Wong 2004.
| Methods | RCT | |
| Participants | Country: China. 7 villages in Changle County, Fujian Province. 2423 healthy participants recruited for a screening endoscopic study. Participants without endoscopic lesions and positive for H. pylori infection (n = 1628) were randomised. Those with peptic ulcer were excluded. Mean age 42.2 (range 35‐65) years, 54.0% men. Method to confirm H. pylori infection: histological examination and rapid urease testing. 37.7% participants with preneoplastic lesions at baseline (gastric atrophy, intestinal metaplasia, dysplasia). Study period: 1994 to Jan 2002 |
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| Interventions | 1. Omeprazole 20 mg, amoxicillin/clavulanic acid 750 mg, metronidazole 400 mg twice daily for 2 weeks (n = 817) 2. Placebo (n = 813) Follow‐up: 7.5 years |
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| Outcomes | Incidence of gastric cancer: gastric cancer in participants with or without precancerous lesions at baseline was the secondary outcome. Histological examination at 7.5 years or, if diagnosed before 7.5 years, review of clinical records and pathology specimens by 3 blinded clinicians. | |
| Notes | This was the first study targeted at a general population (less than 40% with precancerous lesions); a few discrepancies were seen between Wong 2002 abstract and Wong 2004 full publication. Inconsistent sample size between the full publication followed up at 7.5 years (817 vs 813) (Wong 2004) and the conference abstract followed up at 7 years (819 vs 809) (Wong 2002). We used data from the full publication. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation generated by computer. |
| Allocation concealment (selection bias) | Low risk | Randomisation was performed by drawing a sealed envelope that contained a pre‐assigned random treatment generated by computer. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, placebo‐controlled study, endoscopists were blinded and participants were followed by blinded clinical team, likely participants were blinded as well. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Endoscopists and histologists were blinded, clinical team in Hong Kong who reviewed the gastric cancer cases were blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 735/817 vs 703/813 followed at 7.5 years, losses to follow‐up with reasons were balanced between 2 groups (7.7% vs 11.4%); 62% had follow‐up endoscopy, but those who refused endoscopy were followed up in clinics. |
| Selective reporting (reporting bias) | Low risk | Reported prespecified outcomes. |
| Other bias | Unclear risk | Inconsistent sample size between the full publication followed up at 7.5 years (817 vs 813) (Wong 2004) and the conference abstract followed up at 7 years (819 vs 809) (Wong 2002). |