# Psyllium × MRI liver fat: an unmeasured outcome and gaps behind surrogate findings Verdict 2985 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-09-07 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-16 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 80 adults with overweight or obesity and MASLD were randomized; 78 completed. Group/test denominators and detailed eligibility are unverified. - Ingredient, formulation and route: Psyllium 10 g/day added to a weight-loss diet and physical-activity advice - Dose: Psyllium10g/day and ten weeks identify the original study. No new total quantities, product, intake, diet or liver-disease-management advice is created. - Comparator: Ground wheat10g/day. Both groups received the same weight-loss-diet and physical-activity advice. Actual concurrent exposure and adherence details are unverified. - Measured outcome: MRI liver fat was not directly measured. ALT, FibroScan and AST, MRS, other imaging and histology are distinguished separately. - Duration: A ten-week efficacy trial. MRI was not directly measured; post-trial follow-up and direct long-term clinical evidence are unverified. - Questions outside this scope: Transferring ALT/FibroScan findings into direct MRI/MRS or histologic liver-fat outcomes; Combining null AST and unmeasured MRI into the same zero-effect claim; Deriving exact between-group effects/CIs, fibrosis reversal, disease improvement or event prevention from P values; Certifying common advice as identical actual diet/activity/weight or psyllium-alone efficacy; Counting the supporting seed safety citation as identical efficacy replication or copying its harms into the current trial; Adding the same reports, time points, conditions or participants as new independent trials or people; New calculations, hypothetical quantities, grades, independence certification, product intake, diets, liver-disease management or treatment-replacement instructions ## Checklist items ### N01 · Which MRI claim is selected? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The selected claim is reduced MRI-measured liver fat. Its original grade is ? and its note says this was not an outcome measured by the trial. Subclaim score, status and axes are unrecorded and distinguished from the parent ALT/FibroScan verdict C50. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Definitions, population, comparator, time points and denominators for direct MRI measurement, and review of the existing claim boundary, are needed. The ? does not mean zero effect, zero points or absence of all human research. - Required materials and conditions: The existing MRI liver-fat-reduction claim and verdict record - Materials to obtain first: Definitions, population, comparator, time points and denominators for direct MRI measurement, and review of the existing claim boundary, are needed. The ? does not mean zero effect, zero points or absence of all human research. - Further research: Material needed: Definitions, population, comparator, time points and denominators for direct MRI measurement, and review of the existing claim boundary, are needed. The ? does not mean zero effect, zero points or absence of all human research. This records needed materials; no new research was executed. - Conditions for verification: Material for The existing MRI liver-fat-reduction claim and verdict record must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects The existing MRI liver-fat-reduction claim and verdict record with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N02 · Was MRI liver fat directly measured? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The existing crux, summary note and subclaim note record that the trial did not measure MRI liver fat. MRI values, between-group changes, CIs and measurement denominators are not filled using ALT/FibroScan findings. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Actual MRI liver-fat methods, quantification, units, baseline and follow-up measurements, comparator, denominators and CIs are needed. An unmeasured outcome is not a test showing no effect. - Required materials and conditions: Unmeasured MRI and the direct-evidence gap - Materials to obtain first: Actual MRI liver-fat methods, quantification, units, baseline and follow-up measurements, comparator, denominators and CIs are needed. An unmeasured outcome is not a test showing no effect. - Further research: Material needed: Actual MRI liver-fat methods, quantification, units, baseline and follow-up measurements, comparator, denominators and CIs are needed. An unmeasured outcome is not a test showing no effect. This records needed materials; no new research was executed. - Conditions for verification: Material for Unmeasured MRI and the direct-evidence gap must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Unmeasured MRI and the direct-evidence gap with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N03 · Does ALT P=.006 establish an MRI liver-fat effect? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: Original ALT P=.006 is a covariate-adjusted liver-enzyme result, not MRI fat quantity, change or a CI. It is not converted into an MRI liver-fat-reduction effect or amount of normalization. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Original ALT tables and separate direct MRI data, definitions, models, denominators and CIs are needed. Original P values are preserved without new effect or fat-quantity calculations. - Required materials and conditions: Distinguishing liver enzymes from a direct MRI endpoint - Materials to obtain first: Original ALT tables and separate direct MRI data, definitions, models, denominators and CIs are needed. Original P values are preserved without new effect or fat-quantity calculations. - Further research: Material needed: Original ALT tables and separate direct MRI data, definitions, models, denominators and CIs are needed. Original P values are preserved without new effect or fat-quantity calculations. This records needed materials; no new research was executed. - Conditions for verification: Material for Distinguishing liver enzymes from a direct MRI endpoint must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Distinguishing liver enzymes from a direct MRI endpoint with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N04 · Is FibroScan P=.001 the same measurement as MRI? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The original wording of FibroScan fibrosis score P=.001 and the existing explanation that it differs from MRI are preserved. Actual measure, units and device algorithm are unverified and are not converted into MRI fat quantity. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: FibroScan definitions and valid measurements, direct MRI quantification methods, and their respective denominators, models and CIs are needed. A device name alone does not establish fat measurement or histologic effects. - Required materials and conditions: Distinguishing the actual FibroScan measure from MRI methods - Materials to obtain first: FibroScan definitions and valid measurements, direct MRI quantification methods, and their respective denominators, models and CIs are needed. A device name alone does not establish fat measurement or histologic effects. - Further research: Material needed: FibroScan definitions and valid measurements, direct MRI quantification methods, and their respective denominators, models and CIs are needed. A device name alone does not establish fat measurement or histologic effects. This records needed materials; no new research was executed. - Conditions for verification: Material for Distinguishing the actual FibroScan measure from MRI methods must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Distinguishing the actual FibroScan measure from MRI methods with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N05 · Are MRI, MRS, other imaging and histologic outcomes individually verified? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The existing advertising analysis cautions against adding unmeasured MRI or histologic liver-fat findings. Detailed MRS, other imaging and histologic results and values are also not verified as separate direct outcomes in the stored summary. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Actual performance, purpose, definitions, units, time points, denominators and CIs for each method or histologic measure are needed. Unverified information is not replaced with confirmed performance or a zero result. - Required materials and conditions: Actual measurement by each imaging method and histologic indicator - Materials to obtain first: Actual performance, purpose, definitions, units, time points, denominators and CIs for each method or histologic measure are needed. Unverified information is not replaced with confirmed performance or a zero result. - Further research: Material needed: Actual performance, purpose, definitions, units, time points, denominators and CIs for each method or histologic measure are needed. Unverified information is not replaced with confirmed performance or a zero result. This records needed materials; no new research was executed. - Conditions for verification: Material for Actual measurement by each imaging method and histologic indicator must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Actual measurement by each imaging method and histologic indicator with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N06 · Does the null AST result establish a null MRI fat result? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: AST P=.98 is the original null liver-enzyme test result. It is not transferred into zero MRI effect or equivalence for an unmeasured outcome, or obscured by favorable ALT findings. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Test-specific values, denominators, between-group effects, CIs, prespecified hierarchy and separate MRI data are needed. No new conversion between tests is made. - Required materials and conditions: Distinguishing AST P=.98 from other unmeasured tests - Materials to obtain first: Test-specific values, denominators, between-group effects, CIs, prespecified hierarchy and separate MRI data are needed. No new conversion between tests is made. - Further research: Material needed: Test-specific values, denominators, between-group effects, CIs, prespecified hierarchy and separate MRI data are needed. No new conversion between tests is made. This records needed materials; no new research was executed. - Conditions for verification: Material for Distinguishing AST P=.98 from other unmeasured tests must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Distinguishing AST P=.98 from other unmeasured tests with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N07 · Are clinical liver-disease outcomes and MRI measurements the same endpoint? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The Korean text says whether marker changes lead to cirrhosis or hospitalization is unknown; the English text says clinical liver events were not tested. MRI fat quantity is also distinct from clinical-event effects and was not directly measured in this trial. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Clinical-event definitions, adjudication, long-term follow-up, group-specific time at risk, denominators, effects, CIs and direct MRI data are needed. No conversion into zero events or treatment efficacy is made. - Required materials and conditions: Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence - Materials to obtain first: Clinical-event definitions, adjudication, long-term follow-up, group-specific time at risk, denominators, effects, CIs and direct MRI data are needed. No conversion into zero events or treatment efficacy is made. - Further research: Material needed: Clinical-event definitions, adjudication, long-term follow-up, group-specific time at risk, denominators, effects, CIs and direct MRI data are needed. No conversion into zero events or treatment efficacy is made. This records needed materials; no new research was executed. - Conditions for verification: Material for Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Clinical outcomes such as cirrhosis or hospitalization and direct MRI evidence with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N08 · Is the MASLD population the same as the separate NAFLD seed trial? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The main trial involved 80 adults with overweight or obesity and MASLD. The 2016 supporting safety citation concerns NAFLD seed intervention and anthropometry. Differences in diagnosis, disease stage, baseline imaging, medication and formulation are not merged into evidence for the same MRI efficacy question. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Report-specific populations, diagnoses, baseline imaging, liver disease, medication, interventions, durations and direct MRI evidence are needed. No generalization to every liver disease or formulation is made. - Required materials and conditions: Distinguishing the overweight/obese MASLD population from another seed trial - Materials to obtain first: Report-specific populations, diagnoses, baseline imaging, liver disease, medication, interventions, durations and direct MRI evidence are needed. No generalization to every liver disease or formulation is made. - Further research: Material needed: Report-specific populations, diagnoses, baseline imaging, liver disease, medication, interventions, durations and direct MRI evidence are needed. No generalization to every liver disease or formulation is made. This records needed materials; no new research was executed. - Conditions for verification: Material for Distinguishing the overweight/obese MASLD population from another seed trial must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Distinguishing the overweight/obese MASLD population from another seed trial with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01, R02 ### N09 · Can common diet advice and comparator conditions substitute for MRI effects? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The 10g/day interventions, ground-wheat comparator, weight-loss diet and physical-activity advice in both groups are original study conditions. Common advice or weight changes are not assumed to establish MRI liver-fat improvement, an isolated effect or a comparison with no treatment. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Actual diet, activity, weight, medication, adherence, comparator, exposure and direct MRI measurement data are needed. No new diet, liver-disease-management or intake advice is created. - Required materials and conditions: The psyllium versus ground-wheat comparison and common lifestyle advice - Materials to obtain first: Actual diet, activity, weight, medication, adherence, comparator, exposure and direct MRI measurement data are needed. No new diet, liver-disease-management or intake advice is created. - Further research: Material needed: Actual diet, activity, weight, medication, adherence, comparator, exposure and direct MRI measurement data are needed. No new diet, liver-disease-management or intake advice is created. This records needed materials; no new research was executed. - Conditions for verification: Material for The psyllium versus ground-wheat comparison and common lifestyle advice must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects The psyllium versus ground-wheat comparison and common lifestyle advice with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N10 · Are 80 randomized and 78 completed MRI measurement denominators? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: 80 randomized and 78 completed describe participation in the main trial, not numbers or denominators measured by MRI. Time points, tests and report counts are not added as independent trials or participants. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Group-specific randomization, valid scans, missingness, analysis flow, effects and CIs from direct MRI research are needed. No new valid MRI denominator, dropout count or dropout rate is calculated. - Required materials and conditions: Distinguishing randomized/completed counts from an unmeasured endpoint denominator - Materials to obtain first: Group-specific randomization, valid scans, missingness, analysis flow, effects and CIs from direct MRI research are needed. No new valid MRI denominator, dropout count or dropout rate is calculated. - Further research: Material needed: Group-specific randomization, valid scans, missingness, analysis flow, effects and CIs from direct MRI research are needed. No new valid MRI denominator, dropout count or dropout rate is calculated. This records needed materials; no new research was executed. - Conditions for verification: Material for Distinguishing randomized/completed counts from an unmeasured endpoint denominator must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Distinguishing randomized/completed counts from an unmeasured endpoint denominator with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N11 · Does ten-week study exposure show sustained MRI effects? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: Ten weeks, psyllium10g/day and ground wheat10g/day identify the original efficacy trial. With MRI unmeasured, no ten-week MRI effect, persistence, subsequent fat quantity or long-term safety is created. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Direct MRI baseline, follow-up and post-trial data, actual exposure, denominators, comparator and duration are needed. No product-intake, maintenance or treatment-replacement instructions are created. - Required materials and conditions: Duration, actual exposure and post-trial follow-up - Materials to obtain first: Direct MRI baseline, follow-up and post-trial data, actual exposure, denominators, comparator and duration are needed. No product-intake, maintenance or treatment-replacement instructions are created. - Further research: Material needed: Direct MRI baseline, follow-up and post-trial data, actual exposure, denominators, comparator and duration are needed. No product-intake, maintenance or treatment-replacement instructions are created. This records needed materials; no new research was executed. - Conditions for verification: Material for Duration, actual exposure and post-trial follow-up must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Duration, actual exposure and post-trial follow-up with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N12 · Did registration or the prespecified endpoint hierarchy include MRI? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The original record leaves effect size, prespecified primary-endpoint hierarchy and registration unverified; MRI was not a measured endpoint. Registration identifiers or plans are not invented to verify MRI as a prespecified or later endpoint. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Original registration and amendment history, protocols, SAPs, actual endpoints, time points and direct MRI design data are needed. External registration and planning materials remain unread. - Required materials and conditions: Distinguishing unverified registration/prespecified endpoints from unmeasured MRI - Materials to obtain first: Original registration and amendment history, protocols, SAPs, actual endpoints, time points and direct MRI design data are needed. External registration and planning materials remain unread. - Further research: Material needed: Original registration and amendment history, protocols, SAPs, actual endpoints, time points and direct MRI design data are needed. External registration and planning materials remain unread. This records needed materials; no new research was executed. - Conditions for verification: Material for Distinguishing unverified registration/prespecified endpoints from unmeasured MRI must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Distinguishing unverified registration/prespecified endpoints from unmeasured MRI with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N13 · Can P values from other tests fill MRI effects or CIs? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: MRI values, direct effects and CIs remain a gap because MRI was not measured. Covariate-adjusted ALT/FibroScan P values and the parent verdict's interpretation do not provide quantitative MRI evidence. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Direct MRI group values, baseline, changes, adjusted estimates, 95%CIs, units, denominators and clinical importance are needed. No new calculations, hypothetical examples or effect sizes are created. - Required materials and conditions: Direct estimates, within/between-group comparisons and unmeasured outcomes - Materials to obtain first: Direct MRI group values, baseline, changes, adjusted estimates, 95%CIs, units, denominators and clinical importance are needed. No new calculations, hypothetical examples or effect sizes are created. - Further research: Material needed: Direct MRI group values, baseline, changes, adjusted estimates, 95%CIs, units, denominators and clinical importance are needed. No new calculations, hypothetical examples or effect sizes are created. This records needed materials; no new research was executed. - Conditions for verification: Material for Direct estimates, within/between-group comparisons and unmeasured outcomes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Direct estimates, within/between-group comparisons and unmeasured outcomes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N14 · What direct evidence would address the MRI gap? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The current record contains selected ten-week liver-test signals and unmeasured MRI. Other surrogates or the separate seed safety citation do not fill this gap; needed direct MRI materials are identified. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: MRI liver-fat methods, baseline, follow-up, denominators, effects, CIs, actual exposure and harms for the same formulation, common advice, comparator and selected MASLD population are needed. Only research needs are recorded; no new research, calculation or regrading is performed. - Required materials and conditions: MRI measurements addressing the same question - Materials to obtain first: MRI liver-fat methods, baseline, follow-up, denominators, effects, CIs, actual exposure and harms for the same formulation, common advice, comparator and selected MASLD population are needed. Only research needs are recorded; no new research, calculation or regrading is performed. - Further research: Material needed: MRI liver-fat methods, baseline, follow-up, denominators, effects, CIs, actual exposure and harms for the same formulation, common advice, comparator and selected MASLD population are needed. Only research needs are recorded; no new research, calculation or regrading is performed. This records needed materials; no new research was executed. - Conditions for verification: Material for MRI measurements addressing the same question must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects MRI measurements addressing the same question with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N15 · Are the same reports, participants or time points counted as independent evidence? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: Parent2985 and the ALT/FibroScan and MRI sheets share the Akbarzadeh2026 efficacy-trial context and Akbarian2016 supporting safety citation. Tests, conditions and time points from the same participants are not added as new independent trials or people. Unique-trial and total unique-participant counts remain unverified. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Links between efficacy/safety reports, cohorts, actual interventions, analysis populations and time points are needed. Material-item counts are not unique-trial or participant counts or quality scores. - Required materials and conditions: Links between parent/subclaims and reports/studies - Materials to obtain first: Links between efficacy/safety reports, cohorts, actual interventions, analysis populations and time points are needed. Material-item counts are not unique-trial or participant counts or quality scores. - Further research: Material needed: Links between efficacy/safety reports, cohorts, actual interventions, analysis populations and time points are needed. Material-item counts are not unique-trial or participant counts or quality scores. This records needed materials; no new research was executed. - Conditions for verification: Material for Links between parent/subclaims and reports/studies must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Links between parent/subclaims and reports/studies with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01, R02 ### N16 · Which materials were actually read? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The complete stored parent-verdict summary was read for production and an exact whole-byte copy preserved. External abstracts, full texts, registration, protocols and SAPs remain unread. URLs or PMCIDs are not treated as verification of reading, access or condition fulfillment. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Acquisition and reading records for actual full texts, supplements, plans and registration materials are needed. External source-link access and operation were not tested. - Required materials and conditions: Distinguishing the complete stored parent summary from external material - Materials to obtain first: Acquisition and reading records for actual full texts, supplements, plans and registration materials are needed. External source-link access and operation were not tested. - Further research: Material needed: Acquisition and reading records for actual full texts, supplements, plans and registration materials are needed. External source-link access and operation were not tested. This records needed materials; no new research was executed. - Conditions for verification: Material for Distinguishing the complete stored parent summary from external material must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Distinguishing the complete stored parent summary from external material with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01, R02 ### N17 · Where are citation and registration identifiers recorded? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The 2026 efficacy citation has PMID42621560, PMCID PMC13489564 and DOI10.4103/ijpvm.ijpvm_254_24. The 2016 supporting citation has PMID27761216, PMCID PMC5070040 and DOI10.4103/2008-7802.191865. Neither citation/evidence record contains a separate registration identifier. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Exact original bibliographic, study and registration identifiers, content and dates are needed. Full-text or registration URLs are not newly inferred from a PMCID. - Required materials and conditions: PMID, PMCID and DOI for each citation - Materials to obtain first: Exact original bibliographic, study and registration identifiers, content and dates are needed. Full-text or registration URLs are not newly inferred from a PMCID. - Further research: Material needed: Exact original bibliographic, study and registration identifiers, content and dates are needed. Full-text or registration URLs are not newly inferred from a PMCID. This records needed materials; no new research was executed. - Conditions for verification: Material for PMID, PMCID and DOI for each citation must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects PMID, PMCID and DOI for each citation with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01, R02 ### N18 · Are historical bilingual and cross-check records distinguished from this review? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: Bilingual text, subclaims, notes and historical Codex PubMed/PMC/scoring checks and verification statements in citation summaries are preserved. This production uses stored summaries; external material is unread and existing content, model and claim-boundary reviews remain incomplete. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Existing review of original text, translation, corrections and claim boundaries is needed. Historical verification is not presented as completed current clinical review, new calculations or independence certification. - Required materials and conditions: Original bilingual wording, subclaim records and historical verification - Materials to obtain first: Existing review of original text, translation, corrections and claim boundaries is needed. Historical verification is not presented as completed current clinical review, new calculations or independence certification. - Further research: Material needed: Existing review of original text, translation, corrections and claim boundaries is needed. Historical verification is not presented as completed current clinical review, new calculations or independence certification. This records needed materials; no new research was executed. - Conditions for verification: Material for Original bilingual wording, subclaim records and historical verification must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Original bilingual wording, subclaim records and historical verification with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01, R02 ### N19 · Are the subclaim record and parent C50/axes distinguished? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The selected original grade/note and absent score, status and axes are retained. Parent C50, Caution, B/S/R1/I2/EX/B2 and unrecorded precision are parent context. They do not fill the selected MRI liver-fat score or axes or certify independence. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Existing review of the selected subclaim and original parent values is needed. No new score, axes, efficacy grade or verdict change is created. - Required materials and conditions: Subclaim grade/note and absent score/status/axes - Materials to obtain first: Existing review of the selected subclaim and original parent values is needed. No new score, axes, efficacy grade or verdict change is created. - Further research: Material needed: Existing review of the selected subclaim and original parent values is needed. No new score, axes, efficacy grade or verdict change is created. This records needed materials; no new research was executed. - Conditions for verification: Material for Subclaim grade/note and absent score/status/axes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Subclaim grade/note and absent score/status/axes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01, R02 ### N20 · Are the original evidence date and empty corrections distinguished from production? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: Original evidence date2026-09-07, the empty correction array and empty deliberation string are retained. This is not a production or review date or certification that no external corrections exist. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Follow-up/correction materials and the complete pre-change original and event history are needed. Absent dates or correction values are not invented. - Required materials and conditions: Original evidence date and empty correction/deliberation values - Materials to obtain first: Follow-up/correction materials and the complete pre-change original and event history are needed. Absent dates or correction values are not invented. - Further research: Material needed: Follow-up/correction materials and the complete pre-change original and event history are needed. Absent dates or correction values are not invented. This records needed materials; no new research was executed. - Conditions for verification: Material for Original evidence date and empty correction/deliberation values must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Original evidence date and empty correction/deliberation values with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01, R02 ### N21 · Are funding, support, employee authors and analysis roles distinguished? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The main funding record reports academic Isfahan University research and no conflicts. It does not mean product support, company-employee authors or company analysis/reporting involvement are all verified. Funding details for the 2016 supporting citation are separately unrecorded. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Report-specific funding, COI, product/ingredient support, author affiliations and analysis/publication roles are needed. Parent I2 is not used as new independence certification. - Required materials and conditions: Company-related items and report-specific verification scope - Materials to obtain first: Report-specific funding, COI, product/ingredient support, author affiliations and analysis/publication roles are needed. Parent I2 is not used as new independence certification. - Further research: Material needed: Report-specific funding, COI, product/ingredient support, author affiliations and analysis/publication roles are needed. Parent I2 is not used as new independence certification. This records needed materials; no new research was executed. - Conditions for verification: Material for Company-related items and report-specific verification scope must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Company-related items and report-specific verification scope with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01, R02 ### N22 · Are allocation, measurement, missingness and selective-reporting details verified? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The main trial used block randomization and records covariate adjustment and limitations of completer-focused analysis. Allocation concealment, blinding, test devices/validity, missingness, covariate prespecification and selective-reporting details remain separately unverified. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Original methods, protocols, SAPs, registration/amendment history, test tables, denominators and models are needed. Design names or objective tests alone do not establish formal RoB/GRADE or completed review. - Required materials and conditions: Boundaries of block randomization, covariate adjustment and completer analysis - Materials to obtain first: Original methods, protocols, SAPs, registration/amendment history, test tables, denominators and models are needed. Design names or objective tests alone do not establish formal RoB/GRADE or completed review. - Further research: Material needed: Original methods, protocols, SAPs, registration/amendment history, test tables, denominators and models are needed. Design names or objective tests alone do not establish formal RoB/GRADE or completed review. This records needed materials; no new research was executed. - Conditions for verification: Material for Boundaries of block randomization, covariate adjustment and completer analysis must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Boundaries of block randomization, covariate adjustment and completer analysis with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N23 · Does common lifestyle advice establish actual concurrent exposure? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: Weight-loss-diet and physical-activity advice common to both arms is an original condition. Actual diet, activity, weight changes, medication, product exposure, adherence and withdrawal details remain unverified; their joint contribution is not established. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Actual concurrent exposure, weight, diet, activity, baseline/follow-up medication, exposure, adherence and denominators are needed. No diet, intake or liver-disease-management instructions are created. - Required materials and conditions: Weight-loss diet, physical activity, adherence and co-management - Materials to obtain first: Actual concurrent exposure, weight, diet, activity, baseline/follow-up medication, exposure, adherence and denominators are needed. No diet, intake or liver-disease-management instructions are created. - Further research: Material needed: Actual concurrent exposure, weight, diet, activity, baseline/follow-up medication, exposure, adherence and denominators are needed. No diet, intake or liver-disease-management instructions are created. This records needed materials; no new research was executed. - Conditions for verification: Material for Weight-loss diet, physical activity, adherence and co-management must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Weight-loss diet, physical activity, adherence and co-management with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01 ### N24 · Which formulation or group had withdrawals in the supporting safety citation? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: The 2016 citation reports some withdrawals for constipation, nausea or abdominal pain in a separate NAFLD seed intervention. Exact groups, products, counts, exposure denominators and durations are unverified. All withdrawals are not assigned to the current psyllium10g/day trial. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: That report's formulations, ingredients, group-specific events, withdrawals, reasons, durations, harm collection and exposure denominators are needed. A different safety citation is not converted into independent efficacy replication or the original trial's harm rate. - Required materials and conditions: Links between the 2016 seed intervention, withdrawals and harms - Materials to obtain first: That report's formulations, ingredients, group-specific events, withdrawals, reasons, durations, harm collection and exposure denominators are needed. A different safety citation is not converted into independent efficacy replication or the original trial's harm rate. - Further research: Material needed: That report's formulations, ingredients, group-specific events, withdrawals, reasons, durations, harm collection and exposure denominators are needed. A different safety citation is not converted into independent efficacy replication or the original trial's harm rate. This records needed materials; no new research was executed. - Conditions for verification: Material for Links between the 2016 seed intervention, withdrawals and harms must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Links between the 2016 seed intervention, withdrawals and harms with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R02 ### N25 · Are caution statements, observed harms and long-term safety the same? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: Potential gas, bloating, abdominal pain, constipation or nausea and swallowing, narrowing and obstruction boundaries are existing safety statements. Harm collection, group-specific events, exposure denominators, CIs, long-term and rare harms remain separately unverified. Original adequate-fluid wording is preserved without creating new fluid quantities, intake methods or treatment advice. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: Report-specific harm definitions, active collection, group exposure, denominators, withdrawals, attrition and long-term risk-group data are needed. Caution is not converted into safety, no harm or a new established incidence rate. - Required materials and conditions: Potential harms, collection methods, denominators and specific risk groups - Materials to obtain first: Report-specific harm definitions, active collection, group exposure, denominators, withdrawals, attrition and long-term risk-group data are needed. Caution is not converted into safety, no harm or a new established incidence rate. - Further research: Material needed: Report-specific harm definitions, active collection, group exposure, denominators, withdrawals, attrition and long-term risk-group data are needed. Caution is not converted into safety, no harm or a new established incidence rate. This records needed materials; no new research was executed. - Conditions for verification: Material for Potential harms, collection methods, denominators and specific risk groups must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Potential harms, collection methods, denominators and specific risk groups with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01, R02 ### N26 · Which new materials would prompt an update to this table? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread - Current findings: This table transfers the stored MRI liver-fat summary. Related observations can be updated after review of original tables, actual test measures/units, direct imaging, histology, clinical endpoints, between-group effects, denominators, concurrent exposures and harms. - Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification. - Reason for missing information: The complete pre-change original, original materials, condition versions, separate application and change-decision records are needed. No new clinical research, calculation, regrading, independence certification, intake, diet, liver-disease-management or treatment-replacement advice is created. - Required materials and conditions: Separate records for original materials, conditions, observations and verdict changes - Materials to obtain first: The complete pre-change original, original materials, condition versions, separate application and change-decision records are needed. No new clinical research, calculation, regrading, independence certification, intake, diet, liver-disease-management or treatment-replacement advice is created. - Further research: Material needed: The complete pre-change original, original materials, condition versions, separate application and change-decision records are needed. No new clinical research, calculation, regrading, independence certification, intake, diet, liver-disease-management or treatment-replacement advice is created. This records needed materials; no new research was executed. - Conditions for verification: Material for Separate records for original materials, conditions, observations and verdict changes must be linked to the selected subclaim, parent context, original report, direct endpoints, time points, comparator and denominators, with unread external material distinguished. - Why this condition is needed: This condition connects Separate records for original materials, conditions, observations and verdict changes with the selected question, actual population/intervention/comparator, tests/imaging/histology/clinical outcomes, time points, within- and between-group comparisons, denominators and harms. - Application exceptions: Only original numbers are preserved. Distinguish actual ALT/AST/FibroScan measures, MRI/MRS/other imaging/histology/clinical liver disease, population, intervention, comparator, common advice, denominators, within- and between-group comparisons, duration, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, psyllium/product intake, diets, liver-disease management or treatment-replacement advice is created. - Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification. - Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced. - Related sources: R01, R02 ## Evidence and sources ### R01 Akbarzadeh Z, Nourian M, Askari G, Maracy MR, Amani R. Benefit of Psyllium with Weight Loss Diet in Preventing Liver Dysfunction in Overweight or Obese Adults with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD). Int J Prev Med. 2026;17:46. PMID: 42621560. PMCID: PMC13489564. DOI: 10.4103/ijpvm.ijpvm_254_24. [PubMed](https://pubmed.ncbi.nlm.nih.gov/42621560/) Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread Findings recorded in the summary: ALT P=.006, FibroScan score P=.001; AST P=.98 Record level: Corresponding efficacy summary in the evidence record; directness for MRI/other endpoints is distinguished by condition rows and report roles. Independent replication: The Akbarzadeh2026 report concerns ten-week add-on psyllium ALT/FibroScan signals, null AST and gaps in effect size and endpoint hierarchy; MRI was not directly measured. The Akbarian2016 citation provides supporting harm/withdrawal information from a separate NAFLD seed-intervention/anthropometric study; it is not replication of current ALT/FibroScan/MRI efficacy. Parent2985 and both existing subclaims share these citations. Tables or tests, conditions and time points from the same participants are not added as new independent trials or people. Different citations do not certify unique trials or independence; unique-trial and total unique-participant counts remain unverified. Links are provisional by citation and actual cohort/independent-study relationships remain unreviewed. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Local preserved copy of the complete parent summary | Stored summary read | Summary read | Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred. | | External abstract | Original citation links or required-material slots; external public/access status unverified | Unread; access not attempted | Not read | Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred. | | External full text | Original citation links or required-material slots; external public/access status unverified | Unread; access not attempted | Not read | Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred. | | Original registration | Original citation links or required-material slots; external public/access status unverified | Unread; access not attempted | Not read | Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred. | | Original protocol | Original citation links or required-material slots; external public/access status unverified | Unread; access not attempted | Not read | Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred. | ### R02 Akbarian SA, Asgary S, Feizi A, Iraj B, Askari G. Comparative Study on the Effect of Plantago psyllium and Ocimum basilicum Seeds on Anthropometric Measures in Nonalcoholic Fatty Liver Patients. Int J Prev Med. 2016;7:114. PMID: 27761216. PMCID: PMC5070040. DOI: 10.4103/2008-7802.191865. [PubMed](https://pubmed.ncbi.nlm.nih.gov/27761216/) Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread Findings recorded in the summary: Some participants withdrew because of constipation, nausea or abdominal pain in a separate NAFLD seed-intervention trial. Record level: Supporting safety citation; exact groups, formulations, counts, effects and harm denominators are unverified. Independent replication: The Akbarzadeh2026 report concerns ten-week add-on psyllium ALT/FibroScan signals, null AST and gaps in effect size and endpoint hierarchy; MRI was not directly measured. The Akbarian2016 citation provides supporting harm/withdrawal information from a separate NAFLD seed-intervention/anthropometric study; it is not replication of current ALT/FibroScan/MRI efficacy. Parent2985 and both existing subclaims share these citations. Tables or tests, conditions and time points from the same participants are not added as new independent trials or people. Different citations do not certify unique trials or independence; unique-trial and total unique-participant counts remain unverified. Links are provisional by citation and actual cohort/independent-study relationships remain unreviewed. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Local preserved copy of the complete parent summary | Stored summary read | Summary read | Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred. | | External abstract | Original citation links or required-material slots; external public/access status unverified | Unread; access not attempted | Not read | Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred. | | External full text | Original citation links or required-material slots; external public/access status unverified | Unread; access not attempted | Not read | Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred. | | Original registration | Original citation links or required-material slots; external public/access status unverified | Unread; access not attempted | Not read | Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred. | | Original protocol | Original citation links or required-material slots; external public/access status unverified | Unread; access not attempted | Not read | Only original PubMed links, PMCIDs and absent/unverified registration information are preserved. No new reading, access, prespecification or verification is certified. Full-text or registration URLs are not inferred. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. ## What the statuses mean - Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy. - Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety - Review incomplete: Review of existing content incomplete - Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation - Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings - Inaccessible: Not applied during this preparation because actual access was not tested - Not applicable: Use with a reason for non-applicability based on an explicit question boundary - Conflicting data: Judge after actual material comparison; review was not performed during this preparation - Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials ## Change history 2026-10-16 · Public page/materials 1.0. The reader view and materials were prepared from the existing 26 items. No new clinical search, verification-status changes or scoring were performed.