title: Effects of selective COX-2 inhibitor and Helicobacter pylori eradication on precancerous gastric lesions.
abstract: OBJECTIVE
  Helicobacter pylori infection and overexpression of cyclo-oxygenase-2 (COX-2) are associated with gastric cancer and its precursors. To evaluate the effect of a selective COX-2 inhibitor alone and combined with H pylori eradication on the evolution of precancerous gastric lesions, a randomised, placebo-controlled trial was conducted in Linqu County, Shandong Province, China.
  
  
  METHODS
  A total of 1024 participants aged 35-64 years with H pylori infection and advanced gastric lesions were randomly assigned in a factorial design to two interventions or placebo: anti-H pylori treatment for 7 days, and a COX-2 inhibitor (celecoxib) for 24 months. The effects of the interventions were evaluated by the regression or progression of advanced gastric lesions.
  
  
  RESULTS
  Of the 1024 participants who received anti-H pylori treatment or placebo, 919 completed a subsequent 24-month treatment with celecoxib or placebo. The H pylori eradication rate by per-protocol analysis was 78.2%. Compared with placebo, the proportions of regression of gastric lesions significantly increased in the celecoxib treatment (52.8% vs 41.2%) and anti-H pylori treatment (59.3% vs 41.2%) group, and OR by per-protocol analysis was 1.72 (95% CI 1.07 to 2.76) for celecoxib and 2.19 (95% CI 1.32 to 3.64) for H pylori eradication. No statistically significant effect was found for H pylori eradication followed by celecoxib on the regression of advanced gastric lesions (OR 1.48, 95% CI 0.91 to 2.40).
  
  
  CONCLUSIONS
  This population-based intervention trial revealed that celecoxib treatment or H pylori eradication alone had beneficial effects on the regression of advanced gastric lesions. No favourable effects were seen for H pylori eradication followed by celecoxib treatment. Trial registration HARECCTR0500053 in accordance with WHO ICTRP requirements.
authors.affiliation: Department of Medicine, University of Hong Kong, Hong Kong, China.
authors.forename: Benjamin C Y
authors.initials: BC
authors.lastname: Wong
authors.forename: Lian
authors.initials: L
authors.lastname: Zhang
authors.forename: Jun-ling
authors.initials: JL
authors.lastname: Ma
authors.forename: Kai-feng
authors.initials: KF
authors.lastname: Pan
authors.forename: Ji-you
authors.initials: JY
authors.lastname: Li
authors.forename: Lin
authors.initials: L
authors.lastname: Shen
authors.forename: Wei-dong
authors.initials: WD
authors.lastname: Liu
authors.forename: Guo-shuang
authors.initials: GS
authors.lastname: Feng
authors.forename: Xiao-dong
authors.initials: XD
authors.lastname: Zhang
authors.forename: Jie
authors.initials: J
authors.lastname: Li
authors.forename: Ai-ping
authors.initials: AP
authors.lastname: Lu
authors.forename: Harry H X
authors.initials: HH
authors.lastname: Xia
authors.forename: Shiukum
authors.initials: S
authors.lastname: Lam
authors.forename: Wei-cheng
authors.initials: WC
authors.lastname: You
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000068579:Celecoxib; D017291:Clarithromycin / Q000008:administration & dosage / Q000627:therapeutic use; D052246:Cyclooxygenase 2 Inhibitors / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000627:therapeutic use; D011230:Precancerous Conditions / Q000209:etiology* / Q000473:pathology / Q000517:prevention & control; D011720:Pyrazoles / Q000627:therapeutic use*; D013270:Stomach / Q000473:pathology; D013274:Stomach Neoplasms / Q000209:etiology* / Q000473:pathology / Q000517:prevention & control; D013449:Sulfonamides / Q000627:therapeutic use*
chemical_list: D000900:Anti-Bacterial Agents; D052246:Cyclooxygenase 2 Inhibitors; D011720:Pyrazoles; D013449:Sulfonamides; D000658:Amoxicillin; D017291:Clarithromycin; D000068579:Celecoxib; D009853:Omeprazole