Study: Chronic Sinusitis is
an Immune Disorder
Sinus News - Vol. 5, No. 9
May 1, 2004
Researchers at the University at Buffalo and the Mayo Clinic have
shown that chronic sinusitis is an immune disorder caused by fungus,
opening up a promising new avenue for treating this ubiquitous and
debilitating condition, for which there is no FDA-approved therapy.
Results of their research suggest that common airborne fungi lodge
in the mucus lining of the sinuses in most people, but initiate
an immune response only in individuals prone to chronic sinusitis.
The immune response causes the fungi to be attacked, which leads
to damage of the sinus membranes, resulting in full-blown symptoms.
"We hope this study will lead to the first treatment aimed
at the root cause of chronic sinusitis, rather than a treatment
just to mask the symptoms," said David A. Sherris, M.D., interim
chair of the UB Department of Otolaryngology.
Sherris presented the study findings on March 23, 2004, at the
annual meeting of the American Academy of Allergy, Asthma and Immunology
in San Francisco. The research was conducted while Sherris was at
the Mayo Clinic.
Through a randomized, placebo-controlled, double-blind pilot trial
using the fungicide Amphotericin-B applied intranasally, the researchers
found that the treatment group showed a significant decrease in
the inflammatory thickening of the sinus membranes compared to the
Inflammation in the mucus also decreased significantly in those
receiving the drug, compared to placebo, and 70 percent of patients
on the medication had a decrease in the amount of nasal swelling,
"We showed in 1999 that fungal organisms were present in the
mucus of 96 percent of patients who had surgery for chronic sinusitis,
and that inflammatory cells were clumped around the fungi, which
indicated to us that the condition was an immune disorder caused
by fungus, " said Sherris. "But many doctors didn't believe
"Next, we conducted various immunologic studies and an open
trial using the fungicide treatment and found that 75 percent of
patients improved on the new therapy. Now we have similar results
from a randomized, blinded trial with a control group, which is
the 'gold standard' in drug testing. Our next step is to conduct
a multi-center trial using antifungals, which we hope will lead
to FDA approval of antifungal treatment for this chronic disease."
Chronic sinusitis, a disease of the nasal passages and the surrounding
sinus cavities, is thought to affect 16.8 percent of the adult population
of the U.S. It causes long-term nasal congestion, production of
thick mucus, loss of sense of smell and creates an environment for
opportunistic bacterial infections that exacerbate those symptoms.
Sherris said studies have shown that chronic sinusitis exceeds even
congestive heart failure in its adverse effects on quality of life.
Little is known about the causes of sinusitis. Without a specific
target for intervention, physicians often simply treated the secondary
bacterial infections in hopes of providing a modicum of relief.
The current trial involved 24 patients with chronic sinusitis who
were randomly assigned to receive the treatment or a placebo. Neither
the patients nor the investigators knew who received the drug or
the inactive agent. The final analysis involved data from 10 treatment
patients and 14 controls, all of whom were in the trial for six
Researchers took CT scans (special x-rays of the sinuses) at baseline
and at 6 months. They also graded patients' inflammation by direct
exam with an endoscope in the nose at the start of the study, and
at 3 and 6 months.
The CT scans showed that the treatment group had a mean 8.8 percent
decrease in inflammatory mucus thickening, while the placebo group
had an increase of 2.5 percent. Sherris said 70 percent of patients
in the treatment group also showed significant improvement when
their nasal passages were viewed through an endoscope, while the
placebo group showed no change. Markers of inflammation in the mucus
also decreased significantly in the treatment group, compared to
the placebo group.
Additional researchers on the study, all from the Mayo Clinic,
were Jens U. Ponikau, M.D., Amy Weaver, Evangelo Frigas, M.D., and
Hirohito Kita, M.D.
The research was supported by grants from the National Institutes
of Health and the Mayo Foundation for Education and Research.
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