# Adjunctive berberine during continued antipsychotic therapy × Reduction of body weight in antipsychotic-associated weight gain Verdict 3072 · Evidence Check Stored-material review date: 2026-10-05 Original evidence review date: 2026-09-08 Review-criteria version: 1.1 Public page/material preparation date: 2026-10-27 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: People with schizophrenia-spectrum disorders and antipsychotic-associated metabolic syndrome. Detailed diagnosis, eligibility, age, baseline weight and balance between arms remain unverified. - Ingredient, formulation and route: 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. - Measured outcome: 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. - Questions outside this scope: 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. ## Checklist items ### N01 · Does this sheet concern weight in kg at 12 weeks with 600 mg/day add-on treatment during continued antipsychotic therapy? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: The current manuscript’s question and narrow scope were identified. This state does not establish efficacy or recommend use. - Reason for missing information: The current manuscript’s question and narrow scope were identified. This state does not establish efficacy or recommend use. - Required materials and conditions: The current manuscript’s question, claim conditions, weight-outcome definition and exclusions. - Materials to obtain first: The current manuscript’s question, claim conditions, weight-outcome definition and exclusions. - Further research: Future research should prespecify the same population, 600 mg/day, common antipsychotic treatment and 12-week weight contrast in kg. - Conditions for verification: Connect the original claim to the actual population, oral HCl, placebo background and 12-week change in kg, excluding other questions. - Why this condition is needed: This boundary prevents all effects of an ingredient on a single page being assigned one efficacy state. - Application exceptions: Do not automatically combine general obesity, other metabolic markers or the 8-week report for the same ingredient with this question. - Remaining uncertainty: The current manuscript’s question and narrow scope were identified. This state does not establish efficacy or recommend use. - Referenced methods: 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. - Related sources: S01 ### N02 · Are the diagnostic, metabolic-syndrome and antipsychotic-associated weight-gain eligibility criteria established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: The population is named, but actual eligibility criteria and sample composition remain missing. - Reason for missing information: The population is named, but actual eligibility criteria and sample composition remain missing. - Required materials and conditions: Main-trial eligibility criteria, diagnostic methods, age, recruitment setting and baseline table. - Materials to obtain first: Main-trial eligibility criteria, diagnostic methods, age, recruitment setting and baseline table. - Further research: Add-on trials with the same eligibility criteria should report baseline diagnosis, age, metabolic-syndrome components and reasons for exclusion. - Conditions for verification: Link schizophrenia-spectrum diagnosis, metabolic-syndrome definition, recruitment and inclusion/exclusion criteria to the actual outcome population. - Why this condition is needed: Similar population labels alone cannot establish applicability to the actual participants. - Application exceptions: Do not use this record to fill eligibility criteria for other psychiatric disorders or general obesity. - Remaining uncertainty: The population is named, but actual eligibility criteria and sample composition remain missing. - Referenced methods: 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. - Related sources: S01 ### N03 · Are the weight-gain definition, baseline weight and balance between arms established? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: Antipsychotic-associated metabolic syndrome is recorded, but baseline weight, magnitude and duration of gain and numerical balance between arms are absent. - Why unverified: A sample record of 113 participants cannot substitute for baseline status or balance. - Reason for missing information: A sample record of 113 participants cannot substitute for baseline status or balance. - Required materials and conditions: Antipsychotic exposure duration, baseline weight/BMI, weight-gain definition and baseline characteristics by arm. - Materials to obtain first: Antipsychotic exposure duration, baseline weight/BMI, weight-gain definition and baseline characteristics by arm. - Further research: Future trials should define medication exposure and weight-gain duration and report baseline weight and major characteristics by arm. - Conditions for verification: Establish timing and definition of medication-associated weight gain and each arm’s baseline weight/BMI, disease and treatment status. - Why this condition is needed: Actual baseline information is needed to avoid attributing baseline differences to berberine. - Application exceptions: Do not treat an unverified baseline table as established imbalance or absence of weight gain. - Remaining uncertainty: A sample record of 113 participants cannot substitute for baseline status or balance. - Referenced methods: 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. - Related sources: S01 ### N04 · Are the composition, manufacture and content quality of the actual HCl 100 mg tablets established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original 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. - Why unverified: The nominal ingredient and formulation are identified, but details of actual trial-product quality remain missing. - Reason for missing information: The nominal ingredient and formulation are identified, but details of actual trial-product quality remain missing. - Required materials and conditions: Trial-product manufacturing, batch, content-testing, excipient and active-ingredient composition documents. - Materials to obtain first: Trial-product manufacturing, batch, content-testing, excipient and active-ingredient composition documents. - Further research: Future trials should use the same HCl formulation and disclose batch-specific content and composition verification. - Conditions for verification: Establish product composition and actual content of berberine hydrochloride as the sole active ingredient in 100 mg tablets. - Why this condition is needed: Similar ingredient names do not guarantee the same trial product. - Application exceptions: Do not substitute results for botanical extracts, combinations, dihydroberberine or topical products for these HCl tablets. - Remaining uncertainty: The nominal ingredient and formulation are identified, but details of actual trial-product quality remain missing. - Referenced methods: 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. - Related sources: S01 ### N05 · Are actual dosing frequency, adherence and exposure duration for 600 mg/day established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The nominal dose is 600 mg/day for 12 weeks. Actual frequency, adherence distribution, missed doses and dose changes are not retained. - Why unverified: The planned dose and duration cannot be treated as every participant’s actual exposure. - Reason for missing information: The planned dose and duration cannot be treated as every participant’s actual exposure. - Required materials and conditions: Arm-specific dosing schedules, tablet counts, adherence measures, returned medication and dose-change information. - Materials to obtain first: Arm-specific dosing schedules, tablet counts, adherence measures, returned medication and dose-change information. - Further research: Future trials at the same dose should collect adherence data and prespecify separate analyses of assignment and actual-exposure effects. - Conditions for verification: 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. - Why this condition is needed: Differences between nominal and actual exposure can affect interpretation of weight and discontinuation. - Application exceptions: Do not calculate actual dosing frequency or individual cumulative exposure from 100 mg tablet strength. - Remaining uncertainty: The planned dose and duration cannot be treated as every participant’s actual exposure. - Referenced methods: 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. - Related sources: S01 ### N06 · Are antipsychotic types, doses, changes and concomitant treatment in both arms established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: The common-treatment framework is identified, but arm-specific actual concomitant treatment and deviations remain missing. - Reason for missing information: The common-treatment framework is identified, but arm-specific actual concomitant treatment and deviations remain missing. - Required materials and conditions: Antipsychotic types, doses and changes by arm, concomitant medications, lifestyle interventions and rescue treatment. - Materials to obtain first: Antipsychotic types, doses and changes by arm, concomitant medications, lifestyle interventions and rescue treatment. - Further research: Future trials should define common-treatment principles and report changes and concomitant treatment by arm, analyzing the specified effect of interest. - Conditions for verification: Link continued common antipsychotic treatment and arm-specific medication, lifestyle and glucose-treatment changes to weight outcomes. - Why this condition is needed: This is required to distinguish concomitant-treatment differences from the selected ingredient’s contribution. - Application exceptions: Do not transfer an effect of stopping antipsychotics to the added effect of berberine. - Remaining uncertainty: The common-treatment framework is identified, but arm-specific actual concomitant treatment and deviations remain missing. - Referenced methods: 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. - Related sources: S01 ### N07 · Are placebo ingredients, appearance, administration and common management established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: A placebo label alone cannot establish the control formulation or identical common management. - Reason for missing information: A placebo label alone cannot establish the control formulation or identical common management. - Required materials and conditions: Placebo composition, manufacture, administration schedule and common treatment procedures in both arms. - Materials to obtain first: Placebo composition, manufacture, administration schedule and common treatment procedures in both arms. - Further research: Future add-on trials should prespecify a placebo with matching appearance/administration and common treatment procedures. - Conditions for verification: Establish the actual placebo add-on formulation, matching of appearance/administration to the active arm and common management. - Why this condition is needed: The actual comparator is needed to interpret the add-on contrast. - Application exceptions: Do not turn missing comparator details into a new fact of placebo failure or active control. - Remaining uncertainty: A placebo label alone cannot establish the control formulation or identical common management. - Referenced methods: 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. - Related sources: S01 ### N08 · Are random-sequence generation, concealment and actual design established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: A randomized double-blind placebo-controlled design is retained. Sequence generation, concealment and actual arm-specific procedures are not established by the summary alone. - Why unverified: The RCT label is present, but the whole allocation process is not established. - Reason for missing information: The RCT label is present, but the whole allocation process is not established. - Required materials and conditions: Main-trial methods, sequence generation/concealment, responsible personnel and participant-flow diagram. - Materials to obtain first: Main-trial methods, sequence generation/concealment, responsible personnel and participant-flow diagram. - Further research: Future trials should disclose sequence generation, concealment and staff roles and link these to outcome-specific analysis populations. - Conditions for verification: Beyond the randomized double-blind placebo-controlled label, establish allocation sequence, concealment and participant flow by arm. - Why this condition is needed: The design name alone cannot establish that allocation-bias concerns are resolved. - Application exceptions: Do not turn unverified methods into established nonrandom allocation or inadequate allocation. - Remaining uncertainty: The RCT label is present, but the whole allocation process is not established. - Referenced methods: 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. - Related sources: S01 ### N09 · Who was blinded, and are unblinding and assessment procedures established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The double-blind design label is present. Actual blinded parties, unblinding status and assessment procedures are absent from the retained summary. - Why unverified: Distinguish the design label from verification of measurement blinding for the weight result. - Reason for missing information: Distinguish the design label from verification of measurement blinding for the weight result. - Required materials and conditions: Trial methods describing who was blinded, unblinding and weight-assessment procedures. - Materials to obtain first: Trial methods describing who was blinded, unblinding and weight-assessment procedures. - Further research: Future trials should link assessor/analyst blinding and unblinding information to outcome reporting. - Conditions for verification: Establish blinding of participants, treating staff, weight assessors and analysts, with unblinding and measurement procedures. - Why this condition is needed: This distinguishes a blinding label from actual measurement limitations. - Application exceptions: Do not automatically waive assessment-procedure checks because weight is objective. - Remaining uncertainty: Distinguish the design label from verification of measurement blinding for the weight result. - Referenced methods: 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. - Related sources: S01 ### N10 · Is the retained main effect between-group change in weight in kg from baseline to 12 weeks? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: This condition identifies the endpoint, units and between-group direction of the retained estimate. Actual measurement, denominators and model remain addressed in other rows. - Reason for missing information: This condition identifies the endpoint, units and between-group direction of the retained estimate. Actual measurement, denominators and model remain addressed in other rows. - Required materials and conditions: Outcome definition and timing in the current claim conditions and the units of the evidence result. - Materials to obtain first: Outcome definition and timing in the current claim conditions and the units of the evidence result. - Further research: Future reports should separately tabulate the between-group estimate of change in kg from baseline and other metabolic markers. - Conditions for verification: Link the retained outcome definition: net change from baseline, 12 weeks, kg and a between-group contrast. - Why this condition is needed: This record boundary prevents different scales or within-arm changes being combined as the same effect. - Application exceptions: Do not read the MD as final weight or within-arm weight reduction. - Remaining 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. - Referenced methods: 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. - Related sources: S01 ### N11 · Are the weight-measurement device, conditions, repetitions and visit windows established? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: Weight in kg and the 12-week time point are present, but the device, measurement conditions, repetitions and visit windows are absent. - Why unverified: A number in kg alone does not establish actual measurement procedures. - Reason for missing information: A number in kg alone does not establish actual measurement procedures. - Required materials and conditions: Weight-measurement procedures, device calibration, repeated measurements and visit schedule. - Materials to obtain first: Weight-measurement procedures, device calibration, repeated measurements and visit schedule. - Further research: Future trials should define device calibration, identical measurement conditions and visit windows and report measurement errors. - Conditions for verification: Establish device, time, clothing, repetitions and visit windows for baseline and 12-week weight measurements. - Why this condition is needed: Actual information is needed to distinguish observed differences from measurement-condition differences. - Application exceptions: Do not treat missing measurement methods as proof that the weight estimate is erroneous. - Remaining uncertainty: A number in kg alone does not establish actual measurement procedures. - Referenced methods: 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. - Related sources: S01 ### N12 · Are 113 participants and 58/55 identified as retained allocation-sample records? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The main-trial sample record is 113 participants: 58 berberine and 55 placebo. These were not established as week 12 weight analysis or completion denominators. - Why unverified: The original sample records and denominator boundaries were checked. Analysis denominators remain unverified in the next row. - Reason for missing information: The original sample records and denominator boundaries were checked. Analysis denominators remain unverified in the next row. - Required materials and conditions: Allocation-sample records and flow information distinguishing them from actual outcome denominators. - Materials to obtain first: Allocation-sample records and flow information distinguishing them from actual outcome denominators. - Further research: Future reports should separately show allocated, measured, completed and analyzed counts by arm in a flow diagram. - Conditions for verification: Retain the original 113 participants, berberine 58 and placebo 55, without upgrading them to completion, measurement or analysis counts. - Why this condition is needed: This record condition prevents confusion between reported sample counts and analysis denominators. - Application exceptions: Do not back-calculate event or completion counts from the original proportions or discontinuation rate. - Remaining uncertainty: The original sample records and denominator boundaries were checked. Analysis denominators remain unverified in the next row. - Referenced methods: 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. - Related sources: S01 ### N13 · Are actual arm-specific analysis denominators for the 12-week weight MD and CI established? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 113 and 58/55 records are present, but actual analyzed counts for MD −1.08 kg and its CI are absent from the summary. - Why unverified: Allocation records cannot substitute for the analysis n of the effect estimate. - Reason for missing information: Allocation records cannot substitute for the analysis n of the effect estimate. - Required materials and conditions: Arm-specific analysis n, measured n and inclusion criteria in the 12-week weight outcome table. - Materials to obtain first: Arm-specific analysis n, measured n and inclusion criteria in the 12-week weight outcome table. - Further research: Future tables should show arm-specific analysis denominators by time point and model, with rules for including missing outcomes. - Conditions for verification: Establish observed/analyzed counts and inclusion criteria by arm used for the actual MD and CI. - Why this condition is needed: This is required to connect the estimate and interval to their actual denominators. - Application exceptions: Do not automatically fill analysis counts with 58/55 or 113. - Remaining uncertainty: Allocation records cannot substitute for the analysis n of the effect estimate. - Referenced methods: 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. - Related sources: S01 ### N14 · Are completion, dropout reasons, missing-data handling and weight follow-up established by arm? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: Berberine-arm discontinuation of 29.3% is recorded, but completion, missing measurements, dropout reasons and missing-data details are absent. - Why unverified: The discontinuation proportion cannot substitute for completion counts or analysis exclusions. - Reason for missing information: The discontinuation proportion cannot substitute for completion counts or analysis exclusions. - Required materials and conditions: Arm-specific flow diagrams, dropout reasons, time-specific missingness, imputation and sensitivity analyses. - Materials to obtain first: Arm-specific flow diagrams, dropout reasons, time-specific missingness, imputation and sensitivity analyses. - Further research: Future trials should collect outcomes after treatment discontinuation and prespecify sensitivity analyses under different missing-data assumptions. - Conditions for verification: Establish 12-week completion, discontinuation, missing measurements, follow-up results and missing-data rules. - Why this condition is needed: This is needed to establish how discontinuation and loss of observation affect the estimate. - Application exceptions: Do not infer whether weight was measured after discontinuation or why participants stopped. - Remaining uncertainty: The discontinuation proportion cannot substitute for completion counts or analysis exclusions. - Referenced methods: 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. - Related sources: S01 ### N15 · Does the MD estimate assignment or adherence effects, and what model was used? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 12-week between-group MD is retained, but the analysis population, ITT/PP status, model and adjustment variables are absent from the summary. - Why unverified: A between-group MD label alone cannot establish ITT or a particular adjusted model. - Reason for missing information: A between-group MD label alone cannot establish ITT or a particular adjusted model. - Required materials and conditions: Main-trial analysis plan, outcome model, ITT/PP definitions, covariates and missing-data documents. - Materials to obtain first: Main-trial analysis plan, outcome model, ITT/PP definitions, covariates and missing-data documents. - Further research: Future trials should prespecify assignment as the effect of interest and separate missing-data, covariate and adherence analyses. - Conditions for verification: Link ITT/PP, repeated measurements, baseline adjustment, covariates, missing-data handling and the effect of interest to the actual MD. - Why this condition is needed: Analysis information is needed to avoid mixing assignment/adherence effects with within-arm changes. - Application exceptions: Do not assign ITT, completer-only or baseline-adjustment status without verifying the original. - Remaining uncertainty: A between-group MD label alone cannot establish ITT or a particular adjusted model. - Referenced methods: 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. - Related sources: S01 ### N16 · Are −1.08 kg, the 95% CI and P value identified as retained results of the same main trial? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: These values were identified as reported in the retained summary. This does not independently certify the original table or clinical effect. - Reason for missing information: These values were identified as reported in the retained summary. This does not independently certify the original table or clinical effect. - Required materials and conditions: The same result in the current evidence table, bibliographic summary and reader answer. - Materials to obtain first: The same result in the current evidence table, bibliographic summary and reader answer. - Further research: Future reports should present the estimate, interval, denominators and model for the same contrast in one table. - Conditions for verification: 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. - Why this condition is needed: This record condition prevents retaining only significance or changing numerical attribution. - Application exceptions: Do not calculate a new standardized effect or clinical-sufficiency score from the CI and P value. - Remaining uncertainty: These values were identified as reported in the retained summary. This does not independently certify the original table or clinical effect. - Referenced methods: 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. - Related sources: S01 ### N17 · Are the definition, variance, denominator and derivation location for d=.59 established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - Why unverified: The value’s presence is distinct from evidence of its standardized-effect derivation. - Reason for missing information: The value’s presence is distinct from evidence of its standardized-effect derivation. - Required materials and conditions: The original result table’s d definition, SD/SE used, denominator, derivation or editorial calculation record. - Materials to obtain first: The original result table’s d definition, SD/SE used, denominator, derivation or editorial calculation record. - Further research: Future reports should provide the standardized value’s definition, variance and formula and interpret it separately from the kg estimate. - Conditions for verification: Establish retained d=.59 and its standardization method, variance type, denominator and derivation source. - Why this condition is needed: This is needed to prevent using a retained standardized value as an effect-size criterion without its definition. - Application exceptions: Do not newly calculate d=.59 or substitute it for a criterion of clinical importance in kg. - Remaining uncertainty: The value’s presence is distinct from evidence of its standardized-effect derivation. - Referenced methods: 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. - Related sources: S01 ### N18 · Is a meaningful difference in weight in kg for this population established, with its basis? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The manuscript describes the 1.08 kg difference as statistically significant but clinically small. A numerical threshold, its basis and prespecification are absent. - Why unverified: The original interpretation of a clinically small effect is retained, but the specific importance criterion was not currently verified. - Reason for missing information: The original interpretation of a clinically small effect is retained, but the specific importance criterion was not currently verified. - Required materials and conditions: Prespecified basis for a clinically important difference or weight-loss threshold, baseline weight and patient-perspective information. - Materials to obtain first: Prespecified basis for a clinically important difference or weight-loss threshold, baseline weight and patient-perspective information. - Further research: Future trials should prespecify a meaningful difference for this population with its basis and report the interval and treatment burden together. - Conditions for verification: Report a prespecified important difference and source appropriate to the population, duration and burden and connect it to the CI. - Why this condition is needed: This is needed to distinguish statistical significance from a magnitude important to patients. - Application exceptions: Do not set a new minimum kg, percentage or participant threshold or inherit original E~ as condition fulfillment. - Remaining uncertainty: The original interpretation of a clinically small effect is retained, but the specific importance criterion was not currently verified. - Referenced methods: 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. - Related sources: S01 ### N19 · Are time-specific weight variances and the model/CI derivation established? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: A 95% CI is reported, but baseline/change variances by arm and the CI derivation are absent. - Why unverified: A reported interval alone cannot establish original variance or sample-precision information. - Reason for missing information: A reported interval alone cannot establish original variance or sample-precision information. - Required materials and conditions: Arm-specific means of weight change, SD/SE, outcome n, CI derivation and analysis model. - Materials to obtain first: Arm-specific means of weight change, SD/SE, outcome n, CI derivation and analysis model. - Further research: Future outcome tables should provide means, variance type, denominators and interval derivation together. - Conditions for verification: Establish baseline/change variances, SD/SE, outcome denominators and CI derivation by arm. - Why this condition is needed: This information is needed to connect the interval to actual variance and denominators. - Application exceptions: Do not back-calculate SD from the CI or treat 113 participants as sufficient precision. - Remaining uncertainty: A reported interval alone cannot establish original variance or sample-precision information. - Referenced methods: 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. - Related sources: S01 ### N20 · Are prespecified primary status, timing, analysis and reporting of weight directly compared? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: The manuscript describes a prospective hierarchy, but current comparison of plan bytes and revision history remains outstanding. - Reason for missing information: The manuscript describes a prospective hierarchy, but current comparison of plan bytes and revision history remains outstanding. - Required materials and conditions: The original NCT02983188 registration history, protocol, analysis plan and results report. - Materials to obtain first: The original NCT02983188 registration history, protocol, analysis plan and results report. - Further research: Future trials should preregister primary weight, 12-week timing and analysis and disclose all planned outcomes and reasons for changes. - Conditions for verification: Compare planned primary weight/12-week/analysis specifications in registration, protocol and plan with actual results. - Why this condition is needed: This distinguishes the retained hierarchy description from actual comparison with a prospective plan. - Application exceptions: Do not treat an unacquired plan as proof of nonregistration or selective reporting. - Remaining uncertainty: The manuscript describes a prospective hierarchy, but current comparison of plan bytes and revision history remains outstanding. - Referenced methods: 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. - Related sources: S01 ### N21 · Are the NCT02983188 link to the main trial and registration fields directly verified? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The Korean manuscript/bibliography link NCT02983188, but the main-trial registration field says unverified. Original-registration access in this work was 0. - Why unverified: A registration-number clue is identified, but current direct verification of registration fields and linkage remains unverified. Both records are retained. - Reason for missing information: A registration-number clue is identified, but current direct verification of registration fields and linkage remains unverified. Both records are retained. - Required materials and conditions: Official NCT02983188 registration and history, with a comparison of paper identity, eligibility, intervention and endpoint. - Materials to obtain first: Official NCT02983188 registration and history, with a comparison of paper identity, eligibility, intervention and endpoint. - Further research: Future checks should compare official registration history with the paper’s identity, duration and plan without mixing other identifiers. - Conditions for verification: Retain both bibliographic NCT02983188 and the structured registration field marked unverified, and compare trial identity and conditions with the original registry. - Why this condition is needed: This prevents a bibliographic clue and registry verification being shown at the same verification level. - Application exceptions: Do not turn a clue’s presence into reading/approval of registry content or proof of a structured-field error. - Remaining uncertainty: A registration-number clue is identified, but current direct verification of registration fields and linkage remains unverified. Both records are retained. - Referenced methods: 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. - Related sources: S01 ### N22 · Are the content and outcome impact of the Figure 2 caption correction directly compared? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: The correction’s scope and unchanged estimate are described in retained text, but originals were not compared before and after in this work. - Reason for missing information: The correction’s scope and unchanged estimate are described in retained text, but originals were not compared before and after in this work. - Required materials and conditions: The original corrigendum, before-and-after figure captions and main-paper outcome table. - Materials to obtain first: The original corrigendum, before-and-after figure captions and main-paper outcome table. - Further research: Future document checks should preserve linked before-and-after figures, values and change scope for the same trial. - Conditions for verification: Check PMID 36210782, the main paper’s Figure 2 and before-and-after weight results. - Why this condition is needed: This distinguishes correction from independent replication while checking actual change scope. - Application exceptions: Do not count the corrigendum as a new independent weight trial or infer further effect changes from missing records. - Remaining uncertainty: The correction’s scope and unchanged estimate are described in retained text, but originals were not compared before and after in this work. - Referenced methods: 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. - Related sources: S01, S02 ### N23 · Are the actual population, formulation and 900 mg/day conditions of the 8-week supporting trial established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: PMID 34773803 trial methods on eligibility, formulation, 900 mg/day, concomitant medications and placebo. - Materials to obtain first: PMID 34773803 trial methods on eligibility, formulation, 900 mg/day, concomitant medications and placebo. - Further research: Future replication should use the main trial’s conditions or prespecify comparisons of dose and duration differences. - Conditions for verification: Establish population, formulation and background treatment for 900 mg/day over 8 weeks versus placebo during antipsychotic treatment. - Why this condition is needed: This condition checks actual directness and differences in the supporting report’s conditions. - Application exceptions: Do not combine a different dose and duration as identical direct replication. - Remaining 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. - Referenced methods: 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. - Related sources: S03 ### N24 · Are 65 enrolled and 49 completed connected to actual arm-specific weight-analysis denominators? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 65 enrolled and 49 completed are retained, with small-sample/completer limitations recorded. Allocation/analysis counts by arm and reasons for exclusion are absent. - Why unverified: 49 completed cannot establish every arm-specific outcome-analysis denominator. - Reason for missing information: 49 completed cannot establish every arm-specific outcome-analysis denominator. - Required materials and conditions: The 8-week trial flow diagram, arm-specific outcome n, dropout reasons and completer-analysis definition. - Materials to obtain first: The 8-week trial flow diagram, arm-specific outcome n, dropout reasons and completer-analysis definition. - Further research: Future reports should separately show counts at each stage by arm and differences between completer and assignment analyses. - Conditions for verification: Link enrollment, allocation, completion and analysis counts and arm-specific missingness/analysis methods to the actual 8-week result. - Why this condition is needed: This prevents sample records from another report being transferred to the main trial or analysis denominators. - Application exceptions: Do not calculate a new dropout rate or arm-specific event count from enrollment minus completion. - Remaining uncertainty: 49 completed cannot establish every arm-specific outcome-analysis denominator. - Referenced methods: 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. - Related sources: S03 ### N25 · Are the 8-week arm-specific changes and time-by-group P value identified as the original report’s summary? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: The current retained result, bibliographic summary and analysis label for the 8-week trial. - Materials to obtain first: The current retained result, bibliographic summary and analysis label for the 8-week trial. - Further research: Future reports should separately provide arm-specific changes and prespecified between-group estimates, CIs, model and denominators. - Conditions for verification: 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. - Why this condition is needed: This record condition prevents automatic conversion of differently expressed supporting results to the same measure. - Application exceptions: Do not turn a time-by-group test into a single-time-point between-group P value or a new CI. - Remaining 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. - Referenced methods: 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. - Related sources: S03 ### N26 · Were 600 mg/day for 12 weeks and 900 mg/day for 8 weeks identified as different conditions? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: This checks the record boundary separating the conditions. It does not establish replication under identical conditions or long-term effects. - Reason for missing information: This checks the record boundary separating the conditions. It does not establish replication under identical conditions or long-term effects. - Required materials and conditions: A comparison record of both reports’ doses, durations, results, denominators and question boundaries. - Materials to obtain first: A comparison record of both reports’ doses, durations, results, denominators and question boundaries. - Further research: Before future synthesis, verify matching population, ingredient, dose, timing and measure and prespecify separate analyses for different conditions. - Conditions for verification: Connect differences in dose, timing, denominators and result expression without pooling effects. - Why this condition is needed: This distinguishes similar direction from independent replication of the same effect. - Application exceptions: Do not label different conditions alone as a numerical error or direct conflict. - Remaining uncertainty: This checks the record boundary separating the conditions. It does not establish replication under identical conditions or long-term effects. - Referenced methods: 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. - Related sources: S01, S03 ### N27 · Are families and recruitment independence of the main paper, corrigendum and supporting trial established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The manuscript 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. - Why unverified: Bibliographic/manuscript links are present, but material needed to newly certify unique trial and participant counts remains missing. - Reason for missing information: Bibliographic/manuscript links are present, but material needed to newly certify unique trial and participant counts remains missing. - Required materials and conditions: Registration identifiers, institutions, recruitment periods and family-linkage table for the main paper, correction and 8-week report. - Materials to obtain first: Registration identifiers, institutions, recruitment periods and family-linkage table for the main paper, correction and 8-week report. - Further research: Future synthesis should group the main paper, correction and registration into one family and verify independence through recruitment and institutional relationships. - Conditions for verification: Link the main paper/correction to the same family and establish recruitment, institutions, timing and registration relationships for the 8-week report. - Why this condition is needed: This is a required identity condition preventing duplicate counting of reports and studies. - Application exceptions: Do not count 3 reports as 3 independent trials or sum participants. - Remaining uncertainty: Bibliographic/manuscript links are present, but material needed to newly certify unique trial and participant counts remains missing. - Referenced methods: 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. - Related sources: S01, S02, S03 ### N28 · Are main-trial funding, product provision, author interests and influence established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: Hong Kong Health and Medical Research Fund is recorded, with tablet manufacturing/provision separate. Author interests and the supplier’s specific roles are absent. - Why unverified: A public fund’s name cannot prove all independence or absence of bias. - Reason for missing information: A public fund’s name cannot prove all independence or absence of bias. - Required materials and conditions: Main-trial funding, product support, author employment/patents/interests and roles in design, analysis and reporting. - Materials to obtain first: Main-trial funding, product support, author employment/patents/interests and roles in design, analysis and reporting. - Further research: Future research should separately disclose funding, product provision, roles in design/analysis/reporting and all author declarations. - Conditions for verification: Distinguish public funding from manufacturing, product provision, employment, patents, interests and roles at each research stage. - Why this condition is needed: This prevents inheriting the original independent-funding axis as a new certification of independence. - Application exceptions: Do not automatically exclude product support or fill unverified disclosures as no conflicts. - Remaining uncertainty: A public fund’s name cannot prove all independence or absence of bias. - Referenced methods: 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. - Related sources: S01 ### N29 · Are funding, product support and team independence for the 8-week report established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 8-week report records academic support with details requiring verification. Detailed funding, supporter roles and relationships with the main-trial team are absent. - Why unverified: Academic support alone cannot complete direct verification of independent funding or an independent team. - Reason for missing information: Academic support alone cannot complete direct verification of independent funding or an independent team. - Required materials and conditions: Funding, product provision, author employment/declarations and institutional relationships with the main trial for the 8-week report. - Materials to obtain first: Funding, product provision, author employment/declarations and institutional relationships with the main trial for the 8-week report. - Further research: Future family checks should compare funding, team and recruitment relationships and separately report product provision and influence on interpretation. - Conditions for verification: Check the academic-support summary against detailed funding, provision, authors and institutional relationships. - Why this condition is needed: This distinguishes supporting-report independence from a simple count of reports. - Application exceptions: Do not automatically reuse original I2 as current verification of each report’s independence. - Remaining uncertainty: Academic support alone cannot complete direct verification of independent funding or an independent team. - Referenced methods: 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. - Related sources: S03 ### N30 · Are the denominator, timing, reasons and between-arm comparison for 29.3% discontinuation established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: 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. - Why unverified: The proportion is recorded, but information needed to establish incidence, comparative risk or gastrointestinal causation remains missing. - Reason for missing information: The proportion is recorded, but information needed to establish incidence, comparative risk or gastrointestinal causation remains missing. - Required materials and conditions: Discontinuation table, participant counts, denominators, timing, reasons and placebo-arm comparison. - Materials to obtain first: Discontinuation table, participant counts, denominators, timing, reasons and placebo-arm comparison. - Further research: Future trials should distinguish discontinuation from harm, collect arm-specific counts, denominators, timing and causes and follow outcomes after discontinuation. - Conditions for verification: Establish the actual denominator, discontinuation definition, time, reasons and control-arm counts for reported 29.3%. - Why this condition is needed: This supplementary safety condition prevents turning discontinuation into analysis loss or a causal harm rate. - Application exceptions: Do not apply the proportion to 58 participants to create counts or attribute every discontinuation to drug harm. - Remaining uncertainty: The proportion is recorded, but information needed to establish incidence, comparative risk or gastrointestinal causation remains missing. - Referenced methods: 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. - Related sources: S01 ### N31 · Are gastrointestinal-intolerance definitions, collection, severity and arm-specific frequency established? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: Warning text describes gastrointestinal intolerance, but event types, definitions, collection, severity and arm-specific frequencies are absent. - Why unverified: Harm descriptions are retained without establishing comparative-risk magnitude, causality or overall safety. - Reason for missing information: Harm descriptions are retained without establishing comparative-risk magnitude, causality or overall safety. - Required materials and conditions: Main-trial safety table, gastrointestinal-event definitions, collection procedures, arm-specific counts/denominators and links to discontinuation. - Materials to obtain first: Main-trial safety table, gastrointestinal-event definitions, collection procedures, arm-specific counts/denominators and links to discontinuation. - Further research: Future trials should systematically collect harms and separately report symptoms, severity, discontinuation and arm-specific denominators. - Conditions for verification: Establish actual harm descriptions, event identification, collection, severity, participant counts/denominators and comparison. - Why this condition is needed: This prevents declaring safety simply because an efficacy result exists. - Application exceptions: Do not present unverified data as no harm or substitute efficacy estimates for harm rates. - Remaining uncertainty: Harm descriptions are retained without establishing comparative-risk magnitude, causality or overall safety. - Referenced methods: 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. - Related sources: S01 ### N32 · Are direct data on CYP/glucose effects, concomitant medications and psychiatric stability established? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The original warning describes possible overlap of antipsychotic metabolism/glucose effects with CYP interactions. Specific interaction results or psychiatric-stability estimates are absent. - Why unverified: A possibility in warning text does not establish a direct interaction effect or risk magnitude. - Reason for missing information: A possibility in warning text does not establish a direct interaction effect or risk magnitude. - Required materials and conditions: Arm-specific concomitant drugs, concentrations, glucose, psychiatric stability, related adverse events and analyses. - Materials to obtain first: Arm-specific concomitant drugs, concentrations, glucose, psychiatric stability, related adverse events and analyses. - Further research: Future research should use suitable pharmacokinetic and safety follow-up designs to examine exposure and clinical outcomes for specific concomitant drugs. - Conditions for verification: Establish actual concomitant drugs/exposure and collection of drug concentrations, glucose, psychiatric changes and clinical events. - Why this condition is needed: This supplementary boundary distinguishes the original warning from direct clinical-harm results. - Application exceptions: Do not turn a mechanistic warning into established causality of actual events or individual prescribing instructions. - Remaining uncertainty: A possibility in warning text does not establish a direct interaction effect or risk magnitude. - Referenced methods: 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. - Related sources: S01, S03 ### N33 · Are weight maintenance beyond 12 weeks and long-term psychiatric/rare harms directly established? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The manuscript records that both trials are small and short and cannot establish long-term weight or psychiatric stability. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Long-term and post-discontinuation weight follow-up under the same conditions, with exposure/outcome information for psychiatric and rare harms. - Materials to obtain first: Long-term and post-discontinuation weight follow-up under the same conditions, with exposure/outcome information for psychiatric and rare harms. - Further 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. - Conditions for verification: Distinguish direct long-term/post-discontinuation follow-up and psychiatric/rare-harm data from the selected result. - Why this condition is needed: This prevents extending a short-term effect to maintenance or overall safety. - Application exceptions: 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. - Remaining 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. - Referenced methods: 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. - Related sources: S01, S03 ### N34 · Is the boundary between weight in kg, metabolic markers and clinical events explicit? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: Weight is the principal outcome; BMI, waist, lipids and HbA1c are separate secondary outcomes. This sheet addresses only the weight difference in kg. - Why unverified: The record scope separating other endpoints was checked. This does not establish direct effects on metabolic improvement or disease prevention. - Reason for missing information: The record scope separating other endpoints was checked. This does not establish direct effects on metabolic improvement or disease prevention. - Required materials and conditions: The current outcome hierarchy and records distinguishing weight from other metabolic/clinical questions. - Materials to obtain first: The current outcome hierarchy and records distinguishing weight from other metabolic/clinical questions. - Further research: Extension studies should define metabolic markers or patient outcomes as separate questions and prespecified endpoints and evaluate causal contribution alongside weight change. - Conditions for verification: Do not substitute BMI, waist, lipids, HbA1c or clinical events for the selected weight-in-kg result. - Why this condition is needed: This is a required boundary distinguishing numerical changes from other clinical benefits. - Application exceptions: Do not unconditionally require clinical-event trials for the question about weight change itself. - Remaining uncertainty: The record scope separating other endpoints was checked. This does not establish direct effects on metabolic improvement or disease prevention. - Referenced methods: 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. - Related sources: S01 ### N35 · Are optimal-dose, general-obesity and antipsychotic-discontinuation efficacy required for this sheet? Verification status: Not applicable Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Direct dose-comparison, general-obesity or medication-discontinuation information if those extension questions are selected. - Materials to obtain first: Direct dose-comparison, general-obesity or medication-discontinuation information if those extension questions are selected. - Further research: Separate dose or generalization studies should fix population and background treatment and prespecify direct comparisons and effect-modification analyses. - Conditions for verification: Limit this to the selected 600 mg/day, continued-antipsychotic, 12-week question; other efficacy questions are separate. - Why this condition is needed: This conditional nonapplication prevents automatically creating other efficacy claims or mixing them with gaps in the narrow question. - Application exceptions: If the user selects an extension question, design direct-material conditions for that question separately. - Remaining 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. - Referenced methods: 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. - Related sources: S01, S03 ### N36 · Are current local-summary reading and the manuscript’s historical checks/dates separated? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: 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. - Reason for missing information: 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. - Required materials and conditions: Current original source bytes, review receipts, original access fields/review date and status of each external material. - Materials to obtain first: Current original source bytes, review receipts, original access fields/review date and status of each external material. - Further research: Future checks should record access attempts, acquisition, sections actually read, dates and file hashes for each material type. - Conditions for verification: 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. - Why this condition is needed: This required record condition prevents false full-text-reading claims or reuse of an old review date as current. - Application exceptions: Do not copy a review date into an individual historical full-text access date or label URL presence as successful reading. - Remaining 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. - Referenced methods: 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. - Related sources: S01, S02, S03 ### N37 · Is the current scope of unpublished/registered results, additional corrections and selective reporting established? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. - Current findings: The 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. - Why unverified: This conversion cannot determine the presence/absence of current complete evidence, unpublished results or selective reporting. - Reason for missing information: This conversion cannot determine the presence/absence of current complete evidence, unpublished results or selective reporting. - Required materials and conditions: Original search history, registration changes, unpublished results, new corrections/retractions and comparisons of planned outcomes. - Materials to obtain first: Original search history, registration changes, unpublished results, new corrections/retractions and comparisons of planned outcomes. - Further 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. - Conditions for verification: 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. - Why this condition is needed: This distinguishes review of retained material from checking the entire current research record. - Application exceptions: Do not describe no new search as 0 human studies, no further corrections or no bias. - Remaining uncertainty: This conversion cannot determine the presence/absence of current complete evidence, unpublished results or selective reporting. - Referenced methods: 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. - Related sources: S01, S02, S03 ## Evidence and sources ### S01 Li 2022 main trial [PubMed](https://pubmed.ncbi.nlm.nih.gov/34931749/) Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. Findings recorded in the summary: 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. Record 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. Independent replication: 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Retained bilingual evidence, bibliographic and historical summary | Retained copy acquired; summary read | Retained copy acquired; summary read | Stored existing review summary read | The retained summary was actually read; distinguish it from external clinical full-text bytes. 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. | | PubMed bibliographic/abstract entry | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | | DOI bibliographic entry | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | | Paper full text: direct URL and access unverified | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | | Original trial-registration material and protocol | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | ### S02 Figure-caption correction report [PubMed](https://pubmed.ncbi.nlm.nih.gov/36210782/) Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. Findings recorded in the summary: 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. Record level: Retained description of the correction’s scope; not a new independent weight trial or a current comparison of original texts. Independent replication: 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Retained bilingual evidence, bibliographic and historical summary | Retained copy acquired; summary read | Retained copy acquired; summary read | Stored existing review summary read | The retained summary was actually read; distinguish it from external clinical full-text bytes. 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. | | PubMed bibliographic/abstract entry | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | | Corrigendum full text: direct URL and access unverified | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | ### S03 2021 independent 8-week supporting report [PubMed](https://pubmed.ncbi.nlm.nih.gov/34773803/) Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted. Findings recorded in the summary: 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. Record 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. Independent replication: 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. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Retained bilingual evidence, bibliographic and historical summary | Retained copy acquired; summary read | Retained copy acquired; summary read | Stored existing review summary read | The retained summary was actually read; distinguish it from external clinical full-text bytes. 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. | | PubMed bibliographic/abstract entry | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | | Paper full text: direct URL and access unverified | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | | Original trial-registration material and protocol | Bibliography/material type recorded; current public availability unverified | External access not attempted; not acquired | Not read | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Link studies and reports separately; do not omit studies solely because results are unreported. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. ## What the statuses mean - Met: The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety. - Partly verified: Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing. - Unverified: The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access. - Not applicable: The condition has no applicable subject within the current retained set and narrow question. This does not replace a material gap or unread status. ## Change history 2026-10-27 · Public page/materials 1.0. The public view and materials were prepared from the existing 37 items. No new clinical search, verification-state change or scoring was performed.