Completed Commercial Lidocaine Patch as a Treatment for Ear-ringing

The University of California, Davis, is currently recruiting people with chronic tinnitus to participate in a three month clinical trial that uses a 5% transdermal lidocaine patch as a tinnitus treatment. If anyone lives in California, they might want to participate. The full text of the trial can be found here.

Here's an excerpt about the trial, located under "Detailed Description":

Potential research participants will be recruited from the UC Davis Otolaryngology clinic. For this investigation, the investigators will be using the Tinnitus Functional Index, a standardized and validated survey for the impact of tinnitus on an individual's life. The study design will be an unblinded, quasi-experimental protocol to ascertain if transdermal lidocaine can reduce subjective tinnitus. This initial investigation will be studying the efficacy of 5% transdermal lidocaine patches in the treatment of tinnitus. Transdermal lidocaine is currently approved by the FDA for the treatment of post-herpetic neuralgia, but it is used off label for a wide assortment of conditions. The investigators will be following the guidelines used for the general use of transdermal lidocaine and will remain within the dosing approved by the FDA. The investigators intend to sequentially recruit 44 participants for this study, in the order that they present to the UC Davis Otolaryngology clinic.

SUBJECTS Eligible subjects are greater than 18 years of age and have had at least a history of chronic subjective tinnitus. Prior to enrollment, all potential subjects will be screened to see if they meet the inclusion and exclusion criteria as listed in Section 6. Once inclusion and exclusion criteria have been evaluated, appropriate participants will undergo the informed consent process. Following informed consent, all selected participants will undergo a full history and physical exam. We will not be performing a pre-enrollment EKG, as it is not required for the general use of transdermal lidocaine. Each subject will have had an audiogram performed as standard of care for evaluation and management of chronic tinnitus.

MATERIALS AND APPLICATION This investigation will utilize the UC Davis Otolaryngology clinic and its resource within for this investigation. TFI surveys will be provided for the participants. The drug used in this investigation will be 5% lidocaine patches (Endo Pharmaceuticals and Actavis Pharmaceuticals). Study drug will be prescribed by a physician in the Department of the Otolaryngology at UC Davis, to be filled at the pharmacy of the participant's choosing.

The transdermal lidocaine patches will be administered to the participant's torso, either the upper back or chest, at his or her preference. If an individual is so slight of build that he or she can not apply three patches to either his upper chest or upper back, then other locations will be considered, including low back, buttocks, and thighs. Patches will be applied first thing in the morning to these areas daily, and kept on for twelve hours. Following patch removal at night, the patient will undergo a twelve hour drug recess off of the transdermal lidocaine.
​

Here is the criteria:

Inclusion Criteria:

• 18 years of age
• History of chronic subjective tinnitus that cannot be attributed to vascular, neurologic, neoplastic or traumatic causes
• Capable of self-applying the lidocaine patches

Exclusion Criteria:

• History of heart disease
• History of irregular heartbeat
• Prior MI
• Previous exposure to lidocaine as a treatment for tinnitus
• An allergy to adhesives
• Allergy to lidocaine.
• Taking medications, herbal remedies and supplements that may interact with lidocaine, including but not limited to antivirals, benzodiazepines, and St. John's Wart
• Known liver disease
• Known kidney disease
• Adults who do not speak English,
• Adults who cannot consent for him or herself
• Women who are pregnant,
• Women who intend to become pregnant
• Nursing mothers
• Prisoners

​

 

I'm at it again. I wish I could be younger and ignorant. My mom lived about an hour away from me. She was dying of lung cancer. "Trips" for her were difficult. She went to an idiot doctor next to my village, though. I didn't realize what she was getting until I watched. He was treating her pain with lidocaine injections - nothing more. She didn't know and went to him in desperation and I have seen doctors counting on that because desperation leads people to false and imaginary help. I brought him aside and said (in some tactful manner) I know what you're doing - giving false hope to a patient. All you're doing is using lidocaine. It barely helped her (if at all). The effects of simply numbing her worn body were temporary. I believe pot would've been longer lasting and likely more effective from the CBD.

I know we'll see a form of the results in time. What we will not ever know is the efficacy of it or (I'm sorry) if the reporting of results on the small number of people really worked. I've seen too many studies with invalid and incorrect reporting reporting done on purpose.

 

Why is lidocaine now floating around again, as patches this time? I see articles from 2000 where it was injected into the ears.

 

Oh brother. Maybe because it's a good and cheap way for physicians and pharms to make easy money? Injections with it prior to local ear surgery I understand, anything beyond that -- start with my 2nd sentence.

 

I have these exact lidocaine patches for neck pain.

Using three at once sounds excessive. And putting them anywhere on the body would be the method of application? Not up high near the neck? Or the ear?

If I used that many, my arrhythmia would probably be in high gear. I wonder why the dose is so high?

And they are super expensive. $500 a box. So they are NOT cheap. Thank god I get special approvals from my insurance or I would not be able to afford them.

 

Ooops. My mom had the injections covered under insurance in 1997. She had a lot of shots. Lidocaine for neck pain makes complete sense. It's like pushing novacaine (which I can't spell) to allow dental work with minimal pain during and the reality of the pain after. But for tinnitus? It's just seems really, really weird.

I need to steal your name. zzzzzz can't sleep much with T overtaking my brain at different frequencies and notes...

 

Here the surgeon(s)/researchers go again. Pre-Trials million dollar grants, in order to get this on the market as another investment product...and a tempting one at that with all those patients with T. After it's passed, the Surgeon/Researcher will be given the "Doctor of the Year" Award(s) to add to their list of credentials, which is NOT from patients, but Corporations. Very misleading to patients. Long-term outcomes are usually not published like every other product or device (unless many people come forward with serious side-effects and/or are "paid" to go away). Only 3 months for this test-trial? Pharmaceutical co. don't care as long as the money's rolling in. (Yes, I'm cynical because this chemical was ALREADY tried & used for years).
Brianna's input here is very true and it's critical to educate others to be informed to make better decisions.

Lidocaine injections were already tried for years for T and they indicate it does works as a VERY short-term relief for some. So you know what that means - addiction and more money to stay on them. $$$$
Long-term outcome? Very much alike taking Benzodiazepine meds. which patients are having extreme difficulties tapering off & are developing dementia (leading to Alzheimers). How convenient, patients can't complain afterward when it's too late!
Wonder which pharmaceutical co. is funding this "patch" product? USA or Foreign?

 

sakrt! I'm too pooped to respond to your note. I'm GLAD you're back. I keep referring to your experience (referencing your ID) and you disappeared. Yes, folks, unrelated to the thread. Oh, crap, I read enough of what you wrote to know we're in complete synch and in the sink drain as a result. Go ahead, tell me the yuck reality. Continue to make me disillusioned in the system. (Kidding ...) god, what a world. I'll try to find where the patch originated. Will be back manana. Are you feeling any better?

Sorry about the onslaught. I try to eat my last meal about two hours before I start unwinding and I'm late.

 

Are these patches even viable? Are they ever gonna be released commercially?

 

I promised I'd attempt to find out about the company and I will answer your questions best I can, too. Who the company is becomes important if you're really interested in their product. But, I'm not, so this will be short.

1. It's made by Endo International, plc. The website here only refers to the U.S. I don't know where the patch originated. Here's one paragraph from that website:
"Although accessible by others, the U.S. product information on Endo and Endo websites is intended for use by US residents only. You should not construe anything on the site as a promotion or solicitation for any product or for the use of any product outside the United States."
2. The product can be found - so a search on lidoderm as your link may not be the same as ours. I have no idea if you'd find anything different where you live.

The best I can suggest to you about your question is twofold: 1) The top of the thread contains what may now be old info about the status of Lidocaine (in a research study here) using people test subjects. There's likely more information as to whether it is released elsewhere such as your country but my own focus isn't on this product.
2) A gentleman (poster) talks about how he uses the patches (in the U.S.) for his neck pain (that makes sense to me). They are, therefore, available here I just don't know if they can be prescribed for T.

What I often see on the internet is, depending on where you live, gets interesting. One set of information and suggestions are made to the U.S. and a completely different set of info is for "your specific country." I don't know what I saw years ago but the U.S. button took me a pharmaceutical. If you weren't from the U.S. and clicked on the other button, fish oil was recommended.

 

I better pretend I have neck pain lol!

 

Ya know ... as I was writing my response to you, I wanted to write that. But, I couldn't and likely, after doing scans, it would become too obvious. *** Trying to stay on track but let me start with you.*** The problem w/assisted suicide not being allowed for T is there's no proof it's real. My partner sees what's happening to me and knows I'm not riding my motorcycle today. I look d e a d . She gets it because we live together. I went to a cochlear implant thread after getting off earlier to see if I could dispose of the lies around it. There was a thread on T and sub-threads under it. The first thread was about the psychological response surrounding it. It wasn't a surprise. I can't really slug anyone through the internet and that was my first gut reaction to it.

 

People have been allowed the right to die for tinnitus. I mean, if it is really that bad, then firstly, we that person should be given trobalt and the other potassium modulators. And secondly, the doctor should be willing to listen and understand that he needs to try multiple drugs...My doctors excuse for not giving me certain drugs is because he doesn't want to look like he's experimenting on me!? I mean seriously...

 

I've been wanting to create a new thread but I have to do some research first and you brought it up... sort of beating me to the punch and I'll create the thread another time. In the U.S., having tinnitus is not on the list of reasons for physician-assisted suicide. Christian78 from Sweden showed us Dignitas' response - they wouldn't allow T as a cause for p-assisted suicide. What's the deal in England - 1) Is there p-assisted suicide? 2) What are the conditions that allow it if so? Ultimately, that will be the focus of a new thread. I want to understand what happens in other countries. I'm starting with you.

In the U.S., the National Institute of Health (where Presidents go to be treated for illness - it's just outside D.C.) experiments on people who allow it. A woman will be coming to a friend for cranio-sacral therapy (doesn't matter what that is, really) who said she was in two trials. I don't know the number of those who participated. In one, three people were alive at the end of that trial. It's ironic that we can't get p-assisted suicide (god, I need to shorten that!). But the government can do experiments on us that may kill us (with our consent due to the unpredictable results it may cause).

Hey, Danny Boy, do a search (More - Advanced Search) because there's another thread similar to this. Get your voice in there. Gotta run.

 

If lidocaine has a short term effect on T where is it injected?

 

Through the tympanic membrane (eardrum). A colleague of mine who has Menieres disease had the injections - said they really didn't do anything for her, but the procedure were very painful.

Here's another funded redundant "Abstract" link below. Again, like Erik said "...lidocaine has been around for a long long time". ENTs/Otoneuros. have been doing these injections with short-term results. Easy money. Long term outcome of repeated injections? - not stated. (Likely ended up in Alzheimers group homes). Regardless of years of use - they know it's a quick money-maker scheme such as the quote (from abstract) states: "The i.t. approach could open up promising new pharmacological treatment options, particularly, in the field of tinnitus therapy"...therefore the birth of the (short-term) patch. (Made in China, distributed in USA & not for eating).
If this invasive INJECTION approach is short-term. How many patches are required to paste around the head for T when available at Walgreens?
http://www.noiseandhealth.org/artic...me=15;issue=63;spage=83;epage=90;aulast=Meyer

 

Ouch! But about Meniere's disease, there is a treatment that works it's called Regenokine. Dana White the president of the UFC did it and got cured.

 

Humph... crap and now we're all on the same page again. I found a the international pharm that produces the patches and there's also a website that lists the uses for the patch and it doesn't include T. I listed it somewhere on this forum.

Injections are as ridiculous as using them on my mom for "treatment" of her lung cancer. It just numbs the site (after a good hit of pain for the pain). god, what a never-ending bunch of garbage we're going through. Thanks, sakrt. GEESH!!!!

 

Rich people.

Hm, so can you buy these patches and how long is the relief meant to last?

 

If I can find out:
1. Side-effects (I can do that online) and will discuss briefly in thread with the main skeptics here f i r s t .
2. If insurance will cover it (since I know a fellow on a thread said a box (quantity unknown - I didn't ask) costs $500.
3. If insurance may cover it under certain conditions, I have to ensure the trail already created is sufficient enough to cover it. Fortunately, since it's in my records pre-cochlear impland AND after and is consistently in those records spanning several years (3 - 4), that may help.

My brain is slowing down, so with other things in life, it may be a longer process to get through than pre-cochlear T.
I'll give it a go. But at the moment, I doubt insurance will cover it and it's just doubtful it can work. If I was still in corporate, $$ wouldn't be an issue. It appears to be treated like fibro-mayalsia (not spelled correctly) and lyme were treated twenty years ago - they were ignored and doctors did not believe those who suffered from it, including a now fairly incapacity family member. This is also brain complex or Pandora's Box oriented . I'm treading with care. Results may vary, as all US commercials here say. T seems to know no bounds as to where the loudness stops. Also, what doesn't work for me may not work for you.

Thanks, Erik.

 

Danny Boy: We can ask those questions but it's likely person and dependent. I can ask (if any doc in where I live knows the answer ... but that's doubtful). If you opt to use the website on lidocaine patches, you'll likely get an answer more geared towards either non-commitment or a marketing answer.

 

Lol, they can just take my monies...

 

That sounds like the better route for me! I'll stop at our local pharmacy and find out what the
cost is (if they have them) w/our local discount cards rather than through insurance... and I know this
is likely going to land me nowhere and it's en route to other stops that way. They say to give me a cost (so I can comparison shop), they have to put a prescription through.

Hmmm... a laughing British guy is a nicer way to wake up.
* * * * BUT, I THINK I HIT MY FIRST SERIOUS ROADBLOCK:
Lidoderm is lidocaine - It's where I started my search about the patch on Sunday:
Lidoderm be subject to prior authorization requirements.
The following criteria were established by the DoD Pharmacy & Therapeutics (P&T) Committee.
Prior Authorization Criteria for New and Current Users - Manual PA criteria:
a Lidoderm is approved if:
-
The patient has a diagnosis of postherpetic neuralgia

The patient has a diagnosis of another form of peripheral neuropathy
-
The patient has a diagnosis of other pain (non- neuropathic) and an occupational or clinical reason exists that other analgesics are contraindicated
*Coverage for other uses of Lidoderm is not approved.

I'm going to continue my zoning out elsewhere. You guys tell me if it's worth even pursuing.

I will add I looked at a veteran's forum days ago. It was interesting to me, so went back there in the wee wee hours of the morn. All were complaining about how hard it was to get VA approval for T treatment despite the atrocious continuously loud conditions in which they worked - like flying planes, and ... brain isn't working well again ... just other loud exposure. Ooorah.

erik: If you're here, you live in the states, too. I'd like your opinion. You know what our system is like. I'm using any energy I have lately to get through usual stuff.

 

Do update me on if you can get some..In Spain they give you stuff without a prescription lucky sods lol

 

I like your accent . Lucky sods is very cute and I agree. I'm under a bit of an added stress, so looking into patches just became lower on my list. I'll continue checking but it's not on the list for allowable drugs for T is in the states.

 

I wouldn't waste time and energy finding these. I have them and they don't work on t.
And tou do need pre authorization from insurance because it would be used off label for t. Your doctor would have to say that nothing else has worked for "x" condition, therefore the patient needs these patches.
I have them for nerve pain in the neck so it isn't a far cry from post herpetic neuralgia.
Maybe if you plastered your whole body with the patches it may work but I wouldn't put more than one on at a time anyway.
Just trying to give my honest account of my experience with these. I never noticed any change in the t, and they are very expensive and 30 to a box. They started to make generics after their patent timed out but they su#k.
I hope I am wrong on this. It would be wonderful if they worked.

 

SleeplessSoul! Yes, I believe I've referenced you a few times. I said using them for neck pain makes sense but for T... it was a far stretch. Thanks! Nothing like not pursuing research and hitting a brick wall. Thanks!

Honest and open with few euphemisms is what I prefer rather than giving false hope (I didn't have it at all but was willing to offer myself on the alter - within limits).

So, youngsters from the oldsters (sorry, Danny Boy, off you go to Spain) this ends the question about lidocaine for me. Any other sacrificial lambs can follow in the short steps I've taken or the longer steps Sleepless has taken.

 

Brianna. I am no youngster here either!!! Maybe I will stick a patch by my bad, sore ear and see if anything gets quieter and report back. Let's not hold our breath though!
Like your pic from a long time ago, that was a good idea. Lol