{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3076-main", "verdict_number": "3076", "title": "Topical berberine gelatin 5 mg/g × Reduction of pain from minor recurrent aphthous ulcers", "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 with minor recurrent aphthous stomatitis. Actual diagnostic methods, age range, eligibility criteria and baseline ulcers and pain by arm remain unverified.", "intervention": "Gelatin containing 5 mg/g purified berberine was applied topically to oral ulcers. Plant source, salt form, manufacturer/batch and detailed vehicle composition remain unverified.", "dose": "The nominal frequency is 4 applications daily. Gelatin amount per application, actual adherence and retained/swallowed exposure remain unverified. This is not an instruction for personal use.", "comparator": "Vehicle gelatin without berberine. Detailed composition, appearance, co-interventions/rescue treatment and changes by arm remain unverified.", "endpoint": "Pain VAS/score across assessment days. The retained summary records lower pain scores than vehicle and P<.05 in an 84-completer trial. Exact between-group VAS differences, 95% CI, denominators by assessment day and prespecified hierarchy remain unverified. Retain the original C grade, 46 points and Caution.", "duration": "Application lasted 5 days, with assessments recorded on days 1, 2, 4 and 6. Actual results and denominators at each assessment and persistence after treatment remain unverified.", "excluded_extensions": [ "The ingredient name does not make oral tablets, plant extracts, other salts/derivatives, combinations or other topical formulations interchangeable.", "Pain, size, erythema and exudation are separate outcomes. This checklist covers pain; do not extend it to cure, healing duration, recurrence prevention, infection treatment or oral-systemic effects.", "84 is the completed-participant count. Do not invent total allocation, arm/time-specific denominators or ITT/PP analyses. P<.05 does not establish effect size or a clinically large effect.", "Retain the original Caution label and uncertainty about local irritation, allergy, swallowing, pregnancy/lactation, long-term/repeated exposure and interactions. Do not extend this to optimal application amounts, long-term persistence or personal treatment instructions." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which topical formulation, population and pain comparison does this checklist address?", "needed": "Fixed identity of the original claim, application site/formulation/route, population, comparator, pain outcome and time.", "role": "Required (claim identity)", "role_reason": "The ingredient name alone does not justify combining oral use or other ulcer outcomes.", "application_exception": "Do not automatically create separate new efficacy cases for pain, size, erythema and exudation.", "criterion": "Link the original claim and exclusion boundaries for 5 mg/g berberine gelatin applied topically to oral ulcers in adults with minor recurrent aphthous disease, over 5 days, for pain versus vehicle.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 actual intervention, population, outcome, comparator and time in subsequent documents with this question.", "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 pain from minor recurrent aphthous ulcers. The question is limited to topical 5 mg/g gelatin applied 4 times daily for 5 days versus vehicle.", "condition_status": "Met", "status_reason": "Verification concerns the original claim identity and exclusion boundaries. It does not establish precise estimation of the pain effect or clinical confirmation.", "missingness": "Verification concerns the original claim identity and exclusion boundaries. It does not establish precise estimation of the pain effect or clinical confirmation.", "uncertainty": "Verification concerns the original claim identity and exclusion boundaries. It does not establish precise estimation of the pain effect or clinical confirmation.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Fixed identity of the original claim, application site/formulation/route, population, comparator, pain outcome and time." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are diagnosis, eligibility and baseline characteristics of minor recurrent aphthous stomatitis verified?", "needed": "Diagnostic criteria, age, baseline ulcer/pain values, eligibility criteria and characteristics by arm.", "role": "Required (population directness)", "role_reason": "Do not transfer the findings to oral ulcers of other causes, severe disease or children.", "application_exception": "Unverified eligibility criteria do not establish lack of effect in other diseases.", "criterion": "Check the adult/minor recurrent aphthous population record against actual diagnostic methods, age, eligibility criteria and baseline ulcer/pain data.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 eligibility criteria and baseline tables to examine whether the actual analysis population comprises adults with minor recurrent aphthous disease.", "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 conditions specify adults with minor recurrent aphthous stomatitis, and the evidence table names a trial in a Chinese cohort.", "condition_status": "Partly verified", "status_reason": "Actual diagnostic methods, age range, baseline ulcers/pain by arm and full eligibility criteria were not verified within the retained material.", "missingness": "Actual diagnostic methods, age range, baseline ulcers/pain by arm and full eligibility criteria were not verified within the retained material.", "uncertainty": "Actual diagnostic methods, age range, baseline ulcers/pain by arm and full eligibility criteria were not verified within the retained material.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Diagnostic criteria, age, baseline ulcer/pain values, eligibility criteria and characteristics by arm." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are the actual batch, composition and manufacturing specifications of purified berberine 5 mg/g gelatin verified?", "needed": "Trial-product composition, batch, salt form, manufacturing/assay records and vehicle composition.", "role": "Required (intervention identity)", "role_reason": "Do not treat botanical extracts, berberine hydrochloride tablets or derivatives as the same trial product.", "application_exception": "Do not fill the unverified plant source with an invented plant species or another salt specification.", "criterion": "Compare the retained 5 mg/g berberine-gelatin, purified-ingredient and topical-route record with actual batch/salt form/vehicle composition and manufacturing specifications.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 product/batch documents to the actual trial product to check agreement in ingredient concentration and gelatin composition.", "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": "Gelatin containing 5 mg/g berberine is applied topically to oral ulcers. The plant source of purified berberine is unverified in the original text.", "condition_status": "Partly verified", "status_reason": "Original material on the actual batch, full composition/vehicle, salt form and manufacturing assays was not verified within the retained scope.", "missingness": "Original material on the actual batch, full composition/vehicle, salt form and manufacturing assays was not verified within the retained scope.", "uncertainty": "Original material on the actual batch, full composition/vehicle, salt form and manufacturing assays was not verified within the retained scope.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-product composition, batch, salt form, manufacturing/assay records and vehicle composition." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are actual amount, adherence and swallowed exposure with 4 daily applications verified?", "needed": "Amount per application, use records, returns/adherence and swallowed/retained exposure.", "role": "Required (actual exposure)", "role_reason": "Do not convert the 5 mg/g concentration into a total daily dose or systemic absorption.", "application_exception": "Verification of nominal frequency does not establish an optimal application amount or a safe amount to swallow.", "criterion": "Check the nominal frequency of 4 daily applications against actual gelatin amount per application, adherence and retention/swallowing measurements.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 use records and administration procedures to distinguish nominal frequency from actual local exposure. Do not convert concentration into a systemic dose.", "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 nominal frequency is 4 times daily, and the formulation concentration is 5 mg/g.", "condition_status": "Partly verified", "status_reason": "Actual gelatin amount per application, adherence, oral retention and swallowed exposure remain unverified. Total dose or absorption was not calculated in this work.", "missingness": "Actual gelatin amount per application, adherence, oral retention and swallowed exposure remain unverified. Total dose or absorption was not calculated in this work.", "uncertainty": "Actual gelatin amount per application, adherence, oral retention and swallowed exposure remain unverified. Total dose or absorption was not calculated in this work.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Amount per application, use records, returns/adherence and swallowed/retained exposure." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are vehicle composition, matching appearance and additional treatment by arm verified?", "needed": "Comparator composition/appearance, concomitant oral treatment, rescue medication and changes by arm.", "role": "Required (intervention contribution)", "role_reason": "Do not attribute vehicle effects or differences in additional treatment to berberine.", "application_exception": "The existence of a vehicle comparator does not establish that all co-interventions were identical.", "criterion": "Check the vehicle-gelatin comparator without berberine against actual composition/appearance, additional oral care and rescue-treatment material by arm.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 vehicle product and additional treatment by arm with intervention-product/adherence records to examine differences beyond the selected ingredient.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The comparator is vehicle gelatin without berberine, and the original design is recorded as vehicle-placebo controlled.", "condition_status": "Partly verified", "status_reason": "Actual material on detailed vehicle composition/appearance, oral care, rescue treatment and handling of changes by arm remains unverified.", "missingness": "Actual material on detailed vehicle composition/appearance, oral care, rescue treatment and handling of changes by arm remains unverified.", "uncertainty": "Actual material on detailed vehicle composition/appearance, oral care, rescue treatment and handling of changes by arm remains unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Comparator composition/appearance, concomitant oral treatment, rescue medication and changes by arm." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Were the original treatment and assessment time boundaries distinguished?", "needed": "Original records of treatment duration, assessment days and end of follow-up.", "role": "Required (time identity)", "role_reason": "Do not turn 5-day treatment into identical analysis across all assessment days or a long-term effect.", "application_exception": "Actual time-specific analyses remain unverified in other rows.", "criterion": "Distinguish the original record of 5-day application from assessments on days 1, 2, 4 and 6; do not add claims that actual results/denominators at each assessment were verified.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 subsequent schedules and result tables to distinguish application duration from measurement days and attribute only verified results to their assessment times.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original duration is 5 days, with assessments on days 1, 2, 4 and 6. The evidence-table outcome is recorded as a 5-day pain score.", "condition_status": "Met", "status_reason": "Met status applies only to distinguishing attribution of treatment and assessment records. It does not verify between-group values, denominators by assessment day or an integrated time effect.", "missingness": "Met status applies only to distinguishing attribution of treatment and assessment records. It does not verify between-group values, denominators by assessment day or an integrated time effect.", "uncertainty": "Met status applies only to distinguishing attribution of treatment and assessment records. It does not verify between-group values, denominators by assessment day or an integrated time effect.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original records of treatment duration, assessment days and end of follow-up." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are random-sequence generation, allocation concealment and baseline balance verified?", "needed": "Sequence generation, allocation concealment, recruitment/allocation procedures and baseline tables.", "role": "Required (causal comparison)", "role_reason": "A randomized-trial label alone does not resolve allocation bias or baseline differences.", "application_exception": "Do not arbitrarily relabel the design as nonrandomized because allocation details remain unverified.", "criterion": "Check the randomized vehicle-trial record against actual sequence generation, concealment and baseline-balance material by arm.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 methods/allocation records to baseline tables to examine the actual allocation process and its unverified elements.", "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 evidence records a randomized double-blind vehicle-placebo trial.", "condition_status": "Partly verified", "status_reason": "Actual sequence generation, allocation concealment and baseline balance by arm are not verified from the retained material alone.", "missingness": "Actual sequence generation, allocation concealment and baseline balance by arm are not verified from the retained material alone.", "uncertainty": "Actual sequence generation, allocation concealment and baseline balance by arm are not verified from the retained material alone.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence generation, allocation concealment, recruitment/allocation procedures and baseline tables." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Whose masking and its actual maintenance are verified?", "needed": "Masking targets, product distinguishability, maintenance/testing and analyst procedures.", "role": "Required (subjective pain assessment)", "role_reason": "Do not extend the term double-blind to masking of every assessor and analyst.", "application_exception": "Unverified masking does not automatically negate the pain effect.", "criterion": "Check the double-blind record against actual masking targets among participants, clinicians, assessors and analysts, and material on maintenance/testing.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 methods and formulation-comparison material to examine the verified scope of actual masking targets and maintenance.", "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 trial is described as a double-blind vehicle-placebo trial.", "condition_status": "Partly verified", "status_reason": "The actual masking targets, methods, maintenance/testing and assessor/analyst status are not specified in the retained source.", "missingness": "The actual masking targets, methods, maintenance/testing and assessor/analyst status are not specified in the retained source.", "uncertainty": "The actual masking targets, methods, maintenance/testing and assessor/analyst status are not specified in the retained source.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Masking targets, product distinguishability, maintenance/testing and analyst procedures." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are the pain scale, range, direction and collection method verified?", "needed": "Scale name/range/units, assessors, collection procedures and time-specific result tables.", "role": "Required (outcome measurement)", "role_reason": "Do not invent an exact VAS difference without a scale definition.", "application_exception": "Do not substitute ulcer size or healing duration for the pain score.", "criterion": "Check pain VAS/score against the actual scale range, direction, assessors, collection timing/method and measurement conditions by arm.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 scale description and each result table to compare pain variables/units, the meaning of lower scores and agreement in assessment conditions.", "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 measured outcome is pain VAS/score across assessment days, and the manuscript describes lower pain scores than vehicle.", "condition_status": "Partly verified", "status_reason": "The exact scale range, units, direction definition, assessors, collection procedures and time-specific between-group results remain unverified.", "missingness": "The exact scale range, units, direction definition, assessors, collection procedures and time-specific between-group results remain unverified.", "uncertainty": "The exact scale range, units, direction definition, assessors, collection procedures and time-specific between-group results remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Scale name/range/units, assessors, collection procedures and time-specific result tables." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are analgesics, oral treatment and handling of adherence/rescue treatment by arm verified?", "needed": "Co-interventions/rescue treatment, adherence, changes/discontinuation and analytical handling by arm.", "role": "Required (effect of interest)", "role_reason": "Differences in rescue treatment may contribute to pain differences, so actual handling material is needed.", "application_exception": "Missing information does not mean that concomitant medication was absent.", "criterion": "Check actual analgesics, oral treatment, adherence, rescue treatment/discontinuation and analytical handling by arm.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 rescue-medication/co-intervention records to pain-assessment days and analysis populations to examine intervention contribution and the impact of treatment 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 retained source describes topical gelatin versus vehicle, but does not separately provide analgesics, oral treatment or rescue-treatment handling by arm.", "condition_status": "Unverified", "status_reason": "Actual co-interventions/rescue treatment/adherence by arm and their handling in the pain analysis were not verified. This does not establish nonreporting throughout the full paper.", "missingness": "Actual co-interventions/rescue treatment/adherence by arm and their handling in the pain analysis were not verified. This does not establish nonreporting throughout the full paper.", "uncertainty": "Actual co-interventions/rescue treatment/adherence by arm and their handling in the pain analysis were not verified. This does not establish nonreporting throughout the full paper.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Co-interventions/rescue treatment, adherence, changes/discontinuation and analytical handling by arm." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are 84 completers and allocation/measurement/analysis denominators by arm verified?", "needed": "Allocation/measurement/completion/analysis flow and denominators by arm/assessment day.", "role": "Required (denominator attribution)", "role_reason": "Do not automatically substitute completers for randomized participants, ITT participants or denominators by arm.", "application_exception": "Do not split 84 equally between arms or calculate 0 missing participants.", "criterion": "Check the report of 84 completers against actual separate allocation, measurement and time-specific analysis denominators by arm.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 participant flow and denominators in each pain-result table without transferring the 84-completer count to another analysis 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": "The original evidence-table sample entry states 84 completers, and the reader answer also describes an 84-completer trial.", "condition_status": "Partly verified", "status_reason": "Total allocation, completers by arm, measurements/analyses at each assessment and ITT/PP denominators were not verified in this work.", "missingness": "Total allocation, completers by arm, measurements/analyses at each assessment and ITT/PP denominators were not verified in this work.", "uncertainty": "Total allocation, completers by arm, measurements/analyses at each assessment and ITT/PP denominators were not verified in this work.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation/measurement/completion/analysis flow and denominators by arm/assessment day." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are reasons for dropout/missingness and their handling in the pain analysis verified?", "needed": "Dropout/missingness reasons, timing, handling and sensitivity analyses by arm.", "role": "Required (missingness/selection)", "role_reason": "The information that 84 completed the trial does not establish absence of losses.", "application_exception": "Do not fill missing flow information with complete follow-up or 0 dropouts.", "criterion": "Check actual dropout, missingness by assessment day, reasons and pain-analysis/sensitivity handling by arm.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 participant flow to time-specific pain data to examine missingness-related selection and limitations in interpreting the effect of interest.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The retained source provides only 84 completers; actual allocation/dropout/missingness flow is not provided.", "condition_status": "Unverified", "status_reason": "Reasons for dropout/time-specific missingness and their handling in pain analysis were not acquired. Missing-participant counts and bias magnitude were not calculated.", "missingness": "Reasons for dropout/time-specific missingness and their handling in pain analysis were not acquired. Missing-participant counts and bias magnitude were not calculated.", "uncertainty": "Reasons for dropout/time-specific missingness and their handling in pain analysis were not acquired. Missing-participant counts and bias magnitude were not calculated.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dropout/missingness reasons, timing, handling and sensitivity analyses by arm." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are between-arm/within-arm contrasts, analytical models and effects of interest at each assessment verified?", "needed": "Contrast definitions, time-specific original results, models, ITT/PP and adjustment/repeated-measures handling.", "role": "Required (meaning of the estimate)", "role_reason": "Do not turn P values or directions from multiple assessment days into one integrated between-arm change.", "application_exception": "Do not invent ITT, change scores or time-integrated models when the original record does not identify the analysis.", "criterion": "Check actual arm order, final values/changes, between-arm/within-arm contrasts, repeated-measures models and analysis populations for each pain result.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 arm order, assessment time and analysis populations in pain-result tables with model descriptions to establish the actual estimated 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 manuscript describes lower pain scores than vehicle, but does not provide an exact estimate combining all follow-up days or a single prespecified primary outcome.", "condition_status": "Unverified", "status_reason": "Actual time-specific contrasts, final values/changes, analysis populations and repeated-measures/adjustment models were not verified.", "missingness": "Actual time-specific contrasts, final values/changes, analysis populations and repeated-measures/adjustment models were not verified.", "uncertainty": "Actual time-specific contrasts, final values/changes, analysis populations and repeated-measures/adjustment models were not verified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Contrast definitions, time-specific original results, models, ITT/PP and adjustment/repeated-measures handling." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are the reported lower pain scores and actual time-specific between-group values verified?", "needed": "Pain values by arm at each assessment, denominators, actual contrasts and P-test definitions.", "role": "Required (result attribution)", "role_reason": "Retain the favorable direction while preserving uncertainty about effect size.", "application_exception": "P<.05 alone does not establish a clinically large effect, cure or confirmed replication.", "criterion": "Retain the original lower-than-vehicle/P<.05 record and check actual assessment time, arm means/changes, denominators and contrast values.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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": "Attribute each result to the same assessment time, scale, comparison and denominator to compare the original favorable direction with actual magnitude.", "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 evidence result and cited result summary retain lower scores than vehicle and P<.05.", "condition_status": "Partly verified", "status_reason": "Exact pain values by arm at each assessment, differences, denominators and test definitions were not verified within this retained scope.", "missingness": "Exact pain values by arm at each assessment, differences, denominators and test definitions were not verified within this retained scope.", "uncertainty": "Exact pain values by arm at each assessment, differences, denominators and test definitions were not verified within this retained scope.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Pain values by arm at each assessment, denominators, actual contrasts and P-test definitions." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are between-group pain differences, variance, denominators and 95% CI verified?", "needed": "Effect, variance type, denominators, 95% CI and analytical explanations for each actual contrast.", "role": "Required (precise effect)", "role_reason": "Neither 84 participants nor statistical significance substitutes for a precise effect.", "application_exception": "Do not invent a fixed minimum sample size or standard duration as a precision criterion.", "criterion": "Check pain differences, SD/SE, denominators and reported 95% CI for the selected actual contrast.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 original contrasts, variance, denominators and reported intervals to establish which effect the uncertainty concerns. Do not back-calculate in this work.", "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 record describes an unreported/unverified exact between-group difference and 95% CI, retaining only lower pain scores and P<.05.", "condition_status": "Unverified", "status_reason": "Only the historical bibliographic/abstract summary was read in this work; actual contrasts, variance, denominators and CI were not verified. Do not extend this limited status to nonreporting throughout the paper.", "missingness": "Only the historical bibliographic/abstract summary was read in this work; actual contrasts, variance, denominators and CI were not verified. Do not extend this limited status to nonreporting throughout the paper.", "uncertainty": "Only the historical bibliographic/abstract summary was read in this work; actual contrasts, variance, denominators and CI were not verified. Do not extend this limited status to nonreporting throughout the paper.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Effect, variance type, denominators, 95% CI and analytical explanations for each actual contrast." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are prespecified hierarchy and multiplicity handling across outcomes and assessment days verified?", "needed": "Outcome/time hierarchy, multiplicity and reasons for changes in the protocol, registration and SAP.", "role": "Required (selective-reporting review)", "role_reason": "Do not confuse the page’s selected pain question with the trial’s prespecified primary outcome.", "application_exception": "Do not inherit the original false coprimary-split flag as evidence that the prespecified hierarchy of the outcomes was verified.", "criterion": "Check the prespecified primary pain outcome, analytical hierarchy and multiplicity plans/handling among pain, size, erythema, exudation and assessment days.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 prespecified plans and original result tables to compare pain selection/assessment times, analytical changes and multiplicity handling.", "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 core description distinguishes pain, size, erythema and exudation, and the rationale states that a single prespecified primary outcome is not provided.", "condition_status": "Partly verified", "status_reason": "Multiple outcomes are known, but actual material on a single prespecified primary outcome, assessment-day hierarchy, multiplicity and reasons for changes remains unverified.", "missingness": "Multiple outcomes are known, but actual material on a single prespecified primary outcome, assessment-day hierarchy, multiplicity and reasons for changes remains unverified.", "uncertainty": "Multiple outcomes are known, but actual material on a single prespecified primary outcome, assessment-day hierarchy, multiplicity and reasons for changes remains unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome/time hierarchy, multiplicity and reasons for changes in the protocol, registration and SAP." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are a justified important difference for aphthous pain and the actual interval verified?", "needed": "Scale-specific important-difference basis, actual contrasts/CI and patient-relevant interpretation.", "role": "Required (interpretation of pain magnitude)", "role_reason": "Do not automatically equate statistical significance with a magnitude experienced by patients.", "application_exception": "Do not adopt arbitrary VAS points, fulfilment proportions or trial-count criteria.", "criterion": "Check a justified important-difference criterion for this population/pain scale against actual between-group estimates and intervals.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 important-difference basis with actual between-group estimates/intervals for the same scale, population and period to examine the interpretable scope.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The manuscript states that the P value alone does not establish magnitude and records that exact effects and CI were not verified.", "condition_status": "Unverified", "status_reason": "A scale-appropriate important-difference basis and actual between-group effects/intervals for comparison remain unverified.", "missingness": "A scale-appropriate important-difference basis and actual between-group effects/intervals for comparison remain unverified.", "uncertainty": "A scale-appropriate important-difference basis and actual between-group effects/intervals for comparison remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Scale-specific important-difference basis, actual contrasts/CI and patient-relevant interpretation." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are the actual identity and specifications of trial registration, protocol and SAP verified?", "needed": "Registration number, original registration/protocol/SAP, registration date and change history.", "role": "Required (plan comparison)", "role_reason": "Unverified registration number does not establish lack of a prespecified plan or confirmed selective reporting.", "application_exception": "No new search or external registration access is performed in this work.", "criterion": "Separately from the unverified registration record, check actual registration/protocol/SAP identity, dates and outcome/analysis specifications.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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": "Once identity is acquired, compare original outcomes/results/times with prespecified specifications and changes. Do not equate currently unverified registration with nonregistration.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original registration field states that it could not be verified, and the reader answer also states that registration was not verified.", "condition_status": "Unverified", "status_reason": "Actual registration/protocol/SAP identity and specifications were not acquired in the retained input. This does not establish that the trial was unregistered.", "missingness": "Actual registration/protocol/SAP identity and specifications were not acquired in the retained input. This does not establish that the trial was unregistered.", "uncertainty": "Actual registration/protocol/SAP identity and specifications were not acquired in the retained input. This does not establish that the trial was unregistered.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration number, original registration/protocol/SAP, registration date and change history." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are the family link for this report and other direct independent replication materials verified?", "needed": "Report/trial-family map, registration links and identity of replication material for the same question.", "role": "Required (replication/duplication boundary)", "role_reason": "Do not count a paper and its PubMed entry point as separate independent evidence.", "application_exception": "Do not turn absence of a search in this work or unverified replication in the original into 0 worldwide trials or an exact replication count.", "criterion": "Check the linked Jiang report/PMID/DOI and identity/independence of other comparisons with the same formulation, population and pain outcome.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 relationships among PMID/DOI/registration, recruitment cohorts and assessment times to distinguish repeat citations from independent replication. Do not conduct a new exhaustive search or sum participants.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "1 evidence entry and 1 citation link Jiang 2013, PMID 23246229 and DOI 10.1016/j.oooo.2012.09.009; the original manuscript describes one trial and unverified independent replication.", "condition_status": "Partly verified", "status_reason": "Retained report identity is verified, but comparison of unique families through registration/recruitment cohorts and actual material on other direct independent replications remains unverified.", "missingness": "Retained report identity is verified, but comparison of unique families through registration/recruitment cohorts and actual material on other direct independent replications remains unverified.", "uncertainty": "Retained report identity is verified, but comparison of unique families through registration/recruitment cohorts and actual material on other direct independent replications remains unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Report/trial-family map, registration links and identity of replication material for the same question." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are all assessment times and null or unfavorable results for the same pain question verified?", "needed": "Complete pain-result tables, assessment times/denominators, supplementary material and selection criteria.", "role": "Required (result selection)", "role_reason": "A favorable P-value summary does not establish the same direction for every result or absence of contrary results.", "application_exception": "Do not automatically classify numerical differences in other ulcer outcomes as conflicting pain data.", "criterion": "Check actual time-specific favorable, null and unfavorable pain results, contrasts, denominators and reporting scope.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 all pain results by assessment time, scale and contrast to examine favorable-result selection without treating different outcomes as conflicts.", "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 summary describes lower pain scores/P<.05 and a consistent direction, but does not provide all time-specific values.", "condition_status": "Partly verified", "status_reason": "The summary read in this work does not verify all null/unfavorable pain results or the scope of selective reporting.", "missingness": "The summary read in this work does not verify all null/unfavorable pain results or the scope of selective reporting.", "uncertainty": "The summary read in this work does not verify all null/unfavorable pain results or the scope of selective reporting.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete pain-result tables, assessment times/denominators, supplementary material and selection criteria." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are government support, product provision, author employment and full COI material verified?", "needed": "Funding details, product provision, author employment/disclosures and design/analysis roles.", "role": "Required (comparison with original independence records)", "role_reason": "Government-support wording does not establish absence of product/COI issues or proven independence.", "application_exception": "Do not infer absence of bias from the original I1 label or funding name alone.", "criterion": "Check the Chinese non-US government-support record against actual product provision, author employment, roles and full COI disclosures.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 funding, product and author documents to design/analysis roles to examine actual disclosure levels and remaining uncertainty.", "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 funding record describes Chinese non-US government research support and unverified product/COI details.", "condition_status": "Partly verified", "status_reason": "Actual funding details, product provision, author-specific employment/COI and design/analysis control remain unverified.", "missingness": "Actual funding details, product provision, author-specific employment/COI and design/analysis control remain unverified.", "uncertainty": "Actual funding details, product provision, author-specific employment/COI and design/analysis control remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding details, product provision, author employment/disclosures and design/analysis roles." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are the short-term report on 84 people, actual safety denominators, event definitions and collection verified?", "needed": "All exposed/safety denominators, event/person counts by arm, collection methods and discontinuation reasons.", "role": "Supplementary; required for safety claims", "role_reason": "Do not extend an absence description from short-term completers to 0 events overall or to proven safety.", "application_exception": "Do not delete the retained pain observation because harm material is unverified or calculate a new incidence.", "criterion": "Check the short-term description of no obvious adverse effects against actual separate exposed/safety denominators, event definitions, collection and discontinuation reasons by arm.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 exposure by arm with safety tables/collection procedures to compare the scope of the completer-sample description with all actually exposed participants.", "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 safety explanation states that no obvious adverse effects occurred in a short trial involving 84 people.", "condition_status": "Partly verified", "status_reason": "Actual exposure/safety denominators, event counts by arm, diagnosis/collection and detailed dropout/discontinuation information remain unverified. Do not convert this to 0 total events in 84 people.", "missingness": "Actual exposure/safety denominators, event counts by arm, diagnosis/collection and detailed dropout/discontinuation information remain unverified. Do not convert this to 0 total events in 84 people.", "uncertainty": "Actual exposure/safety denominators, event counts by arm, diagnosis/collection and detailed dropout/discontinuation information remain unverified. Do not convert this to 0 total events in 84 people.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "All exposed/safety denominators, event/person counts by arm, collection methods and discontinuation reasons." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are actual irritation, allergy and swallowed-exposure events, timing and alternative explanations verified?", "needed": "Irritation/allergy/swallowing events, exposure amount/timing, baseline/co-interventions and discontinuation/recovery.", "role": "Supplementary; required for the relevant harm", "role_reason": "Do not turn unverified safety issues into observed events or confirmed causality.", "application_exception": "Missing event material does not establish that irritation or allergy did not occur.", "criterion": "Check event definitions, exposure/onset, discontinuation/recovery, concurrent exposure and comparisons, distinguishing signal, frequency and causality.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 event records to actual local/swallowed exposure, timing and alternative explanations/comparators to examine the scope of what can be said.", "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 safety statement records that safety concerning local irritation, allergy and swallowed exposure is not established.", "condition_status": "Unverified", "status_reason": "This input lacks actual person/event counts, exposure/timing, discontinuation/recovery and baseline/co-intervention material for those events; risk magnitude and causality were not verified.", "missingness": "This input lacks actual person/event counts, exposure/timing, discontinuation/recovery and baseline/co-intervention material for those events; risk magnitude and causality were not verified.", "uncertainty": "This input lacks actual person/event counts, exposure/timing, discontinuation/recovery and baseline/co-intervention material for those events; risk magnitude and causality were not verified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Irritation/allergy/swallowing events, exposure amount/timing, baseline/co-interventions and discontinuation/recovery." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are pregnancy/lactation and safety/interaction materials beyond short follow-up verified?", "needed": "Direct exposure, events, duration and concomitant-use/interaction material by population.", "role": "Supplementary; required for expanded safety", "role_reason": "Do not extend 5-day general-adult material to pregnancy/lactation or overall long-term safety.", "application_exception": "Do not require every rare-harm study as a mandatory effect criterion for the original pain question.", "criterion": "Check direct exposure/event/comparison material on pregnancy, lactation, long-term/repeated application and concomitant medication.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 vulnerable-population/repeated-exposure material by formulation, route, population and follow-up, separating it from short-term general-adult material.", "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 safety explanation specifies that pregnancy/lactation safety is not established; the trial is short term at 5 days.", "condition_status": "Unverified", "status_reason": "Direct material on these vulnerable populations, long-term/repeated exposure and interactions was not checked in this work. No new personal-use instructions are created.", "missingness": "Direct material on these vulnerable populations, long-term/repeated exposure and interactions was not checked in this work. No new personal-use instructions are created.", "uncertainty": "Direct material on these vulnerable populations, long-term/repeated exposure and interactions was not checked in this work. No new personal-use instructions are created.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct exposure, events, duration and concomitant-use/interaction material by population." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Were the pain effect and safety limitations retained as separate records?", "needed": "Links among pain observations, original safety text, denominators/duration and interpretation boundaries.", "role": "Required (description boundary)", "role_reason": "A favorable efficacy direction must not erase safety gaps.", "application_exception": "Meeting this record-separation criterion does not establish safety concerning irritation/allergy or pregnancy/lactation.", "criterion": "Link the original pain observation/P value and Caution/safety gaps separately; do not inherit efficacy reporting as safety verification.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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": "When subsequent efficacy/safety material arrives, compare outcome, denominator, period and actual reading scope separately and update the relevant links.", "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": "Lower pain scores than vehicle/P<.05 are retained separately from the original Caution label and unverified local irritation, allergy, swallowing, pregnancy and lactation.", "condition_status": "Met", "status_reason": "Met status is limited to separating attribution of efficacy and safety records. Actual harm-material criteria remain unverified/partly verified.", "missingness": "Met status is limited to separating attribution of efficacy and safety records. Actual harm-material criteria remain unverified/partly verified.", "uncertainty": "Met status is limited to separating attribution of efficacy and safety records. Actual harm-material criteria remain unverified/partly verified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Links among pain observations, original safety text, denominators/duration and interpretation boundaries." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Does this checklist additionally require verification of optimal dosing or long-term persistence?", "needed": "For an extension claim: direct concentration/dose comparisons and long-term/withdrawal material.", "role": "Supplementary; required for the relevant extension", "role_reason": "Do not combine the narrow pain question with every dose-finding or persistence study.", "application_exception": "Actual nominal/application amount is covered in a separate row; unverified optimal amounts do not establish safe amounts.", "criterion": "Do not add optimal concentration/frequency, long-term persistence or withdrawal effects as mandatory confirmation beyond the selected 5 mg/g, 4-times-daily, 5-day scope.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 that extension is separately requested, examine designs comparing concentration/frequency and withdrawal/long-term results using the same pain definition.", "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 scope is pain with topical 5 mg/g gelatin applied 4 times daily for 5 days. Optimal concentration/frequency and long-term persistence were not selected claims.", "condition_status": "Not applicable", "status_reason": "Do not add optimal dosing or long-term persistence as mandatory extensions to the original claim. This does not establish lack of such effects or complete absence of material.", "missingness": "Do not add optimal dosing or long-term persistence as mandatory extensions to the original claim. This does not establish lack of such effects or complete absence of material.", "uncertainty": "Do not add optimal dosing or long-term persistence as mandatory extensions to the original claim. This does not establish lack of such effects or complete absence of material.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "For an extension claim: direct concentration/dose comparisons and long-term/withdrawal material." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Does the same effect question include size, erythema, exudation, healing, recurrence or infection treatment?", "needed": "For an extension: direct outcome definitions, comparisons, denominators, periods and results.", "role": "Supplementary; required for a separate outcome", "role_reason": "Do not extend a significant symptom score to cure or preventive effects.", "application_exception": "Retain other outcome observations, but do not invent values/effects absent from the retained source.", "criterion": "Separate the selected pain outcome from size/erythema/exudation, healing duration, recurrence and infection treatment; do not add those extensions as mandatory outcomes here.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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": "When separately examining an extension, design analyses separating its prespecified definition, direct results, denominators and period from pain.", "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 core description distinguishes four outcomes, and the advertising-limit text restricts extensions to cure, recurrence prevention, infection treatment and oral-systemic effects.", "condition_status": "Not applicable", "status_reason": "These are not direct outcomes of the selected pain question. Nonapplicability does not establish an effect of 0 on other outcomes or worldwide absence of healing/recurrence material.", "missingness": "These are not direct outcomes of the selected pain question. Nonapplicability does not establish an effect of 0 on other outcomes or worldwide absence of healing/recurrence material.", "uncertainty": "These are not direct outcomes of the selected pain question. Nonapplicability does not establish an effect of 0 on other outcomes or worldwide absence of healing/recurrence material.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "For an extension: direct outcome definitions, comparisons, denominators, periods and results." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Were the local summary, historical bibliography/abstract checks and currently unread external material distinguished?", "needed": "Material identity, links/original locations, actual reading scope, dates and original-document SHA.", "role": "Required (reading traceability)", "role_reason": "A PubMed link or an original bibliography/abstract-check statement does not establish full-text reading in this work.", "application_exception": "Do not assign inaccessible status to external material when access was not attempted.", "criterion": "Distinguish actual reading of the retained summary, the historical bibliography/abstract-check narrative, absent individual access records and external access not attempted/unread in this work.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 actual access/reading events, locations, dates and SHA for subsequent material, keeping them separate from historical access.", "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 retained summary was actually read in this work. The manuscript records checking the PMID 23246229 bibliography/abstract, but has no individual access-date/level/location records.", "condition_status": "Met", "status_reason": "Verification concerns material-specific actions and historical boundaries. Full paper, registration/protocol and external bibliography/abstract access were not attempted; they remain unread in this work.", "missingness": "Verification concerns material-specific actions and historical boundaries. Full paper, registration/protocol and external bibliography/abstract access were not attempted; they remain unread in this work.", "uncertainty": "Verification concerns material-specific actions and historical boundaries. Full paper, registration/protocol and external bibliography/abstract access were not attempted; they remain unread in this work.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Material identity, links/original locations, actual reading scope, dates and original-document SHA." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Were the original types and records for C46, axes/flags and corrections retained?", "needed": "Original verdict, score/axes, flags, original decisions/corrections and whole-input SHA.", "role": "Required (original-text identity)", "role_reason": "Do not confuse the earlier clinical verdict with preparation of the current evidence checklist.", "application_exception": "Do not fill absent grade-revalidation, evidence-status or access fields with false values or new verification claims.", "criterion": "Link grade C, score 46, original axes/false flags, empty strings/arrays, grade decisions and corrections/dates to the exact input; do not inherit them as new condition scores.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 changes are requested, preserve the full previous text and case/version records to compare actual differences. This work does not reassess the verdict.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Original C46, B/P/R1/I1/EX/B2/CX, false flags, empty subclaim lists/text fields and the 2026-09-14 English-placeholder correction are preserved in the retained original.", "condition_status": "Met", "status_reason": "This verifies types/original-text preservation, not current revalidation of C46 or calculation of an efficacy score or fulfilment proportion.", "missingness": "This verifies types/original-text preservation, not current revalidation of C46 or calculation of an efficacy score or fulfilment proportion.", "uncertainty": "This verifies types/original-text preservation, not current revalidation of C46 or calculation of an efficacy score or fulfilment proportion.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict, score/axes, flags, original decisions/corrections and whole-input SHA." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Were the original evidence date, current review date and scope of searches/checks distinguished?", "needed": "Original review date, case-review date, inputs used and actual search/calculation/access events.", "role": "Required (scope description)", "role_reason": "Do not turn the original evidence date into a date claiming completion of a current exhaustive literature search.", "application_exception": "Do not invent an original evidence-cutoff field or claim that it was the same field as the recorded review date.", "criterion": "Link the original review date with the case-review date, inputs used and the record of 0 new searches, calculations or external accesses in this work.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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": "When additional events occur, distinguish their performed scope/dates from historical records and link them to the relevant rows.", "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 review date is 2026-09-08, the correction date is 2026-09-14 and the review date for the case record is 2026-10-05. No new search, full-text access, clinical calculation or reassessment is performed in this work.", "condition_status": "Met", "status_reason": "Met status is limited to recording dates and authorized scope. It does not verify completeness of all current literature.", "missingness": "Met status is limited to recording dates and authorized scope. It does not verify completeness of all current literature.", "uncertainty": "Met status is limited to recording dates and authorized scope. It does not verify completeness of all current literature.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original review date, case-review date, inputs used and actual search/calculation/access events." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Were original search strategies, dates, screening/exclusions and unpublished/correction-check logs acquired?", "needed": "Historical search strategies/dates, search results, screening/exclusions and registration/unpublished/correction-check logs.", "role": "Required (scope of insufficiency/absence statements)", "role_reason": "Reading a retained abstract does not establish verification of all clinical literature.", "application_exception": "Unverified logs do not establish 0 human studies, 0 effect or 0 retractions.", "criterion": "Beyond the bibliography/abstract checks and oral/other-outcome exclusions, check actual search strategies/dates, results/screening and unpublished/registration/correction logs.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 formulation/route/population/pain eligibility with search, screening and exclusion reasons. Do not conduct a new search in this work.", "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 research-review text describes checking a PMID record/abstract and excluding oral berberine, ulcer size and healing duration.", "condition_status": "Partly verified", "status_reason": "That scope is described, but actual search strategies/dates, screening results/exclusion lists and unpublished/correction logs are not verified in this retained source.", "missingness": "That scope is described, but actual search strategies/dates, screening results/exclusion lists and unpublished/correction logs are not verified in this retained source.", "uncertainty": "That scope is described, but actual search strategies/dates, screening results/exclusion lists and unpublished/correction logs are not verified in this retained source.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical search strategies/dates, search results, screening/exclusions and registration/unpublished/correction-check logs." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Were update criteria distinguishing new material from condition-version changes recorded?", "needed": "Actual subsequent originals, reading/dates, locations/values/SHA, full previous versions and condition versions/reasons for changes.", "role": "Required (record updates)", "role_reason": "Material additions or display changes must not automatically become clinical confirmation.", "application_exception": "Recording this update rule does not perform subsequent checks, reassessment or deployment.", "criterion": "Provide rules recording evidence additions with actual identity/reading/locations/values/SHA separately from revisions of the question or criteria.", "basis": "Existing method principles distinguish population, topical formulation, application, vehicle, pain scale, assessment days, denominators, allocation, missingness, plans, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These topical berberine-gelatin and aphthous-ulcer pain 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 actual subsequent material with question eligibility, outcome/time, denominators and comparator, then review the relevant rows. Freeze a separate version before applying condition revisions.", "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 checklist provides update rules distinguishing evidence additions from condition revisions and requiring actual material locations, reading, dates and SHA.", "condition_status": "Met", "status_reason": "This is a record rule for this checklist. It does not establish completion of new clinical material, full-text reading, searches or condition updates.", "missingness": "This is a record rule for this checklist. It does not establish completion of new clinical material, full-text reading, searches or condition updates.", "uncertainty": "This is a record rule for this checklist. It does not establish completion of new clinical material, full-text reading, searches or condition updates.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual subsequent originals, reading/dates, locations/values/SHA, full previous versions and condition versions/reasons for changes." } ], "reports": [ { "report_id": "S01", "title": "Jiang 2013 report of topical berberine gelatin and aphthous-ulcer pain", "url": "https://pubmed.ncbi.nlm.nih.gov/23246229/", "report_type": "Retained bibliographic/abstract summary of a randomized double-blind vehicle-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": "The retained PMID and DOI identify the bibliography for the same report. Original registration, recruitment cohorts and other direct independent replications were not compared in this work.", "independent_replication": "1 evidence entry and 1 citation refer to the same report. The PMID and DOI are not counted as separate independent trials. Total unique trials, participants and independent replication are not currently established.", "observed_result": "The retained summary records 84 completers, lower pain scores than vehicle and P<.05. Retain the original description of an unreported/unverified exact between-group difference and 95% CI; external full text remains unread in this work. No new calculations were performed.", "result_level": "A retained summary of pain as a patient-experienced outcome. Actual scale range, time-specific contrasts/denominators, variance and prespecified plans remain unverified. This is not new verification of original result tables or the reporting scope of the full paper.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained bilingual bibliographic/abstract summaries and historical review record", "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": "Actual values and locations in the retained summary were read. Distinguish this from external clinical full-text bytes. Historical manuscript descriptions of bibliography/abstract checks are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "PubMed bibliography/abstract entry point", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "An entry-point link from the retained bibliography. Current URL response and bibliographic/abstract contents were not checked; access, acquisition and reading were not attempted. Historical manuscript descriptions of bibliography/abstract checks are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. 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": "Full paper: direct URL and current access scope unverified", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Direct full-text URL and current availability scope remain unverified. Distinguish the bibliographic entry point from full text; external access, acquisition and reading were not attempted. Historical manuscript descriptions of bibliography/abstract checks are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "Registration/protocol material type: identity unverified", "public_status": "Material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "This identifies a needed material type. Registration number and existence of actual documents remain unverified; external access, acquisition and reading were not attempted. Historical manuscript descriptions of bibliography/abstract checks are historical records. They do not establish current actual reading of external bibliography, abstracts, full text or registration. 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/23246229/" } ] } ], "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.", "Not reported": "Nonreporting is limited to a specific material or section actually read. This work did not assign a reporting status to the entire full paper.", "Inaccessible": "Used only for an actual access failure. Distinguish it from external access not attempted in this work." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Evidence and citation are linked for report S01. Its PMID and DOI identify the same report rather than separate independent replications. Unique trial and participant counts and other direct independent replications 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 32 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-27" }