutes. Laser irradiation was performed four times during a 4-week period. A questionnaire was administered to evaluate the loudness, duration, quality, and annoyance of tinnitus before and after irradiation. The loudness and pitch match for tinnitus were obtained, and distortion product otoacoustic emissions were also examined.
RESULTS:
No significant difference was observed between the active and placebo laser groups with regard to outcome of loudness, duration, quality, and annoyance of tinnitus. In one patient who received active laser treatment, acute hearing deterioration occurred after the third irradiation.
CONCLUSION:
Transmeatal low-power laser irradiation with 60 mW is not effective for the treatment of tinnitus.

Source: http://www.ncbi.nlm.nih.gov/pubmed/11981384

 

[Dr. Nagler]

Dr. Nagler, I was wondering if the study you mention is the following one? Thanks.

Yes.

And to the best of my understanding the study failed only in that it failed to demonstrate efficacy.

You don't do studies for the purpose of demonstrating efficacy. You do studies for the purpose of demonstrating the truth.

The LLLT advocates' criticism is that the Nakashima study protocol was "not correct." But in the 14+ years since that study was completed LLLT advocates have failed to produce an independently conducted study of similar rigor using what they consider to be the "correct" protocol.

Doesn't that bother you at all?

stephen nagler

 

[dboy]

OK, couldn't sleep but definitely going after this as it's been a long day.

The studies were not designed to fail. That's is just the claim of LLLT advocates. Jack Vernon and Mary Meikle were co-investigators on the Nakashima study. Those two tinnitus research superstars do not participate in studies designed to fail.

Nevertheless the dose is ridiculously low.

Unlikely? ATA and NIH fund studies all the time.

Nevertheless, providing a high enough dose for a long enough time would make it an expensive study. Some analysis of ATA finances a couple of pages back made it look unlikely that they could meet the cost. You did not dispute that analysis when it was posted.

Right. But I think you are suggesting that this standard is difficult to achieve, when in point of fact such studies are commonplace.

Maybe for medications. Pharmaceutical companies have huge resources and the logistical issues involved in getting participants to take medications are probably considerably less than those for double blinding a labour intensive long-winded series of therapy sessions. Maybe this is why the doses are so ridiculously low in so many studies.

NO! The results of a reliable and verifiable double blind randomized prospective LLLT tinnitus study would be absolutely guaranteed. That's

I think you misunderstood that point. It was about the lack of widespread adoption of LLLT for tinnitus, nothing to do with trials. I thought I remembered you or someone else making that point.

This stuff has all been debated previously so many times it makes my heart sink. And yet for some crazy reason I find it hard to walk away. Personally I do not know whether LLLT works for T or not, but I know that when I read through all the hundreds of posts restating the same old arguments (on both sides) and when I followed up and thought critically about it all, I felt it was worth a try. Not because I am gullible, but because I am simply unconvinced by the rigid, dogmatic arguments that I read against LLLT (and because it seemed to have helped some people who understood their own condition). Indeed, the dogmatism makes me more inclined to mistrust those arguments. I guess you think that people who come to this conclusion must be missing something. I am pretty sure that I am not and that I understand those arguments fairly completely. I just do not think that they settle the matter.

The LLLT advocates' criticism is that the Nakashima study protocol was "not correct." But in the 14+ years since that study was completed LLLT advocates have failed to produce an independently conducted study of similar rigor using what they consider to be the "correct" protocol.

Doesn't that bother you at all?

I know that was for ATEOS, but let me borrow it and turn it around. It bothers me personally a little, honestly it does. Now does'nt the low dose of treatment in that study bother you at all? Loyalty to your profession, etc., aside? Looking at the numbers with an open heart?

Best wishes and good night.

 

[attheedgeofscience]

And to the best of my understanding the study failed only in that it failed to demonstrate efficacy.

Dr. Nagler, yesterday I provided a thorough overview on how to compare studies of LLLT:

https://www.tinnitustalk.com/threads/low-level-laser-therapy-lllt-for-tinnitus-—-efficacy-debate.7650/page-9#post-88136

Earlier today, you post another study saying:

Jack Vernon and Mary Meikle were co-investigators on the Nakashima study. Those two tinnitus research superstars do not participate in studies designed to fail.

"Jack Vernon & Mary Meikle" Study

Energy (J) = Power (W) x Time (s)
E = (60 mW) x (6 x 60 s)
E = (0,060 W) x (360 s)
E = 21,6 J

Since there were four treatments, the total energy delivered was 4 x 21,6 = 86.4 joules.

Dr. Wilden's Therapy

I have already calculated the energy delivered with Dr. Wilden's therapy (in my post from yesterday, and so I will not do it again).

Energy delivered > 40,000 joules.

Analysis

So in terms of a direct comparison, the ratio is 86 / 40,000 = 0.2% (the study from yesterday was at 0.03%).

Now to be fair... to VERY fair, the study does not mention if the treatment protocol...

The active or placebo laser treatment was administered transmeatally once a week for 6 minutes.

...was done with skin contact or not. If it was, then let's factor in a VERY generous factor (x 10) in energy delivered to the cochlea.

New comparison ratio = (86.4 x 10) / 40,000 = 864 / 40,000 = 2.2%

The study abstract is poorly worded, but it would (possibly seem) that the bilaterial tinnitus patients may have been treated with a "double dose" ie. left/right ear (6 min. each).

New comparison ratio = (86.4 x 10 x 2) / 40,000 = 4.3%

So... in the VERY, VERY, VERY best of circumstances, the energy delivered to the cochlea stands at a comparison ratio of 4.3% ("Vernon/Meikle study" vs. "Dr. Wilden"). But most likely somewhat less eg. 1-2%.

You put your name behind this? You say these guys are "superstars"? Really? Yesterday, I did a calculation for everyone to see (and follow). And now you present me with this as proof LLLT does not work?

I don't know what intentions Jack Vernon and the rest of his "gang" were up to. How could I know? But if the study from yesterday was "trash", then the one from today is "just" garbage...

attheedgeofscience
09/JAN/2015.

 

[Dr. Nagler]

@dboy and @attheedgeofscience -

We disagree.

All the best -

stephen nagler