Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients

Seoul National University Bundang Hospital197 enrolled

Overview

Proton pump inhibitor (PPI) is widely used in patients with gastroesophageal reflux disease (GERD), however, some patients fail to respond to PPI therapy. Recent reporters suggest that depressive disorders, anxiety, sleep dysfunction were related with the symptomatic responses to a PPI treatments. Nevertheless, the predictive factors of response to PPI treatment still remain controversial. Therefore, the aims of this study were to investigate the efficacy of PPI therapy, and to evaluate the predictors of the PPI response in patients with symptomatic GERD by using the questionnaire which consisted of GERD symptoms, GERD impact scale (GIS), Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).

Study Type

OBSERVATIONAL

Enrollment

197

Conditions

Erosive Reflux Disease Non-erosive Reflux Disease Functional Heartburn

Eligibility

Sex: ALLMin age: 16 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult Subjects (From 16 to 85 years old) * The participants with GERD symptoms were treated a PPI therapy. * The participants completed a questionnaire. The questionnaire consisted of demographic data, GERD symptoms, GERD impact scale (GIS), Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF). Exclusion Criteria: * Patients with a history of gastrointestinal surgery, Barrett's esophagus, esophageal motility disorder, peptic ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus) were excluded. * Patients who took the PPI therapy less than 4 weeks were excluded.

Outcomes

Primary Outcomes

Efficacy of PPI therapy in these erosive reflux disease (ERD), non-erosive reflux disease (NERD), and functional heartburn (FH) groups

Responses of dyspeptic symptoms were classified into 4 sections, as follows: complete response (more than 80% of symptom resolution), satisfactory response (symptoms remained less than 50%), partial response (symptoms remained for more than 50%), and refractory response (unresponsive to the eradication therapy). Then, the symptom responses were classified into 2 groups: responder with complete or satisfactory subgroup, and non-responder with partial or refractory responder subgroup.

Time frame: After 8 weeks of initial PPI administration

Secondary Outcomes

Predictors of the response to PPI treatment in patients with symptomatic GERD

The participants were evaluated the predictors of PPI response by using the questionnaire which consisted of GERD symptoms, GERD impact scale (GIS), Epworth sleepiness scale (ESS), Pittsburgh sleep quality index (PSQI), Hospital anxiety and depression scale (HADS), and WHO quality of life scale abbreviated version (WHOQOL-BREF).