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

Abstract

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). 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. 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). Combination therapy with mucolytics and PPI compared to PPI alone did not lead to faster or more effective symptomatic relief in LPR patients.