Characteristics of randomised controlled trials of H. pylori eradication therapy versus placebo or no treatment in the prevention of gastric cancer in healthy individuals
Study | Location | Method used to confirm presence of H. pylori | Sample size (no. receiving H. pylori eradication therapy) | Characteristics of participants | Proportion with pre-neoplastic lesions* at baseline | H. pylori eradication therapy regimen used | Eradication rate† | Last point of follow-up | Method of ascertainment of gastric cancer cases |
Correa 2000 and Correa 2001 22 23 | Two communities in Narino Province, Colombia. | Histological examination of gastric biopsies obtained at upper gastrointestinal endoscopy. | 852 (437) | Mean age 51.1 years (range 29–69 years), 46.1% male. | 100% | Bismuth subsalicylate 262 mg, amoxicillin 500 mg and metronidazole 375 mg t.i.d.‡ for 2 weeks. | 58.0% | 6 years. | Histological examination of gastric biopsies obtained at upper gastrointestinal endoscopy at 6 years. |
Leung 2004 and Zhou 2014 30 31 | Eleven villages in Yantai County, Shandong Province, China. | Histological examination of, and rapid urease testing using, gastric biopsies obtained at upper gastrointestinal endoscopy. | 587 (295)31
552 (276) Zhou 201430 | Mean age 52.0 years (range 35–75 years), 47.8% male. | 33.7% | Omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg b.i.d.§ for 1 week. | 55.6% | 5 years in Leung, 10 years in Zhou. | Histological examination of gastric biopsies obtained at upper gastrointestinal endoscopy at 2, 5, 8 and 10 years. |
Wong 2004 25 | Seven villages in Changle County, Fujian Province, China. | Histological examination of, and rapid urease testing using, gastric biopsies obtained at upper gastrointestinal endoscopy. | 1630 (817) | Mean age 42.2 years (range 35–65 years), 54.0% male. | 37.7% | Omeprazole 20 mg, co-amoxiclav 750 mg and metronidazole 400 mg b.i.d. for 2 weeks. | 83.7% | 7.5 years. | Histological examination of gastric biopsies obtained at upper gastrointestinal endoscopy at 7.5 years or, if diagnosed before 7.5 years, review of clinical records and pathology specimens by three blinded clinicians. |
Saito 2005 24 | 145 centres in Japan. | Not reported. | 692 (379) | Mean age not reported (range 20–59 years), proportion male not reported. | Not reported. | Lansoprazole 30 mg, amoxicillin 1.5 g and clarithromycin 400 mg o.d.¶ for 1 week. | 74.4% | ≥4 years. | Histological examination of gastric biopsies obtained at upper gastrointestinal endoscopy at ≥4 years. |
Ma 2012 and Li 2019 27 28 | Thirteen villages in Linqu County, Shandong Province, China. | Serological testing. | 2258 (1130) | Mean age 46.8 years (range 35–64 years), 50.0% male. | 64.0% | Omeprazole 20 mg and amoxicillin 1 g b.i.d. for 2 weeks. | 73.2% | 22.3 years. | Histological examination of gastric biopsies obtained at upper gastrointestinal endoscopy, or from clinical, laboratory or pathological data. |
Wong 2012 26 | Twelve villages in Linqu County, Shandong Province, China. | Carbon-urea breath testing. | 513 (255) | Mean age 53.0 years (range 35–64 years), 46.4% male. | 100% | Omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg b.i.d. for 1 week. | 63.5% | 5 years. | Histological examination of gastric biopsies obtained at upper gastrointestinal endoscopy at 5 years. |
Choi 2020 29 | One hospital in Goyang, South Korea. | Histological examination of, and rapid urease testing using, gastric biopsies obtained at upper gastrointestinal endoscopy. | 1826 (912) | Mean age 48.8 years (range 40–65 years), 49.5% male. | Not reported. | Lansoprazole 30 mg, amoxicillin 1 g and clarithromycin 500 mg b.i.d. for 1 week | 60.4% | 9.2 years. | Access to the Korean National Cancer Incidence Database to confirm all cases of gastric cancer diagnosed by endoscopic surveillance during the trial. |
*Defined as gastric atrophy, intestinal metaplasia or dysplasia.
†True intention-to-treat analysis, with all drop-outs assumed to have failed eradication therapy.
‡t.i.d., three times per day.
§b.i.d., two times per day.
¶o.d., one time per day.
H. pylori, Helicobacter pylori.