title: Ten-day bismuth-containing quadruple therapy is effective as first-line therapy for Helicobacter pylori-related chronic gastritis: a prospective randomized study in China.
abstract: OBJECTIVE
  To investigate the effectiveness of 10-day bismuth-containing quadruple (B-quadruple) treatment as first-line therapy in patients with Helicobacter pylori-related chronic gastritis.
  
  
  METHODS
  A randomized controlled trial was conducted from October 2011 to December 2013 in Zhejiang, China, including patients with H. pylori-related chronic gastritis who were randomly provided either 10-day omeprazole-based triple therapy (OM-triple; omeprazole 20 mg twice daily, clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily) or 10-day B-quadruple therapy (OM-triple + bismuth subcitrate 120 mg four times daily). H. pylori status, pathologic findings and dyspeptic symptoms were assessed at baseline and after 3 months. The primary outcome was H. pylori eradication rates by intention-to-treat (ITT) and per-protocol (PP) analyses. The secondary outcomes were the histologic and symptomatic benefits from H. pylori eradication.
  
  
  RESULTS
  A total of 351 patients with H. pylori-related chronic gastritis were recruited. The eradication rates of the OM-triple and B-quadruple groups were 58.4% (108/185) and 86.1% (143/166) respectively according to ITT analysis (p <0.01). PP rates of H. pylori eradication were 63.2% (108/171) and 92.3% (143/155) respectively (p <0.01). According to the PP analysis, active and chronic inflammation in gastric mucosa was substantially improved in all treated patients (n=326). However, pathologic atrophic gastritis and intestinal metaplasia did not regress in both groups (n=326). The reduction of dyspeptic symptoms score was significantly higher in the B-quadruple group than in the OM-triple group (0.59±0.057 vs. 0.39±0.046) (p <0.01).
  
  
  CONCLUSIONS
  Ten-day B-quadruple therapy is more effective than OM-triple therapy as first-line therapy for patients with H. pylori-induced chronic gastritis in China.
authors.affiliation: Department of Gastroenterology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang Province, China.
authors.forename: L
authors.initials: L
authors.lastname: Wang
authors.affiliation: Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang Province, China; Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.
authors.forename: Z
authors.initials: Z
authors.lastname: Lin
authors.affiliation: Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang Province, China; Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.
authors.forename: S
authors.initials: S
authors.lastname: Chen
authors.affiliation: Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Gastroenterology, First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.
authors.forename: C
authors.initials: C
authors.lastname: Chen
authors.affiliation: Department of Gastroenterology, First Affiliated Hospital of Wenzhou Medical University, Wenzhou, Zhejiang Province, China.
authors.forename: Z
authors.initials: Z
authors.lastname: Huang
authors.affiliation: Department of Gastroenterology, Central Hospital of Lishui City, Lishui, Zhejiang Province, China.
authors.forename: B
authors.initials: B
authors.lastname: Ye
authors.affiliation: Department of Gastroenterology, Central Hospital of Jinhua City, Jinhua, Zhejiang Province, China.
authors.forename: J
authors.initials: J
authors.lastname: Ding
authors.affiliation: Department of Gastroenterology, Taizhou Hospital of Zhejiang Province, Taizhou, Zhejiang Province, China.
authors.forename: W
authors.initials: W
authors.lastname: Li
authors.affiliation: Department of Gastroenterology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang Province, China.
authors.forename: L
authors.initials: L
authors.lastname: Wu
authors.affiliation: Department of Gastroenterology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China; Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang Province, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Jiang
authors.affiliation: Department of Gastroenterology, First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China.
authors.forename: L
authors.initials: L
authors.lastname: Meng
authors.affiliation: Department of Gastroenterology, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China.
authors.forename: Q
authors.initials: Q
authors.lastname: Du
authors.affiliation: Institute of Gastroenterology, Zhejiang University, Hangzhou, Zhejiang Province, China; Department of Gastroenterology, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, China. Electronic address: sijm@zju.edu.cn.
authors.forename: J
authors.initials: J
authors.lastname: Si
mesh_terms: D000328:Adult; D002681:China; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D005756:Gastritis / Q000188:drug therapy* / Q000382:microbiology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage* / Q000494:pharmacology; D009942:Organometallic Compounds / Q000008:administration & dosage* / Q000494:pharmacology; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D009942:Organometallic Compounds; C002791:bismuth tripotassium dicitrate; D009853:Omeprazole
keywords: Bismuth-containing quadruple therapy; Chronic gastritis; First-line therapy; Helicobacter pylori; Omeprazole-based triple therapy