Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China: a randomized controlled trial.
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.
Wong
Benjamin Chun-Yu
BC
Department of Medicine, University of Hong Kong, Hong Kong, China. bcywong@hku.hk
Lam
Shiu Kum
SK
Wong
Wai Man
WM
Chen
Jian Shun
JS
Zheng
Ting Ting
TT
Feng
Rui E
RE
Lai
Kam Chuen
KC
Hu
Wayne Hsing Cheng
WH
Yuen
Siu Tsan
ST
Leung
Suet Yi
SY
Fong
Daniel Yee Tak
DY
Ho
Joanna
J
Ching
Chi Kong
CK
Chen
Jun Shi
JS
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*
D000890:Anti-Infective Agents; D000897:Anti-Ulcer Agents; D008795:Metronidazole; D019980:Amoxicillin-Potassium Clavulanate Combination; D009853:Omeprazole