{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3040-main", "verdict_number": "3040", "title": "Oral curcumin or curcuminoid supplementation × Reduction of systolic blood pressure in adults with metabolic risk", "view_version": "1.0", "view_created_date": "2026-10-24", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "Original material-specific dates are retained. The stored-summary production timestamp on 2026-10-06 is not an external-reading date; dates for needed external material remain unrecorded. The original evidence date 2026-09-08 remains distinct from actual completed review." }, "claim_context": { "population": "The retained population mixes adults including hypertension, prehypertension or metabolic risk. It is not a single hypertensive population; composition and contributing denominators by diagnosis, baseline SBP, age and comorbidities remain incompletely verified.", "intervention": "The record covers mixed oral curcumin/curcuminoid formulations. Conventional, nano/micellar, phospholipid phytosomal, piperine-combination and topical products remain distinct; product-specific efficacy or formulation equivalence is not established.", "dose": "The original record describes trial-specific doses. Total product amounts, active amounts, frequency, adherence and direct dose comparisons remain unverified; a single recommended or optimum dose is not generated.", "comparator": "The retained comparator is placebo or control management. Placebo ingredients, lifestyle management, maintenance/changes of blood-pressure medicines, rescue medicines and adherence remain incompletely verified. Combined effects are not assigned to curcumin alone or replacement of blood-pressure medicines.", "endpoint": "The selected endpoint is change in office systolic blood pressure (SBP). Change/final values, baseline adjustment and measurement arrangements remain distinct. Ambulatory/home blood pressure, DBP, endothelial function and cardiovascular events address different questions.", "duration": "Durations vary by trial, with some at least 12 weeks. The overall pooled estimate is not relabeled as an estimate restricted to the at least 12 week subgroup, long-term persistence or a post-discontinuation effect.", "excluded_extensions": [ "The original D/30/Caution and B/S/RX/I2/E0/B2/C0 are retained. Historical cross-checking, independence and generic English verification wording are not inherited as current original-source reading or independent clinical validation.", "The overall WMD −0.06 mmHg, 95% CI −0.62 to 0.50, P=.85; I²=44.2% is retained unchanged. No new conversion, pooling, subgroup difference or clinical numerical result is calculated.", "The original interpretation of a clear null result and the entire CI lying within 1 mmHg is retained. It is not extended to a universal clinical-importance threshold, equivalence, no effect for every formulation/population or certification of a new verdict.", "Signals in women, the at least 12 week subgroup and DBP are original qualitative narratives. Their effects, intervals, denominators, prespecification and interactions remain unverified; the overall SBP estimate is not copied to individual subgroups.", "17 studies and 1,377 people describe the original review's reported scope. Unique trials, participants, group-specific analysis denominators and independent teams are not certified here; reports and samples are not summed or newly established as independent replication.", "The name dose-response meta-analysis does not establish direct dose-comparison or optimum-dose results. I²=44.2% also does not establish identical effects across formulations, populations or durations, or equivalence of individual products.", "Original precautions against replacing blood-pressure medicines, and for individual review of possible hypotension/interactions during concomitant use, are retained. Actual harm collection, event counts, exposure/denominators, causality, direct interactions and long-term safety remain unverified.", "The original evidence date 2026-09-08, correction of 1 English field on 2026-09-14 and stored-summary production date 2026-10-06 remain distinct. Production timestamps are not completed external-reading/content-review dates; actual review dates remain unrecorded." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which systolic-blood-pressure question is addressed?", "needed": "Oral curcumin/curcuminoid supplementation and office SBP change in adults with metabolic risk", "role": "Required", "role_reason": "Material on Oral curcumin/curcuminoid supplementation and office SBP change in adults with metabolic risk is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Oral curcumin/curcuminoid supplementation and office SBP change in adults with metabolic risk must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original eligibility criteria and endpoint tables specifying the same population, formulation, comparator and office SBP are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original question concerns systolic-blood-pressure reduction in adults with metabolic risk, with office SBP as the endpoint. Medicine replacement and other endpoints are excluded.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original eligibility criteria and endpoint tables specifying the same population, formulation, comparator and office SBP are needed.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original eligibility criteria and endpoint tables specifying the same population, formulation, comparator and office SBP are needed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which formulations were pooled, and do they match individual products?", "needed": "Original-trial tables separating conventional curcumin, nano/micellar, phytosomal and piperine-combination formulations", "role": "Required", "role_reason": "Material on Original-trial tables separating conventional curcumin, nano/micellar, phytosomal and piperine-combination formulations is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Original-trial tables separating conventional curcumin, nano/micellar, phytosomal and piperine-combination formulations must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Actual formulations, absorption enhancers, standardized amounts and product information for included trials are unavailable; efficacy or equivalence of an individual product is not established. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained formulation is mixed oral products. The product notes do not treat conventional curcumin, nano/micellar, phytosomal, piperine-combination and topical products as equivalent.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Actual formulations, absorption enhancers, standardized amounts and product information for included trials are unavailable; efficacy or equivalence of an individual product is not established.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual formulations, absorption enhancers, standardized amounts and product information for included trials are unavailable; efficacy or equivalence of an individual product is not established." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Which doses and administration frequencies were compared?", "needed": "Trial-specific active-curcumin/curcuminoid amounts, total product amounts and administration frequencies", "role": "Required", "role_reason": "Material on Trial-specific active-curcumin/curcuminoid amounts, total product amounts and administration frequencies is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Trial-specific active-curcumin/curcuminoid amounts, total product amounts and administration frequencies must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original amount/dose/adherence tables are needed. The phrase dose response in the meta-analysis title does not establish an optimum dose. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "Doses vary by trial. Representative doses, conversions of total product amounts to active amounts and recommended doses are not generated.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original amount/dose/adherence tables are needed. The phrase dose response in the meta-analysis title does not establish an optimum dose.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original amount/dose/adherence tables are needed. The phrase dose response in the meta-analysis title does not establish an optimum dose." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How are duration and outcome timepoints arranged?", "needed": "Trial-specific exposure durations and final SBP timepoints", "role": "Required", "role_reason": "Material on Trial-specific exposure durations and final SBP timepoints is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Trial-specific exposure durations and final SBP timepoints must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Trial-specific durations, measurement schedules and original extracted values by duration group are needed. Long-term persistence and post-discontinuation effects remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "Durations vary by trial, with some at least 12 weeks. The overall pooled estimate is not labeled as an estimate restricted to trials lasting at least 12 weeks.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Trial-specific durations, measurement schedules and original extracted values by duration group are needed. Long-term persistence and post-discontinuation effects remain unverified.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific durations, measurement schedules and original extracted values by duration group are needed. Long-term persistence and post-discontinuation effects remain unverified." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Do the included adults share the same risks and diagnoses?", "needed": "Composition by diagnosis/baseline risk among adults with hypertension, prehypertension or metabolic risk", "role": "Required", "role_reason": "Material on Composition by diagnosis/baseline risk among adults with hypertension, prehypertension or metabolic risk is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Composition by diagnosis/baseline risk among adults with hypertension, prehypertension or metabolic risk must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original-trial tables by diagnosis, baseline SBP, age, comorbidities and eligibility/exclusion criteria are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The population includes adults with hypertension, prehypertension or metabolic risk. It is not relabeled as a single hypertensive population.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original-trial tables by diagnosis, baseline SBP, age, comorbidities and eligibility/exclusion criteria are needed.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original-trial tables by diagnosis, baseline SBP, age, comorbidities and eligibility/exclusion criteria are needed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Was the comparator placebo or control management?", "needed": "Trial-specific placebo/control management and common-care arrangements", "role": "Required", "role_reason": "Material on Trial-specific placebo/control management and common-care arrangements is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Trial-specific placebo/control management and common-care arrangements must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Trial-specific material separating placebo ingredients, blinding, shared dietary/exercise management and additional interventions is needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The comparator is placebo or control management. Identical placebo and lifestyle-care arrangements across all trials are not established.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Trial-specific material separating placebo ingredients, blinding, shared dietary/exercise management and additional interventions is needed.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific material separating placebo ingredients, blinding, shared dietary/exercise management and additional interventions is needed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How do concomitant blood-pressure medicines and lifestyle management differ?", "needed": "Baseline blood-pressure medicines, changes, diet/exercise management and whether these were shared across groups", "role": "Required", "role_reason": "Material on Baseline blood-pressure medicines, changes, diet/exercise management and whether these were shared across groups is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Baseline blood-pressure medicines, changes, diet/exercise management and whether these were shared across groups must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original-trial records on medicine doses/changes, lifestyle management, rescue medicines and adherence are needed. Efficacy is not separated as the supplement-only effect. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original precaution says curcumin does not replace blood-pressure medicines and possible hypotension/interactions during concomitant use require individual review. Included-trial co-treatment arrangements are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original-trial records on medicine doses/changes, lifestyle management, rescue medicines and adherence are needed. Efficacy is not separated as the supplement-only effect.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original-trial records on medicine doses/changes, lifestyle management, rescue medicines and adherence are needed. Efficacy is not separated as the supplement-only effect." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What included-material unit does the reported 17 represent?", "needed": "Review inclusion lists and study-to-report links", "role": "Required", "role_reason": "Material on Review inclusion lists and study-to-report links is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Review inclusion lists and study-to-report links must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Links among included articles, registrations, duplicate reports and multiple arms are needed. Reported scope remains distinct from verified unique-trial counts. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The research description says mean differences from 17 trials were pooled; the evidence scope says 17 studies and 1,377 people. Original wording is retained without certifying 17 unique trials here.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Links among included articles, registrations, duplicate reports and multiple arms are needed. Reported scope remains distinct from verified unique-trial counts.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Links among included articles, registrations, duplicate reports and multiple arms are needed. Reported scope remains distinct from verified unique-trial counts." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What denominator does 1,377 people represent?", "needed": "Trial-specific allocation, analysis, completion and SBP-endpoint denominators", "role": "Required", "role_reason": "Material on Trial-specific allocation, analysis, completion and SBP-endpoint denominators is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Trial-specific allocation, analysis, completion and SBP-endpoint denominators must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Trial/group-specific randomized, analyzed and completed denominators, with participant-overlap information, are needed. The final unique-participant total remains null. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "1,377 people is the original reported scope. Group-specific allocation, analysis, completion and SBP analysis denominators are not generated. Unique-participant totals remain unverified.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Trial/group-specific randomized, analyzed and completed denominators, with participant-overlap information, are needed. The final unique-participant total remains null.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial/group-specific randomized, analyzed and completed denominators, with participant-overlap information, are needed. The final unique-participant total remains null." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Can review reports be linked to original-trial families?", "needed": "Included-trial identifiers and study-family links for the Hadi review", "role": "Required", "role_reason": "Material on Included-trial identifiers and study-family links for the Hadi review is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Included-trial identifiers and study-family links for the Hadi review must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Articles, registrations and additional reports for included trials, with the review extraction table, are needed. Shared trials and reused samples remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The structured report is a single review by Hadi and colleagues. One review report remains distinct from counts of original trials and independent teams. Original-trial families/overlap remain unverified.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Articles, registrations and additional reports for included trials, with the review extraction table, are needed. Shared trials and reused samples remain unverified.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Articles, registrations and additional reports for included trials, with the review extraction table, are needed. Shared trials and reused samples remain unverified." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "In which units is the overall SBP effect reported?", "needed": "Overall office-SBP WMD, units and original comparison arrangements", "role": "Required", "role_reason": "Material on Overall office-SBP WMD, units and original comparison arrangements is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Overall office-SBP WMD, units and original comparison arrangements must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original pooling tables, extracted values, weights, analysis models and change/final-value distinctions are needed. New estimates, conversions and clinical numerical calculations are not produced. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The overall result is WMD −0.06 mmHg, 95% CI −0.62 to 0.50, P=.85; I²=44.2%. The numbers are retained without new conversion or pooling.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original pooling tables, extracted values, weights, analysis models and change/final-value distinctions are needed. New estimates, conversions and clinical numerical calculations are not produced.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original pooling tables, extracted values, weights, analysis models and change/final-value distinctions are needed. New estimates, conversions and clinical numerical calculations are not produced." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What is the scope of the original CI and null interpretation?", "needed": "Original 95% CI and source of SBP-importance criteria", "role": "Required", "role_reason": "Material on Original 95% CI and source of SBP-importance criteria is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Original 95% CI and source of SBP-importance criteria must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Unread original analysis tables and prespecified importance/equivalence criteria are needed. Equivalence for all formulations/populations or a new D verdict is not certified here. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original reader answer describes a clear null result, and the key rationale says the entire CI lies within 1 mmHg. Those original verdict statements are retained without new equivalence/null certification.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Unread original analysis tables and prespecified importance/equivalence criteria are needed. Equivalence for all formulations/populations or a new D verdict is not certified here.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Unread original analysis tables and prespecified importance/equivalence criteria are needed. Equivalence for all formulations/populations or a new D verdict is not certified here." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "How are I² and between-trial differences retained?", "needed": "Overall heterogeneity and explanations by formulation, diagnosis, dose and duration", "role": "Required", "role_reason": "Material on Overall heterogeneity and explanations by formulation, diagnosis, dose and duration is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Overall heterogeneity and explanations by formulation, diagnosis, dose and duration must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original heterogeneity tables, extracted values, model/sensitivity analyses and prediction intervals are needed. I² alone does not establish equal results across formulations. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "I²=44.2% is an original value. The counterview retains possible post hoc subgrouping and heterogeneity. This number does not establish identical formulations, populations or durations.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original heterogeneity tables, extracted values, model/sensitivity analyses and prediction intervals are needed. I² alone does not establish equal results across formulations.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original heterogeneity tables, extracted values, model/sensitivity analyses and prediction intervals are needed. I² alone does not establish equal results across formulations." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Is office SBP measurement distinguished from other blood-pressure measures?", "needed": "Office-SBP equipment, repetitions, timing, assessors and original endpoint definitions", "role": "Required", "role_reason": "Material on Office-SBP equipment, repetitions, timing, assessors and original endpoint definitions is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Office-SBP equipment, repetitions, timing, assessors and original endpoint definitions must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Trial-specific measurement procedures, assessor blinding and repeated-measurement/averaging rules are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The selected endpoint is office systolic-blood-pressure change. It is not replaced with ambulatory/home blood pressure or DBP.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Trial-specific measurement procedures, assessor blinding and repeated-measurement/averaging rules are needed.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific measurement procedures, assessor blinding and repeated-measurement/averaging rules are needed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are change values, baseline adjustment and analysis timepoints aligned?", "needed": "SBP change versus final/baseline-adjusted values and intended analysis populations", "role": "Required", "role_reason": "Material on SBP change versus final/baseline-adjusted values and intended analysis populations is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on SBP change versus final/baseline-adjusted values and intended analysis populations must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original extraction tables, analysis plans, baseline values, variance handling, endpoint timepoints and duplicate-timepoint selection rules are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The selected endpoint describes SBP change, while the research description says mean differences were pooled. Detailed arrangements for change/final values, adjustment and timepoint selection remain unverified.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original extraction tables, analysis plans, baseline values, variance handling, endpoint timepoints and duplicate-timepoint selection rules are needed.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original extraction tables, analysis plans, baseline values, variance handling, endpoint timepoints and duplicate-timepoint selection rules are needed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What is known about allocation and blinding in original trials?", "needed": "Trial-specific randomization, concealment and participant/assessor blinding", "role": "Required", "role_reason": "Material on Trial-specific randomization, concealment and participant/assessor blinding is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Trial-specific randomization, concealment and participant/assessor blinding must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original-trial methods, registration/protocols and the review's individual risk-assessment bases are needed. Official RoB2 findings are not generated. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The retained design is a systematic review and dose-response meta-analysis. Adequacy of original-trial allocation, concealment and blinding is not judged here.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original-trial methods, registration/protocols and the review's individual risk-assessment bases are needed. Official RoB2 findings are not generated.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original-trial methods, registration/protocols and the review's individual risk-assessment bases are needed. Official RoB2 findings are not generated." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What is known about attrition, missingness and outcome selection?", "needed": "Trial-specific attrition reasons, missing-data handling, analysis sets and selective reporting", "role": "Required", "role_reason": "Material on Trial-specific attrition reasons, missing-data handling, analysis sets and selective reporting is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Trial-specific attrition reasons, missing-data handling, analysis sets and selective reporting must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Group flow diagrams, analysis denominators, missing-data handling, all SBP timepoints and registration-to-report comparisons are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The stored sample description gives overall scope without specific group-level attrition, missingness or analysis-exclusion reasons. Unread original material is not relabeled as having no missingness.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Group flow diagrams, analysis denominators, missing-data handling, all SBP timepoints and registration-to-report comparisons are needed.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group flow diagrams, analysis denominators, missing-data handling, all SBP timepoints and registration-to-report comparisons are needed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is the prespecified hierarchy of overall SBP and subgroups verified?", "needed": "Prespecified overall-SBP analysis and women/duration subgroup plans", "role": "Required", "role_reason": "Material on Prespecified overall-SBP analysis and women/duration subgroup plans is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Prespecified overall-SBP analysis and women/duration subgroup plans must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Review registration, protocols/SAPs with primary-endpoint/subgroup/multiplicity plans, and original-trial prespecified endpoint hierarchies, are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original explanation says signals in women or trials lasting at least 12 weeks do not replace the overall SBP main result. The counterview retains possible post hoc subgrouping. Prespecification remains unverified.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Review registration, protocols/SAPs with primary-endpoint/subgroup/multiplicity plans, and original-trial prespecified endpoint hierarchies, are needed.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Review registration, protocols/SAPs with primary-endpoint/subgroup/multiplicity plans, and original-trial prespecified endpoint hierarchies, are needed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are signals in women distinguished from the overall adult effect?", "needed": "Women-subgroup effects, intervals, denominators and interaction tests", "role": "Supplementary", "role_reason": "Material on Women-subgroup effects, intervals, denominators and interaction tests is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Women-subgroup effects, intervals, denominators and interaction tests must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original sex-subgroup tables, prespecification, interactions and included-trial counts are needed. The overall −0.06 mmHg is not copied as a women-only estimate. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original explanation mentions a signal in women. The structured evidence contains no women-only effect, CI or denominator. The overall WMD is not copied as an individual women-subgroup estimate.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original sex-subgroup tables, prespecification, interactions and included-trial counts are needed. The overall −0.06 mmHg is not copied as a women-only estimate.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original sex-subgroup tables, prespecification, interactions and included-trial counts are needed. The overall −0.06 mmHg is not copied as a women-only estimate." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are signals in the subgroup lasting at least 12 weeks distinguished from all durations?", "needed": "Trial composition, effects, intervals and denominators for durations of at least 12 weeks versus shorter durations", "role": "Supplementary", "role_reason": "Material on Trial composition, effects, intervals and denominators for durations of at least 12 weeks versus shorter durations is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Trial composition, effects, intervals and denominators for durations of at least 12 weeks versus shorter durations must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original duration-group tables, prespecification, other formulation/population differences accompanying duration, and interaction material are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "Some durations of at least 12 weeks and the corresponding subgroup signal are described. The structured overall result is not relabeled as an individual long-duration estimate or persistent effect.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original duration-group tables, prespecification, other formulation/population differences accompanying duration, and interaction material are needed.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original duration-group tables, prespecification, other formulation/population differences accompanying duration, and interaction material are needed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Is a DBP reduction kept from becoming an SBP success?", "needed": "Separate SBP/DBP endpoints, denominators and timepoints", "role": "Supplementary", "role_reason": "Material on Separate SBP/DBP endpoints, denominators and timepoints is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Separate SBP/DBP endpoints, denominators and timepoints must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original DBP results and endpoint hierarchy address a separate question. DBP estimates and grades are not merged into these SBP rows. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "Possible DBP reductions are a separate-analysis narrative in the counterview; the verdict-scope note says only SBP was graded. DBP results are not transferred into SBP success.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original DBP results and endpoint hierarchy address a separate question. DBP estimates and grades are not merged into these SBP rows.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original DBP results and endpoint hierarchy address a separate question. DBP estimates and grades are not merged into these SBP rows." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are mechanistic endpoints such as endothelial function kept separate?", "needed": "Distinguishing endothelial function/biomarkers from SBP change", "role": "Supplementary", "role_reason": "Material on Distinguishing endothelial function/biomarkers from SBP change is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Distinguishing endothelial function/biomarkers from SBP change must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate definitions, trials and original results for mechanistic endpoints are needed. Mechanistic improvement is not relabeled as an SBP or clinical-event effect. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The verdict-scope note separates DBP and endothelial function. Endothelial/mechanistic improvement is not relabeled as this office-SBP result or a clinical-event effect.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Separate definitions, trials and original results for mechanistic endpoints are needed. Mechanistic improvement is not relabeled as an SBP or clinical-event effect.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate definitions, trials and original results for mechanistic endpoints are needed. Mechanistic improvement is not relabeled as an SBP or clinical-event effect." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Does dose-response meta-analysis establish direct dose comparisons?", "needed": "Distinguishing within-trial direct dose comparisons from between-trial dose-response models", "role": "Supplementary", "role_reason": "Material on Distinguishing within-trial direct dose comparisons from between-trial dose-response models is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Distinguishing within-trial direct dose comparisons from between-trial dose-response models must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Trial-specific doses, effects, covariates, model/sensitivity analyses and direct dose trials are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original design is a dose-response meta-analysis. Actual direct dose-comparison and optimum-dose results are absent from the stored summary. The name dose response does not establish a recommended amount.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Trial-specific doses, effects, covariates, model/sensitivity analyses and direct dose trials are needed.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific doses, effects, covariates, model/sensitivity analyses and direct dose trials are needed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Is independent replication within a formulation verified separately?", "needed": "Unique trials and independent teams sharing formulation, population, comparator and timepoint", "role": "Required", "role_reason": "Material on Unique trials and independent teams sharing formulation, population, comparator and timepoint is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Unique trials and independent teams sharing formulation, population, comparator and timepoint must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original included-trial links, funding/authors and product information are needed. Mixed-formulation pooling alone does not establish independent replication for a particular formulation. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original grading rationale describes a precise synthesis across multiple independent studies. Included trials and independent teams are not certified here or promoted into formulation-specific replication.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original included-trial links, funding/authors and product information are needed. Mixed-formulation pooling alone does not establish independent replication for a particular formulation.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original included-trial links, funding/authors and product information are needed. Mixed-formulation pooling alone does not establish independent replication for a particular formulation." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are clinical events and replacement of blood-pressure medicines separate questions?", "needed": "Direct material distinguishing an SBP surrogate from cardiovascular events and stopping/replacing medicines", "role": "Supplementary", "role_reason": "Material on Direct material distinguishing an SBP surrogate from cardiovascular events and stopping/replacing medicines is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Direct material distinguishing an SBP surrogate from cardiovascular events and stopping/replacing medicines must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct research on cardiovascular events or stopping/replacing medicines is not verified in this material. Prevention, treatment or replacement effects are not added here. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The advertising limits say claims of replacing blood-pressure medicines or treating hypertension contradict the evidence. The current endpoint is SBP change, not direct results on clinical events or medicine replacement.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Direct research on cardiovascular events or stopping/replacing medicines is not verified in this material. Prevention, treatment or replacement effects are not added here.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct research on cardiovascular events or stopping/replacing medicines is not verified in this material. Prevention, treatment or replacement effects are not added here." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are four routes of company involvement kept separate?", "needed": "Review/trial funding, product support, employee authorship and COI", "role": "Required", "role_reason": "Material on Review/trial funding, product support, employee authorship and COI is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Review/trial funding, product support, employee authorship and COI must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original funding, product provision, author affiliations and COI disclosures for the review and original trials are needed. Non-commercial researchers do not establish absence of company involvement in every trial. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The funding description says non-commercial researchers and mixed funding of included trials. The English funding wording is a generic statement distinguishing involvement routes. This is not relabeled as absence of company involvement in all trials.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Original funding, product provision, author affiliations and COI disclosures for the review and original trials are needed. Non-commercial researchers do not establish absence of company involvement in every trial.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, product provision, author affiliations and COI disclosures for the review and original trials are needed. Non-commercial researchers do not establish absence of company involvement in every trial." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are harm-collection methods known?", "needed": "Adverse-event definitions, active/passive collection, durations and group-specific classification", "role": "Supplementary", "role_reason": "Material on Adverse-event definitions, active/passive collection, durations and group-specific classification is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Adverse-event definitions, active/passive collection, durations and group-specific classification must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Included-trial harm methods, event tables, withdrawals and severity records are needed. Unread material is not labeled as no harm. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original safety detail retains caution and possible hypotension/interactions during concomitant use. Harm-collection methods and event tables are not preserved in detail.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Included-trial harm methods, event tables, withdrawals and severity records are needed. Unread material is not labeled as no harm.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Included-trial harm methods, event tables, withdrawals and severity records are needed. Unread material is not labeled as no harm." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What are harm denominators and exposure durations?", "needed": "Group-specific safety denominators, actual dosing, exposure durations and harm analyses", "role": "Supplementary", "role_reason": "Material on Group-specific safety denominators, actual dosing, exposure durations and harm analyses is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Group-specific safety denominators, actual dosing, exposure durations and harm analyses must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Safety sets, exposure amounts/time, group-specific event counts and discontinuation records are needed. Incidence is not calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "1,377 people describes the evidence scope, not a safety denominator. Durations also vary by trial. Group-specific event counts, exposure and harm denominators remain unverified.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Safety sets, exposure amounts/time, group-specific event counts and discontinuation records are needed. Incidence is not calculated.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety sets, exposure amounts/time, group-specific event counts and discontinuation records are needed. Incidence is not calculated." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What evidence level underlies concomitant hypotension/interaction precautions?", "needed": "Concomitant blood-pressure medicines, event timing, alternative causes and direct comparisons", "role": "Supplementary", "role_reason": "Material on Concomitant blood-pressure medicines, event timing, alternative causes and direct comparisons is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Concomitant blood-pressure medicines, event timing, alternative causes and direct comparisons must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Medicine types/changes, event timing, comparators, rechallenge and alternative-cause material are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original wording is a precaution requiring individual review of concomitant use. It is not actual hypotension incidence, established causation or a direct interaction comparison.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Medicine types/changes, event timing, comparators, rechallenge and alternative-cause material are needed.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Medicine types/changes, event timing, comparators, rechallenge and alternative-cause material are needed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are long-term, rare-event and vulnerable-population harms verified?", "needed": "Harm material on long exposure, rare events and vulnerable populations", "role": "Supplementary", "role_reason": "Material on Harm material on long exposure, rare events and vulnerable populations is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Harm material on long exposure, rare events and vulnerable populations must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term follow-up, vulnerable populations, independent harm reports and exposure/denominators are needed. These harms are not newly investigated or established here. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "Mixed durations and precautions alone do not certify long-term, rare-event or vulnerable-population safety, or independent harm replication. Corresponding original material remains unverified.", "condition_status": "Unverified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Long-term follow-up, vulnerable populations, independent harm reports and exposure/denominators are needed. These harms are not newly investigated or established here.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term follow-up, vulnerable populations, independent harm reports and exposure/denominators are needed. These harms are not newly investigated or established here." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Is actual reading scope distinguished from original-source links?", "needed": "Distinguishing stored summary, abstract, full text, registration and protocols/SAPs", "role": "Required", "role_reason": "Material on Distinguishing stored summary, abstract, full text, registration and protocols/SAPs is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Distinguishing stored summary, abstract, full text, registration and protocols/SAPs must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: External original material remains unread until acquired and reviewed. A URL does not establish reading, accessibility or fulfillment of conditions. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The full stored record was read for preparation. The original PubMed URL is linked, while external abstracts, full texts, registration and protocols/SAPs remain unread in this work.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: External original material remains unread until acquired and reviewed. A URL does not establish reading, accessibility or fulfillment of conditions.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External original material remains unread until acquired and reviewed. A URL does not establish reading, accessibility or fulfillment of conditions." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "How are historical English corrections and remaining generic wording retained?", "needed": "Original Korean/English material and targets/limits of the 2026-09-14 correction", "role": "Supplementary", "role_reason": "Material on Original Korean/English material and targets/limits of the 2026-09-14 correction is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Original Korean/English material and targets/limits of the 2026-09-14 correction must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Historical corrected English and external papers are not newly compared here. The original correction is not relabeled as completed current content QA or certified original-paper reading. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The correction records replacement of English placeholders while retaining grade, score, citations and evidence date. Remaining generic English sample, funding and result wording is preserved in the original; historical correction targets and external English material are not newly reviewed.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: Historical corrected English and external papers are not newly compared here. The original correction is not relabeled as completed current content QA or certified original-paper reading.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical corrected English and external papers are not newly compared here. The original correction is not relabeled as completed current content QA or certified original-paper reading." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are original grade, axes, dates and new preparation distinguished?", "needed": "Original D30, Caution, axes, evidence date and correction", "role": "Required", "role_reason": "Material on Original D30, Caution, axes, evidence date and correction is needed to connect the relevant formulation, population, comparator, SBP measurement/timepoint, report/trial, denominator, overlap or harm scope.", "application_exception": "Review reports remain distinct from unique original trials and participants. Overall SBP, women/duration subgroups, DBP and endothelial function remain separate; scope is not extended to product-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.", "criterion": "Original records on Original D30, Caution, axes, evidence date and correction must link to reports, trials, denominators, formulations, populations, SBP measurements and timepoints, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish formulation, population, comparator, measurement/timepoint, reports/trials, denominators, overlap, support and harms in the retained SBP record.", "condition_origin": "These existing conditions are linked to the retained SBP question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: New material and verdict changes are handled through separate review and events. The original verdict date is not relabeled as a current search-end or external-reading date. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread, with no access attempt.", "observation": "The original D/30/Caution, evidence date 2026-09-08, axes and correction are retained. Preparation is not a new efficacy grade or independent clinical certification; the original date is not relabeled as a current search-end or external-reading date.", "condition_status": "Partly verified", "status_reason": "Information in stored summaries is linked to gaps in detailed material. External verification and content review remain incomplete; fulfilled conditions, effects, safety, prespecification and independence are not certified.", "missingness": "Material gap: New material and verdict changes are handled through separate review and events. The original verdict date is not relabeled as a current search-end or external-reading date.", "uncertainty": "Gaps remain in mixed formulations, diagnoses, doses, durations, measurement, timepoints, denominators, overlap, missingness, heterogeneity, support and harms. Original numbers, grades and independence narratives do not constitute new calculation, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "New material and verdict changes are handled through separate review and events. The original verdict date is not relabeled as a current search-end or external-reading date." } ], "reports": [ { "report_id": "R01", "title": "2023 · Systematic review and dose-response meta-analysis of curcumin and blood pressure", "url": "https://pubmed.ncbi.nlm.nih.gov/37567790/", "report_type": "Stored description of a systematic review and dose-response meta-analysis; external methods, searches and inclusion tables remain unread", "existence": "The information comes from a stored review summary and bibliography. Existence/public availability, acquisition and actual reading of external abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain separately unverified.", "acquired_read": "Stored existing review summary read; external material unread", "study_family": "One review report remains distinct from its reported scope of 17 studies and 1,377 people. Overlap and unique counts of original trials, additional reports and participants, and independent teams, remain unverified; final unique-trial/participant totals are not generated.", "independent_replication": "Review reports remain distinct from unique trials, independent teams and participant totals; these are not certified in this work.", "observed_result": "WMD −0.06 mmHg, 95% CI −0.62~0.50, P=.85; I²=44.2%", "result_level": "This is the stored pooled difference for overall office SBP. It remains distinct from women/duration subgroups and DBP results, and is not external verification of original analyses, denominators or timepoints, or a new calculation.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Existing stored summary acquired", "access_status": "Stored summary", "acquired": true, "actually_read": "Stored summary read", "as_of": "2026-10-06T12:26:23.725440+09:00", "qualification": "The stored report/citation summary was read. This does not record possession or full-text reading of the external original article. Only the stored summary and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread. URLs and original narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Original material-specific dates are retained. The stored-summary production timestamp on 2026-10-06 is not an external-reading date; dates for needed external material remain unrecorded. The original evidence date 2026-09-08 remains distinct from actual completed review." }, { "material_type": "External abstract · Original PubMed link", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Only the original PubMed URL is linked. Actual abstract reading, accessibility and bibliographic-content verification remain incomplete. Only the stored summary and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread. URLs and original narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Original material-specific dates are retained. The stored-summary production timestamp on 2026-10-06 is not an external-reading date; dates for needed external material remain unrecorded. The original evidence date 2026-09-08 remains distinct from actual completed review." }, { "material_type": "External full text · Unacquired/unread", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Original full texts, supplements, included trials and result tables remain unacquired/unread. Abstracts or summaries are not relabeled as full-text reading. Only the stored summary and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread. URLs and original narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Original material-specific dates are retained. The stored-summary production timestamp on 2026-10-06 is not an external-reading date; dates for needed external material remain unrecorded. The original evidence date 2026-09-08 remains distinct from actual completed review." }, { "material_type": "Review/original-trial registration material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Actual registration identifiers, contents, amendments and original-trial alignment remain unverified. Prespecification of articles/plans is not certified. Only the stored summary and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread. URLs and original narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Original material-specific dates are retained. The stored-summary production timestamp on 2026-10-06 is not an external-reading date; dates for needed external material remain unrecorded. The original evidence date 2026-09-08 remains distinct from actual completed review." }, { "material_type": "Protocols and statistical analysis plans", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; no access attempt", "acquired": false, "actually_read": "Unread", "as_of": null, "qualification": "Original protocols, analysis plans, endpoint hierarchy, timepoints, multiplicity and attrition-handling rules remain unread. Only the stored summary and bibliography were read. External abstracts, full texts, registration, protocols/analysis plans, original trials, result tables and support disclosures remain unread. URLs and original narratives alone do not certify existence/public availability, accessibility, acquisition, reading, fulfilled conditions or independence. Original material-specific dates are retained. The stored-summary production timestamp on 2026-10-06 is not an external-reading date; dates for needed external material remain unrecorded. The original evidence date 2026-09-08 remains distinct from actual completed review." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/37567790/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "One review report remains distinct from its reported scope of 17 studies and 1,377 people. Overlap and unique counts of original trials, additional reports and participants, and independent teams, remain unverified; final unique-trial/participant totals are not generated." }, "history": [ { "date": "2026-10-24", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 33 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-24" }