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).
Conclusion 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.
- Gastric cancer
- precancerous lesions
- Helicobacter pylori
- COX-2 inhibitor
- intervention trial
- clinical trials
- gastric cancer
- cell proliferation
- functional dyspepsia
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BCYW and LZ contributed equally to this article.
Funding This study was supported in part by grants from National High Technology R&D Program (2006AA02A402), National Basic Research Program of China (973 Program, 2010CB529303), National Natural Science Foundation (30471957, 30772515), a grant from Peking University and the Earmarked Research Grant from the Research Grant Council, Hong Kong (Project code: HKU 7256/01M).
Competing interests None.
Patient consent Obtained.
Ethics approval The project was approved by the institutional review board of Peking University School of Oncology (PUSO) and University of Hong Kong (EC-1721-01).
Provenance and peer review Not commissioned; externally peer reviewed.
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