title: Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China: a randomized controlled trial.
abstract: BACKGROUND
  Although chronic Helicobacter pylori infection is associated with gastric cancer, the effect of H pylori treatment on prevention of gastric cancer development in chronic carriers is unknown.
  
  
  OBJECTIVE
  To determine whether treatment of H pylori infection reduces the incidence of gastric cancer.
  
  
  METHODS
  Prospective, randomized, placebo-controlled, population-based primary prevention study of 1630 healthy carriers of H pylori infection from Fujian Province, China, recruited in July 1994 and followed up until January 2002. A total of 988 participants did not have precancerous lesions (gastric atrophy, intestinal metaplasia, or gastric dysplasia) on study entry.
  
  
  METHODS
  Patients were randomly assigned to receive H pylori eradication treatment: a 2-week course of omeprazole, 20 mg, a combination product of amoxicillin and clavulanate potassium, 750 mg, and metronidazole, 400 mg, all twice daily (n = 817); or placebo (n = 813).
  
  
  METHODS
  The primary outcome measure was incidence of gastric cancer during follow-up, compared between H pylori eradication and placebo groups. The secondary outcome measure was incidence of gastric cancer in patients with or without precancerous lesions, compared between the 2 groups.
  
  
  RESULTS
  Among the 18 new cases of gastric cancers that developed, no overall reduction was observed in participants who received H pylori eradication treatment (n = 7) compared with those who did not (n = 11) (P =.33). In a subgroup of patients with no precancerous lesions on presentation, no patient developed gastric cancer during a follow-up of 7.5 years after H pylori eradication treatment compared with those who received placebo (0 vs 6; P =.02). Smoking (hazard ratio [HR], 6.2; 95% confidence interval [CI], 2.3-16.5; P<.001) and older age (HR, 1.10; 95% CI, 1.05-1.15; P<.001) were independent risk factors for the development of gastric cancer in this cohort.
  
  
  CONCLUSIONS
  We found that the incidence of gastric cancer development at the population level was similar between participants receiving H pylori eradication treatment and those receiving placebo during a period of 7.5 years in a high-risk region of China. In the subgroup of H pylori carriers without precancerous lesions, eradication of H pylori significantly decreased the development of gastric cancer. Further studies to investigate the role of H pylori eradication in participants with precancerous lesions are warranted.
authors.affiliation: Department of Medicine, University of Hong Kong, Hong Kong, China. bcywong@hku.hk
authors.forename: Benjamin Chun-Yu
authors.initials: BC
authors.lastname: Wong
authors.forename: Shiu Kum
authors.initials: SK
authors.lastname: Lam
authors.forename: Wai Man
authors.initials: WM
authors.lastname: Wong
authors.forename: Jian Shun
authors.initials: JS
authors.lastname: Chen
authors.forename: Ting Ting
authors.initials: TT
authors.lastname: Zheng
authors.forename: Rui E
authors.initials: RE
authors.lastname: Feng
authors.forename: Kam Chuen
authors.initials: KC
authors.lastname: Lai
authors.forename: Wayne Hsing Cheng
authors.initials: WH
authors.lastname: Hu
authors.forename: Siu Tsan
authors.initials: ST
authors.lastname: Yuen
authors.forename: Suet Yi
authors.initials: SY
authors.lastname: Leung
authors.forename: Daniel Yee Tak
authors.initials: DY
authors.lastname: Fong
authors.forename: Joanna
authors.initials: J
authors.lastname: Ho
authors.forename: Chi Kong
authors.initials: CK
authors.lastname: Ching
authors.forename: Jun Shi
authors.initials: JS
authors.lastname: Chen
mesh_terms: D000328:Adult; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000627:therapeutic use; D000890:Anti-Infective Agents / Q000627:therapeutic use; D000897:Anti-Ulcer Agents / Q000627:therapeutic use; D002681:China / Q000453:epidemiology; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D016480:Helicobacter pylori; D006801:Humans; D015994:Incidence; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D011230:Precancerous Conditions / Q000453:epidemiology / Q000382:microbiology* / Q000473:pathology / Q000517:prevention & control*; D011446:Prospective Studies; D012307:Risk Factors; D013274:Stomach Neoplasms / Q000453:epidemiology / Q000382:microbiology* / Q000473:pathology / Q000517:prevention & control*
chemical_list: D000890:Anti-Infective Agents; D000897:Anti-Ulcer Agents; D008795:Metronidazole; D019980:Amoxicillin-Potassium Clavulanate Combination; D009853:Omeprazole