Researchers Show Chronic Sinusitis Is Immune Disorder; Antifungal
Medicine Effective Treatment
BUFFALO, N.Y. -- 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 today (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 control
group.
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, results
showed.
"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 us."
"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 this disease. 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 months.
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.
The University at Buffalo is a premier research-intensive public
university, the largest and most comprehensive campus in the State
University of New York