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. Author manuscript; available in PMC: 2021 Dec 27.
Published in final edited form as: Gastrointest Endosc Clin N Am. 2021 Jul;31(3):519–542. doi: 10.1016/j.giec.2021.03.006

Table 1.

RCTs evaluating the association between H pylori eradication and gastric cancer

First Author, Publication year Country/Region Study Population Intervention Follow-up Outcome Measures
Choi et al,19 2020 Korea, single center Participants with a family history of gastric cancer, n = 1826 randomized (n = 1587 evaluated for H pylori eradication)
  1. Lansoprazole 30 mg, Amoxicillin 1g, Clarithromycin 500 mg BID × 7 d

  2. Placebo × 7 d

    H pylori eradication = 70.1%

Median duration of follow-up was 9.2 y (IQR, 6.2–10.6) and 10.2 y (IQR, 8.9–11.6) for incident gastric cancer and overall survival, respectively
  1. Incident gastric cancer

  2. Overall survival

  3. Incident gastric adenoma

Correa et al23 2000
Correa et al,106 2001
Colombia, 2 communities in Narino Province Participants with confirmed histologic diagnoses of gastric preneoplasia, n = 976 randomized (n = 852 in intention to treat; n = 631 complete case analyses); age 29–69, mean 51.1 y; 46.1% male
  1. Bismuth 262 mg, amoxicillin 500 mg, metronidazole 375 mg TID × 14 d
    • With or without dietary supplements
  2. Placebo
    • With or without dietary supplements
      H pylori eradication rate = 58.0%
Cited analysis, 6 y.
Note: multiple points of follow-up have been published to date, with the most recent a 16-y analysis.107
  1. Progression of preneoplastic lesions (based on histologic score, and global assessment).
    • Gastric cancer outcome published separately108
  2. Relative risk of progression, no change, regression of histologic lesions

Leung et al,34 2004 China, 11 villages in Yantai County, Shandong Province Participants with vs without dyspepsia, who underwent upper endoscopy with biopsy. n = 587 randomized (34% with gastric preneoplasia at baseline); age 35–75 y, mean, 52.0 y; 47.8% male
Note: 33.7% with preneoplasia at baseline
  1. Omeprazole 20 mg, amoxicillin 1g, clarithromycin 500 mg BID × 7 d

  2. Placebo × 7 d

    H pylori eradication rate = 55.6%

Cited analysis, 5 y
Note: 10-y follow-up also published.108
  1. Histologic outcomes at 2 and 5 y (subsequently, 8 and 10 y)

Saito et al 2005 (abstract only; full study not published as of Feb. 2020) Japan, 145 centers Participants were healthy volunteers with H pylori infection. n = 629 randomized; age 20–59 y, mean not reported
  1. Lansoprazole 30 mg, amoxicillin 1.5 g, clarithromycin 400 mg once daily × 7 d

  2. No eradication

    H pylori eradication rate = 74.4%

Follow-up stated as “≥4y”
  1. Histologic regression or progression of atrophy by at least 1 grade (Note: did not report on gastric cancer incidence, although this was a priori planned outcome)

Wong 200432 China, 7 villages in Changle Country, Fujian Province Participants undergoing screening endoscopy (age 35–65 y, mean 42.2 y). n = 2423 evaluated, and n = 1628 with H pylori infection but without endoscopic lesions (eg, peptic ulcer) were randomized
Note: 37.7% with premalignant lesions at baseline (gastric atrophy, intestinal metaplasia, gastric cancer)
  1. Omeprazole 20 mg, amoxicillin/clavulanic acid 750 mg, metronidazole 400 mg BID × 14 d

  2. Placebo × 14 d

    H pylori eradication rate = 83.7%

Follow-up time, 7.5 y
  1. Incidence of gastric cancer

  2. Incidence in those with vs without premalignant lesions

Wong et al,30 2012 China, 12 villages Linqu County, Shandong Province Participants with H pylori infection and advanced gastric lesions (severe chronic atrophy, intestinal metaplasia, dysplasia); age 35–64 y, mean 53 y
n = 1024 randomized,
2 × 2 factorial design
ALL participants had premalignant lesions at baseline
  1. Omeprazole 20 mg, amoxicillin 1g, clarithromycin 500 mg BID × 7 d
    1. PLUS placebo BID, OR
    2. PLUS celecoxib
  2. Placebo

  3. Celecoxib + placebo

    H pylori eradication rate = 63.5%

Follow-up time, 5 y
  1. Gastric cancer

  2. Regression or progression of gastric premalignant lesions

You et al,33 2006 China, 13 villages Linqu County, Shandong Province Participants were selected randomly and underwent upper endoscopy, n = 2258 participants randomized; age 35–64 y, mean 46.8 y
2 × 2 × 2 factorial design
Note: H pylori confirmed via serologic testing
64% had preneoplastic lesions at baseline
  1. Omeprazole 20 mg, Amoxicillin 1g BID × 14 d a. with or without vitamin or garlic supplementation

  2. Placebo ± vitamin or garlic supplementation
    • “Vitamins” = vitamin C, E, selenium
    • Garlic = garlic oil and Kyolic aged garlic extract
Follow-up time, 14.7 y
Note: multiple points of follow-up have been published to date, with the most recent a 22-y analysis.82
  1. Prevalence of dysplasia or gastric cancer

  2. Prevalence of other precancerous lesions (severe chronic atrophic gastritis, intestinal metaplasia)

  3. Average ‘severity’ score

Abbreviation: BID, 2 times per day; IQR, interquartile range; TID, 3 times per day.

Data from Refs.19,23,29,30,3234,82,106108