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

Ann Otol Rhinol Laryngol. 2020 Aug;129(8):781-787. doi: 10.1177/0003489420913592. Epub 2020 Mar 18.

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.

Keywords: ambroxol-theophyllin-7-acetate; expectorants; globus sensation; laryngopharyngeal reflux; proton pump inhibitors.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Expectorants / therapeutic use*
  • Female
  • Follow-Up Studies
  • Humans
  • Laryngopharyngeal Reflux / diagnosis
  • Laryngopharyngeal Reflux / drug therapy*
  • Laryngoscopy
  • Male
  • Middle Aged
  • Prospective Studies
  • Proton Pump Inhibitors / therapeutic use*
  • Treatment Outcome

Substances

  • Expectorants
  • Proton Pump Inhibitors