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Helicobacter pylori eradication to prevent gastric cancer in a high-risk region of China: a randomized controlled trial.

Wong, Benjamin Chun-Yu; Lam, Shiu Kum; Wong, Wai Man; Chen, Jian Shun; Zheng, Ting Ting; Feng, Rui E; Lai, Kam Chuen; Hu, Wayne Hsing Cheng; Yuen, Siu Tsan; Leung, Suet Yi; Fong, Daniel Yee Tak; Ho, Joanna; Ching, Chi Kong; Chen, Jun Shi.
JAMA; 291(2): 187-94, 2004 Jan 14.
Artigo em Inglês | MEDLINE | ID: mdl-14722144
CONTEXT: 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. DESIGN, SETTING, AND PARTICIPANTS: 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.INTERVENTION: 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).

MAIN OUTCOME MEASURES:

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.
Selo DaSilva