S A Anzić1, M Turkalj2,3, A Župan2, M Labor3,4, D Plavec3,5, T Baudoin6. 1. ENT Department, Children's Hospital Srebrnjak, Zagreb, Croatia. 2. Department for Allergy and Pulmonology, Children's Hospital Srebrnjak, Zagreb, Croatia. 3. Faculty of Medicine, J.J. Strossmayer University of Osijek, Osijek, Croatia. 4. Department of Medicine, University Hospital Center Osijek, Osijek, Croatia. 5. Research Department, Children's Hospital Srebrnjak, Zagreb, Croatia. 6. ENT Department, University Hospital Center Sisters of Charity, Zagreb, Croatia.
Abstract
OBJECTIVES: Gastroesophageal reflux recommended treatment (dose and duration) with proton-pump inhibitor (PPI) compared to placebo significantly reduces the signs and symptoms 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 comorbid CRS. MAIN OUTCOME MEASURES: Significant reduction in signs and symptoms (reflux symptom index (RSI) score as subjective, and reflux finding score (RFS) as objective measure) 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 symptoms 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.
RCT Entities:
OBJECTIVES: Gastroesophageal reflux recommended treatment (dose and duration) with proton-pump inhibitor (PPI) compared to placebo significantly reduces the signs and symptoms 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 comorbid CRS. MAIN OUTCOME MEASURES: Significant reduction in signs and symptoms (reflux symptom index (RSI) score as subjective, and reflux finding score (RFS) as objective measure) 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 symptoms 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.