Nasonex Sinus Implant for Chronic Sinusitis

The FDA on August 15, 2011 approved of a novel dissolvable sinus implant that slowly releases mometasone furoate steroid (same active ingredient as Nasonex steroid nasal spray) directly onto the sinus mucosa.

The spring-like implant is placed at the time of sinus surgery and automatically expands and conforms to the sinus cavity regardless of size and shape.

The theory is that by continuously delivering a low dose steroid directly to the sinus cavity, sinus inflammation will decrease and risk of scarring will decrease resulting in an overall decrease in chronic sinusitis for the patient after sinus surgery.

This is a GREAT idea and studies have born out its effectiveness. Hopefully other drug-eluting dissolvable stents like this will be developed in the future!

Developed by Intersect ENT, the implant is called "Propel."

Read about the FDA approval here.

References:
Safety and efficacy of a novel bioabsorbable, steroid eluting sinus stent. INTERNATIONAL FORUM OF ALLERGY & RHINOLOGY. 2011;1(1):23-32.

Advances in the Surgical Management of Chronic Sinusitis and Nasal Polyps. CURRENT ALLERGY AND ASTHMA REPORTS. Published online 08 February 2011

Controlled steroid delivery via bioabsorbable stent: Safety and performance in a rabbit model. AMERICAL JOURNAL OF RHINOLOGY & ALLERGY. November–December 2009, Vol. 23, No. 6.

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Novel Treatment for Non-Allergic Rhinits

Non-allergic rhinitis is an extremely frustrating sino-nasal disorder that is characterized by all the same symptoms of sinusitis and allergies, but NOT due to sinusitis or allergies. Rather, I consider non-allergic rhinitis to be the over-sensitive nose syndrome whereby breathing in air containing particulates (whether smoke, perfume, dust, pollen, etc) PHYSICALLY irritates the nose causing symptoms.

This is in contrast to allergies where the pollen causes an immunologic reaction causing symptoms or sinusitis which is due to an infection.

Non-allergic rhinitis is diagnosed by a negative allergy test (meaning symptoms are not due to allergies) and normal CT sinus scan (meaning symptoms are not due to a sinus infection).

Usually, treatment encompasses avoiding triggers (ie, perfume, smoke, dust, etc), applying a barrier nasal emollient (ie, ponaris), anti-histamine nasal spray (ie, astelin, astepro, patanase), and nasal hygiene using saline flushes which washes away the irritants causing symptoms.

Well, a new study published this month have shown another mode of treatment is quite helpful... ICX72, a proprietary homeopathic preparation of Capsicum annum and Eucalyptol, otherwise known as Sinus Buster!

When used twice daily over two weeks, symptoms were found to be significantly improved when compared to placebo. Furthermore, sinus buster alleviates symptoms attributable to non-allergic rhinitis within 52.6 seconds on average.

Past studies have shown improvement using Sinus Buster, but this is the first controlled study demonstrating efficacy.

Of note, unlike nasal decongestant sprays like Afrin which can result in addiction over time (rhinitis medicamentosa), there does not appear to be any addictive component with this nasal spray.

Read the study abstract here.

Read more about this condition here.



Reference:
A randomized, double-blind, parallel trial comparing capsaicin nasal spray with placebo in subjects with a significant component of nonallergic rhinitis. Annals of Allergy, Asthma & Immunology. Volume 107, Issue 2, Pages 171-178 (August 2011)

Intranasal Capsicum spray in idiopathic rhinitis: a randomized prospective application regimen trial. Acta Otolaryngol. 2009 Apr;129(4):367-71.

Intranasal capsaicin reduces nasal hyperreactivity in idiopathic rhinitis: a double-blind randomized application regimen study. Allergy. 2003 Aug;58(8):754-61.

The long-term effects of capsaicin aqueous spray on the nasal mucosa. Clin Exp Allergy. 1998 Nov;28(11):1351-8.

Beneficial effects of intranasal applications of capsaicin in patients with vasomotor rhinitis. Eur Arch Otorhinolaryngol. 1991;248(4):191-4.

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Can a Deviated Septum Cause Facial Pain?

Yes...

There is a phenomenon caused Sluder's Neuralgia whereby a patient may suffer fairly severe pain over the cheek and around the eye due to a severe deviated septum... not just any deviated septum, but a sub-type called a septal spur.

As an introduction, a nasal septum is a wall that divides the nasal cavity down the middle. This nasal wall is much larger than people realize... perhaps a little bigger than a large man's watch.

In some individuals, the septum (purple arrow) may be deviated to one side causing narrowing resulting in symptoms of nasal obstruction.

In a further subset of individuals, the septum may be even more deviated with a "spur" digging into the side of the nasal cavity as shown by the black arrowhead below.

In this scenario, the patient will feel pain in the cheek and eye region on the same side as the septal spur. If nasal swelling occurs, the pain will become more severe. Such swelling may occur from allergies or a viral infection. As such, the pain fluctuates depending on how much mucosal swelling is present.

This situation is analogous to a bunion on the foot. Just like the septal spur, if the bunion digs too hard into a shoe, a person may feel foot pain. If the foot swells due to standing or edema, the pain may become more severe.

Shown below is a septal spur before and after mucosal lining swelling has occurred.

Treatment is a surgical procedure called septoplasty which basically removes the spur and straightens the septum back to the midline.

Read more about the procedure here.

Read more about this type of headache here.

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Nebulizer Treatment for Chronic Sinusitis

Many people are already aware of nebulizer treatments to help with breathing during asthma attacks and other pulmonary conditions.

What many people may not be aware of is that such nebulizer treatments can also potentially be used for chronic sinus infections. One of the best known company offering such treatment is Sinus Dynamics.

Using one of several different nebulizers, compounded liquid medications (antibiotics and/or steroids) selected by the physician are nebulized/atomized which the patient than breathes into the nasal passages. The small size of the particles allow medication to theoretically move through the tiniest of sinus openings directly onto the infected tissue. Treatments are quick generally lasting 3 – 5 minutes (depending on medication and device). Here's a video demonstrating how it is used.



Sinus Dynamics™ specifically is contracted by over 14,000 insurance companies across the nation, which means that most patients are able to receive their treatment for little to no cost out of pocket.

Most ENT doctors are already familiar with this product.

Personally, I prescribe this mode of treatment for the particularly difficult sinus infection that has not responded to oral antibiotics and sinus surgery. The major advantage of such a device is not only the fact that it is topical, but much stronger antibiotics can be prescribed that otherwise would be toxic if given orally. Furthermore, more than one medication can be administered simultaneously (for example, a steroid, tetracycline antibiotic, and ceftazidime antibiotic).

Typically, I require a culture with sensitivities to determine what medication would be optimal for this mode of treatment. Another requirement is prior sinus surgery given studies showing greater effectiveness of the delivery system.

Once cultures are obtained and a determination of the optimal medication to treat, a prescription is faxed to the company who will than take care of the insurance coverage and than ship the device and medication(s) to you. The normal turn-around time is less than 1 week depending on the prescription.

An instructional video is included with the prescription as well as customer service representatives via phone to walk through the first treatment if needed.

Of course, sinus nebulizer treatment is not the only topical treatment than can be provided.

Other topical sinus treatments which may be just as effective if not more include saline flushes containing medications (which can be compounded by any willing pharmacy) as well as application of antibiotic ointments directly into the sinus cavity (which is performed by the ENT under endoscopic guidance).

It is up to your ENT physician to determine what is the best course of treatment based on your history, endoscopic sinus evaluation, culture results, CT scans, and response to prior medical regimens.

It should also be noted that there have been several studies performed suggesting such nebulizer treatment for sinus infections to be ineffective. However, it certainly is worth trying when all else has failed (or insurance has denied other treatment protocols).

References:
Nebulized antibiotics for the treatment of refractory bacterial chronic rhinosinusitis. Ann Pharmacother. 2011 Jun;45(6):798-802. Epub 2011 Jun 7.

Current concepts in topical therapy for chronic sinonasal disease. J Otolaryngol Head Neck Surg. 2010 Jun;39(3):217-31.

A prospective controlled trial of pulsed nasal nebulizer in maximally dissected cadavers. Am J Rhinol. 2008 Jul-Aug;22(4):390-4.

Nebulized bacitracin/colimycin: a treatment option in recalcitrant chronic rhinosinusitis with Staphylococcus aureus? A double-blind, randomized, placebo-controlled, cross-over pilot study. Rhinology. 2008 Jun;46(2):92-8.

Deposition of aerosolized particles in the maxillary sinuses before and after endoscopic sinus surgery. Am J Rhinol. 2007 Mar-Apr;21(2):196-7.

Comparison of topical medication delivery systems after sinus surgery. Laryngoscope. 2004 Feb;114(2):201-4.

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Xylitol (Natural Compound) to Prevent Recurrent Sinus and Ear Infections?

Image by Lauri Andler from Wikipedia

I only recently became aware of a natural sugar compound called "Xylitol" from a colleague's blog, BoogorDoctor, managed by Dr. Russell Faust. I certainly have never heard of it during medical school or surgical training.

This naturally-occurring sugar substitute apparently has all sorts of anti-bacterial as well as anti-fungal properties and has been known to doctors and scientists but hardly marketed or promoted in any fashion.

However, the importance of this compound is that it DOES appear to significantly decrease the incidence of ear infections and sinus infections when used regularly (in essence, xylitol mixed in with salt-water sprayed into the nose several times a day). See references below for links to research papers.

It's cheap, over-the-counter and at least from the studies I've reviewed, does seem to work. However, to be fair, it only works when given regularly even if healthy. If given when sick, it does not work (see this study). Also to be fair, there are some studies that suggest that xylitol does NOT work at all.

However, given there are minimal (if any) side effects and safe for kids, it is certainly something worth trying before surgical consideration, especially in children.

Why is this compound not more well-known?

Probably because it's cheap and therefore not a money-maker... which means not a lot of dollars goes into marketing the product whether directly to patients or doctors.

In any case, you can get it on Amazon.com here (or possibly at a local pharmacy).

I should also mention that Xlear is the only product series that uses the optimal concentration xylitol (others use only the bare minimum concentration to meet ingredient inclusion).




References:
A Story About a Sugar: The X-Factor. Blog by Dr. Faust

Xylitol as a prophylaxis for acute otitis media: systematic review. Int J Audiol. 2010 Oct;49(10):754-61.

A novel use of xylitol sugar in preventing acute otitis media. Pediatrics. 1998 Oct;102(4 Pt 1):879-84.

Xylitol chewing gum in prevention of acute otitis media: double blind randomised trial. BMJ. 1996 Nov 9;313(7066):1180-4.

Failure of xylitol given three times a day for preventing acute otitis media. Pediatr Infect Dis J. 2007 May;26(5):423-7.

Xylitol administered only during respiratory infections failed to prevent acute otitis media. Pediatrics. 2002 Feb;109(2):E19.

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Saline Nasal Flush - Mayo Clinic Video

Ever since our office produced one of the first videos on saline nasal flushes back in December 5, 2007, there have a been a number of additional videos created by medical offices and companies ever since.

The most recent is Mayo Clinic which you can watch here.



Here's our video we made back in 2007.

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Baby Shampoo Used to Treat Chronic Sinusitis

Yes... It's absolutely true! There's even research on this (limited).

The mixture ratio is 1/2 teaspoon of Johnsons No-Tears Baby Shampoo in 8 ounces of saltwater rinsed into the nose using a sinus rinse bottle can help with chronic sinusitis, especially when there's a lot of crusting present and to which all other therapies have failed to resolve.

The shampoo appears to work via several mechanisms theoretically:

1) It is directly toxic to germs
2) The soap action helps break apart crusting (similarly to the way detergent gets rid of mud from a kid's shirt in the washer)
3) The soap also helps break down and remove biofilms in the sinus cavities which tends to resist antibiotics and cause recurrent sinus infections (just like dishwasher fluid gets filmy food residue off plates)

For saline flushes, the NeilMed Sinus Rinse bottle is recommended for two reasons.

The black cap of the bottle is about 1 teaspoon... and the bottle itself is 8 ounces.

So, for the particularly difficult chronic sinusitis infection patient who has tons of crusting for which all other treatments have failed, the saltwater is made up as per routine using the NeilMed Sinus Rinse bottle, but than to also add 1/2 capful of the Johnson's No-Tears Baby Shampoo as well before use.

They are to flush their nose twice a day for a few weeks.

Reference:
Baby shampoo nasal irrigations for the symptomatic post-functional endoscopic sinus surgery patient. Am J Rhinol. 2008 Jan-Feb;22(1):34-7.

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Can Humming Ease Sinus Problems?

Well... according to a recent New York Times article published Dec 20, 2010, the answer is yes...

Apparently, humming can keep air moving through the sinuses and nasal cavity which suggests improved ventilation. Good sinus ventilation means healthy sinuses.

Their conclusion is based on two studies listed under the references below. Unfortunately, the conclusion can't extend to stating humming prevents sinus infections. The only way to evaluate that hypothesis is to do a study comparing two groups of patients with chronic sinus infections and instruct one to hum and the other not to and see if there's any difference in the intervention group over time. Even better would be to do a prospective double-blinded study, but not sure how one can perform a double-blinded study in this case.

Read the NYT article here.

References:
Humming greatly increases nasal nitric oxide. Am J Respir Crit Care Med. 2002 Jul 15;166(2):144-5.

Assessment of nasal and sinus nitric oxide output using single-breath humming exhalations. Eur Respir J. 2003 Aug;22(2):323-9.

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Sinus X-Rays Are Worthless

Oftentimes, I see patients come in with sinus x-rays with this or that finding. What many patients as well as physicians may not realize is that sinus x-rays are notoriously unreliable in determining whether sinus infection is present or not. Indeed, I NEVER order a sinus x-ray. Just how unreliable are sinus x-rays?

In adults, it may be literally a flip of the coin whether the sinus x-ray is providing a correct diagnosis compared with the gold standard CT sinus.

Depending on what study you look at, the specificity of a sinus x-ray hovers around 50% (how often it correctly states normal sinuses). Sensitivity is a little better at around 80% (how often it correctly detects actual sinusitis).

Several studies have concluded that sinus plain film x-rays are unreliable and no longer routinely indicated for the evaluation of nasal and paranasal sinus disease. When radiographic evaluation is indicated a limited CT series provides superior information.

Take home message?

Do not order a sinus x-ray when evaluating for sinus disease/sinusitis!!! Why bother ordering a test that is going to be wrong almost half the time?

(If a CT sinus comes back normal, the patient most definitely does NOT have acute or chronic sinusitis.)

Interestingly, sinus x-rays in kids (2+ years old) may be more reliable and in this sub-population, may be beneficial [Link]. But this study unfortunately did not include CT sinus scans to verify sinus x-ray findings. It should also be noted that sinus x-rays younger than 2 years old is also unreliable [Link].

Reference:
Radiographic evaluation for nasal dysfunction: computed tomography versus plain films. Head Neck. 11 (5), 405-9. 1989

Comparison of sinus x-rays with computed tomography scans in acute sinusitis. Acad Emerg Med. 1 (3), 235-9. 1994

Sinusitis and chronic cough in children. J Asthma Allergy 5:27-32. 2012.

Maxillary sinus radiographs in children with nonrespiratory complaints. Pediatrics. 1984;73(3):306–308.

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NPR on Endoscopic Sinus Surgery

NPR published a story on Oct 4, 2010 describing endoscopic sinus surgery using image guidance. The NPR story is actually quite balanced with accurate portrayal of what sinus surgery can or can't do.

Just like in the NPR story, our office performs the same high-definition endoscopic sinus surgery using BrainLAB image guidance (which provides the real-time 3-dimenstional guidance).

Prior to sinus surgery, a patient must fail medical management first (unless nasal masses like polyps are found) including allergy control.

Read the NPR story here.

Read more about sinus surgery here.

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USNews: Cold versus Allergies... How to Tell The Difference

US News and World Report came out with a story on July 27, 2010 regarding how one can tell the difference between an allergy versus a cold, especially since each has symptoms in common.

Especially with mild symptoms, it may be hard even for an ENT to distinguish the two. Add chronic sinus infections and flu to the mix, it can be downright difficult without allergy testing, CT scans, and other types of testing to come up with a correct diagnosis.

To help distinguish among these possible illnesses, at least based on history, here is a chart our office has made.

NIH also has produced a chart that can be seen here.

Click here to read the US News & World Report story.

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New Webpage on Balloon Sinuplasty to Treat Chronic Sinusitis

A new webpage has been created describing the balloon sinuplasty technique to address chronic sinus infections.

Briefly, a balloon catheter (similar to angioplasty used to treat clogged heart arteries) is used to enlarge the openings into the sinus cavities without the need for any cutting or tissue removal.

Read more here.

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New Video On Balloon Sinuplasty for Chronic Sinusitis Uploaded

A new video describing balloon sinuplasty has been uploaded on our YouTube channel. Balloon sinuplasty is a relatively new minimally invasive sinus surgery technique to open up diseased sinus cavities without removing mucosa or bone.

In essence, the technique involves threading a tiny guidewire to first identify the sinus opening and than acts as a guide for the balloon catheter. Once the balloon is positioned at the opening of the sinus cavity, it is inflated thereby enlarging the sinus cavity opening.

Watch this sinus surgery technique below or on our YouTube channel here.



Here is an animation of what exactly is going on:

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LA Times: Neti-Pots and Other Saline Sinus Rinses Effective

The LA Times on March 15, 2010 published a story entitled "Are neti pots on the nose?". The story describes the effectiveness of regular saline flushes to the nose in reducing as well as preventing allergy symptoms, colds, and sinus infections. Devices that can flush the nose/sinus include Neti-Pots as well as Neilmed Sinus Rinse. Electronic devices also exist (see below).

Studies support this claim.

Though patients can purchase saline packets, patients can make their own saline solution by combining one teaspoon of kosher salt and a half teaspoon of baking soda with a pint of lukewarm tap water.

Read the LA Times story here.

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NYT: Blowing the Nose May Actually Make You Sicker???

On February 9, 2009, the New York Times published an interesting story regarding what happens if you blow your nose too hard. The story "The Claim: Never Blow Your Nose When You Have a Cold" reported that nose blowing generated enormous pressure — “equivalent to a person’s diastolic blood pressure reading,” — and propelled mucus into the sinuses every time. It was unclear whether this was harmful, but added that during sickness it could shoot viruses or bacteria into the sinuses, and possibly cause further infection.

The story is based on research done at the University of Virginia and published in the journal of Clinical Infectious Diseases in 2000. Read the research here.

Based on this research, it does seem wise to avoid nose-blowing, but if one must, to use decongestants and blow only one nostril at a time gently. Using saline flushes would be helpful as well.

Read the story here.

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Recurrent Chronic Sinusitis Often Due to Allergies

A 2009 research paper lends credence that allergies may be a VERY important player in patients who suffer from recurrent sinus infections. Such patients will improve with antibiotics only to have their sinus infection symptoms recur shortly after completing the antibiotics.

The research described how allergy exposure to patients resulted in a rapid and radiographically significant response of sinus disease including mucosal thickening and/or opacification. How fast? Within 60 MINUTES!!!

These findings lend support that should patients suffer from recurrent sinus infections that do not clear readily with antibiotics alone should be investigated for allergies. Furthermore, allergy testing and management should be performed in all patients considering sinus surgery. Why? Because if allergies are playing a role, opening up the sinuses via surgery will only exacerbate allergy triggered sinus infections.

What is our office protocol for evaluating patients with chronic sinus infections?

1) History supportive of recurrent sinus infections in spite of antibiotics as well as trial of allergy medications
2) CT Sinus documenting presence of sinus disease for surgical consideration as well as elucidating whether true sinus problems are causing the symptoms
3) Allergy testing (Our office performs immunoCAP blood testing instead of skin prick testing)

If allergy testing is positive, aggressive allergy control is the first step prior to (or at the very least concurrent with) any other intervention including sinus surgery.


Reference:
Diagnostic Value of Nasal Allergen Challenge Combined With Radiography and Ultrasonogrphy in Chronic Maxillary Disease. Arch Otolaryngol Head Neck Surg. 2009 Dec;135(12):1246-55. doi: 10.1001/archoto.2009.189.

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MRSA Sinusitis

There seems to be an increasing number of patients I see with MRSA sinusitis. Not many, but definitely not rare. These patients are understandably very concerned with how to treat their MRSA sinusitis.

Beyond the usual protocol that applies to any MRSA infection, if the sinusitis is severe, sinus surgery is recommended for 3 main reasons.

1) Get the infection cleaned out surgically (much like draining an abscess of the skin)
2) Enlarge the openings of the sinus cavity to allow good post-op topical treatment in order to potentially avoid oral and IV antibiotics (though they still may be needed)
3) Sinus infection can be carefully followed endoscopically in the future

By opening up the sinuses, topical treatment can be performed that is sometimes more effective that IV or oral routes as higher concentrations of medication can be delivered right to the area of concern (instead of oral or IV routes which go throughout the entire body causing side effects).

Such topical treatment include:

• Saline flushes (Neilmed Sinus Rinse is our preferred method though irrigation devices shown below are also fine)
• Bactroban Cream or Cortisporin Ointment injection directly into the sinus cavity
• Antibiotic flushes to the sinus cavity
• Chemical saline flushes to the sinus cavity (my favorite being No-Tears Johnson's Baby Shampoo - 1 tsp in 250 cc of saline)

Debridement of the sinus cavity can also be easily performed after sinus surgery in the office.

Once the active MRSA sinusitis infection has cleared, continued topical treatment with daily saline nasal flushes help prevent future sinus infections.

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Saline Nasal Sinus Irrigation Systems

I must admit... our office is a big fan of the Neilmed Sinus Rinse bottle for patients who suffer from chronic sinusitis and severe allergies as it is cheap, easy to clean, and it works. However, many patients who are already fans of flushing the nose with saline water end up purchasing saline irrigation systems. There's a bunch of these devices sold on Amazon.com. Check them out below, but I would suggest that you first become adept and able to tolerate saline flushes using the Neilmed sinus rinse bottle first prior to paying almost $100 for these devices.

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NYT: Does Snotty Colored Discharge Require Antibiotics? No!!!

The New York Times published a story on Oct 6, 2009 entitled "The Claim: With a Runny Nose, Green Calls for an Antibiotic." It actually is a pretty good article though I'm not sure how much impact this will have in clinical practice.

The story reports that green discharge from the nose is NOT indicative of a bacterial sinus infection and as such, this symptom should not be the sole reason why antibiotics should be prescribed.

It does reference a research paper that backs this claim up. There are others.

In any case, the last sentence of the story is worth reiterating: "THE BOTTOM LINE: The color of nasal discharge should not dictate the medicine."

Not sure how accepting patients will be of this factoid given how ingrained colored discharge has been equated with sinus infection.

I personally have encouraged saline nasal flushes starting from as early as 5 years old as the main treatment for this issue which some patients have been more accepting than others.

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