No abstract available.

BACKGROUND/AIMS: Gastroesophageal reflux disease is a highly prevalent disease. Assessing treatment efficacy is critical in that clinical endpoints are properly evaluated. Clinical tools for symptoms severity assessment should be discriminative, predictive and evaluative. METHODS: In this study we compared a patient-oriented symptoms evaluation (ReQuest(TM)) vs a structured interview assessment initiated by a physician (sickness impact profile [SIP]). Both questionnaires were analyzed in a multidimensional space using latent factors. Five dimensions were found: 1 for the short ReQuest(TM) questionnaire and 4 for SIP. RESULTS: We included 1,522 women and 1,296 men; mean age was 36 +/- 7 years, and mean body mass index was 26 +/- 4. The score questionnaire assessment evaluation by physicians and patients did not correlate between them (between r = 0.03 and 0.26) except nausea and sleep disorder (r = 0.45 and 0.51) but both were sensitive enough to detect changes after treatment (P < 0.05). Medical specialty of the physician showed effect on the score of both, ReQuest(TM) and SIP evaluation. Questionnaire variance decomposition due to specialist was only 2% (P < 0.05). CONCLUSIONS: While both evaluations are orthogonal (non-correlated), meaning patients and physicians measured diverse aspects of the same disease, they both were able to measure patient's improvement with treatment.
2-Pyridinylmethylsulfinylbenzimidazoles ; Body Mass Index ; Female ; Gastroesophageal Reflux ; Humans ; Monitoring, Physiologic ; Nausea ; Surveys and Questionnaires ; Specialization ; Treatment Outcome

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.
Arousal ; Gastroesophageal Reflux* ; Heartburn ; Humans ; Magnesium* ; Mexico ; Observational Study ; Prospective Studies ; Proton Pump Inhibitors ; Surveys and Questionnaires