ABSTRACT
BACKGROUND AND AIM: The prospective, open-label, randomized study aims to compare the efficacy of lansoprazole, a fast orally disintegrating proton pump inhibitor (PPI), and dexlansoprazole, a dual delayed release PPI, in patients with atypical symptoms of gastroesophageal reflux disease (GERD). METHODS: Patients with atypical GERD symptoms with a total reflux symptom index score > 10 were eligible for enrollment. From February 2018 to December 2019, 232 subjects were randomly assigned (1:1 ratio) to receive oral lansoprazole, Takepron OD 30 mg, once daily before breakfast or oral dexlansoprazole, Dexilant 60 mg, once daily before breakfast for 8 weeks. The primary end-point is to compare the symptoms response rate after an 8-week PPI therapy between the two groups. RESULTS: There were 232 study subjects enrolling in this study. After the 8-week PPI therapy, dexlansoprazole-treated group had a significantly higher response rate than lansoprazole-treated group in cough (76.5% vs 38.0%) and globus (69.7% vs 30.8%) (P all < 0.05 by intention-to-treat). Multivariate logistic regression analysis showed that the use of dexlansoprazole, presence of dyslipidemia, and typical GERD symptoms (acid reflux and heartburn) were predictors for symptom response for cough; the use of dexlansoprazole and presence of erosive esophagitis were predictors for symptom response for globus (P all < 0.05). No predictor for therapy response to hoarseness was noted. CONCLUSIONS: There is a higher response rate for cough and globus symptoms in patients with atypical GERD after the 8-week PPI therapy with dexlansoprazole rather than lansoprazole.
Subject(s)
Dexlansoprazole/administration & dosage , Gastroesophageal Reflux/drug therapy , Lansoprazole/administration & dosage , Proton Pump Inhibitors/administration & dosage , Aged , Cough/drug therapy , Cough/etiology , Dyslipidemias , Esophagitis , Female , Gastroesophageal Reflux/complications , Globus Sensation/drug therapy , Globus Sensation/etiology , Hoarseness/drug therapy , Hoarseness/etiology , Humans , Male , Middle Aged , Prospective Studies , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: To evaluate the patient-reported reflux symptom index (RSI) and the doctors-reported Reflux finding score (RFS) as potential predictors for proton pump inhibitor (PPI) response in patients with suspected lower pharyngeal reflux, presenting with globus pharyngeus as their primary complaint. METHODS: The research project was performed at the ENT department of Isala hospital Zwolle, the Netherlands. A before and after design was used for this single institution prospective exploratory study. 101 participants with globus pharyngeus symptoms as a primary complaint were included. All participants were assessed by an otorhinolaryngologist at enrollment and after eight weeks of esomeprazole use. Fiberoptic laryngoscopy was performed to document the RFS, and RSI questionnaires were self-administered by the participants. Our main outcome measurement was the patient- reported therapeutic response evaluation, that differentiated three categories: responders, partial responders and non-responders. For evaluation of the assessment tools, RFS > 7 and RSI > 13 were considered deviant. RESULTS: Among the 101 participants, 43 (42.6%) were responders, 28 (27.7%) partial responders and 30 (29.7%) non-responders. Both baseline RSI > 13 and RFS > 7 were statistically significant associated with treatment response. Also, combined into RSI/RFS baseline categories, a significant overall association between baseline scores and patient-reported treatment response was found. Patients reported success rates for deviant RSI and RFS baseline scores were 76.6% and 96%, respectively. 95.5% of patients with both deviant RSI and RFS baseline scores, reported (partial) treatment response. CONCLUSION: Both together, as well individually, pre-treatment RSI and RFS ratings can help predict treatment response of empirical PPI treatment in patients experiencing globus pharyngeus symptoms.
