title: Esomeprazole regimens for reflux symptoms in Chinese patients with chronic gastritis.
abstract: OBJECTIVE
  To compare symptom control with esomeprazole regimens for non-erosive reflux disease and chronic gastritis in patients with a negative endoscopy.
  
  
  METHODS
  This randomized, open-label study was designed in line with clinical practice in China. Patients with typical reflux symptoms for ≥ 3 mo and a negative endoscopy who had a Gastroesophageal Reflux Disease Questionnaire score ≥ 8 were randomized to initial treatment with esomeprazole 20 mg once daily either for 8 wk or for 2 wk. Patients with symptom relief could enter another 24 wk of maintenance/on-demand treatment, where further courses of esomeprazole 20 mg once daily were given if symptoms recurred. The primary endpoint was the symptom control rate at week 24 of the maintenance/on-demand treatment period. Secondary endpoints were symptom relief rate, success rate (defined as patients who had symptom relief after initial treatment and after 24 wk of maintenance treatment), time-to-first-relapse and satisfaction rate.
  
  
  RESULTS
  Based on the data collected in the modified intention-to-treat population (MITT; patients in the ITT population with symptom relief after initial esomeprazole treatment, n = 262), the symptom control rate showed a small but statistically significant difference in favor of the 8-wk regimen (94.9% vs 87.3%, P = 0.0473). Among the secondary endpoints, based on the data collected in the ITT population (n = 305), the 8-wk group presented marginally better results in symptom relief after initial esomeprazole treatment (88.3% vs 83.4%, P = 0.2513) and success rate over the whole study (83.8% vs 72.8%, P = 0.0258). The 8-wk regimen was found to provide a 46% reduction in risk of relapse vs the 2-wk regimen (HR = 0.543; 95%CI: 0.388-0.761). In addition, fewer unscheduled visits and higher patient satisfaction supported the therapeutic benefits of the 8-wk regimen over the 2-wk regimen. Safety was comparable between the two groups, with both regimens being well tolerated.
  
  
  CONCLUSIONS
  Chinese patients diagnosed with chronic gastritis achieved marginally better control of reflux symptoms with an 8-wk vs a 2-wk esomeprazole regimen, with a similar safety profile.
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Jing
authors.initials: J
authors.lastname: Sun
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Yao-Zong
authors.initials: YZ
authors.lastname: Yuan
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Xiao-Hua
authors.initials: XH
authors.lastname: Hou
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Duo-Wu
authors.initials: DW
authors.lastname: Zou
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Bin
authors.initials: B
authors.lastname: Lu
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Min-Hu
authors.initials: MH
authors.lastname: Chen
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Fei
authors.initials: F
authors.lastname: Liu
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Kai-Chun
authors.initials: KC
authors.lastname: Wu
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Xiao-Ping
authors.initials: XP
authors.lastname: Zou
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Yan-Qing
authors.initials: YQ
authors.lastname: Li
authors.affiliation: Jing Sun, Yao-Zong Yuan, Department of Gastroenterology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
authors.forename: Li-Ya
authors.initials: LY
authors.lastname: Zhou
mesh_terms: D000328:Adult; D044466:Asian People; D002681:China / Q000453:epidemiology; D002908:Chronic Disease; D004334:Drug Administration Schedule; D016099:Endoscopy, Gastrointestinal; D064098:Esomeprazole / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005756:Gastritis / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D005764:Gastroesophageal Reflux / Q000175:diagnosis / Q000188:drug therapy* / Q000208:ethnology; D006801:Humans; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D012074:Remission Induction; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D054328:Proton Pump Inhibitors; D064098:Esomeprazole
keywords: Chronic gastritis regimen; Esomeprazole; Non-erosive reflux disease regimen; Symptom control rate