Adjunctive berberine during continued antipsychotic therapy × Reduction of body weight in antipsychotic-associated weight gain

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Evidence conditionDoes this sheet concern weight in kg at 12 weeks with 600 mg/day add-on treatment during continued antipsychotic therapy?Required	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. S01	The current manuscript’s question and narrow scope were identified. This state does not establish efficacy or recommend use.	The current manuscript’s question, claim conditions, weight-outcome definition and exclusions.	Future research should prespecify the same population, 600 mg/day, common antipsychotic treatment and 12-week weight contrast in kg.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionAre the diagnostic, metabolic-syndrome and antipsychotic-associated weight-gain eligibility criteria established?Required	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. S01	The population is named, but actual eligibility criteria and sample composition remain missing.	Main-trial eligibility criteria, diagnostic methods, age, recruitment setting and baseline table.	Add-on trials with the same eligibility criteria should report baseline diagnosis, age, metabolic-syndrome components and reasons for exclusion.
3	Unverified	Full text not readStored summary read	N03 · Evidence conditionAre the weight-gain definition, baseline weight and balance between arms established?Required	Antipsychotic-associated metabolic syndrome is recorded, but baseline weight, magnitude and duration of gain and numerical balance between arms are absent. S01	A sample record of 113 participants cannot substitute for baseline status or balance.	Antipsychotic exposure duration, baseline weight/BMI, weight-gain definition and baseline characteristics by arm.	Future trials should define medication exposure and weight-gain duration and report baseline weight and major characteristics by arm.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionAre the composition, manufacture and content quality of the actual HCl 100 mg tablets established?Required	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. S01	The nominal ingredient and formulation are identified, but details of actual trial-product quality remain missing.	Trial-product manufacturing, batch, content-testing, excipient and active-ingredient composition documents.	Future trials should use the same HCl formulation and disclose batch-specific content and composition verification.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre actual dosing frequency, adherence and exposure duration for 600 mg/day established?Required	The nominal dose is 600 mg/day for 12 weeks. Actual frequency, adherence distribution, missed doses and dose changes are not retained. S01	The planned dose and duration cannot be treated as every participant’s actual exposure.	Arm-specific dosing schedules, tablet counts, adherence measures, returned medication and dose-change information.	Future trials at the same dose should collect adherence data and prespecify separate analyses of assignment and actual-exposure effects.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre antipsychotic types, doses, changes and concomitant treatment in both arms established?Required	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. S01	The common-treatment framework is identified, but arm-specific actual concomitant treatment and deviations remain missing.	Antipsychotic types, doses and changes by arm, concomitant medications, lifestyle interventions and rescue treatment.	Future trials should define common-treatment principles and report changes and concomitant treatment by arm, analyzing the specified effect of interest.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre placebo ingredients, appearance, administration and common management established?Required	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. S01	A placebo label alone cannot establish the control formulation or identical common management.	Placebo composition, manufacture, administration schedule and common treatment procedures in both arms.	Future add-on trials should prespecify a placebo with matching appearance/administration and common treatment procedures.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionAre random-sequence generation, concealment and actual design established?Required	A randomized double-blind placebo-controlled design is retained. Sequence generation, concealment and actual arm-specific procedures are not established by the summary alone. S01	The RCT label is present, but the whole allocation process is not established.	Main-trial methods, sequence generation/concealment, responsible personnel and participant-flow diagram.	Future trials should disclose sequence generation, concealment and staff roles and link these to outcome-specific analysis populations.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWho was blinded, and are unblinding and assessment procedures established?Required	The double-blind design label is present. Actual blinded parties, unblinding status and assessment procedures are absent from the retained summary. S01	Distinguish the design label from verification of measurement blinding for the weight result.	Trial methods describing who was blinded, unblinding and weight-assessment procedures.	Future trials should link assessor/analyst blinding and unblinding information to outcome reporting.
10	Met	Full text not readStored summary read	N10 · Evidence conditionIs the retained main effect between-group change in weight in kg from baseline to 12 weeks?Required	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. S01	This condition identifies the endpoint, units and between-group direction of the retained estimate. Actual measurement, denominators and model remain addressed in other rows.	Outcome definition and timing in the current claim conditions and the units of the evidence result.	Future reports should separately tabulate the between-group estimate of change in kg from baseline and other metabolic markers.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionAre the weight-measurement device, conditions, repetitions and visit windows established?Required	Weight in kg and the 12-week time point are present, but the device, measurement conditions, repetitions and visit windows are absent. S01	A number in kg alone does not establish actual measurement procedures.	Weight-measurement procedures, device calibration, repeated measurements and visit schedule.	Future trials should define device calibration, identical measurement conditions and visit windows and report measurement errors.
12	Met	Full text not readStored summary read	N12 · Evidence conditionAre 113 participants and 58/55 identified as retained allocation-sample records?Required	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. S01	The original sample records and denominator boundaries were checked. Analysis denominators remain unverified in the next row.	Allocation-sample records and flow information distinguishing them from actual outcome denominators.	Future reports should separately show allocated, measured, completed and analyzed counts by arm in a flow diagram.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionAre actual arm-specific analysis denominators for the 12-week weight MD and CI established?Required	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. S01	Allocation records cannot substitute for the analysis n of the effect estimate.	Arm-specific analysis n, measured n and inclusion criteria in the 12-week weight outcome table.	Future tables should show arm-specific analysis denominators by time point and model, with rules for including missing outcomes.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionAre completion, dropout reasons, missing-data handling and weight follow-up established by arm?Required	Berberine-arm discontinuation of 29.3% is recorded, but completion, missing measurements, dropout reasons and missing-data details are absent. S01	The discontinuation proportion cannot substitute for completion counts or analysis exclusions.	Arm-specific flow diagrams, dropout reasons, time-specific missingness, imputation and sensitivity analyses.	Future trials should collect outcomes after treatment discontinuation and prespecify sensitivity analyses under different missing-data assumptions.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionDoes the MD estimate assignment or adherence effects, and what model was used?Required	The 12-week between-group MD is retained, but the analysis population, ITT/PP status, model and adjustment variables are absent from the summary. S01	A between-group MD label alone cannot establish ITT or a particular adjusted model.	Main-trial analysis plan, outcome model, ITT/PP definitions, covariates and missing-data documents.	Future trials should prespecify assignment as the effect of interest and separate missing-data, covariate and adherence analyses.
16	Met	Full text not readStored summary read	N16 · Evidence conditionAre −1.08 kg, the 95% CI and P value identified as retained results of the same main trial?Required	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. S01	These values were identified as reported in the retained summary. This does not independently certify the original table or clinical effect.	The same result in the current evidence table, bibliographic summary and reader answer.	Future reports should present the estimate, interval, denominators and model for the same contrast in one table.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionAre the definition, variance, denominator and derivation location for d=.59 established?Required	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. S01	The value’s presence is distinct from evidence of its standardized-effect derivation.	The original result table’s d definition, SD/SE used, denominator, derivation or editorial calculation record.	Future reports should provide the standardized value’s definition, variance and formula and interpret it separately from the kg estimate.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionIs a meaningful difference in weight in kg for this population established, with its basis?Required	The manuscript describes the 1.08 kg difference as statistically significant but clinically small. A numerical threshold, its basis and prespecification are absent. S01	The original interpretation of a clinically small effect is retained, but the specific importance criterion was not currently verified.	Prespecified basis for a clinically important difference or weight-loss threshold, baseline weight and patient-perspective information.	Future trials should prespecify a meaningful difference for this population with its basis and report the interval and treatment burden together.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionAre time-specific weight variances and the model/CI derivation established?Required	A 95% CI is reported, but baseline/change variances by arm and the CI derivation are absent. S01	A reported interval alone cannot establish original variance or sample-precision information.	Arm-specific means of weight change, SD/SE, outcome n, CI derivation and analysis model.	Future outcome tables should provide means, variance type, denominators and interval derivation together.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre prespecified primary status, timing, analysis and reporting of weight directly compared?Required	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. S01	The manuscript describes a prospective hierarchy, but current comparison of plan bytes and revision history remains outstanding.	The original NCT02983188 registration history, protocol, analysis plan and results report.	Future trials should preregister primary weight, 12-week timing and analysis and disclose all planned outcomes and reasons for changes.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre the NCT02983188 link to the main trial and registration fields directly verified?Required	The Korean manuscript/bibliography link NCT02983188, but the main-trial registration field says unverified. Original-registration access in this work was 0. S01	A registration-number clue is identified, but current direct verification of registration fields and linkage remains unverified. Both records are retained.	Official NCT02983188 registration and history, with a comparison of paper identity, eligibility, intervention and endpoint.	Future checks should compare official registration history with the paper’s identity, duration and plan without mixing other identifiers.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre the content and outcome impact of the Figure 2 caption correction directly compared?Required	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. S01 S02	The correction’s scope and unchanged estimate are described in retained text, but originals were not compared before and after in this work.	The original corrigendum, before-and-after figure captions and main-paper outcome table.	Future document checks should preserve linked before-and-after figures, values and change scope for the same trial.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre the actual population, formulation and 900 mg/day conditions of the 8-week supporting trial established?Required	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. S03	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.	PMID 34773803 trial methods on eligibility, formulation, 900 mg/day, concomitant medications and placebo.	Future replication should use the main trial’s conditions or prespecify comparisons of dose and duration differences.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre 65 enrolled and 49 completed connected to actual arm-specific weight-analysis denominators?Required	65 enrolled and 49 completed are retained, with small-sample/completer limitations recorded. Allocation/analysis counts by arm and reasons for exclusion are absent. S03	49 completed cannot establish every arm-specific outcome-analysis denominator.	The 8-week trial flow diagram, arm-specific outcome n, dropout reasons and completer-analysis definition.	Future reports should separately show counts at each stage by arm and differences between completer and assignment analyses.
25	Met	Full text not readStored summary read	N25 · Evidence conditionAre the 8-week arm-specific changes and time-by-group P value identified as the original report’s summary?Required	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. S03	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.	The current retained result, bibliographic summary and analysis label for the 8-week trial.	Future reports should separately provide arm-specific changes and prespecified between-group estimates, CIs, model and denominators.
26	Met	Full text not readStored summary read	N26 · Evidence conditionWere 600 mg/day for 12 weeks and 900 mg/day for 8 weeks identified as different conditions?Required	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. S01 S03	This checks the record boundary separating the conditions. It does not establish replication under identical conditions or long-term effects.	A comparison record of both reports’ doses, durations, results, denominators and question boundaries.	Before future synthesis, verify matching population, ingredient, dose, timing and measure and prespecify separate analyses for different conditions.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre families and recruitment independence of the main paper, corrigendum and supporting trial established?Required	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. S01 S02 S03	Bibliographic/manuscript links are present, but material needed to newly certify unique trial and participant counts remains missing.	Registration identifiers, institutions, recruitment periods and family-linkage table for the main paper, correction and 8-week report.	Future synthesis should group the main paper, correction and registration into one family and verify independence through recruitment and institutional relationships.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre main-trial funding, product provision, author interests and influence established?Required	Hong Kong Health and Medical Research Fund is recorded, with tablet manufacturing/provision separate. Author interests and the supplier’s specific roles are absent. S01	A public fund’s name cannot prove all independence or absence of bias.	Main-trial funding, product support, author employment/patents/interests and roles in design, analysis and reporting.	Future research should separately disclose funding, product provision, roles in design/analysis/reporting and all author declarations.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionAre funding, product support and team independence for the 8-week report established?Required	The 8-week report records academic support with details requiring verification. Detailed funding, supporter roles and relationships with the main-trial team are absent. S03	Academic support alone cannot complete direct verification of independent funding or an independent team.	Funding, product provision, author employment/declarations and institutional relationships with the main trial for the 8-week report.	Future family checks should compare funding, team and recruitment relationships and separately report product provision and influence on interpretation.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionAre the denominator, timing, reasons and between-arm comparison for 29.3% discontinuation established?Supplementary; required to interpret discontinuation and safety	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. S01	The proportion is recorded, but information needed to establish incidence, comparative risk or gastrointestinal causation remains missing.	Discontinuation table, participant counts, denominators, timing, reasons and placebo-arm comparison.	Future trials should distinguish discontinuation from harm, collect arm-specific counts, denominators, timing and causes and follow outcomes after discontinuation.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionAre gastrointestinal-intolerance definitions, collection, severity and arm-specific frequency established?Supplementary; required to interpret observed harms	Warning text describes gastrointestinal intolerance, but event types, definitions, collection, severity and arm-specific frequencies are absent. S01	Harm descriptions are retained without establishing comparative-risk magnitude, causality or overall safety.	Main-trial safety table, gastrointestinal-event definitions, collection procedures, arm-specific counts/denominators and links to discontinuation.	Future trials should systematically collect harms and separately report symptoms, severity, discontinuation and arm-specific denominators.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionAre direct data on CYP/glucose effects, concomitant medications and psychiatric stability established?Supplementary; required for interaction extensions	The original warning describes possible overlap of antipsychotic metabolism/glucose effects with CYP interactions. Specific interaction results or psychiatric-stability estimates are absent. S01 S03	A possibility in warning text does not establish a direct interaction effect or risk magnitude.	Arm-specific concomitant drugs, concentrations, glucose, psychiatric stability, related adverse events and analyses.	Future research should use suitable pharmacokinetic and safety follow-up designs to examine exposure and clinical outcomes for specific concomitant drugs.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionAre weight maintenance beyond 12 weeks and long-term psychiatric/rare harms directly established?Supplementary; required for long-term extensions	The manuscript records that both trials are small and short and cannot establish long-term weight or psychiatric stability. S01 S03	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.	Long-term and post-discontinuation weight follow-up under the same conditions, with exposure/outcome information for psychiatric and rare harms.	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.
34	Met	Full text not readStored summary read	N34 · Evidence conditionIs the boundary between weight in kg, metabolic markers and clinical events explicit?Required	Weight is the principal outcome; BMI, waist, lipids and HbA1c are separate secondary outcomes. This sheet addresses only the weight difference in kg. S01	The record scope separating other endpoints was checked. This does not establish direct effects on metabolic improvement or disease prevention.	The current outcome hierarchy and records distinguishing weight from other metabolic/clinical questions.	Extension studies should define metabolic markers or patient outcomes as separate questions and prespecified endpoints and evaluate causal contribution alongside weight change.
35	Not applicable	Full text not readStored summary read	N35 · Evidence conditionAre optimal-dose, general-obesity and antipsychotic-discontinuation efficacy required for this sheet?Supplementary; required if the relevant extension is selected	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. S01 S03	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.	Direct dose-comparison, general-obesity or medication-discontinuation information if those extension questions are selected.	Separate dose or generalization studies should fix population and background treatment and prespecify direct comparisons and effect-modification analyses.
36	Met	Full text not readStored summary read	N36 · Evidence conditionAre current local-summary reading and the manuscript’s historical checks/dates separated?Required	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. S01 S02 S03	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.	Current original source bytes, review receipts, original access fields/review date and status of each external material.	Future checks should record access attempts, acquisition, sections actually read, dates and file hashes for each material type.
37	Unverified	Full text not readStored summary read	N37 · Evidence conditionIs the current scope of unpublished/registered results, additional corrections and selective reporting established?Required	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. S01 S02 S03	This conversion cannot determine the presence/absence of current complete evidence, unpublished results or selective reporting.	Original search history, registration changes, unpublished results, new corrections/retractions and comparisons of planned outcomes.	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.

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37 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence review date: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: 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.
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.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Li 2022 main trial

PubMed

Material type: Retained summary of a 12-week randomized double-blind placebo-controlled weight trial
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 stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Retained summary of a figure-caption correction for the same trial as the main paper
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 stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Retained summary of a randomized placebo-controlled weight trial with a different dose and duration
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 stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

Version 1.1 · Criteria record date 2026-10-05. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Does this sheet concern weight in kg at 12 weeks with 600 mg/day add-on treatment during continued antipsychotic therapy?

Required materials and conditions: The current manuscript’s question, claim conditions, weight-outcome definition and exclusions.
Conditions for verification: Connect the original claim to the actual population, oral HCl, placebo background and 12-week change in kg, excluding other questions.
Requirement and applicability: Required
Application exceptions: Do not automatically combine general obesity, other metabolic markers or the 8-week report for the same ingredient with this question.
Why this condition is needed: This boundary prevents all effects of an ingredient on a single page being assigned one efficacy state.
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.

N02 · Are the diagnostic, metabolic-syndrome and antipsychotic-associated weight-gain eligibility criteria established?

Required materials and conditions: Main-trial eligibility criteria, diagnostic methods, age, recruitment setting and baseline table.
Conditions for verification: Link schizophrenia-spectrum diagnosis, metabolic-syndrome definition, recruitment and inclusion/exclusion criteria to the actual outcome population.
Requirement and applicability: Required
Application exceptions: Do not use this record to fill eligibility criteria for other psychiatric disorders or general obesity.
Why this condition is needed: Similar population labels alone cannot establish applicability to the actual participants.
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.

N03 · Are the weight-gain definition, baseline weight and balance between arms established?

Required materials and conditions: Antipsychotic exposure duration, baseline weight/BMI, weight-gain definition and baseline 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.
Requirement and applicability: Required
Application exceptions: Do not treat an unverified baseline table as established imbalance or absence of weight gain.
Why this condition is needed: Actual baseline information is needed to avoid attributing baseline differences to berberine.
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.

N04 · Are the composition, manufacture and content quality of the actual HCl 100 mg tablets established?

Required materials and conditions: Trial-product manufacturing, batch, content-testing, excipient and active-ingredient composition documents.
Conditions for verification: Establish product composition and actual content of berberine hydrochloride as the sole active ingredient in 100 mg tablets.
Requirement and applicability: Required
Application exceptions: Do not substitute results for botanical extracts, combinations, dihydroberberine or topical products for these HCl tablets.
Why this condition is needed: Similar ingredient names do not guarantee the same trial product.
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.

N05 · Are actual dosing frequency, adherence and exposure duration for 600 mg/day established?

Required materials and conditions: Arm-specific dosing schedules, tablet counts, adherence measures, returned medication and dose-change information.
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.
Requirement and applicability: Required
Application exceptions: Do not calculate actual dosing frequency or individual cumulative exposure from 100 mg tablet strength.
Why this condition is needed: Differences between nominal and actual exposure can affect interpretation of weight and discontinuation.
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.

N06 · Are antipsychotic types, doses, changes and concomitant treatment in both arms established?

Required materials and conditions: Antipsychotic types, doses and changes by arm, concomitant medications, lifestyle interventions and rescue treatment.
Conditions for verification: Link continued common antipsychotic treatment and arm-specific medication, lifestyle and glucose-treatment changes to weight outcomes.
Requirement and applicability: Required
Application exceptions: Do not transfer an effect of stopping antipsychotics to the added effect of berberine.
Why this condition is needed: This is required to distinguish concomitant-treatment differences from the selected ingredient’s contribution.
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.

N07 · Are placebo ingredients, appearance, administration and common management established?

Required materials and conditions: Placebo composition, manufacture, administration schedule and common treatment procedures in both arms.
Conditions for verification: Establish the actual placebo add-on formulation, matching of appearance/administration to the active arm and common management.
Requirement and applicability: Required
Application exceptions: Do not turn missing comparator details into a new fact of placebo failure or active control.
Why this condition is needed: The actual comparator is needed to interpret the add-on contrast.
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.

N08 · Are random-sequence generation, concealment and actual design established?

Required materials and conditions: Main-trial methods, sequence generation/concealment, responsible personnel and participant-flow diagram.
Conditions for verification: Beyond the randomized double-blind placebo-controlled label, establish allocation sequence, concealment and participant flow by arm.
Requirement and applicability: Required
Application exceptions: Do not turn unverified methods into established nonrandom allocation or inadequate allocation.
Why this condition is needed: The design name alone cannot establish that allocation-bias concerns are resolved.
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.

N09 · Who was blinded, and are unblinding and assessment procedures established?

Required materials and conditions: Trial methods describing who was blinded, unblinding and weight-assessment procedures.
Conditions for verification: Establish blinding of participants, treating staff, weight assessors and analysts, with unblinding and measurement procedures.
Requirement and applicability: Required
Application exceptions: Do not automatically waive assessment-procedure checks because weight is objective.
Why this condition is needed: This distinguishes a blinding label from actual measurement limitations.
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.

N10 · Is the retained main effect between-group change in weight in kg from baseline to 12 weeks?

Required materials and conditions: Outcome definition and timing in the current claim conditions and the units of the evidence result.
Conditions for verification: Link the retained outcome definition: net change from baseline, 12 weeks, kg and a between-group contrast.
Requirement and applicability: Required
Application exceptions: Do not read the MD as final weight or within-arm weight reduction.
Why this condition is needed: This record boundary prevents different scales or within-arm changes being combined as the same 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.

N11 · Are the weight-measurement device, conditions, repetitions and visit windows established?

Required materials and conditions: Weight-measurement procedures, device calibration, repeated measurements and visit schedule.
Conditions for verification: Establish device, time, clothing, repetitions and visit windows for baseline and 12-week weight measurements.
Requirement and applicability: Required
Application exceptions: Do not treat missing measurement methods as proof that the weight estimate is erroneous.
Why this condition is needed: Actual information is needed to distinguish observed differences from measurement-condition differences.
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.

N12 · Are 113 participants and 58/55 identified as retained allocation-sample records?

Required materials and conditions: Allocation-sample records and flow information distinguishing them from actual outcome denominators.
Conditions for verification: Retain the original 113 participants, berberine 58 and placebo 55, without upgrading them to completion, measurement or analysis counts.
Requirement and applicability: Required
Application exceptions: Do not back-calculate event or completion counts from the original proportions or discontinuation rate.
Why this condition is needed: This record condition prevents confusion between reported sample counts and analysis denominators.
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.

N13 · Are actual arm-specific analysis denominators for the 12-week weight MD and CI established?

Required materials and conditions: Arm-specific analysis n, measured n and inclusion criteria in the 12-week weight outcome table.
Conditions for verification: Establish observed/analyzed counts and inclusion criteria by arm used for the actual MD and CI.
Requirement and applicability: Required
Application exceptions: Do not automatically fill analysis counts with 58/55 or 113.
Why this condition is needed: This is required to connect the estimate and interval to their actual denominators.
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.

N14 · Are completion, dropout reasons, missing-data handling and weight follow-up established by arm?

Required materials and conditions: Arm-specific flow diagrams, dropout reasons, time-specific missingness, imputation and sensitivity analyses.
Conditions for verification: Establish 12-week completion, discontinuation, missing measurements, follow-up results and missing-data rules.
Requirement and applicability: Required
Application exceptions: Do not infer whether weight was measured after discontinuation or why participants stopped.
Why this condition is needed: This is needed to establish how discontinuation and loss of observation affect the 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.

N15 · Does the MD estimate assignment or adherence effects, and what model was used?

Required materials and conditions: Main-trial analysis plan, outcome model, ITT/PP definitions, covariates and missing-data documents.
Conditions for verification: Link ITT/PP, repeated measurements, baseline adjustment, covariates, missing-data handling and the effect of interest to the actual MD.
Requirement and applicability: Required
Application exceptions: Do not assign ITT, completer-only or baseline-adjustment status without verifying the original.
Why this condition is needed: Analysis information is needed to avoid mixing assignment/adherence effects with within-arm changes.
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.

N16 · Are −1.08 kg, the 95% CI and P value identified as retained results of the same main trial?

Required materials and conditions: The same result in the current evidence table, bibliographic summary and reader answer.
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.
Requirement and applicability: Required
Application exceptions: Do not calculate a new standardized effect or clinical-sufficiency score from the CI and P value.
Why this condition is needed: This record condition prevents retaining only significance or changing numerical attribution.
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.

N17 · Are the definition, variance, denominator and derivation location for d=.59 established?

Required materials and conditions: The original result table’s d definition, SD/SE used, denominator, derivation or editorial calculation record.
Conditions for verification: Establish retained d=.59 and its standardization method, variance type, denominator and derivation source.
Requirement and applicability: Required
Application exceptions: Do not newly calculate d=.59 or substitute it for a criterion of clinical importance in kg.
Why this condition is needed: This is needed to prevent using a retained standardized value as an effect-size criterion without its definition.
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.

N18 · Is a meaningful difference in weight in kg for this population established, with its basis?

Required materials and conditions: Prespecified basis for a clinically important difference or weight-loss threshold, baseline weight and patient-perspective information.
Conditions for verification: Report a prespecified important difference and source appropriate to the population, duration and burden and connect it to the CI.
Requirement and applicability: Required
Application exceptions: Do not set a new minimum kg, percentage or participant threshold or inherit original E~ as condition fulfillment.
Why this condition is needed: This is needed to distinguish statistical significance from a magnitude important to patients.
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.

N19 · Are time-specific weight variances and the model/CI derivation established?

Required materials and conditions: Arm-specific means of weight change, SD/SE, outcome n, CI derivation and analysis model.
Conditions for verification: Establish baseline/change variances, SD/SE, outcome denominators and CI derivation by arm.
Requirement and applicability: Required
Application exceptions: Do not back-calculate SD from the CI or treat 113 participants as sufficient precision.
Why this condition is needed: This information is needed to connect the interval to actual variance and denominators.
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.

N20 · Are prespecified primary status, timing, analysis and reporting of weight directly compared?

Required materials and conditions: The original NCT02983188 registration history, protocol, analysis plan and results report.
Conditions for verification: Compare planned primary weight/12-week/analysis specifications in registration, protocol and plan with actual results.
Requirement and applicability: Required
Application exceptions: Do not treat an unacquired plan as proof of nonregistration or selective reporting.
Why this condition is needed: This distinguishes the retained hierarchy description from actual comparison with a prospective plan.
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.

N21 · Are the NCT02983188 link to the main trial and registration fields directly verified?

Required materials and conditions: Official NCT02983188 registration and history, with a comparison of paper identity, eligibility, intervention and endpoint.
Conditions for verification: Retain both bibliographic NCT02983188 and the structured registration field marked unverified, and compare trial identity and conditions with the original registry.
Requirement and applicability: Required
Application exceptions: Do not turn a clue’s presence into reading/approval of registry content or proof of a structured-field error.
Why this condition is needed: This prevents a bibliographic clue and registry verification being shown at the same verification level.
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.

N22 · Are the content and outcome impact of the Figure 2 caption correction directly compared?

Required materials and conditions: The original corrigendum, before-and-after figure captions and main-paper outcome table.
Conditions for verification: Check PMID 36210782, the main paper’s Figure 2 and before-and-after weight results.
Requirement and applicability: Required
Application exceptions: Do not count the corrigendum as a new independent weight trial or infer further effect changes from missing records.
Why this condition is needed: This distinguishes correction from independent replication while checking actual change scope.
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.

N23 · Are the actual population, formulation and 900 mg/day conditions of the 8-week supporting trial established?

Required materials and conditions: PMID 34773803 trial methods on eligibility, formulation, 900 mg/day, concomitant medications and placebo.
Conditions for verification: Establish population, formulation and background treatment for 900 mg/day over 8 weeks versus placebo during antipsychotic treatment.
Requirement and applicability: Required
Application exceptions: Do not combine a different dose and duration as identical direct replication.
Why this condition is needed: This condition checks actual directness and differences in the supporting report’s conditions.
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.

N24 · Are 65 enrolled and 49 completed connected to actual arm-specific weight-analysis denominators?

Required materials and conditions: The 8-week trial flow diagram, arm-specific outcome n, dropout reasons and completer-analysis definition.
Conditions for verification: Link enrollment, allocation, completion and analysis counts and arm-specific missingness/analysis methods to the actual 8-week result.
Requirement and applicability: Required
Application exceptions: Do not calculate a new dropout rate or arm-specific event count from enrollment minus completion.
Why this condition is needed: This prevents sample records from another report being transferred to the main trial or analysis denominators.
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.

N25 · Are the 8-week arm-specific changes and time-by-group P value identified as the original report’s summary?

Required materials and conditions: The current retained result, bibliographic summary and analysis label for the 8-week trial.
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.
Requirement and applicability: Required
Application exceptions: Do not turn a time-by-group test into a single-time-point between-group P value or a new CI.
Why this condition is needed: This record condition prevents automatic conversion of differently expressed supporting results to the same measure.
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.

N26 · Were 600 mg/day for 12 weeks and 900 mg/day for 8 weeks identified as different conditions?

Required materials and conditions: A comparison record of both reports’ doses, durations, results, denominators and question boundaries.
Conditions for verification: Connect differences in dose, timing, denominators and result expression without pooling effects.
Requirement and applicability: Required
Application exceptions: Do not label different conditions alone as a numerical error or direct conflict.
Why this condition is needed: This distinguishes similar direction from independent replication of the same 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.

N27 · Are families and recruitment independence of the main paper, corrigendum and supporting trial established?

Required materials and conditions: Registration identifiers, institutions, recruitment periods and family-linkage table for the main paper, correction and 8-week report.
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.
Requirement and applicability: Required
Application exceptions: Do not count 3 reports as 3 independent trials or sum participants.
Why this condition is needed: This is a required identity condition preventing duplicate counting of reports and studies.
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.

N28 · Are main-trial funding, product provision, author interests and influence established?

Required materials and conditions: Main-trial funding, product support, author employment/patents/interests and roles in design, analysis and reporting.
Conditions for verification: Distinguish public funding from manufacturing, product provision, employment, patents, interests and roles at each research stage.
Requirement and applicability: Required
Application exceptions: Do not automatically exclude product support or fill unverified disclosures as no conflicts.
Why this condition is needed: This prevents inheriting the original independent-funding axis as a new certification of independence.
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.

N29 · Are funding, product support and team independence for the 8-week report established?

Required materials and conditions: Funding, product provision, author employment/declarations and institutional relationships with the main trial for the 8-week report.
Conditions for verification: Check the academic-support summary against detailed funding, provision, authors and institutional relationships.
Requirement and applicability: Required
Application exceptions: Do not automatically reuse original I2 as current verification of each report’s independence.
Why this condition is needed: This distinguishes supporting-report independence from a simple count of reports.
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.

N30 · Are the denominator, timing, reasons and between-arm comparison for 29.3% discontinuation established?

Required materials and conditions: Discontinuation table, participant counts, denominators, timing, reasons and placebo-arm comparison.
Conditions for verification: Establish the actual denominator, discontinuation definition, time, reasons and control-arm counts for reported 29.3%.
Requirement and applicability: Supplementary; required to interpret discontinuation and safety
Application exceptions: Do not apply the proportion to 58 participants to create counts or attribute every discontinuation to drug harm.
Why this condition is needed: This supplementary safety condition prevents turning discontinuation into analysis loss or a causal harm rate.
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.

N31 · Are gastrointestinal-intolerance definitions, collection, severity and arm-specific frequency established?

Required materials and conditions: Main-trial safety table, gastrointestinal-event definitions, collection procedures, arm-specific counts/denominators and links to discontinuation.
Conditions for verification: Establish actual harm descriptions, event identification, collection, severity, participant counts/denominators and comparison.
Requirement and applicability: Supplementary; required to interpret observed harms
Application exceptions: Do not present unverified data as no harm or substitute efficacy estimates for harm rates.
Why this condition is needed: This prevents declaring safety simply because an efficacy result exists.
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.

N32 · Are direct data on CYP/glucose effects, concomitant medications and psychiatric stability established?

Required materials and conditions: Arm-specific concomitant drugs, concentrations, glucose, psychiatric stability, related adverse events and analyses.
Conditions for verification: Establish actual concomitant drugs/exposure and collection of drug concentrations, glucose, psychiatric changes and clinical events.
Requirement and applicability: Supplementary; required for interaction extensions
Application exceptions: Do not turn a mechanistic warning into established causality of actual events or individual prescribing instructions.
Why this condition is needed: This supplementary boundary distinguishes the original warning from direct clinical-harm results.
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.

N33 · Are weight maintenance beyond 12 weeks and long-term psychiatric/rare harms directly established?

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.
Conditions for verification: Distinguish direct long-term/post-discontinuation follow-up and psychiatric/rare-harm data from the selected result.
Requirement and applicability: Supplementary; required for long-term extensions
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.
Why this condition is needed: This prevents extending a short-term effect to maintenance 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.

N34 · Is the boundary between weight in kg, metabolic markers and clinical events explicit?

Required materials and conditions: The current outcome hierarchy and records distinguishing weight from other metabolic/clinical questions.
Conditions for verification: Do not substitute BMI, waist, lipids, HbA1c or clinical events for the selected weight-in-kg result.
Requirement and applicability: Required
Application exceptions: Do not unconditionally require clinical-event trials for the question about weight change itself.
Why this condition is needed: This is a required boundary distinguishing numerical changes from other clinical benefits.
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.

N35 · Are optimal-dose, general-obesity and antipsychotic-discontinuation efficacy required for this sheet?

Required materials and conditions: Direct dose-comparison, general-obesity or medication-discontinuation information if those extension questions are selected.
Conditions for verification: Limit this to the selected 600 mg/day, continued-antipsychotic, 12-week question; other efficacy questions are separate.
Requirement and applicability: Supplementary; required if the relevant extension is selected
Application exceptions: If the user selects an extension question, design direct-material conditions for that question separately.
Why this condition is needed: This conditional nonapplication prevents automatically creating other efficacy claims or mixing them with gaps in the narrow question.
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.

N36 · Are current local-summary reading and the manuscript’s historical checks/dates separated?

Required materials and conditions: Current original source bytes, review receipts, original access fields/review date and status of each external material.
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.
Requirement and applicability: Required
Application exceptions: Do not copy a review date into an individual historical full-text access date or label URL presence as successful reading.
Why this condition is needed: This required record condition prevents false full-text-reading claims or reuse of an old review date as current.
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.

N37 · Is the current scope of unpublished/registered results, additional corrections and selective reporting established?

Required materials and conditions: Original search history, registration changes, unpublished results, new corrections/retractions and comparisons of planned outcomes.
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.
Requirement and applicability: Required
Application exceptions: Do not describe no new search as 0 human studies, no further corrections or no bias.
Why this condition is needed: This distinguishes review of retained material from checking the entire current research record.
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.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.
Extent of review: 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

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Link studies and reports separately; do not omit studies solely because results are unreported.
Extent of review: 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

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.
Extent of review: 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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.
Extent of review: 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/material version 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.

The stored-material review date (2026-10-05) and original evidence review date (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Does this sheet concern weight in kg at 12 weeks with 600 mg/day add-on treatment during continued antipsychotic therapy?

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.
Verification status: Met
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.
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.
Remaining uncertainty: The current manuscript’s question and narrow scope were identified. This state does not establish efficacy or recommend use.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The population is named, but actual eligibility criteria and sample composition remain missing.
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.
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?

Current findings: Antipsychotic-associated metabolic syndrome is recorded, but baseline weight, magnitude and duration of gain and numerical balance between arms are absent.
Verification status: Unverified
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.
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.
Remaining uncertainty: A sample record of 113 participants cannot substitute for baseline status or balance.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The nominal ingredient and formulation are identified, but details of actual trial-product quality remain missing.
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.
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?

Current findings: The nominal dose is 600 mg/day for 12 weeks. Actual frequency, adherence distribution, missed doses and dose changes are not retained.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The planned dose and duration cannot be treated as every participant’s actual exposure.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The common-treatment framework is identified, but arm-specific actual concomitant treatment and deviations remain missing.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: A placebo label alone cannot establish the control formulation or identical common management.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The RCT label is present, but the whole allocation process is not established.
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.
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?

Current findings: The double-blind design label is present. Actual blinded parties, unblinding status and assessment procedures are absent from the retained summary.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Distinguish the design label from verification of measurement blinding for the weight result.
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.
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?

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.
Verification status: Met
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.
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.
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.
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.
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?

Current findings: Weight in kg and the 12-week time point are present, but the device, measurement conditions, repetitions and visit windows are absent.
Verification status: Unverified
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.
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.
Remaining uncertainty: A number in kg alone does not establish actual measurement procedures.
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.
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?

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.
Verification status: Met
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.
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.
Remaining uncertainty: The original sample records and denominator boundaries were checked. Analysis denominators remain unverified in the next row.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: Allocation records cannot substitute for the analysis n of the effect estimate.
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.
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?

Current findings: Berberine-arm discontinuation of 29.3% is recorded, but completion, missing measurements, dropout reasons and missing-data details are absent.
Verification status: Unverified
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.
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.
Remaining uncertainty: The discontinuation proportion cannot substitute for completion counts or analysis exclusions.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: A between-group MD label alone cannot establish ITT or a particular adjusted model.
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.
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?

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.
Verification status: Met
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.
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.
Remaining uncertainty: These values were identified as reported in the retained summary. This does not independently certify the original table or clinical effect.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The value’s presence is distinct from evidence of its standardized-effect derivation.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: The original interpretation of a clinically small effect is retained, but the specific importance criterion was not currently verified.
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.
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?

Current findings: A 95% CI is reported, but baseline/change variances by arm and the CI derivation are absent.
Verification status: Unverified
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.
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.
Remaining uncertainty: A reported interval alone cannot establish original variance or sample-precision information.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The manuscript describes a prospective hierarchy, but current comparison of plan bytes and revision history remains outstanding.
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.
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?

Current findings: The Korean manuscript/bibliography link NCT02983188, but the main-trial registration field says unverified. Original-registration access in this work was 0.
Verification status: Partly verified
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.
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.
Remaining uncertainty: A registration-number clue is identified, but current direct verification of registration fields and linkage remains unverified. Both records are retained.
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.
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?

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.
Verification status: Partly verified
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.
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.
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.
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.
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?

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.
Verification status: Partly verified
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.
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.
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.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: 49 completed cannot establish every arm-specific outcome-analysis denominator.
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.
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?

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.
Verification status: Met
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.
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.
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.
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.
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?

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.
Verification status: Met
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.
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.
Remaining uncertainty: This checks the record boundary separating the conditions. It does not establish replication under identical conditions or long-term effects.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Bibliographic/manuscript links are present, but material needed to newly certify unique trial and participant counts remains missing.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: A public fund’s name cannot prove all independence or absence of bias.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Academic support alone cannot complete direct verification of independent funding or an independent team.
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.
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?

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.
Verification status: Partly verified
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.
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.
Remaining uncertainty: The proportion is recorded, but information needed to establish incidence, comparative risk or gastrointestinal causation remains missing.
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.
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?

Current findings: Warning text describes gastrointestinal intolerance, but event types, definitions, collection, severity and arm-specific frequencies are absent.
Verification status: Partly verified
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.
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.
Remaining uncertainty: Harm descriptions are retained without establishing comparative-risk magnitude, causality or overall safety.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: A possibility in warning text does not establish a direct interaction effect or risk magnitude.
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.
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?

Current findings: The manuscript records that both trials are small and short and cannot establish long-term weight or psychiatric stability.
Verification status: Unverified
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.
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.
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.
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.
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?

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.
Verification status: Met
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.
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.
Remaining uncertainty: The record scope separating other endpoints was checked. This does not establish direct effects on metabolic improvement or disease prevention.
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.
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?

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.
Verification status: Not applicable
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.
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.
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.
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.
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?

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.
Verification status: Met
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.
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.
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.
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.
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?

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.
Verification status: Unverified
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.
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.
Remaining uncertainty: This conversion cannot determine the presence/absence of current complete evidence, unpublished results or selective reporting.
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.
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