# Esomeprazole, amoxicillin, clarithromycin, and berberine hydrochloride × First-line Helicobacter pylori eradication Verdict 3073 · Evidence Check Stored-material review date: 2026-10-05 Original evidence review date: 2026-09-08 Review-criteria version: 1.1 Public page/material preparation date: 2026-10-27 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: Treatment-naive adults with H. pylori infection. Actual inclusion/exclusion criteria and baseline characteristics are not established by the retained summary. - Ingredient, formulation and route: 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. - Measured outcome: 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. - Questions outside this scope: 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. ## Checklist items ### N01 · Which combination, population and eradication comparison are being examined? Verification status: Met Reading scope: 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. - Current findings: 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. - Why unverified: This establishes the question boundary, not the efficacy of individual components or proof of noninferiority. - Reason for missing information: This establishes the question boundary, not the efficacy of individual components or proof of noninferiority. - Required materials and conditions: Original locations for the current claim, formulation, route, population, endpoint, comparator and timing - Materials to obtain first: Original locations for the current claim, formulation, route, population, endpoint, comparator and timing - Further research: When the article is revised, cross-check formulation, endpoint and comparator, and record the independent question’s inclusions and exclusions again. - Conditions for verification: 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. - Why this condition is needed: Needed to avoid combining different regimens or endpoints as the same eradication evidence. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: This establishes the question boundary, not the efficacy of individual components or proof of noninferiority. - Referenced methods: 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. - Related sources: S1 ### N02 · Can the salt, source, specification and batch of the actual tablets be established? Verification status: Partly verified Reading scope: 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. - Current findings: 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. - Why unverified: The salt is named, but the actual product, batch, impurities and source remain unverified. - Reason for missing information: The salt is named, but the actual product, batch, impurities and source remain unverified. - Required materials and conditions: Product, content, batch and quality records for the trial’s berberine hydrochloride tablets - Materials to obtain first: Product, content, batch and quality records for the trial’s berberine hydrochloride tablets - Further research: Obtain trial-product records, then compare the nominal ingredient with batch-test records to examine transferability to other extracts or derivatives. - Conditions for verification: Link the nominal HCl to the actual administered product and its quality; retain the unverified plant source. - Why this condition is needed: Needed to establish whether the actual trial product matches the advertised ingredient. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The salt is named, but the actual product, batch, impurities and source remain unverified. - Referenced methods: 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. - Related sources: S1 ### N03 · Is the nominal dose linked to actual medication use? Verification status: Partly verified Reading scope: 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. - Current findings: 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. - Why unverified: The nominal berberine dose cannot replace actual total exposure or common-drug doses. - Reason for missing information: The nominal berberine dose cannot replace actual total exposure or common-drug doses. - Required materials and conditions: Doses and medication records for berberine 500 mg 2 times daily and the 3 common medicines - Materials to obtain first: Doses and medication records for berberine 500 mg 2 times daily and the 3 common medicines - Further research: Compare prescriptions and medication records by arm to assess differences between actual exposure and the planned regimen. - Conditions for verification: Distinguish each drug’s planned dose from actual use, changes and discontinuation. - Why this condition is needed: Needed to avoid reducing differences in exposure to the entire 4-drug regimen to one ingredient’s nominal dose. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The nominal berberine dose cannot replace actual total exposure or common-drug doses. - Referenced methods: 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. - Related sources: S1 ### N04 · Can the 14-day plan and actual treatment completion be established? Verification status: Partly verified Reading scope: 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. - Current findings: The retained claim conditions specify a 14-day regimen. Actual completion rates and discontinuation times by arm are absent from the current record. - Why unverified: A nominal 14-day duration does not establish that all randomized participants completed the same duration. - Reason for missing information: A nominal 14-day duration does not establish that all randomized participants completed the same duration. - Required materials and conditions: Treatment start, end, discontinuation and medication-completion records by arm - Materials to obtain first: Treatment start, end, discontinuation and medication-completion records by arm - Further research: Link timing and adherence records by arm to examine differences in actual treatment duration within analysis populations. - Conditions for verification: Link the 14-day plan to individual actual treatment duration and discontinuation. - Why this condition is needed: Needed to establish whether exposure-duration differences are mixed into eradication analyses. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: A nominal 14-day duration does not establish that all randomized participants completed the same duration. - Referenced methods: 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. - Related sources: S1 ### N05 · Is the actual match between the bismuth comparator regimen and common medicines established? Verification status: Partly verified Reading scope: 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. - Current findings: The comparator is the same antibiotic 4-drug regimen containing bismuth tartrate. The retained comparison is active treatment with common PPI, amoxicillin and clarithromycin. - Why unverified: Nominal common ingredients are linked, but exact doses by arm, actual concomitant-treatment changes and rescue treatment remain unverified. - Reason for missing information: Nominal common ingredients are linked, but exact doses by arm, actual concomitant-treatment changes and rescue treatment remain unverified. - Required materials and conditions: Bismuth tartrate regimen, common PPI/antibiotics and changes by arm - Materials to obtain first: Bismuth tartrate regimen, common PPI/antibiotics and changes by arm - Further research: Compare prescriptions, rescue treatment and changes in both arms side by side to examine whether the intended comparison was maintained. - Conditions for verification: Distinguish the ingredient substitution in the active 4-drug comparison from actual differences in common treatment. - Why this condition is needed: Needed to avoid attributing differences in common medicines or rescue treatment to berberine. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: Nominal common ingredients are linked, but exact doses by arm, actual concomitant-treatment changes and rescue treatment remain unverified. - Referenced methods: 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. - Related sources: S1 ### N06 · Has the scope of attribution to the combination been distinguished? Verification status: Met Reading scope: 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. - Current findings: The original key explanation and summary note specify a comparison of the entire 4-drug regimen, not a monotherapy trial. - Why unverified: The attribution limit is retained; independent contributions of individual ingredients remain unverified. - Reason for missing information: The attribution limit is retained; independent contributions of individual ingredients remain unverified. - Required materials and conditions: Composition of the 4-drug regimen and the original boundary on extensions to single-component efficacy - Materials to obtain first: Composition of the 4-drug regimen and the original boundary on extensions to single-component efficacy - Further research: If individual contributions are newly asked about, define eligibility and design for a separate regimen comparison, apart from the current results. - Conditions for verification: Do not elevate the comparison of the entire 4-drug regimen to berberine monotherapy or antibiotic replacement. - Why this condition is needed: Needed to avoid confusing effects of the common antibiotics/PPI with effects of individual ingredients. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The attribution limit is retained; independent contributions of individual ingredients remain unverified. - Referenced methods: 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. - Related sources: S1 ### N07 · Are eligibility and baseline characteristics of the actual treatment-naive infected adults established? Verification status: Partly verified Reading scope: 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. - Current findings: The claim conditions specify treatment-naive infected adults. Actual inclusion/exclusion, baseline balance and mixed-population proportions are not established by the retained summary. - Why unverified: The population is named, but material on actual diagnosis, previous exposure and baseline distributions is insufficient. - Reason for missing information: The population is named, but material on actual diagnosis, previous exposure and baseline distributions is insufficient. - Required materials and conditions: Infection diagnosis, treatment history, inclusion/exclusion, age and baseline-characteristic tables - Materials to obtain first: Infection diagnosis, treatment history, inclusion/exclusion, age and baseline-characteristic tables - Further research: Compare eligibility criteria and baseline tables by arm to examine population match and differences in treatment history. - Conditions for verification: Link the nominal population of treatment-naive adults with H. pylori infection to the actual selected population. - Why this condition is needed: Needed to establish differences between the first-line question’s population and actual recruitment. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The population is named, but material on actual diagnosis, previous exposure and baseline distributions is insufficient. - Referenced methods: 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. - Related sources: S1 ### N08 · Is the actual allocation process of the randomized noninferiority trial established? Verification status: Partly verified Reading scope: 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. - Current findings: 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. - Why unverified: The randomized label alone cannot establish the specific allocation process or baseline balance. - Reason for missing information: The randomized label alone cannot establish the specific allocation process or baseline balance. - Required materials and conditions: Random-sequence generation, allocation procedure, unit and baseline-balance material - Materials to obtain first: Random-sequence generation, allocation procedure, unit and baseline-balance material - Further research: Compare methods, allocation records and baseline tables to examine allocation for this eradication comparison. - Conditions for verification: Establish actual material on random-sequence generation, allocation unit, implementation and baseline balance by arm. The RCT label cannot replace that material. - Why this condition is needed: Needed to distinguish an allocation label from review of actual group formation. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The randomized label alone cannot establish the specific allocation process or baseline balance. - Referenced methods: 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. - Related sources: S1 ### N09 · Can allocation concealment during recruitment be established? Verification status: Unverified Reading scope: 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. - Current findings: The original B2 is a historical judgment; the retained evidence table lacks detailed material on concealment implementation. - Why unverified: Open-label conduct does not directly establish success or failure of allocation concealment. - Reason for missing information: Open-label conduct does not directly establish success or failure of allocation concealment. - Required materials and conditions: Original material on concealment procedures, responsible staff and recruitment/allocation sequence - Materials to obtain first: Original material on concealment procedures, responsible staff and recruitment/allocation sequence - Further research: Examine methods and operating records to determine whether recruiters could know the next allocation; record this separately from open-label conduct. - Conditions for verification: Establish actual concealment methods and implementation records; do not substitute the historical B2 axis. - Why this condition is needed: Needed to examine allocation concealment and post-treatment blinding as separate processes. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: Open-label conduct does not directly establish success or failure of allocation concealment. - Referenced methods: 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. - Related sources: S1 ### N10 · Can differences between open-label conduct and UBT assessment conditions be established? Verification status: Partly verified Reading scope: 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. - Current findings: The trial is open-label and the outcome is ¹³C-UBT eradication. Assessor blinding and sample-collection conditions by arm remain unverified. - Why unverified: The presence of an objective test name does not prove uniformity or blinding throughout assessment. - Reason for missing information: The presence of an objective test name does not prove uniformity or blinding throughout assessment. - Required materials and conditions: Sample collection, testing, assessor blinding and measurement conditions by arm - Materials to obtain first: Sample collection, testing, assessor blinding and measurement conditions by arm - Further research: Compare original testing procedures and reading information to examine whether knowledge of allocation or collection conditions could affect measurement. - Conditions for verification: Separately from open-label conduct, establish actual material on UBT sample collection, testing, reading procedures and assessor blinding by arm. - Why this condition is needed: Needed to examine treatment blinding and outcome-assessment limitations for this endpoint. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The presence of an objective test name does not prove uniformity or blinding throughout assessment. - Referenced methods: 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. - Related sources: S1 ### N11 · Can the ¹³C-UBT negative threshold and testing limitations be established? Verification status: Partly verified Reading scope: 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. - Current findings: 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. - Why unverified: The named eradication test and nominal negative definition do not establish individual classification criteria. - Reason for missing information: The named eradication test and nominal negative definition do not establish individual classification criteria. - Required materials and conditions: Negative threshold, testing conditions, validity and control of concomitant medicines - Materials to obtain first: Negative threshold, testing conditions, validity and control of concomitant medicines - Further research: Check testing methods, thresholds and valid-sample rules to compare definitions of reported eradication events. - Conditions for verification: Link the original outcome’s negative definition to actual testing procedures and classification criteria. - Why this condition is needed: Needed to establish how reported events were defined and measured. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The named eradication test and nominal negative definition do not establish individual classification criteria. - Referenced methods: 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. - Related sources: S1 ### N12 · Is the result 28 days after treatment linked to actual follow-up timing? Verification status: Partly verified Reading scope: 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. - Current findings: The claim conditions and evidence table link UBT to 28 days after treatment. Individual test dates, visit windows and delays were not retained. - Why unverified: Nominal timing is established, but actual follow-up uniformity and delays remain unverified. - Reason for missing information: Nominal timing is established, but actual follow-up uniformity and delays remain unverified. - Required materials and conditions: Treatment-end dates, UBT dates, permitted visit windows and missing-test records by arm - Materials to obtain first: Treatment-end dates, UBT dates, permitted visit windows and missing-test records by arm - Further research: Compare visit records to examine how actual timing distributions and missing measurements were handled in analysis. - Conditions for verification: Establish individual actual treatment-end dates, UBT visit dates, permitted windows, delays and missing tests linked to the planned measurement 28 days after treatment. - Why this condition is needed: Needed to avoid combining measurements at different times as the same endpoint result. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: Nominal timing is established, but actual follow-up uniformity and delays remain unverified. - Referenced methods: 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. - Related sources: S1 ### N13 · Was the −10% margin prespecified and justified? Verification status: Partly verified Reading scope: 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. - Current findings: 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. - Why unverified: A reported margin differs from verification of prespecification and its importance rationale. - Reason for missing information: A reported margin differs from verification of prespecification and its importance rationale. - Required materials and conditions: Dated registration, protocol, margin rationale and analysis plan - Materials to obtain first: Dated registration, protocol, margin rationale and analysis plan - Further research: Compare registration/protocol versions and dates with the paper to examine the margin, hypothesis and plan changes. - Conditions for verification: Compare the reported −10% with prespecification, clinical rationale and the effect of interest. - Why this condition is needed: Needed to link the allowable loss in noninferiority and result interpretation to prespecified plans. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: A reported margin differs from verification of prespecification and its importance rationale. - Referenced methods: 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. - Related sources: S1 ### N14 · Can the direction, interval and margin comparison for the between-arm difference be established? Verification status: Unverified Reading scope: 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. - Current findings: 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. - Why unverified: Arm-attribution conflicts and an unverified difference interval prevent independent verification of noninferiority from the current numbers alone. - Reason for missing information: Arm-attribution conflicts and an unverified difference interval prevent independent verification of noninferiority from the current numbers alone. - Required materials and conditions: Noninferiority effect measure, difference direction, confidence interval and test definition for each ITT/PP analysis - Materials to obtain first: Noninferiority effect measure, difference direction, confidence interval and test definition for each ITT/PP analysis - Further research: Compare original noninferiority analysis tables and the SAP to establish agreement in difference direction, interval, margin and ITT/PP interpretation. - Conditions for verification: Link the appropriate between-arm estimate and interval for each analysis to the −10% threshold; do not substitute a nonsignificant P value. - Why this condition is needed: The relationship between the estimated between-arm difference and allowable margin is central to this comparison. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: Arm-attribution conflicts and an unverified difference interval prevent independent verification of noninferiority from the current numbers alone. - Referenced methods: 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. - Related sources: S1 ### N15 · Can ITT event counts, denominators and arm attribution be linked? Verification status: Partly verified Reading scope: 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. - Current findings: 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. - Why unverified: The ITT string exists, but exact mapping of 308/304 to arms remains unresolved. - Reason for missing information: The ITT string exists, but exact mapping of 308/304 to arms remains unresolved. - Required materials and conditions: Original ITT tables, allocation flow, arm labels, inclusion rules and corrections - Materials to obtain first: Original ITT tables, allocation flow, arm labels, inclusion rules and corrections - Further research: Compare methods, flow and original ITT tables in parallel; if author corrections exist, record the basis for arm-mapping changes by version. - Conditions for verification: Retain ITT values unchanged while establishing the analysis population and exact arm attribution. - Why this condition is needed: Needed to retain reported randomized-population results together with arm identity. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The ITT string exists, but exact mapping of 308/304 to arms remains unresolved. - Referenced methods: 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. - Related sources: S1 ### N16 · Can PP event counts, denominators and exclusion criteria be established? Verification status: Partly verified Reading scope: 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. - Current findings: 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Original PP tables, arm labels, inclusion/exclusion criteria and flow material - Materials to obtain first: Original PP tables, arm labels, inclusion/exclusion criteria and flow material - Further research: Compare PP inclusion rules and flow with original tables to examine how population differences link to each event count/denominator. - Conditions for verification: Link reported PP values to actual adherent-population inclusion rules and arm attribution. - Why this condition is needed: Needed to avoid mixing adherent-population analyses with randomized-population results. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining 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. - Referenced methods: 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. - Related sources: S1 ### N17 · Is material available to resolve the 308/304 arm-label conflict? Verification status: Unverified Reading scope: 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. - Current findings: 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. - Why unverified: The conflict warning is retained, but exact arm attribution cannot yet be established. - Reason for missing information: The conflict warning is retained, but exact arm attribution cannot yet be established. - Required materials and conditions: Exact arm labels, denominators and author corrections for methods, flow and ITT/PP tables - Materials to obtain first: Exact arm labels, denominators and author corrections for methods, flow and ITT/PP tables - Further research: Compare relevant sections, tables, flow and author corrections; record agreement/conflict and retain original values from each version. - Conditions for verification: Compare conflicting original locations to establish which denominator belongs to which arm; do not swap values arbitrarily. - Why this condition is needed: Arbitrarily changing arm identity could change effect direction and denominator attribution. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The conflict warning is retained, but exact arm attribution cannot yet be established. - Referenced methods: 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. - Related sources: S1 ### N18 · Can appropriate eradication effect estimates and confidence intervals be established? Verification status: Unverified Reading scope: 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. - Current findings: ITT/PP arm rates are reported. The current result field lacks the exact between-arm difference CI or a separate effect estimate. - Why unverified: Arm rates and P values cannot replace a precise effect size or noninferiority interval. - Reason for missing information: Arm rates and P values cannot replace a precise effect size or noninferiority interval. - Required materials and conditions: Between-arm differences, effect measures, confidence intervals, dispersion and report locations for each analysis - Materials to obtain first: Between-arm differences, effect measures, confidence intervals, dispersion and report locations for each analysis - Further research: Check each effect measure, direction, denominator and interval in acquired analysis tables, together with the current arm-attribution conflict. - Conditions for verification: 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. - Why this condition is needed: Needed to avoid substituting sample size or significance for precision. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: Arm rates and P values cannot replace a precise effect size or noninferiority interval. - Referenced methods: 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. - Related sources: S1 ### N19 · Within what scope are the ITT and PP P values retained? Verification status: Met Reading scope: 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. - Current findings: The result field separately reports ITT P=.149 and PP P=.470. Specific test types and hypotheses are currently unverified. - Why unverified: The limited reporting and interpretation boundary for P values is established. This does not establish clinical equivalence or test reproducibility. - Reason for missing information: The limited reporting and interpretation boundary for P values is established. This does not establish clinical equivalence or test reproducibility. - Required materials and conditions: Reported P values and test definitions for both analyses - Materials to obtain first: Reported P values and test definitions for both analyses - Further research: When test definitions from analysis plans and original tables become available, compare interpretation alongside hypotheses, effect measures and intervals. - Conditions for verification: Distinguish retained ITT P=.149 and PP P=.470; do not extend nonsignificance to proof of 0 effect, equivalence or noninferiority. - Why this condition is needed: Needed to avoid misreading nonsignificance as noninferiority or no effect. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The limited reporting and interpretation boundary for P values is established. This does not establish clinical equivalence or test reproducibility. - Referenced methods: 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. - Related sources: S1 ### N20 · Is arm-specific flow from allocation through UBT, ITT and PP established? Verification status: Unverified Reading scope: 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. - Current findings: 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. - Why unverified: Numerical denominators alone cannot establish follow-up completeness, exclusion reasons or missing-data bias. - Reason for missing information: Numerical denominators alone cannot establish follow-up completeness, exclusion reasons or missing-data bias. - Required materials and conditions: Allocation, nonuse, missing follow-up/tests, dropout reasons and missing-data handling by arm - Materials to obtain first: Allocation, nonuse, missing follow-up/tests, dropout reasons and missing-data handling by arm - Further research: Compare flow with each analysis’s inclusion rules and examine robustness to missing-data handling using appropriate sensitivity analyses. - Conditions for verification: Link the reported 612 participants and each analysis denominator to actual flow and missing-data handling. - Why this condition is needed: Needed to distinguish allocated participants from actual observation and analysis denominators. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: Numerical denominators alone cannot establish follow-up completeness, exclusion reasons or missing-data bias. - Referenced methods: 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. - Related sources: S1 ### N21 · Can adherence to common and trial medicines and rescue treatment be established? Verification status: Unverified Reading scope: 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. - Current findings: Nominal 4-drug composition is known, but drug-specific adherence, rescue treatment and discontinuation analyses are not currently retained. - Why unverified: The PP label alone does not establish adherence to all medicines or rules for handling changes. - Reason for missing information: The PP label alone does not establish adherence to all medicines or rules for handling changes. - Required materials and conditions: Drug-specific adherence, discontinuation, rescue treatment and analysis-handling records - Materials to obtain first: Drug-specific adherence, discontinuation, rescue treatment and analysis-handling records - Further research: Compare drug-specific use, changes and discontinuation records with analysis plans to examine differences in the ITT/PP effects of interest. - Conditions for verification: Establish how actual medication use and concurrent-treatment changes in each arm link to estimation of the effect of interest. - Why this condition is needed: Needed to avoid interpreting differences in actual implementation of the combination as one ingredient’s effect. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The PP label alone does not establish adherence to all medicines or rules for handling changes. - Referenced methods: 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. - Related sources: S1 ### N22 · Can the bibliographic NCT number be linked to the unverified registration field? Verification status: Partly verified Reading scope: 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. - Current findings: The bibliography and research-review field contain NCT02296021, but the registration field says “could not verify.” Actual registration material remains unread in this work. - Why unverified: The number’s presence is established, but the structured unverified status and registration-identity comparison remain unresolved. - Reason for missing information: The number’s presence is established, but the structured unverified status and registration-identity comparison remain unresolved. - Required materials and conditions: Original NCT02296021 registration and material linking paper, regimen and population - Materials to obtain first: Original NCT02296021 registration and material linking paper, regimen and population - Further 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. - Conditions for verification: Retain the bibliographic number and registration-field string unchanged and compare whether they refer to the same actual trial. - Why this condition is needed: Needed to avoid automatically elevating a bibliographic number to verification of the registration full text. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The number’s presence is established, but the structured unverified status and registration-identity comparison remain unresolved. - Referenced methods: 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. - Related sources: S1 ### N23 · Were planned UBT endpoints, timing and analyses compared with results? Verification status: Unverified Reading scope: 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. - Current findings: 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. - Why unverified: A historical comparison narrative or the original false indication for coprimary splitting is not current evidence of agreement with prespecified plans. - Reason for missing information: A historical comparison narrative or the original false indication for coprimary splitting is not current evidence of agreement with prespecified plans. - Required materials and conditions: Dated protocol, SAP, registration versions and reasons for changes - Materials to obtain first: Dated protocol, SAP, registration versions and reasons for changes - Further research: Compare plan/result versions, dates and content to record agreement in principal endpoints, analyses and changes. - Conditions for verification: Compare prespecified endpoints, timing, analysis populations and margin with reported ITT/PP results. - Why this condition is needed: Needed to reveal the actual material-comparison scope for judging selective reporting. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: A historical comparison narrative or the original false indication for coprimary splitting is not current evidence of agreement with prespecified plans. - Referenced methods: 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. - Related sources: S1 ### N24 · Are bibliography, registration and bilingual articles being counted as independent studies? Verification status: Met Reading scope: 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. - Current findings: 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. - Why unverified: Report linkage within the retained scope is established; total unique trials across the literature or independent replication have not been certified. - Reason for missing information: Report linkage within the retained scope is established; total unique trials across the literature or independent replication have not been certified. - Required materials and conditions: Report, registration and cohort identities and study-family linkage material - Materials to obtain first: Report, registration and cohort identities and study-family linkage material - Further research: When related material is added, compare author, registration, recruitment and result identities to classify the same family versus independent trials. - Conditions for verification: Distinguish repeat citations/registration links for the current single paper from unverified independent replication. - Why this condition is needed: Needed to avoid double-counting multiple records of the same trial as independent replication. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: Report linkage within the retained scope is established; total unique trials across the literature or independent replication have not been certified. - Referenced methods: 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. - Related sources: S1 ### N25 · Does it apply in other regions and resistance settings? Verification status: Unverified Reading scope: 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. - Current findings: 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. - Why unverified: The current eradication report for one regimen cannot automatically be applied to other regional resistance distributions or recruited populations. - Reason for missing information: The current eradication report for one regimen cannot automatically be applied to other regional resistance distributions or recruited populations. - Required materials and conditions: Recruitment region, antibiotic resistance, previous exposure and direct multicenter comparisons - Materials to obtain first: Recruitment region, antibiotic resistance, previous exposure and direct multicenter comparisons - Further research: Examine comparisons of the same regimen and prespecified effect-modification hypotheses in multicenter studies specifying population and resistance conditions. - Conditions for verification: 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. - Why this condition is needed: Needed to reveal applicability limits from differences in populations and settings of eradication regimens. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The current eradication report for one regimen cannot automatically be applied to other regional resistance distributions or recruited populations. - Referenced methods: 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. - Related sources: S1 ### N26 · Can funding, drug support and author conflicts be established? Verification status: Partly verified Reading scope: 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. - Current findings: 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. - Why unverified: The historical I1 axis or generic English wording is not current evidence of independent funding or absence of product provision. - Reason for missing information: The historical I1 axis or generic English wording is not current evidence of independent funding or absence of product provision. - Required materials and conditions: Original funding, drug-provision, author-affiliation and conflict-disclosure material - Materials to obtain first: Original funding, drug-provision, author-affiliation and conflict-disclosure material - Further research: Compare funding, product support and author disclosures separately; record conflict scope and remaining uncertainties. - Conditions for verification: In addition to retained academic/hospital support, establish actual funding details, drug providers and their roles, author affiliations and original conflict disclosures. - Why this condition is needed: Needed to avoid converting unverified product support into independent research funding. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The historical I1 axis or generic English wording is not current evidence of independent funding or absence of product provision. - Referenced methods: 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. - Related sources: S1 ### N27 · Can actual adverse-event collection and denominators for the 4-drug regimen be established? Verification status: Unverified Reading scope: 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. - Current findings: 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. - Why unverified: A warning does not establish actual event incidence, severity or absence. - Reason for missing information: A warning does not establish actual event incidence, severity or absence. - Required materials and conditions: Adverse events, definitions, collection, discontinuation and exposure/follow-up denominators by arm - Materials to obtain first: Adverse events, definitions, collection, discontinuation and exposure/follow-up denominators by arm - Further research: Examine safety tables, discontinuation records, event definitions and follow-up in both arms; link harm reporting for the same regimen separately from efficacy. - Conditions for verification: 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. - Why this condition is needed: Needed to avoid automatically establishing safety of the same regimen from efficacy reports. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: A warning does not establish actual event incidence, severity or absence. - Referenced methods: 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. - Related sources: S1 ### N28 · How far can harms involving concomitant medicines, long-term exposure or vulnerable groups be described? Verification status: Unverified Reading scope: 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. - Current findings: The warning specifies concomitant antibiotics/PPI. Material on ingredient-specific harm attribution and long-term or special-population safety is not retained. - Why unverified: Concurrent exposure cannot be converted into one ingredient’s causation or a conclusion of safety for all populations. - Reason for missing information: Concurrent exposure cannot be converted into one ingredient’s causation or a conclusion of safety for all populations. - Required materials and conditions: Concomitant medicines, baseline disease, timing, vulnerable groups and rare/long-term events - Materials to obtain first: Concomitant medicines, baseline disease, timing, vulnerable groups and rare/long-term events - Further research: Examine event collection and alternative explanations in suitable harm studies separating concomitant exposure and baseline risk. - Conditions for verification: 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. - Why this condition is needed: Needed to avoid extending harms of combined exposures to a single ingredient or overall safety. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: Concurrent exposure cannot be converted into one ingredient’s causation or a conclusion of safety for all populations. - Referenced methods: 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. - Related sources: S1 ### N29 · Are long-term maintenance, optimal dose and cancer prevention distinguished from current eradication conditions? Verification status: Not applicable Reading scope: 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. - Current findings: 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. - Why unverified: These extensions are not required conditions for the current question. This does not mean their effects are established or unimportant. - Reason for missing information: These extensions are not required conditions for the current question. This does not mean their effects are established or unimportant. - Required materials and conditions: Boundary between the current eradication endpoint and separate duration, dose and clinical-event questions - Materials to obtain first: Boundary between the current eradication endpoint and separate duration, dose and clinical-event questions - Further research: If an extension is requested, define separate eligible populations, endpoints, duration and direct comparative designs, and use the current report separately. - Conditions for verification: Do not impose separate extension trials as universally required for the narrow eradication question 28 days after treatment; distinguish unverified direct material. - Why this condition is needed: Needed to separate the scope of eradication results from long-term clinical and optimal-dose questions. - Application exceptions: Do not add all long-term, optimal-dose and cancer-prevention trials as requirements for the selected eradication question 28 days after treatment. - Remaining uncertainty: These extensions are not required conditions for the current question. This does not mean their effects are established or unimportant. - Referenced methods: 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. - Related sources: S1 ### N30 · Has reading of the current summary been distinguished from reading external papers and registration? Verification status: Met Reading scope: 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. - Current findings: 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Current retained copy, exact original locations, SHA and access history for external abstract/full text/registration - Materials to obtain first: Current retained copy, exact original locations, SHA and access history for external abstract/full text/registration - Further research: When authorized material acquisition occurs, separately record material-specific dates, original locations, versions and copy SHA; review reading status for linked rows again. - Conditions for verification: Link only the retained summary actually read as summary reading; record external links as unread. - Why this condition is needed: Needed to distinguish existence of a summary link from actual full-text reading. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining 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. - Referenced methods: 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. - Related sources: S1 ### N31 · Are the original evidence date and current review/absence scope specified? Verification status: Met Reading scope: 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. - Current findings: 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. - Why unverified: The original review date or historical correction check does not establish review of all current evidence. - Reason for missing information: The original review date or historical correction check does not establish review of all current evidence. - Required materials and conditions: Original verdict review date, current review date, inputs used and correction/search-checking scope - Materials to obtain first: Original verdict review date, current review date, inputs used and correction/search-checking scope - Further research: When search, correction or retraction material is updated, record search scope, retrieval date and versions, then compare affected conditions again. - Conditions for verification: Separate the historical evidence date from the retained-material review date; do not describe an unperformed search as 0 studies. - Why this condition is needed: Needed to avoid exaggerating uncertainty within the retained scope as absence across all current literature. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: The original review date or historical correction check does not establish review of all current evidence. - Referenced methods: 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. - Related sources: S1 ### N32 · Have the original verdict, axes, corrections and data types been preserved unchanged? Verification status: Met Reading scope: 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. - Current findings: Original C50, Warning, H/R1/I1/E~/B2/CX, empty subclaims, generic English evidence-table wording and corrections remain unchanged. - Why unverified: Historical independent-cross-check wording, score and axes are reports in the original document, not current external clinical certification or reassessment. - Reason for missing information: Historical independent-cross-check wording, score and axes are reports in the original document, not current external clinical certification or reassessment. - Required materials and conditions: Copies of original C50, Warning, all axes, Korean/English values and corrections - Materials to obtain first: Copies of original C50, Warning, all axes, Korean/English values and corrections - Further research: When article correction or evidence updating occurs, retain the complete prior record and link original values, versions, reasons for change and condition review. - Conditions for verification: Retain current original values and data types at exact locations; do not automatically inherit them as condition statuses or a new score. - Why this condition is needed: Needed to distinguish the original judgment traceably from the current scoreless condition checklist. - Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work. - Remaining uncertainty: Historical independent-cross-check wording, score and axes are reports in the original document, not current external clinical certification or reassessment. - Referenced methods: 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. - Related sources: S1 ## Evidence and sources ### S1 Zhang 2017 combination-regimen trial [PubMed](https://pubmed.ncbi.nlm.nih.gov/28796053/) Materials actually 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. Findings recorded in the summary: 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. Record 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. Independent replication: 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Retained bilingual bibliography/research summary and historical record | Retained copy acquired; summary read | Retained copy acquired; summary read | Stored existing review summary read | 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. | | PubMed paper entry point | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | | PMC full-text entry point | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | | DOI paper entry point | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | | Registration entry point | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Link studies and reports separately; do not omit studies solely because results are unreported. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. ## What the statuses mean - 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. ## Change history 2026-10-27 · Public page/materials 1.0. The public view and materials were prepared from the existing 32 items. No new clinical search, verification-state change or scoring was performed.