# Berberine hydrochloride tablets × Reduction of colorectal adenoma recurrence after complete polypectomy Verdict 3075 · Evidence Check Stored-material review date: 2026-10-05 Original evidence review date: 2026-09-08 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-27 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 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. ## Checklist items ### N01 · Which adenoma-recurrence question does this checklist address? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original claim is reduced 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. - 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. - 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. - Remaining uncertainty: The identity of the question has been checked. This does not establish cancer prevention, treatment of adenomas or replacement of colonoscopy. - 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? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Product identity with other extracts, dihydroberberine, combinations or topical products has not been established. - 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? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The retained 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. - 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. - 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. - Remaining uncertainty: The nominal administration contract was checked. Actual exposure remains a gap in the co-intervention and adherence items. - 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? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The population is adults aged 18–75 with 1–6 histologically confirmed adenomas completely removed within 6 months. - 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. - 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. - Remaining uncertainty: The population definition was checked. Further exclusions and the baseline-risk distribution remain gaps in the following selection-process 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. - Related sources: S01 ### N05 · Are recruitment, exclusions and baseline balance verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: A 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. - 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. - 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. - Remaining uncertainty: Site-specific and baseline-risk composition and reasons for exclusion cannot be compared within the retained 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. - Related sources: S01 ### N06 · Are differences in co-interventions and adherence beyond matching placebo verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: The influence of actual exposure and co-intervention differences on the mITT recurrence comparison has not been examined. - 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? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The retained 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. - 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. - 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. - Remaining uncertainty: The planned time boundary was checked. Individual actual examination and dropout times remain separately unverified. - 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 ### N08 · How is recurrence distinguished from other adenoma outcomes? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: The selected endpoint was checked. Its value does not supply effect sizes for other outcomes. - 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 ### N09 · Are the actual colonoscopy and histological assessment procedures verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: The retained summary cannot establish differences between arms in examination or pathology collection, or assessment blinding. - 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 ### N10 · Are randomization, concealment and blinding methods verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Allocation and blinding details and baseline balance have not been compared at full-text level. - 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 ### N11 · Can randomized, efficacy and safety denominators be distinguished? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: Attribution of the reported denominators was checked. Inclusion rules for each population and complete participant flow remain gaps in the next 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. - Related sources: S01 ### N12 · Are reasons for missing efficacy data and their handling verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Retain about 20% only as a historical description. Complete ITT results and missing-data sensitivity remain unverified. - 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 ### N13 · Are mITT inclusion rules and the analytical model verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: The exact estimand and sensitivity, whether for assignment, participants with observed data or adherence, remain unverified. - 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 ### N14 · What RR, interval and P value were originally reported for recurrence? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The retained mITT adenoma-recurrence result is 155/429=36% versus 216/462=47%, RR 0.77, 95% CI 0.66~0.91, P=.001. - 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. - 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. - 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. - 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 ### N15 · Can a prespecified clinical-importance threshold be compared with the interval? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: The relationship between statistical significance and prespecified clinical importance cannot be established from this retained 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. - Related sources: S01 ### N16 · Is the historical 11-percentage-point description distinguished from a new effect calculation? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: The original table and calculation history for the historical absolute difference were not newly compared. No new NNT is presented. - 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 ### N17 · Were the trial number and identity compared against original registration material? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Retain the boundary between these coexisting statements. Do not make a new judgment that registration was verified or absent. - 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 ### N18 · Do planned endpoints, timing and analysis agree with the final report? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: Agreement between plans and results, reasons for changes and selective reporting have not been compared. - 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 ### N19 · Is follow-up of the same cohort kept separate from independent replication? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - 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. - 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 ### N20 · Has direct confirmatory material from an independent study family been acquired? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Direct material establishing independent confirmation was not verified in this input. No new search of the full literature was 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. - Related sources: S01 ### N21 · Does heterogeneity between the currently linked study families need comparison? Verification status: Not applicable Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Between-study heterogeneity comparison is currently not applicable. The independent-confirmation gap remains in N20. - 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 ### N22 · Are optimal dose, persistence after stopping and subgroup confirmation required here? Verification status: Not applicable Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - 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. - 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 ### N23 · Is the adenoma-recurrence result kept separate from cancer prevention? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: The boundary between adenoma recurrence and cancer prevention was checked. No direct cancer-prevention estimate was acquired. - 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 ### N24 · Are constipation event definitions and collection verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original 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. - 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. - 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. - Remaining uncertainty: Complete constipation collection, the exact counting unit and causal attribution cannot be established from the current input. - 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 ### N25 · Are harm timing, severity, discontinuation and missingness verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: Absence of discontinuations or serious events cannot be claimed; administration periods and event-collection periods have not been compared. - 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 ### N26 · Are long-term harms, co-medication and vulnerable-group data verified? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original 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. - 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. - 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. - 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. - 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 ### N27 · Is confirmation of independently repeated harm signals required in this checklist? Verification status: Not applicable Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: The repeated-harm requirement is not applicable; this does not establish absence of harm or verified safety. - 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 ### N28 · Are product support, author identity and patents verified beyond the funding name? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: A public funding name alone does not establish absence of product or author conflicts, or independent confirmation. - 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 ### N29 · Which materials were actually read in this work? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Summary reading is the fact being checked. Current direct reading and factual comparison of original clinical material and registration remain outstanding. - 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 ### N30 · Are the current response and identity of the original bibliographic URL verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Access date, access level and acquired-file hash remain unverified. The global review date is not used as a URL access date. - 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 ### N31 · Can the scope of historical search and retraction/correction checks be traced? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original 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. - 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. - 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. - Remaining uncertainty: There is no record verifying current literature or current retraction/correction status. An internal translation correction is not new clinical evidence. - 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 ### N32 · Are the original grade and axes kept separate from current condition statuses? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - 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. - 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. - Remaining uncertainty: This verifies preservation of the original verdict, rather than providing new clinical certification of the original assessment. - 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 ### N33 · Are generic English descriptions kept separate from new specific facts? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original 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. - 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. - 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. - Remaining uncertainty: Generic wording is neither a new specific fact nor evidence of full-text verification. Use the actual Korean values and their locations. - 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 ### N34 · Are empty source values distinguished from absent keys? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - 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. - 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. - Remaining uncertainty: Empty source values were distinguished from absent keys. Original material-specific access and reading levels are missing and remain unverified. - 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 ## Evidence and sources ### S01 Chen 2020 colorectal adenoma recurrence report after polypectomy [PubMed](https://pubmed.ncbi.nlm.nih.gov/31926918/) Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. Findings recorded in the summary: 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. 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Link studies and reports separately; do not omit studies solely because results are unreported. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. ## What the statuses mean - Met: The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety. - Partly verified: Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing. - Unverified: The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access. - Not 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/materials 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.