A Prospective Randomized Clinical Trial of Combination Therapy with Proton Pump Inhibitors and Mucolytics in Patients with Laryngopharyngeal Reflux

Abstract

Objectives: To identify whether combination therapy with mucolytics and proton pump inhibitors (PPIs) leads to faster and more effective symptomatic relief in patients with laryngopharyngeal reflux (LPR). Methods: Patients diagnosed as LPR with a reflux symptom index (RSI) >= 13 and a reflux finding score (RFS) >= 7 were enrolled in this prospective study. Patients were randomly allocated to control (PPI only) or experimental (PPI + mucolytics) groups and changes in RSI and RFS values were assessed at 1- and 3-month follow-up. Results: One hundred sixteen patients were randomly allocated into either the control group (n = 59) or the experimental group (n = 57). The RSI and RFS scores significantly decreased in both groups (all P < .001) after 1 month of treatment; however, there was no significant difference in RSI change between groups (P = .223). After 3 months of treatment, there remained no significant difference in RSI change between groups (P = .592). Conclusions: Combination therapy with mucolytics and PPI compared to PPI alone did not lead to faster or more effective symptomatic relief in LPR patients.