What Would Galileo Say?

If we could be sure of anything in the early 17th century, when Shakespeare climbed onto the world stage, it was that the Earth stood still, and that the Sun and all the rest of the universe revolved around Us: We were at the center of everything – We were the Lords of the Universe. We knew this because Aristotle said so as far back as the 4th century BC. Scientists thereafter agreed and, if that wasn’t enough, it was also set down in Holy Scripture as interpreted by the Catholic Church, notably Pope Urban Vlll.

And then along came Galileo Galilei, later recognized as the father of experimental physics, who proposed something radical: that it was the Sun, not the Earth, that was the center of the universe – that we Earthlings and everything else in the universe revolved around It. The trick to Galileo’s discovery was technology – he had just invented the telescope, and with it the ability to track planetary movement.

Technology is indeed powerful.  It brought us the industrial revolution, it took us to the moon, and in the past 10 years it has allowed us to sequence our genomes. And there is yet one more thing it seems willing to do for us: treat one of the most common medical conditions in the United States that affects an estimated 37 million Americans – chronic sinusitis (CRS).

It’s considered chronic because it will last half a year or more, your head will be swollen & painful especially around you sinuses, you will miss a lot of work, and you will probably have to keep going back to the doctor for repeated treatment. People who have it report worse quality-of-life scores than those suffering from chronic obstructive pulmonary disease, congestive heart failure, back pain, or angina. It is stubbornly resistant to cure despite rigorous treatment regimens including surgery, allergy therapy, and prolonged antibiotic therapy.

In a significant sub-population of patients the reason for this treatment failure is thought to be related to the destruction of the sinus area defenses by the chronic sinus infection, resulting in the development of secondary antibiotic resistant microbial colonization of the sinuses – an infection upon an infection.

However, there is hope. Physician-scientist Merill Biel, MD, PhD, who received funding from the National Institutes of Health and published his investigations in the International Forum of Allergy and Rhinology, led a research team in 2011 and again this year to see if they could eliminate microbial pathogens responsible for chronic CRS. The trick, again, was in the technology – they used a procedure called photodynamic therapy (PDT).

The use of PDT is extensively reported in the literature to be safe and effective for the photodestruction of various microorganisms. It is a 2-step process. You apply a chemical compound to the affected area, and then target a beam of light on that compound. The result is that you destroy those microorganisms – bacteria, virus, or fungi – that have absorbed the compound. Recently, PDT has been more comprehensively studied as a potential alternative to conventional antibiotic therapy as antibiotic resistant strains of bacteria become more prevalent, notably methicillin-resistant staphylococcus aureus (MRSA).

The objective of the Biel study was to demonstrate the effectiveness of a non-invasive PDT treatment method of eradicating antibiotic resistant microorganisms known to cause CRS. What they found was extremely encouraging: that PDT reduced the polymicrobial organisms by >99.9% after just one treatment.

The scientists are careful to point out that their work was done in the lab where they duplicated the structure of the sinus cavities and populated them with the relevant microorganisms. However, because of the promise shown by their work these past few years, human clinical studies are currently planned to assess the safety and efficacy of this treatment for CRS.

It would seem that the sooner the better. Researchers at The University of Pennsylvania in 2007 surveyed physicians who treat CRS and found 86% of them were unhappy with current treatments and said there was a need for something proven to be effective and safe: the >99.9% pathogen reduction rate reported by Biel would seem to fit that need.

Galileo’s theory of the universe was largely rejected in his day. He wrote to a colleague expressing his disappointment that he failed to make believers out of all “educated persons” in the scientific community. “My dear Kepler, what would you say of the learned here, who, replete with the pertinacity [stubbornness] of the asp [venomous snake], have steadfastly refused to cast a glance through the telescope?  What shall we make of this?  Shall we laugh, or shall we cry?”  (Emphasis supplied.)

We can imagine, perhaps, that Galileo, if he were able to observe things today, would hope that the scientific community would at least “glance through the telescope” of Biel’s work. Based on his success so far, we can also imagine 37 million Americans and their families who might hope for the same thing.

Overcoming Resistance: The Case for Photodynamic Therapy

Towards the Light

At the corner of Blegdamsvej & Tagensvej, near Copenhagen University Hospital (“Rigshospitalet”) in Copenhagen, Denmark, stands Towards the Light, a large sculpture of 3 bodies straining towards the sun.  It was put there in honor of Danish scientist Niels Finsen who, in 1903, was awarded the Nobel Prize in medicine for his pioneering work in phototherapy in the treatment of disease, especially lupus & tuberculosis.  Finsen was more than just a scientist doing research – he had a dog in the fight. At only 42 and working from a wheelchair because of disease that attacked his internal organs, he was desperate to find a cure. Unfortunately, he died just one year later, at age 43.

His work though, lives on. No just in the Finsen Laboratory, named in his honor, at Copenhagen University Hospital, but also in the form of photodynamic therapy (PDT) for which his groundbreaking work paved the way.

Photodynamic therapy is the current form of Finsen’s phototherapy. It uses light-sensitive compounds that are exposed selectively to light, whereupon they become toxic to targeted cancerous and other diseased cells. Though relatively unknown, it is making strides into the worldwide medical community.

For example, in July of this year, the Vancouver General Hospital received an international innovation award for its groundbreaking infection control research from the International Consortium for Prevention and Infection Control (ICPIC) in Geneva. More than 5,000 patients were treated, reducing post-surgical infection by almost 40 per cent and saving the hospital $1.3 million in post-surgical infections and re-admissions. The research team, led by Dr. Elizabeth Bryce, competed against 40 international teams to win the prize. The hospital used a process called nasal photodisinfection (MRSAid) to kill harmful bacteria prior to surgery during a 12-month pilot project.

In the United States, the National Cancer Institute’s Factsheet tells us that PDT is used for certain kinds of lung and esophageal cancer, and that its researchers continue to study ways to improve the effectiveness of PDT, and expand it to other cancers of the brain, skin, cervix, prostate, cervix, stomach, and liver.

Yet despite this noble beginning, international recognition, and the endorsement of the NCI, PDT in its various applications remains very much underused. A case in point is its potential use in treating chronic sinusitis (CRS), one of the most common medical complaints in the United States, affecting up to 16% of the population. It is associated with over 13 million physician visits per year and an estimated aggregated cost of over $6 billion annually.

Moreover, the community of physicians who deal with CRS are not happy with current treatment options.  In a 2007 study published in The Journal of Allergy and Clinical Immunology, 202 doctors were surveyed from the US, UK, France, and Germany. 86% said they were generally unhappy withcurrent treatment; the same number wished for more options to treat the surgery refractory population; 91% reported they wanted a treatment proven as efficacious and safe; and, 88% of the respondents agreed that those patients with CRS refractory to surgery suffer from a severe and debilitating condition.

Indeed, in a separate study conducted in 2010 by the University of Pennsylvania, CRS sufferers were found to have worse quality-of-life scores than those suffering from chronic obstructive pulmonary disease, congestive heart failure, back pain, or angina.

The study summary concludes by saying that “… new therapies will undoubtedly play a greater role and change our treatment paradigms.” Such a PDT paradigm exists to treat CRS – it is called Sinuwave, and is vastly underutilized.

Surgeon Christian Betz from Munich’s University Hospital was interviewed by Optics.Org this past May about the under-utilization of PDT. He explained that “PDT is not widely accepted, because it does not fit the traditional way of thinking,” meaning that the vast majority of his peers are simply trained to use surgery when they see something in the body they want removed.

Rigid thinking sometimes dies a slow death, even in science. When Galileo said the Earth revolved around the sun and not the other way around he was thrown in jail. Nineteenth German doctor Ignaz Simmelweis found that you could reduce death rates in hospital obstetric wards from 35% to less than 1% by the mere expedient of doctors washing their hands. The reaction from other Western European doctors? They were offended by the implication that they were “dirty” and for decades went from surgery to surgery literally carrying the blood from the previous patient to the next one.  And of course there’s Darwin, whose mid-nineteenth century “theory” of evolution is still being contested, especially in parts of the U.S.

We are used to thinking of pathogens, bacteria especially, as having the trait of resistance. As it turns out, it is a trait shared by them and us – in both cases to the detriment of our species.

 

 

 

 

 

 

Sinus Surgery: Is It The Only Treatment For Chronic Sinusitis?

A treatment for chronic sinusitis? “Sign us up!” they’re saying. Over 500,000 Americans each year are opting to undergo sinus surgery, also known as FESS, or functional endoscopic sinus surgery. Chronic sinusitis is, as the name denotes, a prolonged infection of the sinuses – the air-filled spaces around the nasal cavity, although someone with sinusitis would hardly call them hollow. Their sinuses are clogged by years of mucus from infection and inflammation left, right, and centre (literally). Sinus surgery is performed, relatively non-invasively, through the nostrils, so as to flush out the infected material and open up the sinus passages that have been blocked for years.

As effective as this surgery is, we aren’t all to go running to the hospital to sign ourselves up at the slightest stuffy nose. There is a certain severity standard that must be met by a candidate before they can get the go-ahead.  Ideally, the candidate is someone who has turned to surgery as a last resort; generally, it is that they have sinusitis that persists even after aggressive medical treatment. Others who should consider the surgery are those who suffer from: sinus disease caused by fungal infection, nasal polyps (growths in the nasal cavity), structural abnormalities of the sinuses, a sinus infection that has spread to the bone, or cancer of the sinus. These cases demand a more drastic treatment because of their more permanent nature.

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Take a chill pill: Why antibiotics don’t always help

Listen up, students!

You can finally stick it to all those school nurses/math professors who wouldn’t let you take a make-up exam for lack of a doctor’s note when you had the sniffles.

A number of studies have shown that the antibiotics often used to treat sinusitis make absolutely no difference when it comes to treatment.

In 2008, the BBC reported that 90% of patients with sinusitis in the UK are prescribed antibiotics. The article added that the results of an analysis of nine trials published in the medical journal The Lancet, shows that these antibiotics had no effect, even if the patient had been sick for more than seven days.

The timeline is the important factor here. The consensus used to be that a longer illness was a sign of a bacterial infection that would be susceptible to antibiotics, rather than a viral infection, in which case antibiotics have no effect. If you have a virus, the best thing to do is to don your fanciest flannel pajamas, and curl up in bed with the latest issue of Us Magazine and a steaming cup of tea. In other words: wait it out.

But length, it turns out, may be meaningless. The study looked at 2600 patients who had been suffering from sinusitis before the treatment. The results showed that 15 patients would need to be treated before one would be cured with antibiotics, indicating that time is not an effective gauge of whether or not antibiotics will be effective.

“If a patient comes to the GP and says they have had the complaint for seven to 10 days that’s not a good enough reason for giving them the antibiotic,” study leader Dr Jim Young, from the Basel Institute for Clinical Epidemiology in Switzerland, told the BBC.

To every student/ minimum wage employee: You’re welcome.

More recently, a study published in the Journal of the American Medical Association brought the point home by showing that in many cases, a placebo worked just as well as antibiotics when it comes to sinusitis treatment. The study observed 166 adults meeting the diagnostic criteria for sinusitis, who were given either amoxicillin or a placebo three times a day for 10 days, The New York Times reported in 2011.

The participants recorded their symptoms every other day. In the end, there was no significant difference between those given the placebo and those placed on antibiotics.

These findings come as good news to proponents of antibiotic restraint. The automatic reflex to treat with antibiotics has had serious consequences, namely the development of resistant strains of bacteria that have become more potent and dangerous over time.

Both the studies mentioned in the BBC and The New York Times mentioned that in cases of sinusitis, a patient should refrain from a doctor’s visit unless they’ve been sick for a week.

Still have questions? The CDC lays it all out here in a video slightly reminiscent of Sesame Street… before Cookie Monster got all healthy and ruined everything.

See A Video on: Snort. Sniffle. Sneeze. No Antibiotics Please!

 

 

 

Brush your teeth, save on Kleenex.

Who knew that teeth were such devious little buggers?

Periodontal disease is like the Stewie Griffin of maladies: small, easily overlooked, but man, when he gets mad, watch out.

Gum disease has already been linked to heart disease, impotence, cancer, and even artificial joint infections. But that’s not the end of it.

In 2011, an estimated 29.6 million adults were living with non-diagnosed sinusitis, an estimated 12.8% according to the Centers for Disease Control and Prevention (CDC).

Sinusitis occurs when the air-filled spaces behind your forehead, nasal bones, cheeks and eyes (known as sinuses) become blocked, preventing the mucus from draining and causing bacteria and other germs to build up. Sinusitis can be caused by something as benign as allergies or a common cold, or more serious conditions like a deviated septum or nasal polyps.

As far back as 1996, scientists were already examining the links between periodontal disease and sinus inflammation or infection. A study published in the American Journal of Roentgenology (say that last word 5 times fast) by J.J. Abrahams and R.M. Glassberg of Yale School of Medecine’s Department of Diagnostic Radiology, showed that patients with known periodontal disease were twice as likely to have maxillary sinusitis, and that the two were causally related.

The maxillary sinus is the largest of the paranasal sinuses, and also the closest to the molars of your upper jaw. As mentioned in a previous post, our mouths are teeming with bacteria. When you “forget” to brush your teeth, that bacteria accumulates in the gaps between your gums and your teeth, causing inflammation of the gums (gingivitis). The longer that goes untreated, the more likely you are to develop periodontal disease (periodontitis).
Periodontal disease causes the gums to recede from the teeth, creating little pockets – the bacterial equivalent of a white picket fence in the suburbs.
Because the maxillary sinus is so close to these little bacterial hideaways, infection is more likely.
Another study, conducted by the Oral Health Group and aptly billed as “A Review for the Dental Practitioner,” explained that the physical proximity between the maxillary sinus and the mouth should also be of concern to dentists because sinusitis is often misdiagnosed as dental disease.
As such, the study recommended that dental practitioners study up on the “anatomy, physiology, and pathology of this complex region.”

If undertreated or ignored, regular sinusitis can develop into something chronic, which is definitely not something you want.

The bottom line? Brush your teeth.

And just for kicks, watch Stewie battle a tooth ache on “Family Guy”:

Sinuwave™ Photodisinfection for Invasive Fungal Sinusitis of Immunocompromised Patients

Acute invasive fungal sinusitis is the most aggressive form of fungal sinusitis. It is most commonly seen in immunocompromised patients and is the source of significant morbidity and mortality. Common causes of immunosuppression are diabetes, advanced AIDS  and neutropenia (low levels of white blood cells (neutrophils) in the blood). Patients with neutropenia include those with solid organ transplants, bone marrow transplants, leukemia, radiation therapy, chemotherapy, and any medication that affect bone marrow.

Ordinarily, fungi feed on dead organic matter, but not live human tissue. In the case of weakened immune defenses, however, fungi are able to attack and invade human tissue, hence the name “invasive fungal infections”.  With the patient having limited immune defenses, this invasive fungal infection can spread rapidly into the blood vessels, eye area, and central nervous system with devastating consequences. Within a few weeks, the disease results in vascular invasion and systemic dissemination. Roughly 12.5% of those with diagnosed fungal rhinosinusitis have invasive fungal rhinosinusitis- acute or chronic. Acute invasive fungal sinusitis is a rare condition with a high mortality rate when not recognized early and treated aggressively.

The key to successful outcomes is early detection and aggressive intervention. Invasive fungal rhinosinusitis is currently treated by aggressive medical (systemic antifungals) and surgical debridement to remove infected tissue in the sinuses using endoscopic sinus surgery. Sinuwave™ Photodisinfection, a non-invasive light activated therapy,  offers an effective alternative or adjunctive therapy for these vulnerable patients suffering from invasive fungal sinusitis. Photodisinfection has been proven to be safe over many years of experience in the dental and hospital acquired infection markets, and has proven to be highly effective at eliminating fungal organisms.

Sinuwave Photodisinfection System to Augment Current Endoscopic Sinus Surgery and Balloon Sinuplasty Procedures

When patients with Chronic Rhinosinusitis (CRS) are not responsive to medical therapy, they may be candidates for an endoscopic procedure that includes endoscopic sinus surgery, balloon sinuplasty, or a hybrid of a combination of these two. Endoscopic sinus surgery involves identifying and removing blockages of the sinus passages using high definition cameras, monitors, and a host of tiny articulating instruments. The operation is commonly performed with a general anesthetic, with instruments that access the sinuses through the nose, and only involving incisions of the face for the most severe of conditions.

The combination of endoscopic procedures and Sinuwave may help improve patient outcomes with minimal tissue removal. Balloon sinuplasty is also a surgical intervention but operates on an entirely different principle. It uses a balloon on a wire catheter to attempt to dilate the sinus passageways, widening the walls of the sinus passageway with the goal of restoring normal drainage without permanently damaging the sinus lining. Side-effects such as scarring of sinus tissue is unlikely using sinuplasty, unlike with surgery, but both of these current procedures are unable to address the underlying cause, only the blockages.

Hybrid procedures, which are becoming more popular as a result of improved patient outcomes, deploy both surgery and sinuplasty. Whether hybrid, surgery or sinuplasty, patient results can be further improved by the addition of Sinuwave™ Photodisinfection technology to remove the fungal and bacterial biofilm infections as well as their virulence factors within the sinuses, in addition to inactivating the host inflammatory cytokines. This 3 prong advantage of Photodisinfection enables ENT’s the ability to clear out the source of infection, and not just remove the blockage of the sinus passages. By clearing out the sinus cavities with several logs of kill, the body has a greater chance of returning to better health and avoid long term pain.

The Advantages of Sinuwave for Refractory Chronic Rhinosinusitis

Sinusitis is a disease in which the sinus cavities around the nasal passages become inflamed and swollen. When symptoms last for longer than12 weeks, the patient is described as suffering from chronic rhinosinusitis (CRS).  Patients typically first seek medical therapy to alleviate their symptoms as well as trying to address the cause. However, 20% of patients are unresponsive to any of the medicines and continue to suffer from the debilitating symptoms associated with CRS.

There are roughly 22 million office visits and 500,000 emergency department visits in the United States alone relating to CRS, indicating that it is a major health concern. The treatment regimen usually consists of the prescription of broad spectrum antibiotics, corticosteroids, and saline nasal irrigation. This disease most commonly affects young and middle aged adults, but may affect other demographics as well. Common symptoms include nasal congestion, throbbing facial pain, fever, headaches, difficulty sleeping and sensations of swelling around the eyes and face.

Sinuwave™ Photodisinfection System offers a unique method of treatment which has several distinct advantages over both medical and surgical CRS treatments. Photodisinfection is a minimally invasive approach to eliminating the pathogens and inflammatory host response involved in the disease process.  Photodisinfection is a 2 step process involving the application of a photosensitizer which is then activated by non-thermal laser light generating singlet oxygen based molecules, or free radicals that are lethal to fungal spores, bacterial biofilms and their virulence factors while not harming human tissue.

The major advantages of Sinuwave™ Photodisinfection for CRS patients are:

* pain-free procedure not requiring anesthesia

* immediate patient relief,

* no antibiotics or developed resistances,

* no removal of tissues are involved,

* no patient compliance requirements

* ease of use

Photodisinfection for Refractory Chronic Rhinosinusitis Patients: A much needed advance for an under-served patient population

Chronic rhinosinusitis (CRS) is one of the most common chronic conditions in the United States. There is a significant subpopulation of CRS patients who remain resistant to cure despite rigorous treatment regimens including surgery, allergy therapy, and prolonged antibiotic therapy. This refractory patient population is thought to exceed 500,000 in the US.

Photodisinfection, also known as antimicrobial photodynamic therapy (aPDT), is a noninvasive, non-antibiotic broad spectrum antimicrobial treatment that can improve outcomes for this under-served patient population by reducing inflammation of sinus tissue and eliminating biofilm in the sinuses. Patients  suffering from refractory Chronic Rhinosinusitis are likely to be infected by super-antigen producing bacterial such as Staph aureus and Pseudomonas aeruginosa. Photodisinfection has been proven to be highly effective at targeting these two pathogens and inactivating inflammatory cytokines.

Sniff, slice or swallow? All guesses are good when it comes to chronic sinusitis

We’ve all had colds that seem never-ending, and wondered if maybe, just maybe, we would one day be able to breathe without sounding like a foghorn.

Well for some people, that kind of nasal hell is just another day in the life.

Sinusitis causes swelling in the sinuses and nose, preventing the accumulated mucus from being drained out. The result is pain and pressure around the eyes, sore teeth, and constant headaches. People who suffer from chronic sinusitis go through that for days or even months at a time.

Physicians have recently come around to the idea that chronic sinusitis is an inflammation-related condition, rather than an infection to be treated with antibiotics. Treatment ideology has also shifted. Rather than relying on pills and other external treatments, doctors increasingly believe in getting medicine directly inside the sinuses, up close and personal.

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