{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3034-main", "verdict_number": "3034", "title": "Oral Nigella sativa seed or seed-oil supplementation × Body-weight reduction in adults with overweight or obesity", "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": "The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, "claim_context": { "population": "The population comprises adults including overweight and obesity. Mixed-disease studies remain separate. Trial-specific diagnostic and eligibility criteria, age, baseline weight and comorbidity composition remain unverified.", "intervention": "The intervention is oral Nigella sativa L. seed powder or seed-oil supplementation, with formulation subgroups distinguished. Products, extraction and constituent quantities remain unverified. Other extracts, topical preparations, purified thymoquinone and combinations are not treated as interchangeable.", "dose": "Doses vary by trial. Powder and oil doses are not converted into equivalents. Actual intake, constituent quantities, adherence and frequency remain unverified; no new representative dose, active dose or recommended dose is created.", "comparator": "The comparator is placebo or a control condition. Matching control composition, management, diet, exercise, medication, other treatment and adherence across trials remains unverified. Controls are not all treated as identical placebo or management.", "endpoint": "The selected endpoint is change in body weight in kg. BMI and waist circumference are separate endpoints. Original measurement, baseline adjustment, final values versus changes, variance and prospective hierarchy remain unverified; BMI is not converted into kg.", "duration": "Duration varies by trial, with the subgroup of 8 weeks or less distinguished. Treatment, measurement, follow-up and post-discontinuation timing remain unverified in detail. The overall estimate is not converted into a short-duration subgroup result or sustained long-term effect.", "excluded_extensions": [ "The selected question concerns oral seed or seed oil and body-weight change in kg in adults with overweight or obesity. Composite glycemia, blood-pressure and lipid claims, other formulations, routes and populations are excluded.", "The existing C·46 points·Caution and B/S/R1/I1/E~/B2/C0 are retained. Historical cross-check wording and the original statement of 0 strengths are not presented as a current quality score, completed content review or new clinical validation.", "The 2018 review’s 13 trials and 875 participants remain distinct from the 2023 review’s 21 trials overall and 15 studies, 16 comparisons and approximately 995 participants for weight. Overlap across reviews is unconfirmed. No new totals of unique trials, participants or harm denominators are created.", "The 2018 weight result of −1.76 kg (95% CI −3.34 to −0.17), I²=87.4%, and the 2023 weight result of −1.46 kg (95% CI −2.53 to −0.39), I²=94.6%, are retained as original reported values. Each remains attributed to its review and endpoint without repooling, recalculation or a new prediction interval.", "The original Korean wording for an obesity subgroup and the original English wording for an overweight/obesity subgroup are retained, with the scope difference unconfirmed. The null finding at 8 weeks or less remains separate from the overall mean; absent subgroup effects, intervals, denominators and interactions are not invented.", "Weight, BMI and waist circumference are distinct. Means are not extended to individual success rates, large weight loss, effects without diet and exercise or long-term persistence, or converted into superiority, equivalence or optimal dosing for a specific formulation.", "PMID29857879, DOI10.1016/j.ctim.2018.04.003, DOI10.1016/j.jff.2023.105565 and review PROSPERO CRD42022358471 are existing bibliography. Review registration does not confirm original-trial registration, prespecification or adherence to plans; external abstracts, full texts, registration and plans remain unread.", "The original evidence date 2026-09-08, the correction date 2026-09-14 for 2 English-placeholder fields and the original production date 2026-10-06 are retained. Generic English evidence wording, funding descriptions and cautions are not promoted to actual full-text reading or certification of independence, harm collection or safety." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which body-weight question is addressed?", "needed": "Oral seed/seed oil and weight change in kg in adults with overweight or obesity", "role": "Required", "role_reason": "Material on Oral seed/seed oil and weight change in kg in adults with overweight or obesity is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Oral seed/seed oil and weight change in kg in adults with overweight or obesity must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: An eligibility table for population, formulation, control and timing of the single weight endpoint is needed. Composite glycemia/blood-pressure/lipid claims are excluded. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original claim is body-weight reduction in adults with overweight or obesity. The principal endpoint is weight change in kg; BMI and waist circumference remain separate.", "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": "What remains unverified in stored summaries: An eligibility table for population, formulation, control and timing of the single weight endpoint is needed. Composite glycemia/blood-pressure/lipid claims are excluded.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: An eligibility table for population, formulation, control and timing of the single weight endpoint is needed. Composite glycemia/blood-pressure/lipid claims are excluded." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are seed powder and seed oil kept separate?", "needed": "Original trials and product/constituent tables by powder/oil formulation", "role": "Required", "role_reason": "Material on Original trials and product/constituent tables by powder/oil formulation is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original trials and product/constituent tables by powder/oil formulation must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Product, extraction, standardized constituent quantities and inclusion tables by formulation are needed. A mixed pooled mean does not establish efficacy or equivalence for each formulation. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The formulation is oral supplementation with seed powder and seed oil distinguished by formulation subgroups. Other extracts, topical preparations, purified thymoquinone and combinations in the original product notes are not treated as interchangeable.", "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": "What remains unverified in stored summaries: Product, extraction, standardized constituent quantities and inclusion tables by formulation are needed. A mixed pooled mean does not establish efficacy or equivalence for each formulation.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Product, extraction, standardized constituent quantities and inclusion tables by formulation are needed. A mixed pooled mean does not establish efficacy or equivalence for each formulation." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Can doses and active quantities be converted into equivalents?", "needed": "Trial-specific dose, frequency, actual exposure and active constituents", "role": "Required", "role_reason": "Material on Trial-specific dose, frequency, actual exposure and active constituents is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Trial-specific dose, frequency, actual exposure and active constituents must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original doses, constituents/units, adherence and actual administration are needed. Powder/oil dose equivalence is unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "Doses vary by trial; powder and oil doses are not converted into equivalents. No new representative dose, active quantity or recommended dose is created.", "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": "What remains unverified in stored summaries: Original doses, constituents/units, adherence and actual administration are needed. Powder/oil dose equivalence is unverified.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original doses, constituents/units, adherence and actual administration are needed. Powder/oil dose equivalence is unverified." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Are overall durations distinguished from 8 weeks or less?", "needed": "Trial-specific duration, weight-measurement timing and the subgroup of 8 weeks or less", "role": "Required", "role_reason": "Material on Trial-specific duration, weight-measurement timing and the subgroup of 8 weeks or less is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Trial-specific duration, weight-measurement timing and the subgroup of 8 weeks or less must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original treatment, measurement, follow-up/post-discontinuation timing and tables by duration group are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "Duration varies by trial, with the subgroup of 8 weeks or less separate. The overall mean is not converted into a result at 8 weeks or less or a sustained long-term 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": "What remains unverified in stored summaries: Original treatment, measurement, follow-up/post-discontinuation timing and tables by duration group are needed.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original treatment, measurement, follow-up/post-discontinuation timing and tables by duration group are needed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are overweight/obesity and mixed-disease studies distinguished?", "needed": "Inclusion composition by diagnosis, baseline weight/BMI and comorbidity", "role": "Required", "role_reason": "Material on Inclusion composition by diagnosis, baseline weight/BMI and comorbidity is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Inclusion composition by diagnosis, baseline weight/BMI and comorbidity must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original-trial tables of diagnosis, selection, age, baseline weight and comorbidity are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The population is adults including overweight and obesity, with mixed-disease studies separate. A mixed review population is not treated as the same sample as a specific obesity 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": "What remains unverified in stored summaries: Original-trial tables of diagnosis, selection, age, baseline weight and comorbidity are needed.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original-trial tables of diagnosis, selection, age, baseline weight and comorbidity are needed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are placebo and control-condition arrangements the same?", "needed": "Trial-specific control constituents, management and cointerventions by arm", "role": "Required", "role_reason": "Material on Trial-specific control constituents, management and cointerventions by arm is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Trial-specific control constituents, management and cointerventions by arm must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original records of control composition, masking, lifestyle management and adherence are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The comparator is placebo or a control condition. Identical placebo and management 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": "What remains unverified in stored summaries: Original records of control composition, masking, lifestyle management and adherence are needed.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original records of control composition, masking, lifestyle management and adherence are needed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Can the effects of concomitant diet and exercise be distinguished?", "needed": "Matching dietary restriction, exercise, management and concomitant use by arm", "role": "Required", "role_reason": "Material on Matching dietary restriction, exercise, management and concomitant use by arm is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Matching dietary restriction, exercise, management and concomitant use by arm must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original diet/exercise arrangements, arm-specific adherence, energy/weight changes and additional interventions are needed. The effect is not isolated as that of seed oil alone. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original rationale, key issue and research description retain concomitant diet/exercise and varied cointerventions. The overall effect is not described as an effect everyone can obtain without diet or exercise.", "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": "What remains unverified in stored summaries: Original diet/exercise arrangements, arm-specific adherence, energy/weight changes and additional interventions are needed. The effect is not isolated as that of seed oil alone.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original diet/exercise arrangements, arm-specific adherence, energy/weight changes and additional interventions are needed. The effect is not isolated as that of seed oil alone." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are medication, other treatment and weight changes distinguished?", "needed": "Baseline medications, disease treatment, changes and arm-specific management", "role": "Required", "role_reason": "Material on Baseline medications, disease treatment, changes and arm-specific management is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Baseline medications, disease treatment, changes and arm-specific management must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Records of medications for glycemia/blood pressure, other treatment, weight-related changes and arm-specific maintenance are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original safety description retains cautions about concomitant medications. Actual medication use, changes and arrangements addressing weight effects in included trials are not specified.", "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": "What remains unverified in stored summaries: Records of medications for glycemia/blood pressure, other treatment, weight-related changes and arm-specific maintenance are needed.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Records of medications for glycemia/blood pressure, other treatment, weight-related changes and arm-specific maintenance are needed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are the 2018 and 2023 reviews retained as separate reports?", "needed": "Search, eligibility and inclusion correspondence for the Mousavi and Naghsh reviews", "role": "Required", "role_reason": "Material on Search, eligibility and inclusion correspondence for the Mousavi and Naghsh reviews is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Search, eligibility and inclusion correspondence for the Mousavi and Naghsh reviews must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Search dates, eligibility criteria, included trials and correspondence with additional reports/registration are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R01 is a 2018 meta-analysis of RCTs; R02 is a 2023 updated meta-analysis of RCTs. The reviews are not counted as independent original 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": "What remains unverified in stored summaries: Search dates, eligibility criteria, included trials and correspondence with additional reports/registration are needed.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Search dates, eligibility criteria, included trials and correspondence with additional reports/registration are needed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What is the scope of the 13 trials and 875 participants in 2018?", "needed": "R01 included trials/participants and weight-endpoint denominators", "role": "Required", "role_reason": "Material on R01 included trials/participants and weight-endpoint denominators is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on R01 included trials/participants and weight-endpoint denominators must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Inclusion tables and original trials/arm-specific randomized, analyzed and completion denominators by weight endpoint are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R01 records 13 trials and 875 participants. These do not certify a single formulation, completed weight analyses or independent-trial counts.", "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": "What remains unverified in stored summaries: Inclusion tables and original trials/arm-specific randomized, analyzed and completion denominators by weight endpoint are needed.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Inclusion tables and original trials/arm-specific randomized, analyzed and completion denominators by weight endpoint are needed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are the updated review’s 21 trials distinguished from 15 studies and 16 weight comparisons?", "needed": "Study/comparison/participant units for the whole review and weight analysis", "role": "Required", "role_reason": "Material on Study/comparison/participant units for the whole review and weight analysis is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Study/comparison/participant units for the whole review and weight analysis must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Multi-arm, shared-control and sample correspondence for the 15 studies/16 comparisons and original extraction tables are needed. The 21 trials are not converted into a count of unique weight trials. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R02 records 21 trials overall; weight comprises 15 studies, 16 comparisons and approximately 995 participants. Whole-review, weight-study and comparison counts remain separate.", "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": "What remains unverified in stored summaries: Multi-arm, shared-control and sample correspondence for the 15 studies/16 comparisons and original extraction tables are needed. The 21 trials are not converted into a count of unique weight trials.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Multi-arm, shared-control and sample correspondence for the 15 studies/16 comparisons and original extraction tables are needed. The 21 trials are not converted into a count of unique weight trials." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What analysis denominator does approximately 995 participants describe?", "needed": "Randomized/analyzed/completed and arm-specific denominators behind the weight-participant description", "role": "Required", "role_reason": "Material on Randomized/analyzed/completed and arm-specific denominators behind the weight-participant description is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Randomized/analyzed/completed and arm-specific denominators behind the weight-participant description must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original extraction, randomization, analysis, completion and missing-data tables, with overlapping-sample links, are needed. No new total is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "Approximately 995 participants is the original scale reported with the weight-analysis scope. Exact participant counts, arm-specific numbers and universal completion are not newly 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": "What remains unverified in stored summaries: Original extraction, randomization, analysis, completion and missing-data tables, with overlapping-sample links, are needed. No new total is calculated.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original extraction, randomization, analysis, completion and missing-data tables, with overlapping-sample links, are needed. No new total is calculated." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Can original trials shared by the reviews be linked?", "needed": "Review–original-trial–additional-report and same-participant correspondence", "role": "Required", "role_reason": "Material on Review–original-trial–additional-report and same-participant correspondence is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Review–original-trial–additional-report and same-participant correspondence must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Each review’s included articles, registration, institution/time and sample correspondence are needed. Final unique-trial and unique-participant totals remain null. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "Overlap in original trials and participants across the meta-analyses is not identified in the stored summaries. The 875 participants and approximately 995 participants are not added.", "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": "What remains unverified in stored summaries: Each review’s included articles, registration, institution/time and sample correspondence are needed. Final unique-trial and unique-participant totals remain null.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Each review’s included articles, registration, institution/time and sample correspondence are needed. Final unique-trial and unique-participant totals remain null." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What is the 2018 weight estimate?", "needed": "R01 weight in kg, 95% CI, heterogeneity and analysis arrangements", "role": "Required", "role_reason": "Material on R01 weight in kg, 95% CI, heterogeneity and analysis arrangements is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on R01 weight in kg, 95% CI, heterogeneity and analysis arrangements must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original pooling tables, inclusions/weights, final values versus changes and models are needed. Effects are not recalculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R01 reports weight −1.76 kg (95% CI −3.34 to −0.17), I²=87.4%, with a null waist-circumference result. Weight and waist results remain separate.", "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": "What remains unverified in stored summaries: Original pooling tables, inclusions/weights, final values versus changes and models are needed. Effects are not recalculated.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original pooling tables, inclusions/weights, final values versus changes and models are needed. Effects are not recalculated." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What is the 2023 overall weight estimate?", "needed": "R02 weight in kg, 95% CI and original analysis scope", "role": "Required", "role_reason": "Material on R02 weight in kg, 95% CI and original analysis scope is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on R02 weight in kg, 95% CI and original analysis scope must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original weight-pooling tables, weights, variance, models and extraction/timing material are needed. Values are not replicated as results for each formulation/population. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R02 weight is −1.46 kg (95% CI −2.53 to −0.39), I²=94.6%. BMI −0.58, I²=87.1%, and a null waist result are retained as separate endpoints.", "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": "What remains unverified in stored summaries: Original weight-pooling tables, weights, variance, models and extraction/timing material are needed. Values are not replicated as results for each formulation/population.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original weight-pooling tables, weights, variance, models and extraction/timing material are needed. Values are not replicated as results for each formulation/population." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is extreme heterogeneity retained alongside the mean?", "needed": "Overall heterogeneity and formulation/disease/duration/cointervention explanations", "role": "Required", "role_reason": "Material on Overall heterogeneity and formulation/disease/duration/cointervention explanations is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Overall heterogeneity and formulation/disease/duration/cointervention explanations must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Heterogeneity, sensitivity/classification, model and original-trial material are needed. Prediction intervals or causal proportions are not invented, and effects are not generalized to everyone. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original 2023 I²=94.6% and 2018 I²=87.4% are retained. The original key issue emphasizes heterogeneity in formulation, diet and population over the mean alone.", "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": "What remains unverified in stored summaries: Heterogeneity, sensitivity/classification, model and original-trial material are needed. Prediction intervals or causal proportions are not invented, and effects are not generalized to everyone.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Heterogeneity, sensitivity/classification, model and original-trial material are needed. Prediction intervals or causal proportions are not invented, and effects are not generalized to everyone." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Is the null obesity-subgroup finding distinguished from the positive overall result?", "needed": "Effects, CIs, denominators and prespecification for obesity/overweight-obesity subgroups", "role": "Required", "role_reason": "Material on Effects, CIs, denominators and prespecification for obesity/overweight-obesity subgroups is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Effects, CIs, denominators and prespecification for obesity/overweight-obesity subgroups must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original subgroup definitions, effects/CIs, denominators, interactions and prospective plans are needed. The overall −1.46 kg is not replicated as the subgroup value. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original Korean answer describes a null obesity subgroup, while the original English answer describes a null overweight/obesity subgroup. Both original wordings are retained; subgroup values absent from structured results are not invented.", "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": "What remains unverified in stored summaries: Original subgroup definitions, effects/CIs, denominators, interactions and prospective plans are needed. The overall −1.46 kg is not replicated as the subgroup value.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original subgroup definitions, effects/CIs, denominators, interactions and prospective plans are needed. The overall −1.46 kg is not replicated as the subgroup value." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is the null finding at 8 weeks or less retained?", "needed": "Duration-subgroup definitions, effects, CIs and denominators", "role": "Required", "role_reason": "Material on Duration-subgroup definitions, effects, CIs and denominators is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Duration-subgroup definitions, effects, CIs and denominators must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original duration tables, prespecification, interactions and formulation/population differences are needed. The overall estimate is not substituted for a short-duration subgroup value. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original answer states that weight effects in trials of 8 weeks or less were not statistically significant. Separate values, CIs and denominators are absent from the structured result.", "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": "What remains unverified in stored summaries: Original duration tables, prespecification, interactions and formulation/population differences are needed. The overall estimate is not substituted for a short-duration subgroup value.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original duration tables, prespecification, interactions and formulation/population differences are needed. The overall estimate is not substituted for a short-duration subgroup value." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are powder/oil subgroups equivalent to a direct superiority comparison?", "needed": "Effects/CIs, denominators and prespecification by formulation, and direct comparisons", "role": "Required", "role_reason": "Material on Effects/CIs, denominators and prespecification by formulation, and direct comparisons is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Effects/CIs, denominators and prespecification by formulation, and direct comparisons must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original formulation-subgroup tables, prospective plans, interactions and direct comparisons are needed. Seed/oil superiority or equivalence is not established. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original formulation description separates subgroups; the grade rationale describes unstable formulation/population subgroups. Exact results for each formulation and direct superiority comparisons are not retained.", "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": "What remains unverified in stored summaries: Original formulation-subgroup tables, prospective plans, interactions and direct comparisons are needed. Seed/oil superiority or equivalence is not established.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original formulation-subgroup tables, prospective plans, interactions and direct comparisons are needed. Seed/oil superiority or equivalence is not established." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are earlier favorable directions kept distinct from independent replication?", "needed": "Links between earlier reviews mentioned in the narrative, structured reports and original trials", "role": "Supplementary", "role_reason": "Material on Links between earlier reviews mentioned in the narrative, structured reports and original trials is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Links between earlier reviews mentioned in the narrative, structured reports and original trials must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Corresponding citations, years and included trials for each narrative statement are needed. Agreement in review directions does not certify independent replication of an identical formulation. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original counterview mentions favorable mean directions in two earlier meta-analyses and an updated analysis. The structured evidence contains two reports; additional unidentified earlier reports are not invented.", "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": "What remains unverified in stored summaries: Corresponding citations, years and included trials for each narrative statement are needed. Agreement in review directions does not certify independent replication of an identical formulation.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Corresponding citations, years and included trials for each narrative statement are needed. Agreement in review directions does not certify independent replication of an identical formulation." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are weight in kg, BMI and waist circumference separate endpoints?", "needed": "Definitions, units, denominators and timing for weight in kg versus BMI/waist", "role": "Required", "role_reason": "Material on Definitions, units, denominators and timing for weight in kg versus BMI/waist is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Definitions, units, denominators and timing for weight in kg versus BMI/waist must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original effects/CIs, units, denominators and hierarchy are requested separately for each endpoint. BMI is not converted into kg. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original rationale and principal endpoint distinguish these endpoints. R02 BMI −0.58/I²=87.1% and null waist results, and R01’s null waist result, are not combined with weight estimates.", "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": "What remains unverified in stored summaries: Original effects/CIs, units, denominators and hierarchy are requested separately for each endpoint. BMI is not converted into kg.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original effects/CIs, units, denominators and hierarchy are requested separately for each endpoint. BMI is not converted into kg." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What are the weight-measurement, baseline-adjustment and change-score arrangements?", "needed": "Measurement procedures, baseline weight, final values versus changes, variance and analysis populations", "role": "Required", "role_reason": "Material on Measurement procedures, baseline weight, final values versus changes, variance and analysis populations is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Measurement procedures, baseline weight, final values versus changes, variance and analysis populations must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original measurement, timing, baseline values, extraction tables, variance handling/models and analysis plans are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The principal endpoint is weight change in kg. Original-trial measurement/adjustment and review extraction arrangements are not retained 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": "What remains unverified in stored summaries: Original measurement, timing, baseline values, extraction tables, variance handling/models and analysis plans are needed.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original measurement, timing, baseline values, extraction tables, variance handling/models and analysis plans are needed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What supports allocation, masking and risk assessment?", "needed": "Original-RCT allocation, concealment, masking and individual assessment grounds", "role": "Required", "role_reason": "Material on Original-RCT allocation, concealment, masking and individual assessment grounds is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original-RCT allocation, concealment, masking and individual assessment grounds must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original-trial methods, registration/plans and the reviews’ assessment grounds are needed. No formal RoB2/GRADE or new suitability judgment is produced. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The reports are meta-analyses of RCTs. Original methods, individual risk assessments and formal-tool results have not been externally read 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": "What remains unverified in stored summaries: Original-trial methods, registration/plans and the reviews’ assessment grounds are needed. No formal RoB2/GRADE or new suitability judgment is produced.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original-trial methods, registration/plans and the reviews’ assessment grounds are needed. No formal RoB2/GRADE or new suitability judgment is produced." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What is known about missing data, withdrawals, analysis exclusions and selective reporting?", "needed": "Missing weight data, withdrawals, analysis sets and all time points by arm", "role": "Required", "role_reason": "Material on Missing weight data, withdrawals, analysis sets and all time points by arm is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Missing weight data, withdrawals, analysis sets and all time points by arm must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific flows, exclusion reasons, missing-data handling, original results at all time points and sensitivity material are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "Retained sample descriptions concern review scale and weight studies/comparisons. Missing data, withdrawals and analysis exclusions by arm are not specified.", "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": "What remains unverified in stored summaries: Arm-specific flows, exclusion reasons, missing-data handling, original results at all time points and sensitivity material are needed.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Arm-specific flows, exclusion reasons, missing-data handling, original results at all time points and sensitivity material are needed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are PROSPERO review registration and original-trial registration distinguished?", "needed": "Review plans for CRD42022358471 and registration for each original trial", "role": "Required", "role_reason": "Material on Review plans for CRD42022358471 and registration for each original trial is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Review plans for CRD42022358471 and registration for each original trial must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original review registration, versions/dates and plans, plus individual-trial registrations, are needed. A recorded identifier is not promoted to current reading or certification of adherence to plans. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R02 is described as PROSPERO-registered, with CRD42022358471 in the citation. Original trial registration is recorded as unconfirmed. A review registration number does not confirm original-trial registration or prespecification.", "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": "What remains unverified in stored summaries: Original review registration, versions/dates and plans, plus individual-trial registrations, are needed. A recorded identifier is not promoted to current reading or certification of adherence to plans.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original review registration, versions/dates and plans, plus individual-trial registrations, are needed. A recorded identifier is not promoted to current reading or certification of adherence to plans." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Is a prospective hierarchy for the main weight analysis and subgroups confirmed?", "needed": "Plans for primary endpoints, duration/disease/formulation subgroups and multiplicity", "role": "Required", "role_reason": "Material on Plans for primary endpoints, duration/disease/formulation subgroups and multiplicity is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Plans for primary endpoints, duration/disease/formulation subgroups and multiplicity must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Review/original-trial protocols, SAPs, registration versions and all result tables are needed. No new conclusion that subgroups were post hoc is made. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "A summary selecting weight, review-registration bibliography and null subgroup findings are retained. Actual prospective endpoint/subgroup arrangements remain unread 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": "What remains unverified in stored summaries: Review/original-trial protocols, SAPs, registration versions and all result tables are needed. No new conclusion that subgroups were post hoc is made.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Review/original-trial protocols, SAPs, registration versions and all result tables are needed. No new conclusion that subgroups were post hoc is made." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are importance, sustained loss and clinical effects kept within the retained scope?", "needed": "Original weight-importance criteria, responders and long-term/post-discontinuation course", "role": "Supplementary", "role_reason": "Material on Original weight-importance criteria, responders and long-term/post-discontinuation course is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original weight-importance criteria, responders and long-term/post-discontinuation course must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct material on prospective importance/responders, body composition, persistence/regain and clinical events is needed. A mean in kg is not converted into individual success rates or large/sustained loss. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original grade rationale retains a small mean, heterogeneity and instability. The advertising assessment does not support large weight loss for everyone without diet or exercise.", "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": "What remains unverified in stored summaries: Direct material on prospective importance/responders, body composition, persistence/regain and clinical events is needed. A mean in kg is not converted into individual success rates or large/sustained loss.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Direct material on prospective importance/responders, body composition, persistence/regain and clinical events is needed. A mean in kg is not converted into individual success rates or large/sustained loss." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are independent replication and optimal dosing of an identical formulation confirmed?", "needed": "Original-trial families and independent teams for an identical product/population/comparator/duration", "role": "Supplementary", "role_reason": "Material on Original-trial families and independent teams for an identical product/population/comparator/duration is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original-trial families and independent teams for an identical product/population/comparator/duration must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct studies linking trial families, products, teams/funding and dose/timing are needed. Final unique-trial and participant numbers remain null. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original R1/I1 axes are retained. The reviews and pooled means across mixed formulations do not newly certify replication or optimal dosing for a particular product.", "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": "What remains unverified in stored summaries: Direct studies linking trial families, products, teams/funding and dose/timing are needed. Final unique-trial and participant numbers remain null.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Direct studies linking trial families, products, teams/funding and dose/timing are needed. Final unique-trial and participant numbers remain null." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are the four channels of company involvement known?", "needed": "Review/trial-specific funding, product support, employee authorship and COI", "role": "Required", "role_reason": "Material on Review/trial-specific funding, product support, employee authorship and COI is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Review/trial-specific funding, product support, employee authorship and COI must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. 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 are needed. Unverified information is not converted into a strength for independence. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "R01 records incomplete tracing of individual-trial funding; R02 records incomplete individual-trial funding and independence. Generic English funding wording is not complete supporting material.", "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": "What remains unverified in stored summaries: Original funding, product provision, author affiliations and COI are needed. Unverified information is not converted into a strength for independence.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original funding, product provision, author affiliations and COI are needed. Unverified information is not converted into a strength for independence." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are harm collection, events and discontinuations known?", "needed": "Adverse-event definitions, active/passive collection, severity and discontinuations", "role": "Supplementary", "role_reason": "Material on Adverse-event definitions, active/passive collection, severity and discontinuations is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Adverse-event definitions, active/passive collection, severity and discontinuations must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original harm methods, events, discontinuations and missing-data material are needed. Unread material is not converted into an absence of events. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original safety label is Caution, with small trials unable to exclude rare/long-term harms. Specific collection methods and event tables are absent from stored summaries.", "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": "What remains unverified in stored summaries: Original harm methods, events, discontinuations and missing-data material are needed. Unread material is not converted into an absence of events.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original harm methods, events, discontinuations and missing-data material are needed. Unread material is not converted into an absence of events." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What are the harm denominators and exposure durations?", "needed": "Arm-specific safety sets, actual administration, exposure and events/controls", "role": "Supplementary", "role_reason": "Material on Arm-specific safety sets, actual administration, exposure and events/controls is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Arm-specific safety sets, actual administration, exposure and events/controls must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Safety denominators, arm-specific event counts, exposure, control groups and withdrawal records are needed. Incidence or participant totals are not calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The 13 trials/875 participants, 21 trials and approximately 995 weight participants do not establish safety denominators. Durations and products also vary.", "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": "What remains unverified in stored summaries: Safety denominators, arm-specific event counts, exposure, control groups and withdrawal records are needed. Incidence or participant totals are not calculated.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Safety denominators, arm-specific event counts, exposure, control groups and withdrawal records are needed. Incidence or participant totals are not calculated." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What is known about concomitant medicines, alternative causes and event timing?", "needed": "Glucose-, blood-pressure-, anticoagulant-, antiseizure- and immune-modifying drugs and event course", "role": "Supplementary", "role_reason": "Material on Glucose-, blood-pressure-, anticoagulant-, antiseizure- and immune-modifying drugs and event course is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Glucose-, blood-pressure-, anticoagulant-, antiseizure- and immune-modifying drugs and event course must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original concomitant use, baseline disease, changes, event timing, controls and dechallenge/rechallenge records are needed. No new causality judgment is made. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original safety wording calls for consultation during medication use. It is not material establishing actual drug-specific interactions, events or causality.", "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": "What remains unverified in stored summaries: Original concomitant use, baseline disease, changes, event timing, controls and dechallenge/rechallenge records are needed. No new causality judgment is made.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Original concomitant use, baseline disease, changes, event timing, controls and dechallenge/rechallenge records are needed. No new causality judgment is made." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are long-term, rare and vulnerable-population harms certified?", "needed": "Long-term follow-up, independent harm reports, vulnerable groups and exposure/denominators", "role": "Supplementary", "role_reason": "Material on Long-term follow-up, independent harm reports, vulnerable groups and exposure/denominators is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Long-term follow-up, independent harm reports, vulnerable groups and exposure/denominators must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term, rare and vulnerable-population material, independent event reports, exposure and denominators are needed. No new harm search or reassessment is executed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original text retains consultation cautions for pregnancy/breastfeeding, children, liver/kidney disease and surgery, and limitations for long-term/rare harms. Mixed short trials do not certify safety in these settings.", "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": "What remains unverified in stored summaries: Long-term, rare and vulnerable-population material, independent event reports, exposure and denominators are needed. No new harm search or reassessment is executed.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Long-term, rare and vulnerable-population material, independent event reports, exposure and denominators are needed. No new harm search or reassessment is executed." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are actual stored-summary reading and external-source links distinguished?", "needed": "Access table for stored JSON, abstracts, full text, review/trial registration and protocols/SAPs", "role": "Required", "role_reason": "Material on Access table for stored JSON, abstracts, full text, review/trial registration and protocols/SAPs is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Access table for stored JSON, abstracts, full text, review/trial registration and protocols/SAPs must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: External material remains unread before user-provided acquisition and review. A URL/registration number alone does not establish reading, accessibility or fulfilled conditions. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The complete stored JSON was read for preparation; PubMed/DOI links and PROSPERO bibliography are retained records. External abstracts, full text, registration and protocols/SAPs remain unread.", "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": "What remains unverified in stored summaries: External material remains unread before user-provided acquisition and review. A URL/registration number alone does not establish reading, accessibility or fulfilled conditions.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: External material remains unread before user-provided acquisition and review. A URL/registration number alone does not establish reading, accessibility or fulfilled conditions." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Are generic English wording, corrections and Korean/English expressions preserved?", "needed": "Original Korean/English records and limits of the 2026-09-14 correction", "role": "Supplementary", "role_reason": "Material on Original Korean/English records and limits of the 2026-09-14 correction is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original Korean/English records and limits of the 2026-09-14 correction must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Earlier correction targets and external English-source comparison are not revisited here. The original correction is not presented as newly completed QA. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "The original correction records changes to 2 English-placeholder fields while retaining grade, score, citations and evidence date. Generic evidence-table wording and the Korean obesity versus English overweight/obesity expressions are also preserved.", "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": "What remains unverified in stored summaries: Earlier correction targets and external English-source comparison are not revisited here. The original correction is not presented as newly completed QA.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: Earlier correction targets and external English-source comparison are not revisited here. The original correction is not presented as newly completed QA." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Are original grades, axes, evidence date and production kept separate?", "needed": "Original C46, Caution, axes, evidence date and correction values", "role": "Required", "role_reason": "Material on Original C46, Caution, axes, evidence date and correction values is needed to connect the relevant formulation, population, comparison, weight endpoint, timing, denominator or harm scope.", "application_exception": "Review-wide counts remain distinct from studies, comparisons and participants in weight analyses, with overlap unconfirmed. Mixed pooled means are not converted into results or safety for each formulation, subgroup or individual; weight, BMI and waist circumference remain distinct.", "criterion": "Original records on Original C46, Caution, axes, evidence date and correction values must link to the relevant report, original trial, analysis unit, timing and denominator, distinguishing stored information from what remains unverified.", "basis": "Existing principles distinguish the question, formulation, population, reports and original trials, endpoints, timing, denominators, heterogeneity, support and harms in the retained body-weight record.", "condition_origin": "These existing conditions are linked to the stored body-weight record. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: New evidence, condition revisions and verdict changes are separate events after user review. The original evidence date is not converted into a current search end date or external-reading date. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "The retained Korean and English summaries and bibliography were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with no access attempt.", "observation": "C/46/Caution, original axes, the evidence date 2026-09-08 and corrections are retained. The original grade rationale’s 0 strengths is a historical statement, not a current quality-score calculation.", "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": "What remains unverified in stored summaries: New evidence, condition revisions and verdict changes are separate events after user review. The original evidence date is not converted into a current search end date or external-reading date.", "uncertainty": "Gaps remain in original-trial overlap, denominators, formulations and cointerventions, subgroup definitions and prespecification, heterogeneity, missing data, support and harms. Original numbers and grades do not constitute new calculations, reassessment or clinical validation.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional material needed: New evidence, condition revisions and verdict changes are separate events after user review. The original evidence date is not converted into a current search end date or external-reading date." } ], "reports": [ { "report_id": "R01", "title": "Mousavi et al. 2018 · Meta-analysis of Nigella sativa, body weight and body composition", "url": "https://pubmed.ncbi.nlm.nih.gov/29857879/", "report_type": "Retained description as a meta-analysis of RCTs; external verification of original trials and methods is incomplete", "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "Stored existing review summary read; external material unread", "study_family": "Shared original trials/participants across the 2018/2023 meta-analysis reports are unconfirmed; review-wide totals, weight studies, comparisons and denominators remain distinct, as do formulation/disease/duration subgroups", "independent_replication": "Reports remain distinct from unique trials, independent teams and participant totals; these are not certified here", "observed_result": "Weight −1.76 kg (95% CI −3.34 to −0.17), I²=87.4%; null waist-circumference result", "result_level": "These are existing reported values. The review-wide 13 trials and 875 participants remain distinct from weight-endpoint denominators; original extraction, weights, models and timing remain unverified in detail.", "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": "Summary read", "as_of": "2026-10-06T12:32:34.048905+09:00 (original summary-production timestamp; not external reading)", "qualification": "The stored review summary was read for preparation. This does not establish acquisition or reading of article full text or verification of original trials. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. The presence of a URL, identifier or review registration alone does not establish acquisition, accessibility, content reading, original-trial prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "External abstract", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the article identity link in the existing bibliography is connected. External abstract content reading and access testing were not performed. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. The presence of a URL, identifier or review registration alone does not establish acquisition, accessibility, content reading, original-trial prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "External full text", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Article full text is unacquired and unread. A bibliographic link is not presented as full-text acquisition or successful access. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. The presence of a URL, identifier or review registration alone does not establish acquisition, accessibility, content reading, original-trial prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "Registration material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Review and original-trial registration contents remain distinct. Registration texts, versions, dates and plans are unread; original-trial prespecification is not inferred. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. The presence of a URL, identifier or review registration alone does not establish acquisition, accessibility, content reading, original-trial prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "Protocols and analysis plans", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Protocols and analysis plans are unread. Prespecification of endpoints, subgroup hierarchy, multiplicity, extraction, variance and models is not newly certified. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. The presence of a URL, identifier or review registration alone does not establish acquisition, accessibility, content reading, original-trial prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/29857879/" } ] }, { "report_id": "R02", "title": "Naghsh et al. 2023 · Updated meta-analysis of Nigella sativa and anthropometric indices", "url": "https://doi.org/10.1016/j.jff.2023.105565", "report_type": "Retained description as a meta-analysis of RCTs reported as registered in PROSPERO; review and original-trial registrations remain distinct, and external contents are unread", "existence": "The information is recorded in stored review summaries and bibliography. Actual acquisition and content reading of external articles, registration, plans and additional material remain separately unverified.", "acquired_read": "Stored existing review summary read; external material unread", "study_family": "Shared original trials/participants across the 2018/2023 meta-analysis reports are unconfirmed; review-wide totals, weight studies, comparisons and denominators remain distinct, as do formulation/disease/duration subgroups", "independent_replication": "Reports remain distinct from unique trials, independent teams and participant totals; these are not certified here", "observed_result": "Weight −1.46 kg (95% CI −2.53 to −0.39), I²=94.6%; BMI −0.58, I²=87.1%; null waist result", "result_level": "These are existing reported values. The 21 trials overall remain distinct from 15 studies, 16 comparisons and approximately 995 participants for weight. Mixed pooled means are not formulation, disease or duration subgroup results; original extraction, denominators and prospective analyses remain unverified in detail.", "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": "Summary read", "as_of": "2026-10-06T12:32:34.048905+09:00 (original summary-production timestamp; not external reading)", "qualification": "The stored review summary was read for preparation. This does not establish acquisition or reading of article full text or verification of original trials. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. The presence of a URL, identifier or review registration alone does not establish acquisition, accessibility, content reading, original-trial prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "External abstract", "public_status": "Original bibliography link only; external content unread", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the article identity link in the existing bibliography is connected. External abstract content reading and access testing were not performed. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. The presence of a URL, identifier or review registration alone does not establish acquisition, accessibility, content reading, original-trial prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "External full text", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Article full text is unacquired and unread. A bibliographic link is not presented as full-text acquisition or successful access. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. The presence of a URL, identifier or review registration alone does not establish acquisition, accessibility, content reading, original-trial prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "Registration material", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Review and original-trial registration contents remain distinct. Registration texts, versions, dates and plans are unread; original-trial prespecification is not inferred. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. The presence of a URL, identifier or review registration alone does not establish acquisition, accessibility, content reading, original-trial prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." }, { "material_type": "Protocols and analysis plans", "public_status": "Needed material; existence and public availability unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Protocols and analysis plans are unread. Prespecification of endpoints, subgroup hierarchy, multiplicity, extraction, variance and models is not newly certified. Existing bibliography is linked; external abstracts, full texts, registration, protocols and analysis plans are unread. The presence of a URL, identifier or review registration alone does not establish acquisition, accessibility, content reading, original-trial prespecification or fulfilled conditions. The date 2026-09-08 is the original evidence date. Material timestamps for stored summaries describe original production on 2026-10-06, not external reading. External-material timestamps and original review and verification dates remain unrecorded." } ], "links": [ { "label": "Official source", "url": "https://doi.org/10.1016/j.jff.2023.105565" } ] } ], "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": "Original trials and participants shared by the 2018/2023 reviews remain unconfirmed. Reports remain distinct from unique trials, independent teams and participant totals; no new summation or certification of independent replication is performed." }, "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 36 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-24" }