Clinical trial NCT01797939: Predictors of Proton Pump Inhibitor Response in Gastroesophageal Reflux Disease Patients
Official title: Predictive Factors of Response to Proton Pump Inhibitor Treatment in Patients With Gastroesophageal Reflux Disease Symptoms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erosive Reflux Disease
Non-erosive Reflux Disease
Functional Heartburn
Keywords: Erosive reflux disease (ERD)
Non-erosive reflux disease (NERD)
Functional heartburn (FH)
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 197
Sex: ALL
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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).

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of PPI therapy in these erosive reflux disease (ERD), non-erosive reflux disease (NERD), and functional heartburn (FH) groups
timeFrame: After 8 weeks of initial PPI administration
Secondary outcomes:
measure: Predictors of the response to PPI treatment in patients with symptomatic GERD
timeFrame: After 8 weeks of initial PPI administration
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: