Esomeprazole, amoxicillin, clarithromycin, and berberine hydrochloride × First-line Helicobacter pylori eradication

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Evidence conditionWhich combination, population and eradication comparison are being examined?Required	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. S1	This establishes the question boundary, not the efficacy of individual components or proof of noninferiority.	Original locations for the current claim, formulation, route, population, endpoint, comparator and timing	When the article is revised, cross-check formulation, endpoint and comparator, and record the independent question’s inclusions and exclusions again.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionCan the salt, source, specification and batch of the actual tablets be established?Required	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. S1	The salt is named, but the actual product, batch, impurities and source remain unverified.	Product, content, batch and quality records for the trial’s berberine hydrochloride tablets	Obtain trial-product records, then compare the nominal ingredient with batch-test records to examine transferability to other extracts or derivatives.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionIs the nominal dose linked to actual medication use?Required	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. S1	The nominal berberine dose cannot replace actual total exposure or common-drug doses.	Doses and medication records for berberine 500 mg 2 times daily and the 3 common medicines	Compare prescriptions and medication records by arm to assess differences between actual exposure and the planned regimen.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionCan the 14-day plan and actual treatment completion be established?Required	The retained claim conditions specify a 14-day regimen. Actual completion rates and discontinuation times by arm are absent from the current record. S1	A nominal 14-day duration does not establish that all randomized participants completed the same duration.	Treatment start, end, discontinuation and medication-completion records by arm	Link timing and adherence records by arm to examine differences in actual treatment duration within analysis populations.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionIs the actual match between the bismuth comparator regimen and common medicines established?Required	The comparator is the same antibiotic 4-drug regimen containing bismuth tartrate. The retained comparison is active treatment with common PPI, amoxicillin and clarithromycin. S1	Nominal common ingredients are linked, but exact doses by arm, actual concomitant-treatment changes and rescue treatment remain unverified.	Bismuth tartrate regimen, common PPI/antibiotics and changes by arm	Compare prescriptions, rescue treatment and changes in both arms side by side to examine whether the intended comparison was maintained.
6	Met	Full text not readStored summary read	N06 · Evidence conditionHas the scope of attribution to the combination been distinguished?Required	The original key explanation and summary note specify a comparison of the entire 4-drug regimen, not a monotherapy trial. S1	The attribution limit is retained; independent contributions of individual ingredients remain unverified.	Composition of the 4-drug regimen and the original boundary on extensions to single-component efficacy	If individual contributions are newly asked about, define eligibility and design for a separate regimen comparison, apart from the current results.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre eligibility and baseline characteristics of the actual treatment-naive infected adults established?Required	The claim conditions specify treatment-naive infected adults. Actual inclusion/exclusion, baseline balance and mixed-population proportions are not established by the retained summary. S1	The population is named, but material on actual diagnosis, previous exposure and baseline distributions is insufficient.	Infection diagnosis, treatment history, inclusion/exclusion, age and baseline-characteristic tables	Compare eligibility criteria and baseline tables by arm to examine population match and differences in treatment history.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionIs the actual allocation process of the randomized noninferiority trial established?Required	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. S1	The randomized label alone cannot establish the specific allocation process or baseline balance.	Random-sequence generation, allocation procedure, unit and baseline-balance material	Compare methods, allocation records and baseline tables to examine allocation for this eradication comparison.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionCan allocation concealment during recruitment be established?Required	The original B2 is a historical judgment; the retained evidence table lacks detailed material on concealment implementation. S1	Open-label conduct does not directly establish success or failure of allocation concealment.	Original material on concealment procedures, responsible staff and recruitment/allocation sequence	Examine methods and operating records to determine whether recruiters could know the next allocation; record this separately from open-label conduct.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionCan differences between open-label conduct and UBT assessment conditions be established?Required	The trial is open-label and the outcome is ¹³C-UBT eradication. Assessor blinding and sample-collection conditions by arm remain unverified. S1	The presence of an objective test name does not prove uniformity or blinding throughout assessment.	Sample collection, testing, assessor blinding and measurement conditions by arm	Compare original testing procedures and reading information to examine whether knowledge of allocation or collection conditions could affect measurement.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionCan the ¹³C-UBT negative threshold and testing limitations be established?Required	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. S1	The named eradication test and nominal negative definition do not establish individual classification criteria.	Negative threshold, testing conditions, validity and control of concomitant medicines	Check testing methods, thresholds and valid-sample rules to compare definitions of reported eradication events.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionIs the result 28 days after treatment linked to actual follow-up timing?Required	The claim conditions and evidence table link UBT to 28 days after treatment. Individual test dates, visit windows and delays were not retained. S1	Nominal timing is established, but actual follow-up uniformity and delays remain unverified.	Treatment-end dates, UBT dates, permitted visit windows and missing-test records by arm	Compare visit records to examine how actual timing distributions and missing measurements were handled in analysis.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWas the −10% margin prespecified and justified?Required	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. S1	A reported margin differs from verification of prespecification and its importance rationale.	Dated registration, protocol, margin rationale and analysis plan	Compare registration/protocol versions and dates with the paper to examine the margin, hypothesis and plan changes.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionCan the direction, interval and margin comparison for the between-arm difference be established?Required	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. S1	Arm-attribution conflicts and an unverified difference interval prevent independent verification of noninferiority from the current numbers alone.	Noninferiority effect measure, difference direction, confidence interval and test definition for each ITT/PP analysis	Compare original noninferiority analysis tables and the SAP to establish agreement in difference direction, interval, margin and ITT/PP interpretation.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionCan ITT event counts, denominators and arm attribution be linked?Required	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. S1	The ITT string exists, but exact mapping of 308/304 to arms remains unresolved.	Original ITT tables, allocation flow, arm labels, inclusion rules and corrections	Compare methods, flow and original ITT tables in parallel; if author corrections exist, record the basis for arm-mapping changes by version.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionCan PP event counts, denominators and exclusion criteria be established?Required	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. S1	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.	Original PP tables, arm labels, inclusion/exclusion criteria and flow material	Compare PP inclusion rules and flow with original tables to examine how population differences link to each event count/denominator.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionIs material available to resolve the 308/304 arm-label conflict?Required	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. S1	The conflict warning is retained, but exact arm attribution cannot yet be established.	Exact arm labels, denominators and author corrections for methods, flow and ITT/PP tables	Compare relevant sections, tables, flow and author corrections; record agreement/conflict and retain original values from each version.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionCan appropriate eradication effect estimates and confidence intervals be established?Required	ITT/PP arm rates are reported. The current result field lacks the exact between-arm difference CI or a separate effect estimate. S1	Arm rates and P values cannot replace a precise effect size or noninferiority interval.	Between-arm differences, effect measures, confidence intervals, dispersion and report locations for each analysis	Check each effect measure, direction, denominator and interval in acquired analysis tables, together with the current arm-attribution conflict.
19	Met	Full text not readStored summary read	N19 · Evidence conditionWithin what scope are the ITT and PP P values retained?Required	The result field separately reports ITT P=.149 and PP P=.470. Specific test types and hypotheses are currently unverified. S1	The limited reporting and interpretation boundary for P values is established. This does not establish clinical equivalence or test reproducibility.	Reported P values and test definitions for both analyses	When test definitions from analysis plans and original tables become available, compare interpretation alongside hypotheses, effect measures and intervals.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionIs arm-specific flow from allocation through UBT, ITT and PP established?Required	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. S1	Numerical denominators alone cannot establish follow-up completeness, exclusion reasons or missing-data bias.	Allocation, nonuse, missing follow-up/tests, dropout reasons and missing-data handling by arm	Compare flow with each analysis’s inclusion rules and examine robustness to missing-data handling using appropriate sensitivity analyses.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionCan adherence to common and trial medicines and rescue treatment be established?Required	Nominal 4-drug composition is known, but drug-specific adherence, rescue treatment and discontinuation analyses are not currently retained. S1	The PP label alone does not establish adherence to all medicines or rules for handling changes.	Drug-specific adherence, discontinuation, rescue treatment and analysis-handling records	Compare drug-specific use, changes and discontinuation records with analysis plans to examine differences in the ITT/PP effects of interest.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionCan the bibliographic NCT number be linked to the unverified registration field?Required	The bibliography and research-review field contain NCT02296021, but the registration field says “could not verify.” Actual registration material remains unread in this work. S1	The number’s presence is established, but the structured unverified status and registration-identity comparison remain unresolved.	Original NCT02296021 registration and material linking paper, regimen and population	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.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionWere planned UBT endpoints, timing and analyses compared with results?Required	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. S1	A historical comparison narrative or the original false indication for coprimary splitting is not current evidence of agreement with prespecified plans.	Dated protocol, SAP, registration versions and reasons for changes	Compare plan/result versions, dates and content to record agreement in principal endpoints, analyses and changes.
24	Met	Full text not readStored summary read	N24 · Evidence conditionAre bibliography, registration and bilingual articles being counted as independent studies?Required	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. S1	Report linkage within the retained scope is established; total unique trials across the literature or independent replication have not been certified.	Report, registration and cohort identities and study-family linkage material	When related material is added, compare author, registration, recruitment and result identities to classify the same family versus independent trials.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionDoes it apply in other regions and resistance settings?Supplementary; required for generalization to other regions	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. S1	The current eradication report for one regimen cannot automatically be applied to other regional resistance distributions or recruited populations.	Recruitment region, antibiotic resistance, previous exposure and direct multicenter comparisons	Examine comparisons of the same regimen and prespecified effect-modification hypotheses in multicenter studies specifying population and resistance conditions.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionCan funding, drug support and author conflicts be established?Required	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. S1	The historical I1 axis or generic English wording is not current evidence of independent funding or absence of product provision.	Original funding, drug-provision, author-affiliation and conflict-disclosure material	Compare funding, product support and author disclosures separately; record conflict scope and remaining uncertainties.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionCan actual adverse-event collection and denominators for the 4-drug regimen be established?Supplementary; required for harm-frequency and safety claims	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. S1	A warning does not establish actual event incidence, severity or absence.	Adverse events, definitions, collection, discontinuation and exposure/follow-up denominators by arm	Examine safety tables, discontinuation records, event definitions and follow-up in both arms; link harm reporting for the same regimen separately from efficacy.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionHow far can harms involving concomitant medicines, long-term exposure or vulnerable groups be described?Supplementary; required for ingredient-specific/long-term safety claims	The warning specifies concomitant antibiotics/PPI. Material on ingredient-specific harm attribution and long-term or special-population safety is not retained. S1	Concurrent exposure cannot be converted into one ingredient’s causation or a conclusion of safety for all populations.	Concomitant medicines, baseline disease, timing, vulnerable groups and rare/long-term events	Examine event collection and alternative explanations in suitable harm studies separating concomitant exposure and baseline risk.
29	Not applicable	Full text not readStored summary read	N29 · Evidence conditionAre long-term maintenance, optimal dose and cancer prevention distinguished from current eradication conditions?Supplementary; required for separate extension questions	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. S1	These extensions are not required conditions for the current question. This does not mean their effects are established or unimportant.	Boundary between the current eradication endpoint and separate duration, dose and clinical-event questions	If an extension is requested, define separate eligible populations, endpoints, duration and direct comparative designs, and use the current report separately.
30	Met	Full text not readStored summary read	N30 · Evidence conditionHas reading of the current summary been distinguished from reading external papers and registration?Required	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. S1	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.	Current retained copy, exact original locations, SHA and access history for external abstract/full text/registration	When authorized material acquisition occurs, separately record material-specific dates, original locations, versions and copy SHA; review reading status for linked rows again.
31	Met	Full text not readStored summary read	N31 · Evidence conditionAre the original evidence date and current review/absence scope specified?Required	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. S1	The original review date or historical correction check does not establish review of all current evidence.	Original verdict review date, current review date, inputs used and correction/search-checking scope	When search, correction or retraction material is updated, record search scope, retrieval date and versions, then compare affected conditions again.
32	Met	Full text not readStored summary read	N32 · Evidence conditionHave the original verdict, axes, corrections and data types been preserved unchanged?Required	Original C50, Warning, H/R1/I1/E~/B2/CX, empty subclaims, generic English evidence-table wording and corrections remain unchanged. S1	Historical independent-cross-check wording, score and axes are reports in the original document, not current external clinical certification or reassessment.	Copies of original C50, Warning, all axes, Korean/English values and corrections	When article correction or evidence updating occurs, retain the complete prior record and link original values, versions, reasons for change and condition review.

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32 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence review date: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: 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.
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.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S1 · Zhang 2017 combination-regimen trial

PubMed

Material type: Retained summary of an open-label randomized phase 4 noninferiority trial
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 stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

Version 1.1 · Criteria record date 2026-10-05. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which combination, population and eradication comparison are being examined?

Required materials and conditions: Original locations for the current claim, formulation, route, population, endpoint, comparator and timing
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.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid combining different regimens or endpoints as the same eradication 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.

N02 · Can the salt, source, specification and batch of the actual tablets be established?

Required materials and conditions: Product, content, batch and quality records for the trial’s berberine hydrochloride tablets
Conditions for verification: Link the nominal HCl to the actual administered product and its quality; retain the unverified plant source.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to establish whether the actual trial product matches the advertised ingredient.
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.

N03 · Is the nominal dose linked to actual medication use?

Required materials and conditions: Doses and medication records for berberine 500 mg 2 times daily and the 3 common medicines
Conditions for verification: Distinguish each drug’s planned dose from actual use, changes and discontinuation.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid reducing differences in exposure to the entire 4-drug regimen to one ingredient’s nominal dose.
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.

N04 · Can the 14-day plan and actual treatment completion be established?

Required materials and conditions: Treatment start, end, discontinuation and medication-completion records by arm
Conditions for verification: Link the 14-day plan to individual actual treatment duration and discontinuation.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to establish whether exposure-duration differences are mixed into eradication analyses.
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.

N05 · Is the actual match between the bismuth comparator regimen and common medicines established?

Required materials and conditions: Bismuth tartrate regimen, common PPI/antibiotics and changes by arm
Conditions for verification: Distinguish the ingredient substitution in the active 4-drug comparison from actual differences in common treatment.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid attributing differences in common medicines or rescue treatment to berberine.
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.

N06 · Has the scope of attribution to the combination been distinguished?

Required materials and conditions: Composition of the 4-drug regimen and the original boundary on extensions to single-component efficacy
Conditions for verification: Do not elevate the comparison of the entire 4-drug regimen to berberine monotherapy or antibiotic replacement.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid confusing effects of the common antibiotics/PPI with effects of individual ingredients.
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.

N07 · Are eligibility and baseline characteristics of the actual treatment-naive infected adults established?

Required materials and conditions: Infection diagnosis, treatment history, inclusion/exclusion, age and baseline-characteristic tables
Conditions for verification: Link the nominal population of treatment-naive adults with H. pylori infection to the actual selected population.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to establish differences between the first-line question’s population and actual recruitment.
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.

N08 · Is the actual allocation process of the randomized noninferiority trial established?

Required materials and conditions: Random-sequence generation, allocation procedure, unit and baseline-balance material
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.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to distinguish an allocation label from review of actual group formation.
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.

N09 · Can allocation concealment during recruitment be established?

Required materials and conditions: Original material on concealment procedures, responsible staff and recruitment/allocation sequence
Conditions for verification: Establish actual concealment methods and implementation records; do not substitute the historical B2 axis.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to examine allocation concealment and post-treatment blinding as separate processes.
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.

N10 · Can differences between open-label conduct and UBT assessment conditions be established?

Required materials and conditions: Sample collection, testing, assessor blinding and measurement conditions by arm
Conditions for verification: Separately from open-label conduct, establish actual material on UBT sample collection, testing, reading procedures and assessor blinding by arm.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to examine treatment blinding and outcome-assessment limitations for this endpoint.
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.

N11 · Can the ¹³C-UBT negative threshold and testing limitations be established?

Required materials and conditions: Negative threshold, testing conditions, validity and control of concomitant medicines
Conditions for verification: Link the original outcome’s negative definition to actual testing procedures and classification criteria.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to establish how reported events were defined and measured.
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.

N12 · Is the result 28 days after treatment linked to actual follow-up timing?

Required materials and conditions: Treatment-end dates, UBT dates, permitted visit windows and missing-test records by arm
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.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid combining measurements at different times as the same endpoint result.
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.

N13 · Was the −10% margin prespecified and justified?

Required materials and conditions: Dated registration, protocol, margin rationale and analysis plan
Conditions for verification: Compare the reported −10% with prespecification, clinical rationale and the effect of interest.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to link the allowable loss in noninferiority and result interpretation to 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.

N14 · Can the direction, interval and margin comparison for the between-arm difference be established?

Required materials and conditions: Noninferiority effect measure, difference direction, confidence interval and test definition for each ITT/PP analysis
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.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: The relationship between the estimated between-arm difference and allowable margin is central to this comparison.
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.

N15 · Can ITT event counts, denominators and arm attribution be linked?

Required materials and conditions: Original ITT tables, allocation flow, arm labels, inclusion rules and corrections
Conditions for verification: Retain ITT values unchanged while establishing the analysis population and exact arm attribution.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to retain reported randomized-population results together with arm identity.
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.

N16 · Can PP event counts, denominators and exclusion criteria be established?

Required materials and conditions: Original PP tables, arm labels, inclusion/exclusion criteria and flow material
Conditions for verification: Link reported PP values to actual adherent-population inclusion rules and arm attribution.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid mixing adherent-population analyses with randomized-population results.
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.

N17 · Is material available to resolve the 308/304 arm-label conflict?

Required materials and conditions: Exact arm labels, denominators and author corrections for methods, flow and ITT/PP tables
Conditions for verification: Compare conflicting original locations to establish which denominator belongs to which arm; do not swap values arbitrarily.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Arbitrarily changing arm identity could change effect direction and denominator attribution.
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.

N18 · Can appropriate eradication effect estimates and confidence intervals be established?

Required materials and conditions: Between-arm differences, effect measures, confidence intervals, dispersion and report locations for each analysis
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.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid substituting sample size or significance for precision.
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.

N19 · Within what scope are the ITT and PP P values retained?

Required materials and conditions: Reported P values and test definitions for both analyses
Conditions for verification: Distinguish retained ITT P=.149 and PP P=.470; do not extend nonsignificance to proof of 0 effect, equivalence or noninferiority.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid misreading nonsignificance as noninferiority or no effect.
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.

N20 · Is arm-specific flow from allocation through UBT, ITT and PP established?

Required materials and conditions: Allocation, nonuse, missing follow-up/tests, dropout reasons and missing-data handling by arm
Conditions for verification: Link the reported 612 participants and each analysis denominator to actual flow and missing-data handling.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to distinguish allocated participants from actual observation and analysis denominators.
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.

N21 · Can adherence to common and trial medicines and rescue treatment be established?

Required materials and conditions: Drug-specific adherence, discontinuation, rescue treatment and analysis-handling records
Conditions for verification: Establish how actual medication use and concurrent-treatment changes in each arm link to estimation of the effect of interest.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid interpreting differences in actual implementation of the combination as one ingredient’s effect.
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.

N22 · Can the bibliographic NCT number be linked to the unverified registration field?

Required materials and conditions: Original NCT02296021 registration and material linking paper, regimen and population
Conditions for verification: Retain the bibliographic number and registration-field string unchanged and compare whether they refer to the same actual trial.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid automatically elevating a bibliographic number to verification of the registration full text.
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.

N23 · Were planned UBT endpoints, timing and analyses compared with results?

Required materials and conditions: Dated protocol, SAP, registration versions and reasons for changes
Conditions for verification: Compare prespecified endpoints, timing, analysis populations and margin with reported ITT/PP results.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to reveal the actual material-comparison scope for judging selective reporting.
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.

N24 · Are bibliography, registration and bilingual articles being counted as independent studies?

Required materials and conditions: Report, registration and cohort identities and study-family linkage material
Conditions for verification: Distinguish repeat citations/registration links for the current single paper from unverified independent replication.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid double-counting multiple records of the same trial as independent replication.
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.

N25 · Does it apply in other regions and resistance settings?

Required materials and conditions: Recruitment region, antibiotic resistance, previous exposure and direct multicenter comparisons
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.
Requirement and applicability: Supplementary; required for generalization to other regions
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to reveal applicability limits from differences in populations and settings of eradication regimens.
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.

N26 · Can funding, drug support and author conflicts be established?

Required materials and conditions: Original funding, drug-provision, author-affiliation and conflict-disclosure material
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.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid converting unverified product support into independent research funding.
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.

N27 · Can actual adverse-event collection and denominators for the 4-drug regimen be established?

Required materials and conditions: Adverse events, definitions, collection, discontinuation and exposure/follow-up denominators by arm
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.
Requirement and applicability: Supplementary; required for harm-frequency and safety claims
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid automatically establishing safety of the same regimen from efficacy reports.
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.

N28 · How far can harms involving concomitant medicines, long-term exposure or vulnerable groups be described?

Required materials and conditions: Concomitant medicines, baseline disease, timing, vulnerable groups and rare/long-term events
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.
Requirement and applicability: Supplementary; required for ingredient-specific/long-term safety claims
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid extending harms of combined exposures to a single ingredient or overall safety.
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.

N29 · Are long-term maintenance, optimal dose and cancer prevention distinguished from current eradication conditions?

Required materials and conditions: Boundary between the current eradication endpoint and separate duration, dose and clinical-event questions
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.
Requirement and applicability: Supplementary; required for separate extension 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.
Why this condition is needed: Needed to separate the scope of eradication results from long-term clinical and optimal-dose questions.
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.

N30 · Has reading of the current summary been distinguished from reading external papers and registration?

Required materials and conditions: Current retained copy, exact original locations, SHA and access history for external abstract/full text/registration
Conditions for verification: Link only the retained summary actually read as summary reading; record external links as unread.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to distinguish existence of a summary link from actual full-text reading.
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.

N31 · Are the original evidence date and current review/absence scope specified?

Required materials and conditions: Original verdict review date, current review date, inputs used and correction/search-checking scope
Conditions for verification: Separate the historical evidence date from the retained-material review date; do not describe an unperformed search as 0 studies.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to avoid exaggerating uncertainty within the retained scope as absence across all current literature.
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.

N32 · Have the original verdict, axes, corrections and data types been preserved unchanged?

Required materials and conditions: Copies of original C50, Warning, all axes, Korean/English values and corrections
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.
Requirement and applicability: Required
Application exceptions: Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.
Why this condition is needed: Needed to distinguish the original judgment traceably from the current scoreless condition checklist.
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.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.
Extent of review: 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

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Link studies and reports separately; do not omit studies solely because results are unreported.
Extent of review: 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

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.
Extent of review: 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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.
Extent of review: 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/material version 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.

The stored-material review date (2026-10-05) and original evidence review date (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which combination, population and eradication comparison are being examined?

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.
Verification status: Met
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.
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.
Remaining uncertainty: This establishes the question boundary, not the efficacy of individual components or proof of noninferiority.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The salt is named, but the actual product, batch, impurities and source remain unverified.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The nominal berberine dose cannot replace actual total exposure or common-drug doses.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: A nominal 14-day duration does not establish that all randomized participants completed the same duration.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Nominal common ingredients are linked, but exact doses by arm, actual concomitant-treatment changes and rescue treatment remain unverified.
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.
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?

Current findings: The original key explanation and summary note specify a comparison of the entire 4-drug regimen, not a monotherapy trial.
Verification status: Met
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.
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.
Remaining uncertainty: The attribution limit is retained; independent contributions of individual ingredients remain unverified.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The population is named, but material on actual diagnosis, previous exposure and baseline distributions is insufficient.
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.
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.

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N08 · Is the actual allocation process of the randomized noninferiority trial established?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The randomized label alone cannot establish the specific allocation process or baseline balance.
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.
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.

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N09 · Can allocation concealment during recruitment be established?

Current findings: The original B2 is a historical judgment; the retained evidence table lacks detailed material on concealment implementation.
Verification status: Unverified
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.
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.
Remaining uncertainty: Open-label conduct does not directly establish success or failure of allocation concealment.
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.
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.

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N10 · Can differences between open-label conduct and UBT assessment conditions be established?

Current findings: The trial is open-label and the outcome is ¹³C-UBT eradication. Assessor blinding and sample-collection conditions by arm remain unverified.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The presence of an objective test name does not prove uniformity or blinding throughout assessment.
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.
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.

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N11 · Can the ¹³C-UBT negative threshold and testing limitations be established?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The named eradication test and nominal negative definition do not establish individual classification criteria.
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.
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.

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N12 · Is the result 28 days after treatment linked to actual follow-up timing?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Nominal timing is established, but actual follow-up uniformity and delays remain unverified.
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.
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.

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N13 · Was the −10% margin prespecified and justified?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: A reported margin differs from verification of prespecification and its importance rationale.
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.
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.

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N14 · Can the direction, interval and margin comparison for the between-arm difference be established?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: Arm-attribution conflicts and an unverified difference interval prevent independent verification of noninferiority from the current numbers alone.
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.
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.

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N15 · Can ITT event counts, denominators and arm attribution be linked?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The ITT string exists, but exact mapping of 308/304 to arms remains unresolved.
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.
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.

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N16 · Can PP event counts, denominators and exclusion criteria be established?

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.
Verification status: Partly verified
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.
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.
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.
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.
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.

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N17 · Is material available to resolve the 308/304 arm-label conflict?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: The conflict warning is retained, but exact arm attribution cannot yet be established.
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.
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.

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N18 · Can appropriate eradication effect estimates and confidence intervals be established?

Current findings: ITT/PP arm rates are reported. The current result field lacks the exact between-arm difference CI or a separate effect estimate.
Verification status: Unverified
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.
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.
Remaining uncertainty: Arm rates and P values cannot replace a precise effect size or noninferiority interval.
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.
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.

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N19 · Within what scope are the ITT and PP P values retained?

Current findings: The result field separately reports ITT P=.149 and PP P=.470. Specific test types and hypotheses are currently unverified.
Verification status: Met
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.
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.
Remaining uncertainty: The limited reporting and interpretation boundary for P values is established. This does not establish clinical equivalence or test reproducibility.
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.
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.

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N20 · Is arm-specific flow from allocation through UBT, ITT and PP established?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: Numerical denominators alone cannot establish follow-up completeness, exclusion reasons or missing-data bias.
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.
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.

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N21 · Can adherence to common and trial medicines and rescue treatment be established?

Current findings: Nominal 4-drug composition is known, but drug-specific adherence, rescue treatment and discontinuation analyses are not currently retained.
Verification status: Unverified
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.
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.
Remaining uncertainty: The PP label alone does not establish adherence to all medicines or rules for handling changes.
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.
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.

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N22 · Can the bibliographic NCT number be linked to the unverified registration field?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The number’s presence is established, but the structured unverified status and registration-identity comparison remain unresolved.
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.
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.

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N23 · Were planned UBT endpoints, timing and analyses compared with results?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: A historical comparison narrative or the original false indication for coprimary splitting is not current evidence of agreement with prespecified plans.
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.
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.

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N24 · Are bibliography, registration and bilingual articles being counted as independent studies?

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.
Verification status: Met
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.
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.
Remaining uncertainty: Report linkage within the retained scope is established; total unique trials across the literature or independent replication have not been certified.
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.
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.

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N25 · Does it apply in other regions and resistance settings?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: The current eradication report for one regimen cannot automatically be applied to other regional resistance distributions or recruited populations.
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.
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.

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N26 · Can funding, drug support and author conflicts be established?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The historical I1 axis or generic English wording is not current evidence of independent funding or absence of product provision.
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.
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.

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N27 · Can actual adverse-event collection and denominators for the 4-drug regimen be established?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: A warning does not establish actual event incidence, severity or absence.
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.
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.

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N28 · How far can harms involving concomitant medicines, long-term exposure or vulnerable groups be described?

Current findings: The warning specifies concomitant antibiotics/PPI. Material on ingredient-specific harm attribution and long-term or special-population safety is not retained.
Verification status: Unverified
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.
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.
Remaining uncertainty: Concurrent exposure cannot be converted into one ingredient’s causation or a conclusion of safety for all populations.
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.
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.

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N29 · Are long-term maintenance, optimal dose and cancer prevention distinguished from current eradication conditions?

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.
Verification status: Not applicable
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.
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.
Remaining uncertainty: These extensions are not required conditions for the current question. This does not mean their effects are established or unimportant.
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.
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.

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N30 · Has reading of the current summary been distinguished from reading external papers and registration?

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.
Verification status: Met
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.
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.
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.
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.
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.

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N31 · Are the original evidence date and current review/absence scope specified?

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.
Verification status: Met
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.
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.
Remaining uncertainty: The original review date or historical correction check does not establish review of all current evidence.
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.
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.

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N32 · Have the original verdict, axes, corrections and data types been preserved unchanged?

Current findings: Original C50, Warning, H/R1/I1/E~/B2/CX, empty subclaims, generic English evidence-table wording and corrections remain unchanged.
Verification status: Met
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.
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.
Remaining uncertainty: Historical independent-cross-check wording, score and axes are reports in the original document, not current external clinical certification or reassessment.
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.
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