# Oral Nigella sativa seed powder plus omeprazole × Claimed equivalence to standard triple therapy for H. pylori eradication Verdict 3031 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-09-08 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-24 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: The population is adults with H. pylori-positive nonulcer dyspepsia. Detailed diagnosis, prior eradication, antibiotic resistance, age, baseline status and inclusion/exclusion criteria remain unverified. Applicability to people with ulcers, children or other clinical questions is not assumed. - Ingredient, formulation and route: The intervention is oral Nigella sativa L. seed-powder capsules combined with omeprazole. The original record that every Nigella arm also received a PPI is retained. Product specifications, manufacture, composition, batch and the contribution of Nigella alone remain unverified. - Dose: The selected arm retains 2 g/day seed powder plus 40 mg/day omeprazole. The 1 g and 3 g dose arms remain separate. Actual dosing frequency, adherence, missed doses and adjustments remain unverified; no new optimal dose, cumulative dose or individual dosing guidance is created. - Comparator: The record compares with the original trial's standard triple therapy of clarithromycin, amoxicillin and omeprazole. Each drug's dose, actual duration, adherence, additional treatment and correspondence between the original and current treatment settings remain unverified. Current treatment recommendations are not newly assessed. - Measured outcome: The original selected endpoint is negative H. pylori stool antigen 4 weeks after treatment ends. Test product, criteria, medication discontinuation, assessor masking, missing tests, misclassification and prospective endpoint/analysis specifications remain unverified. - Duration: The original question distinguishes 4 weeks of treatment from the stool-antigen test 4 weeks after treatment ends. Abbreviated timing in the evidence table is not newly interpreted, and the same treatment schedule is not assigned to every comparison arm. Actual arm-specific schedules, sustained negativity, relapse and reinfection remain unverified. - Questions outside this scope: The selected question is the claimed eradication equivalence of 2 g/day seed powder plus 40 mg/day omeprazole to standard 3-drug therapy. It is not extended to Nigella alone, other formulations, honey combinations, symptoms, ulcer/cancer prevention, antibiotic replacement or long-term safety.; The existing D·34 points·Caution and B/H/R1/I2/E0/B2/C0 are retained. Historical independent-cross-check and independent-study wording does not establish completed content review, certified independent replication or equivalence here.; The records of 110 assigned participants, 88 analyzed participants and original arm-specific analysis denominators 23/21/21/23 remain distinct. Open alternate allocation is not converted into a randomized RCT, and no new dropout count, ITT set, safety denominator or participant total is created.; The original completer results are 3-drug therapy 19/23 (82.6%), 1 g 10/21 (about 47.6%), 2 g 14/21 (66.7%) and 3 g 11/23 (about 47.8%). Dose arms are not counted as independent trials, the shared comparison group is not repeatedly pooled, and no new eradication rate, difference or interval is calculated.; The original P>.05 narrative does not prove equivalence or no effect. The historical Codex reconstruction of a risk difference of −15.9 percentage points and an approximate 95% CI of −41.8 to +10.0 percentage points is retained only as a historical record. It is not used as a current recalculation, trial-reported interval or prospective acceptable margin.; The stored summary records no equivalence margin and no equivalence design. With external registration, protocol and SAP unread, absence of registration or plans is not newly established. Exact P values, prospective hypotheses, margins, sample-size planning, ITT/PP, missing-data sensitivity and multiplicity remain unverified.; The stored wording on King Faisal University grant KFU:8051 and reported absence of conflicts is retained. It is not converted into absence of free product provision, manufacturer involvement, employee authorship or patents, or into new confirmation of independence. Arm-specific harm collection, denominators, causality and long-term or vulnerable-population safety also remain unverified.; PMID20616418, PMCID PMC3003218, DOI10.4103/1319-3767.65201, the original evidence date 2026-09-08 and the English-placeholder correction date 2026-09-14 for 1 field are retained. The date 2026-10-06 is the original production date. Identifiers and historical generic verification wording do not establish current external reading or completed review. ## Checklist items ### N01 · What is the exact scope of the equivalence claim? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original claim is equivalence to standard 3-drug therapy for H. pylori eradication. The selected question remains the 2 g arm of the seed-powder-plus-PPI combination. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: The question is not converted into proof of Nigella alone, other formulations or antibiotic replacement. - Required materials and conditions: The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy - Materials to obtain first: Original records defining the exact population, formulation, dose, comparison and equivalence question - Further research: Material needed: Original records defining the exact population, formulation, dose, comparison and equivalence question This records needed materials; no new research was executed. - Conditions for verification: Original records on The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N02 · Which materials were actually read? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The complete stored summary, 1 evidence entry and 1 citation were used for preparation. External abstracts, full text, registration, protocol and SAP were unread, with no access attempted. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: The PubMed URL or a PMCID does not establish full-text acquisition or completed review. - Required materials and conditions: Separate reading records for the stored JSON summary, external article, registration and plans - Materials to obtain first: Original materials and access histories supplied by the user or acquired in subsequent work - Further research: Material needed: Original materials and access histories supplied by the user or acquired in subsequent work This records needed materials; no new research was executed. - Conditions for verification: Original records on Separate reading records for the stored JSON summary, external article, registration and plans must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Separate reading records for the stored JSON summary, external article, registration and plans is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N03 · What is the identity of the report? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored comparative study is by Salem EM et al., Saudi J Gastroenterol 2010, PMID20616418, PMCIDPMC3003218 and DOI10.4103/1319-3767.65201. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: External originals, registration and the identity of related reports were not cross-checked here. - Required materials and conditions: Link the authors, year, title, PMID/PMCID/DOI and report - Materials to obtain first: Complete original bibliography, related reports and registration lists - Further research: Material needed: Complete original bibliography, related reports and registration lists This records needed materials; no new research was executed. - Conditions for verification: Original records on Link the authors, year, title, PMID/PMCID/DOI and report must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Link the authors, year, title, PMID/PMCID/DOI and report is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N04 · How do the 4 arms relate within the comparison? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored material is a report of an open-label alternate-allocation 4-arm comparison. The 1, 2 and 3 g arms are not turned into three independent trials, and the shared 3-drug group is not repeatedly pooled. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Related report families and original participant matching remain externally unread; established unique clinical totals are not created. - Required materials and conditions: 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships - Materials to obtain first: Original arm structure, participant flow and lists of related reports - Further research: Material needed: Original arm structure, participant flow and lists of related reports This records needed materials; no new research was executed. - Conditions for verification: Original records on 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N05 · To which adults does the question apply? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The population is adults with H. pylori-positive nonulcer dyspepsia. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: The diagnostic process, prior eradication, resistance, ulcer-status assessment, age, detailed selection/exclusion and applicability to other populations remain unverified. - Required materials and conditions: H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status - Materials to obtain first: Selection criteria, baseline characteristics and prior-treatment/resistance tables - Further research: Material needed: Selection criteria, baseline characteristics and prior-treatment/resistance tables This records needed materials; no new research was executed. - Conditions for verification: Original records on H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N06 · What is the seed-powder preparation? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The preparation is a combination of Nigella sativa L. seed-powder capsules and a PPI. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Constituent specifications, batch, manufacture and identity with marketed products remain unverified; fixed oil, aqueous extracts and purified thymoquinone are not substituted. - Required materials and conditions: Powder capsules, plant part, constituent content, quality and batch - Materials to obtain first: Trial-product specifications and constituent/batch records - Further research: Material needed: Trial-product specifications and constituent/batch records This records needed materials; no new research was executed. - Conditions for verification: Original records on Powder capsules, plant part, constituent content, quality and batch must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Powder capsules, plant part, constituent content, quality and batch is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N07 · What combined dose was used in the selected 2 g arm? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The record of 2 g/day seed powder plus 40 mg/day omeprazole is retained. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Actual use, capsule frequency, missed doses and adjustments remain unverified; values from the 1 and 3 g arms do not replace the selected dose. - Required materials and conditions: Nominal and actual powder and omeprazole doses, dosing frequency and adherence - Materials to obtain first: Arm-specific dose, administration and adherence tables - Further research: Material needed: Arm-specific dose, administration and adherence tables This records needed materials; no new research was executed. - Conditions for verification: Original records on Nominal and actual powder and omeprazole doses, dosing frequency and adherence must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Nominal and actual powder and omeprazole doses, dosing frequency and adherence is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N08 · Is the PPI used in every Nigella arm distinguished? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored summary records concomitant omeprazole in every Nigella arm. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: The effect of a PPI-only arm or the contribution of Nigella alone remains unverified in this comparison. - Required materials and conditions: Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone - Materials to obtain first: Direct comparisons or factorial records separating PPI/Nigella alone and in combination - Further research: Material needed: Direct comparisons or factorial records separating PPI/Nigella alone and in combination This records needed materials; no new research was executed. - Conditions for verification: Original records on Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N09 · What treatment formed the standard 3-drug comparison? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The principal comparison is standard 3-drug therapy with clarithromycin, amoxicillin and omeprazole. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Each comparison drug's dose, actual duration, adherence and correspondence between the original and current treatment settings remain unverified; no new recommendation or judgment of the current standard is made. - Required materials and conditions: Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole - Materials to obtain first: Arm-specific drug doses/durations, adherence and treatment-setting specifications - Further research: Material needed: Arm-specific drug doses/durations, adherence and treatment-setting specifications This records needed materials; no new research was executed. - Conditions for verification: Original records on Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N10 · Are treatment and test timing distinguished? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The selected question specifies 4 weeks of treatment followed by stool-antigen testing 4 weeks after treatment ends. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: The evidence table's abbreviation “after 4 weeks” is not newly assigned to treatment start or completion; actual schedules for each arm remain unverified. - Required materials and conditions: 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules - Materials to obtain first: Treatment/test schedules and arm-specific visit records - Further research: Material needed: Treatment/test schedules and arm-specific visit records This records needed materials; no new research was executed. - Conditions for verification: Original records on 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N11 · Are alternate allocation and randomization distinguished? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original design is an open-label alternate-allocation 4-arm comparison; it is not promoted into a randomized RCT. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Allocation sequence, predictability, concealment, baseline differences and adjustment remain unverified. - Required materials and conditions: Actual allocation method, concealment and baseline balance - Materials to obtain first: Allocation methods, baseline tables and adjustment plans - Further research: Material needed: Allocation methods, baseline tables and adjustment plans This records needed materials; no new research was executed. - Conditions for verification: Original records on Actual allocation method, concealment and baseline balance must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Actual allocation method, concealment and baseline balance is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N12 · What measurement or behavioral differences may accompany open-label design? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original open-label design and stool-antigen endpoint are retained. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Assessor masking, additional treatment, symptom expectations and measurement differences remain unverified; a laboratory endpoint alone does not establish absence of bias. - Required materials and conditions: Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement - Materials to obtain first: Records of masking, test conduct and additional treatment in each arm - Further research: Material needed: Records of masking, test conduct and additional treatment in each arm This records needed materials; no new research was executed. - Conditions for verification: Original records on Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N13 · What criteria identify eradication? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The selected endpoint is negative H. pylori stool antigen 4 weeks after treatment ends. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: The test product, sensitivity, negativity threshold, PPI/antibiotic discontinuation and test interval, and misclassification remain unverified. - Required materials and conditions: Stool-antigen testing, negativity criteria, assay, test timing and medication conditions - Materials to obtain first: Assay details, classification/medication-discontinuation rules and test records - Further research: Material needed: Assay details, classification/medication-discontinuation rules and test records This records needed materials; no new research was executed. - Conditions for verification: Original records on Stool-antigen testing, negativity criteria, assay, test timing and medication conditions must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Stool-antigen testing, negativity criteria, assay, test timing and medication conditions is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N14 · How do 110 assigned participants relate to 88 analyzed participants? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original records of 110 assigned, 88 analyzed and analysis denominators 23/21/21/23 are retained. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Initial arm allocations, testing/completion denominators and the ITT population remain unverified; the 88 analyzed participants are not relabeled as all assigned participants. - Required materials and conditions: Allocation, completion, testing, analysis and arm-specific denominators - Materials to obtain first: Participant-flow and arm-specific allocation/testing/analysis tables - Further research: Material needed: Participant-flow and arm-specific allocation/testing/analysis tables This records needed materials; no new research was executed. - Conditions for verification: Original records on Allocation, completion, testing, analysis and arm-specific denominators must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Allocation, completion, testing, analysis and arm-specific denominators is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N15 · How were attrition and missing data handled? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored summary describes completer analysis and 88 analyzed after 110 were assigned. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Arm-specific attrition reasons, handling of untested participants, failure assumptions and ITT/PP differences remain unverified; no new attrition rate is calculated. - Required materials and conditions: Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations - Materials to obtain first: Reasons for attrition/missingness, analysis populations and sensitivity analyses - Further research: Material needed: Reasons for attrition/missingness, analysis populations and sensitivity analyses This records needed materials; no new research was executed. - Conditions for verification: Original records on Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N16 · Which denominators underlie the 2 g and 3-drug eradication results? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: Among completers, 2 g plus omeprazole 14/21 (66.7%) and standard 3-drug therapy 19/23 (82.6%) are retained. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Eradication in the assigned population, original between-group CIs and outcomes for missing tests remain unverified; RR/RD/CIs are not newly calculated. - Required materials and conditions: Original eradication events/denominators, the completer population and comparison direction - Materials to obtain first: Arm-specific eradication tables, assigned/completer analyses and original intervals - Further research: Material needed: Arm-specific eradication tables, assigned/completer analyses and original intervals This records needed materials; no new research was executed. - Conditions for verification: Original records on Original eradication events/denominators, the completer population and comparison direction must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Original eradication events/denominators, the completer population and comparison direction is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N17 · How are the 1 g and 3 g arm results kept separate? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original results of 1 g 10/21 and 3 g 11/23, with stored approximate percentages of 47.6% and 47.8%, are retained. Values from the selected 2 g arm are not reassigned to other doses. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Prospective dose-comparison hypotheses, exact intervals and multiplicity handling remain unverified; an optimal dose is not newly established. - Required materials and conditions: Eradication denominators/results for the other dose arms and direct dose comparisons - Materials to obtain first: Arm-specific dose contrasts, intervals and prospective plans - Further research: Material needed: Arm-specific dose contrasts, intervals and prospective plans This records needed materials; no new research was executed. - Conditions for verification: Original records on Eradication denominators/results for the other dose arms and direct dose comparisons must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Eradication denominators/results for the other dose arms and direct dose comparisons is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N18 · Is a nonsignificant difference kept distinct from equivalence? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored summary records that the P value against standard treatment was nonsignificant, while P>.05 alone does not establish equivalence. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: The exact original P value, prospective equivalence design and acceptable margin remain unverified; nonsignificance is not converted into an effect of 0 or equivalence. - Required materials and conditions: Distinguish superiority P values from equivalence/noninferiority questions - Materials to obtain first: Original tests, hypotheses and equivalence plans - Further research: Material needed: Original tests, hypotheses and equivalence plans This records needed materials; no new research was executed. - Conditions for verification: Original records on Distinguish superiority P values from equivalence/noninferiority questions must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Distinguish superiority P values from equivalence/noninferiority questions is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N19 · Was a noninferiority/equivalence margin prespecified? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored result records “no equivalence margin,” and the summary describes absence of an equivalence design. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: The existence/content of unread original plans is not newly verified; a justified prospective margin remains unverified. - Required materials and conditions: Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans - Materials to obtain first: Original protocol, SAP and margin justification - Further research: Material needed: Original protocol, SAP and margin justification This records needed materials; no new research was executed. - Conditions for verification: Original records on Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N20 · Were sample size and analysis adequate for the equivalence question? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored summary records that antibiotic replacement/equivalent treatment cannot be claimed without adequate sample size and a noninferiority margin. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Sample-size calculation, actual recruitment target, ITT/PP agreement, missing-data sensitivity and intervals against the margin remain unverified; power is not newly calculated. - Required materials and conditions: Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin - Materials to obtain first: Sample-size plans, ITT/PP/SAP and missing-data sensitivity analyses - Further research: Material needed: Sample-size plans, ITT/PP/SAP and missing-data sensitivity analyses This records needed materials; no new research was executed. - Conditions for verification: Original records on Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N21 · What historical event produced the risk difference and CI? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The historical wording retained in the Korean and English verdict rationale is “Codex reconstructed risk difference −15.9 percentage points, approximate 95% CI −41.8 to +10.0 percentage points.” - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: This is not used as a current recalculation, a trial-reported CI or a prospective equivalence judgment. The original calculation method and comparison with the article's interval were not reviewed here. - Required materials and conditions: Distinguish original article intervals from the historical Codex recalculation - Materials to obtain first: Historical calculation records/methods, comparison with the original article and a separate change event - Further research: Material needed: Historical calculation records/methods, comparison with the original article and a separate change event This records needed materials; no new research was executed. - Conditions for verification: Original records on Distinguish original article intervals from the historical Codex recalculation must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Distinguish original article intervals from the historical Codex recalculation is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N22 · Were registration, prospective endpoints and plans actually verified? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The registration identifier is recorded as “unconfirmed”; registration, protocol and SAP were unread, with no access attempted here. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Absence of registration or an unregistered trial is not asserted; a prespecified 1st (primary) endpoint/analysis remains unverified. - Required materials and conditions: Registration identity/history, principal endpoints, analyses/timing and changes - Materials to obtain first: Registration history, original plans and SAP - Further research: Material needed: Registration history, original plans and SAP This records needed materials; no new research was executed. - Conditions for verification: Original records on Registration identity/history, principal endpoints, analyses/timing and changes must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Registration identity/history, principal endpoints, analyses/timing and changes is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N23 · What reporting selection accompanies multiple doses and tests? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: Eradication events/denominators for all three doses and standard 3-drug therapy are retained; the favorable 2 g arm is not selectively retained alone. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Prospective analyses, multiplicity handling, selective reporting and the process of choosing a dose remain unverified. - Required materials and conditions: 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity - Materials to obtain first: Complete endpoint/dose tables, registration and SAP - Further research: Material needed: Complete endpoint/dose tables, registration and SAP This records needed materials; no new research was executed. - Conditions for verification: Original records on 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N24 · Could adherence, additional drugs or resistance affect the comparison? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original comparison of powder plus omeprazole with standard 3-drug therapy is retained. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Actual adherence, other eradication medicines, resistance, prior treatment and arm-specific changes/adjustments remain unverified. - Required materials and conditions: Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences - Materials to obtain first: Adherence, additional-treatment and resistance/baseline records - Further research: Material needed: Adherence, additional-treatment and resistance/baseline records This records needed materials; no new research was executed. - Conditions for verification: Original records on Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N25 · What are the actual limits of funding and independence records? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored wording reports King Faisal University grant KFU:8051 and no conflicts of interest. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: This is not extended to absence of free product support, absence of bias or current certification of clinical independence; the original external funding text remains unread. - Required materials and conditions: Funding sources, sponsor roles, study family and disclosure level - Materials to obtain first: Original support-role, funding and COI text - Further research: Material needed: Original support-role, funding and COI text This records needed materials; no new research was executed. - Conditions for verification: Original records on Funding sources, sponsor roles, study family and disclosure level must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Funding sources, sponsor roles, study family and disclosure level is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N26 · What is recorded about product provision, employee authorship and patents? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored grant and reported absence of COI are not converted into verification of product support or employee authorship. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Specific product support, manufacturer, employment and patent details remain unverified; the generic English “assessed separately” wording is not a current reading record. - Required materials and conditions: Separate specifications of product provision/free support, author employment, patents and COI - Materials to obtain first: Original product-provision, employment, patent and COI specifications - Further research: Material needed: Original product-provision, employment, patent and COI specifications This records needed materials; no new research was executed. - Conditions for verification: Original records on Separate specifications of product provision/free support, author employment, patents and COI must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Separate specifications of product provision/free support, author employment, patents and COI is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N27 · Is there independent replication of the same question? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored evidence is a direct-comparison report, and the original summary uses the historical wording “independent study.” - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: This is not inherited as established independent replication; the number of unique studies in the complete current literature and relationships with other reports remain unverified. - Required materials and conditions: Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design - Materials to obtain first: Related reports and lists of direct trials under the same conditions - Further research: Material needed: Related reports and lists of direct trials under the same conditions This records needed materials; no new research was executed. - Conditions for verification: Original records on Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N28 · Can the record be extended to other combinations or formulations? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored summary treats honey combinations separately and states that different Nigella formulations are not interchangeable. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Results for other combinations/formulations are not used to fill this equivalence question. - Required materials and conditions: Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents - Materials to obtain first: Separate direct comparisons for each combination/formulation - Further research: Material needed: Separate direct comparisons for each combination/formulation This records needed materials; no new research was executed. - Conditions for verification: Original records on Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N29 · What is known about sustained eradication and longer-term dose questions? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The stored question concerns negativity 4 weeks after treatment ends. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Long-term persistence, reinfection, appropriate dosing and subgroup effects remain unverified; the 2 g arm does not establish an optimal dose. - Required materials and conditions: Reinfection/relapse, sustained negativity, other doses and subgroups - Materials to obtain first: Long-term eradication follow-up and direct dose/subgroup records - Further research: Material needed: Long-term eradication follow-up and direct dose/subgroup records This records needed materials; no new research was executed. - Conditions for verification: Original records on Reinfection/relapse, sustained negativity, other doses and subgroups must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Reinfection/relapse, sustained negativity, other doses and subgroups is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N30 · Does eradication negativity answer other clinical-outcome questions? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The selected endpoint is negative stool antigen, and the stored summary limits antibiotic-replacement/equivalent-treatment wording. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: The current negativity values do not fill gaps in direct evidence for symptom improvement, ulcer/cancer prevention or treatment replacement. - Required materials and conditions: Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication - Materials to obtain first: Separate clinical outcomes, durations, denominators and direct comparisons - Further research: Material needed: Separate clinical outcomes, durations, denominators and direct comparisons This records needed materials; no new research was executed. - Conditions for verification: Original records on Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N31 · How was safety information collected? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original Caution label and wording that small trials cannot exclude rare/long-term harms are retained. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Original adverse-event tables, arm-specific denominators/durations, discontinuation and collection scope remain unverified; an antibiotic-free comparison is not judged safer. - Required materials and conditions: Arm-specific adverse events, collection methods, severity, discontinuation and denominators - Materials to obtain first: Arm-specific harms, discontinuation and collection methods - Further research: Material needed: Arm-specific harms, discontinuation and collection methods This records needed materials; no new research was executed. - Conditions for verification: Original records on Arm-specific adverse events, collection methods, severity, discontinuation and denominators must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Arm-specific adverse events, collection methods, severity, discontinuation and denominators is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N32 · What supports attribution of harms in the combination and concomitant drugs? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original cautionary wording on product/extraction differences, medication use and vulnerable populations is retained. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Causation by a particular constituent, interactions, improvement after discontinuation and re-exposure remain unverified; no new causality or incidence is created. - Required materials and conditions: Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations - Materials to obtain first: Concomitant exposures, timelines, discontinuation/recovery and alternative-explanation records - Further research: Material needed: Concomitant exposures, timelines, discontinuation/recovery and alternative-explanation records This records needed materials; no new research was executed. - Conditions for verification: Original records on Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N33 · What is known about long-term/rare harms and vulnerable populations? Verification status: Unverified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original cautions concerning vulnerable populations, surgery and medication are linked unchanged. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: A short adult eradication comparison does not establish safety for every vulnerable population or absence of rare harms. - Required materials and conditions: Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups - Materials to obtain first: Long-term/population-specific exposure, harm and interaction records - Further research: Material needed: Long-term/population-specific exposure, harm and interaction records This records needed materials; no new research was executed. - Conditions for verification: Original records on Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N34 · How are D34, axes and historical cross-checking retained? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: D34, the original axes and verdict explanations, inactive flags and empty subclaim/additional-rationale records are retained unchanged. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Historical independent cross-checking or I2 is not used as current completed content review or certification of equivalence or independent replication. - Required materials and conditions: Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history - Materials to obtain first: Separate histories of the verdict and correction events - Further research: Material needed: Separate histories of the verdict and correction events This records needed materials; no new research was executed. - Conditions for verification: Original records on Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ### N35 · What is the scope of the current English text, corrections and dates? Verification status: Partly verified Reading scope: Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread - Current findings: The original evidence date 2026-09-08, correction of 1 English field on 2026-09-14 with grade D retained, and the current specific/generic English wording are preserved. The original production record does not establish completed content review. - Why unverified: Information retained in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, equivalence, safety, prespecification and independence are not certified. - Reason for missing information: Generic English “verified/assessed” wording is not inherited as new external verification; retractions, new literature and registration were not queried. - Required materials and conditions: Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here - Materials to obtain first: Before/after correction records, user comments and subsequent original material - Further research: Material needed: Before/after correction records, user comments and subsequent original material This records needed materials; no new research was executed. - Conditions for verification: Original records on Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified. - Why this condition is needed: Material on Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms. - Application exceptions: The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval. - Remaining uncertainty: Gaps in product details, concomitant drugs, active comparison, allocation, attrition, eradication testing, prospective hypotheses, acceptable margins, support roles and harms remain. A nonsignificant difference is not converted into equivalence, antibiotic replacement, symptom benefit or long-term safety. - Referenced methods: Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination. - Related sources: S01 ## Evidence and sources ### S01 Salem et al. 2010 · Eradication comparison of seed powder plus omeprazole and standard triple therapy [PubMed](https://pubmed.ncbi.nlm.nih.gov/20616418/) Materials actually read: Summary read; external material unread Findings recorded in the summary: 3-drug therapy 19/23, 1 g 10/21, 2 g 14/21, 3 g 11/23; recorded in the stored summary as having no equivalence margin Record level: The original completer record reports 88 analyzed after 110 were assigned. Initial arm allocations, ITT, original between-group CIs, exact P values and prospective plans remain unverified. The historical Codex reconstructed interval remains distinct from a trial-reported interval. Independent replication: The Salem report comparing standard triple therapy with several powder-plus-omeprazole doses remains distinct from possible related reports. Dose arms and the shared comparison group are not converted into new unique trials or participant totals; an established independent-replication count remains unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Preserved copy of the complete existing review summary | Stored summary | Summary read | PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date. | | External article | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date. | | Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date. | | Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date. | | Funding, product-support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | PMID20616418, PMCID PMC3003218 and DOI10.4103/1319-3767.65201 are retained bibliography. An unconfirmed registration identifier does not establish absence of registration. External articles, registration, protocols, analysis plans and support disclosures are unread; identifiers alone do not establish full-text acquisition or actual reading. The date 2026-09-08 retained in every material item is the original evidence date, not a date of external reading. The date 2026-10-06 is the original production date, not a completed-content-review date. Pending-review wording is not a verification date. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. ## What the statuses mean - Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete. - Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety. - Review incomplete: Review of existing content remains incomplete. - Met: This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work. - Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported. - Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned. - Not applicable: Used only with an application exception and reason based on the question scope. - Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work. - Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade. ## Change history 2026-10-24 · Public page/materials 1.0. The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed.