{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3031-main", "verdict_number": "3031", "title": "Oral Nigella sativa seed powder plus omeprazole × Claimed equivalence to standard triple therapy for H. pylori eradication", "view_version": "1.0", "view_created_date": "2026-10-24", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "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." }, "claim_context": { "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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What is the exact scope of the equivalence claim?", "needed": "The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original records defining the exact population, formulation, dose, comparison and equivalence question This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The question is not converted into proof of Nigella alone, other formulations or antibiotic replacement.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original records defining the exact population, formulation, dose, comparison and equivalence question" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which materials were actually read?", "needed": "Separate reading records for the stored JSON summary, external article, registration and plans", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The PubMed URL or a PMCID does not establish full-text acquisition or completed review.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original materials and access histories supplied by the user or acquired in subsequent work" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What is the identity of the report?", "needed": "Link the authors, year, title, PMID/PMCID/DOI and report", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Complete original bibliography, related reports and registration lists This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored comparative study is by Salem EM et al., Saudi J Gastroenterol 2010, PMID20616418, PMCIDPMC3003218 and DOI10.4103/1319-3767.65201.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External originals, registration and the identity of related reports were not cross-checked here.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete original bibliography, related reports and registration lists" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How do the 4 arms relate within the comparison?", "needed": "3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original arm structure, participant flow and lists of related reports This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Related report families and original participant matching remain externally unread; established unique clinical totals are not created.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original arm structure, participant flow and lists of related reports" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "To which adults does the question apply?", "needed": "H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Selection criteria, baseline characteristics and prior-treatment/resistance tables This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The population is adults with H. pylori-positive nonulcer dyspepsia.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The diagnostic process, prior eradication, resistance, ulcer-status assessment, age, detailed selection/exclusion and applicability to other populations remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Selection criteria, baseline characteristics and prior-treatment/resistance tables" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What is the seed-powder preparation?", "needed": "Powder capsules, plant part, constituent content, quality and batch", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Trial-product specifications and constituent/batch records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The preparation is a combination of Nigella sativa L. seed-powder capsules and a PPI.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Constituent specifications, batch, manufacture and identity with marketed products remain unverified; fixed oil, aqueous extracts and purified thymoquinone are not substituted.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-product specifications and constituent/batch records" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What combined dose was used in the selected 2 g arm?", "needed": "Nominal and actual powder and omeprazole doses, dosing frequency and adherence", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific dose, administration and adherence tables This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The record of 2 g/day seed powder plus 40 mg/day omeprazole is retained.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Actual use, capsule frequency, missed doses and adjustments remain unverified; values from the 1 and 3 g arms do not replace the selected dose.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific dose, administration and adherence tables" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Is the PPI used in every Nigella arm distinguished?", "needed": "Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct comparisons or factorial records separating PPI/Nigella alone and in combination This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored summary records concomitant omeprazole in every Nigella arm.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The effect of a PPI-only arm or the contribution of Nigella alone remains unverified in this comparison.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparisons or factorial records separating PPI/Nigella alone and in combination" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What treatment formed the standard 3-drug comparison?", "needed": "Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific drug doses/durations, adherence and treatment-setting specifications This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The principal comparison is standard 3-drug therapy with clarithromycin, amoxicillin and omeprazole.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific drug doses/durations, adherence and treatment-setting specifications" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are treatment and test timing distinguished?", "needed": "4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Treatment/test schedules and arm-specific visit records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The selected question specifies 4 weeks of treatment followed by stool-antigen testing 4 weeks after treatment ends.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The evidence table's abbreviation “after 4 weeks” is not newly assigned to treatment start or completion; actual schedules for each arm remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Treatment/test schedules and arm-specific visit records" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are alternate allocation and randomization distinguished?", "needed": "Actual allocation method, concealment and baseline balance", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Allocation methods, baseline tables and adjustment plans This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original design is an open-label alternate-allocation 4-arm comparison; it is not promoted into a randomized RCT.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Allocation sequence, predictability, concealment, baseline differences and adjustment remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation methods, baseline tables and adjustment plans" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What measurement or behavioral differences may accompany open-label design?", "needed": "Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Records of masking, test conduct and additional treatment in each arm This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original open-label design and stool-antigen endpoint are retained.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Assessor masking, additional treatment, symptom expectations and measurement differences remain unverified; a laboratory endpoint alone does not establish absence of bias.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Records of masking, test conduct and additional treatment in each arm" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What criteria identify eradication?", "needed": "Stool-antigen testing, negativity criteria, assay, test timing and medication conditions", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Assay details, classification/medication-discontinuation rules and test records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The selected endpoint is negative H. pylori stool antigen 4 weeks after treatment ends.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The test product, sensitivity, negativity threshold, PPI/antibiotic discontinuation and test interval, and misclassification remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Assay details, classification/medication-discontinuation rules and test records" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How do 110 assigned participants relate to 88 analyzed participants?", "needed": "Allocation, completion, testing, analysis and arm-specific denominators", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Participant-flow and arm-specific allocation/testing/analysis tables This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original records of 110 assigned, 88 analyzed and analysis denominators 23/21/21/23 are retained.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Initial arm allocations, testing/completion denominators and the ITT population remain unverified; the 88 analyzed participants are not relabeled as all assigned participants.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant-flow and arm-specific allocation/testing/analysis tables" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "How were attrition and missing data handled?", "needed": "Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Reasons for attrition/missingness, analysis populations and sensitivity analyses This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored summary describes completer analysis and 88 analyzed after 110 were assigned.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Arm-specific attrition reasons, handling of untested participants, failure assumptions and ITT/PP differences remain unverified; no new attrition rate is calculated.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Reasons for attrition/missingness, analysis populations and sensitivity analyses" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Which denominators underlie the 2 g and 3-drug eradication results?", "needed": "Original eradication events/denominators, the completer population and comparison direction", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific eradication tables, assigned/completer analyses and original intervals This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "Among completers, 2 g plus omeprazole 14/21 (66.7%) and standard 3-drug therapy 19/23 (82.6%) are retained.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Eradication in the assigned population, original between-group CIs and outcomes for missing tests remain unverified; RR/RD/CIs are not newly calculated.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific eradication tables, assigned/completer analyses and original intervals" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How are the 1 g and 3 g arm results kept separate?", "needed": "Eradication denominators/results for the other dose arms and direct dose comparisons", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific dose contrasts, intervals and prospective plans This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Prospective dose-comparison hypotheses, exact intervals and multiplicity handling remain unverified; an optimal dose is not newly established.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific dose contrasts, intervals and prospective plans" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is a nonsignificant difference kept distinct from equivalence?", "needed": "Distinguish superiority P values from equivalence/noninferiority questions", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original tests, hypotheses and equivalence plans This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored summary records that the P value against standard treatment was nonsignificant, while P>.05 alone does not establish equivalence.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The exact original P value, prospective equivalence design and acceptable margin remain unverified; nonsignificance is not converted into an effect of 0 or equivalence.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original tests, hypotheses and equivalence plans" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Was a noninferiority/equivalence margin prespecified?", "needed": "Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original protocol, SAP and margin justification This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored result records “no equivalence margin,” and the summary describes absence of an equivalence design.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "The existence/content of unread original plans is not newly verified; a justified prospective margin remains unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original protocol, SAP and margin justification" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Were sample size and analysis adequate for the equivalence question?", "needed": "Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Sample-size plans, ITT/PP/SAP and missing-data sensitivity analyses This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored summary records that antibiotic replacement/equivalent treatment cannot be claimed without adequate sample size and a noninferiority margin.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Sample-size calculation, actual recruitment target, ITT/PP agreement, missing-data sensitivity and intervals against the margin remain unverified; power is not newly calculated.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sample-size plans, ITT/PP/SAP and missing-data sensitivity analyses" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What historical event produced the risk difference and CI?", "needed": "Distinguish original article intervals from the historical Codex recalculation", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_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.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "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.”", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical calculation records/methods, comparison with the original article and a separate change event" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were registration, prospective endpoints and plans actually verified?", "needed": "Registration identity/history, principal endpoints, analyses/timing and changes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Registration history, original plans and SAP This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The registration identifier is recorded as “unconfirmed”; registration, protocol and SAP were unread, with no access attempted here.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Absence of registration or an unregistered trial is not asserted; a prespecified 1st (primary) endpoint/analysis remains unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration history, original plans and SAP" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What reporting selection accompanies multiple doses and tests?", "needed": "1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Complete endpoint/dose tables, registration and SAP This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "Eradication events/denominators for all three doses and standard 3-drug therapy are retained; the favorable 2 g arm is not selectively retained alone.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Prospective analyses, multiplicity handling, selective reporting and the process of choosing a dose remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete endpoint/dose tables, registration and SAP" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Could adherence, additional drugs or resistance affect the comparison?", "needed": "Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Adherence, additional-treatment and resistance/baseline records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original comparison of powder plus omeprazole with standard 3-drug therapy is retained.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Actual adherence, other eradication medicines, resistance, prior treatment and arm-specific changes/adjustments remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adherence, additional-treatment and resistance/baseline records" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What are the actual limits of funding and independence records?", "needed": "Funding sources, sponsor roles, study family and disclosure level", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original support-role, funding and COI text This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored wording reports King Faisal University grant KFU:8051 and no conflicts of interest.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original support-role, funding and COI text" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What is recorded about product provision, employee authorship and patents?", "needed": "Separate specifications of product provision/free support, author employment, patents and COI", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original product-provision, employment, patent and COI specifications This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored grant and reported absence of COI are not converted into verification of product support or employee authorship.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Specific product support, manufacturer, employment and patent details remain unverified; the generic English “assessed separately” wording is not a current reading record.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product-provision, employment, patent and COI specifications" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is there independent replication of the same question?", "needed": "Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Related reports and lists of direct trials under the same conditions This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored evidence is a direct-comparison report, and the original summary uses the historical wording “independent study.”", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Related reports and lists of direct trials under the same conditions" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Can the record be extended to other combinations or formulations?", "needed": "Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate direct comparisons for each combination/formulation This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored summary treats honey combinations separately and states that different Nigella formulations are not interchangeable.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Results for other combinations/formulations are not used to fill this equivalence question.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate direct comparisons for each combination/formulation" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What is known about sustained eradication and longer-term dose questions?", "needed": "Reinfection/relapse, sustained negativity, other doses and subgroups", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term eradication follow-up and direct dose/subgroup records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The stored question concerns negativity 4 weeks after treatment ends.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Long-term persistence, reinfection, appropriate dosing and subgroup effects remain unverified; the 2 g arm does not establish an optimal dose.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term eradication follow-up and direct dose/subgroup records" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Does eradication negativity answer other clinical-outcome questions?", "needed": "Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate clinical outcomes, durations, denominators and direct comparisons This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The selected endpoint is negative stool antigen, and the stored summary limits antibiotic-replacement/equivalent-treatment wording.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "The current negativity values do not fill gaps in direct evidence for symptom improvement, ulcer/cancer prevention or treatment replacement.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate clinical outcomes, durations, denominators and direct comparisons" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "How was safety information collected?", "needed": "Arm-specific adverse events, collection methods, severity, discontinuation and denominators", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific harms, discontinuation and collection methods This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original Caution label and wording that small trials cannot exclude rare/long-term harms are retained.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Original adverse-event tables, arm-specific denominators/durations, discontinuation and collection scope remain unverified; an antibiotic-free comparison is not judged safer.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific harms, discontinuation and collection methods" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What supports attribution of harms in the combination and concomitant drugs?", "needed": "Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Concomitant exposures, timelines, discontinuation/recovery and alternative-explanation records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original cautionary wording on product/extraction differences, medication use and vulnerable populations is retained.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Causation by a particular constituent, interactions, improvement after discontinuation and re-exposure remain unverified; no new causality or incidence is created.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant exposures, timelines, discontinuation/recovery and alternative-explanation records" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What is known about long-term/rare harms and vulnerable populations?", "needed": "Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term/population-specific exposure, harm and interaction records This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "The original cautions concerning vulnerable populations, surgery and medication are linked unchanged.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "A short adult eradication comparison does not establish safety for every vulnerable population or absence of rare harms.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term/population-specific exposure, harm and interaction records" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "How are D34, axes and historical cross-checking retained?", "needed": "Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate histories of the verdict and correction events This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "D34, the original axes and verdict explanations, inactive flags and empty subclaim/additional-rationale records are retained unchanged.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Historical independent cross-checking or I2 is not used as current completed content review or certification of equivalence or independent replication.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate histories of the verdict and correction events" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "What is the scope of the current English text, corrections and dates?", "needed": "Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Before/after correction records, user comments and subsequent original material This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Existing Korean and English stored summaries and the S01 citation read; external articles, registration, protocols, analysis plans and support disclosures unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Generic English “verified/assessed” wording is not inherited as new external verification; retractions, new literature and registration were not queried.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Before/after correction records, user comments and subsequent original material" } ], "reports": [ { "report_id": "S01", "title": "Salem et al. 2010 · Eradication comparison of seed powder plus omeprazole and standard triple therapy", "url": "https://pubmed.ncbi.nlm.nih.gov/20616418/", "report_type": "Open-label alternate-allocation 4-arm comparison; completer analysis", "existence": "The information is recorded in a stored eradication-comparison report, citation and existing Korean and English summaries. Actual reading of external articles, registration, plans and support disclosures remains separately unverified.", "acquired_read": "Summary read; external material unread", "study_family": "TF3031-01", "independent_replication": null, "observed_result": "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", "result_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.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete existing review summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "External article", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Protocol", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Statistical analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "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." }, { "material_type": "Funding, product-support and COI material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-08", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/20616418/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-24", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-24" }