Validation and Diagnostic Usefulness of Gastroesophageal Reflux Disease Questionnaire in a Primary Care Level in Mexico

BACKGROUND/AIMS: Different non-invasive diagnostics strategies have been used to assess patients with gastroesophageal reflux. Gastroesophageal reflux disease (GERD) questionnaire (GerdQ) is a 6-item, easy to use questionnaire that was developed primarily as a diagnostic tool for GERD in primary care. Our aim was to validate and assess diagnostic utility of GerdQ questionnaire in Mexican patients in the primary care setting. METHODS: The study was performed in 3 phases: (1) a questionnaire translation and comprehension study (n = 20), (2) are a reproducibility and validation study (50 patients and 50 controls) and (3) a study to assess the clinical utility in 252 subjects with GERD symptoms. Diagnostic accuracy was calculated using endoscopy and/or pH-metry as the gold standard. RESULTS: Internal consistency measured by the Cronbach's alpha coefficient was 0.81 for patients and 0.90 for healthy controls, with a mixed coefficient of 0.93. Reproducibility for GerdQ was very good and its discriminating validity was 88%. Most of the patients with erosive reflux and non-erosive reflux with abnormal pH-metry had scores > 8, meanwhile most of the patients with functional heartburn and hypersensitive esophagus had < 8. Sensitivity, specificity and positive predictive value of GerdQ compared to the gold standard were 72%, 72% and 87%, respectively. CONCLUSIONS: In Mexico, the GerdQ questionnaire Spanish validated version is useful for GERD diagnosis in the primary care setting.

Relief of Night-time Symptoms Associated With Gastroesophageal Reflux Disease Following 4 Weeks of Treatment With Pantoprazole Magnesium: The Mexican Gastroesophageal Reflux Disease Working Group

BACKGROUND/AIMS: To evaluate the effectiveness of pantoprazole magnesium (pantoprazole-Mg) 40 mg in the relief of esophageal and extra-esophageal symptoms of gastroesophageal reflux disease (GERD), particularly night-time symptoms. METHODS: Patients (aged 18-50 years) with 3-month history of heartburn and/or acid regurgitation plus at least one other symptom in the last week were enrolled in a nationwide, prospective and observational study in Mexico. Patients received pantoprazole-Mg 40 mg once daily during 4 weeks. Symptoms were assessed through a physician-administered structured interview and the patient-completed ReQuest in Practice(TM) questionnaire. Night-time GERD was defined as arousal from sleep during the night due to GERD-associated symptoms. RESULTS: Out of 4,343 patients included at basal visit, 3,665 were considered for the effectiveness per protocol analysis. At baseline, patients had a median of 8 GERD related symptoms. Patients with night-time GERD symptoms (42.7%) were more likely to have extra-esophageal symptoms (P < 0.001) than other GERD patients. Pantoprazole-Mg 40 mg once daily for 4 weeks improved a broad range of GERD-associated symptoms from baseline (80% reduction on physicians assessments; 68-77% reduction on ReQuest in Practice(TM) dimensions), including both day- and night-time GERD symptoms; improvements were the greatest for extra-esophageal symptoms in patients with night-time symptoms. Pantoprazole-Mg was well tolerated. CONCLUSIONS: Pantoprazole-Mg 40 mg significantly improved a broad range of esophageal and extra-esophageal GERD related symptoms including sleep disturbances, as well as well-being, in patients with daytime or night-time GERD, making it a good option for patients with GERD, especially when extra-esophageal and night-time symptoms are present.