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. 2015 Jul 22;2015(7):CD005583. doi: 10.1002/14651858.CD005583.pub2

Wong 2012a.

Methods RCT
Participants Country: China. 12 villages in Linqu County, Shandong Province.
1024 participants with H. pylori infection and advanced gastric lesions (severe chronic atrophic gastritis, intestinal metaplasia, indefinite dysplasia, or dysplasia); mean age 53.0 (range 35 to 64) years, 46.4% men.
Method to confirm H. pylori infection:13Carbon‐urea breath testing. Histology was also performed.
100% participants with preneoplastic lesions at baseline
Study period: 2002‐2009
Interventions Anti‐H. pylori treatment and/or COX‐2 inhibitor or placebo in a 2x2 factorial design:
1. Omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg + placebo twice daily for 1 week (n = 255)
2. Placebo (n = 258)
3. Omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg twice daily for 1 week + celecoxib (n = 255)
4. Celecoxib + placebo (n = 256)
Follow‐up: 5 years
Outcomes Gastric cancer: histological examination at 5 years. Regression or progression of advanced gastric lesions.
Notes 2x2 factorial design, in the main analysis we did not include data from the 2 arms that used celecoxib, only data for H. pylori eradication only vs placebo only (n = 513). The celecoxib arms were included in a sensitivity analysis.
Eradication rate: 63.5%
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised treatment assignments were generated blindly by Westat Inc, (Rockville, MD, USA) after eligibility was determined.
Allocation concealment (selection bias) Low risk Central randomisation was used.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind, placebo‐controlled trial. All placebos were identical in number, size, and colour to the original medications. Both participants and investigators were blinded to treatment assignments.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Endoscopists and pathologists were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 234/258 (90.7%) vs 233/255 (91.4%) participants had follow‐up gastric biopsy data and the authors reported outcomes for these, losses to follow‐up with reasons were balanced and provided, 89.7% completed the repeat upper endoscopy and histology.
Selective reporting (reporting bias) Low risk Reported prespecified outcomes.
Other bias Low risk No other risk of bias was noted.