{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3075-main", "verdict_number": "3075", "title": "Berberine hydrochloride tablets × Reduction of colorectal adenoma recurrence after complete polypectomy", "view_version": "1.0", "view_created_date": "2026-10-27", "criteria_version": "1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, "claim_context": { "population": "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.", "comparator": "Matching placebo. Detailed composition, co-interventions, rescue treatment, actual adherence and changes by arm remain unverified.", "endpoint": "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.", "intervention": "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.", "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.", "excluded_extensions": [ "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." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which adenoma-recurrence question does this checklist address?", "needed": "The exact original claim, population, formulation, endpoint, comparison and canonical URL.", "role": "Required", "role_reason": "Needed to avoid combining effects for separate endpoints and products into a single result.", "application_exception": "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.", "criterion": "Fix the single question of oral berberine hydrochloride versus matching placebo for adenoma recurrence over 1–2 years in adults after complete polypectomy.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original claim is reduced 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.", "condition_status": "Met", "status_reason": "The original claim, claim conditions and summary note specify the population, intervention, comparator and endpoint boundaries.", "missingness": "The identity of the question has been checked. This does not establish cancer prevention, treatment of adenomas or replacement of colonoscopy.", "uncertainty": "The identity of the question has been checked. This does not establish cancer prevention, treatment of adenomas or replacement of colonoscopy.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The exact original claim, population, formulation, endpoint, comparison and canonical URL." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are the tablet ingredient, source and product identity verified?", "needed": "Tablet composition, manufacturer, product standards, plant source and analytical certification material.", "role": "Required", "role_reason": "Needed to avoid transferring trial results to products with similar ingredient names.", "application_exception": "An unverified plant source does not erase the recorded identity as purified berberine hydrochloride.", "criterion": "Identify the berberine hydrochloride tablet separately from unverified information about its plant source and product.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare manufacturing and composition documents with the trial product to establish the limits of identity with hydrochloride, plant extracts, derivatives and combinations.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "The ingredient and tablet formulation are recorded, but the plant source and detailed product identity remain unverified.", "missingness": "Product identity with other extracts, dihydroberberine, combinations or topical products has not been established.", "uncertainty": "Product identity with other extracts, dihydroberberine, combinations or topical products has not been established.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Tablet composition, manufacturer, product standards, plant source and analytical certification material." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What oral dose and administration frequency were specified?", "needed": "Formulation, route, content per tablet, frequency, nominal daily amount and administration records.", "role": "Required", "role_reason": "Needed to avoid treating 0.3 g as the total daily amount or changing the administration route.", "application_exception": "Unverified actual intake or adherence does not mean the nominal dose was not recorded.", "criterion": "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.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare tablet content and administration frequency, and link actual intake records separately from the nominal prescription if acquired.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained 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.", "condition_status": "Met", "status_reason": "The formulation, route and dose in the claim conditions agree with the corresponding English contract.", "missingness": "The nominal administration contract was checked. Actual exposure remains a gap in the co-intervention and adherence items.", "uncertainty": "The nominal administration contract was checked. Actual exposure remains a gap in the co-intervention and adherence items.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Formulation, route, content per tablet, frequency, nominal daily amount and administration records." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Which adults after polypectomy were included?", "needed": "Diagnosis, age, adenoma count, histological confirmation, complete removal and the interval before enrollment.", "role": "Required", "role_reason": "Needed to avoid extending post-polypectomy recurrence results to general prevention or treatment of existing lesions.", "application_exception": "Verification of eligibility wording does not establish representativeness for all ages or all adenoma-risk groups.", "criterion": "Limit the population to adults aged 18–75 with 1–6 histologically confirmed adenomas completely removed within 6 months.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Separate the population conditions and compare the trial population with treatment of residual adenomas, a general adenoma-free population and cancer patients.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The population is adults aged 18–75 with 1–6 histologically confirmed adenomas completely removed within 6 months.", "condition_status": "Met", "status_reason": "The exact population is retained in the claim conditions and corresponding English text.", "missingness": "The population definition was checked. Further exclusions and the baseline-risk distribution remain gaps in the following selection-process item.", "uncertainty": "The population definition was checked. Further exclusions and the baseline-risk distribution remain gaps in the following selection-process item.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Diagnosis, age, adenoma count, histological confirmation, complete removal and the interval before enrollment." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are recruitment, exclusions and baseline balance verified?", "needed": "Recruitment flow, exclusion criteria, baseline tables by arm, adenoma risk and site composition.", "role": "Required", "role_reason": "Needed to avoid transferring results in selected post-polypectomy patients to all adults.", "application_exception": "Failure to acquire baseline tables does not establish baseline imbalance or lack of representativeness.", "criterion": "Actual recruitment and exclusion conditions at the 7 hospitals, and baseline risks by arm, must be linked to the analysis population.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare the enrollment-to-analysis flow and baseline tables to examine differences between the selected population and the target population.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "A 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.", "condition_status": "Partly verified", "status_reason": "The hospital count and population are known, but selection and baseline material that could affect the analysis remain missing.", "missingness": "Site-specific and baseline-risk composition and reasons for exclusion cannot be compared within the retained material.", "uncertainty": "Site-specific and baseline-risk composition and reasons for exclusion cannot be compared within the retained material.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment flow, exclusion criteria, baseline tables by arm, adenoma risk and site composition." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are differences in co-interventions and adherence beyond matching placebo verified?", "needed": "Placebo composition, co-interventions and rescue treatment, adherence, changes by arm and analytical handling.", "role": "Required", "role_reason": "Needed to avoid attributing differences in other treatments or intake behaviour to the formulation.", "application_exception": "The matching-placebo label alone does not establish that every actual co-intervention and adherence pattern was identical.", "criterion": "Check co-interventions, rescue treatment, adherence, deviations and their handling beyond the difference between matching placebo and berberine.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare treatment and adherence records by arm to distinguish the assigned formulation difference from contributions of other changes.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "The comparator type is recorded, but the relationship of actual co-interventions and deviations to the effect of interest remains unverified.", "missingness": "The influence of actual exposure and co-intervention differences on the mITT recurrence comparison has not been examined.", "uncertainty": "The influence of actual exposure and co-intervention differences on the mITT recurrence comparison has not been examined.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo composition, co-interventions and rescue treatment, adherence, changes by arm and analytical handling." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What follow-up period and examination times apply to adenoma recurrence?", "needed": "Administration and follow-up periods, colonoscopy schedules by arm and the re-examination rule after a negative result.", "role": "Required", "role_reason": "Needed to distinguish a single fixed endpoint from a conditional examination pathway.", "application_exception": "Do not turn the 1–2-year contract into complete observation of every participant for exactly 2 years or into an effect after stopping.", "criterion": "Retain the contract of 1–2 years of follow-up and a 2-year colonoscopy if the 1-year colonoscopy is negative.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link recurrence results to the examination schedule and separately examine unexamined intervals and persistence after stopping.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained 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.", "condition_status": "Met", "status_reason": "The claim conditions and English contract specify the conditional re-examination rule.", "missingness": "The planned time boundary was checked. Individual actual examination and dropout times remain separately unverified.", "uncertainty": "The planned time boundary was checked. Individual actual examination and dropout times remain separately unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Administration and follow-up periods, colonoscopy schedules by arm and the re-examination rule after a negative result." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How is recurrence distinguished from other adenoma outcomes?", "needed": "Principal-endpoint definitions, other adenoma outcomes, cancer outcomes and reporting locations.", "role": "Required", "role_reason": "Needed to avoid combining effects on counts, advanced lesions or cancer with the principal recurrence effect.", "application_exception": "The absence of direct values for other endpoints does not erase the recorded recurrence result.", "criterion": "Distinguish at least one recurrent adenoma at follow-up colonoscopy from adenoma counts, advanced adenomas and cancer.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Make an outcome-definition table and check whether each value represents a proportion of people with recurrence or a count of adenomas.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Met", "status_reason": "The principal endpoint in the claim conditions and the summary note explicitly distinguish outcomes.", "missingness": "The selected endpoint was checked. Its value does not supply effect sizes for other outcomes.", "uncertainty": "The selected endpoint was checked. Its value does not supply effect sizes for other outcomes.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Principal-endpoint definitions, other adenoma outcomes, cancer outcomes and reporting locations." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are the actual colonoscopy and histological assessment procedures verified?", "needed": "Colonoscopy and pathology procedures, quality control, assessor blinding and examination-completion tables by arm.", "role": "Required", "role_reason": "Needed to distinguish detection conditions from actual recurrence differences.", "application_exception": "The double-blind label alone does not establish that colonoscopy and pathology assessors were blinded.", "criterion": "Adenoma-identification procedures, examination quality, assessor blinding and examination differences by arm must be linked to the selected result.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare endpoint-collection procedures and completed examinations by arm to examine how detection differences limit the recurrence comparison.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "The broad measurement approach is recorded, but details needed to compare limitations in actual outcome measurement are missing.", "missingness": "The retained summary cannot establish differences between arms in examination or pathology collection, or assessment blinding.", "uncertainty": "The retained summary cannot establish differences between arms in examination or pathology collection, or assessment blinding.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Colonoscopy and pathology procedures, quality control, assessor blinding and examination-completion tables by arm." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are randomization, concealment and blinding methods verified?", "needed": "Allocation sequences, concealment, allocation by site, blinding procedures and the original methods text.", "role": "Required", "role_reason": "Needed to avoid promoting an RCT label into verification of detailed allocation procedures.", "application_exception": "Unverified details do not establish a nonrandomized design, and no new formal risk-of-bias assessment is performed.", "criterion": "Distinguish the multicentre randomized double-blind label from actual sequence generation, allocation concealment and blinding procedures.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare methods sections and allocation records against bias domains for the selected result, retaining unverified domains separately.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "The design label is known, but actual allocation procedures supporting the causal comparison remain unverified.", "missingness": "Allocation and blinding details and baseline balance have not been compared at full-text level.", "uncertainty": "Allocation and blinding details and baseline balance have not been compared at full-text level.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation sequences, concealment, allocation by site, blinding procedures and the original methods text." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Can randomized, efficacy and safety denominators be distinguished?", "needed": "Definitions of randomized, efficacy-analysis and safety populations, and event and denominator tables by arm.", "role": "Required", "role_reason": "Needed to avoid calculating event proportions for different analysis populations with a single denominator.", "application_exception": "Do not generate unreported randomized or completed counts by arm through subtraction or reverse calculation.", "criterion": "Retain 1,108 randomized participants, the 891-person mITT population with denominators 429/462, and safety denominators 446/478 for their respective outcomes.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Link each denominator to its analysis population in a comparison table and identify displays that substitute randomized counts for efficacy or safety denominators.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Met", "status_reason": "The reader answer, evidence population description and safety explanation give different denominators.", "missingness": "Attribution of the reported denominators was checked. Inclusion rules for each population and complete participant flow remain gaps in the next item.", "uncertainty": "Attribution of the reported denominators was checked. Inclusion rules for each population and complete participant flow remain gaps in the next item.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Definitions of randomized, efficacy-analysis and safety populations, and event and denominator tables by arm." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are reasons for missing efficacy data and their handling verified?", "needed": "Missing efficacy data, dropout reasons by arm, missing-data handling, sensitivity analyses and the participant-flow diagram.", "role": "Required", "role_reason": "Needed to avoid interpreting results among analyzed participants as complete follow-up of everyone randomized.", "application_exception": "Do not recalculate the manuscript’s approximate 20% as a new exact percentage or classify all missing observations as treatment failures.", "criterion": "Verify exclusion reasons, losses by arm and sensitivity handling when efficacy data for only 891 of the 1,108 randomized participants were analyzed.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare reasons for missingness and examination status by arm, and check prespecified sensitivity-analysis plans examining assumptions of the original analysis.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "Data loss is recorded, but reasons and handling material needed to examine its influence on the result remain missing.", "missingness": "Retain about 20% only as a historical description. Complete ITT results and missing-data sensitivity remain unverified.", "uncertainty": "Retain about 20% only as a historical description. Complete ITT results and missing-data sensitivity remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Missing efficacy data, dropout reasons by arm, missing-data handling, sensitivity analyses and the participant-flow diagram." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are mITT inclusion rules and the analytical model verified?", "needed": "The mITT definition, analysis plan, adjustment variables, ITT/PP results and handling of incomplete examinations.", "role": "Required", "role_reason": "Needed to avoid automatically interpreting the mITT label as complete ITT or an adherence effect.", "application_exception": "Unverified adjustment or model details do not establish an unadjusted analysis.", "criterion": "Distinguish the actual modified-ITT inclusion rules, adjustment and effect of interest from the effect of original assignment.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare the analysis plan with result tables to examine how mITT inclusion rules differ from the selected assignment effect.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "The analysis name and denominators are recorded, but actual effect definitions and inclusion rules remain unverified.", "missingness": "The exact estimand and sensitivity, whether for assignment, participants with observed data or adherence, remain unverified.", "uncertainty": "The exact estimand and sensitivity, whether for assignment, participants with observed data or adherence, remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The mITT definition, analysis plan, adjustment variables, ITT/PP results and handling of incomplete examinations." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What RR, interval and P value were originally reported for recurrence?", "needed": "Events and denominators, original proportions, effect measure, CI, P value and original table locations for the selected result.", "role": "Required", "role_reason": "Needed to avoid transferring a precise relative risk to another endpoint or analysis.", "application_exception": "Do not reverse-calculate new event counts, precise proportions or new confidence intervals from displayed percentages.", "criterion": "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.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained mITT adenoma-recurrence result is 155/429=36% versus 216/462=47%, RR 0.77, 95% CI 0.66~0.91, P=.001.", "condition_status": "Met", "status_reason": "The evidence result, citation result summary and reader answer contain the same original values.", "missingness": "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.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Events and denominators, original proportions, effect measure, CI, P value and original table locations for the selected result." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Can a prespecified clinical-importance threshold be compared with the interval?", "needed": "The prespecified clinical-importance threshold, its basis, the original effect interval and planning documents.", "role": "Required", "role_reason": "Needed to avoid establishing a sufficiently important patient effect from a P value or large sample size alone.", "application_exception": "An unverified threshold does not establish absence of effect or clinical unimportance.", "criterion": "Clinical sufficiency requires verification of the relationship between a prespecified minimum clinically important difference for recurrence and the reported RR interval.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare an acquired prespecified importance threshold with the original interval’s range, without inventing thresholds or new scores.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "An interval is available, but the prespecified clinical-importance threshold needed for comparison is missing.", "missingness": "The relationship between statistical significance and prespecified clinical importance cannot be established from this retained material.", "uncertainty": "The relationship between statistical significance and prespecified clinical importance cannot be established from this retained material.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The prespecified clinical-importance threshold, its basis, the original effect interval and planning documents." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is the historical 11-percentage-point description distinguished from a new effect calculation?", "needed": "The original absolute-difference wording, its analysis, calculation history and any reported original interval.", "role": "Required", "role_reason": "Needed to avoid promoting a historical rounded description into a new precise estimate or number needed to treat.", "application_exception": "The relative RR and historical absolute difference are different measures; that alone does not establish conflicting data.", "criterion": "Retain the manuscript’s 11-percentage-point absolute difference as a historical description without generating a new absolute difference, NNT or CI.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Met", "status_reason": "The boundary between historical wording and the absence of a new calculation was fixed.", "missingness": "The original table and calculation history for the historical absolute difference were not newly compared. No new NNT is presented.", "uncertainty": "The original table and calculation history for the historical absolute difference were not newly compared. No new NNT is presented.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original absolute-difference wording, its analysis, calculation history and any reported original interval." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Were the trial number and identity compared against original registration material?", "needed": "The original NCT02226185 registration, identity links between paper and registration, and update history.", "role": "Required", "role_reason": "Needed to distinguish the presence of a number string from verification of original registration material.", "application_exception": "Coexistence of a recorded number and not verified does not establish nonregistration or an incorrect number.", "criterion": "Retain NCT02226185 in the citation and not verified in the evidence registration field, and separately check identity against original registration material.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare registration, paper and follow-up report identities to establish whether they concern the same trial before using them for plan comparisons.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "A registration-number string is recorded, but comparison with the identity and content of original registration material remains unverified.", "missingness": "Retain the boundary between these coexisting statements. Do not make a new judgment that registration was verified or absent.", "uncertainty": "Retain the boundary between these coexisting statements. Do not make a new judgment that registration was verified or absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original NCT02226185 registration, identity links between paper and registration, and update history." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Do planned endpoints, timing and analysis agree with the final report?", "needed": "Protocols, SAP, registration revisions, final result tables and selective-reporting comparison records.", "role": "Required", "role_reason": "Needed to expose missing material for checking the possibility of favorable analytical selection.", "application_exception": "Unacquired planning documents do not establish that selective reporting occurred.", "criterion": "Directly compare recurrence definitions, timing and denominators in registration, protocols and analysis plans with the final report.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare planned and actual endpoints, analyses and examination times across document versions and check reasons for changes.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Result reporting alone cannot establish agreement with prespecified plans.", "missingness": "Agreement between plans and results, reasons for changes and selective reporting have not been compared.", "uncertainty": "Agreement between plans and results, reasons for changes and selective reporting have not been compared.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocols, SAP, registration revisions, final result tables and selective-reporting comparison records." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Is follow-up of the same cohort kept separate from independent replication?", "needed": "Trial numbers, populations, recruitment periods and overlapping-identity tables for the final paper and follow-up reports.", "role": "Required", "role_reason": "Needed to avoid counting the existence of follow-up reports as independent confirmatory trials.", "application_exception": "No separate follow-up bibliography is currently available; do not create new report IDs or unique participant totals.", "criterion": "Link the final paper and follow-up of the same cohort within one trial family, distinguishing report counts from trial counts.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Met", "status_reason": "The key explanation and research-review description explicitly distinguish overlap within the same cohort.", "missingness": "The boundary for treating reports as one study family was checked. Separate follow-up bibliography and participant totals across the full family remain unverified.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial numbers, populations, recruitment periods and overlapping-identity tables for the final paper and follow-up reports." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Has direct confirmatory material from an independent study family been acquired?", "needed": "Original reports, registrations, recruitment, formulation, population and outcome details, and overlap comparisons for independent trials.", "role": "Supplementary; required for independent-replication claims", "role_reason": "Needed to avoid treating a single trial’s precision as verification of independent reproducibility.", "application_exception": "Unverified independent confirmation within the retained scope does not establish 0 studies worldwide or treatment ineffectiveness.", "criterion": "Verify results from independent trials and nonoverlapping study families assessing the same formulation, population and recurrence contract.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If further trials are acquired, compare family identity, formulation, population, timing and analysis before examining independent replication.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Unverified", "status_reason": "The current retained material does not contain acquired identities and results for a separate independent direct trial.", "missingness": "Direct material establishing independent confirmation was not verified in this input. No new search of the full literature was performed.", "uncertainty": "Direct material establishing independent confirmation was not verified in this input. No new search of the full literature was performed.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original reports, registrations, recruitment, formulation, population and outcome details, and overlap comparisons for independent trials." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Does heterogeneity between the currently linked study families need comparison?", "needed": "Comparisons of results, formulation, population, duration and analysis if other independent families are added.", "role": "Supplementary; required for application across families", "role_reason": "Needed to avoid inventing a between-study distribution from a single retained family.", "application_exception": "This nonapplicability is limited to comparison within the currently linked single family and does not replace the unverified independent-replication item.", "criterion": "Do not apply a between-study effect-distribution comparison within the current scope of only one linked report family.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Only when an independent family is newly acquired, compare results and contract differences side by side and examine comparability.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Not applicable", "status_reason": "Results from multiple independent families are not currently linked for comparison.", "missingness": "Between-study heterogeneity comparison is currently not applicable. The independent-confirmation gap remains in N20.", "uncertainty": "Between-study heterogeneity comparison is currently not applicable. The independent-confirmation gap remains in N20.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Comparisons of results, formulation, population, duration and analysis if other independent families are added." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are optimal dose, persistence after stopping and subgroup confirmation required here?", "needed": "Direct dose comparisons, post-discontinuation follow-up and prespecified subgroup or interaction material if an extension question is defined.", "role": "Supplementary; required for the relevant extension claim", "role_reason": "Needed to avoid extending the principal effect to every dose, persistence after stopping or subpopulation.", "application_exception": "Retain examination of duration and adherence for the original claim; unacquired extension trials do not establish failure of the original recurrence result.", "criterion": "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.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future extension questions should separately design and assess direct dose comparisons, prespecified subgroup interactions and follow-up after stopping.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Not applicable", "status_reason": "Requirements for extended effects are not added to the current narrow original claim.", "missingness": "This does not mean extension evidence was verified. Actual adherence and individual follow-up gaps for the original claim remain in other items.", "uncertainty": "This does not mean extension evidence was verified. Actual adherence and individual follow-up gaps for the original claim remain in other items.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose comparisons, post-discontinuation follow-up and prespecified subgroup or interaction material if an extension question is defined." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Is the adenoma-recurrence result kept separate from cancer prevention?", "needed": "Definitions, event counts, follow-up and separate effect results for adenoma recurrence and clinical cancer events.", "role": "Required extension boundary", "role_reason": "Needed to avoid promoting a favorable surrogate difference into prevention of cancer events.", "application_exception": "A cancer-event trial is not imposed as a prerequisite for the adenoma-recurrence value.", "criterion": "Distinguish the surrogate nature of adenoma and observation of 0 colorectal cancers from proof of a cancer-prevention effect.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Met", "status_reason": "The verdict rationale and advertising restrictions prohibit extensions to cancer prevention or replacement of colonoscopy.", "missingness": "The boundary between adenoma recurrence and cancer prevention was checked. No direct cancer-prevention estimate was acquired.", "uncertainty": "The boundary between adenoma recurrence and cancer prevention was checked. No direct cancer-prevention estimate was acquired.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Definitions, event counts, follow-up and separate effect results for adenoma recurrence and clinical cancer events." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are constipation event definitions and collection verified?", "needed": "Safety tables, constipation definitions, person/event distinctions, collection methods and inclusion rules for 446/478.", "role": "Supplementary; required for safety descriptions", "role_reason": "Needed to avoid turning efficacy denominators or reported counts into safety incidence rates.", "application_exception": "Retain 6/446 versus 1/478 without calculating a new risk ratio, difference or attributable rate.", "criterion": "Verify the 6/446 versus 1/478 constipation comparison together with person/event definitions, collection and denominators.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare original safety tables and collection plans to verify constipation counting units and exposed/control denominators.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original 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.", "condition_status": "Partly verified", "status_reason": "The constipation comparison and denominators are recorded, but details of collection and counting units remain unverified.", "missingness": "Complete constipation collection, the exact counting unit and causal attribution cannot be established from the current input.", "uncertainty": "Complete constipation collection, the exact counting unit and causal attribution cannot be established from the current input.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety tables, constipation definitions, person/event distinctions, collection methods and inclusion rules for 446/478." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are harm timing, severity, discontinuation and missingness verified?", "needed": "Safety timelines, severity, stopping and recovery, follow-up and missingness by arm, and tables of all adverse events.", "role": "Supplementary; required for the safety scope", "role_reason": "Needed to avoid extending limited constipation reporting into complete safety across all periods.", "application_exception": "Do not infer identical exposure and complete follow-up for all safety participants from the 1–2-year efficacy plan.", "criterion": "Verify administration start and stopping, harm onset and recovery, severity, discontinuation and losses to safety follow-up.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Examine exposure and event timelines and follow-up losses by arm without converting absent reporting into 0 events.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Unverified", "status_reason": "No direct material is available to compare the selected harm’s timeline, discontinuation, complete collection and follow-up.", "missingness": "Absence of discontinuations or serious events cannot be claimed; administration periods and event-collection periods have not been compared.", "uncertainty": "Absence of discontinuations or serious events cannot be claimed; administration periods and event-collection periods have not been compared.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety timelines, severity, stopping and recovery, follow-up and missingness by arm, and tables of all adverse events." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are long-term harms, co-medication and vulnerable-group data verified?", "needed": "Co-medications, baseline events, interactions, long-term and vulnerable-group exposure, follow-up and harm material.", "role": "Supplementary; required for safety extensions", "role_reason": "Needed to avoid treating a single recurrence trial as evidence of harmlessness for every population.", "application_exception": "Unverified interactions also do not establish that an interaction occurred.", "criterion": "Retain the reported warning and distinguish direct information on long-term clinical safety, drug interactions and use outside the population.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original 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.", "condition_status": "Unverified", "status_reason": "The original warning is retained, but direct evidence for extended safety remains unverified.", "missingness": "Long-term safety, co-medication safety and safety outside the population are not established. No new administration instructions or safety grade are assigned.", "uncertainty": "Long-term safety, co-medication safety and safety outside the population are not established. No new administration instructions or safety grade are assigned.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Co-medications, baseline events, interactions, long-term and vulnerable-group exposure, follow-up and harm material." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is confirmation of independently repeated harm signals required in this checklist?", "needed": "Unique-event and study-family material and recitation comparisons if a repeated-harm claim is added.", "role": "Supplementary; required for repeated-harm claims", "role_reason": "Needed to avoid automatically imposing a separate repeated-harm condition on an efficacy question.", "application_exception": "This nonapplicability does not turn unverified constipation or long-term harms into harmlessness.", "criterion": "Do not add a repeated-harm confirmation requirement to the current adenoma-recurrence checklist; retain limitations of safety reporting.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If a future repeated-harm question is defined, compare unique events and families and link repeated citations to the same signal.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Not applicable", "status_reason": "A requirement for the separate extension claim of independently repeated harms does not apply to the current original question.", "missingness": "The repeated-harm requirement is not applicable; this does not establish absence of harm or verified safety.", "uncertainty": "The repeated-harm requirement is not applicable; this does not establish absence of harm or verified safety.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Unique-event and study-family material and recitation comparisons if a repeated-harm claim is added." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are product support, author identity and patents verified beyond the funding name?", "needed": "Funding, trial-product provision, author affiliations and employment, patents, complete COI declarations and roles.", "role": "Supplementary; required for independence claims", "role_reason": "Needed to avoid claiming independence or absence of bias from a single funder name.", "application_exception": "Funding is not an automatic exclusion reason, and the original I2 is not inherited as a new independence judgment.", "criterion": "Separately link verification levels for reported funding, product support, author employment, patents and declared conflicts of interest.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Separately compare funding, product, author and patent declarations to check funding sources and roles in result analysis.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "The funding name is recorded, but material on other dimensions of independence and roles remains missing.", "missingness": "A public funding name alone does not establish absence of product or author conflicts, or independent confirmation.", "uncertainty": "A public funding name alone does not establish absence of product or author conflicts, or independent confirmation.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding, trial-product provision, author affiliations and employment, patents, complete COI declarations and roles." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Which materials were actually read in this work?", "needed": "Actual reading, access, acquisition and locations for each material, safe links and timestamps.", "role": "Required", "role_reason": "Needed to avoid mistaking a blue summary-reading link for actual reading of clinical full text.", "application_exception": "Do not mark unattempted access as inaccessible or successful.", "criterion": "Distinguish actual reading of the retained summary from external PubMed and full-text access that was not attempted, acquired or read.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_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.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Met", "status_reason": "Actual local reading and the boundary of unattempted external access were distinguished.", "missingness": "Summary reading is the fact being checked. Current direct reading and factual comparison of original clinical material and registration remain outstanding.", "uncertainty": "Summary reading is the fact being checked. Current direct reading and factual comparison of original clinical material and registration remain outstanding.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual reading, access, acquisition and locations for each material, safe links and timestamps." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are the current response and identity of the original bibliographic URL verified?", "needed": "Original bibliography, PMID/DOI, current URL response and identity comparisons with paper and registration.", "role": "Required", "role_reason": "Needed to avoid turning a URL string into successful current access or acquisition of paper full text.", "application_exception": "The PubMed URL is a bibliography and abstract-index entry point. Its current offered scope remains unverified because it was not opened.", "criterion": "Distinguish the Chen 2020, PMID 31926918, DOI and original PubMed URL strings from verification of current response and agreement with the original document.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "In a future authorized material check, compare identifiers and original-document identity and distinguish the material type offered by the link.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "Retained bibliography and URL strings are available, but current original-material identity and access were not verified.", "missingness": "Access date, access level and acquired-file hash remain unverified. The global review date is not used as a URL access date.", "uncertainty": "Access date, access level and acquired-file hash remain unverified. The global review date is not used as a URL access date.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original bibliography, PMID/DOI, current URL response and identity comparisons with paper and registration." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Can the scope of historical search and retraction/correction checks be traced?", "needed": "Historical search strategies and dates, selection logs, evidence for retraction/correction checks and latest authorized review records.", "role": "Required", "role_reason": "Needed to avoid exaggerating retained descriptions into a current full-literature search or certification of no current retraction.", "application_exception": "No new search does not establish 0 current studies or absence of retractions/corrections.", "criterion": "Distinguish historical descriptions of final, follow-up and retraction/correction review from actual logs and the current checking scope by date.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "If historical logs are acquired, compare their scope with the described review and record corrections, new evidence and condition revisions as separate events.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Partly verified", "status_reason": "Historical descriptions and an internal correction are recorded, but actual search and publication-status logs are absent from the current input.", "missingness": "There is no record verifying current literature or current retraction/correction status. An internal translation correction is not new clinical evidence.", "uncertainty": "There is no record verifying current literature or current retraction/correction status. An internal translation correction is not new clinical evidence.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical search strategies and dates, selection logs, evidence for retraction/correction checks and latest authorized review records." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are the original grade and axes kept separate from current condition statuses?", "needed": "Current grade, score, safety, axes, original grade decision and complete originals before and after correction.", "role": "Required", "role_reason": "Needed to avoid promoting historical scores or cross-check wording into current checklist fulfillment or clinical certification.", "application_exception": "The independent-cross-check wording in the original grade decision is quoted only as a historical description.", "criterion": "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.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare typed current-source and preserved values to check that nulls, Booleans, empty strings and historical assessments remain unchanged.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "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.", "condition_status": "Met", "status_reason": "The original grade, score, axes and grade decision are linked unchanged; no new grade or score is generated.", "missingness": "This verifies preservation of the original verdict, rather than providing new clinical certification of the original assessment.", "uncertainty": "This verifies preservation of the original verdict, rather than providing new clinical certification of the original assessment.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Current grade, score, safety, axes, original grade decision and complete originals before and after correction." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are generic English descriptions kept separate from new specific facts?", "needed": "Korean/English evidence and citation correspondence, and records before and after the English-placeholder correction.", "role": "Required", "role_reason": "Needed to avoid filling gaps in original Korean material with remaining generic English descriptions.", "application_exception": "This conversion does not replace the original source translation; remaining generic descriptions are preserved.", "criterion": "Distinguish specific bilingual contracts from remaining generic placeholders in evidence and citations, preserving the originals unchanged.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Compare bilingual correspondence without treating generic explanations as additional evidence for specific denominators, funding, confidence intervals or original-document reading.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original 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.", "condition_status": "Met", "status_reason": "Specific information was distinguished from generic wording in the complete current bilingual material and internal correction record.", "missingness": "Generic wording is neither a new specific fact nor evidence of full-text verification. Use the actual Korean values and their locations.", "uncertainty": "Generic wording is neither a new specific fact nor evidence of full-text verification. Use the actual Korean values and their locations.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Korean/English evidence and citation correspondence, and records before and after the English-placeholder correction." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are empty source values distinguished from absent keys?", "needed": "All current source keys, typed original values and comparisons of access/effect field presence.", "role": "Required", "role_reason": "Needed to avoid automatically turning absent keys, nulls, empty lists and unverified values into the same fact.", "application_exception": "Access records in this new checklist are its own records; do not imply that these access fields existed in the original source.", "criterion": "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.", "basis": "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.", "condition_origin": "These post-polypectomy berberine-hydrochloride and adenoma-recurrence conditions were developed with knowledge of the retained content and frozen before application. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Check key presence and typed values separately; distinguish original structure from added records if subsequent material is acquired.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The 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.", "condition_status": "Met", "status_reason": "The actual keys and values in the complete retained source were read to establish the original structure.", "missingness": "Empty source values were distinguished from absent keys. Original material-specific access and reading levels are missing and remain unverified.", "uncertainty": "Empty source values were distinguished from absent keys. Original material-specific access and reading levels are missing and remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "All current source keys, typed original values and comparisons of access/effect field presence." } ], "reports": [ { "report_id": "S01", "title": "Chen 2020 colorectal adenoma recurrence report after polypectomy", "url": "https://pubmed.ncbi.nlm.nih.gov/31926918/", "report_type": "Retained bibliography and research summary of a multicentre randomized double-blind placebo trial", "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "study_family": "A report provisionally linked by the registration number in its bibliography. Original registration, the current paper and follow-up reports were not directly compared.", "independent_replication": "1 evidence entry and 1 citation link to the same report. Follow-up of the same cohort is not counted as independent replication. Total unique trials, participants and independent confirmation are not currently established.", "observed_result": "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.", "result_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.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "PubMed bibliography/abstract-index entry point", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current 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." }, { "material_type": "Retained bilingual bibliography and research summary", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "The retained summary was actually read; distinguish it from external clinical full-text bytes. 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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31926918/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Link studies and reports separately; do not omit studies solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Met": "The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.", "Partly verified": "Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.", "Unverified": "The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.", "Not 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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-27", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-27" }