Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients

Predictive Factors of Response to Proton Pump Inhibitor Treatment in Patients With Gastroesophageal Reflux Disease Symptoms

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 Overview

• Status: Completed
• Conditions: Erosive Reflux Disease; Non-erosive Reflux Disease; Functional Heartburn

• Study Type: Observational
• Enrollment (Actual): 197

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Even the patients complain GERD symptoms such as heartburn and acid regurgitation the final diagnosis could be erosive reflux disease(ERD), non-erosive reflux disease (NERD) and even functional heartburn (FH).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Erosive reflux disease (ERD)
Non-erovise reflux disease (NERD)
Functional heartburn (FH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 8 weeks of initial PPI administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	After 8 weeks of initial PPI administration

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 21, 2013
• First Submitted That Met QC Criteria: February 22, 2013
• First Posted (Estimate): February 25, 2013

Study Record Updates

• Last Update Posted (Estimate): February 25, 2013
• Last Update Submitted That Met QC Criteria: February 22, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Keywords: Erosive reflux disease (ERD); Non-erosive reflux disease (NERD); Functional heartburn (FH)
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Heartburn
• Other Study ID Numbers: B-1302-192-107

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No