J Neurogastroenterol Motil.  2024 Oct;30(4):459-467. 10.5056/jnm23118.

The Impact of a Twice-daily Versus Once-daily Proton Pump Inhibitor Dosing Regimen on Laryngopharyngeal Reflux Symptoms: A Prospective Randomized Controlled Trial

Affiliations
  • 1Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea
  • 2Department of Otorhinolaryngology-Head and Neck Surgery, Seoul National University College of Medicine, Seoul, Korea
  • 3Department of Otorhinolaryngology-Head and Neck Surgery, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
  • 4Medical Research Collaborating Center, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-do, Korea
  • 5Department of Otorhinolaryngology-Head and Neck Surgery, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Chungcheongbuk-do, Korea
  • 6Sensory Organ Research Institute, Seoul National University Medical Research Center, Seoul, Korea
  • 7Department of Otorhinolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

Abstract

Background/Aims
Proton pump inhibitors (PPIs) play a crucial role in managing laryngopharyngeal reflux (LPR), but the optimal dosing regimen remains unclear. We aim to compare the effectiveness of the same total PPI dose administered twice daily versus once daily in LPR patients.
Methods
We conducted a prospective randomized controlled trial at a tertiary referral hospital, enrolling a total of 132 patients aged 19 to 79 with LPR. These patients were randomly assigned to receive either a 10 mg twice daily (BID) or a 20 mg once daily (QD) dose of ilaprazole for 12 weeks. The Reflux Symptom Index (RSI) and Reflux Finding Score (RFS) were assessed at 8 weeks and 16 weeks. The primary endpoint was the RSI response, defined as a reduction of 50% or more in the total RSI score from baseline. We also analyzed the efficacy of the dosing regimens and the impact of dosing and duration on treatment outcomes.
Results
The BID group did not display a higher response rate for RSI than the QD group. The changes in total RSI scores at the 8-week and 16-week visits showed no significant differences between the 2 groups. Total RFS alterations were also comparable between both groups. Each dosing regimen demonstrated significant decreases in RSI and RFS.
Conclusions
Both BID and QD PPI dosing regimens improved subjective symptom scores and objective laryngoscopic findings. There was no significant difference in RSI improvement between the 2 dosing regimens, indicating that either dosing regimen could be considered a viable treatment option.

Keyword

Ilaprazole; Laryngopharyngeal reflux; Proton pump inhibitors; Reflux Finding Score; Reflux Symptom Index
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