{ "schema_version": "chamgap-public-criteria-1.0", "title": "Adjunctive Curcumin for Schizophrenia Negative Symptoms—A Small 4-Trial Effect With Low Certainty", "language": "en", "translation_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which add-on treatment question is covered?", "needed": "PANSS negative-symptom comparisons in adults with chronic schizophrenia who continued stable antipsychotic medication", "role": "Required", "role_reason": "Material on PANSS negative-symptom comparisons in adults with chronic schizophrenia who continued stable antipsychotic medication is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on PANSS negative-symptom comparisons in adults with chronic schizophrenia who continued stable antipsychotic medication must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Stopping or replacing concurrent medication and cure are outside this question. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are mixed oral formulations distinguished from the key nano formulation?", "needed": "Product, ingredients, nano technology and active amount in each original trial", "role": "Required", "role_reason": "Material on Product, ingredients, nano technology and active amount in each original trial is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Product, ingredients, nano technology and active amount in each original trial must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product-specific composition, bioavailability, standardization and the mapping of formulations to individual trials remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "To which trial does 160 mg/day apply?", "needed": "Separate doses for the key nano trial and other trials", "role": "Required", "role_reason": "Material on Separate doses for the key nano trial and other trials is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Separate doses for the key nano trial and other trials must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The mixed pooled effect cannot be attributed to a single product at 160 mg/day. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are 16 weeks and the durations of the pooled trials distinguished?", "needed": "Treatment, follow-up and endpoint times for each trial", "role": "Required", "role_reason": "Material on Treatment, follow-up and endpoint times for each trial is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Treatment, follow-up and endpoint times for each trial must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Exact times for each trial, persistence of effects and changes after stopping remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Who was included and what medication-stability conditions applied?", "needed": "Diagnosis, recruitment and medication-stability conditions in adults with chronic schizophrenia", "role": "Required", "role_reason": "Material on Diagnosis, recruitment and medication-stability conditions in adults with chronic schizophrenia is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Diagnosis, recruitment and medication-stability conditions in adults with chronic schizophrenia must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Diagnostic criteria, symptom stage, medication-specific stability periods and detailed eligibility/exclusion criteria remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Was the common treatment underlying curcumin the same?", "needed": "Antipsychotic medications, doses and changes in the placebo-add-on and active-add-on groups", "role": "Required", "role_reason": "Material on Antipsychotic medications, doses and changes in the placebo-add-on and active-add-on groups is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Antipsychotic medications, doses and changes in the placebo-add-on and active-add-on groups must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Details of concurrent drug types, dose changes, rescue treatment and adherence are missing, preventing a narrower attribution of the additional contribution. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are the 4 RCTs in the review distinguished from participant totals?", "needed": "Trial counts, unique participants and endpoint-specific analysis denominators", "role": "Required", "role_reason": "Material on Trial counts, unique participants and endpoint-specific analysis denominators is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Trial counts, unique participants and endpoint-specific analysis denominators must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The total review population and endpoint-specific analysis denominators are not recorded. The number 4 is not used as a participant count. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Which denominator does the key trial count of 56 people represent?", "needed": "Separate allocation, analysis, completion and missing-participant counts", "role": "Required", "role_reason": "Material on Separate allocation, analysis, completion and missing-participant counts is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Separate allocation, analysis, completion and missing-participant counts must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The exact roles of allocation, analysis and completion denominators and the group counts remain separately unverified. Group counts are not calculated from 1:1. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are the review and key trial kept from being counted twice?", "needed": "Mapping of the review inclusion list to the identity of the key paper", "role": "Required", "role_reason": "Material on Mapping of the review inclusion list to the identity of the key paper is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Mapping of the review inclusion list to the identity of the key paper must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Whether the key trial was included and the overlapping trial-family mapping remain unverified. The 2 reports are not counted as 2 unique trials or 5 trials. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What is the pooled effect for negative symptoms?", "needed": "Pooled measure and direction for the defined negative-symptom outcome", "role": "Required", "role_reason": "Material on Pooled measure and direction for the defined negative-symptom outcome is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Pooled measure and direction for the defined negative-symptom outcome must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Weighting methods, calculation of effect direction, original trial-level data and conversion to other PANSS domains remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are the small pooled signal and low certainty retained together?", "needed": "Reported interval, certainty and limits of interpretation", "role": "Required", "role_reason": "Material on Reported interval, certainty and limits of interpretation is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Reported interval, certainty and limits of interpretation must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The borderline statistical signal is not changed into a large clinical effect or high certainty. No additional precision assessment has been performed. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Is P=.05 in the key trial an effect size?", "needed": "Between-group effect size at 16 weeks and the original 95% CI", "role": "Required", "role_reason": "Material on Between-group effect size at 16 weeks and the original 95% CI is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Between-group effect size at 16 weeks and the original 95% CI must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The exact between-group effect size and 95% CI remain unverified. An effect or CI is not calculated from P. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How was PANSS negative measured?", "needed": "Scale assessors, timing, blinding and measurement reproducibility", "role": "Required", "role_reason": "Material on Scale assessors, timing, blinding and measurement reproducibility is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Scale assessors, timing, blinding and measurement reproducibility must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Assessor training, agreement, measurement methods at each timepoint and details of measurement bias remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Were negative symptoms the prespecified principal endpoint?", "needed": "Original protocol, registration, endpoint hierarchy and analysis plan", "role": "Required", "role_reason": "Material on Original protocol, registration, endpoint hierarchy and analysis plan is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Original protocol, registration, endpoint hierarchy and analysis plan must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original registration, protocol and SAP were not read during this work, leaving the prespecified endpoint hierarchy and any changes unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are the randomization procedures of the key trial known?", "needed": "Sequence generation, allocation concealment and allocation implementation", "role": "Required", "role_reason": "Material on Sequence generation, allocation concealment and allocation implementation is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Sequence generation, allocation concealment and allocation implementation must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Random sequence, allocation concealment, implementation responsibilities and baseline imbalance data remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Was blinding maintained?", "needed": "Participant/assessor blinding and placebo distinguishability", "role": "Required", "role_reason": "Material on Participant/assessor blinding and placebo distinguishability is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Participant/assessor blinding and placebo distinguishability must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Placebo appearance, taste, smell, blinding success and possible allocation inference from medication adverse effects remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What were the effect of interest and analysis population?", "needed": "ITT, adherent-participant analyses, baseline adjustment and model", "role": "Required", "role_reason": "Material on ITT, adherent-participant analyses, baseline adjustment and model is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on ITT, adherent-participant analyses, baseline adjustment and model must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Distinction between assignment and adherence effects, use of ITT, baseline adjustment, model and covariates remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Who was lost and how were missing data handled?", "needed": "Withdrawals, reasons, analysis inclusion and missing-data handling", "role": "Required", "role_reason": "Material on Withdrawals, reasons, analysis inclusion and missing-data handling is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Withdrawals, reasons, analysis inclusion and missing-data handling must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Actual endpoint-specific analysis/completion denominators, withdrawal reasons and imputation methods remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are negative and positive symptom results kept separate?", "needed": "Direction and denominators for each PANSS domain", "role": "Required", "role_reason": "Material on Direction and denominators for each PANSS domain is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Direction and denominators for each PANSS domain must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: This is not extended to positive-symptom improvement; exact domain-specific effects and CIs remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Is the total-score result also retained?", "needed": "Separation of PANSS total and negative-subscale results", "role": "Required", "role_reason": "Material on Separation of PANSS total and negative-subscale results is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Separation of PANSS total and negative-subscale results must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The negative-subscale signal is not transferred to overall PANSS improvement. The original total-score estimate remains unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Is extension to cognition, inflammatory markers or cure avoided?", "needed": "Boundary between the selected symptom endpoint and other claims", "role": "Required", "role_reason": "Material on Boundary between the selected symptom endpoint and other claims is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Boundary between the selected symptom endpoint and other claims must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct effects on mechanisms, cognition and cure have not been verified in this table. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Does a statistical change represent an important symptom difference?", "needed": "Important differences in PANSS negative symptoms, function and quality of life", "role": "Required", "role_reason": "Material on Important differences in PANSS negative symptoms, function and quality of life is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Important differences in PANSS negative symptoms, function and quality of life must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Criteria for a clinically important difference and links to patient-important outcomes such as function, quality of life and hospitalization remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "How heterogeneous were trial formulations and conditions?", "needed": "Mapping of formulation, dose, duration, population and effect for each trial", "role": "Required", "role_reason": "Material on Mapping of formulation, dose, duration, population and effect for each trial is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Mapping of formulation, dose, duration, population and effect for each trial must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original trial-level effects, heterogeneity measures, influence analyses and separate formulation-specific effects remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Has independent replication been newly certified?", "needed": "Mapping of independent teams, unique trials and same-formulation replication", "role": "Required", "role_reason": "Material on Mapping of independent teams, unique trials and same-formulation replication is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Mapping of independent teams, unique trials and same-formulation replication must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: This is the history of the retained verdict. Current unique-trial counts, independent-team counts and replication of the same product are not established. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Can an optimal dose, subgroup or durable effect be stated?", "needed": "Direct dose comparisons, prespecified subgroups and long-term follow-up", "role": "Required", "role_reason": "Material on Direct dose comparisons, prespecified subgroups and long-term follow-up is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Direct dose comparisons, prespecified subgroups and long-term follow-up must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Optimal dose, dose response, medication-specific subgroups and long-term persistence remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Do the review and original trial have the same funders?", "needed": "Research funding and actual supporting institutions for each material", "role": "Required", "role_reason": "Material on Research funding and actual supporting institutions for each material is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Research funding and actual supporting institutions for each material must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: University/noncommercial descriptions do not exclude commercial involvement, and funding details remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are product support, employee authors and conflicts distinguished?", "needed": "Product supply, company authors and declared conflicts separately from funding", "role": "Required", "role_reason": "Material on Product supply, company authors and declared conflicts separately from funding is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Product supply, company authors and declared conflicts separately from funding must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product support, employee authorship, individual conflicts and funding for each included trial remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "How far does the short-term adverse-event comparison extend?", "needed": "Trial-specific event definitions, collection, duration and between-group data", "role": "Supplementary", "role_reason": "Material on Trial-specific event definitions, collection, duration and between-group data is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Trial-specific event definitions, collection, duration and between-group data must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Without event types, affected-person counts, denominators, exact risk differences and collection methods, no difference in harms or overall safety is established. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are interactions with antipsychotic medication established?", "needed": "Medication-specific metabolic, bleeding and hepatobiliary events and exposures", "role": "Supplementary", "role_reason": "Material on Medication-specific metabolic, bleeding and hepatobiliary events and exposures is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Medication-specific metabolic, bleeding and hepatobiliary events and exposures must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct medication-specific interaction data, temporal ordering of events, other causes and denominators remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What limits apply to long-term safety?", "needed": "Long-term/rare events, vulnerable populations and follow-up loss", "role": "Supplementary", "role_reason": "Material on Long-term/rare events, vulnerable populations and follow-up loss is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Long-term/rare events, vulnerable populations and follow-up loss must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The key 16-week trial and short-term summary are not extended to long-term safety or safety in all populations. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are the English placeholder correction and current material distinguished?", "needed": "Retained Korean/English values and the correction event", "role": "Required", "role_reason": "Material on Retained Korean/English values and the correction event is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Retained Korean/English values and the correction event must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: The presence of generic English evidence wording is not promoted to verification of the original English paper. Comparison of the corrected material with original sources remains incomplete. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Were the existing grade, axes and verdict date retained?", "needed": "Historical preservation of C50, Caution, original axes and original record date", "role": "Required", "role_reason": "Material on Historical preservation of C50, Caution, original axes and original record date is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Historical preservation of C50, Caution, original axes and original record date must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: No new efficacy grade, score, official assessment or independent clinical certification is produced. The verdict date is not the end date of a current search. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What was actually read and what remains unread?", "needed": "Separation of the stored summary from external abstract, full text, registration and planning material", "role": "Required", "role_reason": "Material on Separation of the stored summary from external abstract, full text, registration and planning material is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Separation of the stored summary from external abstract, full text, registration and planning material must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: A PubMed URL does not establish external abstract/full-text reading. Registration, protocol, SAP and the search-end scope remain unverified. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are registration identifiers linked to the actual trials?", "needed": "Registration numbers and corresponding prospective plans for each original trial", "role": "Required", "role_reason": "Material on Registration numbers and corresponding prospective plans for each original trial is needed to connect the relevant mixed oral formulations, population, common medication, add-on comparison, negative symptoms, pooled/individual metrics, denominators, study families or harm scope.", "application_exception": "The meta-analysis and representative trial are not added together, and a mixed pooled effect is not attributed to a particular product. Standardized metrics are not converted to PANSS points, and group counts are not calculated from an allocation ratio. Significance values are not converted to effects or confidence intervals; negative symptoms are not extended to other symptoms, function, cure or medication replacement.", "criterion": "Original records on Registration numbers and corresponding prospective plans for each original trial must link to formulation, dose, duration, population, common treatment, placebo comparison, PANSS domain, pooled/individual analyses and denominators, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, oral route, common medication, placebo add-on comparison, PANSS domains, pooled metrics, timepoints, denominators, study overlap, certainty, support and harms in the retained synthesis and representative trial.", "condition_origin": "These existing conditions are linked to the retained oral-curcumin add-on and PANSS negative-symptom question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Unverified registration is not changed into absence of registration. Review registration and original RCT registration are also distinguished. Existence and acquisition of the required original report, methods, original result tables, registration and planning material must first be recorded separately. This records needed materials; no new research was executed." } ] }