Eight weeks of omeprazole 20 mg significantly reduces both
laryngopharyngeal reflux and comorbid chronic rhinosinusitis
signs and symptoms: Randomised, double-blind,
ENT Department, Children’s Hospital
Srebrnjak, Zagreb, Croatia
Department for Allergy and Pulmonology,
Children’s Hospital Srebrnjak, Zagreb,
Faculty of Medicine, J.J. Strossmayer
University of Osijek, Osijek, Croatia
Department of Medicine, University
Hospital Center Osijek, Osijek, Croatia
Research Department, Children’s Hospital
Srebrnjak, Zagreb, Croatia
ENT Department, University Hospital
Center Sisters of Charity, Zagreb, Croatia
D. Plavec, Research Department, Children’s
Hospital Srebrnjak, Zagreb, Croatia.
Objectives: Gastroesophageal reflux recommended treatment (dose and duration) with
proton-pump inhibitor (PPI) compared to placebo significantly reduces the signs and symp-
toms of laryngopharyngeal reflux (LPR) and comorbid chronic rhinosinusitis (CRS).
Design: Double-blind randomised placebo-controlled trial.
Setting: Eight weeks of treatment with omeprazole 20 mg once daily (OD).
Participants: Sixty patients (28 women, aged 19-87 years) with diagnosed LPR and
Main outcome measures: Significant reduction in signs and symptoms (reflux symp-
tom index (RSI) score as subjective, and reflux finding score (RFS) as objective mea-
sure) of LPR after 8 weeks of treatment with omeprazole 20 mg OD when
compared to placebo. Secondary objectives were significant reduction in signs and
symptoms of comorbid CRS after 8 weeks of treatment with omeprazole 20 mg OD
when compared to placebo and the association of the severity of signs and symp-
toms of LPR with the ones of CRS.
Results: RSI and RFS decreased significantly more in the active treatment group
after 8 weeks compared to placebo (P < .001 for both). CRS and endoscopy scoring
decreased both significantly more in the active group after 8 weeks compared to
placebo (P < .001 for both). CRS scoring significantly correlated with RSI (R = 0.312,
P = .015) but not with RFS (R = 0.199, P = .127).
Conclusions: The results of our trial suggest that omeprazole 20 mg OD for
8 weeks was effective in reducing signs and symptoms of both LPR and CRS,
although in most patients still present at the end of the trial.
Chronic rhinosinusitis (CRS) is in the realm of scientific interest, as its
aetiology and association with other respiratory and multimorbid dis-
orders have not yet been clarified.
It is a public health concern as
between 10% and 30% of the adult population suffer from CRS.
patients with CRS, one should rule out or treat allergies, asthma or
other underlying conditions as infections, inflammation associated
with environmental factors, anatomic alterations or a combination of
Latest literature proposes laryngopharyngeal reflux
(LPR) as the underlying contributory factor for chronic inflammation in
both upper and lower airways.
The mechanism leading to airways
mucous membrane damage is still not fully understood, but chemical
injury induced by low pH and gastric enzymes as a consequence of a
retrograde flow of the gastric content to upper aerodigestive tract cer-
tainly plays a role.
Although common, LPR is still often unrecognised
or wrongly attributed within the everyday practice. The necessity of
Trial registration: ClinicalTrials.gov Identifier NCT03086070 Registered 21 March 2017,
Accepted: 5 October 2017
© 2017 John Wiley & Sons Ltd wileyonlinelibrary.com/journal/coa Clinical Otolaryngology. 2018;43:496–501.