{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3073-main", "verdict_number": "3073", "title": "Esomeprazole, amoxicillin, clarithromycin, and berberine hydrochloride × First-line Helicobacter pylori eradication", "view_version": "1.0", "view_created_date": "2026-10-27", "criteria_version": "1.1", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, "claim_context": { "population": "Treatment-naive adults with H. pylori infection. Actual inclusion/exclusion criteria and baseline characteristics are not established by the retained summary.", "intervention": "Oral PPI+amoxicillin+clarithromycin+berberine 4-drug therapy. Plant source, product, batch and quality details of the purified berberine hydrochloride remain unverified.", "dose": "The nominal regimen is berberine hydrochloride 500 mg 2 times daily +3 standard medicines. Exact common-drug doses and individual actual use remain unverified. This is not an instruction for personal use.", "comparator": "The same antibiotic 4-drug regimen containing bismuth tartrate. This is an active comparison with common PPI, amoxicillin and clarithromycin. Do not transfer it to ingredient-specific contributions or efficacy as an antibiotic replacement.", "endpoint": "Negative ¹³C urea breath test 28 days after treatment. Retain the original C grade, 50 points and Warning. The −10% noninferiority margin and reported arm values are retained records; actual test definition, difference confidence interval and arm attribution remain unverified.", "duration": "A 14-day regimen and ¹³C-UBT 28 days after treatment. Actual treatment completion, test dates and permitted visit windows remain unverified.", "excluded_extensions": [ "Do not transfer this to berberine monotherapy or antibiotic replacement. The comparison concerns the entire combination including common antibiotics and a PPI.", "Retain the 612 participants and 308/304 arm-label conflict. Do not count ITT and PP as independent trials or swap event counts and denominators arbitrarily.", "Do not read nonsignificant P values as proof of no effect, equivalence or noninferiority. Actual comparisons of the prespecified margin, between-arm difference interval and analysis plan remain outstanding.", "Do not extend this to other antibiotics, resistance settings, retreatment populations, long-term reinfection, cancer prevention or optimal dosing. Retain warnings about allergy, diarrhea, resistance and multidrug interactions; actual harm frequency remains unverified." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which combination, population and eradication comparison are being examined?", "needed": "Original locations for the current claim, formulation, route, population, endpoint, comparator and timing", "role": "Required", "role_reason": "Needed to avoid combining different regimens or endpoints as the same eradication evidence.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Link the first-line eradication question for an oral berberine-containing antibiotic/PPI 4-drug regimen to the original record; distinguish the single-component question.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When the article is revised, cross-check formulation, endpoint and comparator, and record the independent question’s inclusions and exclusions again.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original claim concerns first-line H. pylori eradication: one comparison of a 14-day 4-drug combination and ¹³C-UBT 28 days after treatment against an active bismuth 4-drug regimen.", "condition_status": "Met", "status_reason": "This establishes the question boundary, not the efficacy of individual components or proof of noninferiority.", "missingness": "This establishes the question boundary, not the efficacy of individual components or proof of noninferiority.", "uncertainty": "This establishes the question boundary, not the efficacy of individual components or proof of noninferiority.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original locations for the current claim, formulation, route, population, endpoint, comparator and timing" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Can the salt, source, specification and batch of the actual tablets be established?", "needed": "Product, content, batch and quality records for the trial’s berberine hydrochloride tablets", "role": "Required", "role_reason": "Needed to establish whether the actual trial product matches the advertised ingredient.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Link the nominal HCl to the actual administered product and its quality; retain the unverified plant source.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Obtain trial-product records, then compare the nominal ingredient with batch-test records to examine transferability to other extracts or derivatives.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained claim conditions specify purified berberine hydrochloride and an unverified plant source. Product, batch and complete composition records are absent from the retained scope.", "condition_status": "Partly verified", "status_reason": "The salt is named, but the actual product, batch, impurities and source remain unverified.", "missingness": "The salt is named, but the actual product, batch, impurities and source remain unverified.", "uncertainty": "The salt is named, but the actual product, batch, impurities and source remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Product, content, batch and quality records for the trial’s berberine hydrochloride tablets" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Is the nominal dose linked to actual medication use?", "needed": "Doses and medication records for berberine 500 mg 2 times daily and the 3 common medicines", "role": "Required", "role_reason": "Needed to avoid reducing differences in exposure to the entire 4-drug regimen to one ingredient’s nominal dose.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Distinguish each drug’s planned dose from actual use, changes and discontinuation.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare prescriptions and medication records by arm to assess differences between actual exposure and the planned regimen.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The combination specifies berberine hydrochloride 500 mg 2 times daily and 3 common medicines. Exact common-drug doses and individual medication records were not retained.", "condition_status": "Partly verified", "status_reason": "The nominal berberine dose cannot replace actual total exposure or common-drug doses.", "missingness": "The nominal berberine dose cannot replace actual total exposure or common-drug doses.", "uncertainty": "The nominal berberine dose cannot replace actual total exposure or common-drug doses.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Doses and medication records for berberine 500 mg 2 times daily and the 3 common medicines" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Can the 14-day plan and actual treatment completion be established?", "needed": "Treatment start, end, discontinuation and medication-completion records by arm", "role": "Required", "role_reason": "Needed to establish whether exposure-duration differences are mixed into eradication analyses.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Link the 14-day plan to individual actual treatment duration and discontinuation.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link timing and adherence records by arm to examine differences in actual treatment duration within analysis populations.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained claim conditions specify a 14-day regimen. Actual completion rates and discontinuation times by arm are absent from the current record.", "condition_status": "Partly verified", "status_reason": "A nominal 14-day duration does not establish that all randomized participants completed the same duration.", "missingness": "A nominal 14-day duration does not establish that all randomized participants completed the same duration.", "uncertainty": "A nominal 14-day duration does not establish that all randomized participants completed the same duration.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Treatment start, end, discontinuation and medication-completion records by arm" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Is the actual match between the bismuth comparator regimen and common medicines established?", "needed": "Bismuth tartrate regimen, common PPI/antibiotics and changes by arm", "role": "Required", "role_reason": "Needed to avoid attributing differences in common medicines or rescue treatment to berberine.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Distinguish the ingredient substitution in the active 4-drug comparison from actual differences in common treatment.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare prescriptions, rescue treatment and changes in both arms side by side to examine whether the intended comparison was maintained.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The comparator is the same antibiotic 4-drug regimen containing bismuth tartrate. The retained comparison is active treatment with common PPI, amoxicillin and clarithromycin.", "condition_status": "Partly verified", "status_reason": "Nominal common ingredients are linked, but exact doses by arm, actual concomitant-treatment changes and rescue treatment remain unverified.", "missingness": "Nominal common ingredients are linked, but exact doses by arm, actual concomitant-treatment changes and rescue treatment remain unverified.", "uncertainty": "Nominal common ingredients are linked, but exact doses by arm, actual concomitant-treatment changes and rescue treatment remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Bismuth tartrate regimen, common PPI/antibiotics and changes by arm" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Has the scope of attribution to the combination been distinguished?", "needed": "Composition of the 4-drug regimen and the original boundary on extensions to single-component efficacy", "role": "Required", "role_reason": "Needed to avoid confusing effects of the common antibiotics/PPI with effects of individual ingredients.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Do not elevate the comparison of the entire 4-drug regimen to berberine monotherapy or antibiotic replacement.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If individual contributions are newly asked about, define eligibility and design for a separate regimen comparison, apart from the current results.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original key explanation and summary note specify a comparison of the entire 4-drug regimen, not a monotherapy trial.", "condition_status": "Met", "status_reason": "The attribution limit is retained; independent contributions of individual ingredients remain unverified.", "missingness": "The attribution limit is retained; independent contributions of individual ingredients remain unverified.", "uncertainty": "The attribution limit is retained; independent contributions of individual ingredients remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Composition of the 4-drug regimen and the original boundary on extensions to single-component efficacy" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are eligibility and baseline characteristics of the actual treatment-naive infected adults established?", "needed": "Infection diagnosis, treatment history, inclusion/exclusion, age and baseline-characteristic tables", "role": "Required", "role_reason": "Needed to establish differences between the first-line question’s population and actual recruitment.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Link the nominal population of treatment-naive adults with H. pylori infection to the actual selected population.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare eligibility criteria and baseline tables by arm to examine population match and differences in treatment history.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The claim conditions specify treatment-naive infected adults. Actual inclusion/exclusion, baseline balance and mixed-population proportions are not established by the retained summary.", "condition_status": "Partly verified", "status_reason": "The population is named, but material on actual diagnosis, previous exposure and baseline distributions is insufficient.", "missingness": "The population is named, but material on actual diagnosis, previous exposure and baseline distributions is insufficient.", "uncertainty": "The population is named, but material on actual diagnosis, previous exposure and baseline distributions is insufficient.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Infection diagnosis, treatment history, inclusion/exclusion, age and baseline-characteristic tables" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Is the actual allocation process of the randomized noninferiority trial established?", "needed": "Random-sequence generation, allocation procedure, unit and baseline-balance material", "role": "Required", "role_reason": "Needed to distinguish an allocation label from review of actual group formation.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Establish actual material on random-sequence generation, allocation unit, implementation and baseline balance by arm. The RCT label cannot replace that material.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare methods, allocation records and baseline tables to examine allocation for this eradication comparison.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The evidence table describes an open-label randomized phase 4 noninferiority trial. Details of sequence generation and allocation unit are absent from the current summary.", "condition_status": "Partly verified", "status_reason": "The randomized label alone cannot establish the specific allocation process or baseline balance.", "missingness": "The randomized label alone cannot establish the specific allocation process or baseline balance.", "uncertainty": "The randomized label alone cannot establish the specific allocation process or baseline balance.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Random-sequence generation, allocation procedure, unit and baseline-balance material" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Can allocation concealment during recruitment be established?", "needed": "Original material on concealment procedures, responsible staff and recruitment/allocation sequence", "role": "Required", "role_reason": "Needed to examine allocation concealment and post-treatment blinding as separate processes.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Establish actual concealment methods and implementation records; do not substitute the historical B2 axis.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine methods and operating records to determine whether recruiters could know the next allocation; record this separately from open-label conduct.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original B2 is a historical judgment; the retained evidence table lacks detailed material on concealment implementation.", "condition_status": "Unverified", "status_reason": "Open-label conduct does not directly establish success or failure of allocation concealment.", "missingness": "Open-label conduct does not directly establish success or failure of allocation concealment.", "uncertainty": "Open-label conduct does not directly establish success or failure of allocation concealment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material on concealment procedures, responsible staff and recruitment/allocation sequence" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Can differences between open-label conduct and UBT assessment conditions be established?", "needed": "Sample collection, testing, assessor blinding and measurement conditions by arm", "role": "Required", "role_reason": "Needed to examine treatment blinding and outcome-assessment limitations for this endpoint.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Separately from open-label conduct, establish actual material on UBT sample collection, testing, reading procedures and assessor blinding by arm.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare original testing procedures and reading information to examine whether knowledge of allocation or collection conditions could affect measurement.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The trial is open-label and the outcome is ¹³C-UBT eradication. Assessor blinding and sample-collection conditions by arm remain unverified.", "condition_status": "Partly verified", "status_reason": "The presence of an objective test name does not prove uniformity or blinding throughout assessment.", "missingness": "The presence of an objective test name does not prove uniformity or blinding throughout assessment.", "uncertainty": "The presence of an objective test name does not prove uniformity or blinding throughout assessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Sample collection, testing, assessor blinding and measurement conditions by arm" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Can the ¹³C-UBT negative threshold and testing limitations be established?", "needed": "Negative threshold, testing conditions, validity and control of concomitant medicines", "role": "Required", "role_reason": "Needed to establish how reported events were defined and measured.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Link the original outcome’s negative definition to actual testing procedures and classification criteria.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Check testing methods, thresholds and valid-sample rules to compare definitions of reported eradication events.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The principal endpoint is a negative ¹³C urea breath test 28 days after treatment. Actual negative thresholds and test-validity conditions are absent from the retained scope.", "condition_status": "Partly verified", "status_reason": "The named eradication test and nominal negative definition do not establish individual classification criteria.", "missingness": "The named eradication test and nominal negative definition do not establish individual classification criteria.", "uncertainty": "The named eradication test and nominal negative definition do not establish individual classification criteria.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Negative threshold, testing conditions, validity and control of concomitant medicines" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Is the result 28 days after treatment linked to actual follow-up timing?", "needed": "Treatment-end dates, UBT dates, permitted visit windows and missing-test records by arm", "role": "Required", "role_reason": "Needed to avoid combining measurements at different times as the same endpoint result.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Establish individual actual treatment-end dates, UBT visit dates, permitted windows, delays and missing tests linked to the planned measurement 28 days after treatment.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare visit records to examine how actual timing distributions and missing measurements were handled in analysis.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The claim conditions and evidence table link UBT to 28 days after treatment. Individual test dates, visit windows and delays were not retained.", "condition_status": "Partly verified", "status_reason": "Nominal timing is established, but actual follow-up uniformity and delays remain unverified.", "missingness": "Nominal timing is established, but actual follow-up uniformity and delays remain unverified.", "uncertainty": "Nominal timing is established, but actual follow-up uniformity and delays remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Treatment-end dates, UBT dates, permitted visit windows and missing-test records by arm" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Was the −10% margin prespecified and justified?", "needed": "Dated registration, protocol, margin rationale and analysis plan", "role": "Required", "role_reason": "Needed to link the allowable loss in noninferiority and result interpretation to prespecified plans.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Compare the reported −10% with prespecification, clinical rationale and the effect of interest.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare registration/protocol versions and dates with the paper to examine the margin, hypothesis and plan changes.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained rationale reports a noninferiority margin of −10%. Original prespecified plans and justification of the margin were not acquired or read in the current work.", "condition_status": "Partly verified", "status_reason": "A reported margin differs from verification of prespecification and its importance rationale.", "missingness": "A reported margin differs from verification of prespecification and its importance rationale.", "uncertainty": "A reported margin differs from verification of prespecification and its importance rationale.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dated registration, protocol, margin rationale and analysis plan" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Can the direction, interval and margin comparison for the between-arm difference be established?", "needed": "Noninferiority effect measure, difference direction, confidence interval and test definition for each ITT/PP analysis", "role": "Required", "role_reason": "The relationship between the estimated between-arm difference and allowable margin is central to this comparison.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Link the appropriate between-arm estimate and interval for each analysis to the −10% threshold; do not substitute a nonsignificant P value.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare original noninferiority analysis tables and the SAP to establish agreement in difference direction, interval, margin and ITT/PP interpretation.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The article describes a noninferiority trial, but the current result string contains only arm rates and two P values; the difference CI and test definition are absent.", "condition_status": "Unverified", "status_reason": "Arm-attribution conflicts and an unverified difference interval prevent independent verification of noninferiority from the current numbers alone.", "missingness": "Arm-attribution conflicts and an unverified difference interval prevent independent verification of noninferiority from the current numbers alone.", "uncertainty": "Arm-attribution conflicts and an unverified difference interval prevent independent verification of noninferiority from the current numbers alone.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Noninferiority effect measure, difference direction, confidence interval and test definition for each ITT/PP analysis" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Can ITT event counts, denominators and arm attribution be linked?", "needed": "Original ITT tables, allocation flow, arm labels, inclusion rules and corrections", "role": "Required", "role_reason": "Needed to retain reported randomized-population results together with arm identity.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Retain ITT values unchanged while establishing the analysis population and exact arm attribution.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare methods, flow and original ITT tables in parallel; if author corrections exist, record the basis for arm-mapping changes by version.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained result is ITT bismuth 266/308 (86.4%), berberine 274/304 (90.1%), P=.149. The article warns that methods allocation labels conflict with flow and PP denominators.", "condition_status": "Partly verified", "status_reason": "The ITT string exists, but exact mapping of 308/304 to arms remains unresolved.", "missingness": "The ITT string exists, but exact mapping of 308/304 to arms remains unresolved.", "uncertainty": "The ITT string exists, but exact mapping of 308/304 to arms remains unresolved.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original ITT tables, allocation flow, arm labels, inclusion rules and corrections" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Can PP event counts, denominators and exclusion criteria be established?", "needed": "Original PP tables, arm labels, inclusion/exclusion criteria and flow material", "role": "Required", "role_reason": "Needed to avoid mixing adherent-population analyses with randomized-population results.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Link reported PP values to actual adherent-population inclusion rules and arm attribution.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare PP inclusion rules and flow with original tables to examine how population differences link to each event count/denominator.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Retained PP values are 266/297 (89.6%) versus 273/299 (91.3%), P=.470. They remain a different analysis population from ITT; detailed exclusion criteria are unverified.", "condition_status": "Partly verified", "status_reason": "PP arm mapping and exclusion reasons remain unverified. Do not immediately treat differences between ITT and PP event counts as errors or replace them with identical counts.", "missingness": "PP arm mapping and exclusion reasons remain unverified. Do not immediately treat differences between ITT and PP event counts as errors or replace them with identical counts.", "uncertainty": "PP arm mapping and exclusion reasons remain unverified. Do not immediately treat differences between ITT and PP event counts as errors or replace them with identical counts.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original PP tables, arm labels, inclusion/exclusion criteria and flow material" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Is material available to resolve the 308/304 arm-label conflict?", "needed": "Exact arm labels, denominators and author corrections for methods, flow and ITT/PP tables", "role": "Required", "role_reason": "Arbitrarily changing arm identity could change effect direction and denominator attribution.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Compare conflicting original locations to establish which denominator belongs to which arm; do not swap values arbitrarily.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare relevant sections, tables, flow and author corrections; record agreement/conflict and retain original values from each version.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original key explanation explicitly records an internal 308/304 arm-label conflict. The retained record has no original tables or author confirmation resolving it.", "condition_status": "Unverified", "status_reason": "The conflict warning is retained, but exact arm attribution cannot yet be established.", "missingness": "The conflict warning is retained, but exact arm attribution cannot yet be established.", "uncertainty": "The conflict warning is retained, but exact arm attribution cannot yet be established.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact arm labels, denominators and author corrections for methods, flow and ITT/PP tables" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Can appropriate eradication effect estimates and confidence intervals be established?", "needed": "Between-arm differences, effect measures, confidence intervals, dispersion and report locations for each analysis", "role": "Required", "role_reason": "Needed to avoid substituting sample size or significance for precision.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Establish actual between-arm effect measures, difference direction, denominators and reported confidence intervals for ITT and PP. Do not substitute arm rates or P values or back-calculate values in this work.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Check each effect measure, direction, denominator and interval in acquired analysis tables, together with the current arm-attribution conflict.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "ITT/PP arm rates are reported. The current result field lacks the exact between-arm difference CI or a separate effect estimate.", "condition_status": "Unverified", "status_reason": "Arm rates and P values cannot replace a precise effect size or noninferiority interval.", "missingness": "Arm rates and P values cannot replace a precise effect size or noninferiority interval.", "uncertainty": "Arm rates and P values cannot replace a precise effect size or noninferiority interval.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Between-arm differences, effect measures, confidence intervals, dispersion and report locations for each analysis" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Within what scope are the ITT and PP P values retained?", "needed": "Reported P values and test definitions for both analyses", "role": "Required", "role_reason": "Needed to avoid misreading nonsignificance as noninferiority or no effect.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Distinguish retained ITT P=.149 and PP P=.470; do not extend nonsignificance to proof of 0 effect, equivalence or noninferiority.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When test definitions from analysis plans and original tables become available, compare interpretation alongside hypotheses, effect measures and intervals.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The result field separately reports ITT P=.149 and PP P=.470. Specific test types and hypotheses are currently unverified.", "condition_status": "Met", "status_reason": "The limited reporting and interpretation boundary for P values is established. This does not establish clinical equivalence or test reproducibility.", "missingness": "The limited reporting and interpretation boundary for P values is established. This does not establish clinical equivalence or test reproducibility.", "uncertainty": "The limited reporting and interpretation boundary for P values is established. This does not establish clinical equivalence or test reproducibility.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Reported P values and test definitions for both analyses" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Is arm-specific flow from allocation through UBT, ITT and PP established?", "needed": "Allocation, nonuse, missing follow-up/tests, dropout reasons and missing-data handling by arm", "role": "Required", "role_reason": "Needed to distinguish allocated participants from actual observation and analysis denominators.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Link the reported 612 participants and each analysis denominator to actual flow and missing-data handling.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare flow with each analysis’s inclusion rules and examine robustness to missing-data handling using appropriate sensitivity analyses.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The total of 612 and ITT/PP denominators are retained. Arm-specific details of missingness, exclusion reasons and missing-data handling are absent from the current record.", "condition_status": "Unverified", "status_reason": "Numerical denominators alone cannot establish follow-up completeness, exclusion reasons or missing-data bias.", "missingness": "Numerical denominators alone cannot establish follow-up completeness, exclusion reasons or missing-data bias.", "uncertainty": "Numerical denominators alone cannot establish follow-up completeness, exclusion reasons or missing-data bias.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation, nonuse, missing follow-up/tests, dropout reasons and missing-data handling by arm" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Can adherence to common and trial medicines and rescue treatment be established?", "needed": "Drug-specific adherence, discontinuation, rescue treatment and analysis-handling records", "role": "Required", "role_reason": "Needed to avoid interpreting differences in actual implementation of the combination as one ingredient’s effect.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Establish how actual medication use and concurrent-treatment changes in each arm link to estimation of the effect of interest.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare drug-specific use, changes and discontinuation records with analysis plans to examine differences in the ITT/PP effects of interest.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Nominal 4-drug composition is known, but drug-specific adherence, rescue treatment and discontinuation analyses are not currently retained.", "condition_status": "Unverified", "status_reason": "The PP label alone does not establish adherence to all medicines or rules for handling changes.", "missingness": "The PP label alone does not establish adherence to all medicines or rules for handling changes.", "uncertainty": "The PP label alone does not establish adherence to all medicines or rules for handling changes.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Drug-specific adherence, discontinuation, rescue treatment and analysis-handling records" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Can the bibliographic NCT number be linked to the unverified registration field?", "needed": "Original NCT02296021 registration and material linking paper, regimen and population", "role": "Required", "role_reason": "Needed to avoid automatically elevating a bibliographic number to verification of the registration full text.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Retain the bibliographic number and registration-field string unchanged and compare whether they refer to the same actual trial.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare regimen, population, institutions and timing in registration and paper; record identifier linkage and the basis for updating the structured field as a separate event.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The bibliography and research-review field contain NCT02296021, but the registration field says “could not verify.” Actual registration material remains unread in this work.", "condition_status": "Partly verified", "status_reason": "The number’s presence is established, but the structured unverified status and registration-identity comparison remain unresolved.", "missingness": "The number’s presence is established, but the structured unverified status and registration-identity comparison remain unresolved.", "uncertainty": "The number’s presence is established, but the structured unverified status and registration-identity comparison remain unresolved.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original NCT02296021 registration and material linking paper, regimen and population" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Were planned UBT endpoints, timing and analyses compared with results?", "needed": "Dated protocol, SAP, registration versions and reasons for changes", "role": "Required", "role_reason": "Needed to reveal the actual material-comparison scope for judging selective reporting.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Compare prespecified endpoints, timing, analysis populations and margin with reported ITT/PP results.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare plan/result versions, dates and content to record agreement in principal endpoints, analyses and changes.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The current article describes historical comparison of full text, tables and abstract. Original bytes and versions of prespecified plans were not acquired or read in this work.", "condition_status": "Unverified", "status_reason": "A historical comparison narrative or the original false indication for coprimary splitting is not current evidence of agreement with prespecified plans.", "missingness": "A historical comparison narrative or the original false indication for coprimary splitting is not current evidence of agreement with prespecified plans.", "uncertainty": "A historical comparison narrative or the original false indication for coprimary splitting is not current evidence of agreement with prespecified plans.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dated protocol, SAP, registration versions and reasons for changes" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are bibliography, registration and bilingual articles being counted as independent studies?", "needed": "Report, registration and cohort identities and study-family linkage material", "role": "Required", "role_reason": "Needed to avoid double-counting multiple records of the same trial as independent replication.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Distinguish repeat citations/registration links for the current single paper from unverified independent replication.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When related material is added, compare author, registration, recruitment and result identities to classify the same family versus independent trials.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 1 evidence-table entry and 1 citation share the identity of the Zhang paper. Registration numbers and KO/EN articles are not separate independent trials.", "condition_status": "Met", "status_reason": "Report linkage within the retained scope is established; total unique trials across the literature or independent replication have not been certified.", "missingness": "Report linkage within the retained scope is established; total unique trials across the literature or independent replication have not been certified.", "uncertainty": "Report linkage within the retained scope is established; total unique trials across the literature or independent replication have not been certified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Report, registration and cohort identities and study-family linkage material" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Does it apply in other regions and resistance settings?", "needed": "Recruitment region, antibiotic resistance, previous exposure and direct multicenter comparisons", "role": "Supplementary; required for generalization to other regions", "role_reason": "Needed to reveal applicability limits from differences in populations and settings of eradication regimens.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Establish direct comparisons of the same 4-drug regimen in other populations specifying recruitment region, antibiotic resistance and previous exposure. Retain the current single-center report’s generalizability limit.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine comparisons of the same regimen and prespecified effect-modification hypotheses in multicenter studies specifying population and resistance conditions.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original applicability explanation specifies limitations from single-center, open-label conduct and regional antibiotic-resistance differences. Direct comparisons from other regions are not retained.", "condition_status": "Unverified", "status_reason": "The current eradication report for one regimen cannot automatically be applied to other regional resistance distributions or recruited populations.", "missingness": "The current eradication report for one regimen cannot automatically be applied to other regional resistance distributions or recruited populations.", "uncertainty": "The current eradication report for one regimen cannot automatically be applied to other regional resistance distributions or recruited populations.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment region, antibiotic resistance, previous exposure and direct multicenter comparisons" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Can funding, drug support and author conflicts be established?", "needed": "Original funding, drug-provision, author-affiliation and conflict-disclosure material", "role": "Required", "role_reason": "Needed to avoid converting unverified product support into independent research funding.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "In addition to retained academic/hospital support, establish actual funding details, drug providers and their roles, author affiliations and original conflict disclosures.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare funding, product support and author disclosures separately; record conflict scope and remaining uncertainties.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The funding explanation records Chinese academic/hospital support and a need to check drug-support details. Specific provider and author-disclosure originals were not retained.", "condition_status": "Partly verified", "status_reason": "The historical I1 axis or generic English wording is not current evidence of independent funding or absence of product provision.", "missingness": "The historical I1 axis or generic English wording is not current evidence of independent funding or absence of product provision.", "uncertainty": "The historical I1 axis or generic English wording is not current evidence of independent funding or absence of product provision.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, drug-provision, author-affiliation and conflict-disclosure material" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Can actual adverse-event collection and denominators for the 4-drug regimen be established?", "needed": "Adverse events, definitions, collection, discontinuation and exposure/follow-up denominators by arm", "role": "Supplementary; required for harm-frequency and safety claims", "role_reason": "Needed to avoid automatically establishing safety of the same regimen from efficacy reports.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Establish actual arm-specific adverse-event definitions, collection methods, severity, discontinuation, exposure and safety-analysis denominators and follow-up. Do not substitute the original warning sentence for event-frequency data.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine safety tables, discontinuation records, event definitions and follow-up in both arms; link harm reporting for the same regimen separately from efficacy.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original safety explanation records a need to manage allergy, diarrhea, resistance and multidrug interactions. Event counts, collection methods and safety-analysis denominators are absent from the current summary.", "condition_status": "Unverified", "status_reason": "A warning does not establish actual event incidence, severity or absence.", "missingness": "A warning does not establish actual event incidence, severity or absence.", "uncertainty": "A warning does not establish actual event incidence, severity or absence.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse events, definitions, collection, discontinuation and exposure/follow-up denominators by arm" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "How far can harms involving concomitant medicines, long-term exposure or vulnerable groups be described?", "needed": "Concomitant medicines, baseline disease, timing, vulnerable groups and rare/long-term events", "role": "Supplementary; required for ingredient-specific/long-term safety claims", "role_reason": "Needed to avoid extending harms of combined exposures to a single ingredient or overall safety.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Establish concomitant medicines, baseline risk, exposure/event timing needed for ingredient-specific attribution, and direct exposure/event and comparative material for long-term use and vulnerable groups. A combination 4-drug warning cannot replace ingredient-specific causation or overall safety.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine event collection and alternative explanations in suitable harm studies separating concomitant exposure and baseline risk.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The warning specifies concomitant antibiotics/PPI. Material on ingredient-specific harm attribution and long-term or special-population safety is not retained.", "condition_status": "Unverified", "status_reason": "Concurrent exposure cannot be converted into one ingredient’s causation or a conclusion of safety for all populations.", "missingness": "Concurrent exposure cannot be converted into one ingredient’s causation or a conclusion of safety for all populations.", "uncertainty": "Concurrent exposure cannot be converted into one ingredient’s causation or a conclusion of safety for all populations.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant medicines, baseline disease, timing, vulnerable groups and rare/long-term events" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are long-term maintenance, optimal dose and cancer prevention distinguished from current eradication conditions?", "needed": "Boundary between the current eradication endpoint and separate duration, dose and clinical-event questions", "role": "Supplementary; required for separate extension questions", "role_reason": "Needed to separate the scope of eradication results from long-term clinical and optimal-dose questions.", "application_exception": "Do not add all long-term, optimal-dose and cancer-prevention trials as requirements for the selected eradication question 28 days after treatment.", "criterion": "Do not impose separate extension trials as universally required for the narrow eradication question 28 days after treatment; distinguish unverified direct material.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If an extension is requested, define separate eligible populations, endpoints, duration and direct comparative designs, and use the current report separately.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The current question is eradication after a 14-day combination. Optimal berberine dose, long-term reinfection, cancer prevention and antibiotic replacement are outside the direct question.", "condition_status": "Not applicable", "status_reason": "These extensions are not required conditions for the current question. This does not mean their effects are established or unimportant.", "missingness": "These extensions are not required conditions for the current question. This does not mean their effects are established or unimportant.", "uncertainty": "These extensions are not required conditions for the current question. This does not mean their effects are established or unimportant.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Boundary between the current eradication endpoint and separate duration, dose and clinical-event questions" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Has reading of the current summary been distinguished from reading external papers and registration?", "needed": "Current retained copy, exact original locations, SHA and access history for external abstract/full text/registration", "role": "Required", "role_reason": "Needed to distinguish existence of a summary link from actual full-text reading.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Link only the retained summary actually read as summary reading; record external links as unread.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When authorized material acquisition occurs, separately record material-specific dates, original locations, versions and copy SHA; review reading status for linked rows again.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The complete current retained Korean/English record, evidence and bibliography were actually read. External PubMed, PMC, DOI and registration material were not accessed, acquired or read in this work.", "condition_status": "Met", "status_reason": "Historical descriptions of full-text/table comparisons in the research-review field were not reused as current reading. Actual clinical full text remains unread in this work.", "missingness": "Historical descriptions of full-text/table comparisons in the research-review field were not reused as current reading. Actual clinical full text remains unread in this work.", "uncertainty": "Historical descriptions of full-text/table comparisons in the research-review field were not reused as current reading. Actual clinical full text remains unread in this work.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Current retained copy, exact original locations, SHA and access history for external abstract/full text/registration" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are the original evidence date and current review/absence scope specified?", "needed": "Original verdict review date, current review date, inputs used and correction/search-checking scope", "role": "Required", "role_reason": "Needed to avoid exaggerating uncertainty within the retained scope as absence across all current literature.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Separate the historical evidence date from the retained-material review date; do not describe an unperformed search as 0 studies.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When search, correction or retraction material is updated, record search scope, retrieval date and versions, then compare affected conditions again.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original verdict review date is 2026-09-08 and correction record is 2026-09-14. This work converts that retained summary; no new literature, correction or retraction search was performed.", "condition_status": "Met", "status_reason": "The original review date or historical correction check does not establish review of all current evidence.", "missingness": "The original review date or historical correction check does not establish review of all current evidence.", "uncertainty": "The original review date or historical correction check does not establish review of all current evidence.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict review date, current review date, inputs used and correction/search-checking scope" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Have the original verdict, axes, corrections and data types been preserved unchanged?", "needed": "Copies of original C50, Warning, all axes, Korean/English values and corrections", "role": "Required", "role_reason": "Needed to distinguish the original judgment traceably from the current scoreless condition checklist.", "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.", "criterion": "Retain current original values and data types at exact locations; do not automatically inherit them as condition statuses or a new score.", "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When article correction or evidence updating occurs, retain the complete prior record and link original values, versions, reasons for change and condition review.", "current_reports": [ "S1" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Original C50, Warning, H/R1/I1/E~/B2/CX, empty subclaims, generic English evidence-table wording and corrections remain unchanged.", "condition_status": "Met", "status_reason": "Historical independent-cross-check wording, score and axes are reports in the original document, not current external clinical certification or reassessment.", "missingness": "Historical independent-cross-check wording, score and axes are reports in the original document, not current external clinical certification or reassessment.", "uncertainty": "Historical independent-cross-check wording, score and axes are reports in the original document, not current external clinical certification or reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Copies of original C50, Warning, all axes, Korean/English values and corrections" } ], "reports": [ { "report_id": "S1", "title": "Zhang 2017 combination-regimen trial", "url": "https://pubmed.ncbi.nlm.nih.gov/28796053/", "report_type": "Retained summary of an open-label randomized phase 4 noninferiority trial", "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "study_family": "Evidence, bibliography and registration links for one paper. Total unique studies and independent replication have not been certified.", "independent_replication": "Do not double-count 1 evidence entry, 1 citation, PubMed, PMC, registration or bilingual articles as independent trials. Current verifications of the total unique study count: 0.", "observed_result": "ITT bismuth 266/308=86.4%, berberine 274/304=90.1%, P=.149; PP 266/297=89.6%, 273/299=91.3%, P=.470. Retain the arm-label/denominator-attribution conflict; do not calculate new differences or intervals.", "result_level": "Retained reported eradication values for the combination. Original tables were not read, arm attribution was not resolved and the noninferiority test was not reproduced in the current work.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained bilingual bibliography/research summary and historical record", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "The retained summary was actually read; distinguish it from external clinical full-text bytes. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "PubMed paper entry point", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "PMC full-text entry point", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "DOI paper entry point", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "Registration entry point", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/28796053/" } ] } ], "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; distinguish intervention variants.", "review_level": "Retained method-application records were reused. External originals were not reread and method 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": "Link studies and reports separately; do not omit studies solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method 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": "Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method 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": "Retained method-application records were reused. External originals were not reread and method 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.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Met": "The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.", "Partly verified": "Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.", "Unverified": "The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.", "Not applicable": "Separate optimal-dose, long-term and cancer-prevention extensions are not universally required for the selected eradication question 28 days after treatment.", "Review incomplete": "Original-material comparisons or searches were not performed within the authorized scope.", "Not reported": "A scope-limited status indicating that an item was not stated in a specific material or section actually read.", "Inaccessible": "Used only for material for which access was actually attempted and failed. Not assigned to clinical material in this work.", "Insufficient evidence matching the conditions": "Used only when related studies within a defined scope have been reviewed and evidence is insufficient to answer the condition. Not applied wholesale in this work.", "Conflicting data": "Used when incompatible material for the same question, time and analysis has actually been compared. Different review numbers alone do not establish this status." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The evidence table, bibliography, PubMed, PMC, DOI and registration for S1 are linkage clues for one report identity. Do not count ITT, PP or bilingual articles as independent trials. Total unique trials and participants are not currently established." }, "history": [ { "date": "2026-10-27", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 32 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-27" }