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

I don't want to derail things, but I do want to make a counterpoint to mick's complaints about medical studies showing eggs are bad, etc.

There never were any such studies. Nutritionists did retrospective studies looking at correlations between certain kinds of diets and published observational studies that showed (sometimes) correlations between coronary health and certain classes of foods. There was a bandwagon effect, and lots of arguments about dietary cholesterol and heart attacks made it into the popular (and medical) minds.

But the kinds of studies required in science and medicine were never done. They are very hard--almost impossible--to do as prospective randomized trials.

So the shifting view on eggs and health isn't a reversal of scientific research findings. It is a reversal based on better (but still questionable) retrospective observational research.

LLLT is a very different kind of issue. It is dead simple to do a large experiment with a control group and a treatment group and compare the outcomes with the appropriate statistical methods. Dead simple.

 

Would this be considered a legit website to get information about these trials?

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3063436/

 

The site you pointed to is a library, containing good studies and bad.

The Iranian study you are pointing to is unblinded. Moreover, self-controls are the poorest controls there are.

That's why it is important to read the literature critically.

Stephen Nagler

 

While I am not an advocate for LLLT for tinnitus, this provides some support for the concept. There appears to be some evidence that low-power laser light can stimulate stem cells. I have not yet read the journal article listed as a reference for the below article. As I always say, each person has to judge for himself whether the findings are real or not. The details are hopefully in the journal article to enable one to do that.

From http://www.sciencedaily.com/releases/2014/05/140528150559.htm

A Harvard-led team is the first to demonstrate the ability to use low-power light to trigger stem cells inside the body to regenerate tissue, an advance they reported in Science Translational Medicine. The research, led by Wyss Institute Core Faculty member David Mooney, Ph.D., lays the foundation for a host of clinical applications in restorative dentistry and regenerative medicine more broadly, such as wound healing, bone regeneration, and more.
The team used a low-power laser to trigger human dental stem cells to form dentin, the hard tissue that is similar to bone and makes up the bulk of teeth. What's more, they outlined the precise molecular mechanism involved, and demonstrated its prowess using multiple laboratory and animal models.
A number of biologically active molecules, such as regulatory proteins called growth factors, can trigger stem cells to differentiate into different cell types. Current regeneration efforts require scientists to isolate stem cells from the body, manipulate them in a laboratory, and return them to the body -- efforts that face a host of regulatory and technical hurdles to their clinical translation. But Mooney's approach is different and, he hopes, easier to get into the hands of practicing clinicians.
"Our treatment modality does not introduce anything new to the body, and lasers are routinely used in medicine and dentistry, so the barriers to clinical translation are low," said Mooney, who is also the Robert P. Pinkas Family Professor of Bioengineering at Harvard's School of Engineering and Applied Sciences (SEAS). "It would be a substantial advance in the field if we can regenerate teeth rather than replace them."
The team first turned to lead author and dentist Praveen Arany, D.D.S., Ph.D., who is now an Assistant Clinical Investigator at the National Institutes of Health (NIH). At the time of the research, he was a Harvard graduate student and then postdoctoral fellow affiliated with SEAS and the Wyss Institute.
Arany took rodents to the laboratory version of a dentist's office to drill holes in their molars, treat the tooth pulp that contains adult dental stem cells with low-dose laser treatments, applied temporary caps, and kept the animals comfortable and healthy. After about 12 weeks, high-resolution x-ray imaging and microscopy confirmed that the laser treatments triggered the enhanced dentin formation.
"It was definitely my first time doing rodent dentistry," said Arany, who faced several technical challenges in performing oral surgery on such a small scale. The dentin was strikingly similar in composition to normal dentin, but did have slightly different morphological organization. Moreover, the typical reparative dentin bridge seen in human teeth was not as readily apparent in the minute rodent teeth, owing to the technical challenges with the procedure.
"This is one of those rare cases where it would be easier to do this work on a human," Mooney said.
Next the team performed a series of culture-based experiments to unveil the precise molecular mechanism responsible for the regenerative effects of the laser treatment. It turns out that a ubiquitous regulatory cell protein called transforming growth factor beta-1 (TGF-β1) played a pivotal role in triggering the dental stem cells to grow into dentin. TGF-β1 exists in latent form until activated by any number of molecules.
Here is the chemical domino effect the team confirmed: In a dose-dependent manner, the laser first induced reactive oxygen species (ROS), which are chemically active molecules containing oxygen that play an important role in cellular function. The ROS activated the latent TGF-β1complex which, in turn, differentiated the stem cells into dentin.
Nailing down the mechanism was key because it places on firm scientific footing the decades-old pile of anecdotes about low-level light therapy (LLLT), also known as Photobiomodulation (PBM).
Since the dawn of medical laser use in the late 1960s, doctors have been accumulating anecdotal evidence that low-level light therapy can stimulate all kind of biological processes including rejuvenating skin and stimulating hair growth, among others. But interestingly enough, the same laser can be also be used to ablate skin and remove hair -- depending on the way the clinician uses the laser. The clinical effects of low-power lasers have been subtle and largely inconsistent. The new work marks the first time that scientists have gotten to the nub of how low-level laser treatments work on a molecular level, and lays the foundation for controlled treatment protocols.
"The scientific community is actively exploring a host of approaches to using stem cells for tissue regeneration efforts," said Wyss Institute Founding Director Don Ingber, M.D., Ph.D., "and Dave and his team have added an innovative, noninvasive and remarkably simple but powerful tool to the toolbox."
Next Arany aims to take this work to human clinical trials. He is currently working with his colleagues at the National Institute of Dental and Craniofacial Research (NIDCR), which is one of the National Institutes of Health (NIH), to outline the requisite safety and efficacy parameters. "We are also excited about expanding these observations to other regenerative applications with other types of stem cells," he said.
Story Source:
The above story is based on materials provided by Wyss Institute for Biologically Inspired Engineering at Harvard. Note: Materials may be edited for content and length.
Journal Reference:

1. P. R. Arany, A. Cho, T. D. Hunt, G. Sidhu, K. Shin, E. Hahm, G. X. Huang, J. Weaver, A. C.-H. Chen, B. L. Padwa, M. R. Hamblin, M. H. Barcellos-Hoff, A. B. Kulkarni, D. J. Mooney. Photoactivation of Endogenous Latent Transforming Growth Factor- 1 Directs Dental Stem Cell Differentiation for Regeneration. Science Translational Medicine, 2014; 6 (238): 238ra69 DOI: 10.1126/scitranslmed.3008234

 

Hi,

I'm also very neutral to LLLT. But my first thought was, if there is a use ( I always read from LLLT used for neck pain treatment) it might do something in the ear too. Now if they could really proof some effect at the
moluecular level, even better... Ok, it's maybe too optimistic to make a bridge over to the ears.
I really don't know.. I'm not a cell-researcher I'm just a sufferer with some hope.

Greets Tom

 

I'm not. In fact, I'd be absolutely thrilled if LLLT worked for tinnitus. I'd be jumping up and down and screaming from the rooftops about the benefits of LLLT in tinnitus. But LLLT doesn't work for tinnitus. And wishing that it did isn't going to change that reality.

Stephen Nagler

 

Yes indeed, there is no proof to help for T, this is true. But maybe it helps for some other conditions like pressure in the ear, hearing distrotion, hearing loss... (all speculation)
And if there is a positive effect, it might indirecty affect the perception of T?

But at least, it's possible that LLLT does something positive in cells and nerves...


Greets Tom

 

I think if they changed the outcome expectations of LLLT to match that of TRT and added a counseling component, you would probably see it having similar success rates as TRT.

 

I think the point is that LLLT supposedly decreases T volume. If expectations were changed the way you say we probably wouldn't be having this conversation. Imo.

 

Dr. Nagler,

I'm confused by your certainty that LLLT does not help T while you at the same time seem to say nothing is proven until a well designed double blind study proves it. Have I missed something? Is there such a study? Again, my opinion based on what I have read and seen is that LLLT is unlikely to help T, but I also recognize that that it remains a possibility. I think there is a a bit of a difference between wishing and hoping, and I don't think anyone believes that the act of wishing or hoping is going to change an outcome other than it allows one to fight against the urge that "that the game is over". I can tell you for sure that I pulled out of a lot losing sport situations in my life by hoping and being ready pounce on a break in my favor. Without hope I would have given up. Hoping is a positive thing. The fact that hope exists is what keeps a lot of people going in life. Frankly, at this point in in time it looks highly likely that I will be dead within a couple of years, and that I'm headed for a lot misery and unpleasant treatment (nothing to do with T), but I am still hoping that something will be found to change all that. Hope is all I have at the moment, and I find it beneficial to bury myself in it as much as possible. There are unproven treatments that might help me. Without hope I might as well find Dr. Kevorkian.

mick

 

Mick, I would argue that there is--in the greater scheme of things--good evidence that LLLT does not help tinnitus. Because if it did, a prospective controlled randomized trial would have been done by now and Dr. Wilden would be rich and famous beyond anyone's dreams.

This is not complicated. Where there is a treatment that can be easily tested in a randomized trial, after a certain period of time--particularly if people are receiving the treatment--it becomes clear that the treatment doesn't work.

There is plenty of hope re both habituation and cure, but it doesn't come from LLLT.

I certainly hope that you are wrong about your own health prospects and that you find good care in that regard.

 

Yes. Please see my post #299 in this thread.

smn

 

All that matters to me is that LLLT does not accomplish what LLLT currently purports to accomplish, which currently makes it a rip-off.

smn

 

I'll agree, I'm pretty neutral to it as well. I do think that it is interesting it has been observed to stimulate cell growth in some ways. However, I'm skeptical that it would really do a lot of good. As with a lot of tinnitus treatments, it seems a few benefit but the majority do not.

There are a couple problems with this I can see:

1. Researchers studying this don't know or understand the mechanism driving this cell stimulating growth, or what it's capabilities and limitations are.
2. They have not identified specific etiologies of tinnitus for their studies.

Some of the problems may be worked out and it might turn out to be a useful treatment someday. Who knows. I'm putting my money on AM-101 or Autifony's AUT0063 compound, as the mechanisms of action are better understood and they are going to great lengths to define sub types of tinnitus which will respond to treatment. That, and they have a ton of money to back them up. Follow the money, my friends.

 

@mick , been going through many t forums and FB groups for a year now and read a lot. Yes LLT has helped
Some sufferers.

 

By that reasoning, LLLT may have actually inhibited the spontaneous resolution of tinnitus for many others.

Stephen Nagler

 

Overall: there is no relevant clinical study that shows a relevant effect on treating Tinnitus.
But, what this treatment works some kind of indirect. Let's say, LLLT does something positive
at the celular level in the inner ear and this would give an enhancement in hearing.
Less pressure, better hearing would be probably lead to less regognition in T.

At least, the new findings in this teeth-article suggest that the light is not just pulsing red light,
it can have some effect.

I'm not making a brigde from teeth to inner ear, but it's quite surprising that LLLT can have an effect.
Maybe there is now some more knowledge about the effect in neck pain treatment.
And maybe it does really something in the inner ear.../maybe not...

Greets Tom

 

Hello all,

it is very interesting to read this thread for me. Here in Germany it is a very similar discussion in the Tinnitus plattforms. But it is also very agressiv. So I left those plattforms because nearly all positiv success stories about lasertherapie are talked into "dirt" (don´t know if you say this in english?). But those who negate the Lasertreatment are also always a few "hardliners" who did not make any experience with the treatment, but never stopp saying that it doesn´t work. I also could not understand this behaviour here.
After I received my tinnitus, I read a lot in Tinnitus forums and after that I became nearly depressive because you find so many negativism. I am a absolut positiv thinking person and I think it was necessary for me not to lose HOPE. So What I cannot understad is, that if someone doesn´t have a experience about a certain treatment, why do negate it? Saying that you do not know if it works is enough!! It is not necessary that you say it doesn´t work!!!
( I was suffering from another illness years ago and all "normal doctors" couldn´t help me with this autoimmundeseas. So I found a Homöopath and I was going this way. Even if all said that this are only shugar pills, this homöopath cured my illness. But what I learned is, that you need to be open for things even if a lot of others say this cannot work!)
So back to the Tinnitus, I am a very grateful patient because my life really changed with the tinnitus and it changes now extremly since it is again away! But I will never forget who or what helped me.
The most people in forums who always say that the laertreatment doesn´t work NEVER MADE AN OWN EXPERIENCE with this treatment. So please don´t take away those people who still have hope their hope please, please, please!!! Hope is so important when you suffer from tinnitus.

I would be very interested if the hardliners against lasertherapy would accept a free treatment or not. If you would not have to pay for the treatment would you try it or would you not? Because if the laser is only a red light you dont need to have fear about the treatment because it is just red light, but if the lasertreatment is working you would have to leave your "hard line " against this treatment and you perhapes could have a chance to cure your ears. So again would you try it if it is for free?
(than I also think if it doesn´t depend on the costs why shouldn´t you try something were you read that some people had success with???)
As I am in contact with a lot of people who suffer from tinnitus i want to say that it is absolutely necessary not to give up hope. So please again stop taking hope away -this doesn´t make any sense!!!

Thanks for reading (and sorry for bad english)
Helmut

 

Hi Helmut,
thank for your input. Indeed, hope is something very good for the mind.
Especially if you have ear problems because it's something very complex and hearing is also quite in your head.

Anyway, I can also understand people who are against this treatment, because there isn't any proof available like a big double blind study. It's also true that the people offering this treatment never forced or participated in an official clinical trial like other treatments have to do. This is a fact and that's why has LLLT a "diffuse" image.

As a sufferer, I bought also some home therapy equipement and I still hope there will be an effect. This is all I can do. But in general it's a high cost application. Not everyone can afford treatment for 4000 $ US. And that's a big point. Nobody of all this people will say, ok it doesn't work here is your money back. I experiences this also with HBO therapy....
All this therapies aren't covered by any insurrance and this will have it's reason.

Anyway, I'm desperated enough like many of us to stay open minded and try some treatments just because of hope.

I really must say this laser has some fascination and as read this red light might have really an effect.

Dr. Wildens literature has in my opinion some good points, but when it comes to his "hearing aid industry conspiration" theory it's completly non sense.
What should a hard of hearing person do? Lasertherapy which didn't garantee him to receive more dB? Anf this is also a very "hardliner" aspect.
In other words, Dr. Wilden claims as the only one that he can cure hearing loss.
Where is the proof for this?

Ok, I will see at my own audiogram if this will be the case. They speak from 10-20dB....that's a lot if you have 40db hearing loss....

So you see, it's a really controverse thing and that's why we have to discuss it!

All the best
TOM

 

I have not read every post in this thread, so I apologize if this statement has already been made - it is such an obvious assertion that I would not doubt that it has been made. The argument that the proof that LLLT does not work is that a study clearly proving it does work has not been done simply does not hold water from a deductive logic standpoint . It does not matter that such a study could be done easily, inexpensively, or that successful completion of such a study that proves it does work would garner a Nobel Prize. If the study has not been done, then it has not been done, and one cannot ascertain the outcome of such a study until it is done. One can argue that the outcome of such a study is likely, or even very, very, very likely to show that LLLT does not work for T. That is still not the same as actually performing the study and having the results in hand.

I am not at all arguing that the odds of LLLT being effective for tinnitus are high. I think the evidence supports that the odds are low, but that is inductive reasoning, not deductive. Until the study has been done, the outcome is simply and plainly unknown.

I think the only claim that one can make at this point is that it is highly probable to not be effective, and is probably not worth spending money on. That is not same as saying that it does not work. It's all a matter of probability. I'm not at arguing that any one spend a dime on LLLT. I'm only arguing that from a scientific, deductive reasoning standpoint that it has not yet been proven to work or not work against the gold standard - a well controlled, well executed double blind study.

Note that even a well controlled, double blind study is not 100% absolute proof of anything either. It is still a matter of probabilities. The probability that the study conclusions are reliable would be very high, but still not 100 percent. It is still inductive reasoning, and therefore not 100% proof. It might be 99.999999%, but not 100%. That is the only difference between what I am saying and those who say with absolute certainty that LLLT does not work. They do not have a leg to stand on to support a claim that LLLT does not work (that's an absolute statement, meaning 100%). My assertion is only that 100% does not exist in the world medicine. All anyone can truthfully state that it is probable that LLLT not work and the gold standard of proof - a well controlled double blind study -has yet to be provided.

 

Mick, you are right.

And the charlatans and scammers of the world depend on just that type of thinking for their success!

Stephen Nagler

 

As another example, there is no well controlled double blind study that proves TRT works, yet it's obvious that it has helped some people.

-Mike

 

I'm not arguing whether or not there has been a double blind TRT study. There hasn't. Up to very recently it has been impossible to do one, although industry finally came up with the technology three years ago, and a multi-center double-blind randomized prospective TRT study is presently being conducted in the US Military. As it should be. (Think about it - how do you blind a tinnitus sufferer using broadband sound devices set exactly as instructed in TRT and blind the person doing the instructing at the same time!!! The technology for doing so had to be incredibly innovative.)

No, my argument is that there has been no such study for LLLT and that it would be simple and extremely inexpensive to do one. Such has been the case ever since the very first LLLT device was aimed at a tinnitus sufferer's ear and the $$ began flowing into the LLLT scammers' coffers.

Stephen Nagler

 

Because I like stirring the pot sometimes .. if an alleged scammer truly believes that what he is providing is helpful, is he/she truly a scammer? To be a scammer, one has to have fraud as an intent.

I agree that scammers exploit the lack of facts and uncertainty in the world along with the hopes and dreams of their prey. I trust that people, when provided with evidence and information, are quite capable on their own to decide who is and who is not a scammer, and what is best for them. I would rather provide the data to them and let them make up their minds for themselves rather than they take my word for it. If they analyze the data and risks themselves, and decide differently from me, that is their perogative.

When I first went to the doctor who discovered my cancer I thought he was a quack. In fact, I am still quite certain that he is selling products that are useless, and that his understanding of medicine is not that great. Nonetheless, he did what none of the many, many previous doctors did not do - he found out what was wrong with me. I was well aware that I was taking a risk to go to this guy (I weighed it as a very small risk), but felt that I was smart enough to sort out the mumbo-jumbo from the facts. Now all the more reputable doctors with all the Best Doctor awards who I saw are all congratulating me for being persistant when before they held me in contempt for being persistent with them. (To be more accurate, I guess I really don't think the doctor who found my cancer is a quack, as much as I think that he easily believes in unproven treatments. I really don't think his intention is to fraud. I believe he thinks he is doing good. And in my case, he did. I am now putting my trust into the hands of the recognized experts in treating this cancer, but they were not expert enough to find it. A lot of their presuppositions about me and this variety of cancer were plainly and flatly wrong, and that is what prevented them from finding the truth.)

I just think it is wrong to take a not fully substantiated hard line on things when simply stating what is known and not known is more prudent.

mick

 

If you keep stirring the pot, you never get to eat the meal.

Look. If Wilden is not a scammer, then he's the most ignorant man on the face of the planet.

Either way, tinnitus sufferers come out on the losing end. And that's what I care about.

smn

 

Now I getting this - it is more about Wilden than LLLT. Okay - I get that.

 

No. It's about tinnitus sufferers.

And anybody who runs a clinic where LLLT is offered to tinnitus sufferers is either a scammer or an idiot. Since scammers are sneaky and since there is no law against idiocy, it behooves us in the tinnitus community to be constantly vigilant.

Stephen Nagler

 

According to the AM101 study, in the placebo group up to 65% of participants showed some improvement in their subjective tinnitus loudness. Thats is a lot of people who got better without any actual medical treatment. This was in three months from the injection. Is it possible that the people who got better using LLLT would have fallen in to this category.
@mick your argument is correct but I don't know how accurate it is to say people arguing against LLLT don't have a leg to stand on. Using your argument i could insert any number of words in place of LLLT and your argument would be true. Would you agree that the burden of proof is on LLLT advocates? They are the ones making a pretty extraordinary claims.

 

Actually, that's the "beauty" of the LLLT scam! As long as we keep making appointments, the LLLT scammers don't have to prove a thing And as long as the LLLT scammers keep making extraordinary claims they do not have to prove, we'll keep making appointments!

Stephen Nagler

 

Thats what baffles me though, I can understand that people want it to work and would try anything to get there T better and i probably would have bought into before i started learning about T. There is one set of facts for all of us, there is not a different truth for you and and another for me. My cousin who works for a big pharmacuetical company told me the same thing you and @jchinnis keep saying about conducting a proper study. I don't know much about medicine but hearing that from three people who I have a lot of respect for and are very accomplished in their respective fields, and from common sense , its not anything I have any faith in as a treatment for T.