Oral berberine added to conventional heart-failure therapy × Reduction of all-cause mortality in chronic congestive heart failure

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 conditionAre the independent claim and inclusion/exclusion boundaries linked to the original article?Required	The original claim is reduced all-cause mortality in chronic congestive heart failure. Scope is limited to add-on treatment under then-conventional common therapy and mean 24-month mortality in the selected ischemic/idiopathic dilated-cardiomyopathy population with ventricular arrhythmia. S01	The original claim is linked to the table boundaries. Met does not establish the size or certainty of the all-cause mortality effect.	Canonical locations for the original claim, population, add-on treatment, comparator, mortality endpoint, timing and exclusions	If article boundaries change, preserve the whole previous article and compare intervention, comparator, endpoint and timing again.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionAre actual diagnosis, severity, eligibility and baseline characteristics verified?Required	The 156 participants are recorded as heart-failure patients with ischemic or idiopathic dilated cardiomyopathy and ventricular ectopy or nonsustained ventricular tachycardia. Detailed severity, eligibility and baseline tables are absent from this input. S01	Diagnosis and parts of the selected population are recorded, but actual eligibility and arm-specific baseline characteristics remain unverified.	Eligibility tables, heart-failure severity, baseline function, etiologic composition and arm-specific baseline tables	Compare original recruitment criteria and baseline tables; examine representativeness of the selected population and balance between arms.
3	Unverified	Full text not readStored summary read	N03 · Evidence conditionAre mortality effects separately verified for ischemic/idiopathic etiologies and ventricular-arrhythmia subgroups?Supplementary; required for subgroup extensions	Only the population description of ischemic/idiopathic dilated cardiomyopathy and ventricular ectopy or nonsustained ventricular tachycardia is available. Subgroup denominators and effects were not retained. S01	Population labels do not verify subgroup mortality effects.	Denominators by etiology/arrhythmia type, prespecified subgroup plans, effects and interaction material	Examine prespecified subgroups and interaction analyses separately from the overall population result.
4	Unverified	Full text not readStored summary read	N04 · Evidence conditionAre the actual berberine salt, formulation, product and manufacturing specifications verified?Required	The exposure is oral adjunctive berberine; the original article leaves the exact salt form, plant source, product and formulation unverified. S01	Ingredient name and dose range alone do not establish actual product specifications.	Original product name, salt/formulation/content specifications and manufacturing, batch and quality documents	Cross-compare original methods and product documents; examine identity with other salts, extracts and combinations separately.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre actual dose, frequency, titration and adherence for 1.2–2.0 g/day verified?Required	Oral adjunctive use is recorded as 1.2–2.0 g/day. Frequency, titration, actual individual dose and adherence were not verified from the current input. S01	Route and reported dose range are available, but actual administration and adherence material are absent.	Dosing schedules, dose-selection/titration records, exposure definitions, adherence and discontinuation records	Compare actual prescribing/use records with the original protocol; examine handling of adherence for the effect of interest.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre actual exposure, changes and discontinuation during mean 24-month follow-up after the 8-week assessment verified?Required	The original duration is an 8-week treatment assessment and mean 24-month follow-up. Continued use of the same dose throughout 24 months, discontinuation and changes remain unverified. S01	The two time labels are recorded, but actual long-term exposure information is absent.	Treatment, discontinuation, concomitant changes, individual follow-up/exposure and event-time records after 8 weeks	Link time-varying exposure and treatment changes to mortality follow-up and compare them with the analysis effect of interest.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre actual arm-specific placebo and then-conventional common treatment, including changes, verified?Required	The comparator is placebo plus then-standard heart-failure treatment. The article records ACE inhibitors, digoxin, diuretics and nitrates in 2003, but lacks arm-specific doses, changes and rescue treatment. S01	Comparator strategy and then-used drug classes are recorded, but actual arm-specific implementation and changes remain unverified.	Placebo specifications and documents for arm-specific background-treatment doses, changes, rescue treatment and handling	Compare original prescribing/common-treatment documents by arm; examine attribution of add-on effects and concurrent changes.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionAre random-sequence generation, allocation concealment and baseline balance verified?Required	A randomized placebo-controlled add-on trial is recorded, but details of allocation concealment remain unverified. S01	The design label is recorded, but generation, concealment and balance material were not verified.	Original allocation methods, concealment procedures, implementation responsibilities and arm-specific baseline tables	Read actual allocation procedures and baseline tables; examine limitations relevant to the selected all-cause mortality result.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionIs blinding of participants, clinicians, death adjudicators and analysts verified?Required	The retained original design explicitly leaves blinding details unverified. Beyond placebo use, no blinding material for participants, clinicians, adjudicators or analysts is available. S01	A placebo-control label alone does not verify actual role-specific blinding.	Blinding methods, role-specific maintenance/unblinding and death-adjudicator/analyst material	Compare role-specific blinding procedures with original methods and outcome collection/adjudication.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre the all-cause mortality definition, ascertainment sources, adjudication and collection times verified?Required	The endpoint is recorded as mean 24-month all-cause mortality. Actual ascertainment sources, adjudication procedures, event dates and arm-specific collection methods are absent from this input. S01	The all-cause mortality label is recorded, but actual collection, adjudication and timing conditions remain unverified.	Death definitions, ascertainment sources, adjudicators, follow-up collection methods and event dates	Compare definitions and collection routes in death-adjudication/follow-up material between arms.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionAre the prespecified hierarchy and assessment timing for all-cause mortality verified?Required	The original reader answer states that a prespecified mortality endpoint is unverified. The generic English endpoint wording does not provide prespecified hierarchy material. S01	No record establishes acquisition of pretrial endpoint-hierarchy or timing documents.	Dated registration/protocol endpoint hierarchies, assessment times and change histories	Compare prospective documents with actual reporting chronologically to examine endpoint selection and changes.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionIs the relationship of 156 participants and 79/77 to allocated, exposed, completed and analyzed denominators verified?Required	Retained sample size is 156 participants, 79 versus 77. Deaths are listed as 7/79 versus 13/77, but detailed flow identifying each denominator as allocated, exposed, completed or analyzed is absent. S01	Reported participants and event denominators are available, but actual flow and analysis-population distinctions remain unverified.	Participant-flow diagrams, arm-specific allocation/exposure/completion/analysis counts and exclusion reasons	Link original flow diagrams to mortality-analysis tables and compare each denominator's definition separately.
13	Met	Full text not readStored summary read	N13 · Evidence conditionAre original death counts and the paper P value attributed to exact reporting locations?Required	The retained mortality report is berberine 7/79, placebo 13/77 deaths and paper P<.02. HR, CI and risk reduction were not calculated from the event counts. S01	Original reported values are linked to source locations unchanged. A precise mortality effect has not been verified.	Original result wording, exact death-count/P-value locations and editions	When new material arrives, compare original result tables and time-to-event analysis while preserving them separately from the current original record.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionAre individual follow-up duration, censoring, study termination and complete death ascertainment verified?Required	The article records mean 24-month follow-up and unverified completeness. Individual duration, censoring, risk sets and loss of contact were not retained. S01	Mean duration and aggregate event counts alone do not verify complete follow-up or censoring.	Individual or arm-specific follow-up distributions, censoring/loss-of-contact/termination records and survival-curve risk sets	Examine survival-follow-up flow and risk sets to compare event ascertainment and censoring assumptions.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionAre arm-specific dropout, exclusion and missingness counts and their handling in mortality analysis verified?Required	156 participants, 79/77 and death counts are available, but this input lacks dropout, analysis-exclusion and missingness counts and handling material. S01	Reported denominators do not prove absence or appropriate handling of missingness and dropout.	Dropout/exclusion/missingness tables, arm-specific reasons and documents for handling missing mortality status	Examine consistency among original flow diagrams, analysis populations, missing-data handling and mortality reporting.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionAre formal between-arm mortality effects, the effect of interest, model and 95% CI verified?Required	The original result records HR and 95% CI as unreported. Formal between-arm mortality estimates and time-to-event analysis details remain unverified. S01	Original counts and P value are available, but material for comparing formal effects, intervals and models is absent.	Formal between-arm estimates, 95% CI, estimation measure, model, effect of interest and analysis-population definitions	Compare the original survival/mortality analysis effect of interest, model and interval, attributing them separately from aggregate events.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionAre the test, contrast, time handling and multiplicity underlying paper P<.02 verified?Required	Paper P<.02 is retained, but the original explanation states that it and crude event counts cannot be cross-verified without time-to-event analysis details. S01	The P value itself is recorded, but its analysis, contrast and time-handling basis remain unverified.	Original statistical methods/result tables, tests, contrasts, time handling and multiplicity plans	Compare the original P value with the analysis description; do not equate it automatically with a different test on aggregate event counts.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionIs material available to judge mortality-effect magnitude, precision and clinical importance?Required	The event direction for the hard endpoint is retained, but effect magnitude, 95% CI and complete follow-up remain unverified. Do not use the original C50 explanation as a new minimum-sample-size criterion. S01	Event counts and the paper P value alone do not establish effect magnitude, precision or clinical importance.	Effects, intervals, baseline risk, follow-up and rationale for interpreting importance	Compare effect/interval interpretation appropriate to the endpoint and population with the original analysis without deriving a new grade.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionAre assignment/adherence effects, ITT/PP populations and handling of treatment changes verified?Required	The article records unverified analysis integrity. ITT/PP, assignment/adherence effects and long-term change-handling material are absent. S01	Original event denominators and a randomized label alone do not verify analysis populations or the effect of interest.	ITT/PP or other analysis-population definitions, long-term adherence/change handling and actual implementation documents	Compare assignment, actual use and change records with analysis plans and state the effect of interest.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionAre the actual trial-registration/protocol identity, editions, dates and originals verified?Required	The original registration field states not identified; Korean/English articles record unverified registration and protocol. No new registry lookup was performed. S01	No material establishes the trial's registration/protocol identity and originals.	Registration/protocol identifiers, dates, editions, originals or actual access records	Compare trial identity for the report before establishing registration/protocol histories and actual provision scope.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionIs consistency between prospective analysis plans and actual endpoints, timing and reporting verified?Required	Prespecified mortality endpoints, registration and protocol are unverified, so comparisons of the SAP with actual mortality analyses have not been possible. S01	Material comparing prospective plans, change histories and complete result tables is absent.	Prospective SAP, analysis lists, change histories and complete actual result tables	Compare prospective/post hoc documents' endpoint, timing and analysis lists; record the verified scope of selection and changes.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre report/trial-family identity and direct independent mortality replication verified?Required; independence verification needed for replication claims	1 evidence entry is linked to 1 Zeng 2003 citation. The original article states that independent confirmatory mortality trials were not identified; no new literature search occurred in this work. S01	A retained report link exists, but external family comparisons and other direct independent replications were not verified.	Related reports/registration identities of the same trial and population, product and mortality-result material from direct replication trials	Link reports to trial families and mortality times/analyses; compare whether recruited populations are independent.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionIs the same adjunctive treatment's mortality effect directly verified under modern standard treatment?Supplementary; required for application to modern treatment	The article explains that then-used ACE inhibitors, digoxin, diuretics and nitrates differ from modern guideline-directed therapy. Direct mortality comparisons under modern background treatment are absent from this input. S01	Then-conventional background-treatment records do not verify additional mortality effects under modern treatment.	Direct comparative trials under modern treatment, arm-specific background treatment, products and mortality estimates	When new direct material is available, compare background treatment, populations, times and effects of interest with the original trial.
24	Met	Full text not readStored summary read	N24 · Evidence conditionAre other salts, extracts, combinations and derivatives distinguished from the actual trial product?Required (product-extension boundary)	The article restricts interchangeability of berberine hydrochloride, plant extracts, compound prescriptions, dihydroberberine, other derivatives and topical products. S01	Automatic extension to other products is distinguished. Actual trial-product specifications have not been verified.	Original product-boundary wording and restrictions on transfer to other products	When product material is added, examine salt, route, composition, exposure equivalence and direct comparisons separately.
25	Met	Full text not readStored summary read	N25 · Evidence conditionIs all-cause mortality distinguished from LVEF, arrhythmia, walking and cause-specific mortality?Required (endpoint-extension boundary)	The original summary states that scope is limited to mean 24-month all-cause mortality and separates LVEF, arrhythmia and walking. No cause-specific death values are invented. S01	Boundaries between all-cause mortality and other endpoints are retained. Effects on separate endpoints have not been graded.	Original wording and locations distinguishing all-cause mortality from other endpoints	If endpoint scope changes, examine definitions, denominators, timing and estimates under new independent boundaries.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionAre direct dose comparisons, optimal dosing and persistence after stopping verified?Supplementary; required for the relevant extension claim	Only the 1.2–2.0 g/day range, 8-week assessment and mean 24-month follow-up are recorded. Direct dose comparisons, optimal dosing and effects after stopping remain unverified. S01	A range and follow-up duration do not replace direct dose/discontinuation comparisons.	Prospective dose comparisons, dose-specific denominators/mortality estimates and post-discontinuation follow-up	Examine designs/analyses directly comparing doses and discontinuation separately from the original single add-on report.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionAre funding, product provision, author employment, full COI and sponsor roles verified?Supplementary; required for interpretation of independence	Korean funding text states that funding, product provision and COI are unverified. The generic English assessed-separately wording and original I1 do not supply original material. S01	Actual declaration, support and sponsor-role material is absent.	Original funding, product provision, employment, COI declarations and sponsor-role documents	Compare individual author declarations, funding and product support separately from trial-family independence.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre identity, public availability and editions of external abstracts, papers and registration/plans actually verified?Required	PMID 12860219, DOI and a PubMed URL are in the current bibliography. External access was not attempted in this work; paper editions, availability and registration/plan identities remain unverified. S01	Bibliographic identifiers and entry points exist, but actual external provision, editions and acquisition were not verified.	External bibliography, abstracts, paper editions, registration/plan identities and actual access/acquisition records	During authorized subsequent acquisition, record identity, availability, access and acquisition separately for each physical material type.
29	Met	Full text not readStored summary read	N29 · Evidence conditionAre generic English wording and the 2026-09-14 correction history retained as original values?Required (original-text and correction attribution)	The 2026-09-14 correction records clarification of 1 generic English verification field. Generic wording remaining in English sample-size, funding, endpoint and result fields is retained and does not establish actual denominator, funding or estimate verification. S01	Current generic wording and correction scope are preserved accurately. The wording does not prove verification of clinical material.	Current bilingual evidence tables, citations, correction originals, dates and scope	If subsequent editing is needed, preserve the whole previous article and distinguish clinical-value changes from translation/display events.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionAre actual adverse-event definitions, collection, severity and discontinuation verified for the same population/exposure?Supplementary; required for harm/safety interpretation	Original safety is Warning, with cautions about bradycardia, hypotension and interactions. Actual event definitions, systematic collection, severity and discontinuation result tables are absent from this input. S01	Cautions and a trial title do not provide actual adverse-event collection/results.	Original adverse-event definitions, collection, timing, severity, discontinuation and causality assessment material	Compare harm collection/adjudication material for the same exposure separately from efficacy reporting.
31	Unverified	Full text not readStored summary read	N31 · Evidence conditionAre harm counts, exposed denominators, observation periods and missingness verified?Supplementary; required for frequency/safety interpretation	Beyond mortality counts of 7/79 versus 13/77, participants/events, exposed denominators, periods and missingness for nonfatal harms have not been verified. S01	Mortality denominators do not verify separate adverse-event frequency or complete collection.	Harm-specific event counts, exposed denominators, periods, missingness and collection systems	Link harm collection tables to exposure/follow-up flow; distinguish spontaneous records from systematic counts.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionIs direct harm material verified for bradycardia, hypotension, interactions and electrolyte, renal and liver status?Supplementary; required for the relevant harm scope	The article warns that bradycardia, hypotension, drug interactions and electrolyte, renal and liver status require separate checks. Direct harm material, denominators and comparisons are absent. S01	A caution list does not establish actual events, magnitude or causality.	Original exposure, event, comparison and follow-up material by concomitant drugs and baseline function	Examine prospectively defined concomitant-drug/baseline-function harm collection or comparisons, distinguishing other causes.
33	Met	Full text not readStored summary read	N33 · Evidence conditionAre original advertising/safety boundaries distinguished from new survival treatment, drug replacement or personal dosing instructions?Required (interpretation-extension boundary)	The original advertising limits prohibit claims of survival treatment, antiarrhythmic replacement or halved mortality risk, retaining a high-dose warning. This table adds no dosing instructions. S01	Extension boundaries for original advertising restrictions and warnings are preserved. New efficacy, safety or personal treatment is not certified.	Original advertising restrictions, safety warnings and locations	If clinical application scope changes, examine direct material, safety and comparator treatment separately before updating presentation.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionAre actual historical search, preservation, verification scope and evidence-date specifications verified?Required	The global original review date is 2026-09-08. The article describes abstract/bibliography and retraction/concern/correction checks, but search strategies, dates, scope records and a native evidence cut-off are absent. S01	Original review date and check descriptions exist, but material needed to complete actual search/preservation/verification specifications is absent.	Dates, databases, strategies, scope and retained documents for historical search/review records	Compare actual historical search records by date, identifier and material type separately from current actions.
35	Partly verified	Full text not readStored summary read	N35 · Evidence conditionAre actual documents, dates and scope of bibliographic-edition and retraction/concern/correction checks verified?Required	Zeng 2003 PMID, DOI and bibliography exist. The original research section records retraction/concern/correction checks, but actual documents, access dates and detailed results are absent. S01	Bibliographic identity and historical descriptions are recorded, but actual evidence of publication-status checks remains unverified.	Bibliographic editions and actual publication-status-check documents, dates, original locations and scope	When authorized new material arrives, compare publication status and edition links by PMID/DOI separately from internal correction history.
36	Met	Full text not readStored summary read	N36 · Evidence conditionAre original C50, axes, empty values and absent fields retained without inheritance into new condition states?Required (original verdict preserved)	Original grade C, score 50, axes B/H/R1/I1/EX/B2/CX and empty subclaim/review-note lists are preserved. Absent structures such as source lists, trial families and evidence cut-offs are not generated as new clinical facts. S01	Original values are preserved without automatic inheritance into condition states, effects or grades.	Complete original bytes, SHA, grade, axes, corrections, empty values and absent fields	If correction is needed, preserve the whole previous article and grading event; handle it under separate authorization/versioning from the current conversion.
37	Met	Full text not readStored summary read	N37 · Evidence conditionAre current local-summary reading, external access not attempted, historical descriptions and unverified access dates separated?Required (actual reading record)	The complete retained material and designated locations were read. External PubMed, abstracts, papers and registration/plans were not accessed or read in this work. Original review dates and abstract/bibliography-check descriptions are historical records; report-specific access-date/level fields are absent. S01	Current actual reading is separated from external unread status and historical records. External original contents were not verified in this work.	Material-specific actual reading, acquisition and access events; distinction among historical descriptions, original review dates and individual access dates	During authorized subsequent reading, append only that material type's actions, dates and locations as separate events.

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37 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: 156 heart-failure patients with ischemic or idiopathic dilated cardiomyopathy and ventricular ectopy or nonsustained ventricular tachycardia. Detailed severity, eligibility and arm-specific baseline characteristics remain unverified.
Ingredient, formulation and route: Oral berberine added to then-conventional common heart-failure treatment. Exact salt form, plant source, product and formulation remain unverified.
Dose: The reported oral dose is 1.2–2.0 g/day. Actual individual dose, frequency, titration and adherence remain unverified. This is not an instruction for personal use.
Comparator: Placebo plus then-conventional heart-failure treatment. The 2003 background of ACE inhibitors, digoxin, diuretics and nitrates is recorded; actual arm-specific doses, changes and rescue treatment remain unverified.
Measured outcome: All-cause mortality over a mean 24-month follow-up. The retained report is berberine 7/79 versus placebo 13/77 deaths, paper P<.02. HR, 95% CI, prespecified endpoint hierarchy, analysis population, censoring and completeness of follow-up remain unverified. Retain the original C grade, 50 points and Warning.
Duration: Distinguish the 8-week treatment assessment from mean 24-month follow-up. Continued use of the same dose throughout long-term follow-up remains unverified.
Questions outside this scope: This is an add-on comparison in the selected population under then-conventional treatment. Do not automatically extend it to modern treatment, all heart-failure patients or mortality effects in ischemic or idiopathic subgroups.; The exact trial product remains unverified. Do not transfer results to berberine hydrochloride, plant extracts, combinations, dihydroberberine, other derivatives or topical products.; Distinguish all-cause mortality from LVEF, arrhythmia, walking and cause-specific death. Do not calculate new risk ratios, intervals or risk reductions from aggregate counts and the paper P value.; Retain the original safety warning. Actual harm material for bradycardia, hypotension, interactions and electrolyte, renal and liver status remains unverified. Do not extend this to established survival treatment, drug replacement, optimal dosing, persistence after stopping or personal treatment instructions.

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.

S01 · Zeng 2003 adjunctive-treatment and all-cause mortality report in chronic heart failure

PubMed

Material type: Retained bibliography and research summary of a randomized placebo-controlled add-on 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: Berberine 7/79 versus placebo 13/77 deaths, paper P<.02. The reported population is 156 participants. HR, 95% CI, prespecified endpoint hierarchy, analysis population, censoring and completeness of follow-up remain unverified. No new effects or intervals were calculated.
Record level: Retained reported all-cause mortality over mean 24-month follow-up in the selected population under then-conventional common treatment. Distinguish 8-week functional assessment from long-term exposure; original tables and survival analysis were not reproduced in this work.
Study overlap and independent replication: The evidence table, bibliography, PMID and DOI for S01 are linkage clues for the same report identity. Do not count bilingual articles as independent trials. Total unique trials, participants and external study-family comparisons are not currently established.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Retained bilingual bibliography and research summary	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 bibliography/abstract entry point	Material type recorded; current public availability unverified	External access not attempted; not acquired	Not read	Current external access, acquisition and reading were not attempted. Bibliography and historical review descriptions do not establish current original-document 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.
Original full text; edition unverified	Material type recorded; current public availability unverified	External access not attempted; not acquired	Not read	Current external access, acquisition and reading were not attempted. Bibliography and historical review descriptions do not establish current original-document 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, protocol and analysis plan; identity and existence unverified	Material type recorded; current public availability unverified	External access not attempted; not acquired	Not read	Current external access, acquisition and reading were not attempted. Bibliography and historical review descriptions do not establish current original-document 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, PMID and DOI for S01 are linkage clues for the same report identity. Do not count bilingual articles as independent trials. Total unique trials, participants and external study-family comparisons are not currently established.

Review criteria

Version 1.0 · 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 · Are the independent claim and inclusion/exclusion boundaries linked to the original article?

Required materials and conditions: Canonical locations for the original claim, population, add-on treatment, comparator, mortality endpoint, timing and exclusions
Conditions for verification: Link the original claim to the question of all-cause mortality with oral berberine added to then-conventional common therapy versus placebo in the selected heart-failure population.
Requirement and applicability: Required
Application exceptions: Korean and English concern the same claim. Do not invent and count separate claims from an empty subclaim list.
Why this condition is needed: Needed to keep mean 24-month all-cause mortality separate from 8-week functional assessment and other heart-failure outcomes.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N02 · Are actual diagnosis, severity, eligibility and baseline characteristics verified?

Required materials and conditions: Eligibility tables, heart-failure severity, baseline function, etiologic composition and arm-specific baseline tables
Conditions for verification: Verify actual inclusion/exclusion criteria, severity and arm-specific baseline characteristics in addition to the recorded diagnosis and ventricular arrhythmia.
Requirement and applicability: Required
Application exceptions: Retain the mixed ischemic/idiopathic population. Do not infer its proportions or subgroup effects.
Why this condition is needed: Needed to distinguish all heart-failure patients from the selected population with ventricular arrhythmia and dilated cardiomyopathy.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N03 · Are mortality effects separately verified for ischemic/idiopathic etiologies and ventricular-arrhythmia subgroups?

Required materials and conditions: Denominators by etiology/arrhythmia type, prespecified subgroup plans, effects and interaction material
Conditions for verification: Verify prespecified definitions by etiology/arrhythmia type, actual denominators, interactions or separate comparative estimates.
Requirement and applicability: Supplementary; required for subgroup extensions
Application exceptions: Do not require every subgroup effect when examining the narrowly defined overall-population claim.
Why this condition is needed: Needed to prevent extending the main effect in a mixed population to specific etiologic or arrhythmia subgroups.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N04 · Are the actual berberine salt, formulation, product and manufacturing specifications verified?

Required materials and conditions: Original product name, salt/formulation/content specifications and manufacturing, batch and quality documents
Conditions for verification: Verify the actual administered product's salt form, formulation, purity, manufacturing batch and quality material.
Requirement and applicability: Required
Application exceptions: Do not fill unverified salt, plant-source or product information from a title or generic ingredient name.
Why this condition is needed: Needed to prevent automatically substituting berberine hydrochloride, plant extracts or other derivatives for the actual trial product.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N05 · Are actual dose, frequency, titration and adherence for 1.2–2.0 g/day verified?

Required materials and conditions: Dosing schedules, dose-selection/titration records, exposure definitions, adherence and discontinuation records
Conditions for verification: Verify oral route, reported daily dose, actual frequency, dose selection/titration and arm-specific adherence.
Requirement and applicability: Required
Application exceptions: Do not choose an arbitrary representative dose or convert salt mass into active-ingredient mass.
Why this condition is needed: Needed to avoid turning a nominal dose range into actual individual exposure or an optimal dose.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N06 · Are actual exposure, changes and discontinuation during mean 24-month follow-up after the 8-week assessment verified?

Required materials and conditions: Treatment, discontinuation, concomitant changes, individual follow-up/exposure and event-time records after 8 weeks
Conditions for verification: Distinguish the 8-week treatment assessment from mean 24-month follow-up; verify subsequent actual continuation, changes, discontinuation and exposure at event times.
Requirement and applicability: Required
Application exceptions: Mean follow-up is not identical exposure duration for every participant.
Why this condition is needed: Needed to avoid treating the 8-week treatment assessment and long-term mortality follow-up as the same dosing duration.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N07 · Are actual arm-specific placebo and then-conventional common treatment, including changes, verified?

Required materials and conditions: Placebo specifications and documents for arm-specific background-treatment doses, changes, rescue treatment and handling
Conditions for verification: Verify placebo plus then-standard treatment and actual arm-specific prescribing, changes and rescue use of ACE inhibitors, digoxin, diuretics and nitrates.
Requirement and applicability: Required
Application exceptions: Do not require every change to be identical in both arms; verify the actual effect of interest and handling methods.
Why this condition is needed: Needed to avoid replacing the additional-berberine comparison with a difference in all then-conventional therapy or an effect under modern treatment.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N08 · Are random-sequence generation, allocation concealment and baseline balance verified?

Required materials and conditions: Original allocation methods, concealment procedures, implementation responsibilities and arm-specific baseline tables
Conditions for verification: Verify actual sequence generation, concealment, allocation implementation and baseline balance.
Requirement and applicability: Required
Application exceptions: Retain the randomized-trial description without inventing detailed procedures.
Why this condition is needed: Needed to avoid claiming that an RCT label resolves allocation procedures and selection differences.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N09 · Is blinding of participants, clinicians, death adjudicators and analysts verified?

Required materials and conditions: Blinding methods, role-specific maintenance/unblinding and death-adjudicator/analyst material
Conditions for verification: Verify actual blinding, maintenance, unblinding and conditions affecting outcome collection for each role.
Requirement and applicability: Required
Application exceptions: Even with relatively objective all-cause mortality, actual adjudication, follow-up and analysis conditions require separate verification. Unverified blinding is not automatic failure.
Why this condition is needed: Needed to distinguish placebo use from verified blinding of everyone involved.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N10 · Are the all-cause mortality definition, ascertainment sources, adjudication and collection times verified?

Required materials and conditions: Death definitions, ascertainment sources, adjudicators, follow-up collection methods and event dates
Conditions for verification: Verify the all-cause mortality label, actual death-ascertainment sources, adjudication criteria, arm-specific collection routes and dates.
Requirement and applicability: Required
Application exceptions: The original endpoint is all-cause mortality. Do not replace it with cardiovascular, sudden or arrhythmic death.
Why this condition is needed: Needed to avoid interpreting death counts as automatically complete and identically ascertained events.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N11 · Are the prespecified hierarchy and assessment timing for all-cause mortality verified?

Required materials and conditions: Dated registration/protocol endpoint hierarchies, assessment times and change histories
Conditions for verification: Verify the primary/secondary hierarchy of mortality endpoints and planned follow-up times in documents preceding trial initiation.
Requirement and applicability: Required
Application exceptions: Neither the original principal-endpoint contract nor the current table's main endpoint proves trial prespecification.
Why this condition is needed: Needed to avoid automatically designating the current claim as the trial's prespecified primary endpoint.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N12 · Is the relationship of 156 participants and 79/77 to allocated, exposed, completed and analyzed denominators verified?

Required materials and conditions: Participant-flow diagrams, arm-specific allocation/exposure/completion/analysis counts and exclusion reasons
Conditions for verification: Verify actual recruitment, allocation, exposure, completion and mortality-analysis flow and denominators in addition to reported 156 participants and 79/77.
Requirement and applicability: Required
Application exceptions: Do not invent actual completed/analyzed counts from generic English wording about distinct denominators.
Why this condition is needed: Needed to distinguish sample-size and death-count denominators from ITT populations or complete-follow-up denominators.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N13 · Are original death counts and the paper P value attributed to exact reporting locations?

Required materials and conditions: Original result wording, exact death-count/P-value locations and editions
Conditions for verification: Link 7/79 versus 13/77 and paper P<.02 to original evidence, citations and bilingual articles without adding newly calculated values.
Requirement and applicability: Required
Application exceptions: Met for this recording condition does not establish a risk ratio, HR, CI or analysis validity.
Why this condition is needed: Needed to distinguish original-value preservation from new effect estimation and retain the favorable event direction.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N14 · Are individual follow-up duration, censoring, study termination and complete death ascertainment verified?

Required materials and conditions: Individual or arm-specific follow-up distributions, censoring/loss-of-contact/termination records and survival-curve risk sets
Conditions for verification: Verify arm-specific follow-up distributions, reasons for censoring, termination, vital-status ascertainment and risk sets.
Requirement and applicability: Required
Application exceptions: Unverified completeness does not establish actual missed deaths or a particular magnitude of bias.
Why this condition is needed: Needed to avoid turning mean 24 months into complete, identical follow-up for every participant.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N15 · Are arm-specific dropout, exclusion and missingness counts and their handling in mortality analysis verified?

Required materials and conditions: Dropout/exclusion/missingness tables, arm-specific reasons and documents for handling missing mortality status
Conditions for verification: Verify arm-specific missingness, dropout, analysis-exclusion reasons, missing vital-status handling and sensitivity material.
Requirement and applicability: Required
Application exceptions: Do not fill unrecorded dropout counts with 0 or derive them backwards from event counts.
Why this condition is needed: Needed to avoid treating original denominators as complete analysis of all allocated participants.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N16 · Are formal between-arm mortality effects, the effect of interest, model and 95% CI verified?

Required materials and conditions: Formal between-arm estimates, 95% CI, estimation measure, model, effect of interest and analysis-population definitions
Conditions for verification: Verify actual between-arm estimates, measure, model, analysis population and interval appropriate to the selected effect of interest.
Requirement and applicability: Required
Application exceptions: Valid unadjusted between-arm estimates are possible. Do not require an adjusted model or HR as the only format for every analysis.
Why this condition is needed: Needed to distinguish the direction of aggregate death counts from time-to-event effect magnitude and precision.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N17 · Are the test, contrast, time handling and multiplicity underlying paper P<.02 verified?

Required materials and conditions: Original statistical methods/result tables, tests, contrasts, time handling and multiplicity plans
Conditions for verification: Verify the test, contrast of interest, time-to-event handling, multiplicity and analysis population corresponding to the reported P value.
Requirement and applicability: Required
Application exceptions: Currently absent analysis details do not establish that the paper P value is wrong.
Why this condition is needed: Needed to avoid recalculating or reattributing the original P value as a simple event-count test.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N18 · Is material available to judge mortality-effect magnitude, precision and clinical importance?

Required materials and conditions: Effects, intervals, baseline risk, follow-up and rationale for interpreting importance
Conditions for verification: Verify valid between-arm effects and intervals, actual follow-up, baseline risk and justified interpretation of importance.
Requirement and applicability: Required
Application exceptions: Do not adopt arbitrary minimum participants, trial counts, duration or effect size. The 200-participant wording in the original grade rationale is historical explanation.
Why this condition is needed: Needed to avoid declaring adequate precision from a hard endpoint, significance or a single sample-size figure alone.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N19 · Are assignment/adherence effects, ITT/PP populations and handling of treatment changes verified?

Required materials and conditions: ITT/PP or other analysis-population definitions, long-term adherence/change handling and actual implementation documents
Conditions for verification: Verify analysis populations, effect of interest, deviation/change/death-handling rules and their actual application.
Requirement and applicability: Required
Application exceptions: Do not invent ITT or PP labels when analysis names are absent.
Why this condition is needed: Needed to distinguish the effect of add-on assignment from effects among actual long-term users.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N20 · Are the actual trial-registration/protocol identity, editions, dates and originals verified?

Required materials and conditions: Registration/protocol identifiers, dates, editions, originals or actual access records
Conditions for verification: Verify the trial's registration/protocol identifiers, initial/change dates, editions and originals.
Requirement and applicability: Required
Application exceptions: Do not borrow registration numbers from other berberine trials. Failure to acquire full text does not prove nonexistence.
Why this condition is needed: Needed to distinguish an unidentified NCT from confirmed nonregistration or results of a current registry search.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N21 · Is consistency between prospective analysis plans and actual endpoints, timing and reporting verified?

Required materials and conditions: Prospective SAP, analysis lists, change histories and complete actual result tables
Conditions for verification: Compare dated SAP/plans with actual mortality/functional outcomes, times, analyses and reasons for changes.
Requirement and applicability: Required
Application exceptions: Unverified protocol/SAP does not establish presence or absence of selective reporting.
Why this condition is needed: Needed to avoid turning absent plans into confirmed selective reporting or retrospectively calling current mortality reports prospective analyses.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N22 · Are report/trial-family identity and direct independent mortality replication verified?

Required materials and conditions: Related reports/registration identities of the same trial and population, product and mortality-result material from direct replication trials
Conditions for verification: Verify the Zeng 2003 evidence/citation link, related reports of the same trial and identity/independence of other direct mortality trials.
Requirement and applicability: Required; independence verification needed for replication claims
Application exceptions: Neither a new search not performed nor unverified replication in the original article establishes 0 replication trials worldwide.
Why this condition is needed: Needed to distinguish a single citation and the original R1 from externally verified replication counts.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N23 · Is the same adjunctive treatment's mortality effect directly verified under modern standard treatment?

Required materials and conditions: Direct comparative trials under modern treatment, arm-specific background treatment, products and mortality estimates
Conditions for verification: Verify direct comparisons and treatment differences under modern background therapy for the same population, product, exposure and mortality endpoint.
Requirement and applicability: Supplementary; required for application to modern treatment
Application exceptions: No new lookup of modern drugs or guidelines occurs in this work. The original claim remains tied to the then-conventional trial.
Why this condition is needed: Needed to avoid directly transferring results under 2003 common treatment to current treatment backgrounds.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N24 · Are other salts, extracts, combinations and derivatives distinguished from the actual trial product?

Required materials and conditions: Original product-boundary wording and restrictions on transfer to other products
Conditions for verification: Do not automatically equate berberine hydrochloride, plant extracts, compound prescriptions, dihydroberberine, other derivatives or topical products with the original exposure.
Requirement and applicability: Required (product-extension boundary)
Application exceptions: Met for product-boundary distinction does not verify the original product's salt/specifications. Actual product verification is asked separately in N04.
Why this condition is needed: Needed to avoid applying mortality results to different products solely because they share an ingredient name.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N25 · Is all-cause mortality distinguished from LVEF, arrhythmia, walking and cause-specific mortality?

Required materials and conditions: Original wording and locations distinguishing all-cause mortality from other endpoints
Conditions for verification: Select only mean 24-month all-cause mortality; keep extended endpoints such as LVEF, arrhythmia, walking and cardiovascular death separate.
Requirement and applicability: Required (endpoint-extension boundary)
Application exceptions: Do not generate new independent tables for other results or combine their values with the mortality effect in this table.
Why this condition is needed: Needed to avoid replacing the original all-cause mortality question with other symptoms, function or cause-specific deaths.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N26 · Are direct dose comparisons, optimal dosing and persistence after stopping verified?

Required materials and conditions: Prospective dose comparisons, dose-specific denominators/mortality estimates and post-discontinuation follow-up
Conditions for verification: Verify direct dose comparisons, actual arm-specific exposure, mortality follow-up after stopping and separate estimates.
Requirement and applicability: Supplementary; required for the relevant extension claim
Application exceptions: Do not universally require optimal-dose or discontinuation studies for the narrow then-conventional add-on question.
Why this condition is needed: Needed to distinguish a dose range and long-term follow-up from optimal dosing or effects persisting after stopping.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N27 · Are funding, product provision, author employment, full COI and sponsor roles verified?

Required materials and conditions: Original funding, product provision, employment, COI declarations and sponsor-role documents
Conditions for verification: Verify original funding, product provision, author relationships, COI declarations and sponsor design/analysis/publication roles.
Requirement and applicability: Supplementary; required for interpretation of independence
Application exceptions: Do not infer industry involvement without material or automatically exclude results.
Why this condition is needed: Needed to distinguish the original I1 or generic English wording from evidence verifying independent funding or conflicts.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N28 · Are identity, public availability and editions of external abstracts, papers and registration/plans actually verified?

Required materials and conditions: External bibliography, abstracts, paper editions, registration/plan identities and actual access/acquisition records
Conditions for verification: Verify recorded PMID, DOI and PubMed entry points alongside actual editions, availability and acquisition of external originals.
Requirement and applicability: Required
Application exceptions: Do not label current access not attempted as failed access. Do not invent registration/plan URLs without established identity.
Why this condition is needed: Needed to distinguish bibliographic entry points from acquisition or successful reading of full texts and registration originals.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N29 · Are generic English wording and the 2026-09-14 correction history retained as original values?

Required materials and conditions: Current bilingual evidence tables, citations, correction originals, dates and scope
Conditions for verification: Link correction dates/scope and current generic English wording to original bytes and typed literals without using them as new verified facts.
Requirement and applicability: Required (original-text and correction attribution)
Application exceptions: The correction records replacement of 1 English field. Retain remaining generic wording historically without arbitrary translation/replacement.
Why this condition is needed: Needed to avoid promoting English placeholders to current specific clinical-material verification.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N30 · Are actual adverse-event definitions, collection, severity and discontinuation verified for the same population/exposure?

Required materials and conditions: Original adverse-event definitions, collection, timing, severity, discontinuation and causality assessment material
Conditions for verification: Verify actual adverse-event definitions, collection methods/times, severity, discontinuation and causality assessment material.
Requirement and applicability: Supplementary; required for harm/safety interpretation
Application exceptions: Efficacy and harms have separate states. Do not remove mortality reporting because harm material remains unverified.
Why this condition is needed: Needed to distinguish original warnings or safety in a title from actual safety results.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N31 · Are harm counts, exposed denominators, observation periods and missingness verified?

Required materials and conditions: Harm-specific event counts, exposed denominators, periods, missingness and collection systems
Conditions for verification: Verify exposed persons, persons/events, follow-up periods, missingness and collection systems for each harm.
Requirement and applicability: Supplementary; required for frequency/safety interpretation
Application exceptions: Do not fill absent event counts with 0 or derive harm incidence from warnings.
Why this condition is needed: Needed to avoid transferring 156 participants and death counts to nonfatal-adverse-event denominators or incidence.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N32 · Is direct harm material verified for bradycardia, hypotension, interactions and electrolyte, renal and liver status?

Required materials and conditions: Original exposure, event, comparison and follow-up material by concomitant drugs and baseline function
Conditions for verification: Verify concomitant drugs, baseline status, events, follow-up and comparative material under the same actual exposure.
Requirement and applicability: Supplementary; required for the relevant harm scope
Application exceptions: Retain original warnings without newly confirming particular drug interactions or vulnerable-population risks.
Why this condition is needed: Needed to distinguish original cautions from verified risks or interaction magnitudes.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N33 · Are original advertising/safety boundaries distinguished from new survival treatment, drug replacement or personal dosing instructions?

Required materials and conditions: Original advertising restrictions, safety warnings and locations
Conditions for verification: Do not extend results to established survival treatment, antiarrhythmic replacement or halved mortality risk; link original warnings to historical text.
Requirement and applicability: Required (interpretation-extension boundary)
Application exceptions: This table does not direct individual treatment, dosing or discontinuation. Do not reduce original warnings.
Why this condition is needed: Needed to prevent advertising favorable death counts as established survival treatment or halved risk.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N34 · Are actual historical search, preservation, verification scope and evidence-date specifications verified?

Required materials and conditions: Dates, databases, strategies, scope and retained documents for historical search/review records
Conditions for verification: Verify actual search dates, databases, strategies and preservation-scope documents in addition to the global original review date and search description.
Requirement and applicability: Required
Application exceptions: Do not infer absent evidence cut-offs, search databases or search strategies.
Why this condition is needed: Needed to distinguish the original review date from a current comprehensive literature search or report-specific access dates.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N35 · Are actual documents, dates and scope of bibliographic-edition and retraction/concern/correction checks verified?

Required materials and conditions: Bibliographic editions and actual publication-status-check documents, dates, original locations and scope
Conditions for verification: Verify PMID, DOI, bibliographic editions and actual publication-status-check documents, original locations, dates and scope.
Requirement and applicability: Required
Application exceptions: Bibliography, internal English corrections and publisher correction/retraction documents are different materials. No current external lookup occurs.
Why this condition is needed: Needed to avoid reusing historical check descriptions as new verification of current publication status.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N36 · Are original C50, axes, empty values and absent fields retained without inheritance into new condition states?

Required materials and conditions: Complete original bytes, SHA, grade, axes, corrections, empty values and absent fields
Conditions for verification: Preserve the complete original material and C50, safety, axes, empty subclaim/review-note lists and absent structures as typed original values without calculating new scores.
Requirement and applicability: Required (original verdict preserved)
Application exceptions: Original axes such as H, R1 and I1 are historical values; they do not replace actual independence or precision verification.
Why this condition is needed: Needed to avoid presenting the current conversion as reevaluation of the original grade or a new condition score.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N37 · Are current local-summary reading, external access not attempted, historical descriptions and unverified access dates separated?

Required materials and conditions: Material-specific actual reading, acquisition and access events; distinction among historical descriptions, original review dates and individual access dates
Conditions for verification: Record only current local-summary reading as true; retain external access not attempted/not acquired/not read and absent actual access dates/levels as unrecorded values.
Requirement and applicability: Required (actual reading record)
Application exceptions: Do not copy original review/correction dates into access dates. Do not inherit one included document's access level into another physical material.
Why this condition is needed: Needed to avoid turning summary-reader links into external full-text-reading badges.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, 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 reported: A scope-limited status indicating that an item was not stated in a specific material or section actually read.
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.
Not applicable: Used only with a reason that an item is outside the actual scope of the selected question. It does not replace unverified or unread status.
Inaccessible: Used only for material for which access was actually attempted and failed. Not assigned to clinical material in this work.
Review incomplete: Original-material comparisons or searches were not performed within the authorized scope.

Change history

2026-10-27 · Public page/material version 1.0

The public view and materials were prepared from the existing 37 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 · Are the independent claim and inclusion/exclusion boundaries linked to the original article?

Current findings: The original claim is reduced all-cause mortality in chronic congestive heart failure. Scope is limited to add-on treatment under then-conventional common therapy and mean 24-month mortality in the selected ischemic/idiopathic dilated-cardiomyopathy population with ventricular arrhythmia.
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 claim is linked to the table boundaries. Met does not establish the size or certainty of the all-cause mortality effect.
Reason for missing information: None (independent-claim record scope)
Required materials and conditions: Canonical locations for the original claim, population, add-on treatment, comparator, mortality endpoint, timing and exclusions
Materials to obtain first: Canonical locations for the original claim, population, add-on treatment, comparator, mortality endpoint, timing and exclusions
Further research: If article boundaries change, preserve the whole previous article and compare intervention, comparator, endpoint and timing again.
Remaining uncertainty: None (independent-claim record scope) No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Link the original claim to the question of all-cause mortality with oral berberine added to then-conventional common therapy versus placebo in the selected heart-failure population.
Why this condition is needed: Needed to keep mean 24-month all-cause mortality separate from 8-week functional assessment and other heart-failure outcomes.
Application exceptions: Korean and English concern the same claim. Do not invent and count separate claims from an empty subclaim list.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N02 · Are actual diagnosis, severity, eligibility and baseline characteristics verified?

Current findings: The 156 participants are recorded as heart-failure patients with ischemic or idiopathic dilated cardiomyopathy and ventricular ectopy or nonsustained ventricular tachycardia. Detailed severity, eligibility and baseline tables are absent from this input.
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: Diagnosis and parts of the selected population are recorded, but actual eligibility and arm-specific baseline characteristics remain unverified.
Reason for missing information: Severity, population proportions, eligibility and baseline tables
Required materials and conditions: Eligibility tables, heart-failure severity, baseline function, etiologic composition and arm-specific baseline tables
Materials to obtain first: Eligibility tables, heart-failure severity, baseline function, etiologic composition and arm-specific baseline tables
Further research: Compare original recruitment criteria and baseline tables; examine representativeness of the selected population and balance between arms.
Remaining uncertainty: Severity, population proportions, eligibility and baseline tables No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify actual inclusion/exclusion criteria, severity and arm-specific baseline characteristics in addition to the recorded diagnosis and ventricular arrhythmia.
Why this condition is needed: Needed to distinguish all heart-failure patients from the selected population with ventricular arrhythmia and dilated cardiomyopathy.
Application exceptions: Retain the mixed ischemic/idiopathic population. Do not infer its proportions or subgroup effects.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N03 · Are mortality effects separately verified for ischemic/idiopathic etiologies and ventricular-arrhythmia subgroups?

Current findings: Only the population description of ischemic/idiopathic dilated cardiomyopathy and ventricular ectopy or nonsustained ventricular tachycardia is available. Subgroup denominators and effects were 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: Population labels do not verify subgroup mortality effects.
Reason for missing information: Subgroup plans, denominators, interactions and mortality estimates
Required materials and conditions: Denominators by etiology/arrhythmia type, prespecified subgroup plans, effects and interaction material
Materials to obtain first: Denominators by etiology/arrhythmia type, prespecified subgroup plans, effects and interaction material
Further research: Examine prespecified subgroups and interaction analyses separately from the overall population result.
Remaining uncertainty: Subgroup plans, denominators, interactions and mortality estimates No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify prespecified definitions by etiology/arrhythmia type, actual denominators, interactions or separate comparative estimates.
Why this condition is needed: Needed to prevent extending the main effect in a mixed population to specific etiologic or arrhythmia subgroups.
Application exceptions: Do not require every subgroup effect when examining the narrowly defined overall-population claim.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N04 · Are the actual berberine salt, formulation, product and manufacturing specifications verified?

Current findings: The exposure is oral adjunctive berberine; the original article leaves the exact salt form, plant source, product and formulation unverified.
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: Ingredient name and dose range alone do not establish actual product specifications.
Reason for missing information: Salt, formulation, product, batch and quality
Required materials and conditions: Original product name, salt/formulation/content specifications and manufacturing, batch and quality documents
Materials to obtain first: Original product name, salt/formulation/content specifications and manufacturing, batch and quality documents
Further research: Cross-compare original methods and product documents; examine identity with other salts, extracts and combinations separately.
Remaining uncertainty: Salt, formulation, product, batch and quality No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify the actual administered product's salt form, formulation, purity, manufacturing batch and quality material.
Why this condition is needed: Needed to prevent automatically substituting berberine hydrochloride, plant extracts or other derivatives for the actual trial product.
Application exceptions: Do not fill unverified salt, plant-source or product information from a title or generic ingredient name.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N05 · Are actual dose, frequency, titration and adherence for 1.2–2.0 g/day verified?

Current findings: Oral adjunctive use is recorded as 1.2–2.0 g/day. Frequency, titration, actual individual dose and adherence were not verified from the current input.
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: Route and reported dose range are available, but actual administration and adherence material are absent.
Reason for missing information: Actual individual dose, frequency, titration and adherence
Required materials and conditions: Dosing schedules, dose-selection/titration records, exposure definitions, adherence and discontinuation records
Materials to obtain first: Dosing schedules, dose-selection/titration records, exposure definitions, adherence and discontinuation records
Further research: Compare actual prescribing/use records with the original protocol; examine handling of adherence for the effect of interest.
Remaining uncertainty: Actual individual dose, frequency, titration and adherence No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify oral route, reported daily dose, actual frequency, dose selection/titration and arm-specific adherence.
Why this condition is needed: Needed to avoid turning a nominal dose range into actual individual exposure or an optimal dose.
Application exceptions: Do not choose an arbitrary representative dose or convert salt mass into active-ingredient mass.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N06 · Are actual exposure, changes and discontinuation during mean 24-month follow-up after the 8-week assessment verified?

Current findings: The original duration is an 8-week treatment assessment and mean 24-month follow-up. Continued use of the same dose throughout 24 months, discontinuation and changes 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 two time labels are recorded, but actual long-term exposure information is absent.
Reason for missing information: Exposure continuation, changes, discontinuation and individual duration after 8 weeks
Required materials and conditions: Treatment, discontinuation, concomitant changes, individual follow-up/exposure and event-time records after 8 weeks
Materials to obtain first: Treatment, discontinuation, concomitant changes, individual follow-up/exposure and event-time records after 8 weeks
Further research: Link time-varying exposure and treatment changes to mortality follow-up and compare them with the analysis effect of interest.
Remaining uncertainty: Exposure continuation, changes, discontinuation and individual duration after 8 weeks No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Distinguish the 8-week treatment assessment from mean 24-month follow-up; verify subsequent actual continuation, changes, discontinuation and exposure at event times.
Why this condition is needed: Needed to avoid treating the 8-week treatment assessment and long-term mortality follow-up as the same dosing duration.
Application exceptions: Mean follow-up is not identical exposure duration for every participant.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N07 · Are actual arm-specific placebo and then-conventional common treatment, including changes, verified?

Current findings: The comparator is placebo plus then-standard heart-failure treatment. The article records ACE inhibitors, digoxin, diuretics and nitrates in 2003, but lacks arm-specific doses, changes and rescue treatment.
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: Comparator strategy and then-used drug classes are recorded, but actual arm-specific implementation and changes remain unverified.
Reason for missing information: Placebo specifications, arm-specific prescriptions, changes and rescue treatment
Required materials and conditions: Placebo specifications and documents for arm-specific background-treatment doses, changes, rescue treatment and handling
Materials to obtain first: Placebo specifications and documents for arm-specific background-treatment doses, changes, rescue treatment and handling
Further research: Compare original prescribing/common-treatment documents by arm; examine attribution of add-on effects and concurrent changes.
Remaining uncertainty: Placebo specifications, arm-specific prescriptions, changes and rescue treatment No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify placebo plus then-standard treatment and actual arm-specific prescribing, changes and rescue use of ACE inhibitors, digoxin, diuretics and nitrates.
Why this condition is needed: Needed to avoid replacing the additional-berberine comparison with a difference in all then-conventional therapy or an effect under modern treatment.
Application exceptions: Do not require every change to be identical in both arms; verify the actual effect of interest and handling methods.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N08 · Are random-sequence generation, allocation concealment and baseline balance verified?

Current findings: A randomized placebo-controlled add-on trial is recorded, but details of allocation concealment 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 design label is recorded, but generation, concealment and balance material were not verified.
Reason for missing information: Randomization generation, concealment, implementation and baseline balance
Required materials and conditions: Original allocation methods, concealment procedures, implementation responsibilities and arm-specific baseline tables
Materials to obtain first: Original allocation methods, concealment procedures, implementation responsibilities and arm-specific baseline tables
Further research: Read actual allocation procedures and baseline tables; examine limitations relevant to the selected all-cause mortality result.
Remaining uncertainty: Randomization generation, concealment, implementation and baseline balance No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify actual sequence generation, concealment, allocation implementation and baseline balance.
Why this condition is needed: Needed to avoid claiming that an RCT label resolves allocation procedures and selection differences.
Application exceptions: Retain the randomized-trial description without inventing detailed procedures.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N09 · Is blinding of participants, clinicians, death adjudicators and analysts verified?

Current findings: The retained original design explicitly leaves blinding details unverified. Beyond placebo use, no blinding material for participants, clinicians, adjudicators or analysts is available.
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 placebo-control label alone does not verify actual role-specific blinding.
Reason for missing information: Role-specific blinding, maintenance and unblinding
Required materials and conditions: Blinding methods, role-specific maintenance/unblinding and death-adjudicator/analyst material
Materials to obtain first: Blinding methods, role-specific maintenance/unblinding and death-adjudicator/analyst material
Further research: Compare role-specific blinding procedures with original methods and outcome collection/adjudication.
Remaining uncertainty: Role-specific blinding, maintenance and unblinding No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify actual blinding, maintenance, unblinding and conditions affecting outcome collection for each role.
Why this condition is needed: Needed to distinguish placebo use from verified blinding of everyone involved.
Application exceptions: Even with relatively objective all-cause mortality, actual adjudication, follow-up and analysis conditions require separate verification. Unverified blinding is not automatic failure.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N10 · Are the all-cause mortality definition, ascertainment sources, adjudication and collection times verified?

Current findings: The endpoint is recorded as mean 24-month all-cause mortality. Actual ascertainment sources, adjudication procedures, event dates and arm-specific collection methods are absent from this input.
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 all-cause mortality label is recorded, but actual collection, adjudication and timing conditions remain unverified.
Reason for missing information: Death definitions, ascertainment sources, adjudication, collection methods and dates
Required materials and conditions: Death definitions, ascertainment sources, adjudicators, follow-up collection methods and event dates
Materials to obtain first: Death definitions, ascertainment sources, adjudicators, follow-up collection methods and event dates
Further research: Compare definitions and collection routes in death-adjudication/follow-up material between arms.
Remaining uncertainty: Death definitions, ascertainment sources, adjudication, collection methods and dates No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify the all-cause mortality label, actual death-ascertainment sources, adjudication criteria, arm-specific collection routes and dates.
Why this condition is needed: Needed to avoid interpreting death counts as automatically complete and identically ascertained events.
Application exceptions: The original endpoint is all-cause mortality. Do not replace it with cardiovascular, sudden or arrhythmic death.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N11 · Are the prespecified hierarchy and assessment timing for all-cause mortality verified?

Current findings: The original reader answer states that a prespecified mortality endpoint is unverified. The generic English endpoint wording does not provide prespecified hierarchy material.
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: No record establishes acquisition of pretrial endpoint-hierarchy or timing documents.
Reason for missing information: Prespecified mortality-endpoint hierarchy, timing and changes
Required materials and conditions: Dated registration/protocol endpoint hierarchies, assessment times and change histories
Materials to obtain first: Dated registration/protocol endpoint hierarchies, assessment times and change histories
Further research: Compare prospective documents with actual reporting chronologically to examine endpoint selection and changes.
Remaining uncertainty: Prespecified mortality-endpoint hierarchy, timing and changes No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify the primary/secondary hierarchy of mortality endpoints and planned follow-up times in documents preceding trial initiation.
Why this condition is needed: Needed to avoid automatically designating the current claim as the trial's prespecified primary endpoint.
Application exceptions: Neither the original principal-endpoint contract nor the current table's main endpoint proves trial prespecification.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N12 · Is the relationship of 156 participants and 79/77 to allocated, exposed, completed and analyzed denominators verified?

Current findings: Retained sample size is 156 participants, 79 versus 77. Deaths are listed as 7/79 versus 13/77, but detailed flow identifying each denominator as allocated, exposed, completed or analyzed is absent.
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: Reported participants and event denominators are available, but actual flow and analysis-population distinctions remain unverified.
Reason for missing information: Allocation, exposure, completion and analysis flow and exclusions
Required materials and conditions: Participant-flow diagrams, arm-specific allocation/exposure/completion/analysis counts and exclusion reasons
Materials to obtain first: Participant-flow diagrams, arm-specific allocation/exposure/completion/analysis counts and exclusion reasons
Further research: Link original flow diagrams to mortality-analysis tables and compare each denominator's definition separately.
Remaining uncertainty: Allocation, exposure, completion and analysis flow and exclusions No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify actual recruitment, allocation, exposure, completion and mortality-analysis flow and denominators in addition to reported 156 participants and 79/77.
Why this condition is needed: Needed to distinguish sample-size and death-count denominators from ITT populations or complete-follow-up denominators.
Application exceptions: Do not invent actual completed/analyzed counts from generic English wording about distinct denominators.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N13 · Are original death counts and the paper P value attributed to exact reporting locations?

Current findings: The retained mortality report is berberine 7/79, placebo 13/77 deaths and paper P<.02. HR, CI and risk reduction were not calculated from the event counts.
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: Original reported values are linked to source locations unchanged. A precise mortality effect has not been verified.
Reason for missing information: None (original-reported-value attribution scope)
Required materials and conditions: Original result wording, exact death-count/P-value locations and editions
Materials to obtain first: Original result wording, exact death-count/P-value locations and editions
Further research: When new material arrives, compare original result tables and time-to-event analysis while preserving them separately from the current original record.
Remaining uncertainty: None (original-reported-value attribution scope) No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Link 7/79 versus 13/77 and paper P<.02 to original evidence, citations and bilingual articles without adding newly calculated values.
Why this condition is needed: Needed to distinguish original-value preservation from new effect estimation and retain the favorable event direction.
Application exceptions: Met for this recording condition does not establish a risk ratio, HR, CI or analysis validity.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N14 · Are individual follow-up duration, censoring, study termination and complete death ascertainment verified?

Current findings: The article records mean 24-month follow-up and unverified completeness. Individual duration, censoring, risk sets and loss of contact were 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: Mean duration and aggregate event counts alone do not verify complete follow-up or censoring.
Reason for missing information: Follow-up distributions, censoring, risk sets and vital-status ascertainment
Required materials and conditions: Individual or arm-specific follow-up distributions, censoring/loss-of-contact/termination records and survival-curve risk sets
Materials to obtain first: Individual or arm-specific follow-up distributions, censoring/loss-of-contact/termination records and survival-curve risk sets
Further research: Examine survival-follow-up flow and risk sets to compare event ascertainment and censoring assumptions.
Remaining uncertainty: Follow-up distributions, censoring, risk sets and vital-status ascertainment No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify arm-specific follow-up distributions, reasons for censoring, termination, vital-status ascertainment and risk sets.
Why this condition is needed: Needed to avoid turning mean 24 months into complete, identical follow-up for every participant.
Application exceptions: Unverified completeness does not establish actual missed deaths or a particular magnitude of bias.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N15 · Are arm-specific dropout, exclusion and missingness counts and their handling in mortality analysis verified?

Current findings: 156 participants, 79/77 and death counts are available, but this input lacks dropout, analysis-exclusion and missingness counts and handling material.
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: Reported denominators do not prove absence or appropriate handling of missingness and dropout.
Reason for missing information: Dropout, exclusion and missingness reasons, handling and sensitivity analyses
Required materials and conditions: Dropout/exclusion/missingness tables, arm-specific reasons and documents for handling missing mortality status
Materials to obtain first: Dropout/exclusion/missingness tables, arm-specific reasons and documents for handling missing mortality status
Further research: Examine consistency among original flow diagrams, analysis populations, missing-data handling and mortality reporting.
Remaining uncertainty: Dropout, exclusion and missingness reasons, handling and sensitivity analyses No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify arm-specific missingness, dropout, analysis-exclusion reasons, missing vital-status handling and sensitivity material.
Why this condition is needed: Needed to avoid treating original denominators as complete analysis of all allocated participants.
Application exceptions: Do not fill unrecorded dropout counts with 0 or derive them backwards from event counts.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N16 · Are formal between-arm mortality effects, the effect of interest, model and 95% CI verified?

Current findings: The original result records HR and 95% CI as unreported. Formal between-arm mortality estimates and time-to-event analysis details remain unverified.
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: Original counts and P value are available, but material for comparing formal effects, intervals and models is absent.
Reason for missing information: Formal estimates, CI, model and effect of interest
Required materials and conditions: Formal between-arm estimates, 95% CI, estimation measure, model, effect of interest and analysis-population definitions
Materials to obtain first: Formal between-arm estimates, 95% CI, estimation measure, model, effect of interest and analysis-population definitions
Further research: Compare the original survival/mortality analysis effect of interest, model and interval, attributing them separately from aggregate events.
Remaining uncertainty: Formal estimates, CI, model and effect of interest No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify actual between-arm estimates, measure, model, analysis population and interval appropriate to the selected effect of interest.
Why this condition is needed: Needed to distinguish the direction of aggregate death counts from time-to-event effect magnitude and precision.
Application exceptions: Valid unadjusted between-arm estimates are possible. Do not require an adjusted model or HR as the only format for every analysis.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N17 · Are the test, contrast, time handling and multiplicity underlying paper P<.02 verified?

Current findings: Paper P<.02 is retained, but the original explanation states that it and crude event counts cannot be cross-verified without time-to-event analysis details.
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 P value itself is recorded, but its analysis, contrast and time-handling basis remain unverified.
Reason for missing information: Test, contrast, time handling, multiplicity and analysis population
Required materials and conditions: Original statistical methods/result tables, tests, contrasts, time handling and multiplicity plans
Materials to obtain first: Original statistical methods/result tables, tests, contrasts, time handling and multiplicity plans
Further research: Compare the original P value with the analysis description; do not equate it automatically with a different test on aggregate event counts.
Remaining uncertainty: Test, contrast, time handling, multiplicity and analysis population No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify the test, contrast of interest, time-to-event handling, multiplicity and analysis population corresponding to the reported P value.
Why this condition is needed: Needed to avoid recalculating or reattributing the original P value as a simple event-count test.
Application exceptions: Currently absent analysis details do not establish that the paper P value is wrong.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N18 · Is material available to judge mortality-effect magnitude, precision and clinical importance?

Current findings: The event direction for the hard endpoint is retained, but effect magnitude, 95% CI and complete follow-up remain unverified. Do not use the original C50 explanation as a new minimum-sample-size criterion.
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: Event counts and the paper P value alone do not establish effect magnitude, precision or clinical importance.
Reason for missing information: Valid effects, intervals, follow-up and importance rationale
Required materials and conditions: Effects, intervals, baseline risk, follow-up and rationale for interpreting importance
Materials to obtain first: Effects, intervals, baseline risk, follow-up and rationale for interpreting importance
Further research: Compare effect/interval interpretation appropriate to the endpoint and population with the original analysis without deriving a new grade.
Remaining uncertainty: Valid effects, intervals, follow-up and importance rationale No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify valid between-arm effects and intervals, actual follow-up, baseline risk and justified interpretation of importance.
Why this condition is needed: Needed to avoid declaring adequate precision from a hard endpoint, significance or a single sample-size figure alone.
Application exceptions: Do not adopt arbitrary minimum participants, trial counts, duration or effect size. The 200-participant wording in the original grade rationale is historical explanation.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N19 · Are assignment/adherence effects, ITT/PP populations and handling of treatment changes verified?

Current findings: The article records unverified analysis integrity. ITT/PP, assignment/adherence effects and long-term change-handling material 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: Original event denominators and a randomized label alone do not verify analysis populations or the effect of interest.
Reason for missing information: Analysis populations, effect of interest and handling of treatment changes
Required materials and conditions: ITT/PP or other analysis-population definitions, long-term adherence/change handling and actual implementation documents
Materials to obtain first: ITT/PP or other analysis-population definitions, long-term adherence/change handling and actual implementation documents
Further research: Compare assignment, actual use and change records with analysis plans and state the effect of interest.
Remaining uncertainty: Analysis populations, effect of interest and handling of treatment changes No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify analysis populations, effect of interest, deviation/change/death-handling rules and their actual application.
Why this condition is needed: Needed to distinguish the effect of add-on assignment from effects among actual long-term users.
Application exceptions: Do not invent ITT or PP labels when analysis names are absent.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N20 · Are the actual trial-registration/protocol identity, editions, dates and originals verified?

Current findings: The original registration field states not identified; Korean/English articles record unverified registration and protocol. No new registry lookup was performed.
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: No material establishes the trial's registration/protocol identity and originals.
Reason for missing information: Registration/protocol identity, dates, editions and originals
Required materials and conditions: Registration/protocol identifiers, dates, editions, originals or actual access records
Materials to obtain first: Registration/protocol identifiers, dates, editions, originals or actual access records
Further research: Compare trial identity for the report before establishing registration/protocol histories and actual provision scope.
Remaining uncertainty: Registration/protocol identity, dates, editions and originals No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify the trial's registration/protocol identifiers, initial/change dates, editions and originals.
Why this condition is needed: Needed to distinguish an unidentified NCT from confirmed nonregistration or results of a current registry search.
Application exceptions: Do not borrow registration numbers from other berberine trials. Failure to acquire full text does not prove nonexistence.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N21 · Is consistency between prospective analysis plans and actual endpoints, timing and reporting verified?

Current findings: Prespecified mortality endpoints, registration and protocol are unverified, so comparisons of the SAP with actual mortality analyses have not been possible.
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: Material comparing prospective plans, change histories and complete result tables is absent.
Reason for missing information: SAP, plan/report comparisons and reasons for changes
Required materials and conditions: Prospective SAP, analysis lists, change histories and complete actual result tables
Materials to obtain first: Prospective SAP, analysis lists, change histories and complete actual result tables
Further research: Compare prospective/post hoc documents' endpoint, timing and analysis lists; record the verified scope of selection and changes.
Remaining uncertainty: SAP, plan/report comparisons and reasons for changes No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Compare dated SAP/plans with actual mortality/functional outcomes, times, analyses and reasons for changes.
Why this condition is needed: Needed to avoid turning absent plans into confirmed selective reporting or retrospectively calling current mortality reports prospective analyses.
Application exceptions: Unverified protocol/SAP does not establish presence or absence of selective reporting.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N22 · Are report/trial-family identity and direct independent mortality replication verified?

Current findings: 1 evidence entry is linked to 1 Zeng 2003 citation. The original article states that independent confirmatory mortality trials were not identified; no new literature search occurred 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: A retained report link exists, but external family comparisons and other direct independent replications were not verified.
Reason for missing information: External family comparisons and direct independent replication
Required materials and conditions: Related reports/registration identities of the same trial and population, product and mortality-result material from direct replication trials
Materials to obtain first: Related reports/registration identities of the same trial and population, product and mortality-result material from direct replication trials
Further research: Link reports to trial families and mortality times/analyses; compare whether recruited populations are independent.
Remaining uncertainty: External family comparisons and direct independent replication No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify the Zeng 2003 evidence/citation link, related reports of the same trial and identity/independence of other direct mortality trials.
Why this condition is needed: Needed to distinguish a single citation and the original R1 from externally verified replication counts.
Application exceptions: Neither a new search not performed nor unverified replication in the original article establishes 0 replication trials worldwide.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N23 · Is the same adjunctive treatment's mortality effect directly verified under modern standard treatment?

Current findings: The article explains that then-used ACE inhibitors, digoxin, diuretics and nitrates differ from modern guideline-directed therapy. Direct mortality comparisons under modern background treatment are absent from this input.
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: Then-conventional background-treatment records do not verify additional mortality effects under modern treatment.
Reason for missing information: Direct comparisons under modern background therapy, equivalence and mortality estimates
Required materials and conditions: Direct comparative trials under modern treatment, arm-specific background treatment, products and mortality estimates
Materials to obtain first: Direct comparative trials under modern treatment, arm-specific background treatment, products and mortality estimates
Further research: When new direct material is available, compare background treatment, populations, times and effects of interest with the original trial.
Remaining uncertainty: Direct comparisons under modern background therapy, equivalence and mortality estimates No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify direct comparisons and treatment differences under modern background therapy for the same population, product, exposure and mortality endpoint.
Why this condition is needed: Needed to avoid directly transferring results under 2003 common treatment to current treatment backgrounds.
Application exceptions: No new lookup of modern drugs or guidelines occurs in this work. The original claim remains tied to the then-conventional trial.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N24 · Are other salts, extracts, combinations and derivatives distinguished from the actual trial product?

Current findings: The article restricts interchangeability of berberine hydrochloride, plant extracts, compound prescriptions, dihydroberberine, other derivatives and topical products.
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: Automatic extension to other products is distinguished. Actual trial-product specifications have not been verified.
Reason for missing information: None (product-extension boundary record)
Required materials and conditions: Original product-boundary wording and restrictions on transfer to other products
Materials to obtain first: Original product-boundary wording and restrictions on transfer to other products
Further research: When product material is added, examine salt, route, composition, exposure equivalence and direct comparisons separately.
Remaining uncertainty: None (product-extension boundary record) No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Do not automatically equate berberine hydrochloride, plant extracts, compound prescriptions, dihydroberberine, other derivatives or topical products with the original exposure.
Why this condition is needed: Needed to avoid applying mortality results to different products solely because they share an ingredient name.
Application exceptions: Met for product-boundary distinction does not verify the original product's salt/specifications. Actual product verification is asked separately in N04.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N25 · Is all-cause mortality distinguished from LVEF, arrhythmia, walking and cause-specific mortality?

Current findings: The original summary states that scope is limited to mean 24-month all-cause mortality and separates LVEF, arrhythmia and walking. No cause-specific death values are invented.
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: Boundaries between all-cause mortality and other endpoints are retained. Effects on separate endpoints have not been graded.
Reason for missing information: None (endpoint-boundary record)
Required materials and conditions: Original wording and locations distinguishing all-cause mortality from other endpoints
Materials to obtain first: Original wording and locations distinguishing all-cause mortality from other endpoints
Further research: If endpoint scope changes, examine definitions, denominators, timing and estimates under new independent boundaries.
Remaining uncertainty: None (endpoint-boundary record) No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Select only mean 24-month all-cause mortality; keep extended endpoints such as LVEF, arrhythmia, walking and cardiovascular death separate.
Why this condition is needed: Needed to avoid replacing the original all-cause mortality question with other symptoms, function or cause-specific deaths.
Application exceptions: Do not generate new independent tables for other results or combine their values with the mortality effect in this table.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N26 · Are direct dose comparisons, optimal dosing and persistence after stopping verified?

Current findings: Only the 1.2–2.0 g/day range, 8-week assessment and mean 24-month follow-up are recorded. Direct dose comparisons, optimal dosing and effects after stopping remain unverified.
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 range and follow-up duration do not replace direct dose/discontinuation comparisons.
Reason for missing information: Direct dose/discontinuation comparisons and separate estimates
Required materials and conditions: Prospective dose comparisons, dose-specific denominators/mortality estimates and post-discontinuation follow-up
Materials to obtain first: Prospective dose comparisons, dose-specific denominators/mortality estimates and post-discontinuation follow-up
Further research: Examine designs/analyses directly comparing doses and discontinuation separately from the original single add-on report.
Remaining uncertainty: Direct dose/discontinuation comparisons and separate estimates No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify direct dose comparisons, actual arm-specific exposure, mortality follow-up after stopping and separate estimates.
Why this condition is needed: Needed to distinguish a dose range and long-term follow-up from optimal dosing or effects persisting after stopping.
Application exceptions: Do not universally require optimal-dose or discontinuation studies for the narrow then-conventional add-on question.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N27 · Are funding, product provision, author employment, full COI and sponsor roles verified?

Current findings: Korean funding text states that funding, product provision and COI are unverified. The generic English assessed-separately wording and original I1 do not supply original material.
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: Actual declaration, support and sponsor-role material is absent.
Reason for missing information: Funding, products, employment, COI and sponsor roles
Required materials and conditions: Original funding, product provision, employment, COI declarations and sponsor-role documents
Materials to obtain first: Original funding, product provision, employment, COI declarations and sponsor-role documents
Further research: Compare individual author declarations, funding and product support separately from trial-family independence.
Remaining uncertainty: Funding, products, employment, COI and sponsor roles No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify original funding, product provision, author relationships, COI declarations and sponsor design/analysis/publication roles.
Why this condition is needed: Needed to distinguish the original I1 or generic English wording from evidence verifying independent funding or conflicts.
Application exceptions: Do not infer industry involvement without material or automatically exclude results.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N28 · Are identity, public availability and editions of external abstracts, papers and registration/plans actually verified?

Current findings: PMID 12860219, DOI and a PubMed URL are in the current bibliography. External access was not attempted in this work; paper editions, availability and registration/plan identities 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: Bibliographic identifiers and entry points exist, but actual external provision, editions and acquisition were not verified.
Reason for missing information: External editions, availability, acquisition and registration/plan identities
Required materials and conditions: External bibliography, abstracts, paper editions, registration/plan identities and actual access/acquisition records
Materials to obtain first: External bibliography, abstracts, paper editions, registration/plan identities and actual access/acquisition records
Further research: During authorized subsequent acquisition, record identity, availability, access and acquisition separately for each physical material type.
Remaining uncertainty: External editions, availability, acquisition and registration/plan identities No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify recorded PMID, DOI and PubMed entry points alongside actual editions, availability and acquisition of external originals.
Why this condition is needed: Needed to distinguish bibliographic entry points from acquisition or successful reading of full texts and registration originals.
Application exceptions: Do not label current access not attempted as failed access. Do not invent registration/plan URLs without established identity.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N29 · Are generic English wording and the 2026-09-14 correction history retained as original values?

Current findings: The 2026-09-14 correction records clarification of 1 generic English verification field. Generic wording remaining in English sample-size, funding, endpoint and result fields is retained and does not establish actual denominator, funding or estimate verification.
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: Current generic wording and correction scope are preserved accurately. The wording does not prove verification of clinical material.
Reason for missing information: None (original-text/correction preservation scope)
Required materials and conditions: Current bilingual evidence tables, citations, correction originals, dates and scope
Materials to obtain first: Current bilingual evidence tables, citations, correction originals, dates and scope
Further research: If subsequent editing is needed, preserve the whole previous article and distinguish clinical-value changes from translation/display events.
Remaining uncertainty: None (original-text/correction preservation scope) No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Link correction dates/scope and current generic English wording to original bytes and typed literals without using them as new verified facts.
Why this condition is needed: Needed to avoid promoting English placeholders to current specific clinical-material verification.
Application exceptions: The correction records replacement of 1 English field. Retain remaining generic wording historically without arbitrary translation/replacement.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N30 · Are actual adverse-event definitions, collection, severity and discontinuation verified for the same population/exposure?

Current findings: Original safety is Warning, with cautions about bradycardia, hypotension and interactions. Actual event definitions, systematic collection, severity and discontinuation result tables are absent from this input.
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: Cautions and a trial title do not provide actual adverse-event collection/results.
Reason for missing information: Event definitions, collection, severity and discontinuation results
Required materials and conditions: Original adverse-event definitions, collection, timing, severity, discontinuation and causality assessment material
Materials to obtain first: Original adverse-event definitions, collection, timing, severity, discontinuation and causality assessment material
Further research: Compare harm collection/adjudication material for the same exposure separately from efficacy reporting.
Remaining uncertainty: Event definitions, collection, severity and discontinuation results No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify actual adverse-event definitions, collection methods/times, severity, discontinuation and causality assessment material.
Why this condition is needed: Needed to distinguish original warnings or safety in a title from actual safety results.
Application exceptions: Efficacy and harms have separate states. Do not remove mortality reporting because harm material remains unverified.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N31 · Are harm counts, exposed denominators, observation periods and missingness verified?

Current findings: Beyond mortality counts of 7/79 versus 13/77, participants/events, exposed denominators, periods and missingness for nonfatal harms have not been verified.
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: Mortality denominators do not verify separate adverse-event frequency or complete collection.
Reason for missing information: Harm-specific denominators, events, periods and missingness
Required materials and conditions: Harm-specific event counts, exposed denominators, periods, missingness and collection systems
Materials to obtain first: Harm-specific event counts, exposed denominators, periods, missingness and collection systems
Further research: Link harm collection tables to exposure/follow-up flow; distinguish spontaneous records from systematic counts.
Remaining uncertainty: Harm-specific denominators, events, periods and missingness No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify exposed persons, persons/events, follow-up periods, missingness and collection systems for each harm.
Why this condition is needed: Needed to avoid transferring 156 participants and death counts to nonfatal-adverse-event denominators or incidence.
Application exceptions: Do not fill absent event counts with 0 or derive harm incidence from warnings.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N32 · Is direct harm material verified for bradycardia, hypotension, interactions and electrolyte, renal and liver status?

Current findings: The article warns that bradycardia, hypotension, drug interactions and electrolyte, renal and liver status require separate checks. Direct harm material, denominators and comparisons 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: A caution list does not establish actual events, magnitude or causality.
Reason for missing information: Harms, denominators and comparisons by concomitant drugs and baseline status
Required materials and conditions: Original exposure, event, comparison and follow-up material by concomitant drugs and baseline function
Materials to obtain first: Original exposure, event, comparison and follow-up material by concomitant drugs and baseline function
Further research: Examine prospectively defined concomitant-drug/baseline-function harm collection or comparisons, distinguishing other causes.
Remaining uncertainty: Harms, denominators and comparisons by concomitant drugs and baseline status No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify concomitant drugs, baseline status, events, follow-up and comparative material under the same actual exposure.
Why this condition is needed: Needed to distinguish original cautions from verified risks or interaction magnitudes.
Application exceptions: Retain original warnings without newly confirming particular drug interactions or vulnerable-population risks.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N33 · Are original advertising/safety boundaries distinguished from new survival treatment, drug replacement or personal dosing instructions?

Current findings: The original advertising limits prohibit claims of survival treatment, antiarrhythmic replacement or halved mortality risk, retaining a high-dose warning. This table adds no dosing instructions.
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: Extension boundaries for original advertising restrictions and warnings are preserved. New efficacy, safety or personal treatment is not certified.
Reason for missing information: None (original interpretation-boundary record)
Required materials and conditions: Original advertising restrictions, safety warnings and locations
Materials to obtain first: Original advertising restrictions, safety warnings and locations
Further research: If clinical application scope changes, examine direct material, safety and comparator treatment separately before updating presentation.
Remaining uncertainty: None (original interpretation-boundary record) No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Do not extend results to established survival treatment, antiarrhythmic replacement or halved mortality risk; link original warnings to historical text.
Why this condition is needed: Needed to prevent advertising favorable death counts as established survival treatment or halved risk.
Application exceptions: This table does not direct individual treatment, dosing or discontinuation. Do not reduce original warnings.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N34 · Are actual historical search, preservation, verification scope and evidence-date specifications verified?

Current findings: The global original review date is 2026-09-08. The article describes abstract/bibliography and retraction/concern/correction checks, but search strategies, dates, scope records and a native evidence cut-off are absent.
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: Original review date and check descriptions exist, but material needed to complete actual search/preservation/verification specifications is absent.
Reason for missing information: Search dates, databases, strategies and actual scope
Required materials and conditions: Dates, databases, strategies, scope and retained documents for historical search/review records
Materials to obtain first: Dates, databases, strategies, scope and retained documents for historical search/review records
Further research: Compare actual historical search records by date, identifier and material type separately from current actions.
Remaining uncertainty: Search dates, databases, strategies and actual scope No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify actual search dates, databases, strategies and preservation-scope documents in addition to the global original review date and search description.
Why this condition is needed: Needed to distinguish the original review date from a current comprehensive literature search or report-specific access dates.
Application exceptions: Do not infer absent evidence cut-offs, search databases or search strategies.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N35 · Are actual documents, dates and scope of bibliographic-edition and retraction/concern/correction checks verified?

Current findings: Zeng 2003 PMID, DOI and bibliography exist. The original research section records retraction/concern/correction checks, but actual documents, access dates and detailed results are absent.
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: Bibliographic identity and historical descriptions are recorded, but actual evidence of publication-status checks remains unverified.
Reason for missing information: Publication-status documents, dates, editions and original locations
Required materials and conditions: Bibliographic editions and actual publication-status-check documents, dates, original locations and scope
Materials to obtain first: Bibliographic editions and actual publication-status-check documents, dates, original locations and scope
Further research: When authorized new material arrives, compare publication status and edition links by PMID/DOI separately from internal correction history.
Remaining uncertainty: Publication-status documents, dates, editions and original locations No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Verify PMID, DOI, bibliographic editions and actual publication-status-check documents, original locations, dates and scope.
Why this condition is needed: Needed to avoid reusing historical check descriptions as new verification of current publication status.
Application exceptions: Bibliography, internal English corrections and publisher correction/retraction documents are different materials. No current external lookup occurs.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N36 · Are original C50, axes, empty values and absent fields retained without inheritance into new condition states?

Current findings: Original grade C, score 50, axes B/H/R1/I1/EX/B2/CX and empty subclaim/review-note lists are preserved. Absent structures such as source lists, trial families and evidence cut-offs are not generated as new clinical facts.
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: Original values are preserved without automatic inheritance into condition states, effects or grades.
Reason for missing information: None (original-value/absence preservation scope)
Required materials and conditions: Complete original bytes, SHA, grade, axes, corrections, empty values and absent fields
Materials to obtain first: Complete original bytes, SHA, grade, axes, corrections, empty values and absent fields
Further research: If correction is needed, preserve the whole previous article and grading event; handle it under separate authorization/versioning from the current conversion.
Remaining uncertainty: None (original-value/absence preservation scope) No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Preserve the complete original material and C50, safety, axes, empty subclaim/review-note lists and absent structures as typed original values without calculating new scores.
Why this condition is needed: Needed to avoid presenting the current conversion as reevaluation of the original grade or a new condition score.
Application exceptions: Original axes such as H, R1 and I1 are historical values; they do not replace actual independence or precision verification.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N37 · Are current local-summary reading, external access not attempted, historical descriptions and unverified access dates separated?

Current findings: The complete retained material and designated locations were read. External PubMed, abstracts, papers and registration/plans were not accessed or read in this work. Original review dates and abstract/bibliography-check descriptions are historical records; report-specific access-date/level fields are absent.
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: Current actual reading is separated from external unread status and historical records. External original contents were not verified in this work.
Reason for missing information: None (current-action/historical-date separation record)
Required materials and conditions: Material-specific actual reading, acquisition and access events; distinction among historical descriptions, original review dates and individual access dates
Materials to obtain first: Material-specific actual reading, acquisition and access events; distinction among historical descriptions, original review dates and individual access dates
Further research: During authorized subsequent reading, append only that material type's actions, dates and locations as separate events.
Remaining uncertainty: None (current-action/historical-date separation record) No new effect, interval, denominator, incidence or grade calculations/reassessment.
Conditions for verification: Record only current local-summary reading as true; retain external access not attempted/not acquired/not read and absent actual access dates/levels as unrecorded values.
Why this condition is needed: Needed to avoid turning summary-reader links into external full-text-reading badges.
Application exceptions: Do not copy original review/correction dates into access dates. Do not inherit one included document's access level into another physical material.
Referenced methods: Existing method principles distinguish population, product, add-on treatment, comparator, all-cause mortality, timing, analysis, follow-up, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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