2.2. Assessments
redness, erosion, epigastric pain, abdominal distention, heartburn, edema, Edema, erosions, hemorrhage, belching, anorexia
EROSION, GASTRIC EROSION, EDEMA, EDEMA, HEMORRHAGE, GASTRIC EROSION, ANOREXIA
All patients were assessed by EGD, at baseline and 2 weeks after beginning the study drugs, for the evaluation of gastric erosion, edema, redness and hemorrhage. An erosion is a defect that does not extend beyond the lamina muscularis mucosae and in this study, all cases confirmed to be erosions at the investigator discretion were included. Gastric erosion was scored from 1 to 4 according to the number of erosions (1: no visible erosion, 2: 1–2 erosions, 3: 3–5 erosions, 4: ≥6 erosions). All endoscopic findings were evaluated by the investigators of each center first and then reviewed by a central reading center, which is composed of 3 independent endoscopy experts, to achieve a unified result. In addition, subjective GI symptoms such as epigastric pain (postprandial, fasting, nocturnal, regardless of diet), nausea/vomiting, abdominal distention, anorexia, heartburn and belching, were recorded at the beginning and end of treatment.The primary efficacy endpoint was the improvement rate of erosions, defined as the percentage of patients with ≥ 50% decreased erosion. Patients who had ≥ 50% reduction in initial scores at the follow-up EGD 2 weeks after treatment initiation were classified as effective cases; effective (4 to 1 or 3 to 1 or 2 to 1 or 4 to 2), ineffective (else other). Secondary efficacy endpoints were erosion cure rates, and improvement rates of edema, redness, hemorrhage, and GI symptoms. Cure of erosions was defined as the disappearance of all erosions. Improvement rates of edema, redness, and hemorrhage were defined as a ≥ 50% reduction in the initial scores at the follow-up EGD 2 weeks after treatment initiation. Edema was scored 1 or 2, redness from 1 to 4, and hemorrhage was scored from 1 to 5 (Table Endoscopic scoring of gastric erosion, edema, redness, and hemorrhage.