Berberine hydrochloride tablets × Reduction of colorectal adenoma recurrence after complete polypectomy

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Evidence conditionWhich adenoma-recurrence question does this checklist address?Required	The original claim is reduced colorectal adenoma recurrence after complete polypectomy. It is limited to a comparison with matching placebo of at least one recurrent adenoma at follow-up colonoscopy over 1–2 years. S01	The original claim, claim conditions and summary note specify the population, intervention, comparator and endpoint boundaries.	The exact original claim, population, formulation, endpoint, comparison and canonical URL.	Compare inclusion and exclusion boundaries to check whether adenoma counts, advanced adenomas, cancer prevention or treatment of existing adenomas have been mixed into the principal effect.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionAre the tablet ingredient, source and product identity verified?Required	The claim conditions specify purified berberine hydrochloride and explicitly leave its plant source unverified. The retained summary does not specify the manufacturer or detailed product standards. S01	The ingredient and tablet formulation are recorded, but the plant source and detailed product identity remain unverified.	Tablet composition, manufacturer, product standards, plant source and analytical certification material.	Compare manufacturing and composition documents with the trial product to establish the limits of identity with hydrochloride, plant extracts, derivatives and combinations.
3	Met	Full text not readStored summary read	N03 · Evidence conditionWhat oral dose and administration frequency were specified?Required	The retained contract is oral berberine hydrochloride as a 0.3 g tablet, taken 2 times daily for a prescribed 0.6 g/day. Actual cumulative intake and adherence remain separately unverified. S01	The formulation, route and dose in the claim conditions agree with the corresponding English contract.	Formulation, route, content per tablet, frequency, nominal daily amount and administration records.	Compare tablet content and administration frequency, and link actual intake records separately from the nominal prescription if acquired.
4	Met	Full text not readStored summary read	N04 · Evidence conditionWhich adults after polypectomy were included?Required	The population is adults aged 18–75 with 1–6 histologically confirmed adenomas completely removed within 6 months. S01	The exact population is retained in the claim conditions and corresponding English text.	Diagnosis, age, adenoma count, histological confirmation, complete removal and the interval before enrollment.	Separate the population conditions and compare the trial population with treatment of residual adenomas, a general adenoma-free population and cancer patients.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre recruitment, exclusions and baseline balance verified?Required	A multicentre trial at 7 hospitals and the post-polypectomy population are recorded. Detailed recruitment, exclusions and baseline-balance tables are absent from this retained summary. S01	The hospital count and population are known, but selection and baseline material that could affect the analysis remain missing.	Recruitment flow, exclusion criteria, baseline tables by arm, adenoma risk and site composition.	Compare the enrollment-to-analysis flow and baseline tables to examine differences between the selected population and the target population.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre differences in co-interventions and adherence beyond matching placebo verified?Required	The matching-placebo control is explicit. Detailed placebo composition, co-interventions, rescue treatment, actual adherence and changes in administration by arm are not specified in the summary. S01	The comparator type is recorded, but the relationship of actual co-interventions and deviations to the effect of interest remains unverified.	Placebo composition, co-interventions and rescue treatment, adherence, changes by arm and analytical handling.	Compare treatment and adherence records by arm to distinguish the assigned formulation difference from contributions of other changes.
7	Met	Full text not readStored summary read	N07 · Evidence conditionWhat follow-up period and examination times apply to adenoma recurrence?Required	The retained period is 1–2 years, with a 2-year colonoscopy if the 1-year colonoscopy is negative. The result is recurrence identified at follow-up colonoscopy. S01	The claim conditions and English contract specify the conditional re-examination rule.	Administration and follow-up periods, colonoscopy schedules by arm and the re-examination rule after a negative result.	Link recurrence results to the examination schedule and separately examine unexamined intervals and persistence after stopping.
8	Met	Full text not readStored summary read	N08 · Evidence conditionHow is recurrence distinguished from other adenoma outcomes?Required	The principal endpoint is at least one recurrent adenoma at follow-up colonoscopy. Retain the manuscript boundary separating adenoma counts, advanced adenomas and colorectal cancer as other questions. S01	The principal endpoint in the claim conditions and the summary note explicitly distinguish outcomes.	Principal-endpoint definitions, other adenoma outcomes, cancer outcomes and reporting locations.	Make an outcome-definition table and check whether each value represents a proportion of people with recurrence or a count of adenomas.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionAre the actual colonoscopy and histological assessment procedures verified?Required	The colonoscopic-recurrence endpoint and double-blind trial label are recorded. Examination quality, histological procedures, assessor-specific blinding and completed examinations by arm remain unverified in detail. S01	The broad measurement approach is recorded, but details needed to compare limitations in actual outcome measurement are missing.	Colonoscopy and pathology procedures, quality control, assessor blinding and examination-completion tables by arm.	Compare endpoint-collection procedures and completed examinations by arm to examine how detection differences limit the recurrence comparison.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre randomization, concealment and blinding methods verified?Required	The retained description is a multicentre, double-blind, randomized placebo trial at 7 hospitals. Sequence generation and implementation of concealment and blinding are absent from the current summary. S01	The design label is known, but actual allocation procedures supporting the causal comparison remain unverified.	Allocation sequences, concealment, allocation by site, blinding procedures and the original methods text.	Compare methods sections and allocation records against bias domains for the selected result, retaining unverified domains separately.
11	Met	Full text not readStored summary read	N11 · Evidence conditionCan randomized, efficacy and safety denominators be distinguished?Required	There were 1,108 randomized participants and 891 in the mITT population with efficacy data. Recurrence denominators are 429 versus 462, while constipation denominators are 446 versus 478. S01	The reader answer, evidence population description and safety explanation give different denominators.	Definitions of randomized, efficacy-analysis and safety populations, and event and denominator tables by arm.	Link each denominator to its analysis population in a comparison table and identify displays that substitute randomized counts for efficacy or safety denominators.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre reasons for missing efficacy data and their handling verified?Required	The manuscript states that only 891 participants were analyzed for efficacy and that about 20% of efficacy data were missing. Reasons, handling and sensitivity results by arm are absent from the summary. S01	Data loss is recorded, but reasons and handling material needed to examine its influence on the result remain missing.	Missing efficacy data, dropout reasons by arm, missing-data handling, sensitivity analyses and the participant-flow diagram.	Compare reasons for missingness and examination status by arm, and check prespecified sensitivity-analysis plans examining assumptions of the original analysis.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionAre mITT inclusion rules and the analytical model verified?Required	Results were reported for modified ITT populations of 429 versus 462 participants. Inclusion rules, adjustment models and complete ITT or PP results were not verified in the current summary. S01	The analysis name and denominators are recorded, but actual effect definitions and inclusion rules remain unverified.	The mITT definition, analysis plan, adjustment variables, ITT/PP results and handling of incomplete examinations.	Compare the analysis plan with result tables to examine how mITT inclusion rules differ from the selected assignment effect.
14	Met	Full text not readStored summary read	N14 · Evidence conditionWhat RR, interval and P value were originally reported for recurrence?Required	The retained mITT adenoma-recurrence result is 155/429=36% versus 216/462=47%, RR 0.77, 95% CI 0.66~0.91, P=.001. S01	The evidence result, citation result summary and reader answer contain the same original values.	Events and denominators, original proportions, effect measure, CI, P value and original table locations for the selected result.	Compare original result tables with retained citation values and check whether labels have changed to another measure such as HR or a within-group test instead of RR.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionCan a prespecified clinical-importance threshold be compared with the interval?Required	The RR interval and P value are retained, together with the manuscript statement that a prespecified minimum clinically important difference for adenoma recurrence was not verified. S01	An interval is available, but the prespecified clinical-importance threshold needed for comparison is missing.	The prespecified clinical-importance threshold, its basis, the original effect interval and planning documents.	Compare an acquired prespecified importance threshold with the original interval’s range, without inventing thresholds or new scores.
16	Met	Full text not readStored summary read	N16 · Evidence conditionIs the historical 11-percentage-point description distinguished from a new effect calculation?Required	The 11-percentage-point absolute difference in the limitations and counterpoint descriptions is a retained historical value. This checklist does not calculate a new absolute difference, NNT or interval. S01	The boundary between historical wording and the absence of a new calculation was fixed.	The original absolute-difference wording, its analysis, calculation history and any reported original interval.	Link the historical description to original reported rates to check whether it is presented as a new calculation; do not fill in an NNT that was not calculated.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWere the trial number and identity compared against original registration material?Required	The citation and research-review description contain NCT02226185, while the evidence registration-check field says not verified. Both are retained; original registration material was not opened in this work. S01	A registration-number string is recorded, but comparison with the identity and content of original registration material remains unverified.	The original NCT02226185 registration, identity links between paper and registration, and update history.	Compare registration, paper and follow-up report identities to establish whether they concern the same trial before using them for plan comparisons.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionDo planned endpoints, timing and analysis agree with the final report?Required	Recurrence over 1–2 years and mITT results are recorded. The current input contains no material directly comparing planned endpoints, denominators and timing in original registration, protocols or the SAP. S01	Result reporting alone cannot establish agreement with prespecified plans.	Protocols, SAP, registration revisions, final result tables and selective-reporting comparison records.	Compare planned and actual endpoints, analyses and examination times across document versions and check reasons for changes.
19	Met	Full text not readStored summary read	N19 · Evidence conditionIs follow-up of the same cohort kept separate from independent replication?Required	The manuscript states that the final NCT02226185 paper was distinguished from follow-up of the same cohort. The current evidence list and citation list each contain 1 entry; follow-up reports are not counted as new independent trials. S01	The key explanation and research-review description explicitly distinguish overlap within the same cohort.	Trial numbers, populations, recruitment periods and overlapping-identity tables for the final paper and follow-up reports.	If follow-up material is acquired, compare recruitment, trial numbers and participant overlap, then link it as a separate timepoint within the same family.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionHas direct confirmatory material from an independent study family been acquired?Supplementary; required for independent-replication claims	The manuscript retains lack of independent confirmation as a limitation. Direct evidence in the current input is one report; follow-up of the same cohort is not independent replication. S01	The current retained material does not contain acquired identities and results for a separate independent direct trial.	Original reports, registrations, recruitment, formulation, population and outcome details, and overlap comparisons for independent trials.	If further trials are acquired, compare family identity, formulation, population, timing and analysis before examining independent replication.
21	Not applicable	Full text not readStored summary read	N21 · Evidence conditionDoes heterogeneity between the currently linked study families need comparison?Supplementary; required for application across families	The current evidence and bibliography concern one report, and follow-up of the same cohort is treated within the same family. No distribution of effects across different linked families is currently compared. S01	Results from multiple independent families are not currently linked for comparison.	Comparisons of results, formulation, population, duration and analysis if other independent families are added.	Only when an independent family is newly acquired, compare results and contract differences side by side and examine comparability.
22	Not applicable	Full text not readStored summary read	N22 · Evidence conditionAre optimal dose, persistence after stopping and subgroup confirmation required here?Supplementary; required for the relevant extension claim	The current question is the specified regimen and recurrence comparison over 1–2 years. Direct optimal-dose, post-discontinuation persistence and prespecified subgroup confirmation remain separate questions. S01	Requirements for extended effects are not added to the current narrow original claim.	Direct dose comparisons, post-discontinuation follow-up and prespecified subgroup or interaction material if an extension question is defined.	Future extension questions should separately design and assess direct dose comparisons, prespecified subgroup interactions and follow-up after stopping.
23	Met	Full text not readStored summary read	N23 · Evidence conditionIs the adenoma-recurrence result kept separate from cancer prevention?Required extension boundary	The manuscript describes adenoma as a surrogate for colorectal cancer and states that no colorectal cancers were observed in the trial. Observing 0 events establishes neither cancer-prevention efficacy nor equivalence. S01	The verdict rationale and advertising restrictions prohibit extensions to cancer prevention or replacement of colonoscopy.	Definitions, event counts, follow-up and separate effect results for adenoma recurrence and clinical cancer events.	Evaluating cancer prevention requires a comparative trial with a separate clinical cancer endpoint and sufficient follow-up, analyzed separately from the adenoma surrogate result.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre constipation event definitions and collection verified?Supplementary; required for safety descriptions	The original warning reports constipation as 6/446 versus 1/478. The summary does not specify whether counts represent people or events, the event definition, systematic collection or safety inclusion rules. S01	The constipation comparison and denominators are recorded, but details of collection and counting units remain unverified.	Safety tables, constipation definitions, person/event distinctions, collection methods and inclusion rules for 446/478.	Compare original safety tables and collection plans to verify constipation counting units and exposed/control denominators.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionAre harm timing, severity, discontinuation and missingness verified?Supplementary; required for the safety scope	Constipation reporting and the 1–2-year efficacy contract are recorded. Onset and recovery times, severity, discontinuation, all adverse events and losses by arm remain unverified in detail. S01	No direct material is available to compare the selected harm’s timeline, discontinuation, complete collection and follow-up.	Safety timelines, severity, stopping and recovery, follow-up and missingness by arm, and tables of all adverse events.	Examine exposure and event timelines and follow-up losses by arm without converting absent reporting into 0 events.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionAre long-term harms, co-medication and vulnerable-group data verified?Supplementary; required for safety extensions	The original text states that long-term clinical safety and drug interactions are not fully established. Specific co-medications, alternative causes and vulnerable-group results are absent from the current summary. S01	The original warning is retained, but direct evidence for extended safety remains unverified.	Co-medications, baseline events, interactions, long-term and vulnerable-group exposure, follow-up and harm material.	Separately examine long-term follow-up and harm-observation designs including co-medication and baseline risks, and compare the limited safety scope of this trial.
27	Not applicable	Full text not readStored summary read	N27 · Evidence conditionIs confirmation of independently repeated harm signals required in this checklist?Supplementary; required for repeated-harm claims	The current question concerns adenoma recurrence and does not claim independently repeated harms. Constipation comparison, collection, timing and long-term limitations remain separately addressed in N24~N26. S01	A requirement for the separate extension claim of independently repeated harms does not apply to the current original question.	Unique-event and study-family material and recitation comparisons if a repeated-harm claim is added.	If a future repeated-harm question is defined, compare unique events and families and link repeated citations to the same signal.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre product support, author identity and patents verified beyond the funding name?Supplementary; required for independence claims	The evidence funding entry names the National Natural Science Foundation of China. Product provision, author employment and patents, complete declarations and the funder’s role remain unverified in detail. S01	The funding name is recorded, but material on other dimensions of independence and roles remains missing.	Funding, trial-product provision, author affiliations and employment, patents, complete COI declarations and roles.	Separately compare funding, product, author and patent declarations to check funding sources and roles in result analysis.
29	Met	Full text not readStored summary read	N29 · Evidence conditionWhich materials were actually read in this work?Required	The entire original-byte retained source was read, including Korean/English content, evidence, citations and structure. External PubMed responses, original full text, registration, follow-up reports and older separate files were not opened. S01	Actual local reading and the boundary of unattempted external access were distinguished.	Actual reading, access, acquisition and locations for each material, safe links and timestamps.	Compare action records for each material with retained source locations to check that a summary link is not presented as external full-text reading.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionAre the current response and identity of the original bibliographic URL verified?Required	The bibliography contains Chen YX et al., Lancet Gastroenterol Hepatol. 2020;5:267-275, PMID 31926918, DOI 10.1016/S2468-1253(19)30409-1. The original link is PubMed. Current URL response and agreement with text or identifiers were not checked. S01	Retained bibliography and URL strings are available, but current original-material identity and access were not verified.	Original bibliography, PMID/DOI, current URL response and identity comparisons with paper and registration.	In a future authorized material check, compare identifiers and original-document identity and distinguish the material type offered by the link.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionCan the scope of historical search and retraction/correction checks be traced?Required	The original verdict review date is 2026-09-08. The research-review description says final and same-cohort follow-up material and retractions/corrections were checked. There is 1 English-placeholder correction dated 2026-09-14; no current search or external recheck was performed. S01	Historical descriptions and an internal correction are recorded, but actual search and publication-status logs are absent from the current input.	Historical search strategies and dates, selection logs, evidence for retraction/correction checks and latest authorized review records.	If historical logs are acquired, compare their scope with the described review and record corrections, new evidence and condition revisions as separate events.
32	Met	Full text not readStored summary read	N32 · Evidence conditionAre the original grade and axes kept separate from current condition statuses?Required	Retain the original C grade, 54 points, Warning, S/R1/I2/E+/B2/CX and claim type B, along with false values for co-primary splitting, a large hard-endpoint trial, absence of human studies and primary failure with secondary positivity, and the empty override-reason string. S01	The original grade, score, axes and grade decision are linked unchanged; no new grade or score is generated.	Current grade, score, safety, axes, original grade decision and complete originals before and after correction.	Compare typed current-source and preserved values to check that nulls, Booleans, empty strings and historical assessments remain unchanged.
33	Met	Full text not readStored summary read	N33 · Evidence conditionAre generic English descriptions kept separate from new specific facts?Required	The original English article contains specific values, but the evidence’s population, funding, endpoint, result and weight descriptions in English and some corresponding citation text are generic verification wording. Retain the history of 1 correction and the current text unchanged. S01	Specific information was distinguished from generic wording in the complete current bilingual material and internal correction record.	Korean/English evidence and citation correspondence, and records before and after the English-placeholder correction.	Compare bilingual correspondence without treating generic explanations as additional evidence for specific denominators, funding, confidence intervals or original-document reading.
34	Met	Full text not readStored summary read	N34 · Evidence conditionAre empty source values distinguished from absent keys?Required	The source has 20 top-level keys, an empty subclaim list, an empty deliberation string and no image request. Source-list, principal-effect and material-specific access-level, location and date keys are absent from the original structure. S01	The actual keys and values in the complete retained source were read to establish the original structure.	All current source keys, typed original values and comparisons of access/effect field presence.	Check key presence and typed values separately; distinguish original structure from added records if subsequent material is acquired.

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34 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence review date: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Population: Adults aged 18–75 with 1–6 histologically confirmed adenomas completely removed within 6 months. Detailed recruitment, exclusions and baseline risks by arm remain unverified.
Ingredient, formulation and route: Oral berberine hydrochloride tablets. Plant source, manufacturer and detailed product standards remain unverified.
Dose: The contract specifies a 0.3 g tablet 2 times daily, nominally 0.6 g/day. Actual cumulative intake and adherence remain unverified. This is not an instruction for personal use.
Comparator: Matching placebo. Detailed composition, co-interventions, rescue treatment, actual adherence and changes by arm remain unverified.
Measured outcome: At least one recurrent adenoma at follow-up colonoscopy. Distinguish 1,108 randomized participants from the 891-person mITT set with efficacy data. Retain recurrence of 155/429=36% versus 216/462=47%, RR 0.77, 95% CI 0.66~0.91, P=.001. Retain the original C grade, 54 points and Warning.
Duration: Follow-up is 1–2 years, with a 2-year colonoscopy if the 1-year colonoscopy is negative. Individual actual administration, examinations, losses and persistence after stopping remain unverified.
Questions outside this scope: This recurrence comparison concerns the selected population after complete polypectomy. Do not extend it to general cancer prevention, treatment of residual adenomas or effects at every age and risk level.; Berberine hydrochloride tablets, plant extracts, combinations, dihydroberberine, other derivatives and topical products are not interchangeable.; Distinguish adenoma recurrence from adenoma counts, advanced adenomas and colorectal cancer. The existing 11-percentage-point absolute difference and approximately 20% missing efficacy data are historical descriptions; no new effect, interval or NNT is calculated.; Retain the original safety warning and separate constipation denominators of 6/446 versus 1/478. Long-term safety, interactions and safety outside the population remain unverified. Do not extend this to replacement of colonoscopy, optimal dosing, persistence after stopping or personal treatment instructions.

Evidence and sources

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

S01 · Chen 2020 colorectal adenoma recurrence report after polypectomy

PubMed

Material type: Retained bibliography and research summary of a multicentre randomized double-blind placebo trial
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Findings recorded in the stored summary: Among 1,108 randomized participants, recurrence in the 891-person mITT set was 155/429=36% versus 216/462=47%, RR 0.77, 95% CI 0.66~0.91, P=.001. Constipation of 6/446 versus 1/478 uses separate safety denominators. No new effects or intervals were calculated.
Record level: A retained surrogate-endpoint result for adenoma recurrence. Missingness, mITT inclusion rules, analytical models and prespecified clinical-importance thresholds remain unverified. This is not new verification of direct cancer prevention or original-table analysis.
Study overlap and independent replication: Only the evidence and citation for report S01 are currently linked. A registration number in the bibliography does not establish verification of original registration. Follow-up of the same cohort is not added as independent replication or unique participants. Total unique trials and participants remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
PubMed bibliography/abstract-index entry point	Material type recorded; current public availability unverified	External access not attempted; not acquired	Not read	Current URL response, offered material scope and original-document identity remain unverified. External access, acquisition and reading were not attempted. Historical manuscript descriptions of final, follow-up and retraction/correction review do not establish current actual reading of PubMed or the original paper. 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.
Retained bilingual bibliography and research summary	Retained copy acquired; summary read	Retained copy acquired; summary read	Stored existing review summary read	The retained summary was actually read; distinguish it from external clinical full-text bytes. Historical manuscript descriptions of final, follow-up and retraction/correction review do not establish current actual reading of PubMed or the original paper. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.

Report counts versus independent study counts

Only the evidence and citation for report S01 are currently linked. A registration number in the bibliography does not establish verification of original registration. Follow-up of the same cohort is not added as independent replication or unique participants. Total unique trials and participants remain unverified.

Review criteria

Version 1.0 · Criteria record date 2026-10-05. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which adenoma-recurrence question does this checklist address?

Required materials and conditions: The exact original claim, population, formulation, endpoint, comparison and canonical URL.
Conditions for verification: Fix the single question of oral berberine hydrochloride versus matching placebo for adenoma recurrence over 1–2 years in adults after complete polypectomy.
Requirement and applicability: Required
Application exceptions: An empty subclaim list does not establish the worldwide absence of other claims, and the checklist is not expanded into every combination of assessment axes.
Why this condition is needed: Needed to avoid combining effects for separate endpoints and products into a single result.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N02 · Are the tablet ingredient, source and product identity verified?

Required materials and conditions: Tablet composition, manufacturer, product standards, plant source and analytical certification material.
Conditions for verification: Identify the berberine hydrochloride tablet separately from unverified information about its plant source and product.
Requirement and applicability: Required
Application exceptions: An unverified plant source does not erase the recorded identity as purified berberine hydrochloride.
Why this condition is needed: Needed to avoid transferring trial results to products with similar ingredient names.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N03 · What oral dose and administration frequency were specified?

Required materials and conditions: Formulation, route, content per tablet, frequency, nominal daily amount and administration records.
Conditions for verification: Retain the nominal oral regimen of a 0.3 g tablet 2 times daily, 0.6 g/day, and distinguish it from actual adherence and exposure.
Requirement and applicability: Required
Application exceptions: Unverified actual intake or adherence does not mean the nominal dose was not recorded.
Why this condition is needed: Needed to avoid treating 0.3 g as the total daily amount or changing the administration route.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N04 · Which adults after polypectomy were included?

Required materials and conditions: Diagnosis, age, adenoma count, histological confirmation, complete removal and the interval before enrollment.
Conditions for verification: Limit the population to adults aged 18–75 with 1–6 histologically confirmed adenomas completely removed within 6 months.
Requirement and applicability: Required
Application exceptions: Verification of eligibility wording does not establish representativeness for all ages or all adenoma-risk groups.
Why this condition is needed: Needed to avoid extending post-polypectomy recurrence results to general prevention or treatment of existing lesions.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N05 · Are recruitment, exclusions and baseline balance verified?

Required materials and conditions: Recruitment flow, exclusion criteria, baseline tables by arm, adenoma risk and site composition.
Conditions for verification: Actual recruitment and exclusion conditions at the 7 hospitals, and baseline risks by arm, must be linked to the analysis population.
Requirement and applicability: Required
Application exceptions: Failure to acquire baseline tables does not establish baseline imbalance or lack of representativeness.
Why this condition is needed: Needed to avoid transferring results in selected post-polypectomy patients to all adults.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N06 · Are differences in co-interventions and adherence beyond matching placebo verified?

Required materials and conditions: Placebo composition, co-interventions and rescue treatment, adherence, changes by arm and analytical handling.
Conditions for verification: Check co-interventions, rescue treatment, adherence, deviations and their handling beyond the difference between matching placebo and berberine.
Requirement and applicability: Required
Application exceptions: The matching-placebo label alone does not establish that every actual co-intervention and adherence pattern was identical.
Why this condition is needed: Needed to avoid attributing differences in other treatments or intake behaviour to the formulation.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N07 · What follow-up period and examination times apply to adenoma recurrence?

Required materials and conditions: Administration and follow-up periods, colonoscopy schedules by arm and the re-examination rule after a negative result.
Conditions for verification: Retain the contract of 1–2 years of follow-up and a 2-year colonoscopy if the 1-year colonoscopy is negative.
Requirement and applicability: Required
Application exceptions: Do not turn the 1–2-year contract into complete observation of every participant for exactly 2 years or into an effect after stopping.
Why this condition is needed: Needed to distinguish a single fixed endpoint from a conditional examination pathway.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N08 · How is recurrence distinguished from other adenoma outcomes?

Required materials and conditions: Principal-endpoint definitions, other adenoma outcomes, cancer outcomes and reporting locations.
Conditions for verification: Distinguish at least one recurrent adenoma at follow-up colonoscopy from adenoma counts, advanced adenomas and cancer.
Requirement and applicability: Required
Application exceptions: The absence of direct values for other endpoints does not erase the recorded recurrence result.
Why this condition is needed: Needed to avoid combining effects on counts, advanced lesions or cancer with the principal recurrence effect.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N09 · Are the actual colonoscopy and histological assessment procedures verified?

Required materials and conditions: Colonoscopy and pathology procedures, quality control, assessor blinding and examination-completion tables by arm.
Conditions for verification: Adenoma-identification procedures, examination quality, assessor blinding and examination differences by arm must be linked to the selected result.
Requirement and applicability: Required
Application exceptions: The double-blind label alone does not establish that colonoscopy and pathology assessors were blinded.
Why this condition is needed: Needed to distinguish detection conditions from actual recurrence differences.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N10 · Are randomization, concealment and blinding methods verified?

Required materials and conditions: Allocation sequences, concealment, allocation by site, blinding procedures and the original methods text.
Conditions for verification: Distinguish the multicentre randomized double-blind label from actual sequence generation, allocation concealment and blinding procedures.
Requirement and applicability: Required
Application exceptions: Unverified details do not establish a nonrandomized design, and no new formal risk-of-bias assessment is performed.
Why this condition is needed: Needed to avoid promoting an RCT label into verification of detailed allocation procedures.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N11 · Can randomized, efficacy and safety denominators be distinguished?

Required materials and conditions: Definitions of randomized, efficacy-analysis and safety populations, and event and denominator tables by arm.
Conditions for verification: Retain 1,108 randomized participants, the 891-person mITT population with denominators 429/462, and safety denominators 446/478 for their respective outcomes.
Requirement and applicability: Required
Application exceptions: Do not generate unreported randomized or completed counts by arm through subtraction or reverse calculation.
Why this condition is needed: Needed to avoid calculating event proportions for different analysis populations with a single denominator.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N12 · Are reasons for missing efficacy data and their handling verified?

Required materials and conditions: Missing efficacy data, dropout reasons by arm, missing-data handling, sensitivity analyses and the participant-flow diagram.
Conditions for verification: Verify exclusion reasons, losses by arm and sensitivity handling when efficacy data for only 891 of the 1,108 randomized participants were analyzed.
Requirement and applicability: Required
Application exceptions: Do not recalculate the manuscript’s approximate 20% as a new exact percentage or classify all missing observations as treatment failures.
Why this condition is needed: Needed to avoid interpreting results among analyzed participants as complete follow-up of everyone randomized.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N13 · Are mITT inclusion rules and the analytical model verified?

Required materials and conditions: The mITT definition, analysis plan, adjustment variables, ITT/PP results and handling of incomplete examinations.
Conditions for verification: Distinguish the actual modified-ITT inclusion rules, adjustment and effect of interest from the effect of original assignment.
Requirement and applicability: Required
Application exceptions: Unverified adjustment or model details do not establish an unadjusted analysis.
Why this condition is needed: Needed to avoid automatically interpreting the mITT label as complete ITT or an adherence effect.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N14 · What RR, interval and P value were originally reported for recurrence?

Required materials and conditions: Events and denominators, original proportions, effect measure, CI, P value and original table locations for the selected result.
Conditions for verification: Attribute 155/429=36% versus 216/462=47%, RR 0.77, 95% CI 0.66~0.91 and P=.001 to the same mITT recurrence comparison.
Requirement and applicability: Required
Application exceptions: Do not reverse-calculate new event counts, precise proportions or new confidence intervals from displayed percentages.
Why this condition is needed: Needed to avoid transferring a precise relative risk to another endpoint or analysis.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N15 · Can a prespecified clinical-importance threshold be compared with the interval?

Required materials and conditions: The prespecified clinical-importance threshold, its basis, the original effect interval and planning documents.
Conditions for verification: Clinical sufficiency requires verification of the relationship between a prespecified minimum clinically important difference for recurrence and the reported RR interval.
Requirement and applicability: Required
Application exceptions: An unverified threshold does not establish absence of effect or clinical unimportance.
Why this condition is needed: Needed to avoid establishing a sufficiently important patient effect from a P value or large sample size alone.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N16 · Is the historical 11-percentage-point description distinguished from a new effect calculation?

Required materials and conditions: The original absolute-difference wording, its analysis, calculation history and any reported original interval.
Conditions for verification: Retain the manuscript’s 11-percentage-point absolute difference as a historical description without generating a new absolute difference, NNT or CI.
Requirement and applicability: Required
Application exceptions: The relative RR and historical absolute difference are different measures; that alone does not establish conflicting data.
Why this condition is needed: Needed to avoid promoting a historical rounded description into a new precise estimate or number needed to treat.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N17 · Were the trial number and identity compared against original registration material?

Required materials and conditions: The original NCT02226185 registration, identity links between paper and registration, and update history.
Conditions for verification: Retain NCT02226185 in the citation and not verified in the evidence registration field, and separately check identity against original registration material.
Requirement and applicability: Required
Application exceptions: Coexistence of a recorded number and not verified does not establish nonregistration or an incorrect number.
Why this condition is needed: Needed to distinguish the presence of a number string from verification of original registration material.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N18 · Do planned endpoints, timing and analysis agree with the final report?

Required materials and conditions: Protocols, SAP, registration revisions, final result tables and selective-reporting comparison records.
Conditions for verification: Directly compare recurrence definitions, timing and denominators in registration, protocols and analysis plans with the final report.
Requirement and applicability: Required
Application exceptions: Unacquired planning documents do not establish that selective reporting occurred.
Why this condition is needed: Needed to expose missing material for checking the possibility of favorable analytical selection.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N19 · Is follow-up of the same cohort kept separate from independent replication?

Required materials and conditions: Trial numbers, populations, recruitment periods and overlapping-identity tables for the final paper and follow-up reports.
Conditions for verification: Link the final paper and follow-up of the same cohort within one trial family, distinguishing report counts from trial counts.
Requirement and applicability: Required
Application exceptions: No separate follow-up bibliography is currently available; do not create new report IDs or unique participant totals.
Why this condition is needed: Needed to avoid counting the existence of follow-up reports as independent confirmatory trials.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N20 · Has direct confirmatory material from an independent study family been acquired?

Required materials and conditions: Original reports, registrations, recruitment, formulation, population and outcome details, and overlap comparisons for independent trials.
Conditions for verification: Verify results from independent trials and nonoverlapping study families assessing the same formulation, population and recurrence contract.
Requirement and applicability: Supplementary; required for independent-replication claims
Application exceptions: Unverified independent confirmation within the retained scope does not establish 0 studies worldwide or treatment ineffectiveness.
Why this condition is needed: Needed to avoid treating a single trial’s precision as verification of independent reproducibility.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N21 · Does heterogeneity between the currently linked study families need comparison?

Required materials and conditions: Comparisons of results, formulation, population, duration and analysis if other independent families are added.
Conditions for verification: Do not apply a between-study effect-distribution comparison within the current scope of only one linked report family.
Requirement and applicability: Supplementary; required for application across families
Application exceptions: This nonapplicability is limited to comparison within the currently linked single family and does not replace the unverified independent-replication item.
Why this condition is needed: Needed to avoid inventing a between-study distribution from a single retained family.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N22 · Are optimal dose, persistence after stopping and subgroup confirmation required here?

Required materials and conditions: Direct dose comparisons, post-discontinuation follow-up and prespecified subgroup or interaction material if an extension question is defined.
Conditions for verification: Do not add optimal-dose, persistence-after-stopping or subgroup-confirmation requirements to the original 0.3 g BID principal effect over 1–2 years.
Requirement and applicability: Supplementary; required for the relevant extension claim
Application exceptions: Retain examination of duration and adherence for the original claim; unacquired extension trials do not establish failure of the original recurrence result.
Why this condition is needed: Needed to avoid extending the principal effect to every dose, persistence after stopping or subpopulation.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N23 · Is the adenoma-recurrence result kept separate from cancer prevention?

Required materials and conditions: Definitions, event counts, follow-up and separate effect results for adenoma recurrence and clinical cancer events.
Conditions for verification: Distinguish the surrogate nature of adenoma and observation of 0 colorectal cancers from proof of a cancer-prevention effect.
Requirement and applicability: Required extension boundary
Application exceptions: A cancer-event trial is not imposed as a prerequisite for the adenoma-recurrence value.
Why this condition is needed: Needed to avoid promoting a favorable surrogate difference into prevention of cancer events.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N24 · Are constipation event definitions and collection verified?

Required materials and conditions: Safety tables, constipation definitions, person/event distinctions, collection methods and inclusion rules for 446/478.
Conditions for verification: Verify the 6/446 versus 1/478 constipation comparison together with person/event definitions, collection and denominators.
Requirement and applicability: Supplementary; required for safety descriptions
Application exceptions: Retain 6/446 versus 1/478 without calculating a new risk ratio, difference or attributable rate.
Why this condition is needed: Needed to avoid turning efficacy denominators or reported counts into safety incidence rates.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N25 · Are harm timing, severity, discontinuation and missingness verified?

Required materials and conditions: Safety timelines, severity, stopping and recovery, follow-up and missingness by arm, and tables of all adverse events.
Conditions for verification: Verify administration start and stopping, harm onset and recovery, severity, discontinuation and losses to safety follow-up.
Requirement and applicability: Supplementary; required for the safety scope
Application exceptions: Do not infer identical exposure and complete follow-up for all safety participants from the 1–2-year efficacy plan.
Why this condition is needed: Needed to avoid extending limited constipation reporting into complete safety across all periods.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N26 · Are long-term harms, co-medication and vulnerable-group data verified?

Required materials and conditions: Co-medications, baseline events, interactions, long-term and vulnerable-group exposure, follow-up and harm material.
Conditions for verification: Retain the reported warning and distinguish direct information on long-term clinical safety, drug interactions and use outside the population.
Requirement and applicability: Supplementary; required for safety extensions
Application exceptions: Unverified interactions also do not establish that an interaction occurred.
Why this condition is needed: Needed to avoid treating a single recurrence trial as evidence of harmlessness for every population.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N27 · Is confirmation of independently repeated harm signals required in this checklist?

Required materials and conditions: Unique-event and study-family material and recitation comparisons if a repeated-harm claim is added.
Conditions for verification: Do not add a repeated-harm confirmation requirement to the current adenoma-recurrence checklist; retain limitations of safety reporting.
Requirement and applicability: Supplementary; required for repeated-harm claims
Application exceptions: This nonapplicability does not turn unverified constipation or long-term harms into harmlessness.
Why this condition is needed: Needed to avoid automatically imposing a separate repeated-harm condition on an efficacy question.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N28 · Are product support, author identity and patents verified beyond the funding name?

Required materials and conditions: Funding, trial-product provision, author affiliations and employment, patents, complete COI declarations and roles.
Conditions for verification: Separately link verification levels for reported funding, product support, author employment, patents and declared conflicts of interest.
Requirement and applicability: Supplementary; required for independence claims
Application exceptions: Funding is not an automatic exclusion reason, and the original I2 is not inherited as a new independence judgment.
Why this condition is needed: Needed to avoid claiming independence or absence of bias from a single funder name.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N29 · Which materials were actually read in this work?

Required materials and conditions: Actual reading, access, acquisition and locations for each material, safe links and timestamps.
Conditions for verification: Distinguish actual reading of the retained summary from external PubMed and full-text access that was not attempted, acquired or read.
Requirement and applicability: Required
Application exceptions: Do not mark unattempted access as inaccessible or successful.
Why this condition is needed: Needed to avoid mistaking a blue summary-reading link for actual reading of clinical full text.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N30 · Are the current response and identity of the original bibliographic URL verified?

Required materials and conditions: Original bibliography, PMID/DOI, current URL response and identity comparisons with paper and registration.
Conditions for verification: Distinguish the Chen 2020, PMID 31926918, DOI and original PubMed URL strings from verification of current response and agreement with the original document.
Requirement and applicability: Required
Application exceptions: The PubMed URL is a bibliography and abstract-index entry point. Its current offered scope remains unverified because it was not opened.
Why this condition is needed: Needed to avoid turning a URL string into successful current access or acquisition of paper full text.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N31 · Can the scope of historical search and retraction/correction checks be traced?

Required materials and conditions: Historical search strategies and dates, selection logs, evidence for retraction/correction checks and latest authorized review records.
Conditions for verification: Distinguish historical descriptions of final, follow-up and retraction/correction review from actual logs and the current checking scope by date.
Requirement and applicability: Required
Application exceptions: No new search does not establish 0 current studies or absence of retractions/corrections.
Why this condition is needed: Needed to avoid exaggerating retained descriptions into a current full-literature search or certification of no current retraction.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N32 · Are the original grade and axes kept separate from current condition statuses?

Required materials and conditions: Current grade, score, safety, axes, original grade decision and complete originals before and after correction.
Conditions for verification: Preserve C, 54, Warning, S/R1/I2/E+/B2/CX and original Boolean and empty-string values as source material without creating a new verdict.
Requirement and applicability: Required
Application exceptions: The independent-cross-check wording in the original grade decision is quoted only as a historical description.
Why this condition is needed: Needed to avoid promoting historical scores or cross-check wording into current checklist fulfillment or clinical certification.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N33 · Are generic English descriptions kept separate from new specific facts?

Required materials and conditions: Korean/English evidence and citation correspondence, and records before and after the English-placeholder correction.
Conditions for verification: Distinguish specific bilingual contracts from remaining generic placeholders in evidence and citations, preserving the originals unchanged.
Requirement and applicability: Required
Application exceptions: This conversion does not replace the original source translation; remaining generic descriptions are preserved.
Why this condition is needed: Needed to avoid filling gaps in original Korean material with remaining generic English descriptions.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

N34 · Are empty source values distinguished from absent keys?

Required materials and conditions: All current source keys, typed original values and comparisons of access/effect field presence.
Conditions for verification: Distinguish empty subclaim lists and deliberation strings from absent source-list, principal-effect and access fields; do not represent an absent key as an original null value.
Requirement and applicability: Required
Application exceptions: Access records in this new checklist are its own records; do not imply that these access fields existed in the original source.
Why this condition is needed: Needed to avoid automatically turning absent keys, nulls, empty lists and unverified values into the same fact.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

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

Referenced principle: Link studies and reports separately; do not omit studies solely because results are unreported.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

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

Referenced principle: Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

What the statuses mean

Met: The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.
Partly verified: Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.
Unverified: The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.
Not applicable: 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.
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.
Review incomplete: Original-material comparisons or searches were not performed within the authorized scope.
Not applicable (alias): An alias for not applicable: reasoned nonapplicability, not a replacement for unread status.
Not read: External material was not directly read in this work; distinguish this from reading a retained summary.

Change history

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

The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed.

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

Researcher downloads

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

View all item details

N01 · Which adenoma-recurrence question does this checklist address?

Current findings: The original claim is reduced colorectal adenoma recurrence after complete polypectomy. It is limited to a comparison with matching placebo of at least one recurrent adenoma at follow-up colonoscopy over 1–2 years.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The original claim, claim conditions and summary note specify the population, intervention, comparator and endpoint boundaries.
Reason for missing information: The identity of the question has been checked. This does not establish cancer prevention, treatment of adenomas or replacement of colonoscopy.
Required materials and conditions: The exact original claim, population, formulation, endpoint, comparison and canonical URL.
Materials to obtain first: The exact original claim, population, formulation, endpoint, comparison and canonical URL.
Further research: Compare inclusion and exclusion boundaries to check whether adenoma counts, advanced adenomas, cancer prevention or treatment of existing adenomas have been mixed into the principal effect.
Remaining uncertainty: The identity of the question has been checked. This does not establish cancer prevention, treatment of adenomas or replacement of colonoscopy.
Conditions for verification: Fix the single question of oral berberine hydrochloride versus matching placebo for adenoma recurrence over 1–2 years in adults after complete polypectomy.
Why this condition is needed: Needed to avoid combining effects for separate endpoints and products into a single result.
Application exceptions: An empty subclaim list does not establish the worldwide absence of other claims, and the checklist is not expanded into every combination of assessment axes.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N02 · Are the tablet ingredient, source and product identity verified?

Current findings: The claim conditions specify purified berberine hydrochloride and explicitly leave its plant source unverified. The retained summary does not specify the manufacturer or detailed product standards.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The ingredient and tablet formulation are recorded, but the plant source and detailed product identity remain unverified.
Reason for missing information: Product identity with other extracts, dihydroberberine, combinations or topical products has not been established.
Required materials and conditions: Tablet composition, manufacturer, product standards, plant source and analytical certification material.
Materials to obtain first: Tablet composition, manufacturer, product standards, plant source and analytical certification material.
Further research: Compare manufacturing and composition documents with the trial product to establish the limits of identity with hydrochloride, plant extracts, derivatives and combinations.
Remaining uncertainty: Product identity with other extracts, dihydroberberine, combinations or topical products has not been established.
Conditions for verification: Identify the berberine hydrochloride tablet separately from unverified information about its plant source and product.
Why this condition is needed: Needed to avoid transferring trial results to products with similar ingredient names.
Application exceptions: An unverified plant source does not erase the recorded identity as purified berberine hydrochloride.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N03 · What oral dose and administration frequency were specified?

Current findings: The retained contract is oral berberine hydrochloride as a 0.3 g tablet, taken 2 times daily for a prescribed 0.6 g/day. Actual cumulative intake and adherence remain separately unverified.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The formulation, route and dose in the claim conditions agree with the corresponding English contract.
Reason for missing information: The nominal administration contract was checked. Actual exposure remains a gap in the co-intervention and adherence items.
Required materials and conditions: Formulation, route, content per tablet, frequency, nominal daily amount and administration records.
Materials to obtain first: Formulation, route, content per tablet, frequency, nominal daily amount and administration records.
Further research: Compare tablet content and administration frequency, and link actual intake records separately from the nominal prescription if acquired.
Remaining uncertainty: The nominal administration contract was checked. Actual exposure remains a gap in the co-intervention and adherence items.
Conditions for verification: Retain the nominal oral regimen of a 0.3 g tablet 2 times daily, 0.6 g/day, and distinguish it from actual adherence and exposure.
Why this condition is needed: Needed to avoid treating 0.3 g as the total daily amount or changing the administration route.
Application exceptions: Unverified actual intake or adherence does not mean the nominal dose was not recorded.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N04 · Which adults after polypectomy were included?

Current findings: The population is adults aged 18–75 with 1–6 histologically confirmed adenomas completely removed within 6 months.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The exact population is retained in the claim conditions and corresponding English text.
Reason for missing information: The population definition was checked. Further exclusions and the baseline-risk distribution remain gaps in the following selection-process item.
Required materials and conditions: Diagnosis, age, adenoma count, histological confirmation, complete removal and the interval before enrollment.
Materials to obtain first: Diagnosis, age, adenoma count, histological confirmation, complete removal and the interval before enrollment.
Further research: Separate the population conditions and compare the trial population with treatment of residual adenomas, a general adenoma-free population and cancer patients.
Remaining uncertainty: The population definition was checked. Further exclusions and the baseline-risk distribution remain gaps in the following selection-process item.
Conditions for verification: Limit the population to adults aged 18–75 with 1–6 histologically confirmed adenomas completely removed within 6 months.
Why this condition is needed: Needed to avoid extending post-polypectomy recurrence results to general prevention or treatment of existing lesions.
Application exceptions: Verification of eligibility wording does not establish representativeness for all ages or all adenoma-risk groups.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N05 · Are recruitment, exclusions and baseline balance verified?

Current findings: A multicentre trial at 7 hospitals and the post-polypectomy population are recorded. Detailed recruitment, exclusions and baseline-balance tables are absent from this retained summary.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The hospital count and population are known, but selection and baseline material that could affect the analysis remain missing.
Reason for missing information: Site-specific and baseline-risk composition and reasons for exclusion cannot be compared within the retained material.
Required materials and conditions: Recruitment flow, exclusion criteria, baseline tables by arm, adenoma risk and site composition.
Materials to obtain first: Recruitment flow, exclusion criteria, baseline tables by arm, adenoma risk and site composition.
Further research: Compare the enrollment-to-analysis flow and baseline tables to examine differences between the selected population and the target population.
Remaining uncertainty: Site-specific and baseline-risk composition and reasons for exclusion cannot be compared within the retained material.
Conditions for verification: Actual recruitment and exclusion conditions at the 7 hospitals, and baseline risks by arm, must be linked to the analysis population.
Why this condition is needed: Needed to avoid transferring results in selected post-polypectomy patients to all adults.
Application exceptions: Failure to acquire baseline tables does not establish baseline imbalance or lack of representativeness.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N06 · Are differences in co-interventions and adherence beyond matching placebo verified?

Current findings: The matching-placebo control is explicit. Detailed placebo composition, co-interventions, rescue treatment, actual adherence and changes in administration by arm are not specified in the summary.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The comparator type is recorded, but the relationship of actual co-interventions and deviations to the effect of interest remains unverified.
Reason for missing information: The influence of actual exposure and co-intervention differences on the mITT recurrence comparison has not been examined.
Required materials and conditions: Placebo composition, co-interventions and rescue treatment, adherence, changes by arm and analytical handling.
Materials to obtain first: Placebo composition, co-interventions and rescue treatment, adherence, changes by arm and analytical handling.
Further research: Compare treatment and adherence records by arm to distinguish the assigned formulation difference from contributions of other changes.
Remaining uncertainty: The influence of actual exposure and co-intervention differences on the mITT recurrence comparison has not been examined.
Conditions for verification: Check co-interventions, rescue treatment, adherence, deviations and their handling beyond the difference between matching placebo and berberine.
Why this condition is needed: Needed to avoid attributing differences in other treatments or intake behaviour to the formulation.
Application exceptions: The matching-placebo label alone does not establish that every actual co-intervention and adherence pattern was identical.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

Related sources S01

N07 · What follow-up period and examination times apply to adenoma recurrence?

Current findings: The retained period is 1–2 years, with a 2-year colonoscopy if the 1-year colonoscopy is negative. The result is recurrence identified at follow-up colonoscopy.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The claim conditions and English contract specify the conditional re-examination rule.
Reason for missing information: The planned time boundary was checked. Individual actual examination and dropout times remain separately unverified.
Required materials and conditions: Administration and follow-up periods, colonoscopy schedules by arm and the re-examination rule after a negative result.
Materials to obtain first: Administration and follow-up periods, colonoscopy schedules by arm and the re-examination rule after a negative result.
Further research: Link recurrence results to the examination schedule and separately examine unexamined intervals and persistence after stopping.
Remaining uncertainty: The planned time boundary was checked. Individual actual examination and dropout times remain separately unverified.
Conditions for verification: Retain the contract of 1–2 years of follow-up and a 2-year colonoscopy if the 1-year colonoscopy is negative.
Why this condition is needed: Needed to distinguish a single fixed endpoint from a conditional examination pathway.
Application exceptions: Do not turn the 1–2-year contract into complete observation of every participant for exactly 2 years or into an effect after stopping.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N08 · How is recurrence distinguished from other adenoma outcomes?

Current findings: The principal endpoint is at least one recurrent adenoma at follow-up colonoscopy. Retain the manuscript boundary separating adenoma counts, advanced adenomas and colorectal cancer as other questions.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The principal endpoint in the claim conditions and the summary note explicitly distinguish outcomes.
Reason for missing information: The selected endpoint was checked. Its value does not supply effect sizes for other outcomes.
Required materials and conditions: Principal-endpoint definitions, other adenoma outcomes, cancer outcomes and reporting locations.
Materials to obtain first: Principal-endpoint definitions, other adenoma outcomes, cancer outcomes and reporting locations.
Further research: Make an outcome-definition table and check whether each value represents a proportion of people with recurrence or a count of adenomas.
Remaining uncertainty: The selected endpoint was checked. Its value does not supply effect sizes for other outcomes.
Conditions for verification: Distinguish at least one recurrent adenoma at follow-up colonoscopy from adenoma counts, advanced adenomas and cancer.
Why this condition is needed: Needed to avoid combining effects on counts, advanced lesions or cancer with the principal recurrence effect.
Application exceptions: The absence of direct values for other endpoints does not erase the recorded recurrence result.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N09 · Are the actual colonoscopy and histological assessment procedures verified?

Current findings: The colonoscopic-recurrence endpoint and double-blind trial label are recorded. Examination quality, histological procedures, assessor-specific blinding and completed examinations by arm remain unverified in detail.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The broad measurement approach is recorded, but details needed to compare limitations in actual outcome measurement are missing.
Reason for missing information: The retained summary cannot establish differences between arms in examination or pathology collection, or assessment blinding.
Required materials and conditions: Colonoscopy and pathology procedures, quality control, assessor blinding and examination-completion tables by arm.
Materials to obtain first: Colonoscopy and pathology procedures, quality control, assessor blinding and examination-completion tables by arm.
Further research: Compare endpoint-collection procedures and completed examinations by arm to examine how detection differences limit the recurrence comparison.
Remaining uncertainty: The retained summary cannot establish differences between arms in examination or pathology collection, or assessment blinding.
Conditions for verification: Adenoma-identification procedures, examination quality, assessor blinding and examination differences by arm must be linked to the selected result.
Why this condition is needed: Needed to distinguish detection conditions from actual recurrence differences.
Application exceptions: The double-blind label alone does not establish that colonoscopy and pathology assessors were blinded.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N10 · Are randomization, concealment and blinding methods verified?

Current findings: The retained description is a multicentre, double-blind, randomized placebo trial at 7 hospitals. Sequence generation and implementation of concealment and blinding are absent from the current summary.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The design label is known, but actual allocation procedures supporting the causal comparison remain unverified.
Reason for missing information: Allocation and blinding details and baseline balance have not been compared at full-text level.
Required materials and conditions: Allocation sequences, concealment, allocation by site, blinding procedures and the original methods text.
Materials to obtain first: Allocation sequences, concealment, allocation by site, blinding procedures and the original methods text.
Further research: Compare methods sections and allocation records against bias domains for the selected result, retaining unverified domains separately.
Remaining uncertainty: Allocation and blinding details and baseline balance have not been compared at full-text level.
Conditions for verification: Distinguish the multicentre randomized double-blind label from actual sequence generation, allocation concealment and blinding procedures.
Why this condition is needed: Needed to avoid promoting an RCT label into verification of detailed allocation procedures.
Application exceptions: Unverified details do not establish a nonrandomized design, and no new formal risk-of-bias assessment is performed.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N11 · Can randomized, efficacy and safety denominators be distinguished?

Current findings: There were 1,108 randomized participants and 891 in the mITT population with efficacy data. Recurrence denominators are 429 versus 462, while constipation denominators are 446 versus 478.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The reader answer, evidence population description and safety explanation give different denominators.
Reason for missing information: Attribution of the reported denominators was checked. Inclusion rules for each population and complete participant flow remain gaps in the next item.
Required materials and conditions: Definitions of randomized, efficacy-analysis and safety populations, and event and denominator tables by arm.
Materials to obtain first: Definitions of randomized, efficacy-analysis and safety populations, and event and denominator tables by arm.
Further research: Link each denominator to its analysis population in a comparison table and identify displays that substitute randomized counts for efficacy or safety denominators.
Remaining uncertainty: Attribution of the reported denominators was checked. Inclusion rules for each population and complete participant flow remain gaps in the next item.
Conditions for verification: Retain 1,108 randomized participants, the 891-person mITT population with denominators 429/462, and safety denominators 446/478 for their respective outcomes.
Why this condition is needed: Needed to avoid calculating event proportions for different analysis populations with a single denominator.
Application exceptions: Do not generate unreported randomized or completed counts by arm through subtraction or reverse calculation.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N12 · Are reasons for missing efficacy data and their handling verified?

Current findings: The manuscript states that only 891 participants were analyzed for efficacy and that about 20% of efficacy data were missing. Reasons, handling and sensitivity results by arm are absent from the summary.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Data loss is recorded, but reasons and handling material needed to examine its influence on the result remain missing.
Reason for missing information: Retain about 20% only as a historical description. Complete ITT results and missing-data sensitivity remain unverified.
Required materials and conditions: Missing efficacy data, dropout reasons by arm, missing-data handling, sensitivity analyses and the participant-flow diagram.
Materials to obtain first: Missing efficacy data, dropout reasons by arm, missing-data handling, sensitivity analyses and the participant-flow diagram.
Further research: Compare reasons for missingness and examination status by arm, and check prespecified sensitivity-analysis plans examining assumptions of the original analysis.
Remaining uncertainty: Retain about 20% only as a historical description. Complete ITT results and missing-data sensitivity remain unverified.
Conditions for verification: Verify exclusion reasons, losses by arm and sensitivity handling when efficacy data for only 891 of the 1,108 randomized participants were analyzed.
Why this condition is needed: Needed to avoid interpreting results among analyzed participants as complete follow-up of everyone randomized.
Application exceptions: Do not recalculate the manuscript’s approximate 20% as a new exact percentage or classify all missing observations as treatment failures.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N13 · Are mITT inclusion rules and the analytical model verified?

Current findings: Results were reported for modified ITT populations of 429 versus 462 participants. Inclusion rules, adjustment models and complete ITT or PP results were not verified in the current summary.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The analysis name and denominators are recorded, but actual effect definitions and inclusion rules remain unverified.
Reason for missing information: The exact estimand and sensitivity, whether for assignment, participants with observed data or adherence, remain unverified.
Required materials and conditions: The mITT definition, analysis plan, adjustment variables, ITT/PP results and handling of incomplete examinations.
Materials to obtain first: The mITT definition, analysis plan, adjustment variables, ITT/PP results and handling of incomplete examinations.
Further research: Compare the analysis plan with result tables to examine how mITT inclusion rules differ from the selected assignment effect.
Remaining uncertainty: The exact estimand and sensitivity, whether for assignment, participants with observed data or adherence, remain unverified.
Conditions for verification: Distinguish the actual modified-ITT inclusion rules, adjustment and effect of interest from the effect of original assignment.
Why this condition is needed: Needed to avoid automatically interpreting the mITT label as complete ITT or an adherence effect.
Application exceptions: Unverified adjustment or model details do not establish an unadjusted analysis.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N14 · What RR, interval and P value were originally reported for recurrence?

Current findings: The retained mITT adenoma-recurrence result is 155/429=36% versus 216/462=47%, RR 0.77, 95% CI 0.66~0.91, P=.001.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The evidence result, citation result summary and reader answer contain the same original values.
Reason for missing information: The original reported values and their attribution were checked. Rereading original full-text tables and checking analytical methods remain outside the current reading and verification scope.
Required materials and conditions: Events and denominators, original proportions, effect measure, CI, P value and original table locations for the selected result.
Materials to obtain first: Events and denominators, original proportions, effect measure, CI, P value and original table locations for the selected result.
Further research: Compare original result tables with retained citation values and check whether labels have changed to another measure such as HR or a within-group test instead of RR.
Remaining uncertainty: The original reported values and their attribution were checked. Rereading original full-text tables and checking analytical methods remain outside the current reading and verification scope.
Conditions for verification: Attribute 155/429=36% versus 216/462=47%, RR 0.77, 95% CI 0.66~0.91 and P=.001 to the same mITT recurrence comparison.
Why this condition is needed: Needed to avoid transferring a precise relative risk to another endpoint or analysis.
Application exceptions: Do not reverse-calculate new event counts, precise proportions or new confidence intervals from displayed percentages.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N15 · Can a prespecified clinical-importance threshold be compared with the interval?

Current findings: The RR interval and P value are retained, together with the manuscript statement that a prespecified minimum clinically important difference for adenoma recurrence was not verified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: An interval is available, but the prespecified clinical-importance threshold needed for comparison is missing.
Reason for missing information: The relationship between statistical significance and prespecified clinical importance cannot be established from this retained material.
Required materials and conditions: The prespecified clinical-importance threshold, its basis, the original effect interval and planning documents.
Materials to obtain first: The prespecified clinical-importance threshold, its basis, the original effect interval and planning documents.
Further research: Compare an acquired prespecified importance threshold with the original interval’s range, without inventing thresholds or new scores.
Remaining uncertainty: The relationship between statistical significance and prespecified clinical importance cannot be established from this retained material.
Conditions for verification: Clinical sufficiency requires verification of the relationship between a prespecified minimum clinically important difference for recurrence and the reported RR interval.
Why this condition is needed: Needed to avoid establishing a sufficiently important patient effect from a P value or large sample size alone.
Application exceptions: An unverified threshold does not establish absence of effect or clinical unimportance.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N16 · Is the historical 11-percentage-point description distinguished from a new effect calculation?

Current findings: The 11-percentage-point absolute difference in the limitations and counterpoint descriptions is a retained historical value. This checklist does not calculate a new absolute difference, NNT or interval.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The boundary between historical wording and the absence of a new calculation was fixed.
Reason for missing information: The original table and calculation history for the historical absolute difference were not newly compared. No new NNT is presented.
Required materials and conditions: The original absolute-difference wording, its analysis, calculation history and any reported original interval.
Materials to obtain first: The original absolute-difference wording, its analysis, calculation history and any reported original interval.
Further research: Link the historical description to original reported rates to check whether it is presented as a new calculation; do not fill in an NNT that was not calculated.
Remaining uncertainty: The original table and calculation history for the historical absolute difference were not newly compared. No new NNT is presented.
Conditions for verification: Retain the manuscript’s 11-percentage-point absolute difference as a historical description without generating a new absolute difference, NNT or CI.
Why this condition is needed: Needed to avoid promoting a historical rounded description into a new precise estimate or number needed to treat.
Application exceptions: The relative RR and historical absolute difference are different measures; that alone does not establish conflicting data.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N17 · Were the trial number and identity compared against original registration material?

Current findings: The citation and research-review description contain NCT02226185, while the evidence registration-check field says not verified. Both are retained; original registration material was not opened in this work.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: A registration-number string is recorded, but comparison with the identity and content of original registration material remains unverified.
Reason for missing information: Retain the boundary between these coexisting statements. Do not make a new judgment that registration was verified or absent.
Required materials and conditions: The original NCT02226185 registration, identity links between paper and registration, and update history.
Materials to obtain first: The original NCT02226185 registration, identity links between paper and registration, and update history.
Further research: Compare registration, paper and follow-up report identities to establish whether they concern the same trial before using them for plan comparisons.
Remaining uncertainty: Retain the boundary between these coexisting statements. Do not make a new judgment that registration was verified or absent.
Conditions for verification: Retain NCT02226185 in the citation and not verified in the evidence registration field, and separately check identity against original registration material.
Why this condition is needed: Needed to distinguish the presence of a number string from verification of original registration material.
Application exceptions: Coexistence of a recorded number and not verified does not establish nonregistration or an incorrect number.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N18 · Do planned endpoints, timing and analysis agree with the final report?

Current findings: Recurrence over 1–2 years and mITT results are recorded. The current input contains no material directly comparing planned endpoints, denominators and timing in original registration, protocols or the SAP.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Result reporting alone cannot establish agreement with prespecified plans.
Reason for missing information: Agreement between plans and results, reasons for changes and selective reporting have not been compared.
Required materials and conditions: Protocols, SAP, registration revisions, final result tables and selective-reporting comparison records.
Materials to obtain first: Protocols, SAP, registration revisions, final result tables and selective-reporting comparison records.
Further research: Compare planned and actual endpoints, analyses and examination times across document versions and check reasons for changes.
Remaining uncertainty: Agreement between plans and results, reasons for changes and selective reporting have not been compared.
Conditions for verification: Directly compare recurrence definitions, timing and denominators in registration, protocols and analysis plans with the final report.
Why this condition is needed: Needed to expose missing material for checking the possibility of favorable analytical selection.
Application exceptions: Unacquired planning documents do not establish that selective reporting occurred.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N19 · Is follow-up of the same cohort kept separate from independent replication?

Current findings: The manuscript states that the final NCT02226185 paper was distinguished from follow-up of the same cohort. The current evidence list and citation list each contain 1 entry; follow-up reports are not counted as new independent trials.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The key explanation and research-review description explicitly distinguish overlap within the same cohort.
Reason for missing information: The boundary for treating reports as one study family was checked. Separate follow-up bibliography and participant totals across the full family remain unverified.
Required materials and conditions: Trial numbers, populations, recruitment periods and overlapping-identity tables for the final paper and follow-up reports.
Materials to obtain first: Trial numbers, populations, recruitment periods and overlapping-identity tables for the final paper and follow-up reports.
Further research: If follow-up material is acquired, compare recruitment, trial numbers and participant overlap, then link it as a separate timepoint within the same family.
Remaining uncertainty: The boundary for treating reports as one study family was checked. Separate follow-up bibliography and participant totals across the full family remain unverified.
Conditions for verification: Link the final paper and follow-up of the same cohort within one trial family, distinguishing report counts from trial counts.
Why this condition is needed: Needed to avoid counting the existence of follow-up reports as independent confirmatory trials.
Application exceptions: No separate follow-up bibliography is currently available; do not create new report IDs or unique participant totals.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N20 · Has direct confirmatory material from an independent study family been acquired?

Current findings: The manuscript retains lack of independent confirmation as a limitation. Direct evidence in the current input is one report; follow-up of the same cohort is not independent replication.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The current retained material does not contain acquired identities and results for a separate independent direct trial.
Reason for missing information: Direct material establishing independent confirmation was not verified in this input. No new search of the full literature was performed.
Required materials and conditions: Original reports, registrations, recruitment, formulation, population and outcome details, and overlap comparisons for independent trials.
Materials to obtain first: Original reports, registrations, recruitment, formulation, population and outcome details, and overlap comparisons for independent trials.
Further research: If further trials are acquired, compare family identity, formulation, population, timing and analysis before examining independent replication.
Remaining uncertainty: Direct material establishing independent confirmation was not verified in this input. No new search of the full literature was performed.
Conditions for verification: Verify results from independent trials and nonoverlapping study families assessing the same formulation, population and recurrence contract.
Why this condition is needed: Needed to avoid treating a single trial’s precision as verification of independent reproducibility.
Application exceptions: Unverified independent confirmation within the retained scope does not establish 0 studies worldwide or treatment ineffectiveness.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N21 · Does heterogeneity between the currently linked study families need comparison?

Current findings: The current evidence and bibliography concern one report, and follow-up of the same cohort is treated within the same family. No distribution of effects across different linked families is currently compared.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Results from multiple independent families are not currently linked for comparison.
Reason for missing information: Between-study heterogeneity comparison is currently not applicable. The independent-confirmation gap remains in N20.
Required materials and conditions: Comparisons of results, formulation, population, duration and analysis if other independent families are added.
Materials to obtain first: Comparisons of results, formulation, population, duration and analysis if other independent families are added.
Further research: Only when an independent family is newly acquired, compare results and contract differences side by side and examine comparability.
Remaining uncertainty: Between-study heterogeneity comparison is currently not applicable. The independent-confirmation gap remains in N20.
Conditions for verification: Do not apply a between-study effect-distribution comparison within the current scope of only one linked report family.
Why this condition is needed: Needed to avoid inventing a between-study distribution from a single retained family.
Application exceptions: This nonapplicability is limited to comparison within the currently linked single family and does not replace the unverified independent-replication item.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N22 · Are optimal dose, persistence after stopping and subgroup confirmation required here?

Current findings: The current question is the specified regimen and recurrence comparison over 1–2 years. Direct optimal-dose, post-discontinuation persistence and prespecified subgroup confirmation remain separate questions.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Requirements for extended effects are not added to the current narrow original claim.
Reason for missing information: This does not mean extension evidence was verified. Actual adherence and individual follow-up gaps for the original claim remain in other items.
Required materials and conditions: Direct dose comparisons, post-discontinuation follow-up and prespecified subgroup or interaction material if an extension question is defined.
Materials to obtain first: Direct dose comparisons, post-discontinuation follow-up and prespecified subgroup or interaction material if an extension question is defined.
Further research: Future extension questions should separately design and assess direct dose comparisons, prespecified subgroup interactions and follow-up after stopping.
Remaining uncertainty: This does not mean extension evidence was verified. Actual adherence and individual follow-up gaps for the original claim remain in other items.
Conditions for verification: Do not add optimal-dose, persistence-after-stopping or subgroup-confirmation requirements to the original 0.3 g BID principal effect over 1–2 years.
Why this condition is needed: Needed to avoid extending the principal effect to every dose, persistence after stopping or subpopulation.
Application exceptions: Retain examination of duration and adherence for the original claim; unacquired extension trials do not establish failure of the original recurrence result.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N23 · Is the adenoma-recurrence result kept separate from cancer prevention?

Current findings: The manuscript describes adenoma as a surrogate for colorectal cancer and states that no colorectal cancers were observed in the trial. Observing 0 events establishes neither cancer-prevention efficacy nor equivalence.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The verdict rationale and advertising restrictions prohibit extensions to cancer prevention or replacement of colonoscopy.
Reason for missing information: The boundary between adenoma recurrence and cancer prevention was checked. No direct cancer-prevention estimate was acquired.
Required materials and conditions: Definitions, event counts, follow-up and separate effect results for adenoma recurrence and clinical cancer events.
Materials to obtain first: Definitions, event counts, follow-up and separate effect results for adenoma recurrence and clinical cancer events.
Further research: Evaluating cancer prevention requires a comparative trial with a separate clinical cancer endpoint and sufficient follow-up, analyzed separately from the adenoma surrogate result.
Remaining uncertainty: The boundary between adenoma recurrence and cancer prevention was checked. No direct cancer-prevention estimate was acquired.
Conditions for verification: Distinguish the surrogate nature of adenoma and observation of 0 colorectal cancers from proof of a cancer-prevention effect.
Why this condition is needed: Needed to avoid promoting a favorable surrogate difference into prevention of cancer events.
Application exceptions: A cancer-event trial is not imposed as a prerequisite for the adenoma-recurrence value.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N24 · Are constipation event definitions and collection verified?

Current findings: The original warning reports constipation as 6/446 versus 1/478. The summary does not specify whether counts represent people or events, the event definition, systematic collection or safety inclusion rules.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The constipation comparison and denominators are recorded, but details of collection and counting units remain unverified.
Reason for missing information: Complete constipation collection, the exact counting unit and causal attribution cannot be established from the current input.
Required materials and conditions: Safety tables, constipation definitions, person/event distinctions, collection methods and inclusion rules for 446/478.
Materials to obtain first: Safety tables, constipation definitions, person/event distinctions, collection methods and inclusion rules for 446/478.
Further research: Compare original safety tables and collection plans to verify constipation counting units and exposed/control denominators.
Remaining uncertainty: Complete constipation collection, the exact counting unit and causal attribution cannot be established from the current input.
Conditions for verification: Verify the 6/446 versus 1/478 constipation comparison together with person/event definitions, collection and denominators.
Why this condition is needed: Needed to avoid turning efficacy denominators or reported counts into safety incidence rates.
Application exceptions: Retain 6/446 versus 1/478 without calculating a new risk ratio, difference or attributable rate.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N25 · Are harm timing, severity, discontinuation and missingness verified?

Current findings: Constipation reporting and the 1–2-year efficacy contract are recorded. Onset and recovery times, severity, discontinuation, all adverse events and losses by arm remain unverified in detail.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: No direct material is available to compare the selected harm’s timeline, discontinuation, complete collection and follow-up.
Reason for missing information: Absence of discontinuations or serious events cannot be claimed; administration periods and event-collection periods have not been compared.
Required materials and conditions: Safety timelines, severity, stopping and recovery, follow-up and missingness by arm, and tables of all adverse events.
Materials to obtain first: Safety timelines, severity, stopping and recovery, follow-up and missingness by arm, and tables of all adverse events.
Further research: Examine exposure and event timelines and follow-up losses by arm without converting absent reporting into 0 events.
Remaining uncertainty: Absence of discontinuations or serious events cannot be claimed; administration periods and event-collection periods have not been compared.
Conditions for verification: Verify administration start and stopping, harm onset and recovery, severity, discontinuation and losses to safety follow-up.
Why this condition is needed: Needed to avoid extending limited constipation reporting into complete safety across all periods.
Application exceptions: Do not infer identical exposure and complete follow-up for all safety participants from the 1–2-year efficacy plan.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N26 · Are long-term harms, co-medication and vulnerable-group data verified?

Current findings: The original text states that long-term clinical safety and drug interactions are not fully established. Specific co-medications, alternative causes and vulnerable-group results are absent from the current summary.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The original warning is retained, but direct evidence for extended safety remains unverified.
Reason for missing information: Long-term safety, co-medication safety and safety outside the population are not established. No new administration instructions or safety grade are assigned.
Required materials and conditions: Co-medications, baseline events, interactions, long-term and vulnerable-group exposure, follow-up and harm material.
Materials to obtain first: Co-medications, baseline events, interactions, long-term and vulnerable-group exposure, follow-up and harm material.
Further research: Separately examine long-term follow-up and harm-observation designs including co-medication and baseline risks, and compare the limited safety scope of this trial.
Remaining uncertainty: Long-term safety, co-medication safety and safety outside the population are not established. No new administration instructions or safety grade are assigned.
Conditions for verification: Retain the reported warning and distinguish direct information on long-term clinical safety, drug interactions and use outside the population.
Why this condition is needed: Needed to avoid treating a single recurrence trial as evidence of harmlessness for every population.
Application exceptions: Unverified interactions also do not establish that an interaction occurred.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N27 · Is confirmation of independently repeated harm signals required in this checklist?

Current findings: The current question concerns adenoma recurrence and does not claim independently repeated harms. Constipation comparison, collection, timing and long-term limitations remain separately addressed in N24~N26.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: A requirement for the separate extension claim of independently repeated harms does not apply to the current original question.
Reason for missing information: The repeated-harm requirement is not applicable; this does not establish absence of harm or verified safety.
Required materials and conditions: Unique-event and study-family material and recitation comparisons if a repeated-harm claim is added.
Materials to obtain first: Unique-event and study-family material and recitation comparisons if a repeated-harm claim is added.
Further research: If a future repeated-harm question is defined, compare unique events and families and link repeated citations to the same signal.
Remaining uncertainty: The repeated-harm requirement is not applicable; this does not establish absence of harm or verified safety.
Conditions for verification: Do not add a repeated-harm confirmation requirement to the current adenoma-recurrence checklist; retain limitations of safety reporting.
Why this condition is needed: Needed to avoid automatically imposing a separate repeated-harm condition on an efficacy question.
Application exceptions: This nonapplicability does not turn unverified constipation or long-term harms into harmlessness.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N28 · Are product support, author identity and patents verified beyond the funding name?

Current findings: The evidence funding entry names the National Natural Science Foundation of China. Product provision, author employment and patents, complete declarations and the funder’s role remain unverified in detail.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The funding name is recorded, but material on other dimensions of independence and roles remains missing.
Reason for missing information: A public funding name alone does not establish absence of product or author conflicts, or independent confirmation.
Required materials and conditions: Funding, trial-product provision, author affiliations and employment, patents, complete COI declarations and roles.
Materials to obtain first: Funding, trial-product provision, author affiliations and employment, patents, complete COI declarations and roles.
Further research: Separately compare funding, product, author and patent declarations to check funding sources and roles in result analysis.
Remaining uncertainty: A public funding name alone does not establish absence of product or author conflicts, or independent confirmation.
Conditions for verification: Separately link verification levels for reported funding, product support, author employment, patents and declared conflicts of interest.
Why this condition is needed: Needed to avoid claiming independence or absence of bias from a single funder name.
Application exceptions: Funding is not an automatic exclusion reason, and the original I2 is not inherited as a new independence judgment.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N29 · Which materials were actually read in this work?

Current findings: The entire original-byte retained source was read, including Korean/English content, evidence, citations and structure. External PubMed responses, original full text, registration, follow-up reports and older separate files were not opened.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual local reading and the boundary of unattempted external access were distinguished.
Reason for missing information: Summary reading is the fact being checked. Current direct reading and factual comparison of original clinical material and registration remain outstanding.
Required materials and conditions: Actual reading, access, acquisition and locations for each material, safe links and timestamps.
Materials to obtain first: Actual reading, access, acquisition and locations for each material, safe links and timestamps.
Further research: Compare action records for each material with retained source locations to check that a summary link is not presented as external full-text reading.
Remaining uncertainty: Summary reading is the fact being checked. Current direct reading and factual comparison of original clinical material and registration remain outstanding.
Conditions for verification: Distinguish actual reading of the retained summary from external PubMed and full-text access that was not attempted, acquired or read.
Why this condition is needed: Needed to avoid mistaking a blue summary-reading link for actual reading of clinical full text.
Application exceptions: Do not mark unattempted access as inaccessible or successful.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N30 · Are the current response and identity of the original bibliographic URL verified?

Current findings: The bibliography contains Chen YX et al., Lancet Gastroenterol Hepatol. 2020;5:267-275, PMID 31926918, DOI 10.1016/S2468-1253(19)30409-1. The original link is PubMed. Current URL response and agreement with text or identifiers were not checked.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Retained bibliography and URL strings are available, but current original-material identity and access were not verified.
Reason for missing information: Access date, access level and acquired-file hash remain unverified. The global review date is not used as a URL access date.
Required materials and conditions: Original bibliography, PMID/DOI, current URL response and identity comparisons with paper and registration.
Materials to obtain first: Original bibliography, PMID/DOI, current URL response and identity comparisons with paper and registration.
Further research: In a future authorized material check, compare identifiers and original-document identity and distinguish the material type offered by the link.
Remaining uncertainty: Access date, access level and acquired-file hash remain unverified. The global review date is not used as a URL access date.
Conditions for verification: Distinguish the Chen 2020, PMID 31926918, DOI and original PubMed URL strings from verification of current response and agreement with the original document.
Why this condition is needed: Needed to avoid turning a URL string into successful current access or acquisition of paper full text.
Application exceptions: The PubMed URL is a bibliography and abstract-index entry point. Its current offered scope remains unverified because it was not opened.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N31 · Can the scope of historical search and retraction/correction checks be traced?

Current findings: The original verdict review date is 2026-09-08. The research-review description says final and same-cohort follow-up material and retractions/corrections were checked. There is 1 English-placeholder correction dated 2026-09-14; no current search or external recheck was performed.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Historical descriptions and an internal correction are recorded, but actual search and publication-status logs are absent from the current input.
Reason for missing information: There is no record verifying current literature or current retraction/correction status. An internal translation correction is not new clinical evidence.
Required materials and conditions: Historical search strategies and dates, selection logs, evidence for retraction/correction checks and latest authorized review records.
Materials to obtain first: Historical search strategies and dates, selection logs, evidence for retraction/correction checks and latest authorized review records.
Further research: If historical logs are acquired, compare their scope with the described review and record corrections, new evidence and condition revisions as separate events.
Remaining uncertainty: There is no record verifying current literature or current retraction/correction status. An internal translation correction is not new clinical evidence.
Conditions for verification: Distinguish historical descriptions of final, follow-up and retraction/correction review from actual logs and the current checking scope by date.
Why this condition is needed: Needed to avoid exaggerating retained descriptions into a current full-literature search or certification of no current retraction.
Application exceptions: No new search does not establish 0 current studies or absence of retractions/corrections.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N32 · Are the original grade and axes kept separate from current condition statuses?

Current findings: Retain the original C grade, 54 points, Warning, S/R1/I2/E+/B2/CX and claim type B, along with false values for co-primary splitting, a large hard-endpoint trial, absence of human studies and primary failure with secondary positivity, and the empty override-reason string.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The original grade, score, axes and grade decision are linked unchanged; no new grade or score is generated.
Reason for missing information: This verifies preservation of the original verdict, rather than providing new clinical certification of the original assessment.
Required materials and conditions: Current grade, score, safety, axes, original grade decision and complete originals before and after correction.
Materials to obtain first: Current grade, score, safety, axes, original grade decision and complete originals before and after correction.
Further research: Compare typed current-source and preserved values to check that nulls, Booleans, empty strings and historical assessments remain unchanged.
Remaining uncertainty: This verifies preservation of the original verdict, rather than providing new clinical certification of the original assessment.
Conditions for verification: Preserve C, 54, Warning, S/R1/I2/E+/B2/CX and original Boolean and empty-string values as source material without creating a new verdict.
Why this condition is needed: Needed to avoid promoting historical scores or cross-check wording into current checklist fulfillment or clinical certification.
Application exceptions: The independent-cross-check wording in the original grade decision is quoted only as a historical description.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N33 · Are generic English descriptions kept separate from new specific facts?

Current findings: The original English article contains specific values, but the evidence’s population, funding, endpoint, result and weight descriptions in English and some corresponding citation text are generic verification wording. Retain the history of 1 correction and the current text unchanged.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Specific information was distinguished from generic wording in the complete current bilingual material and internal correction record.
Reason for missing information: Generic wording is neither a new specific fact nor evidence of full-text verification. Use the actual Korean values and their locations.
Required materials and conditions: Korean/English evidence and citation correspondence, and records before and after the English-placeholder correction.
Materials to obtain first: Korean/English evidence and citation correspondence, and records before and after the English-placeholder correction.
Further research: Compare bilingual correspondence without treating generic explanations as additional evidence for specific denominators, funding, confidence intervals or original-document reading.
Remaining uncertainty: Generic wording is neither a new specific fact nor evidence of full-text verification. Use the actual Korean values and their locations.
Conditions for verification: Distinguish specific bilingual contracts from remaining generic placeholders in evidence and citations, preserving the originals unchanged.
Why this condition is needed: Needed to avoid filling gaps in original Korean material with remaining generic English descriptions.
Application exceptions: This conversion does not replace the original source translation; remaining generic descriptions are preserved.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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N34 · Are empty source values distinguished from absent keys?

Current findings: The source has 20 top-level keys, an empty subclaim list, an empty deliberation string and no image request. Source-list, principal-effect and material-specific access-level, location and date keys are absent from the original structure.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The actual keys and values in the complete retained source were read to establish the original structure.
Reason for missing information: Empty source values were distinguished from absent keys. Original material-specific access and reading levels are missing and remain unverified.
Required materials and conditions: All current source keys, typed original values and comparisons of access/effect field presence.
Materials to obtain first: All current source keys, typed original values and comparisons of access/effect field presence.
Further research: Check key presence and typed values separately; distinguish original structure from added records if subsequent material is acquired.
Remaining uncertainty: Empty source values were distinguished from absent keys. Original material-specific access and reading levels are missing and remain unverified.
Conditions for verification: Distinguish empty subclaim lists and deliberation strings from absent source-list, principal-effect and access fields; do not represent an absent key as an original null value.
Why this condition is needed: Needed to avoid automatically turning absent keys, nulls, empty lists and unverified values into the same fact.
Application exceptions: Access records in this new checklist are its own records; do not imply that these access fields existed in the original source.
Referenced methods: Existing method principles distinguish population, tablet identity, dose, placebo, adenoma recurrence, examinations, denominators, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.

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