{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3072-main", "verdict_number": "3072", "title": "Adjunctive berberine during continued antipsychotic therapy × Reduction of body weight in antipsychotic-associated weight gain", "view_version": "1.0", "view_created_date": "2026-10-27", "criteria_version": "1.1", "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": "People with schizophrenia-spectrum disorders and antipsychotic-associated metabolic syndrome. Detailed diagnosis, eligibility, age, baseline weight and balance between arms remain unverified.", "intervention": "Oral add-on treatment with berberine hydrochloride 100 mg tablets. Plant source, manufacturing batch, actual content and complete composition remain unverified. Do not substitute botanical extracts, combinations, other derivatives or topical products.", "dose": "The nominal dose was 600 mg/day. Actual dosing frequency, adherence, missed doses, discontinuation and dose changes remain unverified. The actual schedule is not calculated from tablet strength; this is not an instruction for personal use.", "comparator": "Placebo plus continued antipsychotic treatment. Specific antipsychotic types, doses and changes in each arm, and placebo composition, appearance and common management remain unverified. This does not concern stopping antipsychotics.", "endpoint": "The between-group difference in net weight change from baseline to week 12. Retained values are MD −1.08 kg, 95% CI −1.76 to −0.40, P=.002, d=.59. Actual analysis denominators, model, standardization and clinical-importance threshold remain unverified. The original C grade, 54 points and Warning are retained records.", "duration": "The main trial lasted 12 weeks. The supporting report used 900 mg/day for 8 weeks, with a different dose and duration. Do not pool these reports or extend them to long-term weight maintenance or psychiatric stability.", "excluded_extensions": [ "The 113 participants and 58/55 arm counts are retained sample records. Do not automatically use them as week 12 weight analysis or completion denominators, or as the denominator for 29.3% discontinuation.", "Retain 65 enrolled and 49 completing in the 8-week report, berberine −1.10 kg versus placebo +1.45 kg, and time-by-group P=.001. Do not calculate a new between-arm difference, CI or dropout rate.", "Weight is described as the prespecified primary outcome; BMI, waist, lipids and HbA1c are separate secondary outcomes. Do not transfer this to large weight loss in general obesity, clinical-event prevention, an optimal dose or benefits of stopping medication.", "Retain gastrointestinal intolerance, discontinuation and concomitant-treatment cautions concerning CYP and glucose effects. Do not newly establish event frequency, causality, individual safety or long-term psychiatric stability." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Does this sheet concern weight in kg at 12 weeks with 600 mg/day add-on treatment during continued antipsychotic therapy?", "needed": "The current manuscript’s question, claim conditions, weight-outcome definition and exclusions.", "role": "Required", "role_reason": "This boundary prevents all effects of an ingredient on a single page being assigned one efficacy state.", "application_exception": "Do not automatically combine general obesity, other metabolic markers or the 8-week report for the same ingredient with this question.", "criterion": "Connect the original claim to the actual population, oral HCl, placebo background and 12-week change in kg, excluding other questions.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future research should prespecify the same population, 600 mg/day, common antipsychotic treatment and 12-week weight contrast in kg.", "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 selected question is between-group change in weight in kg at 12 weeks with berberine hydrochloride 600 mg/day versus placebo as add-on treatment in patients with antipsychotic-associated metabolic syndrome.", "condition_status": "Met", "status_reason": "The current manuscript’s question and narrow scope were identified. This state does not establish efficacy or recommend use.", "missingness": "The current manuscript’s question and narrow scope were identified. This state does not establish efficacy or recommend use.", "uncertainty": "The current manuscript’s question and narrow scope were identified. This state does not establish efficacy or recommend use.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The current manuscript’s question, claim conditions, weight-outcome definition and exclusions." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are the diagnostic, metabolic-syndrome and antipsychotic-associated weight-gain eligibility criteria established?", "needed": "Main-trial eligibility criteria, diagnostic methods, age, recruitment setting and baseline table.", "role": "Required", "role_reason": "Similar population labels alone cannot establish applicability to the actual participants.", "application_exception": "Do not use this record to fill eligibility criteria for other psychiatric disorders or general obesity.", "criterion": "Link schizophrenia-spectrum diagnosis, metabolic-syndrome definition, recruitment and inclusion/exclusion criteria to the actual outcome population.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Add-on trials with the same eligibility criteria should report baseline diagnosis, age, metabolic-syndrome components and reasons for exclusion.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The population is recorded as patients with schizophrenia-spectrum disorders and antipsychotic-associated metabolic syndrome. Specific diagnostic and eligibility criteria and age distribution are not established by the retained summary.", "condition_status": "Partly verified", "status_reason": "The population is named, but actual eligibility criteria and sample composition remain missing.", "missingness": "The population is named, but actual eligibility criteria and sample composition remain missing.", "uncertainty": "The population is named, but actual eligibility criteria and sample composition remain missing.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Main-trial eligibility criteria, diagnostic methods, age, recruitment setting and baseline table." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are the weight-gain definition, baseline weight and balance between arms established?", "needed": "Antipsychotic exposure duration, baseline weight/BMI, weight-gain definition and baseline characteristics by arm.", "role": "Required", "role_reason": "Actual baseline information is needed to avoid attributing baseline differences to berberine.", "application_exception": "Do not treat an unverified baseline table as established imbalance or absence of weight gain.", "criterion": "Establish timing and definition of medication-associated weight gain and each arm’s baseline weight/BMI, disease and treatment status.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should define medication exposure and weight-gain duration and report baseline weight and major characteristics by arm.", "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": "Antipsychotic-associated metabolic syndrome is recorded, but baseline weight, magnitude and duration of gain and numerical balance between arms are absent.", "condition_status": "Unverified", "status_reason": "A sample record of 113 participants cannot substitute for baseline status or balance.", "missingness": "A sample record of 113 participants cannot substitute for baseline status or balance.", "uncertainty": "A sample record of 113 participants cannot substitute for baseline status or balance.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Antipsychotic exposure duration, baseline weight/BMI, weight-gain definition and baseline characteristics by arm." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are the composition, manufacture and content quality of the actual HCl 100 mg tablets established?", "needed": "Trial-product manufacturing, batch, content-testing, excipient and active-ingredient composition documents.", "role": "Required", "role_reason": "Similar ingredient names do not guarantee the same trial product.", "application_exception": "Do not substitute results for botanical extracts, combinations, dihydroberberine or topical products for these HCl tablets.", "criterion": "Establish product composition and actual content of berberine hydrochloride as the sole active ingredient in 100 mg tablets.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should use the same HCl formulation and disclose batch-specific content and composition verification.", "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 record add-on treatment with berberine hydrochloride 100 mg tablets. The plant source is unverified; manufacturing batch, actual content and full composition documents are absent.", "condition_status": "Partly verified", "status_reason": "The nominal ingredient and formulation are identified, but details of actual trial-product quality remain missing.", "missingness": "The nominal ingredient and formulation are identified, but details of actual trial-product quality remain missing.", "uncertainty": "The nominal ingredient and formulation are identified, but details of actual trial-product quality remain missing.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-product manufacturing, batch, content-testing, excipient and active-ingredient composition documents." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are actual dosing frequency, adherence and exposure duration for 600 mg/day established?", "needed": "Arm-specific dosing schedules, tablet counts, adherence measures, returned medication and dose-change information.", "role": "Required", "role_reason": "Differences between nominal and actual exposure can affect interpretation of weight and discontinuation.", "application_exception": "Do not calculate actual dosing frequency or individual cumulative exposure from 100 mg tablet strength.", "criterion": "Establish actual frequency, exposure duration, adherence measurement, missed doses/discontinuation and dose changes by arm, linking these to nominal 600 mg/day for 12 weeks.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials at the same dose should collect adherence data and prespecify separate analyses of assignment and actual-exposure effects.", "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 nominal dose is 600 mg/day for 12 weeks. Actual frequency, adherence distribution, missed doses and dose changes are not retained.", "condition_status": "Partly verified", "status_reason": "The planned dose and duration cannot be treated as every participant’s actual exposure.", "missingness": "The planned dose and duration cannot be treated as every participant’s actual exposure.", "uncertainty": "The planned dose and duration cannot be treated as every participant’s actual exposure.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific dosing schedules, tablet counts, adherence measures, returned medication and dose-change information." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are antipsychotic types, doses, changes and concomitant treatment in both arms established?", "needed": "Antipsychotic types, doses and changes by arm, concomitant medications, lifestyle interventions and rescue treatment.", "role": "Required", "role_reason": "This is required to distinguish concomitant-treatment differences from the selected ingredient’s contribution.", "application_exception": "Do not transfer an effect of stopping antipsychotics to the added effect of berberine.", "criterion": "Link continued common antipsychotic treatment and arm-specific medication, lifestyle and glucose-treatment changes to weight outcomes.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should define common-treatment principles and report changes and concomitant treatment by arm, analyzing the specified 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 comparator is placebo plus existing antipsychotic treatment; this is add-on therapy during continued antipsychotic use. Specific medications, doses and treatment changes by arm are absent from the retained summary.", "condition_status": "Partly verified", "status_reason": "The common-treatment framework is identified, but arm-specific actual concomitant treatment and deviations remain missing.", "missingness": "The common-treatment framework is identified, but arm-specific actual concomitant treatment and deviations remain missing.", "uncertainty": "The common-treatment framework is identified, but arm-specific actual concomitant treatment and deviations remain missing.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Antipsychotic types, doses and changes by arm, concomitant medications, lifestyle interventions and rescue treatment." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are placebo ingredients, appearance, administration and common management established?", "needed": "Placebo composition, manufacture, administration schedule and common treatment procedures in both arms.", "role": "Required", "role_reason": "The actual comparator is needed to interpret the add-on contrast.", "application_exception": "Do not turn missing comparator details into a new fact of placebo failure or active control.", "criterion": "Establish the actual placebo add-on formulation, matching of appearance/administration to the active arm and common management.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future add-on trials should prespecify a placebo with matching appearance/administration and common treatment procedures.", "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 main trial is recorded as placebo-controlled, with placebo plus existing antipsychotic treatment as comparator. Placebo composition and details of matching appearance and administration are absent.", "condition_status": "Partly verified", "status_reason": "A placebo label alone cannot establish the control formulation or identical common management.", "missingness": "A placebo label alone cannot establish the control formulation or identical common management.", "uncertainty": "A placebo label alone cannot establish the control formulation or identical common management.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo composition, manufacture, administration schedule and common treatment procedures in both arms." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are random-sequence generation, concealment and actual design established?", "needed": "Main-trial methods, sequence generation/concealment, responsible personnel and participant-flow diagram.", "role": "Required", "role_reason": "The design name alone cannot establish that allocation-bias concerns are resolved.", "application_exception": "Do not turn unverified methods into established nonrandom allocation or inadequate allocation.", "criterion": "Beyond the randomized double-blind placebo-controlled label, establish allocation sequence, concealment and participant flow by arm.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should disclose sequence generation, concealment and staff roles and link these to outcome-specific analysis populations.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "A randomized double-blind placebo-controlled design is retained. Sequence generation, concealment and actual arm-specific procedures are not established by the summary alone.", "condition_status": "Partly verified", "status_reason": "The RCT label is present, but the whole allocation process is not established.", "missingness": "The RCT label is present, but the whole allocation process is not established.", "uncertainty": "The RCT label is present, but the whole allocation process is not established.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Main-trial methods, sequence generation/concealment, responsible personnel and participant-flow diagram." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Who was blinded, and are unblinding and assessment procedures established?", "needed": "Trial methods describing who was blinded, unblinding and weight-assessment procedures.", "role": "Required", "role_reason": "This distinguishes a blinding label from actual measurement limitations.", "application_exception": "Do not automatically waive assessment-procedure checks because weight is objective.", "criterion": "Establish blinding of participants, treating staff, weight assessors and analysts, with unblinding and measurement procedures.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should link assessor/analyst blinding and unblinding information to outcome reporting.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The double-blind design label is present. Actual blinded parties, unblinding status and assessment procedures are absent from the retained summary.", "condition_status": "Partly verified", "status_reason": "Distinguish the design label from verification of measurement blinding for the weight result.", "missingness": "Distinguish the design label from verification of measurement blinding for the weight result.", "uncertainty": "Distinguish the design label from verification of measurement blinding for the weight result.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial methods describing who was blinded, unblinding and weight-assessment procedures." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Is the retained main effect between-group change in weight in kg from baseline to 12 weeks?", "needed": "Outcome definition and timing in the current claim conditions and the units of the evidence result.", "role": "Required", "role_reason": "This record boundary prevents different scales or within-arm changes being combined as the same effect.", "application_exception": "Do not read the MD as final weight or within-arm weight reduction.", "criterion": "Link the retained outcome definition: net change from baseline, 12 weeks, kg and a between-group contrast.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future reports should separately tabulate the between-group estimate of change in kg from baseline and other metabolic markers.", "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 selected endpoint is between-group difference in net weight change from baseline to 12 weeks, retained as MD in kg. BMI, waist, lipids and HbA1c are separate secondary outcomes.", "condition_status": "Met", "status_reason": "This condition identifies the endpoint, units and between-group direction of the retained estimate. Actual measurement, denominators and model remain addressed in other rows.", "missingness": "This condition identifies the endpoint, units and between-group direction of the retained estimate. Actual measurement, denominators and model remain addressed in other rows.", "uncertainty": "This condition identifies the endpoint, units and between-group direction of the retained estimate. Actual measurement, denominators and model remain addressed in other rows.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome definition and timing in the current claim conditions and the units of the evidence result." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are the weight-measurement device, conditions, repetitions and visit windows established?", "needed": "Weight-measurement procedures, device calibration, repeated measurements and visit schedule.", "role": "Required", "role_reason": "Actual information is needed to distinguish observed differences from measurement-condition differences.", "application_exception": "Do not treat missing measurement methods as proof that the weight estimate is erroneous.", "criterion": "Establish device, time, clothing, repetitions and visit windows for baseline and 12-week weight measurements.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should define device calibration, identical measurement conditions and visit windows and report measurement errors.", "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": "Weight in kg and the 12-week time point are present, but the device, measurement conditions, repetitions and visit windows are absent.", "condition_status": "Unverified", "status_reason": "A number in kg alone does not establish actual measurement procedures.", "missingness": "A number in kg alone does not establish actual measurement procedures.", "uncertainty": "A number in kg alone does not establish actual measurement procedures.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Weight-measurement procedures, device calibration, repeated measurements and visit schedule." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are 113 participants and 58/55 identified as retained allocation-sample records?", "needed": "Allocation-sample records and flow information distinguishing them from actual outcome denominators.", "role": "Required", "role_reason": "This record condition prevents confusion between reported sample counts and analysis denominators.", "application_exception": "Do not back-calculate event or completion counts from the original proportions or discontinuation rate.", "criterion": "Retain the original 113 participants, berberine 58 and placebo 55, without upgrading them to completion, measurement or analysis counts.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future reports should separately show allocated, measured, completed and analyzed counts by arm in a flow diagram.", "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 main-trial sample record is 113 participants: 58 berberine and 55 placebo. These were not established as week 12 weight analysis or completion denominators.", "condition_status": "Met", "status_reason": "The original sample records and denominator boundaries were checked. Analysis denominators remain unverified in the next row.", "missingness": "The original sample records and denominator boundaries were checked. Analysis denominators remain unverified in the next row.", "uncertainty": "The original sample records and denominator boundaries were checked. Analysis denominators remain unverified in the next row.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation-sample records and flow information distinguishing them from actual outcome denominators." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are actual arm-specific analysis denominators for the 12-week weight MD and CI established?", "needed": "Arm-specific analysis n, measured n and inclusion criteria in the 12-week weight outcome table.", "role": "Required", "role_reason": "This is required to connect the estimate and interval to their actual denominators.", "application_exception": "Do not automatically fill analysis counts with 58/55 or 113.", "criterion": "Establish observed/analyzed counts and inclusion criteria by arm used for the actual MD and CI.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future tables should show arm-specific analysis denominators by time point and model, with rules for including missing outcomes.", "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 113 and 58/55 records are present, but actual analyzed counts for MD −1.08 kg and its CI are absent from the summary.", "condition_status": "Unverified", "status_reason": "Allocation records cannot substitute for the analysis n of the effect estimate.", "missingness": "Allocation records cannot substitute for the analysis n of the effect estimate.", "uncertainty": "Allocation records cannot substitute for the analysis n of the effect estimate.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific analysis n, measured n and inclusion criteria in the 12-week weight outcome table." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are completion, dropout reasons, missing-data handling and weight follow-up established by arm?", "needed": "Arm-specific flow diagrams, dropout reasons, time-specific missingness, imputation and sensitivity analyses.", "role": "Required", "role_reason": "This is needed to establish how discontinuation and loss of observation affect the estimate.", "application_exception": "Do not infer whether weight was measured after discontinuation or why participants stopped.", "criterion": "Establish 12-week completion, discontinuation, missing measurements, follow-up results and missing-data rules.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should collect outcomes after treatment discontinuation and prespecify sensitivity analyses under different missing-data assumptions.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Berberine-arm discontinuation of 29.3% is recorded, but completion, missing measurements, dropout reasons and missing-data details are absent.", "condition_status": "Unverified", "status_reason": "The discontinuation proportion cannot substitute for completion counts or analysis exclusions.", "missingness": "The discontinuation proportion cannot substitute for completion counts or analysis exclusions.", "uncertainty": "The discontinuation proportion cannot substitute for completion counts or analysis exclusions.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific flow diagrams, dropout reasons, time-specific missingness, imputation and sensitivity analyses." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Does the MD estimate assignment or adherence effects, and what model was used?", "needed": "Main-trial analysis plan, outcome model, ITT/PP definitions, covariates and missing-data documents.", "role": "Required", "role_reason": "Analysis information is needed to avoid mixing assignment/adherence effects with within-arm changes.", "application_exception": "Do not assign ITT, completer-only or baseline-adjustment status without verifying the original.", "criterion": "Link ITT/PP, repeated measurements, baseline adjustment, covariates, missing-data handling and the effect of interest to the actual MD.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should prespecify assignment as the effect of interest and separate missing-data, covariate and adherence analyses.", "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 12-week between-group MD is retained, but the analysis population, ITT/PP status, model and adjustment variables are absent from the summary.", "condition_status": "Unverified", "status_reason": "A between-group MD label alone cannot establish ITT or a particular adjusted model.", "missingness": "A between-group MD label alone cannot establish ITT or a particular adjusted model.", "uncertainty": "A between-group MD label alone cannot establish ITT or a particular adjusted model.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Main-trial analysis plan, outcome model, ITT/PP definitions, covariates and missing-data documents." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are −1.08 kg, the 95% CI and P value identified as retained results of the same main trial?", "needed": "The same result in the current evidence table, bibliographic summary and reader answer.", "role": "Required", "role_reason": "This record condition prevents retaining only significance or changing numerical attribution.", "application_exception": "Do not calculate a new standardized effect or clinical-sufficiency score from the CI and P value.", "criterion": "Link MD −1.08 kg, 95% CI −1.76 to −0.40 and P=.002 to the original record location, units and 12-week between-group contrast.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future reports should present the estimate, interval, denominators and model for the same contrast in one table.", "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 main trial’s retained values are MD −1.08 kg, 95% CI −1.76 to −0.40 and P=.002, attributed to the 12-week between-group weight difference in kg.", "condition_status": "Met", "status_reason": "These values were identified as reported in the retained summary. This does not independently certify the original table or clinical effect.", "missingness": "These values were identified as reported in the retained summary. This does not independently certify the original table or clinical effect.", "uncertainty": "These values were identified as reported in the retained summary. This does not independently certify the original table or clinical effect.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The same result in the current evidence table, bibliographic summary and reader answer." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are the definition, variance, denominator and derivation location for d=.59 established?", "needed": "The original result table’s d definition, SD/SE used, denominator, derivation or editorial calculation record.", "role": "Required", "role_reason": "This is needed to prevent using a retained standardized value as an effect-size criterion without its definition.", "application_exception": "Do not newly calculate d=.59 or substitute it for a criterion of clinical importance in kg.", "criterion": "Establish retained d=.59 and its standardization method, variance type, denominator and derivation source.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future reports should provide the standardized value’s definition, variance and formula and interpret it separately from the kg estimate.", "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": "d=.59 appears in evidence and bibliographic result strings. The calculation method, variance type, denominator and attribution to original reporting versus historical calculation are absent.", "condition_status": "Partly verified", "status_reason": "The value’s presence is distinct from evidence of its standardized-effect derivation.", "missingness": "The value’s presence is distinct from evidence of its standardized-effect derivation.", "uncertainty": "The value’s presence is distinct from evidence of its standardized-effect derivation.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original result table’s d definition, SD/SE used, denominator, derivation or editorial calculation record." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is a meaningful difference in weight in kg for this population established, with its basis?", "needed": "Prespecified basis for a clinically important difference or weight-loss threshold, baseline weight and patient-perspective information.", "role": "Required", "role_reason": "This is needed to distinguish statistical significance from a magnitude important to patients.", "application_exception": "Do not set a new minimum kg, percentage or participant threshold or inherit original E~ as condition fulfillment.", "criterion": "Report a prespecified important difference and source appropriate to the population, duration and burden and connect it to the CI.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should prespecify a meaningful difference for this population with its basis and report the interval and treatment burden together.", "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 the 1.08 kg difference as statistically significant but clinically small. A numerical threshold, its basis and prespecification are absent.", "condition_status": "Unverified", "status_reason": "The original interpretation of a clinically small effect is retained, but the specific importance criterion was not currently verified.", "missingness": "The original interpretation of a clinically small effect is retained, but the specific importance criterion was not currently verified.", "uncertainty": "The original interpretation of a clinically small effect is retained, but the specific importance criterion was not currently verified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified basis for a clinically important difference or weight-loss threshold, baseline weight and patient-perspective information." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are time-specific weight variances and the model/CI derivation established?", "needed": "Arm-specific means of weight change, SD/SE, outcome n, CI derivation and analysis model.", "role": "Required", "role_reason": "This information is needed to connect the interval to actual variance and denominators.", "application_exception": "Do not back-calculate SD from the CI or treat 113 participants as sufficient precision.", "criterion": "Establish baseline/change variances, SD/SE, outcome denominators and CI derivation by arm.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future outcome tables should provide means, variance type, denominators and interval derivation together.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "A 95% CI is reported, but baseline/change variances by arm and the CI derivation are absent.", "condition_status": "Unverified", "status_reason": "A reported interval alone cannot establish original variance or sample-precision information.", "missingness": "A reported interval alone cannot establish original variance or sample-precision information.", "uncertainty": "A reported interval alone cannot establish original variance or sample-precision information.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific means of weight change, SD/SE, outcome n, CI derivation and analysis model." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are prespecified primary status, timing, analysis and reporting of weight directly compared?", "needed": "The original NCT02983188 registration history, protocol, analysis plan and results report.", "role": "Required", "role_reason": "This distinguishes the retained hierarchy description from actual comparison with a prospective plan.", "application_exception": "Do not treat an unacquired plan as proof of nonregistration or selective reporting.", "criterion": "Compare planned primary weight/12-week/analysis specifications in registration, protocol and plan with actual results.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should preregister primary weight, 12-week timing and analysis and disclose all planned outcomes and reasons for changes.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The Korean manuscript records weight as the prespecified primary outcome and BMI, waist, lipids and HbA1c as secondary outcomes. The original plan and result were not directly compared in this work.", "condition_status": "Partly verified", "status_reason": "The manuscript describes a prospective hierarchy, but current comparison of plan bytes and revision history remains outstanding.", "missingness": "The manuscript describes a prospective hierarchy, but current comparison of plan bytes and revision history remains outstanding.", "uncertainty": "The manuscript describes a prospective hierarchy, but current comparison of plan bytes and revision history remains outstanding.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original NCT02983188 registration history, protocol, analysis plan and results report." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are the NCT02983188 link to the main trial and registration fields directly verified?", "needed": "Official NCT02983188 registration and history, with a comparison of paper identity, eligibility, intervention and endpoint.", "role": "Required", "role_reason": "This prevents a bibliographic clue and registry verification being shown at the same verification level.", "application_exception": "Do not turn a clue’s presence into reading/approval of registry content or proof of a structured-field error.", "criterion": "Retain both bibliographic NCT02983188 and the structured registration field marked unverified, and compare trial identity and conditions with the original registry.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future checks should compare official registration history with the paper’s identity, duration and plan without mixing other identifiers.", "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 Korean manuscript/bibliography link NCT02983188, but the main-trial registration field says unverified. Original-registration access in this work was 0.", "condition_status": "Partly verified", "status_reason": "A registration-number clue is identified, but current direct verification of registration fields and linkage remains unverified. Both records are retained.", "missingness": "A registration-number clue is identified, but current direct verification of registration fields and linkage remains unverified. Both records are retained.", "uncertainty": "A registration-number clue is identified, but current direct verification of registration fields and linkage remains unverified. Both records are retained.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Official NCT02983188 registration and history, with a comparison of paper identity, eligibility, intervention and endpoint." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are the content and outcome impact of the Figure 2 caption correction directly compared?", "needed": "The original corrigendum, before-and-after figure captions and main-paper outcome table.", "role": "Required", "role_reason": "This distinguishes correction from independent replication while checking actual change scope.", "application_exception": "Do not count the corrigendum as a new independent weight trial or infer further effect changes from missing records.", "criterion": "Check PMID 36210782, the main paper’s Figure 2 and before-and-after weight results.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future document checks should preserve linked before-and-after figures, values and change scope for the same trial.", "current_reports": [ "S01", "S02" ], "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 Korean manuscript records that the correction changed only the Figure 2 caption order and did not change the weight estimate. Corrigendum PMID 36210782 is in the bibliography.", "condition_status": "Partly verified", "status_reason": "The correction’s scope and unchanged estimate are described in retained text, but originals were not compared before and after in this work.", "missingness": "The correction’s scope and unchanged estimate are described in retained text, but originals were not compared before and after in this work.", "uncertainty": "The correction’s scope and unchanged estimate are described in retained text, but originals were not compared before and after in this work.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original corrigendum, before-and-after figure captions and main-paper outcome table." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are the actual population, formulation and 900 mg/day conditions of the 8-week supporting trial established?", "needed": "PMID 34773803 trial methods on eligibility, formulation, 900 mg/day, concomitant medications and placebo.", "role": "Required", "role_reason": "This condition checks actual directness and differences in the supporting report’s conditions.", "application_exception": "Do not combine a different dose and duration as identical direct replication.", "criterion": "Establish population, formulation and background treatment for 900 mg/day over 8 weeks versus placebo during antipsychotic treatment.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future replication should use the main trial’s conditions or prespecify comparisons of dose and duration differences.", "current_reports": [ "S03" ], "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 Korean manuscript describes an independent randomized placebo-controlled 8-week trial with 900 mg/day pointing in the same direction. Detailed population, product and concomitant-treatment information is absent from the current summary.", "condition_status": "Partly verified", "status_reason": "Dose, duration and design labels are present, but information is insufficient to treat it as the same conditions as 600 mg/day for 12 weeks.", "missingness": "Dose, duration and design labels are present, but information is insufficient to treat it as the same conditions as 600 mg/day for 12 weeks.", "uncertainty": "Dose, duration and design labels are present, but information is insufficient to treat it as the same conditions as 600 mg/day for 12 weeks.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "PMID 34773803 trial methods on eligibility, formulation, 900 mg/day, concomitant medications and placebo." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are 65 enrolled and 49 completed connected to actual arm-specific weight-analysis denominators?", "needed": "The 8-week trial flow diagram, arm-specific outcome n, dropout reasons and completer-analysis definition.", "role": "Required", "role_reason": "This prevents sample records from another report being transferred to the main trial or analysis denominators.", "application_exception": "Do not calculate a new dropout rate or arm-specific event count from enrollment minus completion.", "criterion": "Link enrollment, allocation, completion and analysis counts and arm-specific missingness/analysis methods to the actual 8-week result.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future reports should separately show counts at each stage by arm and differences between completer and assignment analyses.", "current_reports": [ "S03" ], "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": "65 enrolled and 49 completed are retained, with small-sample/completer limitations recorded. Allocation/analysis counts by arm and reasons for exclusion are absent.", "condition_status": "Partly verified", "status_reason": "49 completed cannot establish every arm-specific outcome-analysis denominator.", "missingness": "49 completed cannot establish every arm-specific outcome-analysis denominator.", "uncertainty": "49 completed cannot establish every arm-specific outcome-analysis denominator.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The 8-week trial flow diagram, arm-specific outcome n, dropout reasons and completer-analysis definition." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are the 8-week arm-specific changes and time-by-group P value identified as the original report’s summary?", "needed": "The current retained result, bibliographic summary and analysis label for the 8-week trial.", "role": "Required", "role_reason": "This record condition prevents automatic conversion of differently expressed supporting results to the same measure.", "application_exception": "Do not turn a time-by-group test into a single-time-point between-group P value or a new CI.", "criterion": "Retain berberine −1.10 kg, placebo +1.45 kg and time-by-group P=.001 as an 8-week report, without creating a new between-arm difference.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future reports should separately provide arm-specific changes and prespecified between-group estimates, CIs, model and denominators.", "current_reports": [ "S03" ], "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 8-week report contains berberine −1.10 kg versus placebo +1.45 kg and time-by-group P=.001. No separate between-group MD or CI was newly calculated.", "condition_status": "Met", "status_reason": "The existing result’s attribution was checked. The difference between arm-specific changes was not pooled with the main-trial MD or generated as an official MD.", "missingness": "The existing result’s attribution was checked. The difference between arm-specific changes was not pooled with the main-trial MD or generated as an official MD.", "uncertainty": "The existing result’s attribution was checked. The difference between arm-specific changes was not pooled with the main-trial MD or generated as an official MD.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The current retained result, bibliographic summary and analysis label for the 8-week trial." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Were 600 mg/day for 12 weeks and 900 mg/day for 8 weeks identified as different conditions?", "needed": "A comparison record of both reports’ doses, durations, results, denominators and question boundaries.", "role": "Required", "role_reason": "This distinguishes similar direction from independent replication of the same effect.", "application_exception": "Do not label different conditions alone as a numerical error or direct conflict.", "criterion": "Connect differences in dose, timing, denominators and result expression without pooling effects.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Before future synthesis, verify matching population, ingredient, dose, timing and measure and prespecify separate analyses for different conditions.", "current_reports": [ "S01", "S03" ], "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 main trial provides an MD at 600 mg/day for 12 weeks; support provides arm-specific changes and a time-by-group test at 900 mg/day for 8 weeks. The original same-direction description is retained without pooling effects.", "condition_status": "Met", "status_reason": "This checks the record boundary separating the conditions. It does not establish replication under identical conditions or long-term effects.", "missingness": "This checks the record boundary separating the conditions. It does not establish replication under identical conditions or long-term effects.", "uncertainty": "This checks the record boundary separating the conditions. It does not establish replication under identical conditions or long-term effects.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "A comparison record of both reports’ doses, durations, results, denominators and question boundaries." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are families and recruitment independence of the main paper, corrigendum and supporting trial established?", "needed": "Registration identifiers, institutions, recruitment periods and family-linkage table for the main paper, correction and 8-week report.", "role": "Required", "role_reason": "This is a required identity condition preventing duplicate counting of reports and studies.", "application_exception": "Do not count 3 reports as 3 independent trials or sum participants.", "criterion": "Link the main paper/correction to the same family and establish recruitment, institutions, timing and registration relationships for the 8-week report.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future synthesis should group the main paper, correction and registration into one family and verify independence through recruitment and institutional relationships.", "current_reports": [ "S01", "S02", "S03" ], "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 links main-paper PMID 34931749 and correction PMID 36210782. The 8-week PMID 34773803 is described as a small independent trial, but recruitment relationships were not externally compared.", "condition_status": "Partly verified", "status_reason": "Bibliographic/manuscript links are present, but material needed to newly certify unique trial and participant counts remains missing.", "missingness": "Bibliographic/manuscript links are present, but material needed to newly certify unique trial and participant counts remains missing.", "uncertainty": "Bibliographic/manuscript links are present, but material needed to newly certify unique trial and participant counts remains missing.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration identifiers, institutions, recruitment periods and family-linkage table for the main paper, correction and 8-week report." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are main-trial funding, product provision, author interests and influence established?", "needed": "Main-trial funding, product support, author employment/patents/interests and roles in design, analysis and reporting.", "role": "Required", "role_reason": "This prevents inheriting the original independent-funding axis as a new certification of independence.", "application_exception": "Do not automatically exclude product support or fill unverified disclosures as no conflicts.", "criterion": "Distinguish public funding from manufacturing, product provision, employment, patents, interests and roles at each research stage.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future research should separately disclose funding, product provision, roles in design/analysis/reporting and all author declarations.", "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": "Hong Kong Health and Medical Research Fund is recorded, with tablet manufacturing/provision separate. Author interests and the supplier’s specific roles are absent.", "condition_status": "Partly verified", "status_reason": "A public fund’s name cannot prove all independence or absence of bias.", "missingness": "A public fund’s name cannot prove all independence or absence of bias.", "uncertainty": "A public fund’s name cannot prove all independence or absence of bias.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Main-trial funding, product support, author employment/patents/interests and roles in design, analysis and reporting." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are funding, product support and team independence for the 8-week report established?", "needed": "Funding, product provision, author employment/declarations and institutional relationships with the main trial for the 8-week report.", "role": "Required", "role_reason": "This distinguishes supporting-report independence from a simple count of reports.", "application_exception": "Do not automatically reuse original I2 as current verification of each report’s independence.", "criterion": "Check the academic-support summary against detailed funding, provision, authors and institutional relationships.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future family checks should compare funding, team and recruitment relationships and separately report product provision and influence on interpretation.", "current_reports": [ "S03" ], "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 8-week report records academic support with details requiring verification. Detailed funding, supporter roles and relationships with the main-trial team are absent.", "condition_status": "Partly verified", "status_reason": "Academic support alone cannot complete direct verification of independent funding or an independent team.", "missingness": "Academic support alone cannot complete direct verification of independent funding or an independent team.", "uncertainty": "Academic support alone cannot complete direct verification of independent funding or an independent team.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding, product provision, author employment/declarations and institutional relationships with the main trial for the 8-week report." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are the denominator, timing, reasons and between-arm comparison for 29.3% discontinuation established?", "needed": "Discontinuation table, participant counts, denominators, timing, reasons and placebo-arm comparison.", "role": "Supplementary; required to interpret discontinuation and safety", "role_reason": "This supplementary safety condition prevents turning discontinuation into analysis loss or a causal harm rate.", "application_exception": "Do not apply the proportion to 58 participants to create counts or attribute every discontinuation to drug harm.", "criterion": "Establish the actual denominator, discontinuation definition, time, reasons and control-arm counts for reported 29.3%.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should distinguish discontinuation from harm, collect arm-specific counts, denominators, timing and causes and follow outcomes after discontinuation.", "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": "Berberine-arm discontinuation of 29.3% appears in the original reader answer. Denominator, actual count, counts by reason and placebo-arm discontinuation data are absent.", "condition_status": "Partly verified", "status_reason": "The proportion is recorded, but information needed to establish incidence, comparative risk or gastrointestinal causation remains missing.", "missingness": "The proportion is recorded, but information needed to establish incidence, comparative risk or gastrointestinal causation remains missing.", "uncertainty": "The proportion is recorded, but information needed to establish incidence, comparative risk or gastrointestinal causation remains missing.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Discontinuation table, participant counts, denominators, timing, reasons and placebo-arm comparison." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are gastrointestinal-intolerance definitions, collection, severity and arm-specific frequency established?", "needed": "Main-trial safety table, gastrointestinal-event definitions, collection procedures, arm-specific counts/denominators and links to discontinuation.", "role": "Supplementary; required to interpret observed harms", "role_reason": "This prevents declaring safety simply because an efficacy result exists.", "application_exception": "Do not present unverified data as no harm or substitute efficacy estimates for harm rates.", "criterion": "Establish actual harm descriptions, event identification, collection, severity, participant counts/denominators and comparison.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future trials should systematically collect harms and separately report symptoms, severity, discontinuation and arm-specific denominators.", "current_reports": [ "S01" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "Warning text describes gastrointestinal intolerance, but event types, definitions, collection, severity and arm-specific frequencies are absent.", "condition_status": "Partly verified", "status_reason": "Harm descriptions are retained without establishing comparative-risk magnitude, causality or overall safety.", "missingness": "Harm descriptions are retained without establishing comparative-risk magnitude, causality or overall safety.", "uncertainty": "Harm descriptions are retained without establishing comparative-risk magnitude, causality or overall safety.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Main-trial safety table, gastrointestinal-event definitions, collection procedures, arm-specific counts/denominators and links to discontinuation." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are direct data on CYP/glucose effects, concomitant medications and psychiatric stability established?", "needed": "Arm-specific concomitant drugs, concentrations, glucose, psychiatric stability, related adverse events and analyses.", "role": "Supplementary; required for interaction extensions", "role_reason": "This supplementary boundary distinguishes the original warning from direct clinical-harm results.", "application_exception": "Do not turn a mechanistic warning into established causality of actual events or individual prescribing instructions.", "criterion": "Establish actual concomitant drugs/exposure and collection of drug concentrations, glucose, psychiatric changes and clinical events.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future research should use suitable pharmacokinetic and safety follow-up designs to examine exposure and clinical outcomes for specific concomitant drugs.", "current_reports": [ "S01", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The original warning describes possible overlap of antipsychotic metabolism/glucose effects with CYP interactions. Specific interaction results or psychiatric-stability estimates are absent.", "condition_status": "Unverified", "status_reason": "A possibility in warning text does not establish a direct interaction effect or risk magnitude.", "missingness": "A possibility in warning text does not establish a direct interaction effect or risk magnitude.", "uncertainty": "A possibility in warning text does not establish a direct interaction effect or risk magnitude.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific concomitant drugs, concentrations, glucose, psychiatric stability, related adverse events and analyses." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are weight maintenance beyond 12 weeks and long-term psychiatric/rare harms directly established?", "needed": "Long-term and post-discontinuation weight follow-up under the same conditions, with exposure/outcome information for psychiatric and rare harms.", "role": "Supplementary; required for long-term extensions", "role_reason": "This prevents extending a short-term effect to maintenance or overall safety.", "application_exception": "Do not impose every long-term study as an additional requirement for the narrow 12-week kg question or establish all harms from a short-term warning.", "criterion": "Distinguish direct long-term/post-discontinuation follow-up and psychiatric/rare-harm data from the selected result.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future follow-up in the same population should prespecify weight maintenance, post-discontinuation change, psychiatric and long-term harms and report long-term loss to follow-up.", "current_reports": [ "S01", "S03" ], "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 records that both trials are small and short and cannot establish long-term weight or psychiatric stability.", "condition_status": "Unverified", "status_reason": "Long-term/maintenance information is not established within the retained scope. This gap is not used as a reason to delete the 12-week result.", "missingness": "Long-term/maintenance information is not established within the retained scope. This gap is not used as a reason to delete the 12-week result.", "uncertainty": "Long-term/maintenance information is not established within the retained scope. This gap is not used as a reason to delete the 12-week result.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term and post-discontinuation weight follow-up under the same conditions, with exposure/outcome information for psychiatric and rare harms." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Is the boundary between weight in kg, metabolic markers and clinical events explicit?", "needed": "The current outcome hierarchy and records distinguishing weight from other metabolic/clinical questions.", "role": "Required", "role_reason": "This is a required boundary distinguishing numerical changes from other clinical benefits.", "application_exception": "Do not unconditionally require clinical-event trials for the question about weight change itself.", "criterion": "Do not substitute BMI, waist, lipids, HbA1c or clinical events for the selected weight-in-kg result.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Extension studies should define metabolic markers or patient outcomes as separate questions and prespecified endpoints and evaluate causal contribution alongside weight change.", "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": "Weight is the principal outcome; BMI, waist, lipids and HbA1c are separate secondary outcomes. This sheet addresses only the weight difference in kg.", "condition_status": "Met", "status_reason": "The record scope separating other endpoints was checked. This does not establish direct effects on metabolic improvement or disease prevention.", "missingness": "The record scope separating other endpoints was checked. This does not establish direct effects on metabolic improvement or disease prevention.", "uncertainty": "The record scope separating other endpoints was checked. This does not establish direct effects on metabolic improvement or disease prevention.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "The current outcome hierarchy and records distinguishing weight from other metabolic/clinical questions." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Are optimal-dose, general-obesity and antipsychotic-discontinuation efficacy required for this sheet?", "needed": "Direct dose-comparison, general-obesity or medication-discontinuation information if those extension questions are selected.", "role": "Supplementary; required if the relevant extension is selected", "role_reason": "This conditional nonapplication prevents automatically creating other efficacy claims or mixing them with gaps in the narrow question.", "application_exception": "If the user selects an extension question, design direct-material conditions for that question separately.", "criterion": "Limit this to the selected 600 mg/day, continued-antipsychotic, 12-week question; other efficacy questions are separate.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Separate dose or generalization studies should fix population and background treatment and prespecify direct comparisons and effect-modification analyses.", "current_reports": [ "S01", "S03" ], "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 explicitly bars transfer to large weight loss in general obesity or stopping antipsychotics. The 8-week different-dose report is not a direct comparison of an optimal dose.", "condition_status": "Not applicable", "status_reason": "This narrow sheet does not demand optimal-dose, general-obesity or medication-discontinuation efficacy as new required endpoints. It does not establish those extended benefits or safety.", "missingness": "This narrow sheet does not demand optimal-dose, general-obesity or medication-discontinuation efficacy as new required endpoints. It does not establish those extended benefits or safety.", "uncertainty": "This narrow sheet does not demand optimal-dose, general-obesity or medication-discontinuation efficacy as new required endpoints. It does not establish those extended benefits or safety.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose-comparison, general-obesity or medication-discontinuation information if those extension questions are selected." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Are current local-summary reading and the manuscript’s historical checks/dates separated?", "needed": "Current original source bytes, review receipts, original access fields/review date and status of each external material.", "role": "Required", "role_reason": "This required record condition prevents false full-text-reading claims or reuse of an old review date as current.", "application_exception": "Do not copy a review date into an individual historical full-text access date or label URL presence as successful reading.", "criterion": "Distinguish actual reading of the whole current retained source and its locations/hashes from historical research-review text, original verdict review date and current external access/reading not attempted.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future checks should record access attempts, acquisition, sections actually read, dates and file hashes for each material type.", "current_reports": [ "S01", "S02", "S03" ], "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 whole currently retained summary was read. The original review date is 2026-09-08; descriptions of checking the paper, correction and 8-week RCT are historical records. Individual access-date/access-level fields are absent, and current external access and reading are 0.", "condition_status": "Met", "status_reason": "This record condition distinguishes current actions from historical manuscript descriptions. It does not establish current clinical full-text reading or a current complete literature search.", "missingness": "This record condition distinguishes current actions from historical manuscript descriptions. It does not establish current clinical full-text reading or a current complete literature search.", "uncertainty": "This record condition distinguishes current actions from historical manuscript descriptions. It does not establish current clinical full-text reading or a current complete literature search.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Current original source bytes, review receipts, original access fields/review date and status of each external material." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Is the current scope of unpublished/registered results, additional corrections and selective reporting established?", "needed": "Original search history, registration changes, unpublished results, new corrections/retractions and comparisons of planned outcomes.", "role": "Required", "role_reason": "This distinguishes review of retained material from checking the entire current research record.", "application_exception": "Do not describe no new search as 0 human studies, no further corrections or no bias.", "criterion": "Compare the current scope of registry changes, unpublished results, additional corrections/retractions and planned outcomes, plus the original search history, against actual material. A record of no new search alone does not fulfill verification of the current complete evidence.", "basis": "Existing method principles distinguish population, formulation, actual comparator, body weight in kg, time points, denominators, dispersion, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.", "condition_origin": "These conditions concern weight with adjunctive berberine hydrochloride during continued antipsychotic treatment and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.", "proposed_research": "Future literature updates should link registration, publication, corrections and unpublished results to the fixed question and preserve inclusion/exclusion decisions and reasons for planned-outcome changes.", "current_reports": [ "S01", "S02", "S03" ], "existence": "Retained bilingual research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material have not been separately established.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.", "observation": "The current input contains the original paper, correction, support and a 2026-09-14 English-placeholder correction record. No new literature, unpublished-result or correction/retraction search was performed in this work.", "condition_status": "Unverified", "status_reason": "This conversion cannot determine the presence/absence of current complete evidence, unpublished results or selective reporting.", "missingness": "This conversion cannot determine the presence/absence of current complete evidence, unpublished results or selective reporting.", "uncertainty": "This conversion cannot determine the presence/absence of current complete evidence, unpublished results or selective reporting.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original search history, registration changes, unpublished results, new corrections/retractions and comparisons of planned outcomes." } ], "reports": [ { "report_id": "S01", "title": "Li 2022 main trial", "url": "https://pubmed.ncbi.nlm.nih.gov/34931749/", "report_type": "Retained summary of a 12-week randomized double-blind placebo-controlled weight 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 same main-trial family as correction S02.", "observed_result": "113 participants; 58/55; MD −1.08 kg, 95% CI −1.76 to −0.40, P=.002, d=.59. Actual outcome-analysis denominators, model and standardization definition remain unverified.", "result_level": "Retained reported between-group change in weight in kg at 12 weeks. Original tables were not read and no new effect calculation was performed in this work.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained bilingual evidence, bibliographic and historical summary", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "The retained summary was actually read; distinguish it from external clinical full-text bytes. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "PubMed bibliographic/abstract entry", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "DOI bibliographic entry", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "Paper full text: direct URL and access unverified", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "Original trial-registration material and protocol", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/34931749/" } ] }, { "report_id": "S02", "title": "Figure-caption correction report", "url": "https://pubmed.ncbi.nlm.nih.gov/36210782/", "report_type": "Retained summary of a figure-caption correction for the same trial as the main paper", "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 same trial as main paper S01; not independent replication.", "observed_result": "The manuscript records that only the Figure 2 caption order changed and the weight estimate did not change. The before-and-after figure and original texts were not directly compared in this work.", "result_level": "Retained description of the correction’s scope; not a new independent weight trial or a current comparison of original texts.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained bilingual evidence, bibliographic and historical summary", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "The retained summary was actually read; distinguish it from external clinical full-text bytes. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "PubMed bibliographic/abstract entry", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "Corrigendum full text: direct URL and access unverified", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/36210782/" } ] }, { "report_id": "S03", "title": "2021 independent 8-week supporting report", "url": "https://pubmed.ncbi.nlm.nih.gov/34773803/", "report_type": "Retained summary of a randomized placebo-controlled weight trial with a different dose and duration", "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": "Described as independent support in the manuscript; recruitment and institutional relationships were not externally cross-checked in the current work.", "observed_result": "900 mg/day for 8 weeks; 65 enrolled and 49 completed; berberine −1.10 kg versus placebo +1.45 kg; time-by-group P=.001. Actual arm-specific analysis denominators and a separate between-group MD and CI remain unverified.", "result_level": "Arm-specific changes and a time-by-group test under different conditions. These were not pooled with the main-trial MD and no new between-arm difference was calculated.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained bilingual evidence, bibliographic and historical summary", "public_status": "Retained copy acquired; summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "The retained summary was actually read; distinguish it from external clinical full-text bytes. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "PubMed bibliographic/abstract entry", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "Paper full text: direct URL and access unverified", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." }, { "material_type": "Original trial-registration material and protocol", "public_status": "Bibliography/material type recorded; current public availability unverified", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "Current external access, acquisition and reading were not attempted. Identifiers and historical review descriptions do not establish actual full-text reading. Distinguish bibliographic entry points from current verification of external-document existence, availability, acquisition and reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/34773803/" } ] } ], "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": "The condition has no applicable subject within the current retained set and narrow question. This does not replace a material gap or unread status." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Link the main paper S01 and figure-caption correction S02 to the same study family. S03 is described as independent support, but recruitment and institutional relationships were not externally cross-checked in the current work. Do not count 3 reports as 3 independent trials or sum participants." }, "history": [ { "date": "2026-10-27", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 37 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-27" }