Oral thiamine hydrochloride (vitamin B1) × Reduction of persistent fatigue in quiescent inflammatory bowel disease

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Crossover comparison of IBD-F fatigueWhich population, intervention, comparator, duration and endpoint define this independent comparison?Required	The selected original claim concerns reduction of persistent fatigue in quiescent inflammatory bowel disease. It is limited to an IBD-F comparison of single-ingredient oral thiamine hydrochloride and placebo within the same crossover trial. S04 S05	The boundaries of the current independent comparison are verified. This does not establish the clinical magnitude or long-term persistence of fatigue reduction.	Materials linking the current claim to the actual population, intervention, comparator, time point and IBD-F outcome	Compare the question elements in the manuscript and trial materials; separate a changed scope into an independent question and record the reason for the change.
2	Met	Full text not readStored summary read	N02 · Crossover comparison of IBD-F fatigueWas the actual intervention ingredient and salt form thiamine hydrochloride?Required	The stored structure and the same-TARIF report S05 identify the actual intervention as thiamine hydrochloride. This was not a B2 supplementation trial. S04 S05	The narrow identity of the ingredient and salt is verified. This does not include the detailed dosage form or manufacturing batch.	Trial methods and product identity records specifying the intervention ingredient and salt form	Compare the trial intervention label with the actual product label to establish differences between salt mass and active amount.
3	Partly verified	Full text not readStored summary read	N03 · Crossover comparison of IBD-F fatigueAre the actual product's dosage form, manufacturer, batch and production origin verified?Required	Single-ingredient oral thiamine hydrochloride is identified, but the detailed dosage form, manufacturer and synthetic, fermentation or other production origin are unverified. Plant-part classification does not apply to this chemical intervention. S05	The ingredient and single-ingredient oral intervention are known, but detailed product identity and production origin remain incomplete.	Trial product specifications, manufacturer and batch records, and salt and active-amount labeling	Compare product specifications with the trial methods and separate results for different dosage forms or production origins.
4	Met	Full text not readStored summary read	N04 · Crossover comparison of IBD-F fatigueWas the actual population selected adults with quiescent IBD and persistent fatigue?Required	The stored manuscript concerns adults with quiescent IBD and persistent fatigue after other explanations were excluded. It was not a trial of general vitality or all fatigue disorders. S04 S05	This narrow population condition is stated. It does not mean that unverified diagnostic details or effects in other populations have been established.	Eligibility and exclusion materials covering diagnosis, remission, persistent fatigue and exclusion of alternative causes	Review trial eligibility criteria and the fatigue-assessment pathway to compare included and excluded populations.
5	Unverified	Full text not readStored summary read	N05 · Crossover comparison of IBD-F fatigueAre baseline B1 status and effects within deficiency subgroups verified?Supplementary; required for claims about deficiency subgroups	The selected scope of quiescent IBD after exclusion of other fatigue explanations is known, but effects across all B1-deficiency subgroups are unverified. The structured baseline-status value is empty. S05	The currently stored scope lacks materials verifying deficiency definitions, measurements and subgroup effects.	Baseline B1 measurements, deficiency definitions, subgroup plans and subgroup comparison results	Compare measurements and interaction analyses for prespecified deficiency subgroups, keeping them distinct from the overall effect.
6	Partly verified	Full text not readStored summary read	N06 · Crossover comparison of IBD-F fatigueAre the actual doses and dosing frequency specified by sex and weight?Required	S04 records a research regimen of 600–1800 mg/day according to sex and weight. The thresholds, actual participant-level doses and dosing frequency are not specified in the currently stored materials. S04	The research range and dose-allocation criteria are known, but the actual intervention within each stratum is not fully verified.	Dose schedules by sex and weight, dosing frequency, tablet counts and actual exposure records	Compare dose-allocation schedules with actual dosing records; examine dose effects separately using direct comparisons.
7	Met	Full text not readStored summary read	N07 · Crossover comparison of IBD-F fatigueWas the actual administration route oral?Required	The stored study information and linked records in S04 and S05 identify the actual administration route as oral. S04 S05	The actual oral study route is verified. Equivalence of detailed dosage forms and bioavailability is a separate question.	The actual administration route specified in the trial methods	Compare the claimed route with the actual route in the study methods and separate other routes.
8	Met	Full text not readStored summary read	N08 · Crossover comparison of IBD-F fatigueIs the planned sequence of active treatment, washout and alternate treatment periods verified?Required	The stored citation for S04 specifies 4 weeks of treatment, a 4-week washout and then 4 weeks of the alternate treatment. The main question concerns a 4-week active period. S04	The narrow planned duration can be verified. Actual completion by sequence and carryover are addressed separately in N12 and N13.	The protocol and trial methods specifying crossover sequences and each treatment and washout period	Compare the planned periods with actual visit and treatment schedules, linking effects to each period.
9	Partly verified	Full text not readStored summary read	N09 · Crossover comparison of IBD-F fatigueAre the actual placebo composition and period-specific differences in concomitant and background treatment verified?Required	An oral placebo comparison within the same crossover trial is verified. Total dietary intake, all supplement exposure and arm-level details of concomitant vitamins are unverified. S04	The comparator type is known, but the actual placebo composition and all shared or concomitant interventions are not verified.	Placebo specifications and records of background treatment, concomitant vitamins, diet and changes by period	Compare placebo and background-treatment records by period and sequence, analyzing them alongside differences in the selected intervention.
10	Partly verified	Full text not readStored summary read	N10 · Crossover comparison of IBD-F fatigueAre the actual methods of crossover randomization, concealment and blinding verified?Required	S04 is described as a randomized double-blind placebo-controlled crossover trial. The current summary cannot verify implementation details of sequence generation, allocation concealment or blinding. S04	The design label is verified, but the actual conduct of allocation and blinding has not been fully checked.	Trial methods covering sequence generation, allocation concealment, blinding and baseline balance	Compare sequence generation, allocation and blinding by outcome in the original methods section, distinguishing unverified information from verified problems.
11	Partly verified	Full text not readStored summary read	N11 · Crossover comparison of IBD-F fatigueAre enrollment and the actual analysis denominator for the IBD-F crossover comparison separately identified and verified?Required	S04 records 40 enrolled participants, but the effective denominator for the crossover analysis is unverified. The analysis-denominator value and its linked source list are empty. S04	Only enrollment is verified; the actual analysis denominator for the selected outcome is not established.	Participant flow, numbers measured and completing each period, and the paired IBD-F analysis denominator	Compare participant flow and analysis populations by period and sequence to verify the actual endpoint denominator.
12	Unverified	Full text not readStored summary read	N12 · Crossover comparison of IBD-F fatigueAre period-specific adherence, withdrawals, missing data and analysis handling verified?Required	The current manuscript states that effective analysis numbers were not fully verified. The stored summary does not specify period-specific adherence, withdrawals, missing data or actual analysis handling. S04	Materials on losses, deviations and analysis handling for the selected crossover comparison have not been obtained.	Records of adherence, withdrawals, reasons for missing data, actual analysis populations and handling by period and sequence	Compare period-specific measurement losses and treatment deviations with the analysis plan and examine the implications of handling assumptions.
13	Unverified	Full text not readStored summary read	N13 · Crossover comparison of IBD-F fatigueIs a crossover model addressing sequence, period and carryover effects verified?Required	A 4-week washout is planned, but the formal crossover model is unverified. How sequence, period and carryover effects were examined and handled cannot be established. S04	The currently stored scope lacks actual specifications of the model and carryover handling required for this crossover design.	Crossover sequence data, checks for period and carryover effects, and statistical model specifications	Compare the handling of period, sequence and carryover effects with the selected estimand in the original statistical section.
14	Partly verified	Full text not readStored summary read	N14 · Crossover comparison of IBD-F fatigueAre the IBD-F version, scale direction, assessment times and measurement conditions verified?Required	The selected endpoint is improvement in patient-reported IBD-F fatigue, and the directions of mean reduction and placebo increase are retained. The scale version, scoring range and detailed assessment schedule are unverified. S04	The endpoint and direction are known, but the complete measurement conditions are not verified.	Materials on the IBD-F version, scoring, assessment times, collection procedures and measurement conditions	Review how the scale and assessment schedule were actually used and connect measurement differences or unverified details to the outcome.
15	Met	Full text not readStored summary read	N15 · Crossover comparison of IBD-F fatigueDoes the paper identify IBD-F improvement as its primary endpoint?Required	The primary-endpoint classification value is empty, but its description explicitly confirms IBD-F improvement as the paper-stated primary endpoint. S04	This narrow attribution to the paper-stated primary endpoint is verified. Concordance with the registry or analysis plan was not verified.	Materials linking the paper-defined primary endpoint to the page endpoint	Compare the paper-stated primary-endpoint definition with the page outcome, keeping this distinct from comparison against the registry and plans.
16	Unverified	Full text not readStored summary read	N16 · Crossover comparison of IBD-F fatigueDo endpoints, time points and analyses agree across registration, protocol, analysis plan and results?Required	S04 has the identifier NCT03634735, but the registered-primary-endpoint value is empty and independent registry-to-primary-endpoint concordance is unverified. The actual registration record was not read in this work. S04	The identifier and paper-stated primary-endpoint description alone cannot establish concordance with registration and plans.	The actual registration versions, protocol, analysis plan and results report for NCT03634735	Compare registration-version timing, endpoints and analyses with the paper to identify prespecified plans and changes.
17	Met	Full text not readStored summary read	N17 · Crossover comparison of IBD-F fatigueAre the units, directions and treatment attribution of the reported mean changes verified?Required	The stored S04 result records a mean fatigue reduction of 4.5 points on thiamine and an increase of 0.75 points on placebo. These are treatment-specific mean changes, not an interval for a formal adjusted contrast. S04	The directions, units and attribution of the two descriptive values are stated in the current manuscript. The external original table was not independently verified in this work.	Original results containing treatment-specific IBD-F mean changes, units and directions	Compare directions, changes, units and time points in the results table, reporting them separately from adjusted estimates.
18	Unverified	Full text not readStored summary read	N18 · Crossover comparison of IBD-F fatigueAre the actual effect of interest and adjusted crossover estimate verified?Required	The current manuscript states that the adjusted crossover effect was not fully verified. The retained arithmetic value of −5.25 points is not an adjusted treatment estimate. S04	Statistical materials verifying the formal analysis population and adjusted treatment contrast have not been obtained.	Analysis population, effect of interest, adjusted model specifications and the formal treatment-contrast estimate	Compare the actual effect of interest in the statistical section and results, distinguishing descriptive changes from model estimates.
19	Unverified	Full text not readStored summary read	N19 · Crossover comparison of IBD-F fatigueAre paired dispersion, SD/SE and actual analysis numbers for the selected contrast verified?Required	The manuscript records that paired dispersion and effective analysis numbers were not fully verified. Its attempt to use means, standard deviations and analysis numbers lacked complete verified inputs, so no assumed SD or analysis population size was used. S04	Paired dispersion and the actual denominator for the selected crossover contrast were not verified.	Variance of paired differences, SD/SE, analysis numbers and original analysis specifications	Compare the original tables and model to establish which contrast and analysis population produced the dispersion estimate.
20	Unverified	Full text not readStored summary read	N20 · Crossover comparison of IBD-F fatigueAre the confidence interval and precision of the formal treatment contrast verified?Required	The effect interval for the actual paired treatment contrast is unverified. The reported mean changes and arithmetic difference of −5.25 points are not described as its confidence interval. S04	Without a verified formal contrast interval, precision and the range of clinically possible effects cannot be assessed.	The CI for the formal crossover effect, estimation method, units and connection to the model	After verifying the original interval, examine the range of compatible effects and distinguish its relationship to an importance threshold.
21	Met	Full text not readStored summary read	N21 · Crossover comparison of IBD-F fatigueIs −5.25 points attributed only to the retained descriptive arithmetic?Required	The retained arithmetic record preserves −5.25 points as a string with the direction of fatigue change aligned, explicitly identifying it as descriptive arithmetic rather than an adjusted crossover effect. The correction history records removal of assumption-dependent standardized effect sizes. S04	The narrow attribution and purpose of this retained value are stated. Arithmetic verification was not repeated as a new clinical effect calculation.	Materials linking the retained arithmetic record, its purpose and the correction history	Compare the value, units and purpose of the existing record with the original result, displaying it separately from the formal estimand.
22	Met	Full text not readStored summary read	N22 · Crossover comparison of IBD-F fatigueIs the within-person 3-point improvement threshold identified as an individual response criterion?Required	The stored Korean manuscript explicitly states that the within-person 3-point improvement threshold was not used as a between-group MCID. Interpretation of the response criterion is separated from that of between-group change. S04	Its application to an individual response is verified. Actual responder numbers, proportions and the between-group MCID were not verified.	Materials defining the individual response threshold, its unit of application and its distinction from between-group importance	Compare the response definition and its target of application, examining continuous changes, response rates and between-group thresholds separately.
23	Unverified	Full text not readStored summary read	N23 · Crossover comparison of IBD-F fatigueIs a validated between-group MCID applicable to this IBD-F crossover comparison verified?Required for interpretation of clinical importance	The original unresolved-information record states that a validated between-group MCID in this setting is unverified. It is not replaced with the within-person 3-point improvement threshold. S04	Materials verifying an importance threshold appropriate to the between-group comparison are unavailable.	Evidence for an MCID applicable to this population, IBD-F version and between-group contrast	Compare the validation population, scale and unit of application of the importance threshold, examining it alongside the formal effect interval.
24	Met	Full text not readStored summary read	N24 · Crossover comparison of IBD-F fatigueDo S04, S05 and S06 belong to the same TARIF trial family?Required	S04, S05 and S06 all have the study identifier TARIF-NCT03634735. They are recorded respectively as the direct crossover trial, vitamer support from the same trial, and a follow-up contextual report from the same family. S04 S05 S06	The shared family identity and each report's role are verified in the currently stored materials. No new count of independent replications or unique total participants is calculated.	Trial identifiers and materials linking each report's recruitment, endpoints, time points and analyses	Link reports by registration, cohort, endpoint and time point to distinguish shared participants from independent recruitment.
25	Partly verified	Full text not readStored summary read	N25 · Crossover comparison of IBD-F fatigueAre the follow-up report's actual dose, duration, design and results verified?Supplementary; required for claims about persistence or follow-up effects	S06 retains only its role as a report with different dosing, duration and observational design within the same family. Earlier bibliography and access records are reused; no new effect values are adopted. S06	The family and the difference in follow-up context are known, but specific doses, duration, denominators and effects are unverified.	Original materials on the actual methods, denominators, dose, duration and results of the S06 follow-up report	Compare exposure, design and follow-up with the main crossover trial, distinguishing persistence of effect from observational context.
26	Met	Full text not readStored summary read	N26 · Crossover comparison of IBD-F fatigueDo the populations and interventions in S07 and S08 differ from the selected direct comparison?Required	S07 concerns fatigue in primary biliary cholangitis; S08 uses B1, B6, B12 and magnesium in combination. Neither is attributed as independent replication of an isolated B1 or B2 supplementation comparison in IBD. S07 S08	The population and intervention differences and their exclusion roles are stated in the current materials. No positive, non-significant or harm values absent from this manuscript are invented.	Materials linking other reports' populations and intervention composition to eligibility for the original question	Compare disease, ingredients, comparators and endpoints to assess direct comparability, preserving findings on other questions in their respective roles.
27	Partly verified	Full text not readStored summary read	N27 · Crossover comparison of IBD-F fatigueAre public or nonprofit funding, funder roles, product provision and author relationships actually verified?Supplementary; required for independence claims	S04 records verification of disclosed public or nonprofit support. The English assessment identifies public or nonprofit foundations and records that no funder role was reported. The stored summary lacks full details of funding lists, product provision and author disclosures. S04	Funding type was historically verified, but the current materials cannot fully check actual support, product provision and author relationships.	Original disclosures of funding sources, product provision, funder roles and author conflicts of interest	Compare disclosures with support documents to distinguish verified funding and roles from unverified conflicts.
28	Partly verified	Full text not readStored summary read	N28 · Crossover comparison of IBD-F fatigueAre materials available to reproduce the historical search, selection and correction-check scope for the exact question?Required	The fixed-question record that an eligible human result was identified and the search cutoff of 2026-09-15 are retained. The original historical search record was not read in this work, and the manuscript states that not every native database worldwide was searched exhaustively.	The cutoff and limited verification scope are known, but the complete actual search and selection records were not reproduced and checked.	Historical search and selection logs, the scope of checks for registrations, unpublished evidence and corrections, and date records	Within an authorized follow-up scope, review search and selection records to reproduce coverage of omissions and corrections, distinguishing the evidence cutoff.
29	Unverified	Full text not readStored summary read	N29 · Crossover comparison of IBD-F fatigueAre persistence of fatigue improvement and effects after stopping treatment beyond 4 weeks directly verified?Supplementary; required for claims of sustained effects	The main trial's active treatment lasted 4 weeks. S06 is a follow-up contextual report, but no new effect estimate is adopted and long-term persistence is not established. S04 S06	Materials verifying long-term or post-treatment comparative results and denominators for this question are unavailable.	Comparative results after treatment stops or during long-term follow-up, actual exposure and IBD-F analysis denominators	Link follow-up times with actual exposure and comparators, examining short-term findings separately from sustained effects.
30	Unverified	Full text not readStored summary read	N30 · Crossover comparison of IBD-F fatigueAre direct dose comparisons, an optimal dose and effects by sex and weight verified?Supplementary; required for claims about dose or effect modification	The research allocation of 600–1800 mg/day according to sex and weight is known, but the current manuscript has no verified values for direct dose comparisons, an optimal dose or effects by sex and weight. S04	Dose-allocation information alone cannot verify effect modification or an optimal dose.	Prespecified dose and subgroup plans, direct comparisons, interaction results and denominators	Distinguish dose allocation from effect comparison and check direct estimates and interactions for prespecified subgroups.
31	Met	Full text not readStored summary read	N31 · Crossover comparison of IBD-F fatigueAre vitamer analyses distinguished from patient fatigue and clinical-event outcomes?Required for outcome attribution	The B2-related vitamer analysis in S05 is an observational secondary analysis from the same TARIF family receiving a B1 intervention. The selected question concerns patient symptoms and function rather than circulating vitamers and does not answer prevention of clinical events. S05	The actual intervention, analysis and endpoint categories are distinguished. This does not establish mechanistic causation or prevention of events.	Materials linking vitamer analyses, actual interventions, patient fatigue and separate clinical-event outcomes	Compare the intervention and measurement targets, separating vitamer associations, symptom changes and event prevention into independent questions.
32	Partly verified	Full text not readStored summary read	N32 · Crossover comparison of IBD-F fatigueAre adverse-event collection methods, event and participant counts by arm, and discontinuations verified?Supplementary; required for comparative harms and safety	The historically accessed abstract is recorded as reporting only mild side effects. Arm-level event counts and long-term safety are unverified, and the structured adverse-event value is empty. S04	There is a historical description of mild side effects, but actual collection systems, denominators, discontinuations and comparative risks are unverified.	Adverse-event definitions, collection, event and participant counts by arm or period, exposure denominators and discontinuations	Compare harm collection with actual exposure, distinguishing event counts, participant counts, comparative risks and reporting limitations.
33	Unverified	Full text not readStored summary read	N33 · Crossover comparison of IBD-F fatigueAre actual materials investigating drug interactions and assay interference verified?Supplementary; required for interaction claims and interpretation of assays	Drug-interaction and assay-interference values are empty, and no separate search is recorded. No separate comprehensive search was performed; this does not mean there is no effect.	Actual investigative materials for this separate question are currently unverified.	Evidence on interactions and interference for each concomitant medication and assay, with records of verification scope	Compare evidence appropriate to concomitant exposure and assay methods separately, distinguishing absence of investigation from absence of effects.
34	Unverified	Full text not readStored summary read	N34 · Crossover comparison of IBD-F fatigueIs direct evidence available for pregnancy, children, active IBD or other fatigue disorders?Supplementary; required for population and safety extensions	The original safety explanation explicitly avoids direct application to pregnancy, children, acute exacerbation or other diseases, and does not present a high-dose study as a self-dosing instruction. Direct evidence for these groups is currently unverified. S04	Direct efficacy and harm evidence outside the selected quiescent-IBD population was not verified.	Actual diagnosis, exposure, comparator, fatigue, harm and follow-up materials for each population extension	Define each population as an independent question and review eligibility of direct evidence and limits of applicability and harm assessment.
35	Met	Full text not readStored summary read	N35 · Crossover comparison of IBD-F fatigueAre the stored summaries read in this work distinguished from external materials and historical access levels?Required for reading records	The complete Korean and English text, structure, 5 evidence records and 5 citations in the currently stored summary were read. S04 historically had publisher-abstract and funding access; S05, S07 and S08 had HTML full-text access; S06 had a provided-abstract-extraction record. External materials were neither accessed nor read in this work. S04 S05 S06 S07 S08	The recording condition separating current local-summary review from material-specific historical access is met. This is not current verification of full clinical papers.	Records of each material's existence, access, acquisition and reading status, with exact source locations and hashes	Compare material types with actual action receipts, distinguishing a summary reader from the reading status of an external link.
36	Met	Full text not readStored summary read	N36 · Crossover comparison of IBD-F fatigueAre the evidence cutoff, material-specific access dates, review dates, original judgment and correction history distinguished?Required for version and date attribution	The revision-policy search cutoff and original review date are 2026-09-15. Citations lack material-specific access-date fields, so historical access dates remain empty. Original C50, B/P/R1/I2/EX/B2/CX and the two corrections are retained as historical values.	This narrow record of dates, original values and version attribution is linked to actual fields and hashes. It is not a new clinical grade or official methodological certification.	The current manuscript, versions, dates, original judgment, corrections, revision records and input hashes	Compare actual version and date fields; after a change, preserve the complete earlier version, reasons and separate freezing and application of new conditions.

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36 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence date: 2026-09-15
Scope actually checked: Stored Korean and English manuscript summaries, case-specific conditions and application records, and stored methodological principles. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The date retained material was checked, not the date of a latest clinical-literature search.
Population: Adults with quiescent IBD and persistent fatigue after alternative explanations were excluded; not general wellness or all fatigue disorders
Ingredient, formulation and route: Oral thiamine hydrochloride (vitamin B1)
Dose: 600–1800 mg/day according to sex and weight; research regimen
Comparator: Oral placebo within the same crossover trial
Measured outcome: Improvement in IBD-F fatigue; distinguish individual response threshold from treatment contrast
Duration: 4 weeks of active treatment; crossover design with 4-week washout
Questions outside this scope: Do not extend this to general vitality, all fatigue, B2 supplementation, attribution to a single ingredient in a combination, prevention of clinical events, general deficiency treatment, sustained long-term effects, an optimal dose or personal dosing instructions.

Evidence and sources

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

S04 · Bager et al. — oral thiamine and fatigue in quiescent IBD (2021)

Official source

Material type: Publisher article abstract and funding-information page (historical access)
Materials actually read: Stored manuscript summaries and condition-application records were read. External abstracts, full papers, registrations and analysis plans were not attempted, acquired or read in this work.
Findings recorded in the stored summary: Recorded at preservation: TARIF was a randomized double-blind placebo-controlled crossover trial with 40 enrolled participants; the actual paired IBD-F analysis denominator is unverified. Thiamine 600–1800 mg/day was allocated by sex and weight for 4 weeks, followed by a 4-week washout and 4 weeks of the alternate intervention. A mean fatigue reduction of 4.5 points versus a placebo increase of 0.75 points is recorded; the retained −5.25 points is descriptive arithmetic, not an adjusted crossover effect or CI. The within-person 3-point improvement threshold is distinguished from a between-group MCID. Public or nonprofit support was historically verified, but the complete statistical section and supplement were not obtained at that time.
Record level: The original review's summary and attribution are retained. This is not new reading or regrading of external clinical originals.
Study overlap and independent replication: This is a direct report from the same TARIF trial. Other reports from the same family are not summed as independent replications.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary of bibliography, evidence and manuscript	Stored material	Stored summary accessed and read	Stored summary read	This is the stored summary read in this work. It does not inherit the external paper's full-text reading record.
Publisher article abstract and funding-information page (historical access)	Current public availability unverified	External access not attempted in this work	Not read in this work	Historical recorded access level: publisher abstract and funding information. Material-specific access dates are unverified; external access, acquisition and reading were not performed in this work.

S05 · B-vitamins and metabolites in quiescent IBD with fatigue treated with oral thiamine (2023)

Official source

Material type: Original article HTML full text (historical access)
Materials actually read: Stored manuscript summaries and condition-application records were read. External abstracts, full papers, registrations and analysis plans were not attempted, acquired or read in this work.
Findings recorded in the stored summary: Recorded at preservation: the actual trial intervention was oral thiamine hydrochloride. B2-related vitamer analyses were observational secondary analyses in the same TARIF family, not a B2 supplementation trial or independent replication. The actual denominator for the relevant result is not specified as verified in this manuscript, and historical numerical records were not read in this work.
Record level: The original review's summary and attribution are retained. This is not new reading or regrading of external clinical originals.
Study overlap and independent replication: This is a secondary vitamer analysis from the same TARIF trial family, not independent replication.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary of bibliography, evidence and manuscript	Stored material	Stored summary accessed and read	Stored summary read	This is the stored summary read in this work. It does not inherit the external paper's full-text reading record.
Original article HTML full text (historical access)	Current public availability unverified	External access not attempted in this work	Not read in this work	Historical recorded access level: article HTML full text. Material-specific access dates are unverified; external access, acquisition and reading were not performed in this work.

S06 · Thiamine follow-up in patients with quiescent IBD and fatigue

Official source

Material type: PubMed bibliography and abstract index; record of provided abstract extraction (historical reuse)
Materials actually read: Stored manuscript summaries and condition-application records were read. External abstracts, full papers, registrations and analysis plans were not attempted, acquired or read in this work.
Findings recorded in the stored summary: Recorded at preservation: follow-up context concerns different doses, durations and observational designs within the same TARIF family. Only prior bibliography and access records are reused; this does not verify new effect values in the current work. Actual follow-up doses, durations and denominators are not specified in the current manuscript.
Record level: The original review's summary and attribution are retained. This is not new reading or regrading of external clinical originals.
Study overlap and independent replication: This is a follow-up contextual report from the same TARIF trial family, not independent replication.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary of bibliography, evidence and manuscript	Stored material	Stored summary accessed and read	Stored summary read	This is the stored summary read in this work. It does not inherit the external paper's full-text reading record.
PubMed bibliography and abstract index; record of provided abstract extraction (historical reuse)	Current public availability unverified	External access not attempted in this work	Not read in this work	This records a historically provided abstract extraction. The actual historical access level of the PubMed page itself and material-specific access dates are unverified. External access, acquisition and reading were not performed in this work.

S07 · High-dose oral thiamine and fatigue in primary biliary cholangitis (2024)

Official source

Material type: Original article HTML full text (historical access)
Materials actually read: Stored manuscript summaries and condition-application records were read. External abstracts, full papers, registrations and analysis plans were not attempted, acquired or read in this work.
Findings recorded in the stored summary: Recorded at preservation: this fatigue trial concerned primary biliary cholangitis, a disease distinct from IBD. It was not counted as independent replication or repeated refutation of single-ingredient B1 for IBD fatigue. No detailed effect values or actual analysis denominators were newly adopted in this manuscript.
Record level: The original review's summary and attribution are retained. This is not new reading or regrading of external clinical originals.
Study overlap and independent replication: The population has a different disease, so this is not counted as independent replication or repeated refutation for the selected IBD-fatigue question.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary of bibliography, evidence and manuscript	Stored material	Stored summary accessed and read	Stored summary read	This is the stored summary read in this work. It does not inherit the external paper's full-text reading record.
Original article HTML full text (historical access)	Current public availability unverified	External access not attempted in this work	Not read in this work	Historical recorded access level: article HTML full text. Material-specific access dates are unverified; external access, acquisition and reading were not performed in this work.

S08 · Vitamin B complex plus magnesium and fatigue in IBD (2026)

Official source

Material type: Original article HTML full text (historical access)
Materials actually read: Stored manuscript summaries and condition-application records were read. External abstracts, full papers, registrations and analysis plans were not attempted, acquired or read in this work.
Findings recorded in the stored summary: Recorded at preservation: the IBD-fatigue intervention combined B1, B6, B12 and magnesium. Its findings were not attributed to B2 or isolated B1, or counted as independent replication of a single-ingredient thiamine-hydrochloride comparison. Detailed doses, results and denominators are not specified as verified in this manuscript.
Record level: The original review's summary and attribution are retained. This is not new reading or regrading of external clinical originals.
Study overlap and independent replication: As a combination intervention, this is not included as independent replication of an isolated B1 effect.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary of bibliography, evidence and manuscript	Stored material	Stored summary accessed and read	Stored summary read	This is the stored summary read in this work. It does not inherit the external paper's full-text reading record.
Original article HTML full text (historical access)	Current public availability unverified	External access not attempted in this work	Not read in this work	Historical recorded access level: article HTML full text. Material-specific access dates are unverified; external access, acquisition and reading were not performed in this work.

Report counts versus independent study counts

S04, S05 and S06 report direct results, a secondary vitamer analysis and follow-up context from the same TARIF trial family. Report counts are not summed as independent replications or unique participants. S07 concerns primary biliary cholangitis, a different population; S08 is a combination intervention. Detailed participant overlap and the total unique participant count are unverified.

Review criteria

Version NGM-v3086-TARIF-IBDF-CROSSOVER-1.0 · Criteria record date 2026-10-05. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which population, intervention, comparator, duration and endpoint define this independent comparison?

Required materials and conditions: Materials linking the current claim to the actual population, intervention, comparator, time point and IBD-F outcome
Conditions for verification: The source specifies a comparison of single-ingredient oral thiamine hydrochloride versus placebo for IBD-F over a 4-week active period in adults with quiescent IBD and persistent fatigue.
Requirement and applicability: Required
Application exceptions: The Korean and English versions concern the same claim. Do not create new subclaims from the currently empty list of subclaims.
Why this condition is needed: Needed to keep patient-reported fatigue in quiescent IBD distinct from general vitality or treatment of deficiency.
Referenced methods: C01: M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are this case’s own design / C04: M03 §3.2.1; detailed population conditions are this case’s own design / C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design Adaptation to this IBD-F crossover question: Needed to keep patient-reported fatigue in quiescent IBD distinct from general vitality or treatment of deficiency. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N02 · Was the actual intervention ingredient and salt form thiamine hydrochloride?

Required materials and conditions: Trial methods and product identity records specifying the intervention ingredient and salt form
Conditions for verification: The actual trial ingredient is identified as thiamine hydrochloride and attributed to the oral B1 intervention.
Requirement and applicability: Required
Application exceptions: Do not arbitrarily convert the mass of thiamine hydrochloride into the mass of free thiamine.
Why this condition is needed: Needed to avoid treating other B1 derivatives or B2 vitamer analyses as the same administered ingredient.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid treating other B1 derivatives or B2 vitamer analyses as the same administered ingredient. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N03 · Are the actual product's dosage form, manufacturer, batch and production origin verified?

Required materials and conditions: Trial product specifications, manufacturer and batch records, and salt and active-amount labeling
Conditions for verification: The trial product's detailed dosage form, manufacturer, batch and production origin are specified in the materials.
Requirement and applicability: Required
Application exceptions: Non-applicability of plant-part classification to a chemical ingredient is distinct from unverified production origin, such as synthesis or fermentation.
Why this condition is needed: The same ingredient name alone does not establish that all marketed products match the trial product.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design Adaptation to this IBD-F crossover question: The same ingredient name alone does not establish that all marketed products match the trial product. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N04 · Was the actual population selected adults with quiescent IBD and persistent fatigue?

Required materials and conditions: Eligibility and exclusion materials covering diagnosis, remission, persistent fatigue and exclusion of alternative causes
Conditions for verification: The population is identified as adults with quiescent IBD and persistent fatigue after alternative explanations were excluded.
Requirement and applicability: Required
Application exceptions: Do not extend the term quiescent to equal effects across all IBD subtypes, active disease or ages.
Why this condition is needed: Needed to avoid transferring results directly to populations with different diseases or fatigue-selection criteria.
Referenced methods: C04: M03 §3.2.1; detailed population conditions are this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid transferring results directly to populations with different diseases or fatigue-selection criteria. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N05 · Are baseline B1 status and effects within deficiency subgroups verified?

Required materials and conditions: Baseline B1 measurements, deficiency definitions, subgroup plans and subgroup comparison results
Conditions for verification: Baseline B1 measurements, the deficiency definition and prespecified subgroup comparisons or interaction results are verified.
Requirement and applicability: Supplementary; required for claims about deficiency subgroups
Application exceptions: Even when the value is empty and its information state is recorded as confirmed, do not interpret this as confirmation of all deficiency measurements.
Why this condition is needed: Needed to avoid turning the average result in selected IBD fatigue into a general claim about correcting deficiency.
Referenced methods: C04: M03 §3.2.1; detailed population conditions are this case’s own design / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid turning the average result in selected IBD fatigue into a general claim about correcting deficiency. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N06 · Are the actual doses and dosing frequency specified by sex and weight?

Required materials and conditions: Dose schedules by sex and weight, dosing frequency, tablet counts and actual exposure records
Conditions for verification: The dose by sex and weight criteria, units, salt labeling and actual dosing frequency are specified.
Requirement and applicability: Required
Application exceptions: Do not present the range of 600–1800 mg/day as an optimal dose or an instruction for self-dosing.
Why this condition is needed: Needed to avoid turning the research dose range into a uniform dose for every participant or a recommended dose.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid turning the research dose range into a uniform dose for every participant or a recommended dose. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N07 · Was the actual administration route oral?

Required materials and conditions: The actual administration route specified in the trial methods
Conditions for verification: The actual TARIF intervention route is verified as oral.
Requirement and applicability: Required
Application exceptions: Do not turn verification of an oral route into equivalence with injections, other derivatives or other dosage forms.
Why this condition is needed: Needed to align the claimed route with the actual study route.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design Adaptation to this IBD-F crossover question: Needed to align the claimed route with the actual study route. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N08 · Is the planned sequence of active treatment, washout and alternate treatment periods verified?

Required materials and conditions: The protocol and trial methods specifying crossover sequences and each treatment and washout period
Conditions for verification: The source specifies a crossover plan of 4 weeks of active treatment, a 4-week washout and 4 weeks of the alternate treatment.
Requirement and applicability: Required
Application exceptions: A planned 4-week washout does not itself demonstrate absence of carryover or an adequate washout.
Why this condition is needed: Needed to avoid extending the 4-week active result to long-term observation or persistence after treatment stops.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / E01: M08 §8.1–8.2.3; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid extending the 4-week active result to long-term observation or persistence after treatment stops. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N09 · Are the actual placebo composition and period-specific differences in concomitant and background treatment verified?

Required materials and conditions: Placebo specifications and records of background treatment, concomitant vitamins, diet and changes by period
Conditions for verification: The oral placebo composition, concomitant vitamins, diet, IBD treatment by period and handling of changes are verified.
Requirement and applicability: Required
Application exceptions: Do not interpret the manuscript's single-ingredient B1 intervention as meaning there were no concomitant vitamins or medications.
Why this condition is needed: The label placebo-controlled alone does not establish that all differences in concomitant treatment, diet and therapy were controlled.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; this case’s own application Adaptation to this IBD-F crossover question: The label placebo-controlled alone does not establish that all differences in concomitant treatment, diet and therapy were controlled. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N10 · Are the actual methods of crossover randomization, concealment and blinding verified?

Required materials and conditions: Trial methods covering sequence generation, allocation concealment, blinding and baseline balance
Conditions for verification: The actual methods for generating and concealing crossover sequences and blinding participants and assessors are verified.
Requirement and applicability: Required
Application exceptions: Do not turn unverified methods into confirmed failure of allocation or blinding.
Why this condition is needed: The label randomized double-blind alone cannot establish absence of allocation or measurement bias.
Referenced methods: E01: M08 §8.1–8.2.3; this case’s own application / E03: M08 Table 8.2.a, M03 §3.2.4; this case’s own application Adaptation to this IBD-F crossover question: The label randomized double-blind alone cannot establish absence of allocation or measurement bias. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N11 · Are enrollment and the actual analysis denominator for the IBD-F crossover comparison separately identified and verified?

Required materials and conditions: Participant flow, numbers measured and completing each period, and the paired IBD-F analysis denominator
Conditions for verification: Enrollment, treatment and completion numbers and the actual paired IBD-F analysis denominator are verified and linked to each outcome.
Requirement and applicability: Required
Application exceptions: Do not sum crossover participants as independent groups.
Why this condition is needed: Needed to avoid substituting the 40 enrolled participants for the endpoint analysis population or the denominator of each independent arm.
Referenced methods: C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is this case’s own design / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid substituting the 40 enrolled participants for the endpoint analysis population or the denominator of each independent arm. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N12 · Are period-specific adherence, withdrawals, missing data and analysis handling verified?

Required materials and conditions: Records of adherence, withdrawals, reasons for missing data, actual analysis populations and handling by period and sequence
Conditions for verification: Adherence, losses and their reasons in each period and sequence, and ITT/PP or missing-data handling, are verified.
Requirement and applicability: Required
Application exceptions: Do not calculate withdrawal or missing-data rates from enrollment alone, or interpret unverified withdrawals as 0 withdrawals.
Why this condition is needed: Knowing enrollment does not establish how missing data and deviations from treatment affected the comparison.
Referenced methods: C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is this case’s own design / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; this case’s own application / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Knowing enrollment does not establish how missing data and deviations from treatment affected the comparison. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N13 · Is a crossover model addressing sequence, period and carryover effects verified?

Required materials and conditions: Crossover sequence data, checks for period and carryover effects, and statistical model specifications
Conditions for verification: Actual checks for sequence, period and carryover effects and their handling in the crossover model are verified.
Requirement and applicability: Required
Application exceptions: Do not assume that a 4-week washout eliminates carryover or treat the crossover design as inapplicable.
Why this condition is needed: Needed to avoid replacing self-controlled data with a comparison that ignores dependence and period effects.
Referenced methods: E01: M08 §8.1–8.2.3; this case’s own application / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid replacing self-controlled data with a comparison that ignores dependence and period effects. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N14 · Are the IBD-F version, scale direction, assessment times and measurement conditions verified?

Required materials and conditions: Materials on the IBD-F version, scoring, assessment times, collection procedures and measurement conditions
Conditions for verification: The IBD-F version, score direction, assessment times, collection procedures and blinding conditions are verified.
Requirement and applicability: Required
Application exceptions: Do not dismiss an outcome merely because it is patient-reported or use the double-blind label as complete verification of measurement.
Why this condition is needed: Needed to avoid replacing patient-reported fatigue changes with other functional, vitamer or clinical-event outcomes.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / E03: M08 Table 8.2.a, M03 §3.2.4; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid replacing patient-reported fatigue changes with other functional, vitamer or clinical-event outcomes. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N15 · Does the paper identify IBD-F improvement as its primary endpoint?

Required materials and conditions: Materials linking the paper-defined primary endpoint to the page endpoint
Conditions for verification: The manuscript explicitly records IBD-F improvement as the paper-stated primary endpoint.
Requirement and applicability: Required
Application exceptions: Do not interpret an empty value as absence of the paper-stated primary-endpoint description. Registry concordance is examined separately in N16.
Why this condition is needed: Needed to distinguish verification of the paper-stated primary endpoint from a separate registry comparison.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / E06: M08 Table 8.2.a, M04 §4.6.3; this case’s own application Adaptation to this IBD-F crossover question: Needed to distinguish verification of the paper-stated primary endpoint from a separate registry comparison. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N16 · Do endpoints, time points and analyses agree across registration, protocol, analysis plan and results?

Required materials and conditions: The actual registration versions, protocol, analysis plan and results report for NCT03634735
Conditions for verification: The original registration, protocol and analysis plan are compared with reported endpoints, time points, analyses and reasons for changes.
Requirement and applicability: Required
Application exceptions: Do not turn an unchecked registry comparison into confirmed non-registration or selective reporting.
Why this condition is needed: A registration identifier alone cannot establish concordance between prespecified plans and reporting.
Referenced methods: E06: M08 Table 8.2.a, M04 §4.6.3; this case’s own application / C09: M04 §4.5, §4.6.3; limits on converting the current materials follow the user’s scope and this case’s own design Adaptation to this IBD-F crossover question: A registration identifier alone cannot establish concordance between prespecified plans and reporting. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N17 · Are the units, directions and treatment attribution of the reported mean changes verified?

Required materials and conditions: Original results containing treatment-specific IBD-F mean changes, units and directions
Conditions for verification: A mean fatigue reduction of 4.5 points and placebo increase of 0.75 points are attributed to the respective treatment-specific IBD-F changes.
Requirement and applicability: Required
Application exceptions: Do not use descriptive mean changes as an adjusted crossover effect or confidence interval.
Why this condition is needed: Needed to avoid reversing symptom improvement and placebo worsening or interpreting changes as final scores.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separating verification states is this case’s own design / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid reversing symptom improvement and placebo worsening or interpreting changes as final scores. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N18 · Are the actual effect of interest and adjusted crossover estimate verified?

Required materials and conditions: Analysis population, effect of interest, adjusted model specifications and the formal treatment-contrast estimate
Conditions for verification: The actual analysis population, effect of interest, adjusted crossover model and estimate for the selected contrast are verified.
Requirement and applicability: Required
Application exceptions: Do not invent ITT, PP or adjusted models, or extend the manuscript's verification limits to a claim that the entire paper lacks data.
Why this condition is needed: Needed to avoid turning arithmetic on mean changes into an effect of assignment, an effect of adherence or an adjusted self-controlled contrast.
Referenced methods: E04: M08 §8.2.2, M15 §15.3.1; this case’s own application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid turning arithmetic on mean changes into an effect of assignment, an effect of adherence or an adjusted self-controlled contrast. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N19 · Are paired dispersion, SD/SE and actual analysis numbers for the selected contrast verified?

Required materials and conditions: Variance of paired differences, SD/SE, analysis numbers and original analysis specifications
Conditions for verification: Paired dispersion, SD/SE and the effective analysis denominator appropriate to the selected crossover contrast are verified together.
Requirement and applicability: Required
Application exceptions: Do not approximate Cohen d or SE using the 40 enrolled participants, P values or unverified SD.
Why this condition is needed: Needed to avoid ignoring within-participant crossover correlation or generating an effect size from assumed dispersion or denominators.
Referenced methods: C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is this case’s own design / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application / E05: M15 §15.3.1–15.3.3; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid ignoring within-participant crossover correlation or generating an effect size from assumed dispersion or denominators. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N20 · Are the confidence interval and precision of the formal treatment contrast verified?

Required materials and conditions: The CI for the formal crossover effect, estimation method, units and connection to the model
Conditions for verification: The confidence interval, units and model for the selected formal crossover treatment contrast are verified.
Requirement and applicability: Required
Application exceptions: When the original interval is unverified, do not approximate it from P values or substitute an individual response threshold.
Why this condition is needed: Statistical significance, trial counts or enrollment alone cannot establish that a difference is precise or important.
Referenced methods: C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is this case’s own design / E05: M15 §15.3.1–15.3.3; this case’s own application Adaptation to this IBD-F crossover question: Statistical significance, trial counts or enrollment alone cannot establish that a difference is precise or important. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N21 · Is −5.25 points attributed only to the retained descriptive arithmetic?

Required materials and conditions: Materials linking the retained arithmetic record, its purpose and the correction history
Conditions for verification: The retained arithmetic record links the string −5.25 to its purpose as descriptive arithmetic rather than an adjusted crossover effect.
Requirement and applicability: Required
Application exceptions: Do not recalculate the original formula or restore assumption-dependent standardized effect sizes in this work.
Why this condition is needed: Needed to avoid promoting the historical arithmetic value into a new calculation or an adjusted crossover effect.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separating verification states is this case’s own design / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid promoting the historical arithmetic value into a new calculation or an adjusted crossover effect. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N22 · Is the within-person 3-point improvement threshold identified as an individual response criterion?

Required materials and conditions: Materials defining the individual response threshold, its unit of application and its distinction from between-group importance
Conditions for verification: The manuscript identifies the 3-point improvement threshold as a within-person response criterion.
Requirement and applicability: Required
Application exceptions: Do not use 3 points as a between-group MCID, a response-rate denominator or a new NNT.
Why this condition is needed: Needed to avoid turning an individual response threshold into a clinical-importance threshold for a between-group mean difference.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / E05: M15 §15.3.1–15.3.3; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid turning an individual response threshold into a clinical-importance threshold for a between-group mean difference. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N23 · Is a validated between-group MCID applicable to this IBD-F crossover comparison verified?

Required materials and conditions: Evidence for an MCID applicable to this population, IBD-F version and between-group contrast
Conditions for verification: A validated MCID and supporting evidence appropriate to the relevant IBD-F between-group contrast in quiescent IBD are verified.
Requirement and applicability: Required for interpretation of clinical importance
Application exceptions: Do not borrow the individual 3-point threshold or thresholds from other diseases or scales.
Why this condition is needed: Needed to distinguish the direction of mean change from a between-group difference important to patients.
Referenced methods: E05: M15 §15.3.1–15.3.3; this case’s own application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design Adaptation to this IBD-F crossover question: Needed to distinguish the direction of mean change from a between-group difference important to patients. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N24 · Do S04, S05 and S06 belong to the same TARIF trial family?

Required materials and conditions: Trial identifiers and materials linking each report's recruitment, endpoints, time points and analyses
Conditions for verification: The three reports share the study identifier TARIF-NCT03634735, and their different roles are stated.
Requirement and applicability: Required
Application exceptions: Report counts describe the presence of reports, not numbers of independent studies or participants.
Why this condition is needed: Needed to avoid counting the primary result, vitamer secondary analysis and follow-up observation as three independent replications.
Referenced methods: C02: M04 §4.6.1–4.6.2: distinguishing studies from reports; cohort/outcome linkage is this case’s own application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid counting the primary result, vitamer secondary analysis and follow-up observation as three independent replications. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N25 · Are the follow-up report's actual dose, duration, design and results verified?

Required materials and conditions: Original materials on the actual methods, denominators, dose, duration and results of the S06 follow-up report
Conditions for verification: The follow-up report's actual dose, duration, observational design, denominator and results are specifically verified.
Requirement and applicability: Supplementary; required for claims about persistence or follow-up effects
Application exceptions: Do not label historical numerical records as files read in this work or adopt unverified follow-up values.
Why this condition is needed: The existence of a follow-up citation alone cannot verify long-term persistence of the 4-week crossover effect or independent replication.
Referenced methods: C02: M04 §4.6.1–4.6.2: distinguishing studies from reports; cohort/outcome linkage is this case’s own application / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design Adaptation to this IBD-F crossover question: The existence of a follow-up citation alone cannot verify long-term persistence of the 4-week crossover effect or independent replication. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N26 · Do the populations and interventions in S07 and S08 differ from the selected direct comparison?

Required materials and conditions: Materials linking other reports' populations and intervention composition to eligibility for the original question
Conditions for verification: The actual differences are verified: S07 concerns primary biliary cholangitis, and S08 uses a combination of B1, B6, B12 and magnesium.
Requirement and applicability: Required
Application exceptions: Exclusion on eligibility grounds is not a judgment that a study is invalid or that it found no effect.
Why this condition is needed: Needed to avoid combining results from other diseases and combination products as repeated refutation or independent replication of single-ingredient B1 in IBD.
Referenced methods: C02: M04 §4.6.1–4.6.2: distinguishing studies from reports; cohort/outcome linkage is this case’s own application / C04: M03 §3.2.1; detailed population conditions are this case’s own design / C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separating verification states is this case’s own design / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid combining results from other diseases and combination products as repeated refutation or independent replication of single-ingredient B1 in IBD. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N27 · Are public or nonprofit funding, funder roles, product provision and author relationships actually verified?

Required materials and conditions: Original disclosures of funding sources, product provision, funder roles and author conflicts of interest
Conditions for verification: The disclosed scope of actual funding sources, funder roles, product provision and author conflicts is verified.
Requirement and applicability: Supplementary; required for independence claims
Application exceptions: The original I2 and score of 50 are historical judgments, not inherited as fulfillment of the current condition or a new independence certification.
Why this condition is needed: Needed to avoid treating a public or nonprofit funding label as absence of all conflicts or bias.
Referenced methods: C10: Chamgap’s own independence and attribution conditions. The official methodology sections referenced in this pilot do not endorse all of these detailed items Adaptation to this IBD-F crossover question: Needed to avoid treating a public or nonprofit funding label as absence of all conflicts or bias. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N28 · Are materials available to reproduce the historical search, selection and correction-check scope for the exact question?

Required materials and conditions: Historical search and selection logs, the scope of checks for registrations, unpublished evidence and corrections, and date records
Conditions for verification: Historical search strategies, databases, dates, selection, registration and correction-check scope are compared with original records.
Requirement and applicability: Required
Application exceptions: Do not claim to have read actual search logs merely from their file paths or interpret absence of a new search as absence of research.
Why this condition is needed: Needed to avoid extending the presence of currently stored direct evidence into an exhaustive check of the latest worldwide literature.
Referenced methods: C09: M04 §4.5, §4.6.3; limits on converting the current materials follow the user’s scope and this case’s own design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separating verification states is this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid extending the presence of currently stored direct evidence into an exhaustive check of the latest worldwide literature. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N29 · Are persistence of fatigue improvement and effects after stopping treatment beyond 4 weeks directly verified?

Required materials and conditions: Comparative results after treatment stops or during long-term follow-up, actual exposure and IBD-F analysis denominators
Conditions for verification: Post-treatment or long-term comparative IBD-F estimates and follow-up denominators for the selected intervention are verified.
Requirement and applicability: Supplementary; required for claims of sustained effects
Application exceptions: Do not use a washout period or the existence of follow-up citations as direct proof of sustained effects.
Why this condition is needed: Needed to avoid extending a short active-treatment result into long-term persistence of benefit.
Referenced methods: E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid extending a short active-treatment result into long-term persistence of benefit. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N30 · Are direct dose comparisons, an optimal dose and effects by sex and weight verified?

Required materials and conditions: Prespecified dose and subgroup plans, direct comparisons, interaction results and denominators
Conditions for verification: Direct results from prespecified dose comparisons, sex or weight subgroups and interaction analyses are verified.
Requirement and applicability: Supplementary; required for claims about dose or effect modification
Application exceptions: Do not impose new fixed minimum sample sizes or durations, or perform new dose-response calculations.
Why this condition is needed: Needed to avoid interpreting a dose-allocation range as a dose-response relationship or superiority in a particular stratum.
Referenced methods: E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design / C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid interpreting a dose-allocation range as a dose-response relationship or superiority in a particular stratum. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N31 · Are vitamer analyses distinguished from patient fatigue and clinical-event outcomes?

Required materials and conditions: Materials linking vitamer analyses, actual interventions, patient fatigue and separate clinical-event outcomes
Conditions for verification: The distinction is verified: S05 is a secondary vitamer analysis of participants in a B1 trial, and the selected outcome is patient-reported IBD-F.
Requirement and applicability: Required for outcome attribution
Application exceptions: The current question concerns patient-reported fatigue; clinical-event trials are not imposed as an invariably required condition for this numerical outcome.
Why this condition is needed: Needed to avoid turning vitamer associations in the same cohort into B2 supplementation effects or prevention of IBD events.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / E09: M03 §3.2.4; this case’s own limits on extension / C02: M04 §4.6.1–4.6.2: distinguishing studies from reports; cohort/outcome linkage is this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid turning vitamer associations in the same cohort into B2 supplementation effects or prevention of IBD events. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N32 · Are adverse-event collection methods, event and participant counts by arm, and discontinuations verified?

Required materials and conditions: Adverse-event definitions, collection, event and participant counts by arm or period, exposure denominators and discontinuations
Conditions for verification: Adverse-event definitions, collection methods, severity, event and participant counts, denominators and discontinuations by period and sequence are verified.
Requirement and applicability: Supplementary; required for comparative harms and safety
Application exceptions: Do not impose event-rate conditions on the continuous IBD-F endpoint; examine separate collection methods and denominators for harms.
Why this condition is needed: Needed to avoid turning a summary statement of mild side effects into low incidence or overall safety.
Referenced methods: E10: M19 §19.1.2–19.2.4; this case’s own application / H01: M19 §19.1.2–19.2.4; detailed discrimination is this case’s own design / H03: M19 §19.2.2–19.2.4, M03 §3.2.3; this case’s own application / H04: M19 §19.1.2–19.2.4; this case’s own application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid turning a summary statement of mild side effects into low incidence or overall safety. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N33 · Are actual materials investigating drug interactions and assay interference verified?

Required materials and conditions: Evidence on interactions and interference for each concomitant medication and assay, with records of verification scope
Conditions for verification: Actual materials investigating interactions and interference between the selected intervention and dose, concomitant drugs and assay methods are verified.
Requirement and applicability: Supplementary; required for interaction claims and interpretation of assays
Application exceptions: Do not conduct new safety searches or issue personal instructions to take, stop or withhold supplements or tests in this work.
Why this condition is needed: Needed to avoid turning the original not-searched status into absence of interactions or effects on assays.
Referenced methods: E10: M19 §19.1.2–19.2.4; this case’s own application / H05: M19 §19.2.2–19.2.4: design considerations; detailed confounding records are this case’s own design / H08: M19 §19.1.2–19.2.4; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid turning the original not-searched status into absence of interactions or effects on assays. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N34 · Is direct evidence available for pregnancy, children, active IBD or other fatigue disorders?

Required materials and conditions: Actual diagnosis, exposure, comparator, fatigue, harm and follow-up materials for each population extension
Conditions for verification: Direct evidence on the relevant intervention, exposure, comparator, fatigue and harms is verified for each population extension.
Requirement and applicability: Supplementary; required for population and safety extensions
Application exceptions: Do not turn insufficient direct evidence into instructions to delay treatment or self-administer high doses.
Why this condition is needed: Needed to avoid extending a short high-dose study in quiescent IBD to efficacy and safety in every population.
Referenced methods: C04: M03 §3.2.1; detailed population conditions are this case’s own design / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design / E10: M19 §19.1.2–19.2.4; this case’s own application / H08: M19 §19.1.2–19.2.4; this case’s own application / H09: Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was applied Adaptation to this IBD-F crossover question: Needed to avoid extending a short high-dose study in quiescent IBD to efficacy and safety in every population. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N35 · Are the stored summaries read in this work distinguished from external materials and historical access levels?

Required materials and conditions: Records of each material's existence, access, acquisition and reading status, with exact source locations and hashes
Conditions for verification: The exact locations read in the stored manuscript are recorded separately from each material's historical access and current external access not attempted or material not read.
Requirement and applicability: Required for reading records
Application exceptions: Do not label the historical failure to obtain the full S04 statistical text as a current access failure. External access was not attempted in this work.
Why this condition is needed: Needed to avoid promoting a summary link or historical full-text access into external reading in this work.
Referenced methods: C03: M04 §4.5–4.6: principles for collecting and selecting materials; separating access from reading and the hyperlink requirements are this case’s own design / C09: M04 §4.5, §4.6.3; limits on converting the current materials follow the user’s scope and this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid promoting a summary link or historical full-text access into external reading in this work. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

N36 · Are the evidence cutoff, material-specific access dates, review dates, original judgment and correction history distinguished?

Required materials and conditions: The current manuscript, versions, dates, original judgment, corrections, revision records and input hashes
Conditions for verification: The search cutoff and original review date of 2026-09-15, unverified material-specific access dates and new review date are distinguished, while original grades, scores, axes and corrections are preserved byte for byte.
Requirement and applicability: Required for version and date attribution
Application exceptions: Do not invent separate fields or lists absent from the manuscript; preserve the empty subclaim list and original empty values.
Why this condition is needed: Needed to avoid substituting a global original-review date for material-specific access dates or using C50 as a new condition score.
Referenced methods: C09: M04 §4.5, §4.6.3; limits on converting the current materials follow the user’s scope and this case’s own design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separating verification states is this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid substituting a global original-review date for material-specific access dates or using C50 as a new condition score. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.
Extent of review: Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

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

Referenced principle: Distinguish and link studies and reports; do not omit studies solely because outcomes are unreported.
Extent of review: Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

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

Referenced principle: Fix the outcome and effect of interest, then review randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effects, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.
Extent of review: Stored method principles, application records and copy hashes were checked. No new retrieval of external methods documents or execution of an entire official assessment tool was performed.

What the statuses mean

Met: The relevant narrow identity, attribution of original values, outcome category or explicit recording condition is verified. This does not certify overall clinical efficacy or safety.
Partly verified: Some of the actual information required by the question is verified, but product, measurement, denominator or analysis details remain incomplete.
Unverified: The relevant actual facts or analyses cannot be established within the currently stored scope. This does not mean an effect of 0, absence of research worldwide or an access failure in this work.
Conflicting information: Actual reports of the same fact disagree. This is distinct from successful preservation of a record.
Not reported: Limited to explicitly identified materials or sections actually read. It does not indicate absence of information throughout an unread full paper.
Not applicable: Used only with a specific reason why the question's applicability conditions are not met; not a substitute for unread material.
Inaccessible: Distinguishes historical access failures from failures of an actual current attempt. It is not assigned when external access was not attempted in this work.
Review incomplete: Limited to the absence of comparison with external original materials in this work. This is distinct from the completed local stored-summary review.

Change history

2026-10-31 · Public page/material version 1.0

Public pages and materials were prepared from the existing 36 items. No new clinical search, verification-status changes or scoring were performed.

The stored-material review date (2026-10-05) and original evidence cut-off (2026-09-15) were retained unchanged.

Researcher downloads

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

View all item details

N01 · Which population, intervention, comparator, duration and endpoint define this independent comparison?

Current findings: The selected original claim concerns reduction of persistent fatigue in quiescent inflammatory bowel disease. It is limited to an IBD-F comparison of single-ingredient oral thiamine hydrochloride and placebo within the same crossover trial.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The boundaries of the current independent comparison are verified. This does not establish the clinical magnitude or long-term persistence of fatigue reduction.
Reason for missing information: There is no gap in the boundary of the independent question; product details, analysis and extensions remain separate conditions.
Required materials and conditions: Materials linking the current claim to the actual population, intervention, comparator, time point and IBD-F outcome
Materials to obtain first: Materials linking the current claim to the actual population, intervention, comparator, time point and IBD-F outcome
Further research: Compare the question elements in the manuscript and trial materials; separate a changed scope into an independent question and record the reason for the change.
Remaining uncertainty: There is no gap in the boundary of the independent question; product details, analysis and extensions remain separate conditions. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The source specifies a comparison of single-ingredient oral thiamine hydrochloride versus placebo for IBD-F over a 4-week active period in adults with quiescent IBD and persistent fatigue.
Why this condition is needed: Needed to keep patient-reported fatigue in quiescent IBD distinct from general vitality or treatment of deficiency.
Application exceptions: The Korean and English versions concern the same claim. Do not create new subclaims from the currently empty list of subclaims.
Referenced methods: C01: M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are this case’s own design / C04: M03 §3.2.1; detailed population conditions are this case’s own design / C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design Adaptation to this IBD-F crossover question: Needed to keep patient-reported fatigue in quiescent IBD distinct from general vitality or treatment of deficiency. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04 S05

N02 · Was the actual intervention ingredient and salt form thiamine hydrochloride?

Current findings: The stored structure and the same-TARIF report S05 identify the actual intervention as thiamine hydrochloride. This was not a B2 supplementation trial.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The narrow identity of the ingredient and salt is verified. This does not include the detailed dosage form or manufacturing batch.
Reason for missing information: Product details beyond salt identity are addressed in N03.
Required materials and conditions: Trial methods and product identity records specifying the intervention ingredient and salt form
Materials to obtain first: Trial methods and product identity records specifying the intervention ingredient and salt form
Further research: Compare the trial intervention label with the actual product label to establish differences between salt mass and active amount.
Remaining uncertainty: Product details beyond salt identity are addressed in N03. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The actual trial ingredient is identified as thiamine hydrochloride and attributed to the oral B1 intervention.
Why this condition is needed: Needed to avoid treating other B1 derivatives or B2 vitamer analyses as the same administered ingredient.
Application exceptions: Do not arbitrarily convert the mass of thiamine hydrochloride into the mass of free thiamine.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid treating other B1 derivatives or B2 vitamer analyses as the same administered ingredient. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04 S05

N03 · Are the actual product's dosage form, manufacturer, batch and production origin verified?

Current findings: Single-ingredient oral thiamine hydrochloride is identified, but the detailed dosage form, manufacturer and synthetic, fermentation or other production origin are unverified. Plant-part classification does not apply to this chemical intervention.
Verification status: Partly verified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The ingredient and single-ingredient oral intervention are known, but detailed product identity and production origin remain incomplete.
Reason for missing information: Detailed dosage form, manufacturer, batch, production origin and the basis for conversion to active amount are unavailable.
Required materials and conditions: Trial product specifications, manufacturer and batch records, and salt and active-amount labeling
Materials to obtain first: Trial product specifications, manufacturer and batch records, and salt and active-amount labeling
Further research: Compare product specifications with the trial methods and separate results for different dosage forms or production origins.
Remaining uncertainty: Detailed dosage form, manufacturer, batch, production origin and the basis for conversion to active amount are unavailable. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The trial product's detailed dosage form, manufacturer, batch and production origin are specified in the materials.
Why this condition is needed: The same ingredient name alone does not establish that all marketed products match the trial product.
Application exceptions: Non-applicability of plant-part classification to a chemical ingredient is distinct from unverified production origin, such as synthesis or fermentation.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design Adaptation to this IBD-F crossover question: The same ingredient name alone does not establish that all marketed products match the trial product. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S05

N04 · Was the actual population selected adults with quiescent IBD and persistent fatigue?

Current findings: The stored manuscript concerns adults with quiescent IBD and persistent fatigue after other explanations were excluded. It was not a trial of general vitality or all fatigue disorders.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: This narrow population condition is stated. It does not mean that unverified diagnostic details or effects in other populations have been established.
Reason for missing information: The current summary does not preserve detailed IBD subtype and diagnostic composition or individual exclusion tests.
Required materials and conditions: Eligibility and exclusion materials covering diagnosis, remission, persistent fatigue and exclusion of alternative causes
Materials to obtain first: Eligibility and exclusion materials covering diagnosis, remission, persistent fatigue and exclusion of alternative causes
Further research: Review trial eligibility criteria and the fatigue-assessment pathway to compare included and excluded populations.
Remaining uncertainty: The current summary does not preserve detailed IBD subtype and diagnostic composition or individual exclusion tests. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The population is identified as adults with quiescent IBD and persistent fatigue after alternative explanations were excluded.
Why this condition is needed: Needed to avoid transferring results directly to populations with different diseases or fatigue-selection criteria.
Application exceptions: Do not extend the term quiescent to equal effects across all IBD subtypes, active disease or ages.
Referenced methods: C04: M03 §3.2.1; detailed population conditions are this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid transferring results directly to populations with different diseases or fatigue-selection criteria. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04 S05

N05 · Are baseline B1 status and effects within deficiency subgroups verified?

Current findings: The selected scope of quiescent IBD after exclusion of other fatigue explanations is known, but effects across all B1-deficiency subgroups are unverified. The structured baseline-status value is empty.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The currently stored scope lacks materials verifying deficiency definitions, measurements and subgroup effects.
Reason for missing information: Baseline B1 measurements, assay methods, deficiency thresholds, prespecified subgroups and interaction estimates are unverified.
Required materials and conditions: Baseline B1 measurements, deficiency definitions, subgroup plans and subgroup comparison results
Materials to obtain first: Baseline B1 measurements, deficiency definitions, subgroup plans and subgroup comparison results
Further research: Compare measurements and interaction analyses for prespecified deficiency subgroups, keeping them distinct from the overall effect.
Remaining uncertainty: Baseline B1 measurements, assay methods, deficiency thresholds, prespecified subgroups and interaction estimates are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Baseline B1 measurements, the deficiency definition and prespecified subgroup comparisons or interaction results are verified.
Why this condition is needed: Needed to avoid turning the average result in selected IBD fatigue into a general claim about correcting deficiency.
Application exceptions: Even when the value is empty and its information state is recorded as confirmed, do not interpret this as confirmation of all deficiency measurements.
Referenced methods: C04: M03 §3.2.1; detailed population conditions are this case’s own design / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid turning the average result in selected IBD fatigue into a general claim about correcting deficiency. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S05

N06 · Are the actual doses and dosing frequency specified by sex and weight?

Current findings: S04 records a research regimen of 600–1800 mg/day according to sex and weight. The thresholds, actual participant-level doses and dosing frequency are not specified in the currently stored materials.
Verification status: Partly verified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The research range and dose-allocation criteria are known, but the actual intervention within each stratum is not fully verified.
Reason for missing information: Sex and weight thresholds, stratum-specific doses, dosing frequency, tablet counts and actual amounts taken are unverified.
Required materials and conditions: Dose schedules by sex and weight, dosing frequency, tablet counts and actual exposure records
Materials to obtain first: Dose schedules by sex and weight, dosing frequency, tablet counts and actual exposure records
Further research: Compare dose-allocation schedules with actual dosing records; examine dose effects separately using direct comparisons.
Remaining uncertainty: Sex and weight thresholds, stratum-specific doses, dosing frequency, tablet counts and actual amounts taken are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The dose by sex and weight criteria, units, salt labeling and actual dosing frequency are specified.
Why this condition is needed: Needed to avoid turning the research dose range into a uniform dose for every participant or a recommended dose.
Application exceptions: Do not present the range of 600–1800 mg/day as an optimal dose or an instruction for self-dosing.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid turning the research dose range into a uniform dose for every participant or a recommended dose. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N07 · Was the actual administration route oral?

Current findings: The stored study information and linked records in S04 and S05 identify the actual administration route as oral.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The actual oral study route is verified. Equivalence of detailed dosage forms and bioavailability is a separate question.
Reason for missing information: There is no gap in this narrow route item.
Required materials and conditions: The actual administration route specified in the trial methods
Materials to obtain first: The actual administration route specified in the trial methods
Further research: Compare the claimed route with the actual route in the study methods and separate other routes.
Remaining uncertainty: There is no gap in this narrow route item. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The actual TARIF intervention route is verified as oral.
Why this condition is needed: Needed to align the claimed route with the actual study route.
Application exceptions: Do not turn verification of an oral route into equivalence with injections, other derivatives or other dosage forms.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design Adaptation to this IBD-F crossover question: Needed to align the claimed route with the actual study route. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04 S05

N08 · Is the planned sequence of active treatment, washout and alternate treatment periods verified?

Current findings: The stored citation for S04 specifies 4 weeks of treatment, a 4-week washout and then 4 weeks of the alternate treatment. The main question concerns a 4-week active period.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The narrow planned duration can be verified. Actual completion by sequence and carryover are addressed separately in N12 and N13.
Reason for missing information: Actual deviations from scheduled visits and completion by sequence are unverified.
Required materials and conditions: The protocol and trial methods specifying crossover sequences and each treatment and washout period
Materials to obtain first: The protocol and trial methods specifying crossover sequences and each treatment and washout period
Further research: Compare the planned periods with actual visit and treatment schedules, linking effects to each period.
Remaining uncertainty: Actual deviations from scheduled visits and completion by sequence are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The source specifies a crossover plan of 4 weeks of active treatment, a 4-week washout and 4 weeks of the alternate treatment.
Why this condition is needed: Needed to avoid extending the 4-week active result to long-term observation or persistence after treatment stops.
Application exceptions: A planned 4-week washout does not itself demonstrate absence of carryover or an adequate washout.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / E01: M08 §8.1–8.2.3; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid extending the 4-week active result to long-term observation or persistence after treatment stops. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N09 · Are the actual placebo composition and period-specific differences in concomitant and background treatment verified?

Current findings: An oral placebo comparison within the same crossover trial is verified. Total dietary intake, all supplement exposure and arm-level details of concomitant vitamins are unverified.
Verification status: Partly verified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The comparator type is known, but the actual placebo composition and all shared or concomitant interventions are not verified.
Reason for missing information: Placebo composition and period-specific diet, supplements, medications, rescue treatment and changes in IBD therapy are unverified.
Required materials and conditions: Placebo specifications and records of background treatment, concomitant vitamins, diet and changes by period
Materials to obtain first: Placebo specifications and records of background treatment, concomitant vitamins, diet and changes by period
Further research: Compare placebo and background-treatment records by period and sequence, analyzing them alongside differences in the selected intervention.
Remaining uncertainty: Placebo composition and period-specific diet, supplements, medications, rescue treatment and changes in IBD therapy are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The oral placebo composition, concomitant vitamins, diet, IBD treatment by period and handling of changes are verified.
Why this condition is needed: The label placebo-controlled alone does not establish that all differences in concomitant treatment, diet and therapy were controlled.
Application exceptions: Do not interpret the manuscript's single-ingredient B1 intervention as meaning there were no concomitant vitamins or medications.
Referenced methods: C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; this case’s own application Adaptation to this IBD-F crossover question: The label placebo-controlled alone does not establish that all differences in concomitant treatment, diet and therapy were controlled. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N10 · Are the actual methods of crossover randomization, concealment and blinding verified?

Current findings: S04 is described as a randomized double-blind placebo-controlled crossover trial. The current summary cannot verify implementation details of sequence generation, allocation concealment or blinding.
Verification status: Partly verified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The design label is verified, but the actual conduct of allocation and blinding has not been fully checked.
Reason for missing information: Details of sequence generation, allocation concealment, implementation and assessment of blinding, and baseline balance are unverified.
Required materials and conditions: Trial methods covering sequence generation, allocation concealment, blinding and baseline balance
Materials to obtain first: Trial methods covering sequence generation, allocation concealment, blinding and baseline balance
Further research: Compare sequence generation, allocation and blinding by outcome in the original methods section, distinguishing unverified information from verified problems.
Remaining uncertainty: Details of sequence generation, allocation concealment, implementation and assessment of blinding, and baseline balance are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The actual methods for generating and concealing crossover sequences and blinding participants and assessors are verified.
Why this condition is needed: The label randomized double-blind alone cannot establish absence of allocation or measurement bias.
Application exceptions: Do not turn unverified methods into confirmed failure of allocation or blinding.
Referenced methods: E01: M08 §8.1–8.2.3; this case’s own application / E03: M08 Table 8.2.a, M03 §3.2.4; this case’s own application Adaptation to this IBD-F crossover question: The label randomized double-blind alone cannot establish absence of allocation or measurement bias. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N11 · Are enrollment and the actual analysis denominator for the IBD-F crossover comparison separately identified and verified?

Current findings: S04 records 40 enrolled participants, but the effective denominator for the crossover analysis is unverified. The analysis-denominator value and its linked source list are empty.
Verification status: Partly verified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Only enrollment is verified; the actual analysis denominator for the selected outcome is not established.
Reason for missing information: Numbers measured, completing treatment and included in paired analyses by treatment and period, and definitions of analysis populations, are unverified.
Required materials and conditions: Participant flow, numbers measured and completing each period, and the paired IBD-F analysis denominator
Materials to obtain first: Participant flow, numbers measured and completing each period, and the paired IBD-F analysis denominator
Further research: Compare participant flow and analysis populations by period and sequence to verify the actual endpoint denominator.
Remaining uncertainty: Numbers measured, completing treatment and included in paired analyses by treatment and period, and definitions of analysis populations, are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Enrollment, treatment and completion numbers and the actual paired IBD-F analysis denominator are verified and linked to each outcome.
Why this condition is needed: Needed to avoid substituting the 40 enrolled participants for the endpoint analysis population or the denominator of each independent arm.
Application exceptions: Do not sum crossover participants as independent groups.
Referenced methods: C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is this case’s own design / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid substituting the 40 enrolled participants for the endpoint analysis population or the denominator of each independent arm. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N12 · Are period-specific adherence, withdrawals, missing data and analysis handling verified?

Current findings: The current manuscript states that effective analysis numbers were not fully verified. The stored summary does not specify period-specific adherence, withdrawals, missing data or actual analysis handling.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Materials on losses, deviations and analysis handling for the selected crossover comparison have not been obtained.
Reason for missing information: Period-specific adherence, withdrawal and missing-data numbers and reasons, ITT/PP and imputation procedures are unverified.
Required materials and conditions: Records of adherence, withdrawals, reasons for missing data, actual analysis populations and handling by period and sequence
Materials to obtain first: Records of adherence, withdrawals, reasons for missing data, actual analysis populations and handling by period and sequence
Further research: Compare period-specific measurement losses and treatment deviations with the analysis plan and examine the implications of handling assumptions.
Remaining uncertainty: Period-specific adherence, withdrawal and missing-data numbers and reasons, ITT/PP and imputation procedures are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Adherence, losses and their reasons in each period and sequence, and ITT/PP or missing-data handling, are verified.
Why this condition is needed: Knowing enrollment does not establish how missing data and deviations from treatment affected the comparison.
Application exceptions: Do not calculate withdrawal or missing-data rates from enrollment alone, or interpret unverified withdrawals as 0 withdrawals.
Referenced methods: C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is this case’s own design / E02: M03 §3.2.3, M08 §8.2.2–8.2.3; this case’s own application / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Knowing enrollment does not establish how missing data and deviations from treatment affected the comparison. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N13 · Is a crossover model addressing sequence, period and carryover effects verified?

Current findings: A 4-week washout is planned, but the formal crossover model is unverified. How sequence, period and carryover effects were examined and handled cannot be established.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The currently stored scope lacks actual specifications of the model and carryover handling required for this crossover design.
Reason for missing information: Sequence-specific results, examination of period and carryover effects, and the adjusted model are unverified.
Required materials and conditions: Crossover sequence data, checks for period and carryover effects, and statistical model specifications
Materials to obtain first: Crossover sequence data, checks for period and carryover effects, and statistical model specifications
Further research: Compare the handling of period, sequence and carryover effects with the selected estimand in the original statistical section.
Remaining uncertainty: Sequence-specific results, examination of period and carryover effects, and the adjusted model are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Actual checks for sequence, period and carryover effects and their handling in the crossover model are verified.
Why this condition is needed: Needed to avoid replacing self-controlled data with a comparison that ignores dependence and period effects.
Application exceptions: Do not assume that a 4-week washout eliminates carryover or treat the crossover design as inapplicable.
Referenced methods: E01: M08 §8.1–8.2.3; this case’s own application / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid replacing self-controlled data with a comparison that ignores dependence and period effects. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N14 · Are the IBD-F version, scale direction, assessment times and measurement conditions verified?

Current findings: The selected endpoint is improvement in patient-reported IBD-F fatigue, and the directions of mean reduction and placebo increase are retained. The scale version, scoring range and detailed assessment schedule are unverified.
Verification status: Partly verified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The endpoint and direction are known, but the complete measurement conditions are not verified.
Reason for missing information: The IBD-F version and scoring range, detailed assessment times and collection conditions are unverified.
Required materials and conditions: Materials on the IBD-F version, scoring, assessment times, collection procedures and measurement conditions
Materials to obtain first: Materials on the IBD-F version, scoring, assessment times, collection procedures and measurement conditions
Further research: Review how the scale and assessment schedule were actually used and connect measurement differences or unverified details to the outcome.
Remaining uncertainty: The IBD-F version and scoring range, detailed assessment times and collection conditions are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The IBD-F version, score direction, assessment times, collection procedures and blinding conditions are verified.
Why this condition is needed: Needed to avoid replacing patient-reported fatigue changes with other functional, vitamer or clinical-event outcomes.
Application exceptions: Do not dismiss an outcome merely because it is patient-reported or use the double-blind label as complete verification of measurement.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / E03: M08 Table 8.2.a, M03 §3.2.4; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid replacing patient-reported fatigue changes with other functional, vitamer or clinical-event outcomes. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N15 · Does the paper identify IBD-F improvement as its primary endpoint?

Current findings: The primary-endpoint classification value is empty, but its description explicitly confirms IBD-F improvement as the paper-stated primary endpoint.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: This narrow attribution to the paper-stated primary endpoint is verified. Concordance with the registry or analysis plan was not verified.
Reason for missing information: Independent comparison with registration and plans remains unverified in N16.
Required materials and conditions: Materials linking the paper-defined primary endpoint to the page endpoint
Materials to obtain first: Materials linking the paper-defined primary endpoint to the page endpoint
Further research: Compare the paper-stated primary-endpoint definition with the page outcome, keeping this distinct from comparison against the registry and plans.
Remaining uncertainty: Independent comparison with registration and plans remains unverified in N16. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The manuscript explicitly records IBD-F improvement as the paper-stated primary endpoint.
Why this condition is needed: Needed to distinguish verification of the paper-stated primary endpoint from a separate registry comparison.
Application exceptions: Do not interpret an empty value as absence of the paper-stated primary-endpoint description. Registry concordance is examined separately in N16.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / E06: M08 Table 8.2.a, M04 §4.6.3; this case’s own application Adaptation to this IBD-F crossover question: Needed to distinguish verification of the paper-stated primary endpoint from a separate registry comparison. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N16 · Do endpoints, time points and analyses agree across registration, protocol, analysis plan and results?

Current findings: S04 has the identifier NCT03634735, but the registered-primary-endpoint value is empty and independent registry-to-primary-endpoint concordance is unverified. The actual registration record was not read in this work.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The identifier and paper-stated primary-endpoint description alone cannot establish concordance with registration and plans.
Reason for missing information: The actual registration versions, protocol and analysis plan, timing and reasons for changes, and their comparison with reporting are unverified.
Required materials and conditions: The actual registration versions, protocol, analysis plan and results report for NCT03634735
Materials to obtain first: The actual registration versions, protocol, analysis plan and results report for NCT03634735
Further research: Compare registration-version timing, endpoints and analyses with the paper to identify prespecified plans and changes.
Remaining uncertainty: The actual registration versions, protocol and analysis plan, timing and reasons for changes, and their comparison with reporting are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The original registration, protocol and analysis plan are compared with reported endpoints, time points, analyses and reasons for changes.
Why this condition is needed: A registration identifier alone cannot establish concordance between prespecified plans and reporting.
Application exceptions: Do not turn an unchecked registry comparison into confirmed non-registration or selective reporting.
Referenced methods: E06: M08 Table 8.2.a, M04 §4.6.3; this case’s own application / C09: M04 §4.5, §4.6.3; limits on converting the current materials follow the user’s scope and this case’s own design Adaptation to this IBD-F crossover question: A registration identifier alone cannot establish concordance between prespecified plans and reporting. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N17 · Are the units, directions and treatment attribution of the reported mean changes verified?

Current findings: The stored S04 result records a mean fatigue reduction of 4.5 points on thiamine and an increase of 0.75 points on placebo. These are treatment-specific mean changes, not an interval for a formal adjusted contrast.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The directions, units and attribution of the two descriptive values are stated in the current manuscript. The external original table was not independently verified in this work.
Reason for missing information: Adjusted effects, dispersion, denominators and intervals remain unverified in N18–N20.
Required materials and conditions: Original results containing treatment-specific IBD-F mean changes, units and directions
Materials to obtain first: Original results containing treatment-specific IBD-F mean changes, units and directions
Further research: Compare directions, changes, units and time points in the results table, reporting them separately from adjusted estimates.
Remaining uncertainty: Adjusted effects, dispersion, denominators and intervals remain unverified in N18–N20. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: A mean fatigue reduction of 4.5 points and placebo increase of 0.75 points are attributed to the respective treatment-specific IBD-F changes.
Why this condition is needed: Needed to avoid reversing symptom improvement and placebo worsening or interpreting changes as final scores.
Application exceptions: Do not use descriptive mean changes as an adjusted crossover effect or confidence interval.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separating verification states is this case’s own design / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid reversing symptom improvement and placebo worsening or interpreting changes as final scores. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N18 · Are the actual effect of interest and adjusted crossover estimate verified?

Current findings: The current manuscript states that the adjusted crossover effect was not fully verified. The retained arithmetic value of −5.25 points is not an adjusted treatment estimate.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Statistical materials verifying the formal analysis population and adjusted treatment contrast have not been obtained.
Reason for missing information: The effect of interest, ITT/PP, adjustment variables, crossover model and formal effect estimate are unverified.
Required materials and conditions: Analysis population, effect of interest, adjusted model specifications and the formal treatment-contrast estimate
Materials to obtain first: Analysis population, effect of interest, adjusted model specifications and the formal treatment-contrast estimate
Further research: Compare the actual effect of interest in the statistical section and results, distinguishing descriptive changes from model estimates.
Remaining uncertainty: The effect of interest, ITT/PP, adjustment variables, crossover model and formal effect estimate are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The actual analysis population, effect of interest, adjusted crossover model and estimate for the selected contrast are verified.
Why this condition is needed: Needed to avoid turning arithmetic on mean changes into an effect of assignment, an effect of adherence or an adjusted self-controlled contrast.
Application exceptions: Do not invent ITT, PP or adjusted models, or extend the manuscript's verification limits to a claim that the entire paper lacks data.
Referenced methods: E04: M08 §8.2.2, M15 §15.3.1; this case’s own application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid turning arithmetic on mean changes into an effect of assignment, an effect of adherence or an adjusted self-controlled contrast. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N19 · Are paired dispersion, SD/SE and actual analysis numbers for the selected contrast verified?

Current findings: The manuscript records that paired dispersion and effective analysis numbers were not fully verified. Its attempt to use means, standard deviations and analysis numbers lacked complete verified inputs, so no assumed SD or analysis population size was used.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Paired dispersion and the actual denominator for the selected crossover contrast were not verified.
Reason for missing information: Paired SD/SE, correlation, effective analysis n and their connection to the model are unverified.
Required materials and conditions: Variance of paired differences, SD/SE, analysis numbers and original analysis specifications
Materials to obtain first: Variance of paired differences, SD/SE, analysis numbers and original analysis specifications
Further research: Compare the original tables and model to establish which contrast and analysis population produced the dispersion estimate.
Remaining uncertainty: Paired SD/SE, correlation, effective analysis n and their connection to the model are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Paired dispersion, SD/SE and the effective analysis denominator appropriate to the selected crossover contrast are verified together.
Why this condition is needed: Needed to avoid ignoring within-participant crossover correlation or generating an effect size from assumed dispersion or denominators.
Application exceptions: Do not approximate Cohen d or SE using the 40 enrolled participants, P values or unverified SD.
Referenced methods: C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is this case’s own design / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application / E05: M15 §15.3.1–15.3.3; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid ignoring within-participant crossover correlation or generating an effect size from assumed dispersion or denominators. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N20 · Are the confidence interval and precision of the formal treatment contrast verified?

Current findings: The effect interval for the actual paired treatment contrast is unverified. The reported mean changes and arithmetic difference of −5.25 points are not described as its confidence interval.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Without a verified formal contrast interval, precision and the range of clinically possible effects cannot be assessed.
Reason for missing information: The CI, SE, model and interval level for the selected contrast are unverified.
Required materials and conditions: The CI for the formal crossover effect, estimation method, units and connection to the model
Materials to obtain first: The CI for the formal crossover effect, estimation method, units and connection to the model
Further research: After verifying the original interval, examine the range of compatible effects and distinguish its relationship to an importance threshold.
Remaining uncertainty: The CI, SE, model and interval level for the selected contrast are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The confidence interval, units and model for the selected formal crossover treatment contrast are verified.
Why this condition is needed: Statistical significance, trial counts or enrollment alone cannot establish that a difference is precise or important.
Application exceptions: When the original interval is unverified, do not approximate it from P values or substitute an individual response threshold.
Referenced methods: C07: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is this case’s own design / E05: M15 §15.3.1–15.3.3; this case’s own application Adaptation to this IBD-F crossover question: Statistical significance, trial counts or enrollment alone cannot establish that a difference is precise or important. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N21 · Is −5.25 points attributed only to the retained descriptive arithmetic?

Current findings: The retained arithmetic record preserves −5.25 points as a string with the direction of fatigue change aligned, explicitly identifying it as descriptive arithmetic rather than an adjusted crossover effect. The correction history records removal of assumption-dependent standardized effect sizes.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The narrow attribution and purpose of this retained value are stated. Arithmetic verification was not repeated as a new clinical effect calculation.
Reason for missing information: The formal adjusted effect is unverified and is not filled in with this arithmetic value.
Required materials and conditions: Materials linking the retained arithmetic record, its purpose and the correction history
Materials to obtain first: Materials linking the retained arithmetic record, its purpose and the correction history
Further research: Compare the value, units and purpose of the existing record with the original result, displaying it separately from the formal estimand.
Remaining uncertainty: The formal adjusted effect is unverified and is not filled in with this arithmetic value. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The retained arithmetic record links the string −5.25 to its purpose as descriptive arithmetic rather than an adjusted crossover effect.
Why this condition is needed: Needed to avoid promoting the historical arithmetic value into a new calculation or an adjusted crossover effect.
Application exceptions: Do not recalculate the original formula or restore assumption-dependent standardized effect sizes in this work.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separating verification states is this case’s own design / E04: M08 §8.2.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid promoting the historical arithmetic value into a new calculation or an adjusted crossover effect. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N22 · Is the within-person 3-point improvement threshold identified as an individual response criterion?

Current findings: The stored Korean manuscript explicitly states that the within-person 3-point improvement threshold was not used as a between-group MCID. Interpretation of the response criterion is separated from that of between-group change.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Its application to an individual response is verified. Actual responder numbers, proportions and the between-group MCID were not verified.
Reason for missing information: Individual responder numbers, denominators and between-group importance in this setting remain separately unverified.
Required materials and conditions: Materials defining the individual response threshold, its unit of application and its distinction from between-group importance
Materials to obtain first: Materials defining the individual response threshold, its unit of application and its distinction from between-group importance
Further research: Compare the response definition and its target of application, examining continuous changes, response rates and between-group thresholds separately.
Remaining uncertainty: Individual responder numbers, denominators and between-group importance in this setting remain separately unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The manuscript identifies the 3-point improvement threshold as a within-person response criterion.
Why this condition is needed: Needed to avoid turning an individual response threshold into a clinical-importance threshold for a between-group mean difference.
Application exceptions: Do not use 3 points as a between-group MCID, a response-rate denominator or a new NNT.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / E05: M15 §15.3.1–15.3.3; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid turning an individual response threshold into a clinical-importance threshold for a between-group mean difference. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N23 · Is a validated between-group MCID applicable to this IBD-F crossover comparison verified?

Current findings: The original unresolved-information record states that a validated between-group MCID in this setting is unverified. It is not replaced with the within-person 3-point improvement threshold.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Materials verifying an importance threshold appropriate to the between-group comparison are unavailable.
Reason for missing information: The between-group MCID in this setting and its validation method are unverified.
Required materials and conditions: Evidence for an MCID applicable to this population, IBD-F version and between-group contrast
Materials to obtain first: Evidence for an MCID applicable to this population, IBD-F version and between-group contrast
Further research: Compare the validation population, scale and unit of application of the importance threshold, examining it alongside the formal effect interval.
Remaining uncertainty: The between-group MCID in this setting and its validation method are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: A validated MCID and supporting evidence appropriate to the relevant IBD-F between-group contrast in quiescent IBD are verified.
Why this condition is needed: Needed to distinguish the direction of mean change from a between-group difference important to patients.
Application exceptions: Do not borrow the individual 3-point threshold or thresholds from other diseases or scales.
Referenced methods: E05: M15 §15.3.1–15.3.3; this case’s own application / C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design Adaptation to this IBD-F crossover question: Needed to distinguish the direction of mean change from a between-group difference important to patients. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N24 · Do S04, S05 and S06 belong to the same TARIF trial family?

Current findings: S04, S05 and S06 all have the study identifier TARIF-NCT03634735. They are recorded respectively as the direct crossover trial, vitamer support from the same trial, and a follow-up contextual report from the same family.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The shared family identity and each report's role are verified in the currently stored materials. No new count of independent replications or unique total participants is calculated.
Reason for missing information: Detailed participant overlap between reports is unverified and is not converted into a new total.
Required materials and conditions: Trial identifiers and materials linking each report's recruitment, endpoints, time points and analyses
Materials to obtain first: Trial identifiers and materials linking each report's recruitment, endpoints, time points and analyses
Further research: Link reports by registration, cohort, endpoint and time point to distinguish shared participants from independent recruitment.
Remaining uncertainty: Detailed participant overlap between reports is unverified and is not converted into a new total. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The three reports share the study identifier TARIF-NCT03634735, and their different roles are stated.
Why this condition is needed: Needed to avoid counting the primary result, vitamer secondary analysis and follow-up observation as three independent replications.
Application exceptions: Report counts describe the presence of reports, not numbers of independent studies or participants.
Referenced methods: C02: M04 §4.6.1–4.6.2: distinguishing studies from reports; cohort/outcome linkage is this case’s own application / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid counting the primary result, vitamer secondary analysis and follow-up observation as three independent replications. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04 S05 S06

N25 · Are the follow-up report's actual dose, duration, design and results verified?

Current findings: S06 retains only its role as a report with different dosing, duration and observational design within the same family. Earlier bibliography and access records are reused; no new effect values are adopted.
Verification status: Partly verified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The family and the difference in follow-up context are known, but specific doses, duration, denominators and effects are unverified.
Reason for missing information: Follow-up dosing, duration, completion and analysis numbers, and actual results are unverified.
Required materials and conditions: Original materials on the actual methods, denominators, dose, duration and results of the S06 follow-up report
Materials to obtain first: Original materials on the actual methods, denominators, dose, duration and results of the S06 follow-up report
Further research: Compare exposure, design and follow-up with the main crossover trial, distinguishing persistence of effect from observational context.
Remaining uncertainty: Follow-up dosing, duration, completion and analysis numbers, and actual results are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The follow-up report's actual dose, duration, observational design, denominator and results are specifically verified.
Why this condition is needed: The existence of a follow-up citation alone cannot verify long-term persistence of the 4-week crossover effect or independent replication.
Application exceptions: Do not label historical numerical records as files read in this work or adopt unverified follow-up values.
Referenced methods: C02: M04 §4.6.1–4.6.2: distinguishing studies from reports; cohort/outcome linkage is this case’s own application / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design Adaptation to this IBD-F crossover question: The existence of a follow-up citation alone cannot verify long-term persistence of the 4-week crossover effect or independent replication. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S06

N26 · Do the populations and interventions in S07 and S08 differ from the selected direct comparison?

Current findings: S07 concerns fatigue in primary biliary cholangitis; S08 uses B1, B6, B12 and magnesium in combination. Neither is attributed as independent replication of an isolated B1 or B2 supplementation comparison in IBD.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The population and intervention differences and their exclusion roles are stated in the current materials. No positive, non-significant or harm values absent from this manuscript are invented.
Reason for missing information: Detailed effects and denominators for these other questions were not verified beyond the current manuscript's scope.
Required materials and conditions: Materials linking other reports' populations and intervention composition to eligibility for the original question
Materials to obtain first: Materials linking other reports' populations and intervention composition to eligibility for the original question
Further research: Compare disease, ingredients, comparators and endpoints to assess direct comparability, preserving findings on other questions in their respective roles.
Remaining uncertainty: Detailed effects and denominators for these other questions were not verified beyond the current manuscript's scope. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The actual differences are verified: S07 concerns primary biliary cholangitis, and S08 uses a combination of B1, B6, B12 and magnesium.
Why this condition is needed: Needed to avoid combining results from other diseases and combination products as repeated refutation or independent replication of single-ingredient B1 in IBD.
Application exceptions: Exclusion on eligibility grounds is not a judgment that a study is invalid or that it found no effect.
Referenced methods: C02: M04 §4.6.1–4.6.2: distinguishing studies from reports; cohort/outcome linkage is this case’s own application / C04: M03 §3.2.1; detailed population conditions are this case’s own design / C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separating verification states is this case’s own design / E07: M04 §4.6.1–4.6.2, M15 §15.3.1; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid combining results from other diseases and combination products as repeated refutation or independent replication of single-ingredient B1 in IBD. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S07 S08

N27 · Are public or nonprofit funding, funder roles, product provision and author relationships actually verified?

Current findings: S04 records verification of disclosed public or nonprofit support. The English assessment identifies public or nonprofit foundations and records that no funder role was reported. The stored summary lacks full details of funding lists, product provision and author disclosures.
Verification status: Partly verified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Funding type was historically verified, but the current materials cannot fully check actual support, product provision and author relationships.
Reason for missing information: Individual funding lists, contracts, product provision, complete author disclosures and the actual scope of verification of funder influence are unverified.
Required materials and conditions: Original disclosures of funding sources, product provision, funder roles and author conflicts of interest
Materials to obtain first: Original disclosures of funding sources, product provision, funder roles and author conflicts of interest
Further research: Compare disclosures with support documents to distinguish verified funding and roles from unverified conflicts.
Remaining uncertainty: Individual funding lists, contracts, product provision, complete author disclosures and the actual scope of verification of funder influence are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The disclosed scope of actual funding sources, funder roles, product provision and author conflicts is verified.
Why this condition is needed: Needed to avoid treating a public or nonprofit funding label as absence of all conflicts or bias.
Application exceptions: The original I2 and score of 50 are historical judgments, not inherited as fulfillment of the current condition or a new independence certification.
Referenced methods: C10: Chamgap’s own independence and attribution conditions. The official methodology sections referenced in this pilot do not endorse all of these detailed items Adaptation to this IBD-F crossover question: Needed to avoid treating a public or nonprofit funding label as absence of all conflicts or bias. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N28 · Are materials available to reproduce the historical search, selection and correction-check scope for the exact question?

Current findings: The fixed-question record that an eligible human result was identified and the search cutoff of 2026-09-15 are retained. The original historical search record was not read in this work, and the manuscript states that not every native database worldwide was searched exhaustively.
Verification status: Partly verified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The cutoff and limited verification scope are known, but the complete actual search and selection records were not reproduced and checked.
Reason for missing information: Current comparison of historical search strategies, original logs and the full scope of registration, unpublished-evidence and correction searches is unverified.
Required materials and conditions: Historical search and selection logs, the scope of checks for registrations, unpublished evidence and corrections, and date records
Materials to obtain first: Historical search and selection logs, the scope of checks for registrations, unpublished evidence and corrections, and date records
Further research: Within an authorized follow-up scope, review search and selection records to reproduce coverage of omissions and corrections, distinguishing the evidence cutoff.
Remaining uncertainty: Current comparison of historical search strategies, original logs and the full scope of registration, unpublished-evidence and correction searches is unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Historical search strategies, databases, dates, selection, registration and correction-check scope are compared with original records.
Why this condition is needed: Needed to avoid extending the presence of currently stored direct evidence into an exhaustive check of the latest worldwide literature.
Application exceptions: Do not claim to have read actual search logs merely from their file paths or interpret absence of a new search as absence of research.
Referenced methods: C09: M04 §4.5, §4.6.3; limits on converting the current materials follow the user’s scope and this case’s own design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separating verification states is this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid extending the presence of currently stored direct evidence into an exhaustive check of the latest worldwide literature. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources

N29 · Are persistence of fatigue improvement and effects after stopping treatment beyond 4 weeks directly verified?

Current findings: The main trial's active treatment lasted 4 weeks. S06 is a follow-up contextual report, but no new effect estimate is adopted and long-term persistence is not established.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Materials verifying long-term or post-treatment comparative results and denominators for this question are unavailable.
Reason for missing information: Duration of persistence, actual exposure, follow-up denominators, long-term comparative effects and intervals are unverified.
Required materials and conditions: Comparative results after treatment stops or during long-term follow-up, actual exposure and IBD-F analysis denominators
Materials to obtain first: Comparative results after treatment stops or during long-term follow-up, actual exposure and IBD-F analysis denominators
Further research: Link follow-up times with actual exposure and comparators, examining short-term findings separately from sustained effects.
Remaining uncertainty: Duration of persistence, actual exposure, follow-up denominators, long-term comparative effects and intervals are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Post-treatment or long-term comparative IBD-F estimates and follow-up denominators for the selected intervention are verified.
Why this condition is needed: Needed to avoid extending a short active-treatment result into long-term persistence of benefit.
Application exceptions: Do not use a washout period or the existence of follow-up citations as direct proof of sustained effects.
Referenced methods: E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid extending a short active-treatment result into long-term persistence of benefit. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04 S06

N30 · Are direct dose comparisons, an optimal dose and effects by sex and weight verified?

Current findings: The research allocation of 600–1800 mg/day according to sex and weight is known, but the current manuscript has no verified values for direct dose comparisons, an optimal dose or effects by sex and weight.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Dose-allocation information alone cannot verify effect modification or an optimal dose.
Reason for missing information: Prespecified dose-comparison and subgroup plans, actual stratum-specific effects, denominators and interactions are unverified.
Required materials and conditions: Prespecified dose and subgroup plans, direct comparisons, interaction results and denominators
Materials to obtain first: Prespecified dose and subgroup plans, direct comparisons, interaction results and denominators
Further research: Distinguish dose allocation from effect comparison and check direct estimates and interactions for prespecified subgroups.
Remaining uncertainty: Prespecified dose-comparison and subgroup plans, actual stratum-specific effects, denominators and interactions are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Direct results from prespecified dose comparisons, sex or weight subgroups and interaction analyses are verified.
Why this condition is needed: Needed to avoid interpreting a dose-allocation range as a dose-response relationship or superiority in a particular stratum.
Application exceptions: Do not impose new fixed minimum sample sizes or durations, or perform new dose-response calculations.
Referenced methods: E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design / C05: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and assays is this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid interpreting a dose-allocation range as a dose-response relationship or superiority in a particular stratum. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N31 · Are vitamer analyses distinguished from patient fatigue and clinical-event outcomes?

Current findings: The B2-related vitamer analysis in S05 is an observational secondary analysis from the same TARIF family receiving a B1 intervention. The selected question concerns patient symptoms and function rather than circulating vitamers and does not answer prevention of clinical events.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The actual intervention, analysis and endpoint categories are distinguished. This does not establish mechanistic causation or prevention of events.
Reason for missing information: This table did not verify mechanistic causation involving vitamers or direct comparisons of clinical events.
Required materials and conditions: Materials linking vitamer analyses, actual interventions, patient fatigue and separate clinical-event outcomes
Materials to obtain first: Materials linking vitamer analyses, actual interventions, patient fatigue and separate clinical-event outcomes
Further research: Compare the intervention and measurement targets, separating vitamer associations, symptom changes and event prevention into independent questions.
Remaining uncertainty: This table did not verify mechanistic causation involving vitamers or direct comparisons of clinical events. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The distinction is verified: S05 is a secondary vitamer analysis of participants in a B1 trial, and the selected outcome is patient-reported IBD-F.
Why this condition is needed: Needed to avoid turning vitamer associations in the same cohort into B2 supplementation effects or prevention of IBD events.
Application exceptions: The current question concerns patient-reported fatigue; clinical-event trials are not imposed as an invariably required condition for this numerical outcome.
Referenced methods: C06: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is this case’s own design / E09: M03 §3.2.4; this case’s own limits on extension / C02: M04 §4.6.1–4.6.2: distinguishing studies from reports; cohort/outcome linkage is this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid turning vitamer associations in the same cohort into B2 supplementation effects or prevention of IBD events. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S05

N32 · Are adverse-event collection methods, event and participant counts by arm, and discontinuations verified?

Current findings: The historically accessed abstract is recorded as reporting only mild side effects. Arm-level event counts and long-term safety are unverified, and the structured adverse-event value is empty.
Verification status: Partly verified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: There is a historical description of mild side effects, but actual collection systems, denominators, discontinuations and comparative risks are unverified.
Reason for missing information: Event definitions, systematic collection, severity, participant and event counts, period-specific denominators, discontinuations and comparative estimates are unverified.
Required materials and conditions: Adverse-event definitions, collection, event and participant counts by arm or period, exposure denominators and discontinuations
Materials to obtain first: Adverse-event definitions, collection, event and participant counts by arm or period, exposure denominators and discontinuations
Further research: Compare harm collection with actual exposure, distinguishing event counts, participant counts, comparative risks and reporting limitations.
Remaining uncertainty: Event definitions, systematic collection, severity, participant and event counts, period-specific denominators, discontinuations and comparative estimates are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Adverse-event definitions, collection methods, severity, event and participant counts, denominators and discontinuations by period and sequence are verified.
Why this condition is needed: Needed to avoid turning a summary statement of mild side effects into low incidence or overall safety.
Application exceptions: Do not impose event-rate conditions on the continuous IBD-F endpoint; examine separate collection methods and denominators for harms.
Referenced methods: E10: M19 §19.1.2–19.2.4; this case’s own application / H01: M19 §19.1.2–19.2.4; detailed discrimination is this case’s own design / H03: M19 §19.2.2–19.2.4, M03 §3.2.3; this case’s own application / H04: M19 §19.1.2–19.2.4; this case’s own application / H06: M19 §19.1.2–19.2.4, M04 §4.6.3; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid turning a summary statement of mild side effects into low incidence or overall safety. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N33 · Are actual materials investigating drug interactions and assay interference verified?

Current findings: Drug-interaction and assay-interference values are empty, and no separate search is recorded. No separate comprehensive search was performed; this does not mean there is no effect.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Actual investigative materials for this separate question are currently unverified.
Reason for missing information: The scope of verification of interactions and interference across concomitant drugs and assay methods is unverified.
Required materials and conditions: Evidence on interactions and interference for each concomitant medication and assay, with records of verification scope
Materials to obtain first: Evidence on interactions and interference for each concomitant medication and assay, with records of verification scope
Further research: Compare evidence appropriate to concomitant exposure and assay methods separately, distinguishing absence of investigation from absence of effects.
Remaining uncertainty: The scope of verification of interactions and interference across concomitant drugs and assay methods is unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Actual materials investigating interactions and interference between the selected intervention and dose, concomitant drugs and assay methods are verified.
Why this condition is needed: Needed to avoid turning the original not-searched status into absence of interactions or effects on assays.
Application exceptions: Do not conduct new safety searches or issue personal instructions to take, stop or withhold supplements or tests in this work.
Referenced methods: E10: M19 §19.1.2–19.2.4; this case’s own application / H05: M19 §19.2.2–19.2.4: design considerations; detailed confounding records are this case’s own design / H08: M19 §19.1.2–19.2.4; this case’s own application Adaptation to this IBD-F crossover question: Needed to avoid turning the original not-searched status into absence of interactions or effects on assays. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources

N34 · Is direct evidence available for pregnancy, children, active IBD or other fatigue disorders?

Current findings: The original safety explanation explicitly avoids direct application to pregnancy, children, acute exacerbation or other diseases, and does not present a high-dose study as a self-dosing instruction. Direct evidence for these groups is currently unverified.
Verification status: Unverified
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: Direct efficacy and harm evidence outside the selected quiescent-IBD population was not verified.
Reason for missing information: Direct comparisons in special populations, active disease and other conditions, and long-term or rare harms, are unverified.
Required materials and conditions: Actual diagnosis, exposure, comparator, fatigue, harm and follow-up materials for each population extension
Materials to obtain first: Actual diagnosis, exposure, comparator, fatigue, harm and follow-up materials for each population extension
Further research: Define each population as an independent question and review eligibility of direct evidence and limits of applicability and harm assessment.
Remaining uncertainty: Direct comparisons in special populations, active disease and other conditions, and long-term or rare harms, are unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: Direct evidence on the relevant intervention, exposure, comparator, fatigue and harms is verified for each population extension.
Why this condition is needed: Needed to avoid extending a short high-dose study in quiescent IBD to efficacy and safety in every population.
Application exceptions: Do not turn insufficient direct evidence into instructions to delay treatment or self-administer high doses.
Referenced methods: C04: M03 §3.2.1; detailed population conditions are this case’s own design / E08: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are this case’s own design / E10: M19 §19.1.2–19.2.4; this case’s own application / H08: M19 §19.1.2–19.2.4; this case’s own application / H09: Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was applied Adaptation to this IBD-F crossover question: Needed to avoid extending a short high-dose study in quiescent IBD to efficacy and safety in every population. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04

N35 · Are the stored summaries read in this work distinguished from external materials and historical access levels?

Current findings: The complete Korean and English text, structure, 5 evidence records and 5 citations in the currently stored summary were read. S04 historically had publisher-abstract and funding access; S05, S07 and S08 had HTML full-text access; S06 had a provided-abstract-extraction record. External materials were neither accessed nor read in this work.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: The recording condition separating current local-summary review from material-specific historical access is met. This is not current verification of full clinical papers.
Reason for missing information: The original full statistical text and supplement for S04 and all linked external materials were not checked in this work.
Required materials and conditions: Records of each material's existence, access, acquisition and reading status, with exact source locations and hashes
Materials to obtain first: Records of each material's existence, access, acquisition and reading status, with exact source locations and hashes
Further research: Compare material types with actual action receipts, distinguishing a summary reader from the reading status of an external link.
Remaining uncertainty: The original full statistical text and supplement for S04 and all linked external materials were not checked in this work. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The exact locations read in the stored manuscript are recorded separately from each material's historical access and current external access not attempted or material not read.
Why this condition is needed: Needed to avoid promoting a summary link or historical full-text access into external reading in this work.
Application exceptions: Do not label the historical failure to obtain the full S04 statistical text as a current access failure. External access was not attempted in this work.
Referenced methods: C03: M04 §4.5–4.6: principles for collecting and selecting materials; separating access from reading and the hyperlink requirements are this case’s own design / C09: M04 §4.5, §4.6.3; limits on converting the current materials follow the user’s scope and this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid promoting a summary link or historical full-text access into external reading in this work. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources S04 S05 S06 S07 S08

N36 · Are the evidence cutoff, material-specific access dates, review dates, original judgment and correction history distinguished?

Current findings: The revision-policy search cutoff and original review date are 2026-09-15. Citations lack material-specific access-date fields, so historical access dates remain empty. Original C50, B/P/R1/I2/EX/B2/CX and the two corrections are retained as historical values.
Verification status: Met
Materials actually read: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.
Why unverified: This narrow record of dates, original values and version attribution is linked to actual fields and hashes. It is not a new clinical grade or official methodological certification.
Reason for missing information: Actual material-specific access dates are absent from the manuscript and remain unverified.
Required materials and conditions: The current manuscript, versions, dates, original judgment, corrections, revision records and input hashes
Materials to obtain first: The current manuscript, versions, dates, original judgment, corrections, revision records and input hashes
Further research: Compare actual version and date fields; after a change, preserve the complete earlier version, reasons and separate freezing and application of new conditions.
Remaining uncertainty: Actual material-specific access dates are absent from the manuscript and remain unverified. No new effect sizes, CIs, incidence rates or grades are calculated or reassessed.
Conditions for verification: The search cutoff and original review date of 2026-09-15, unverified material-specific access dates and new review date are distinguished, while original grades, scores, axes and corrections are preserved byte for byte.
Why this condition is needed: Needed to avoid substituting a global original-review date for material-specific access dates or using C50 as a new condition score.
Application exceptions: Do not invent separate fields or lists absent from the manuscript; preserve the empty subclaim list and original empty values.
Referenced methods: C09: M04 §4.5, §4.6.3; limits on converting the current materials follow the user’s scope and this case’s own design / C08: M04 §4.6.3, M15 §15.3.1–15.3.3; separating verification states is this case’s own design Adaptation to this IBD-F crossover question: Needed to avoid substituting a global original-review date for material-specific access dates or using C50 as a new condition score. Roles, exceptions and criteria are this case’s own design; no new clinical assessment was performed.

Related sources