Xylitol/saline nasal irrigations in patients with CRS without polyps, a multicenter double-blind, randomized study in 66 subjects with CRS without polyps

Chronic Rhino Sinusitis (CRS) constitutes one of the commonest conditions
encountered in medicine and affects nearly 14% of the population. CRS is a
condition that can be difficult to treat and is associated with significant
quality-of-life impairment1,2. Patients with CRS often complain of nasal
blockage, nasal discharge, headaches or facial pain/ pressure and a reduction
of smell. Symptoms must persist for a period of 12 weeks or longer in order to
meet the criteria for CRS3. CRS can occur as chronic recurrent rhinosinusitis
with symptom-free intervals in between, but is most of the time continuously
present. Often there is a relationship with lower airway disease like asthma
and allergy. In those cases, treatment of the nose often results in
improvements of the concomitant asthma. Cornerstone of CRS treatment consists
of topical nasal steroids combined with nasal saline irrigation. In case this
treatment fails long term antibiotics might be added in selected patients and
for some (multiple) surgical procedures (FESS) are needed3.

The CRS infection involves the formation of a bacterial biofilm that might play
a significant role in the pathogenesis and persistence of CRS.
Xylitol is a five-carbon sugar alcohol that has gained relative prominence in
the past decade as a naturally occurring antibacterial agent. It is generally
not believed to possess its own antibacterial properties; rather it appears to
enhance the body*s own innate bactericidal mechanisms In vitro, xylitol has a
clear inhibitory effect on the formation of the experimental biofilms. Xylitol
inhibits the acid production of cariogenic bacteria, but also prevents the
formation of a multispecies biofilm Also, xylitol has been shown to reduce
nasal bacterial carriage, otitis media, and dental caries in vivo

A pilot study conducted in 2011 by Weissman et al, showed that xylitol/saline
irrigations resulted in greater improvement of symptoms of CRS as compared to
saline only irrigation. Also, xylitol in water is a well-tolerated agent for
sinonasal irrigation9.

Unfortunately, no more placebo controlled studies could be identified
addressing the beneficial effect of xylitol in nasal saline irrigation for
patients with CRS.

In this study we will compare the therapeutic value of saline only versus
xylitol/saline nasal irrigations in patients with CRS without nasal polyposis
(CRSsNP). We will investigate several parameters by means of 2 different
questionnaires and endoscopic findings.

This study will be a multicenter double-blind, randomized study in 66 subjects
with CRSsNP, who have not previously underwent surgical procedures to the
paranasal sinuses.

Subjects will be treated during 6weeks with saline only- or xylitol/saline
irrigations three times daily and corticosteroid nose drops (Flixonase nasules
®) twice daily. Subjects will be randomized to use either saline only
irrigations or xylitol/saline irrigations.

Signs and symptoms will be measured with disease specific questionnaires. Nasal
endoscopy will give more objective information about the improvement status.
Nasal culture is investigated using nasal swabs at the beginning of the study.

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The subject will fill in a SNOT 22 Questionnaire at week 1 and 6 on the
computer. Also, the VAS score will be asked 2 times. The patient will rinse for
6 weeks, 3 times a day with Saline/Zoutxylitol solution. This rinsing is
standard care.