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 |
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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 |
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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% |
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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. |