Table.
GRADE Evaluation of interventions for Helicobacter pylori infection.
| Important outcomes | Eradication rates, Prevention of gastric cancer, Regression of pre-cancerous lesions, Symptom improvement, Ulcer bleeding, Ulcer healing, Ulcer perforation or obstruction, Ulcer prevention, Ulcer recurrence | ||||||||
| Studies (Participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of H pylori eradication treatment in people with a confirmed duodenal ulcer? | |||||||||
| 2 (207) | Ulcer healing | Eradication treatment versus no eradication treatment | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| At least 27 (at least 2509) | Ulcer recurrence | Eradication treatment versus no eradication treatment | 4 | 0 | –1 | 0 | 0 | Moderate | Consistency point deducted for statistical heterogeneity owing to inclusion of different regimens |
| 9 (825) | Ulcer bleeding | Eradication treatment versus antisecretory drugs | 4 | 0 | 0 | –1 | +1 | High | Directness point deducted for inclusion of both duodenal and gastric ulcer. Effect-size point added for RR <0.5 |
| 34 (3910) | Ulcer healing | Eradication treatment plus antisecretory drugs versus antisecretory drugs alone | 4 | 0 | 0 | 0 | 0 | High | |
| 4 (319) | Ulcer recurrence | Eradication treatment plus antisecretory drugs versus antisecretory drugs alone | 4 | 0 | 0 | 0 | 0 | High | |
| What are the effects of H pylori eradication treatment in people with a confirmed gastric ulcer? | |||||||||
| 11 (1104) | Ulcer recurrence | Eradication treatment versus no eradication treatment | 4 | 0 | 0 | 0 | +1 | High | Effect-size point added for RR <0.5 |
| 9 (825) | Ulcer bleeding | Eradication treatment versus antisecretory drugs | 4 | 0 | 0 | –1 | +1 | High | Directness point deducted for inclusion of both duodenal and gastric ulcer. Effect-size point added for RR <0.5 |
| 14 (1572) | Ulcer healing | Eradication treatment plus antisecretory drugs versus antisecretory drugs alone | 4 | 0 | 0 | 0 | 0 | High | |
| What are the effects of H pylori eradication treatment in people with NSAID-related peptic ulcers? | |||||||||
| 1 (195) | Ulcer healing | Eradication treatment versus antisecretory drugs alone | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for narrow inclusion criteria |
| What are the effects of H pylori eradication treatment for preventing recurrence of NSAID-related peptic ulcers in people with previous ulcers or dyspepsia? | |||||||||
| 2 (502) | Ulcer prevention | Eradication treatment versus antisecretory drugs alone | 4 | –1 | –1 | –1 | 0 | Very low | Quality point deducted for incomplete reporting of results. Consistency point deducted for conflicting results. Directness point deducted for inclusion of different populations |
| What are the effects of H pylori eradication treatment for preventing NSAID-related peptic ulcers in people without previous ulcers? | |||||||||
| 2 (607) | Ulcer prevention | H pylori eradication versus no treatment or placebo | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for no ITT analysis |
| 1 (489) | Ulcer prevention | H pylori eradication treatment versus antisecretory drugs | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of results. Directness point deducted for small number of events (2 with triple eradication treatment, none with omeprazole) |
| What are the effects of H pylori eradication treatment in people with confirmed GORD? | |||||||||
| 2 (1748) | Symptom improvement | H pylori eradication treatment versus placebo | 4 | 0 | 0 | 0 | 0 | High | |
| What are the effects of H pylori eradication treatment on the risk of developing gastric cancer? | |||||||||
| 2 (3888) | Prevention of gastric cancer | H pylori eradication treatment versus placebo for the prevention of gastric cancer in people at high risk of cancer | 4 | 0 | 0 | 0 | 0 | High | |
| 1 (852) | Regression of pre-cancerous lesions | H pylori eradication treatment versus placebo for regression of pre-cancerous lesions | 4 | –1 | 0 | 0 | +1 | High | Quality point deducted for incomplete reporting of results. Effect-size point added for RR >2 |
| What are the effects of H pylori eradication treatment in people with confirmed non-ulcer dyspepsia? | |||||||||
| 13 (3186) | Symptom improvement | H pylori eradication treatment versus placebo | 4 | 0 | 0 | 0 | 0 | High | |
| What are the effects of H pylori eradication treatment in people with uninvestigated dyspepsia? | |||||||||
| 2 (478) | Symptom improvement | H pylori eradication treatment versus placebo in people with uninvestigated dyspepsia | 4 | 0 | 0 | 0 | 0 | High | |
| 8 (at least 3178) | Symptom improvement | Initial H pylori testing plus eradication treatment versus management based on initial endoscopy or versus empirical eradication treatment | 4 | 0 | –1 | –1 | 0 | Low | Consistency point deducted for conflicting results. Directness point deducted for uncertainty of applicability of results to both primary and secondary care settings |
| Do H pylori eradication treatments differ in their effects? | |||||||||
| 5 (1128) | Eradication rates | Quadruple regimen versus triple regimen as first-line treatment | 4 | 0 | 0 | 0 | 0 | High | |
| 3 (184) | Eradication rates | Quadruple regimens versus triple regiments as second-line treatment | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for inclusion of regimens of different durations |
| 6 (2146) | Eradication rates | Sequential eradication regimens versus triple eradication regimens as first-line treatment | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for incomplete reporting of data. Directness point deducted for all studies being conducted in centres in a single country |
| 21 (3998) | Eradication rates | Nitroimidazole-based versus amoxicillin-based triple regimens as first-line treatment | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for incomplete reporting |
| 25 (5324) | Eradication rates | Triple regimens using different proton pump inhibitors versus each other as first-line treatment | 4 | 0 | 0 | 0 | 0 | High | |
| 7 (892) | Eradication rates | Higher-dose clarithromycin-based triple regimens versus lower-dose clarithromycin-based triple regimens as first-line treatment | 4 | 0 | –1 | 0 | 0 | Moderate | Consistency point deducted for different results between SR and subsequent RCTs |
| 9 (773) | Eradication rates | Pre-treatment with proton pump inhibitor versus no pre-treatment | 4 | 0 | 0 | 0 | 0 | High | |
| 10 (2592) | Eradication rates | 14-day triple regimen versus 7-day triple regimen as first-line treatment | 4 | 0 | –1 | 0 | 0 | Moderate | Consistency point deducted for different results between SR and subsequent RCTs |
We initially allocate 4 points to evidence from RCTs, and 2 points to evidence from observational studies. To attain the final GRADE score for a given comparison, points are deducted or added from this initial score based on preset criteria relating to the categories of quality, directness, consistency, and effect size. Quality: based on issues affecting methodological rigour (e.g., incomplete reporting of results, quasi-randomisation, sparse data [<200 people in the analysis]). Consistency: based on similarity of results across studies. Directness: based on generalisability of population or outcomes. Effect size: based on magnitude of effect as measured by statistics such as relative risk, odds ratio, or hazard ratio.