<i>Helicobacter pylori</i> eradication for the prevention of gastric neoplasia

Alexander C Ford; David Forman; Richard Hunt; Yuhong Yuan; Paul Moayyedi

doi:10.1002/14651858.CD005583.pub2

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Figure 1

Study flow diagram for RCTs

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Figure 2

'Risk of bias' graph: review authors' judgements about each 'Risk of bias' item presented as percentages across all included studies.

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Figure 3

'Risk of bias' summary: review authors' judgements about each 'Risk of bias' item for each included study.

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Analysis 1.1

Comparison 1 H. pylori eradication vs control ‐ main analyses, Outcome 1 Incidence of gastric cancer ‐ modified ITT analysis.

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Analysis 1.2

Comparison 1 H. pylori eradication vs control ‐ main analyses, Outcome 2 Incidence of gastric cancer ‐ complete case analysis.

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Analysis 1.3

Comparison 1 H. pylori eradication vs control ‐ main analyses, Outcome 3 Death from gastric cancer ‐ modified ITT analysis.

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Analysis 1.4

Comparison 1 H. pylori eradication vs control ‐ main analyses, Outcome 4 Death from all causes ‐ modified ITT analysis.

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Analysis 1.5

Comparison 1 H. pylori eradication vs control ‐ main analyses, Outcome 5 Incidence of oesophageal squamous cell carcinoma ‐ modified ITT analysis.

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Analysis 2.1

Comparison 2 H. pylori eradication vs control ‐ subgroup analysis according to presence or absence of pre‐neoplastic lesions at baseline, Outcome 1 Incidence of gastric cancer according to presence or absence of pre‐neoplastic lesions at baseline.

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Analysis 3.1

Comparison 3 H. pylori eradication vs control ‐ subgroup analysis according to use of vitamins or antioxidants, Outcome 1 Incidence of gastric cancer according to use of vitamins or anti‐oxidants.

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Analysis 4.1

Comparison 4 H. pylori eradication vs control ‐ sensitivity analyses, Outcome 1 Incidence of gastric cancer ‐ modified ITT analysis substituting the 10‐year follow‐up data from Zhou 2008 with the 5‐year follow‐up data from Leung 2004.

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Analysis 4.2

Comparison 4 H. pylori eradication vs control ‐ sensitivity analyses, Outcome 2 Incidence of gastric cancer ‐ complete case analysis substituting the 10‐year follow‐up data from Zhou 2008 with the 5‐year follow‐up data from Leung 2004.

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Analysis 4.3

Comparison 4 H. pylori eradication vs control ‐ sensitivity analyses, Outcome 3 Incidence of gastric cancer‐ modified ITT analysis including the two arms of celecoxib from Wong 2012.

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Analysis 4.4

Comparison 4 H. pylori eradication vs control ‐ sensitivity analyses, Outcome 4 Incidence of gastric cancer ‐ modified ITT analysis including all randomised patients from Correa 2000 and You 2006 who were found subsequently to be ineligible or did not receive treatment.

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Analysis 4.5

Comparison 4 H. pylori eradication vs control ‐ sensitivity analyses, Outcome 5 Incidence of gastric cancer ‐ missing data imputation based on various assumptions.

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Summary of findings for the main comparison. H. pylori eradication therapy compared to control for the prevention of gastric neoplasia in healthy asymptomatic infected individuals

H. pylori eradication therapy compared to control for the prevention of gastric neoplasia in healthy asymptomatic infected individuals
Patient or population: healthy asymptomatic H. pylori‐infected individuals Settings: general population¹ Intervention:H. pylori eradication therapy to prevent subsequent gastric cancer ² Comparison: control
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	H. pylori eradication therapy to prevent subsequent gastric cancer
Incidence of gastric cancer ‐ modified ITT analysis Histological examination Follow‐up: 4 to 14.7 years	24 per 1000	16 per 1000 (11 to 23)	RR 0.66 (0.46 to 0.95)	6497 (6 studies)	⊕⊕⊕⊝ moderate^3,4,5,6	Number needed to treat to benefit was 124 (95% CI 78 to 843)
Death from gastric cancer ‐ modified ITT analysis	16 per 1000	11 per 1000 (6 to 18)	RR 0.67 (0.4 to 1.11)	4475 (3 studies)	⊕⊕⊕⊝ moderate^4,6,7
Death from all causes ‐ modified ITT analysis	67 per 1000	73 per 1000 (58 to 92)	RR 1.09 (0.86 to 1.38)	5253 (4 studies)	⊕⊕⊕⊝ moderate^4,6,7
Incidence of oesophageal squamous cell carcinoma ‐ modified ITT analysis	1 per 1000	2 per 1000 (0 to 27)	RR 1.99 (0.18 to 21.91)	1630 (1 study)	⊕⊕⊕⊝ moderate⁸
Adverse events	See comment	See comment	Not estimable	0 (0)	See comment	Adverse events were poorly reported across the studies and could not be summarised.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; ITT: intention‐to‐treat; RR: risk ratio
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ As all but one study was conducted in East Asia, it is not possible to assess the effect of searching for and eradicating H. pylori in Western populations. ² Modified ITT analysis. ³ The quality of evidence was downgraded from high to moderate due to serious risk of bias: Three trials were at low risk of bias, one trial was at unclear risk, and two trials were at high risk of bias. In addition, because of the factorial design of some of the trials, it is difficult to determine whether the reduction in relative risk of subsequent gastric cancer was due to H. pylori eradication therapy alone. The eradication regimens used varied considerably between the individual trials, although this reflects the fact that several of these studies were designed before the widespread adoption of proton pump inhibitor triple therapy, which was first described in 1994, as the gold standard for H. pylori eradication. ⁴ No significant heterogeneity was seen between studies. ⁵ The beneficial effect seemed to be more pronounced in the two studies that co‐administered antioxidants and vitamins to participants, but it should be noted that one of these contained the majority of gastric cancers and had the longest duration of follow‐up. There was no significant benefit of H. pylori eradication therapy in preventing subsequent occurrence of gastric cancer when only those participants either with or without preneoplastic lesions at baseline were considered in the analysis. There were no significant subgroup differences. ⁶ Funnel plots were not produced, as there were less than 10 studies included in the analyses. ⁷ The quality of evidence was downgraded from high to moderate due to serious risk of bias: one trial was at high risk of bias, one trial was at unclear risk. ⁸ Only one study was available for this outcome, with wide 95% CI.

Summary of findings for the main comparison. H. pylori eradication therapy compared to control for the prevention of gastric neoplasia in healthy asymptomatic infected individuals

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Comparison 1. H. pylori eradication vs control ‐ main analyses

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Incidence of gastric cancer ‐ modified ITT analysis Show forest plot	6	6497	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.46, 0.95]

2 Incidence of gastric cancer ‐ complete case analysis Show forest plot	6	6038	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.46, 0.94]

3 Death from gastric cancer ‐ modified ITT analysis Show forest plot	3	4475	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.40, 1.11]

4 Death from all causes ‐ modified ITT analysis Show forest plot	4	5253	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.86, 1.38]

5 Incidence of oesophageal squamous cell carcinoma ‐ modified ITT analysis Show forest plot	1	1630	Risk Ratio (M‐H, Random, 95% CI)	1.99 [0.18, 21.91]

Comparison 1. H. pylori eradication vs control ‐ main analyses

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Comparison 2. H. pylori eradication vs control ‐ subgroup analysis according to presence or absence of pre‐neoplastic lesions at baseline

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Incidence of gastric cancer according to presence or absence of pre‐neoplastic lesions at baseline Show forest plot	6	6481	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.45, 1.17]

1.1 Patients with precancerous lesions	4	3425	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.47, 1.59]
1.2 Patients with out precancerous lesions	2	1812	Risk Ratio (M‐H, Random, 95% CI)	0.42 [0.02, 7.69]
1.3 Mixed patients with and without precancerous lesions or ulcer (can't separate)	2	1244	Risk Ratio (M‐H, Random, 95% CI)	0.38 [0.12, 1.23]

Comparison 2. H. pylori eradication vs control ‐ subgroup analysis according to presence or absence of pre‐neoplastic lesions at baseline

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Comparison 3. H. pylori eradication vs control ‐ subgroup analysis according to use of vitamins or antioxidants

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Incidence of gastric cancer according to use of vitamins or anti‐oxidants Show forest plot	6	6497	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.45, 1.01]

1.1 Without antioxidants	6	4160	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.46, 1.45]
1.2 With antioxidants	2	2337	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.31, 0.87]

Comparison 3. H. pylori eradication vs control ‐ subgroup analysis according to use of vitamins or antioxidants

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Comparison 4. H. pylori eradication vs control ‐ sensitivity analyses

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Incidence of gastric cancer ‐ modified ITT analysis substituting the 10‐year follow‐up data from Zhou 2008 with the 5‐year follow‐up data from Leung 2004 Show forest plot	6	6532	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.49, 0.98]

2 Incidence of gastric cancer ‐ complete case analysis substituting the 10‐year follow‐up data from Zhou 2008 with the 5‐year follow‐up data from Leung 2004 Show forest plot	6	5921	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.48, 0.98]

3 Incidence of gastric cancer‐ modified ITT analysis including the two arms of celecoxib from Wong 2012 Show forest plot	6	7008	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.48, 0.97]

4 Incidence of gastric cancer ‐ modified ITT analysis including all randomised patients from Correa 2000 and You 2006 who were found subsequently to be ineligible or did not receive treatment Show forest plot	6	6648	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.47, 0.95]

5 Incidence of gastric cancer ‐ missing data imputation based on various assumptions Show forest plot	6		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 Assuming incidence of gastric cancer for missing participants in both arms same as observed in the trial control arm	6	6497	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.47, 0.94]
5.2 Assuming incidence of gastric cancer for missing participants in treatment arm same as observed in the trial control arm, but no new gastric cancer cases in the control arm among those with missing data	6	6497	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.48, 0.98]

Comparison 4. H. pylori eradication vs control ‐ sensitivity analyses

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