# Oral berberine added to conventional heart-failure therapy × Reduction of all-cause mortality in chronic congestive heart failure Verdict 3074 · Evidence Check Stored-material review date: 2026-10-05 Original evidence review date: 2026-09-08 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-27 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 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. ## Checklist items ### N01 · Are the independent claim and inclusion/exclusion boundaries linked to the original article? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original claim 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. - 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. - 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. - Remaining uncertainty: None (independent-claim record scope) No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Severity, population proportions, eligibility and baseline tables No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: Subgroup plans, denominators, interactions and mortality estimates No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The exposure is oral adjunctive berberine; the original article leaves the exact salt form, plant source, product and formulation unverified. - 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. - 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. - Remaining uncertainty: Salt, formulation, product, batch and quality No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N05 · Are actual dose, frequency, titration and adherence for 1.2–2.0 g/day verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: Actual individual dose, frequency, titration and adherence No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N06 · Are actual exposure, changes and discontinuation during mean 24-month follow-up after the 8-week assessment verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Exposure continuation, changes, discontinuation and individual duration after 8 weeks No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N07 · Are actual arm-specific placebo and then-conventional common treatment, including changes, verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The comparator is 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. - 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. - 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. - Remaining uncertainty: Placebo specifications, arm-specific prescriptions, changes and rescue treatment No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N08 · Are random-sequence generation, allocation concealment and baseline balance verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: A randomized placebo-controlled add-on trial is recorded, but details of allocation concealment remain unverified. - 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. - 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. - Remaining uncertainty: Randomization generation, concealment, implementation and baseline balance No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N09 · Is blinding of participants, clinicians, death adjudicators and analysts verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The retained original design explicitly leaves blinding details unverified. Beyond placebo use, no blinding material for participants, clinicians, adjudicators or analysts is available. - 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. - 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. - Remaining uncertainty: Role-specific blinding, maintenance and unblinding No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N10 · Are the all-cause mortality definition, ascertainment sources, adjudication and collection times verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Death definitions, ascertainment sources, adjudication, collection methods and dates No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N11 · Are the prespecified hierarchy and assessment timing for all-cause mortality verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original reader answer states that a prespecified mortality endpoint is unverified. The generic English endpoint wording does not provide prespecified hierarchy material. - 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. - 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. - Remaining uncertainty: Prespecified mortality-endpoint hierarchy, timing and changes No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N12 · Is the relationship of 156 participants and 79/77 to allocated, exposed, completed and analyzed denominators verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: Retained 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. - 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. - 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. - Remaining uncertainty: Allocation, exposure, completion and analysis flow and exclusions No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N13 · Are original death counts and the paper P value attributed to exact reporting locations? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: None (original-reported-value attribution scope) No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N14 · Are individual follow-up duration, censoring, study termination and complete death ascertainment verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The article records mean 24-month follow-up and unverified completeness. Individual duration, censoring, risk sets and loss of contact were not retained. - 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. - 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. - Remaining uncertainty: Follow-up distributions, censoring, risk sets and vital-status ascertainment No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N15 · Are arm-specific dropout, exclusion and missingness counts and their handling in mortality analysis verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 156 participants, 79/77 and death counts are available, but this input lacks dropout, analysis-exclusion and missingness counts and handling material. - 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. - 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. - Remaining uncertainty: Dropout, exclusion and missingness reasons, handling and sensitivity analyses No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N16 · Are formal between-arm mortality effects, the effect of interest, model and 95% CI verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original result records HR and 95% CI as unreported. Formal between-arm mortality estimates and time-to-event analysis details remain unverified. - 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. - 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. - Remaining uncertainty: Formal estimates, CI, model and effect of interest No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N17 · Are the test, contrast, time handling and multiplicity underlying paper P<.02 verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: Test, contrast, time handling, multiplicity and analysis population No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N18 · Is material available to judge mortality-effect magnitude, precision and clinical importance? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Valid effects, intervals, follow-up and importance rationale No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N19 · Are assignment/adherence effects, ITT/PP populations and handling of treatment changes verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The article records unverified analysis integrity. ITT/PP, assignment/adherence effects and long-term change-handling material are absent. - 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. - 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. - Remaining uncertainty: Analysis populations, effect of interest and handling of treatment changes No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N20 · Are the actual trial-registration/protocol identity, editions, dates and originals verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original registration field states not identified; Korean/English articles record unverified registration and protocol. No new registry lookup was performed. - 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. - 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. - Remaining uncertainty: Registration/protocol identity, dates, editions and originals No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N21 · Is consistency between prospective analysis plans and actual endpoints, timing and reporting verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: Prespecified mortality endpoints, registration and protocol are unverified, so comparisons of the SAP with actual mortality analyses have not been possible. - 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. - 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. - Remaining uncertainty: SAP, plan/report comparisons and reasons for changes No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N22 · Are report/trial-family identity and direct independent mortality replication verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: External family comparisons and direct independent replication No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N23 · Is the same adjunctive treatment's mortality effect directly verified under modern standard treatment? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The article 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. - 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. - 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. - Remaining uncertainty: Direct comparisons under modern background therapy, equivalence and mortality estimates No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N24 · Are other salts, extracts, combinations and derivatives distinguished from the actual trial product? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The article restricts interchangeability of berberine hydrochloride, plant extracts, compound prescriptions, dihydroberberine, other derivatives and topical products. - 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. - 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. - Remaining uncertainty: None (product-extension boundary record) No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N25 · Is all-cause mortality distinguished from LVEF, arrhythmia, walking and cause-specific mortality? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original 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. - 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. - 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. - Remaining uncertainty: None (endpoint-boundary record) No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N26 · Are direct dose comparisons, optimal dosing and persistence after stopping verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: Direct dose/discontinuation comparisons and separate estimates No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N27 · Are funding, product provision, author employment, full COI and sponsor roles verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: Funding, products, employment, COI and sponsor roles No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N28 · Are identity, public availability and editions of external abstracts, papers and registration/plans actually verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: External editions, availability, acquisition and registration/plan identities No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N29 · Are generic English wording and the 2026-09-14 correction history retained as original values? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: None (original-text/correction preservation scope) No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N30 · Are actual adverse-event definitions, collection, severity and discontinuation verified for the same population/exposure? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: Event definitions, collection, severity and discontinuation results No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N31 · Are harm counts, exposed denominators, observation periods and missingness verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: Beyond mortality counts of 7/79 versus 13/77, participants/events, exposed denominators, periods and missingness for nonfatal harms have not been verified. - 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. - 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. - Remaining uncertainty: Harm-specific denominators, events, periods and missingness No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N32 · Is direct harm material verified for bradycardia, hypotension, interactions and electrolyte, renal and liver status? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The article warns that bradycardia, hypotension, drug interactions and electrolyte, renal and liver status require separate checks. Direct harm material, denominators and comparisons are absent. - 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. - 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. - Remaining uncertainty: Harms, denominators and comparisons by concomitant drugs and baseline status No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N33 · Are original advertising/safety boundaries distinguished from new survival treatment, drug replacement or personal dosing instructions? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original advertising limits prohibit claims of survival treatment, antiarrhythmic replacement or halved mortality risk, retaining a high-dose warning. This table adds no dosing instructions. - 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. - 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. - Remaining uncertainty: None (original interpretation-boundary record) No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N34 · Are actual historical search, preservation, verification scope and evidence-date specifications verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Search dates, databases, strategies and actual scope No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N35 · Are actual documents, dates and scope of bibliographic-edition and retraction/concern/correction checks verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: Publication-status documents, dates, editions and original locations No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N36 · Are original C50, axes, empty values and absent fields retained without inheritance into new condition states? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: Original 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. - 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. - 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. - Remaining uncertainty: None (original-value/absence preservation scope) No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ### N37 · Are current local-summary reading, external access not attempted, historical descriptions and unverified access dates separated? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The complete 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. - 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. - 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. - Remaining uncertainty: None (current-action/historical-date separation record) No new effect, interval, denominator, incidence or grade calculations/reassessment. - 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 ## Evidence and sources ### S01 Zeng 2003 adjunctive-treatment and all-cause mortality report in chronic heart failure [PubMed](https://pubmed.ncbi.nlm.nih.gov/12860219/) Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. Findings recorded in the summary: 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. 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Link studies and reports separately; do not omit studies solely because results are unreported. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. ## What the statuses mean - Met: The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety. - Partly verified: Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing. - Unverified: The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access. - Not 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/materials 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.