{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3074-main", "verdict_number": "3074", "title": "Oral berberine added to conventional heart-failure therapy × Reduction of all-cause mortality in chronic congestive heart failure", "view_version": "1.0", "view_created_date": "2026-10-27", "criteria_version": "1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, "claim_context": { "population": "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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Are the independent claim and inclusion/exclusion boundaries linked to the original article?", "needed": "Canonical locations for the original claim, population, add-on treatment, comparator, mortality endpoint, timing and exclusions", "role": "Required", "role_reason": "Needed to keep mean 24-month all-cause mortality separate from 8-week functional assessment and other heart-failure outcomes.", "application_exception": "Korean and English concern the same claim. Do not invent and count separate claims from an empty subclaim list.", "criterion": "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.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If article boundaries change, preserve the whole previous article and compare intervention, comparator, endpoint and timing again.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original claim 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.", "condition_status": "Met", "status_reason": "The original claim is linked to the table boundaries. Met does not establish the size or certainty of the all-cause mortality effect.", "missingness": "None (independent-claim record scope)", "uncertainty": "None (independent-claim record scope) No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Canonical locations for the original claim, population, add-on treatment, comparator, mortality endpoint, timing and exclusions" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are actual diagnosis, severity, eligibility and baseline characteristics verified?", "needed": "Eligibility tables, heart-failure severity, baseline function, etiologic composition and arm-specific baseline tables", "role": "Required", "role_reason": "Needed to distinguish all heart-failure patients from the selected population with ventricular arrhythmia and dilated cardiomyopathy.", "application_exception": "Retain the mixed ischemic/idiopathic population. Do not infer its proportions or subgroup effects.", "criterion": "Verify actual inclusion/exclusion criteria, severity and arm-specific baseline characteristics in addition to the recorded diagnosis and ventricular arrhythmia.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare original recruitment criteria and baseline tables; examine representativeness of the selected population and balance between arms.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "Diagnosis and parts of the selected population are recorded, but actual eligibility and arm-specific baseline characteristics remain unverified.", "missingness": "Severity, population proportions, eligibility and baseline tables", "uncertainty": "Severity, population proportions, eligibility and baseline tables No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility tables, heart-failure severity, baseline function, etiologic composition and arm-specific baseline tables" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are mortality effects separately verified for ischemic/idiopathic etiologies and ventricular-arrhythmia subgroups?", "needed": "Denominators by etiology/arrhythmia type, prespecified subgroup plans, effects and interaction material", "role": "Supplementary; required for subgroup extensions", "role_reason": "Needed to prevent extending the main effect in a mixed population to specific etiologic or arrhythmia subgroups.", "application_exception": "Do not require every subgroup effect when examining the narrowly defined overall-population claim.", "criterion": "Verify prespecified definitions by etiology/arrhythmia type, actual denominators, interactions or separate comparative estimates.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine prespecified subgroups and interaction analyses separately from the overall population result.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Population labels do not verify subgroup mortality effects.", "missingness": "Subgroup plans, denominators, interactions and mortality estimates", "uncertainty": "Subgroup plans, denominators, interactions and mortality estimates No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Denominators by etiology/arrhythmia type, prespecified subgroup plans, effects and interaction material" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are the actual berberine salt, formulation, product and manufacturing specifications verified?", "needed": "Original product name, salt/formulation/content specifications and manufacturing, batch and quality documents", "role": "Required", "role_reason": "Needed to prevent automatically substituting berberine hydrochloride, plant extracts or other derivatives for the actual trial product.", "application_exception": "Do not fill unverified salt, plant-source or product information from a title or generic ingredient name.", "criterion": "Verify the actual administered product's salt form, formulation, purity, manufacturing batch and quality material.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Cross-compare original methods and product documents; examine identity with other salts, extracts and combinations separately.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The exposure is oral adjunctive berberine; the original article leaves the exact salt form, plant source, product and formulation unverified.", "condition_status": "Unverified", "status_reason": "Ingredient name and dose range alone do not establish actual product specifications.", "missingness": "Salt, formulation, product, batch and quality", "uncertainty": "Salt, formulation, product, batch and quality No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product name, salt/formulation/content specifications and manufacturing, batch and quality documents" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are actual dose, frequency, titration and adherence for 1.2–2.0 g/day verified?", "needed": "Dosing schedules, dose-selection/titration records, exposure definitions, adherence and discontinuation records", "role": "Required", "role_reason": "Needed to avoid turning a nominal dose range into actual individual exposure or an optimal dose.", "application_exception": "Do not choose an arbitrary representative dose or convert salt mass into active-ingredient mass.", "criterion": "Verify oral route, reported daily dose, actual frequency, dose selection/titration and arm-specific adherence.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare actual prescribing/use records with the original protocol; examine handling of adherence for the effect of interest.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Route and reported dose range are available, but actual administration and adherence material are absent.", "missingness": "Actual individual dose, frequency, titration and adherence", "uncertainty": "Actual individual dose, frequency, titration and adherence No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dosing schedules, dose-selection/titration records, exposure definitions, adherence and discontinuation records" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are actual exposure, changes and discontinuation during mean 24-month follow-up after the 8-week assessment verified?", "needed": "Treatment, discontinuation, concomitant changes, individual follow-up/exposure and event-time records after 8 weeks", "role": "Required", "role_reason": "Needed to avoid treating the 8-week treatment assessment and long-term mortality follow-up as the same dosing duration.", "application_exception": "Mean follow-up is not identical exposure duration for every participant.", "criterion": "Distinguish the 8-week treatment assessment from mean 24-month follow-up; verify subsequent actual continuation, changes, discontinuation and exposure at event times.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link time-varying exposure and treatment changes to mortality follow-up and compare them with the analysis effect of interest.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original 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.", "condition_status": "Partly verified", "status_reason": "The two time labels are recorded, but actual long-term exposure information is absent.", "missingness": "Exposure continuation, changes, discontinuation and individual duration after 8 weeks", "uncertainty": "Exposure continuation, changes, discontinuation and individual duration after 8 weeks No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Treatment, discontinuation, concomitant changes, individual follow-up/exposure and event-time records after 8 weeks" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are actual arm-specific placebo and then-conventional common treatment, including changes, verified?", "needed": "Placebo specifications and documents for arm-specific background-treatment doses, changes, rescue treatment and handling", "role": "Required", "role_reason": "Needed to avoid replacing the additional-berberine comparison with a difference in all then-conventional therapy or an effect under modern treatment.", "application_exception": "Do not require every change to be identical in both arms; verify the actual effect of interest and handling methods.", "criterion": "Verify placebo plus then-standard treatment and actual arm-specific prescribing, changes and rescue use of ACE inhibitors, digoxin, diuretics and nitrates.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare original prescribing/common-treatment documents by arm; examine attribution of add-on effects and concurrent changes.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The comparator is 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.", "condition_status": "Partly verified", "status_reason": "Comparator strategy and then-used drug classes are recorded, but actual arm-specific implementation and changes remain unverified.", "missingness": "Placebo specifications, arm-specific prescriptions, changes and rescue treatment", "uncertainty": "Placebo specifications, arm-specific prescriptions, changes and rescue treatment No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo specifications and documents for arm-specific background-treatment doses, changes, rescue treatment and handling" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are random-sequence generation, allocation concealment and baseline balance verified?", "needed": "Original allocation methods, concealment procedures, implementation responsibilities and arm-specific baseline tables", "role": "Required", "role_reason": "Needed to avoid claiming that an RCT label resolves allocation procedures and selection differences.", "application_exception": "Retain the randomized-trial description without inventing detailed procedures.", "criterion": "Verify actual sequence generation, concealment, allocation implementation and baseline balance.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Read actual allocation procedures and baseline tables; examine limitations relevant to the selected all-cause mortality result.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "A randomized placebo-controlled add-on trial is recorded, but details of allocation concealment remain unverified.", "condition_status": "Partly verified", "status_reason": "The design label is recorded, but generation, concealment and balance material were not verified.", "missingness": "Randomization generation, concealment, implementation and baseline balance", "uncertainty": "Randomization generation, concealment, implementation and baseline balance No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original allocation methods, concealment procedures, implementation responsibilities and arm-specific baseline tables" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Is blinding of participants, clinicians, death adjudicators and analysts verified?", "needed": "Blinding methods, role-specific maintenance/unblinding and death-adjudicator/analyst material", "role": "Required", "role_reason": "Needed to distinguish placebo use from verified blinding of everyone involved.", "application_exception": "Even with relatively objective all-cause mortality, actual adjudication, follow-up and analysis conditions require separate verification. Unverified blinding is not automatic failure.", "criterion": "Verify actual blinding, maintenance, unblinding and conditions affecting outcome collection for each role.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare role-specific blinding procedures with original methods and outcome collection/adjudication.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained original design explicitly leaves blinding details unverified. Beyond placebo use, no blinding material for participants, clinicians, adjudicators or analysts is available.", "condition_status": "Unverified", "status_reason": "A placebo-control label alone does not verify actual role-specific blinding.", "missingness": "Role-specific blinding, maintenance and unblinding", "uncertainty": "Role-specific blinding, maintenance and unblinding No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Blinding methods, role-specific maintenance/unblinding and death-adjudicator/analyst material" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are the all-cause mortality definition, ascertainment sources, adjudication and collection times verified?", "needed": "Death definitions, ascertainment sources, adjudicators, follow-up collection methods and event dates", "role": "Required", "role_reason": "Needed to avoid interpreting death counts as automatically complete and identically ascertained events.", "application_exception": "The original endpoint is all-cause mortality. Do not replace it with cardiovascular, sudden or arrhythmic death.", "criterion": "Verify the all-cause mortality label, actual death-ascertainment sources, adjudication criteria, arm-specific collection routes and dates.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare definitions and collection routes in death-adjudication/follow-up material between arms.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "The all-cause mortality label is recorded, but actual collection, adjudication and timing conditions remain unverified.", "missingness": "Death definitions, ascertainment sources, adjudication, collection methods and dates", "uncertainty": "Death definitions, ascertainment sources, adjudication, collection methods and dates No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Death definitions, ascertainment sources, adjudicators, follow-up collection methods and event dates" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are the prespecified hierarchy and assessment timing for all-cause mortality verified?", "needed": "Dated registration/protocol endpoint hierarchies, assessment times and change histories", "role": "Required", "role_reason": "Needed to avoid automatically designating the current claim as the trial's prespecified primary endpoint.", "application_exception": "Neither the original principal-endpoint contract nor the current table's main endpoint proves trial prespecification.", "criterion": "Verify the primary/secondary hierarchy of mortality endpoints and planned follow-up times in documents preceding trial initiation.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare prospective documents with actual reporting chronologically to examine endpoint selection and changes.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original reader answer states that a prespecified mortality endpoint is unverified. The generic English endpoint wording does not provide prespecified hierarchy material.", "condition_status": "Unverified", "status_reason": "No record establishes acquisition of pretrial endpoint-hierarchy or timing documents.", "missingness": "Prespecified mortality-endpoint hierarchy, timing and changes", "uncertainty": "Prespecified mortality-endpoint hierarchy, timing and changes No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dated registration/protocol endpoint hierarchies, assessment times and change histories" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Is the relationship of 156 participants and 79/77 to allocated, exposed, completed and analyzed denominators verified?", "needed": "Participant-flow diagrams, arm-specific allocation/exposure/completion/analysis counts and exclusion reasons", "role": "Required", "role_reason": "Needed to distinguish sample-size and death-count denominators from ITT populations or complete-follow-up denominators.", "application_exception": "Do not invent actual completed/analyzed counts from generic English wording about distinct denominators.", "criterion": "Verify actual recruitment, allocation, exposure, completion and mortality-analysis flow and denominators in addition to reported 156 participants and 79/77.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link original flow diagrams to mortality-analysis tables and compare each denominator's definition separately.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Retained 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.", "condition_status": "Partly verified", "status_reason": "Reported participants and event denominators are available, but actual flow and analysis-population distinctions remain unverified.", "missingness": "Allocation, exposure, completion and analysis flow and exclusions", "uncertainty": "Allocation, exposure, completion and analysis flow and exclusions No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant-flow diagrams, arm-specific allocation/exposure/completion/analysis counts and exclusion reasons" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are original death counts and the paper P value attributed to exact reporting locations?", "needed": "Original result wording, exact death-count/P-value locations and editions", "role": "Required", "role_reason": "Needed to distinguish original-value preservation from new effect estimation and retain the favorable event direction.", "application_exception": "Met for this recording condition does not establish a risk ratio, HR, CI or analysis validity.", "criterion": "Link 7/79 versus 13/77 and paper P<.02 to original evidence, citations and bilingual articles without adding newly calculated values.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When new material arrives, compare original result tables and time-to-event analysis while preserving them separately from the current original record.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained 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.", "condition_status": "Met", "status_reason": "Original reported values are linked to source locations unchanged. A precise mortality effect has not been verified.", "missingness": "None (original-reported-value attribution scope)", "uncertainty": "None (original-reported-value attribution scope) No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original result wording, exact death-count/P-value locations and editions" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are individual follow-up duration, censoring, study termination and complete death ascertainment verified?", "needed": "Individual or arm-specific follow-up distributions, censoring/loss-of-contact/termination records and survival-curve risk sets", "role": "Required", "role_reason": "Needed to avoid turning mean 24 months into complete, identical follow-up for every participant.", "application_exception": "Unverified completeness does not establish actual missed deaths or a particular magnitude of bias.", "criterion": "Verify arm-specific follow-up distributions, reasons for censoring, termination, vital-status ascertainment and risk sets.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine survival-follow-up flow and risk sets to compare event ascertainment and censoring assumptions.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The article records mean 24-month follow-up and unverified completeness. Individual duration, censoring, risk sets and loss of contact were not retained.", "condition_status": "Unverified", "status_reason": "Mean duration and aggregate event counts alone do not verify complete follow-up or censoring.", "missingness": "Follow-up distributions, censoring, risk sets and vital-status ascertainment", "uncertainty": "Follow-up distributions, censoring, risk sets and vital-status ascertainment No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual or arm-specific follow-up distributions, censoring/loss-of-contact/termination records and survival-curve risk sets" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are arm-specific dropout, exclusion and missingness counts and their handling in mortality analysis verified?", "needed": "Dropout/exclusion/missingness tables, arm-specific reasons and documents for handling missing mortality status", "role": "Required", "role_reason": "Needed to avoid treating original denominators as complete analysis of all allocated participants.", "application_exception": "Do not fill unrecorded dropout counts with 0 or derive them backwards from event counts.", "criterion": "Verify arm-specific missingness, dropout, analysis-exclusion reasons, missing vital-status handling and sensitivity material.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine consistency among original flow diagrams, analysis populations, missing-data handling and mortality reporting.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "156 participants, 79/77 and death counts are available, but this input lacks dropout, analysis-exclusion and missingness counts and handling material.", "condition_status": "Unverified", "status_reason": "Reported denominators do not prove absence or appropriate handling of missingness and dropout.", "missingness": "Dropout, exclusion and missingness reasons, handling and sensitivity analyses", "uncertainty": "Dropout, exclusion and missingness reasons, handling and sensitivity analyses No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dropout/exclusion/missingness tables, arm-specific reasons and documents for handling missing mortality status" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are formal between-arm mortality effects, the effect of interest, model and 95% CI verified?", "needed": "Formal between-arm estimates, 95% CI, estimation measure, model, effect of interest and analysis-population definitions", "role": "Required", "role_reason": "Needed to distinguish the direction of aggregate death counts from time-to-event effect magnitude and precision.", "application_exception": "Valid unadjusted between-arm estimates are possible. Do not require an adjusted model or HR as the only format for every analysis.", "criterion": "Verify actual between-arm estimates, measure, model, analysis population and interval appropriate to the selected effect of interest.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare the original survival/mortality analysis effect of interest, model and interval, attributing them separately from aggregate events.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original result records HR and 95% CI as unreported. Formal between-arm mortality estimates and time-to-event analysis details remain unverified.", "condition_status": "Unverified", "status_reason": "Original counts and P value are available, but material for comparing formal effects, intervals and models is absent.", "missingness": "Formal estimates, CI, model and effect of interest", "uncertainty": "Formal estimates, CI, model and effect of interest No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Formal between-arm estimates, 95% CI, estimation measure, model, effect of interest and analysis-population definitions" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are the test, contrast, time handling and multiplicity underlying paper P<.02 verified?", "needed": "Original statistical methods/result tables, tests, contrasts, time handling and multiplicity plans", "role": "Required", "role_reason": "Needed to avoid recalculating or reattributing the original P value as a simple event-count test.", "application_exception": "Currently absent analysis details do not establish that the paper P value is wrong.", "criterion": "Verify the test, contrast of interest, time-to-event handling, multiplicity and analysis population corresponding to the reported P value.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare the original P value with the analysis description; do not equate it automatically with a different test on aggregate event counts.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The P value itself is recorded, but its analysis, contrast and time-handling basis remain unverified.", "missingness": "Test, contrast, time handling, multiplicity and analysis population", "uncertainty": "Test, contrast, time handling, multiplicity and analysis population No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original statistical methods/result tables, tests, contrasts, time handling and multiplicity plans" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is material available to judge mortality-effect magnitude, precision and clinical importance?", "needed": "Effects, intervals, baseline risk, follow-up and rationale for interpreting importance", "role": "Required", "role_reason": "Needed to avoid declaring adequate precision from a hard endpoint, significance or a single sample-size figure alone.", "application_exception": "Do not adopt arbitrary minimum participants, trial counts, duration or effect size. The 200-participant wording in the original grade rationale is historical explanation.", "criterion": "Verify valid between-arm effects and intervals, actual follow-up, baseline risk and justified interpretation of importance.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare effect/interval interpretation appropriate to the endpoint and population with the original analysis without deriving a new grade.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Unverified", "status_reason": "Event counts and the paper P value alone do not establish effect magnitude, precision or clinical importance.", "missingness": "Valid effects, intervals, follow-up and importance rationale", "uncertainty": "Valid effects, intervals, follow-up and importance rationale No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Effects, intervals, baseline risk, follow-up and rationale for interpreting importance" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are assignment/adherence effects, ITT/PP populations and handling of treatment changes verified?", "needed": "ITT/PP or other analysis-population definitions, long-term adherence/change handling and actual implementation documents", "role": "Required", "role_reason": "Needed to distinguish the effect of add-on assignment from effects among actual long-term users.", "application_exception": "Do not invent ITT or PP labels when analysis names are absent.", "criterion": "Verify analysis populations, effect of interest, deviation/change/death-handling rules and their actual application.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare assignment, actual use and change records with analysis plans and state the effect of interest.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The article records unverified analysis integrity. ITT/PP, assignment/adherence effects and long-term change-handling material are absent.", "condition_status": "Unverified", "status_reason": "Original event denominators and a randomized label alone do not verify analysis populations or the effect of interest.", "missingness": "Analysis populations, effect of interest and handling of treatment changes", "uncertainty": "Analysis populations, effect of interest and handling of treatment changes No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "ITT/PP or other analysis-population definitions, long-term adherence/change handling and actual implementation documents" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are the actual trial-registration/protocol identity, editions, dates and originals verified?", "needed": "Registration/protocol identifiers, dates, editions, originals or actual access records", "role": "Required", "role_reason": "Needed to distinguish an unidentified NCT from confirmed nonregistration or results of a current registry search.", "application_exception": "Do not borrow registration numbers from other berberine trials. Failure to acquire full text does not prove nonexistence.", "criterion": "Verify the trial's registration/protocol identifiers, initial/change dates, editions and originals.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare trial identity for the report before establishing registration/protocol histories and actual provision scope.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original registration field states not identified; Korean/English articles record unverified registration and protocol. No new registry lookup was performed.", "condition_status": "Unverified", "status_reason": "No material establishes the trial's registration/protocol identity and originals.", "missingness": "Registration/protocol identity, dates, editions and originals", "uncertainty": "Registration/protocol identity, dates, editions and originals No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/protocol identifiers, dates, editions, originals or actual access records" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Is consistency between prospective analysis plans and actual endpoints, timing and reporting verified?", "needed": "Prospective SAP, analysis lists, change histories and complete actual result tables", "role": "Required", "role_reason": "Needed to avoid turning absent plans into confirmed selective reporting or retrospectively calling current mortality reports prospective analyses.", "application_exception": "Unverified protocol/SAP does not establish presence or absence of selective reporting.", "criterion": "Compare dated SAP/plans with actual mortality/functional outcomes, times, analyses and reasons for changes.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare prospective/post hoc documents' endpoint, timing and analysis lists; record the verified scope of selection and changes.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Prespecified mortality endpoints, registration and protocol are unverified, so comparisons of the SAP with actual mortality analyses have not been possible.", "condition_status": "Unverified", "status_reason": "Material comparing prospective plans, change histories and complete result tables is absent.", "missingness": "SAP, plan/report comparisons and reasons for changes", "uncertainty": "SAP, plan/report comparisons and reasons for changes No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Prospective SAP, analysis lists, change histories and complete actual result tables" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are report/trial-family identity and direct independent mortality replication verified?", "needed": "Related reports/registration identities of the same trial and population, product and mortality-result material from direct replication trials", "role": "Required; independence verification needed for replication claims", "role_reason": "Needed to distinguish a single citation and the original R1 from externally verified replication counts.", "application_exception": "Neither a new search not performed nor unverified replication in the original article establishes 0 replication trials worldwide.", "criterion": "Verify the Zeng 2003 evidence/citation link, related reports of the same trial and identity/independence of other direct mortality trials.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link reports to trial families and mortality times/analyses; compare whether recruited populations are independent.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "A retained report link exists, but external family comparisons and other direct independent replications were not verified.", "missingness": "External family comparisons and direct independent replication", "uncertainty": "External family comparisons and direct independent replication No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Related reports/registration identities of the same trial and population, product and mortality-result material from direct replication trials" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Is the same adjunctive treatment's mortality effect directly verified under modern standard treatment?", "needed": "Direct comparative trials under modern treatment, arm-specific background treatment, products and mortality estimates", "role": "Supplementary; required for application to modern treatment", "role_reason": "Needed to avoid directly transferring results under 2003 common treatment to current treatment backgrounds.", "application_exception": "No new lookup of modern drugs or guidelines occurs in this work. The original claim remains tied to the then-conventional trial.", "criterion": "Verify direct comparisons and treatment differences under modern background therapy for the same population, product, exposure and mortality endpoint.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When new direct material is available, compare background treatment, populations, times and effects of interest with the original trial.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The article 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.", "condition_status": "Unverified", "status_reason": "Then-conventional background-treatment records do not verify additional mortality effects under modern treatment.", "missingness": "Direct comparisons under modern background therapy, equivalence and mortality estimates", "uncertainty": "Direct comparisons under modern background therapy, equivalence and mortality estimates No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct comparative trials under modern treatment, arm-specific background treatment, products and mortality estimates" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are other salts, extracts, combinations and derivatives distinguished from the actual trial product?", "needed": "Original product-boundary wording and restrictions on transfer to other products", "role": "Required (product-extension boundary)", "role_reason": "Needed to avoid applying mortality results to different products solely because they share an ingredient name.", "application_exception": "Met for product-boundary distinction does not verify the original product's salt/specifications. Actual product verification is asked separately in N04.", "criterion": "Do not automatically equate berberine hydrochloride, plant extracts, compound prescriptions, dihydroberberine, other derivatives or topical products with the original exposure.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When product material is added, examine salt, route, composition, exposure equivalence and direct comparisons separately.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The article restricts interchangeability of berberine hydrochloride, plant extracts, compound prescriptions, dihydroberberine, other derivatives and topical products.", "condition_status": "Met", "status_reason": "Automatic extension to other products is distinguished. Actual trial-product specifications have not been verified.", "missingness": "None (product-extension boundary record)", "uncertainty": "None (product-extension boundary record) No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product-boundary wording and restrictions on transfer to other products" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Is all-cause mortality distinguished from LVEF, arrhythmia, walking and cause-specific mortality?", "needed": "Original wording and locations distinguishing all-cause mortality from other endpoints", "role": "Required (endpoint-extension boundary)", "role_reason": "Needed to avoid replacing the original all-cause mortality question with other symptoms, function or cause-specific deaths.", "application_exception": "Do not generate new independent tables for other results or combine their values with the mortality effect in this table.", "criterion": "Select only mean 24-month all-cause mortality; keep extended endpoints such as LVEF, arrhythmia, walking and cardiovascular death separate.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If endpoint scope changes, examine definitions, denominators, timing and estimates under new independent boundaries.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original 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.", "condition_status": "Met", "status_reason": "Boundaries between all-cause mortality and other endpoints are retained. Effects on separate endpoints have not been graded.", "missingness": "None (endpoint-boundary record)", "uncertainty": "None (endpoint-boundary record) No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original wording and locations distinguishing all-cause mortality from other endpoints" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are direct dose comparisons, optimal dosing and persistence after stopping verified?", "needed": "Prospective dose comparisons, dose-specific denominators/mortality estimates and post-discontinuation follow-up", "role": "Supplementary; required for the relevant extension claim", "role_reason": "Needed to distinguish a dose range and long-term follow-up from optimal dosing or effects persisting after stopping.", "application_exception": "Do not universally require optimal-dose or discontinuation studies for the narrow then-conventional add-on question.", "criterion": "Verify direct dose comparisons, actual arm-specific exposure, mortality follow-up after stopping and separate estimates.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine designs/analyses directly comparing doses and discontinuation separately from the original single add-on report.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Unverified", "status_reason": "A range and follow-up duration do not replace direct dose/discontinuation comparisons.", "missingness": "Direct dose/discontinuation comparisons and separate estimates", "uncertainty": "Direct dose/discontinuation comparisons and separate estimates No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Prospective dose comparisons, dose-specific denominators/mortality estimates and post-discontinuation follow-up" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are funding, product provision, author employment, full COI and sponsor roles verified?", "needed": "Original funding, product provision, employment, COI declarations and sponsor-role documents", "role": "Supplementary; required for interpretation of independence", "role_reason": "Needed to distinguish the original I1 or generic English wording from evidence verifying independent funding or conflicts.", "application_exception": "Do not infer industry involvement without material or automatically exclude results.", "criterion": "Verify original funding, product provision, author relationships, COI declarations and sponsor design/analysis/publication roles.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare individual author declarations, funding and product support separately from trial-family independence.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Actual declaration, support and sponsor-role material is absent.", "missingness": "Funding, products, employment, COI and sponsor roles", "uncertainty": "Funding, products, employment, COI and sponsor roles No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, product provision, employment, COI declarations and sponsor-role documents" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are identity, public availability and editions of external abstracts, papers and registration/plans actually verified?", "needed": "External bibliography, abstracts, paper editions, registration/plan identities and actual access/acquisition records", "role": "Required", "role_reason": "Needed to distinguish bibliographic entry points from acquisition or successful reading of full texts and registration originals.", "application_exception": "Do not label current access not attempted as failed access. Do not invent registration/plan URLs without established identity.", "criterion": "Verify recorded PMID, DOI and PubMed entry points alongside actual editions, availability and acquisition of external originals.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "During authorized subsequent acquisition, record identity, availability, access and acquisition separately for each physical material type.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Bibliographic identifiers and entry points exist, but actual external provision, editions and acquisition were not verified.", "missingness": "External editions, availability, acquisition and registration/plan identities", "uncertainty": "External editions, availability, acquisition and registration/plan identities No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "External bibliography, abstracts, paper editions, registration/plan identities and actual access/acquisition records" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are generic English wording and the 2026-09-14 correction history retained as original values?", "needed": "Current bilingual evidence tables, citations, correction originals, dates and scope", "role": "Required (original-text and correction attribution)", "role_reason": "Needed to avoid promoting English placeholders to current specific clinical-material verification.", "application_exception": "The correction records replacement of 1 English field. Retain remaining generic wording historically without arbitrary translation/replacement.", "criterion": "Link correction dates/scope and current generic English wording to original bytes and typed literals without using them as new verified facts.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If subsequent editing is needed, preserve the whole previous article and distinguish clinical-value changes from translation/display events.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Met", "status_reason": "Current generic wording and correction scope are preserved accurately. The wording does not prove verification of clinical material.", "missingness": "None (original-text/correction preservation scope)", "uncertainty": "None (original-text/correction preservation scope) No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Current bilingual evidence tables, citations, correction originals, dates and scope" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are actual adverse-event definitions, collection, severity and discontinuation verified for the same population/exposure?", "needed": "Original adverse-event definitions, collection, timing, severity, discontinuation and causality assessment material", "role": "Supplementary; required for harm/safety interpretation", "role_reason": "Needed to distinguish original warnings or safety in a title from actual safety results.", "application_exception": "Efficacy and harms have separate states. Do not remove mortality reporting because harm material remains unverified.", "criterion": "Verify actual adverse-event definitions, collection methods/times, severity, discontinuation and causality assessment material.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare harm collection/adjudication material for the same exposure separately from efficacy reporting.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Original 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.", "condition_status": "Unverified", "status_reason": "Cautions and a trial title do not provide actual adverse-event collection/results.", "missingness": "Event definitions, collection, severity and discontinuation results", "uncertainty": "Event definitions, collection, severity and discontinuation results No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original adverse-event definitions, collection, timing, severity, discontinuation and causality assessment material" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are harm counts, exposed denominators, observation periods and missingness verified?", "needed": "Harm-specific event counts, exposed denominators, periods, missingness and collection systems", "role": "Supplementary; required for frequency/safety interpretation", "role_reason": "Needed to avoid transferring 156 participants and death counts to nonfatal-adverse-event denominators or incidence.", "application_exception": "Do not fill absent event counts with 0 or derive harm incidence from warnings.", "criterion": "Verify exposed persons, persons/events, follow-up periods, missingness and collection systems for each harm.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link harm collection tables to exposure/follow-up flow; distinguish spontaneous records from systematic counts.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Beyond mortality counts of 7/79 versus 13/77, participants/events, exposed denominators, periods and missingness for nonfatal harms have not been verified.", "condition_status": "Unverified", "status_reason": "Mortality denominators do not verify separate adverse-event frequency or complete collection.", "missingness": "Harm-specific denominators, events, periods and missingness", "uncertainty": "Harm-specific denominators, events, periods and missingness No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm-specific event counts, exposed denominators, periods, missingness and collection systems" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Is direct harm material verified for bradycardia, hypotension, interactions and electrolyte, renal and liver status?", "needed": "Original exposure, event, comparison and follow-up material by concomitant drugs and baseline function", "role": "Supplementary; required for the relevant harm scope", "role_reason": "Needed to distinguish original cautions from verified risks or interaction magnitudes.", "application_exception": "Retain original warnings without newly confirming particular drug interactions or vulnerable-population risks.", "criterion": "Verify concomitant drugs, baseline status, events, follow-up and comparative material under the same actual exposure.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine prospectively defined concomitant-drug/baseline-function harm collection or comparisons, distinguishing other causes.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The article warns that bradycardia, hypotension, drug interactions and electrolyte, renal and liver status require separate checks. Direct harm material, denominators and comparisons are absent.", "condition_status": "Unverified", "status_reason": "A caution list does not establish actual events, magnitude or causality.", "missingness": "Harms, denominators and comparisons by concomitant drugs and baseline status", "uncertainty": "Harms, denominators and comparisons by concomitant drugs and baseline status No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original exposure, event, comparison and follow-up material by concomitant drugs and baseline function" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are original advertising/safety boundaries distinguished from new survival treatment, drug replacement or personal dosing instructions?", "needed": "Original advertising restrictions, safety warnings and locations", "role": "Required (interpretation-extension boundary)", "role_reason": "Needed to prevent advertising favorable death counts as established survival treatment or halved risk.", "application_exception": "This table does not direct individual treatment, dosing or discontinuation. Do not reduce original warnings.", "criterion": "Do not extend results to established survival treatment, antiarrhythmic replacement or halved mortality risk; link original warnings to historical text.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If clinical application scope changes, examine direct material, safety and comparator treatment separately before updating presentation.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original advertising limits prohibit claims of survival treatment, antiarrhythmic replacement or halved mortality risk, retaining a high-dose warning. This table adds no dosing instructions.", "condition_status": "Met", "status_reason": "Extension boundaries for original advertising restrictions and warnings are preserved. New efficacy, safety or personal treatment is not certified.", "missingness": "None (original interpretation-boundary record)", "uncertainty": "None (original interpretation-boundary record) No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original advertising restrictions, safety warnings and locations" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are actual historical search, preservation, verification scope and evidence-date specifications verified?", "needed": "Dates, databases, strategies, scope and retained documents for historical search/review records", "role": "Required", "role_reason": "Needed to distinguish the original review date from a current comprehensive literature search or report-specific access dates.", "application_exception": "Do not infer absent evidence cut-offs, search databases or search strategies.", "criterion": "Verify actual search dates, databases, strategies and preservation-scope documents in addition to the global original review date and search description.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare actual historical search records by date, identifier and material type separately from current actions.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "Original review date and check descriptions exist, but material needed to complete actual search/preservation/verification specifications is absent.", "missingness": "Search dates, databases, strategies and actual scope", "uncertainty": "Search dates, databases, strategies and actual scope No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dates, databases, strategies, scope and retained documents for historical search/review records" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Are actual documents, dates and scope of bibliographic-edition and retraction/concern/correction checks verified?", "needed": "Bibliographic editions and actual publication-status-check documents, dates, original locations and scope", "role": "Required", "role_reason": "Needed to avoid reusing historical check descriptions as new verification of current publication status.", "application_exception": "Bibliography, internal English corrections and publisher correction/retraction documents are different materials. No current external lookup occurs.", "criterion": "Verify PMID, DOI, bibliographic editions and actual publication-status-check documents, original locations, dates and scope.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "When authorized new material arrives, compare publication status and edition links by PMID/DOI separately from internal correction history.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Bibliographic identity and historical descriptions are recorded, but actual evidence of publication-status checks remains unverified.", "missingness": "Publication-status documents, dates, editions and original locations", "uncertainty": "Publication-status documents, dates, editions and original locations No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Bibliographic editions and actual publication-status-check documents, dates, original locations and scope" }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Are original C50, axes, empty values and absent fields retained without inheritance into new condition states?", "needed": "Complete original bytes, SHA, grade, axes, corrections, empty values and absent fields", "role": "Required (original verdict preserved)", "role_reason": "Needed to avoid presenting the current conversion as reevaluation of the original grade or a new condition score.", "application_exception": "Original axes such as H, R1 and I1 are historical values; they do not replace actual independence or precision verification.", "criterion": "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.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If correction is needed, preserve the whole previous article and grading event; handle it under separate authorization/versioning from the current conversion.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Original 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.", "condition_status": "Met", "status_reason": "Original values are preserved without automatic inheritance into condition states, effects or grades.", "missingness": "None (original-value/absence preservation scope)", "uncertainty": "None (original-value/absence preservation scope) No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete original bytes, SHA, grade, axes, corrections, empty values and absent fields" }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Are current local-summary reading, external access not attempted, historical descriptions and unverified access dates separated?", "needed": "Material-specific actual reading, acquisition and access events; distinction among historical descriptions, original review dates and individual access dates", "role": "Required (actual reading record)", "role_reason": "Needed to avoid turning summary-reader links into external full-text-reading badges.", "application_exception": "Do not copy original review/correction dates into access dates. Do not inherit one included document's access level into another physical material.", "criterion": "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.", "basis": "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.", "condition_origin": "These conditions for adjunctive berberine and heart-failure all-cause mortality were developed with knowledge of the retained content. Conditions were frozen before a separate application event. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "During authorized subsequent reading, append only that material type's actions, dates and locations as separate events.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The complete 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.", "condition_status": "Met", "status_reason": "Current actual reading is separated from external unread status and historical records. External original contents were not verified in this work.", "missingness": "None (current-action/historical-date separation record)", "uncertainty": "None (current-action/historical-date separation record) No new effect, interval, denominator, incidence or grade calculations/reassessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Material-specific actual reading, acquisition and access events; distinction among historical descriptions, original review dates and individual access dates" } ], "reports": [ { "report_id": "S01", "title": "Zeng 2003 adjunctive-treatment and all-cause mortality report in chronic heart failure", "url": "https://pubmed.ncbi.nlm.nih.gov/12860219/", "report_type": "Retained bibliography and research summary of a randomized placebo-controlled add-on trial", "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "study_family": "A retained report linked by matching title, PMID and DOI. This does not certify external trial identity or unique participant counts.", "observed_result": "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.", "result_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.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained bilingual bibliography and research summary", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "The retained summary was actually read; distinguish it from external clinical full-text bytes. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "PubMed bibliography/abstract entry point", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. 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." }, { "material_type": "Original full text; edition unverified", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. 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." }, { "material_type": "Registration, protocol and analysis plan; identity and existence unverified", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. 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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/12860219/" } ], "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "independent_replication": "1 evidence entry and 1 citation link to the same report. Do not count bilingual articles, PMID and DOI as independent trials. Total unique trials, participants and direct independent replication are not currently established." } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Link studies and reports separately; do not omit studies solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Met": "The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.", "Partly verified": "Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.", "Unverified": "The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.", "Not 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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-27", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 37 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-27" }