Gastric cancer prevention by community eradication of Helicobacter pylori: a cluster-randomized controlled trial
N = 180,284
- Population
- Eligible residents of Linqu County, China, from 980 villages; those who tested positive for H. pylori on a 13C-urea breath test received one of two treatments, and H. pylori-negative individuals were not treated.
- Design
- Community-based, cluster-randomised, controlled, superiority intervention trial in Linqu County, China. Participants who tested positive on a 13C-urea breath test received either a 10-day quadruple regimen (omeprazole 20 mg, tetracycline 750 mg, metronidazole 400 mg, bismuth citrate 300 mg) or symptom-alleviation treatment (daily omeprazole and bismuth citrate); H. pylori-negative individuals received no treatment. 180,284 eligible participants from 980 villages were enrolled; 1035 incident gastric cancers were documented over 11.8 years of follow-up (as described in the abstract). Registered in the Chinese Clinical Trial Registry (ChiCTR-TRC-10000979).
- Primary endpoint
- Gastric cancer incidence
- Arms
- Symptom-alleviation treatment (control): Single daily dose of omeprazole and bismuth citrate
- Anti-H. pylori treatment (experimental): 10-day quadruple therapy: omeprazole, tetracycline, metronidazole, bismuth citrate
- People
- Pan KF, senior author You WC
Gastric cancer incidenceHR 0.86 (95% CI 0.74–0.99)Gastric cancer incidenceHR 0.81 (95% CI 0.69–0.96)
Show the numbers
| Endpoint | Analysis | Anti-H. pylori treatment | Symptom-alleviation treatment | Effect |
|---|---|---|---|---|
| Gastric cancer incidenceIntention-to-treat analysis (arm sizes not given in the abstract) | primaryPan 2024 | — | — | HR 0.86 (95% CI 0.74–0.99) |
| Gastric cancer incidenceParticipants with successful H. pylori eradication | exploratoryPan 2024 | — | — | HR 0.81 (95% CI 0.69–0.96)Analysis by treatment success rather than allocation; the abstract does not state the comparator for this hazard ratio. |
| Endpoint | Analysis | Anti-H. pylori treatment | Symptom-alleviation treatment | Effect |
|---|---|---|---|---|
| Gastric cancer incidenceIntention-to-treat analysis (arm sizes not given in the abstract) | primaryPan 2024 | — | — | HR 0.86 (95% CI 0.74–0.99) |
| Gastric cancer incidenceParticipants with successful H. pylori eradication | exploratoryPan 2024 | — | — | HR 0.81 (95% CI 0.69–0.96)Analysis by treatment success rather than allocation; the abstract does not state the comparator for this hazard ratio. |
Data table
| Endpoint | HR | 95% CI |
|---|---|---|
| Gastric cancer incidence | 0.86 | 0.74–0.99 |
| Gastric cancer incidence | 0.81 | 0.69–0.96 |