Ear Injection of AM-101 May Stop Tinnitus

Phantom ringing of the ears also known as tinnitus is an extremely frustrating condition that afflicts many people. Often triggered by hearing nerve damage, there's no good treatment to fix this condition once it sets in.

Until possibly now... 

AM-101 made by Auris Medical is an experimental drug containing esketamine hydrochloride embedded within a hyaluronic acid gel formulation. It works by blocking the NMDA receptors of the cochlear inner hair cell.

Normally, when there is trauma sustained by the cochlea whether it be loud noise or viral infection, excess amount of a neurotransmitter called glutamate gets release. The problem is that too much glutamate also triggers hearing nerve death due to over-excitation via the NMDA receptor. When these hearing nerves die, it leaves the brain cells responsible for hearing in a permanently switch-on state leading to tinnitus, even if there's no sound present.

AM-101 is hypothesized to block the NMDA receptor from being over-stimulated by the glutamate neurotransmitter thereby preventing hearing nerve death.

But, does it work?

According to one small prospective, double-blind, randomized, placebo-controlled study involving 248 patients, it DOES work to a significant degree.  42% reported their tinnitus was half as quiet as before compared with 14% in the placebo group. After 90 days, 57% of those taking the active gel said their tinnitus was 'much improved' or 'very much improved'.

Of course, the trick is to administer the drug before nerve death has set in after which it would be too late. In the study, only patients with onset of ringing within 3 months were eligible to participate.

Patient also need to realize that the drug is administered by injection through the eardrum and into the middle ear space. This injection technique is commonly used in the treatment of sudden nerve hearing loss where steroids are injected. Watch video of this injection method below.

Unfortunately, AM-101 is not available except under research protocols currently and is undergoing FDA clinical trials. The preliminary results are very promising however.

Reference:
Efficacy and Safety of AM-101 in the Treatment of Acute Inner Ear Tinnitus—A Double-Blind, Randomized, Placebo-Controlled Phase II Study. Otology & Neurotology: April 2014 - Volume 35 - Issue 4 - p 589-597

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Does Sinus and/or Nasal Surgery Help with Sleep Apnea?

Bluntly, the answer is not really... Although it may make sense that improving nasal airflow should help with obstructive sleep apnea, the reality is that it does not make a profound difference. Indeed, there was a study in 2014 that looked into this question.

In this study, 3 groups of patients were looked at divided into patients with mild, moderate, or severe obstructive sleep apnea (OSA). These patients underwent sinus surgery, septoplasty, and turbinate reduction.

What was found was that patients with severe OSA with a mean AHI of 52 would go down to 43 (normal being less than 5) after surgery. Moderate OSA with a mean AHI of 22 down to 20. Patients with mild OSA did not have any significant changes to AHI at all.

In other words, for patients with moderate or severe OSA, although the AHI does decrease somewhat, it does not decrease enough that it really makes any clinical difference. Patients with moderate or severe OSA still had OSA... and still would need to use a CPAP or equivalent machine after surgery to correct their sleep apnea.

Although at first blush, these results may not make sense, it actually does make sense when you consider sleep apnea to be a multi-level disorder affecting not just the nose, but the throat as well.

For example, the back of the tongue may fall backwards obstructing the airway causing sleep apnea. Correcting nasal factors would have absolutely ZERO impact on tongue factors of OSA.

In order to determine where these other anatomic factors may be that may contribute to OSA, a sedated or sleep endoscopy is often performed. Watch the video below.

Granted, patients may STILL wish to pursue sino-nasal surgery due to discomfort with their sinuses and nasal breathing... but patients need to be aware that their OSA may still remain essentially unchanged!

Sino-nasal surgery may also help with CPAP compliance as lower pressures may be required to address OSA compared to before surgery. Why? Because the nasal passages are more open after surgery so it is easier to push air into lungs when using CPAP.

Reference:
Effects of Endoscopic Sinus Surgery and Nasal Surgery in Patients with Obstructive Sleep Apnea. Otolaryngol Head Neck Surg. 2014 Mar 31;151(1):171-175. [Epub ahead of print]

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Cure Hiccups by Pulling on the Tongue

There are many different ways to treat hiccups (otherwise known as singultus). Some of the more bizarre ways of treating hiccups include rectal massage and tongue pulling.

Tongue pulling treatment is most commonly attributed to Sir William Osler (1849-1919). However, origins of tongue pulling can be found in much earlier French references including Jean Laborde (1830-1903), Jean Viaud (1862-1946), and Raphaël Lépine (1840-1919).

It is hypothesized to work by stimulating the vagus nerve thereby easing the diaphragmatic spasms.

Reference:
Treatment of singultus by traction on the tongue: an eponym revised. J Hist Neurosci. 2013;22(2):183-90. doi: 10.1080/0964704X.2012.728389.

[Stimulation of the root of the tongue can cure hiccup. 20 years of "unscientific" experience supports the thesis]. Lakartidningen. 1998 Oct 7;95(41):4477-9.

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Nasal Spray Cure for the Common Cold?

Well maybe not cure per se, but at least effective treatment to reduce the duration and severity of the viral cold at least. Austrian researchers have reported on the results of a randomized, double-blind, placebo-controlled trial involving 211 patients suffering from early symptoms of the common cold. [link]

Treatment of the non-placebo group involved using a nasal spray containing carrageenan (a sulphated polysaccharide found in red seaweed/algae) three times per day for 7 days. Cold symptoms were found to resolve 2.1 days faster and viral loads in the nasal washings were significantly decreased compared to placebo group. At day 21 of observation, one sixth of patients given the placebo were still ill, while only one twentieth were in the treatment group.

Personally, I would like to see larger studies conducted by other independent groups to verify the findings.

So how does this nasal spray work?

The problem with the common cold is that there are SO many viruses that manifest the same disease including rhinovirus, coronavirus, parainfluenza, influenza, respiratory syncytial virus, adenovirus, enterovirus, and metapneumovirus. As such, an effective treatment should be able to disable all these virus types and not just one.

The way carrageenan works is by sticking to the virus regardless of type and preventing it from attaching to the nasal lining. As such, the virus is unable to enter into the body and cause problems. It essentially blocks the virus like the wall of a castle.

The caveat is that in order for this nasal spray to work, you have to start using the medication as soon as cold symptoms appear (within 2 days). Remember... it works by blocking the virus from entering the body. If you wait too long, the virus has already entered the body making any type of blocking medication ineffective.

Where can you buy it?

It is available over-the-counter in most European countries and Canada. But NOT available in the United States.

The nasal spray is made by Marinomed in Europe using their Mavirex technology and also licensed for marketing/distribution by Boehringer. Carragelose is the brand name of the carrageenan ingredient. Depending on the country, the actual name of the nasal spray is sold under is different.

For example, in England, the nasal spray is called "Cold and Flu Defence Nasal Spray".

To make sure you have the right nasal spray, look under ingredients and make sure carragelose is listed.

On another note... Afrin nasal spray has also been shown to have some anti-viral activity in unpublished reports. Just be aware to not use it more than 3 days or else you may get addicted to it.


References:
Efficacy of a Carrageenan nasal spray in patients with common cold: a randomized controlled trial. Respiratory Research 2013, 14:124 doi:10.1186/1465-9921-14-124

Efficacy and safety of an antiviral Iota-Carrageenan nasal spray: a randomized, double-blind, placebo-controlled exploratory study in volunteers with early symptoms of the common cold. Respir Res 2010. doi:10.1186/1465-9921-11-108

Lessons learned from a double-blind randomised placebo-controlled study with a iota-carrageenan nasal spray as medical device in children with acute symptoms of common cold. BMC Complement Altern Med 2012. doi:10.1186/1472-6882-12-147

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Cure for Noise-Induced Hearing Loss?

Normally, when mammals (including humans) are exposed to very loud sounds, permanent hearing loss may result due to cochlear hair cell injury. However, an experimental drug code-named LY411575 was found to regenerate new hair cells by suppressing a protein called Notch.

In essence, this drug restored hearing to mice deafened by loud noise.

Listen to an explanation by Harvard researcher Dr. Edge in this video.

However, human trials are a very long way off… so prevention is still the best way to avoid permanent noise-induced hearing loss. Wear hearing protection whenever loud sounds may be present!

Reference:
Notch Inhibition Induces Cochlear Hair Cell Regeneration and Recovery of Hearing after Acoustic Trauma. Neuron Volume 77, Issue 1, 58-69, 9 January 2013

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Can Melatonin Stop Ringing in the Ears (Tinnitus)?

In a rigorous study, researchers have found that taking melatonin 3mg nightly for 1 month did significantly help with patients suffering from chronic tinnitus (ringing in the ears).

Of course, the caveats are that melatonin significantly helped in patients with these specific characteristics:

• Male
• No history of depression
• Tinnitus has been present for a long time
• History of loud noise exposure
• Tinnitus is severe and on both sides

Given melatonin is a relatively benign supplement that can be purchased over-the-counter, it can't hurt to give it a try!

BTW... what did I mean by rigorous study above? It means that it was a prospective, randomized, double-blind, crossover clinical trial. That's pretty much as good a study as one reasonably achieve!

Reference:
Melatonin: can it stop the ringing? Ann Otol Rhinol Laryngol. 2011 Jul;120(7):433-40.

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Actor Larry Hagman Dies of Throat Cancer

Image by Toglenn from Wikipedia

Today, on November 24, 2013, media has reported that actor Larry Hagman died of complications related to his throat cancer at the age of 81. It is unclear exactly where the throat cancer was localized to (tongue, tonsil, supraglottis, hypopharynx, oropharynx, etc).

Larry Hagman is a well-known actor playing oil baron J.R. Ewing in the soap opera Dallas (1980s as well as 2012) as well as Major Nelson in  the TV sitcom I Dream of Jeannie. Most impressive was the fact that he continued to act while undergoing cancer treatment for the Dallas remake.

In June 2011, Mr. Hagman was diagnosed with stage 2 throat cancer. After treatment with radiation and chemotherapy, on Aug 29, 2012, media reported that the actor was "cancer free."

Sadly, such media reports of "cure" or "cancer free" were way premature and actually misleading given his death merely 2 months later.

I reported in my blog on Aug 30, 2012 that there's no such thing as "cure" or being "cancer free" when it comes to throat cancer, especially right after cancer treatment.

One can use words like "shrunk", "excellent response", or even "no clear evidence for cancer at this time", but terms like "cure" or "cancer free" should never be used.

Throat cancer, especially stage 2, has the potential to come back, even if there's no perceptible signs of it after treatment. There is ALWAYS the possibility of cancer coming back in the future.

The risk of cancer recurrence is highest within the first 2-3 years after treatment completion, and markedly decreases after 5 years.

Typically if cancer has not come back after 5 years, the word "cure" may than be used, but even than, such patients are seen yearly for the rest of their life for cancer monitoring.

Given the high risk of cancer recurrence, patients are seen frequently for the first 2-3 years after treatment.

Every 2 months for the first year. Every 3-4 months in the 2nd year. Every 4 months in the 3rd year. Every 6 months in the 4th year. Yearly starting at 5 years after treatment.

This type of follow-up applies to all head and neck cancer.

Sources:
Larry Hagman is cancer-free. SFGate 8/29/12

Larry Hagman. Wikipedia

Larry Hagman dead at 81, portrayed notorious TV villain J.R. Ewing. Yahoo News 11/24/12.

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Mozart May Help with Tinnitus

Currently, there is no fast, good, and cheap way of resolving tinnitus. Tinnitus is in essence hearing a ringing or buzzing that does not exist in reality. At best, it may be something you hear, but does not bother.

At worst, it can literally drive a person crazy.

Neuromonics is perhaps one of the very few treatment protocols that has been proven to work resolving/improving tinnitus in 80-90% of patients over a period of months.

However, it is expensive... typically around $6000 out-of-pocket.

In a study out of Italy, a group of patients between 22 and 78 years of age who suffered from tinnitus were told to listen to Mozart's Sonata k448for 1 hour daily for 1 month. This was followed by instruction to listen to Beethoven's Fur Elisesonata for 1 hour daily for another month.

For all the parameters investigated, there was a general significant improvement between the pre- and post-listening evaluation. Significant improvement in several parameters were seen even after a single exposure to Mozart's sonata.

So apparently listening to Mozart may not help only baby's to become smarter (debatable), but it can help adults as well.

It's also cheap... about as much as it takes to download the songs from a music store.

Some other thoughts that may require additional research...

• What if a patient hates classical music?
• Does "how" a patient listens to the music affect results? (Playing the music in background while doing some other activity versus doing nothing other than listening to the music.)
• How long does the improvement last after treatment?
• What about other songs by Mozart?

But... all in all... given it is cheap... it certainly can't hurt to give it a try.

Reference:
The Mozart effect in patients suffering from tinnitus. Acta Oto-laryngologica. Posted online on October 1, 2012. (doi:10.3109/00016489.2012.684398)

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Actor Larry Hagman Treated for Throat Cancer

Image by Toglenn from Wikipedia

In June 2011, actor Larry Hagman was diagnosed with stage 2 throat cancer. It is unclear exactly where the throat cancer was localized to (tongue, tonsil, supraglottis, hypopharynx, oropharynx, etc), but it was treated medically with radiation and chemotherapy.

Larry Hagman is a well-known actor playing oil baron J.R. Ewing in the soap opera Dallas (1980s as well as 2012) as well as Major Nelson in  the TV sitcom I Dream of Jeannie. Most impressive was the fact that he continued to act while undergoing cancer treatment for the Dallas remake.

Yesterday, Aug 29, 2012, media reported that the actor is now "cancer free."

Hogwash...

Throat cancer, especially stage 2, has the potential to come back. Though there may be no detectable signs of cancer currently, there is the possibility of cancer coming back in the future.

The risk of cancer recurrence is highest within the first 2-3 years after treatment completion, and markedly decreases after 5 years.

Typically if cancer has not come back after 5 years, the word "cure" may than be used, but even than, such patients are seen yearly for the rest of their life for cancer monitoring.

Given the high risk of cancer recurrence, patients are seen frequently for the first 2-3 years after treatment.

Every 2 months for the first year. Every 3-4 months in the 2nd year. Every 4 months in the 3rd year. Every 6 months in the 4th year. Yearly starting at 5 years after treatment.

This type of follow-up applies to all head and neck cancer.

Source:
Larry Hagman is cancer-free. SFGate 8/29/12

Larry Hagman. Wikipedia

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Scientists Publish Research on Breakthrough Treatment for Tonsil Stones

Title sounds very exciting... even more so when I realized it was talking about the research paper that I co-authored with fellow ENT colleague Dr. Richard Thrasher on a new way of addressing tonsil stones.

I never really considered myself a "scientist,"but glad to hear that at least somebody considers me one!

This article apparently came out on MedicalXpress, a medical news website. It has also been picked up in a few other channels as listed under sources.

Source:
Scientists Publish Research on Breakthrough Treatment for Tonsil Stones. MedicalXpress 6/20/12

New Minimally Invasive Technique to Treat Tonsil Stones Developed by Dr. Chang. Fauquier ENT Blog. 6/14/20

Ear, Nose & Throat Journal publishes research on breakthrough treatment for tonsil stones. EurekaAlert 6/20/12

Reference:
Coblation cryptolysis to treat tonsil stones: A retrospective case series. Ear Nose Throat J. 2012 Jun;91(6):238-54.

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Skin Patch Immunotherapy for Allergy Cure

Over the years, there have been a variety of systems via which physicians and researchers have attempted to cure patients of their inhalant allergies.

These include (click here for a description of each):

• Allergy shots
• Under the tongue allergy drops (SLIT)
• Intra-Lymphatic Injections (ILIT)
• Allergy Tablets
• Epicutaneous Immunotherapy (EPIT)
• Intra-Nasal Spray
• Bronchial Inhalers

Well... we can now add skin patches to the list.

European researchers conducted a placebo-controlled, double-blinded trial involving 132 patients with grass pollen allergies. The patients were randomly divided into one of four groups: placebo, low-dose, medium-dose or high-dose patches. Patients applied six weekly patches prepared with grass allergens prior to and during the 2008 grass season and ALL reported improvement in their symptoms (30% in 2008) though one year later, there was a dose-dependent improvement with essentially no improvement in low-dose and placebo groups.

Unfortunately, higher-dose patches had higher rates of adverse events including pruritus, erythema, wheal, or eczema leading to an overall drop-out rate of 8.3% from the study.

This all may sound good and promising, but two of the study's authors hold patents on patch-based immunotherapy which may lead to study bias.

My take? More study is needed...

Reference:
Epicutaneous allergen-specific immunotherapy ameliorates grass pollen–induced rhinoconjunctivitis: A double-blind, placebo-controlled dose escalation study. The Journal of Allergy and Clinical Immunology Volume 129, Issue 1 , Pages 128-135, January 2012

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Cuddly Robot That Cures Snoring!

The robot which is shaped like a polar bear essentially listens for snoring while monitoring oxygen levels of the snorer. The individual sleeps on this robotic bear. When oxygen levels drop coupled with snoring heard through its microphone, the robot lifts its paw and tickles the forehead which induces the snoring individual to shift position resulting in snore cessation all without actually waking the individual. Watch video below.

Of course, there's no studies I'm aware of that actually determines whether this works or not, but the concept is sound.

The robot was developed in Japan in Tokyo's Waseda University and was unveiled during the International Robot Show, but not yet commercially available.

The name of the robotic bear is "Jukusui-Kun".

Read more about this here.

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Cold Sores Due to a Single Gene

Specifically, individuals who suffer from cold sores triggered by Herpes Virus Simplex - 1 (HSV-1) several times a year may have a single nucleotide polymorphism in their gene C21orf91 – dubbed rs1062202. Researchers have suggested it be called by the more "easy-to-remember" name Cold Sore Susceptibility Gene 1 (CSSG1).

Having this genetic change of swapping a thymine to a cytosine nucleotide was significantly associated (p=0.0047) with more frequent cold sores. Analysis has also found collections of 5 variants that are transmitted together with the C21orf91 gene of which two seemed to be neutral in terms of cold sore frequency, one was protective, and two were associated with increased susceptibility.

What does this all mean for an individual? It means if your parents get them a lot, than you may too.

Such individuals may benefit from regular use of anti-viral antibiotics to prevent such frequent recurrences.

Reference:
C21orf91 genotypes correlate with herpes simplex labialis (cold sore) frequency: Description of a cold sore susceptibility gene. J Inf Dis 2011; DOI: 10.1093/infdis/jir633.

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