Effects of selective COX-2 inhibitor and Helicobacter pylori eradication on precancerous gastric lesions

• Published in: Gut Vol. 61; no. 6; p. 812
• Main Authors: Wong, Benjamin C Y, Zhang, Lian, Ma, Jun-ling, Pan, Kai-feng, Li, Ji-you, Shen, Lin, Liu, Wei-dong, Feng, Guo-shuang, Zhang, Xiao-dong, Li, Jie, Lu, Ai-ping, Xia, Harry H X, Lam, Shiukum, You, Wei-cheng
• Format: Journal Article
• Language: English
• Published: England 01-06-2012
• Subjects: Adult; Amoxicillin - administration & dosage; Amoxicillin - therapeutic use; Anti-Bacterial Agents - administration & dosage; Anti-Bacterial Agents - therapeutic use; Celecoxib; Clarithromycin - administration & dosage; Clarithromycin - therapeutic use; Cyclooxygenase 2 Inhibitors - therapeutic use; Double-Blind Method; Drug Therapy, Combination; Female; Helicobacter Infections - complications; Helicobacter Infections - drug therapy; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole - administration & dosage; Omeprazole - therapeutic use; Precancerous Conditions - etiology; Precancerous Conditions - pathology; Precancerous Conditions - prevention & control; Pyrazoles - therapeutic use; Stomach - pathology; Stomach Neoplasms - etiology; Stomach Neoplasms - pathology; Stomach Neoplasms - prevention & control; Sulfonamides - therapeutic use
• ISSN: 1468-3288
• DOI: 10.1136/gutjnl-2011-300154

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.
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.
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).
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.