Trial of Proton Pump Inhibitor With Prokinetics or Placebo in Patients With Laryngopharyngeal Reflux Disease

Samsung Medical Center200 enrolled

Overview

Based on meta-analysis of prokinetics trials in laryngopharyngeal reflux disease (LPRD) (Glicksman et al. 2014), well designed study was performed in 4 articles. But, those studies had several problems including inclusion criteria, randomization methods, and placebo medication. They had similar results that prokinetics and proton pump inhibitor (PPI) had synergistic effect for management of LPRD. Therefore, the aim of study is to evaluate the efficacy of prokinetics as an additional medication to proton pump inhibitor by well designed randomized double blind case-control study.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

200

Conditions

Laryngopharyngeal Reflux Disease

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Age between 20 and 65 years * Reflux Symptom Index (RSI) \> 7 and, Reflux Finding Score (RFS) \> 13 Exclusion Criteria * Taken proton pump inhibitor within 3months * Taken steroid within 3months * Pregnancy * Breast feeding

Outcomes

Primary Outcomes

Reflux symptom index (questionnaire)

Reflux symptom index is validated questionnaire for laryngopharyngeal reflux disease. It consists of 9 items, and scale of each item ranges from 0 to 5 with maximal total score of 45.

Time frame: 1 month after medication

Reflux finding score (scoring of laryngeal stroboscopy finding score)

Reflux finding score is an 8-item clinical severity scale based on findings during laryngeal stroboscopy. The scale ranges from 0 (no abnormal findings) to a maximum of 26 (worst score possible).