Single-ingredient ordinary thiamine (vitamin B1) × Pain relief in painful diabetic peripheral neuropathy

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 · Independent claimWhich B1, population and pain question is being checked?Required for the selected B1-only pain comparison	This is one independent claim about patient-reported pain in painful diabetic peripheral neuropathy with ordinary oral B1 alone. The subclaim array is empty. S03 S22	Verifying the identity of the question does not establish an eligible treatment effect.	Identity of the question: ordinary oral thiamine alone, adults with painful DPN, patient-reported pain, and placebo/no addition on matched usual care	Compare each candidate's ingredient, population and outcome boundaries with the original question.
2	Unverified	Full text not readStored summary read	N02 · Molecule and single ingredientWas the actual exposure to thiamine alone verified in an eligible result?Required for the selected B1-only pain comparison	The actual study ingredient and chemical-form values are blank and unconfirmed. Their linked-source lists are also empty.	The Korean ingredient name defines the question; it is not a verified molecular identity in an eligible study.	Exact vitamer, salt, single-ingredient identity and actual administration documents	Link formulation documents with arm-specific outcomes to examine actual exposure.
3	Unverified	Full text not readStored summary read	N03 · Formulation and originWere the salt, release form, manufacture and purity of an eligible formulation verified?Required for the selected B1-only pain comparison	The question concerns ordinary thiamine alone by mouth; the salt, formulation and manufacturing origin in an eligible trial are unconfirmed.	Non-applicability of plant classification does not verify product specifications.	Exact salt, formulation, manufacturing origin, purity, batch and excipients	Compare the formulation specifications and batch with the scope of the corresponding result.
4	Unverified	Full text not readStored summary read	N04 · Actual routeWere records of actual oral administration obtained for an eligible trial?Required for the selected B1-only pain comparison	The question specifies oral administration, but the actual route in an eligible study is blank and unconfirmed. Its linked-source list is also empty.	The actual administration route in an eligible study was not verified.	Actual administration route, adherence and exposure records	Link administration methods and medication records to the original result.
5	Partly verified	Full text not readStored summary read	N05 · Dose and concurrent B6Were both the eligible single-ingredient dose and the component amounts in the combination comparison verified?Required for the selected B1-only pain comparison	S22 compares B1 25 mg+B6 50 mg with B1 1 mg+B6 1 mg. The actual dose in an eligible monotherapy trial is blank and unconfirmed. S22	Do not transfer combination-comparison dose records into evidence for B1 alone or a recommended dose.	Nominal and actual dose, frequency and concurrent ingredients in an eligible monotherapy trial	Use arm-specific administration and ingredient tables to examine whether only B1 differs.
6	Unverified	Full text not readStored summary read	N06 · DurationWere treatment and follow-up durations verified in an eligible monotherapy trial?Required for the selected B1-only pain comparison	Treatment and follow-up duration in an eligible monotherapy trial is blank and unconfirmed. Its linked-source list is also empty.	Do not invent a verified appropriate duration or long-term effect for the current question.	Actual treatment, assessment and post-treatment follow-up schedules	Link plans, outcome tables and assessment schedules.
7	Unverified	Full text not readStored summary read	N07 · Population selectionWere diagnostic and selection records obtained for adults with painful DPN in an eligible study?Required for the selected B1-only pain comparison	The question concerns adults with painful DPN, as does the S03 registry title. Actual eligible results and the analysis population remain unconfirmed. S03	A registry title and question wording do not substitute for details of the actual eligible population.	DPN and pain diagnosis, inclusion/exclusion, baseline severity and diabetes status	Compare selection and baseline tables with the analysis population.
8	Unverified	Full text not readStored summary read	N08 · Baseline nutritional statusWere B1 deficiency and baseline status verified in the eligible population?Required for the selected B1-only pain comparison	Baseline nutritional-status values are blank and unconfirmed. Full details of deficiency assessment in the eligible population are also unconfirmed.	Deficient versus non-deficient status and effect modification cannot currently be established.	Baseline B1 status, testing methods, deficiency criteria and arm-specific distributions	Compare tests, diagnosis and arm-specific baseline tables with the outcomes.
9	Unverified	Full text not readStored summary read	N09 · Diet and concurrent exposuresWere total intake, concurrent vitamins and usual care verified?Required for the selected B1-only pain comparison	Total dietary intake and concurrent-vitamin records are blank and unconfirmed. S22 also changes B6. S22	Details of total intake and concurrent treatment in an eligible single-ingredient comparison were not established.	Arm-specific exposure to total diet, all supplements, concurrent vitamins and usual care	Compare intake, medication and concurrent-treatment records with arm-specific results.
10	Unverified	Full text not readStored summary read	N10 · Actual comparatorWere matched placebo/no addition and usual care verified for an eligible result?Required for the selected B1-only pain comparison	The question specifies placebo/no addition on matched usual care; actual eligible comparative results are unconfirmed. S22 compares amounts of mixed ingredients. S03 S22	Do not establish the comparator specified in the question as the actual design of an eligible trial.	Actual comparator composition, schedule, usual care and arm-specific changes	Link assignment, administration and care records to the original result.
11	Unverified	Full text not readStored summary read	N11 · Pain measureWere the actual pain scale and assessment times verified for an eligible result?Required for the selected B1-only pain comparison	The question concerns patient-reported neuropathic pain, but the specific scale in an eligible trial is unconfirmed. The S03 record states that the result body and actual scale were not obtained in the historical review. S03	Do not arbitrarily assign NRS or another specific scale or unit.	Patient-reported pain scale, direction, units and baseline/follow-up times	Link the scale, assessment plan and outcome table to the same population.
12	Unverified	Full text not readStored summary read	N12 · Primary outcome and selective reportingWere the registered/planned primary outcome and actual pain results compared?Required for the selected B1-only pain comparison	The registered primary outcome and the relationship between the study primary outcome and this page's outcome are blank and unconfirmed. An independent registry comparison and eligible results are also unconfirmed. S03	Agreement with or deviation from a prespecified primary outcome, or selective reporting, cannot currently be established.	Dated registration, protocol, SAP and locations of the actual results	Directly compare the timing of registry/protocol changes with published results.
13	Unverified	Full text not readStored summary read	N13 · Design and biasWere assignment, blinding and analysis methods verified for an eligible comparison?Required for the selected B1-only pain comparison	S03 historically recorded failure to access the official body; eligible results remain unconfirmed. The original bias axis is blank. S03	Do not turn unconfirmed methods into verified bias or a new score.	Randomization, concealment, blinding, planned analyses and change records	Compare plans, methods and results, distinguishing unconfirmed information from verified defects.
14	Unverified	Full text not readStored summary read	N14 · Denominators and missing dataWere the actual analysis denominator and missing-data handling verified for the pain result?Required for the selected B1-only pain comparison	The actual analysis population size is blank and unconfirmed. The existing evidence record states that only verified denominators are retained in historical numerical records, and that assignment totals do not replace analysis denominators. S03 S22	Eligible analysis n, attrition and missing-data handling were not obtained.	Assigned, exposed, measured and analyzed n; attrition, analysis sets and missing-data handling	Link participant flow, arm-specific results and analysis plans.
15	Unverified	Full text not readStored summary read	N15 · Effect and intervalWere the between-group pain effect and uncertainty interval verified for B1 alone?Required for the selected B1-only pain comparison	An eligible effect estimate and interval were not verified for the exact question. The original effect and precision axes are also blank. S03 S22	Do not invent a conclusion of no effect, arbitrary values or a probability of success.	Eligible between-group effect, units, analysis model, denominator and CI	Compare between-group results with the model, denominator and time, and record interpretive limits.
16	Unverified	Full text not readStored summary read	N16 · Clinical magnitudeWere meaningful differences and responder data obtained for the pain measure?Required for the selected B1-only pain comparison	The specific eligible pain scale and results are unconfirmed. The original effect-size review record states that no NNT was generated because an appropriate verified event table was unavailable.	Do not generate a common threshold, responder rate, NNT or approximate effect.	Scale-specific clinical meaning, responder definition, person denominator and period	Link measurement validity and responder definitions with the actual comparative results.
17	Unverified	Full text not readStored summary read	N17 · Registry candidateWas the actual result body obtained for NCT00279266?Required for the selected B1-only pain comparison	S03 is a historical record of reaching the official registry's opening page without being able to read the result body. Whether results exist was not established. S03	External access attempts in this work: 0. Do not infer non-conduct, a null result, withdrawn status, completed status or 0 results.	Original registry body, change history, results and linked papers	If a later update is authorized, compare original locations, times and changes for the registration and linked results.
18	Met	Full text not readStored summary read	N18 · Combination exclusionWas the Abbas–Swai comparison excluded from the effect of B1 alone?Required for the selected B1-only pain comparison	S22 compares B1 25 mg+B6 50 mg with B1 1 mg+B6 1 mg. Because B6 also changes, it cannot identify the effect of B1 alone. The existing record also excluded this comparison as direct evidence for the single ingredient. S22	This exclusion does not mean the study itself, or all B-vitamin effects, are absent.	Arm-specific B1+B6 amounts and identifiability of each ingredient's contribution	Compare arm-specific administration tables with the scope of the results.
19	Partly verified	Full text not readStored summary read	N19 · Reports and study familiesWere the actual study and participant-family relationships between the two reports verified?Required for the selected B1-only pain comparison	S03 is the NCT00279266 candidate; S22 has the stored study identifier Abbas-Swai-1997. Two reports do not mean 2 eligible single-ingredient replications. S03 S22	Actual unique participants, direct replication and complete independence between families are not certified.	Link reports to registration/study families, then outcomes, times and analyses	Link registration, paper, participant and time identities to examine duplication.
20	Met	Full text not readStored summary read	N20 · Current reading scopeWere stored summaries, unread external materials and historical access distinguished?Required for the selected B1-only pain comparison	The entire stored manuscript summary was read; current external lookups total 0. S03's registry opening page and S22's indexed author abstract are historical access records. Individual access dates are not recorded. S03 S22	The original review date is a global review date; it is not reused as an individual source-access date.	Actual acquisition, reading, historical access level, locations and dates for each material	If later authorized, record actual source bytes, access date and exact location for each material.
21	Met	Full text not readStored summary read	N21 · Cutoff date and search scopeWere the original cutoff, search limitations and scope of this conversion distinguished?Required for the selected B1-only pain comparison	The search cutoff and original review date are 2026-09-15. The record is not an exhaustive search of native databases worldwide; this work converts the stored summary into a table.	Do not attribute the search-scope record to a new report when its linked-source list is empty.	Search cutoff, original review date, current summary-review date and actual work scope	In an authorized update, compare actual search logs with subsequent materials and corrections.
22	Unverified	Full text not readStored summary read	N22 · Replication and independenceWas evidence of independent replication verified for the exact single-ingredient pain comparison?Required for the selected B1-only pain comparison	Eligible results were not verified, so the replication and independence axes are blank. Related judgments with different molecules or population/outcome boundaries were not treated as the same completed claim. S03 S22	Do not create repeated refutation or independent replication from related IDs or report counts.	Eligible replication results, teams, funding and participant/data overlap	Compare outcomes, study families, authors/funding and data overlap.
23	Unverified	Full text not readStored summary read	N23 · Funding and conflicts of interestWere funding, author roles and conflicts of interest obtained for the eligible result?Supplementary; required for independence claims	Funding information for both evidence records is unconfirmed or recorded as unused in this page's grade; the independence axis is blank. S03 S22	Original funding materials were not newly read, and independence is not certified.	Original funding, affiliations, roles, COI and data independence	Compare original funding/COI declarations with the actual study and data relationships.
24	Met	Full text not readStored summary read	N24 · Preserving the original judgmentWere the original ?, blank values and bounded eligible-human-result-unverified flag preserved?Required for the selected B1-only pain comparison	The original grade is ?, with no score. Unused assessment axes are blank. The eligible-human-result-unverified flag is recorded as true and is limited to not identifying an eligible result within the documented search scope. S03 S22	No new scoring or calculation was performed, and the original judgment was not based on access failure alone.	Original grade, score, axes, judgment scope and revision policy	Compare the original stored-manuscript bytes with each linked location to verify display scope.
25	Met	Full text not readStored summary read	N25 · Clinical and biochemical boundariesWas the pain question distinguished from circulating vitamers?Required for the selected B1-only pain comparison	The record distinguishing biochemical measures from clinical outcomes has a blank value and confirmed information status. It states that patient symptom/function questions are separate from circulating vitamers.	This is neither a verified pain effect nor an actual biochemical measurement.	Question boundaries between patient symptoms/function and biochemical measures	Examine candidate measures separately from actual patient outcomes.
26	Unverified	Full text not readStored summary read	N26 · SafetyWere harms and discontinuation data obtained for the same single-ingredient product, population and period?Supplementary; required for safety claims	Eligible efficacy and safety results for the exact monotherapy are unconfirmed. The adverse-event record is blank and unconfirmed; the original safety status is unknown. S03 S22	Unconfirmed harms do not mean AE0 or safety; combination results are not inherited.	AE collection, person/event denominators, discontinuation, period, concurrent treatment and vulnerable populations	Compare exposure, harm collection, discontinuation and follow-up records.
27	Unverified	Full text not readStored summary read	N27 · Assay interference and drug interactionsIs there a separate verification scope for assay interference and concurrent drugs?Supplementary; required for interpreting interference or interactions	Assay-interference and drug-interaction records have blank values and are marked as not separately searched. The original record states that no separate systematic or comprehensive search was conducted.	Reading the summary alone does not verify absence of interference or interactions.	Actual assay/drug exposure, interference and interaction information, and work scope	In an authorized extension, separately review actual assay and concurrent-exposure materials.
28	Not applicable	Full text not readStored summary read	N28 · Long-term and optimal-dose extensionsDoes the current pain question also include optimal-dose and post-treatment persistence claims?Supplementary; required for optimal-dose or long-term extensions	This table compares B1 alone for painful DPN pain; it does not add optimal-dose or post-treatment persistence claims as requirements.	Not applicable is not a judgment of absent long-term data, safety or no effect.	Boundary between the fixed question and separate dose-comparison or long-term/post-treatment persistence questions	When an extension is requested, review direct dose comparisons and post-treatment/long-term follow-up as separate questions.
29	Not applicable	Full text not readStored summary read	N29 · Deficiency and other-outcome extensionsDoes this table include correction of deficiency neuropathy or other nerve outcomes?Supplementary; required for deficiency or other-outcome extensions	Adults with painful DPN are distinguished from confirmed B1-deficiency neuropathy. Related 162 and 544 have different ingredient or population/outcome boundaries.	Non-applicability of an extension is not interpreted as no effect in related research.	Separate boundaries for confirmed deficiency, nerve function, symptoms and the selected pain comparison	For an extension, directly review the corresponding diagnosis/outcome materials as a separate independent question.
30	Met	Full text not readStored summary read	N30 · Updates and correctionsWere updates for new evidence, access or corrections linked with preservation of previous originals?Required for the selected B1-only pain comparison	The original policy calls for updates after new eligible evidence, full text/registry results, or numerical/unit/source corrections, preserving previous values, reasons, sources and dates. S03 S22	This stored record was written before public deployment. Separating this table is not a new clinical-evidence review or regrading event.	Triggers, verified materials, reasons for changes, dates and previous originals/judgments	Compare the identity, location and hashes of new materials/corrections separately from change decisions.
31	Met	Full text not readStored summary read	N31 · Contrary and conflicting resultsWere all verified related materials and the original limits on refutation preserved?Required for the selected B1-only pain comparison	Both the S03 registry candidate and S22 combination comparison were preserved. The stored summary states that repeated refutation RX was not established, so F was not assigned. S03 S22	This preservation does not certify a direct effect or worldwide absence of research.	Roles, results and exclusion reasons for both reports, and the original scope of refutation	Compare original roles, results and exclusion reasons against the same single-ingredient question.

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31 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 painful diabetic peripheral neuropathy; distinct from confirmed B1 (thiamine)-deficiency neuropathy
Ingredient, formulation and route: Question: ordinary thiamine alone by mouth; salt and formulation in an eligible outcome study unconfirmed
Dose: Actual dose in an eligible monotherapy outcome study unconfirmed
Comparator: Question: placebo/no addition on matched usual care; actual eligible comparative results unconfirmed
Measured outcome: Patient-reported neuropathic pain; specific scale in an eligible study unconfirmed
Duration: Treatment and follow-up duration in an eligible monotherapy study unconfirmed
Questions outside this scope: Benfotiamine, B1+B6 and other combinations, correction of confirmed B1-deficiency neuropathy, other nerve-function outcomes, optimal dose and long-term persistence are separate questions. Existing 162/544/110/1429 are retained as metadata only; their individual manuscripts were not read for this work.

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.

S03 · Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy

Official source

Material type: Historical record of an official registry opening page and failed result-body 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: The official registry URL was reached, but its result body was not readable. A trial candidate is not the same as an obtained outcome result.
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: Distinguishes the identities and roles of two stored reports; does not certify 2 eligible monotherapy studies, a unique-participant total or independent replication.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored bibliographic information, summaries and historical review records	Stored locally	Obtained	Summary read	The locations and values in the stored summary were verified. This does not mean the original clinical full text was obtained.
ClinicalTrials.gov registry webpage and unobtained result body	Unconfirmed (current external lookups 0)	Access not attempted	Unread	Current external entry link provided; material unread. Historical indexed author abstracts, registry opening pages and failed result access are not promoted to current access records.

S22 · Abbas and Swai — thiamine plus pyridoxine in symptomatic diabetic neuropathy (1997)

Official source

Material type: Indexed author-abstract record of a comparison changing B1+B6 doses together
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: The neuropathy trial compared B1 25 mg plus B6 50 mg with B1 1 mg plus B6 1 mg. Because B6 also changed, it does not isolate thiamine (B1).
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: Distinguishes the identities and roles of two stored reports; does not certify 2 eligible monotherapy studies, a unique-participant total or independent replication.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored bibliographic information, summaries and historical review records	Stored locally	Obtained	Summary read	The locations and values in the stored summary were verified. This does not mean the original clinical full text was obtained.
PubMed paper bibliography/author abstract and linked full-text entry	Unconfirmed (current external lookups 0)	Access not attempted	Unread	Current external entry link provided; material unread. Historical indexed author abstracts, registry opening pages and failed result access are not promoted to current access records.

Report counts versus independent study counts

S03 is the NCT00279266 registry candidate; S22 records the Abbas–Swai B1+B6 combination comparison. Their identities and roles are distinguished, but the two reports are not counted as 2 eligible thiamine-only trials or independent replications. Actual unique participants and complete independence between families remain unconfirmed.

Review criteria

Version 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 B1, population and pain question is being checked?

Required materials and conditions: Identity of the question: ordinary oral thiamine alone, adults with painful DPN, patient-reported pain, and placebo/no addition on matched usual care
Conditions for verification: Fix one question by linking the original effect, population, outcome, comparator and empty subclaim list.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Benfotiamine, B1+B6 and correction of confirmed deficiency are separate questions.
Why this condition is needed: The exact comparison must be distinguished from related ingredients and deficiency neuropathy.
Referenced methods: M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.1: detailed population conditions are internally designed; M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed

N02 · Was the actual exposure to thiamine alone verified in an eligible result?

Required materials and conditions: Exact vitamer, salt, single-ingredient identity and actual administration documents
Conditions for verification: Verify the actual molecule and single ingredient in an eligible result from the original administration documents.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not transfer results for benfotiamine or comparisons that also change B6.
Why this condition is needed: Ordinary thiamine in the question must not be mistaken for the actual trial formulation.
Referenced methods: M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application

N03 · Were the salt, release form, manufacture and purity of an eligible formulation verified?

Required materials and conditions: Exact salt, formulation, manufacturing origin, purity, batch and excipients
Conditions for verification: Verify the actual product specifications used in the eligible comparison.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Plant-part classification is not applicable, but gaps in manufacture and formulation remain.
Why this condition is needed: Results for different salts, derivatives or products must not be combined as if they concerned the same formulation.
Referenced methods: M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed

N04 · Were records of actual oral administration obtained for an eligible trial?

Required materials and conditions: Actual administration route, adherence and exposure records
Conditions for verification: Link the eligible result and actual oral administration within the same documents.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: The route specified in the question does not verify an unobtained registry result.
Why this condition is needed: The oral-route condition in the question must be distinguished from actual study records.
Referenced methods: M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application

N05 · Were both the eligible single-ingredient dose and the component amounts in the combination comparison verified?

Required materials and conditions: Nominal and actual dose, frequency and concurrent ingredients in an eligible monotherapy trial
Conditions for verification: Verify the single-ingredient dose and actual intake separately from each component amount in the combination comparison.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: 25 mg+B6 50 mg versus 1 mg+B6 1 mg is an excluded combination comparison.
Why this condition is needed: A comparison that also changes B6 must not be treated as a B1 dose effect.
Referenced methods: M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed

N06 · Were treatment and follow-up durations verified in an eligible monotherapy trial?

Required materials and conditions: Actual treatment, assessment and post-treatment follow-up schedules
Conditions for verification: Verify treatment, assessment and follow-up times for the selected result.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not inherit another trial's duration for this question.
Why this condition is needed: An arbitrary minimum number of weeks must not replace an unconfirmed duration.
Referenced methods: M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M08 Table 8.2.a, M04 §4.6.3: internal application; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed

N07 · Were diagnostic and selection records obtained for adults with painful DPN in an eligible study?

Required materials and conditions: DPN and pain diagnosis, inclusion/exclusion, baseline severity and diabetes status
Conditions for verification: Link the diagnostic and selection criteria for the actual eligible population with the outcome population.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Confirmed B1-deficiency neuropathy is separate.
Why this condition is needed: A registry title alone must not establish the actual analysis population.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; detailed dose, persistence and effect-modification conditions are internally designed

N08 · Were B1 deficiency and baseline status verified in the eligible population?

Required materials and conditions: Baseline B1 status, testing methods, deficiency criteria and arm-specific distributions
Conditions for verification: Verify actual baseline status and assessment methods in the eligible population.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not infer deficiency from symptoms alone.
Why this condition is needed: Deficiency correction must be distinguished from the question of DPN pain without deficiency.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; detailed dose, persistence and effect-modification conditions are internally designed

N09 · Were total intake, concurrent vitamins and usual care verified?

Required materials and conditions: Arm-specific exposure to total diet, all supplements, concurrent vitamins and usual care
Conditions for verification: Verify arm-specific concurrent exposures and shared treatment in an eligible comparison.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: The B6 change in S22 is not interpreted as a single-ingredient effect.
Why this condition is needed: Confounding in comparisons that change vitamins and treatment together must be distinguished.
Referenced methods: M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed

N10 · Were matched placebo/no addition and usual care verified for an eligible result?

Required materials and conditions: Actual comparator composition, schedule, usual care and arm-specific changes
Conditions for verification: Verify the actual comparator and shared care for an eligible result.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not recast a comparison that changes both B1 and B6 amounts as a matched single-ingredient comparison.
Why this condition is needed: The planned comparison in the question must be distinguished from the comparison actually observed.
Referenced methods: M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application; M08 §8.2.2, M15 §15.3.1: internal application

N11 · Were the actual pain scale and assessment times verified for an eligible result?

Required materials and conditions: Patient-reported pain scale, direction, units and baseline/follow-up times
Conditions for verification: Verify the actual measure and assessment times for the selected patient-reported pain outcome.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not import the NRS scale from another case.
Why this condition is needed: A registry title or general symptoms must not be converted into a specific pain result.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs; M08 Table 8.2.a, M03 §3.2.4; internal application

N12 · Were the registered/planned primary outcome and actual pain results compared?

Required materials and conditions: Dated registration, protocol, SAP and locations of the actual results
Conditions for verification: Verify agreement between the prespecified plan and reported outcomes, times and analyses.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Failure to obtain the registry body is not conclusive evidence of selective reporting.
Why this condition is needed: A title mentioning pain must not establish it as the prespecified primary outcome.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design; M08 Table 8.2.a, M03 §3.2.4: internal application; M08 §8.2.2, M15 §15.3.1: internal application; M08 Table 8.2.a, M04 §4.6.3: internal application

N13 · Were assignment, blinding and analysis methods verified for an eligible comparison?

Required materials and conditions: Randomization, concealment, blinding, planned analyses and change records
Conditions for verification: Verify methods and material limitations for the actual eligible comparison.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not replace the original blank bias value with a new B grade.
Why this condition is needed: Unobtained methods must not be scored as invented defects.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4: design-specific adaptation is internally designed; M08 §8.1–8.2.3: internal application; M08 §8.2.2, M15 §15.3.1: internal application

N14 · Were the actual analysis denominator and missing-data handling verified for the pain result?

Required materials and conditions: Assigned, exposed, measured and analyzed n; attrition, analysis sets and missing-data handling
Conditions for verification: Verify denominators and missing-data handling for the specific outcome, time and analysis.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: A path to a numerical-data file does not mean that file was actually read for this work.
Why this condition is needed: The assigned population must not replace the analysis denominator.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4: design-specific adaptation is internally designed; M15 §15.3.1–15.3.3: internal application; M08 Table 8.2.a, M04 §4.6.3: internal application

N15 · Were the between-group pain effect and uncertainty interval verified for B1 alone?

Required materials and conditions: Eligible between-group effect, units, analysis model, denominator and CI
Conditions for verification: Verify the estimate and interval for the selected single-ingredient comparison from actual results.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not calculate a new effect size from P values, within-group changes or combination results.
Why this condition is needed: An unverified effect must not become an effect of 0 or the effect of another combination.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M15 §15.3.1–15.3.3: internal application; M08 Table 8.2.a, M04 §4.6.3: internal application

N16 · Were meaningful differences and responder data obtained for the pain measure?

Required materials and conditions: Scale-specific clinical meaning, responder definition, person denominator and period
Conditions for verification: Verify clinical-magnitude information corresponding to the actual scale and result.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not invent an event table for a continuous outcome.
Why this condition is needed: Do not invent a common MCID or NNT while the specific scale is unconfirmed.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4: internal application; M15 §15.3.1–15.3.3: internal application; M03 §3.2.4: internal boundary for expanded claims

N17 · Was the actual result body obtained for NCT00279266?

Required materials and conditions: Original registry body, change history, results and linked papers
Conditions for verification: Separately verify existence, acquisition and content of the actual registry body and results.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not turn historical access failure into a current connection failure or proof of no results.
Why this condition is needed: A candidate registry entry must be distinguished from actual result acquisition.
Referenced methods: M04 §4.6.1–4.6.2: distinguish studies from reports; cohort/result linkage is an internal application; M04 §4.5–4.6: material collection/selection principles; separating access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design

N18 · Was the Abbas–Swai comparison excluded from the effect of B1 alone?

Required materials and conditions: Arm-specific B1+B6 amounts and identifiability of each ingredient's contribution
Conditions for verification: Link actual combination amounts and the original exclusion reason to the same material.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not erase related human research as nonexistent.
Why this condition is needed: A comparison that also changes other ingredients must not be mistaken for a single-ingredient causal effect.
Referenced methods: M04 §4.6.1–4.6.2: distinguish studies from reports; cohort/result linkage is an internal application; M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application

N19 · Were the actual study and participant-family relationships between the two reports verified?

Required materials and conditions: Link reports to registration/study families, then outcomes, times and analyses
Conditions for verification: Verify actual registration, study and participant relationships from original materials, distinguishing unconfirmed links.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Do not count unconfirmed links or duplicates as verified replication.
Why this condition is needed: Bibliographic counts must not become counts of eligible studies or unique participants.
Referenced methods: M04 §4.6.1–4.6.2 on distinguishing studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

N20 · Were stored summaries, unread external materials and historical access distinguished?

Required materials and conditions: Actual acquisition, reading, historical access level, locations and dates for each material
Conditions for verification: Distinguish and link actual reading of the stored local summary from current external non-attempt/non-reading.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Registry opening-page access and indexed author-abstract records remain historical.
Why this condition is needed: Providing a URL must not be promoted to reading the original full text.
Referenced methods: M04 §4.5–4.6 on collecting/selecting material; access/reading separation and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; the limits of this material conversion follow the user's scope and internal design

N21 · Were the original cutoff, search limitations and scope of this conversion distinguished?

Required materials and conditions: Search cutoff, original review date, current summary-review date and actual work scope
Conditions for verification: Separate the original cutoff and search scope from the lack of current external work.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: A search-log path alone does not establish that the log was read for this work.
Why this condition is needed: A conversion of stored materials must not be exaggerated into a new exhaustive literature search.
Referenced methods: M04 §4.5–4.6 on collecting/selecting material; access/reading separation and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; the limits of this material conversion follow the user's scope and internal design

N22 · Was evidence of independent replication verified for the exact single-ingredient pain comparison?

Required materials and conditions: Eligible replication results, teams, funding and participant/data overlap
Conditions for verification: Verify eligible replication and independent identities for the same ingredient, population and outcome.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: The individual manuscripts for benfotiamine 544 and general nerve function 162 were not read for this work.
Why this condition is needed: Related research must be distinguished from replication of the single-ingredient claim.
Referenced methods: M04 §4.6.1–4.6.2: distinguish studies from reports; cohort/result linkage is an internal application; Chamgap's own independence/attribution conditions are not fully guaranteed by the official method sections used in this demonstration; M04 §4.6.1–4.6.2, M15 §15.3.1: internal application

N23 · Were funding, author roles and conflicts of interest obtained for the eligible result?

Required materials and conditions: Original funding, affiliations, roles, COI and data independence
Conditions for verification: Directly verify declarations and roles for the eligible result.
Requirement and applicability: Supplementary; required for independence claims
Application exceptions: Do not transfer funding information from another study.
Why this condition is needed: Unconfirmed information must not become proof of non-involvement or verified bias.
Referenced methods: Chamgap's own independence/attribution conditions are not fully guaranteed by the official method sections used in this demonstration; M04 §4.6.1–4.6.2, M15 §15.3.1: internal application

N24 · Were the original ?, blank values and bounded eligible-human-result-unverified flag preserved?

Required materials and conditions: Original grade, score, axes, judgment scope and revision policy
Conditions for verification: Preserve original values, blanks, false values, empty arrays and judgment scope without conversion.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Document-quality A and grade ? are separate; they do not mean no effect or 0 studies worldwide.
Why this condition is needed: Checklist status must not be confused with the existing clinical grade or a new certification.
Referenced methods: M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design

N25 · Was the pain question distinguished from circulating vitamers?

Required materials and conditions: Question boundaries between patient symptoms/function and biochemical measures
Conditions for verification: Verify the distinction between the original patient symptom/function question and biochemistry.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Preserve the blank biochemical value and the confirmed information status.
Why this condition is needed: Biochemical changes must not replace a pain effect.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M03 §3.2.4: internal boundary for expanded claims

N26 · Were harms and discontinuation data obtained for the same single-ingredient product, population and period?

Required materials and conditions: AE collection, person/event denominators, discontinuation, period, concurrent treatment and vulnerable populations
Conditions for verification: Verify actual harms, collection scope and denominators for that single-ingredient exposure.
Requirement and applicability: Supplementary; required for safety claims
Application exceptions: Do not change the original unknown safety status into a new safety grade.
Why this condition is needed: Tolerability of other B-vitamin combinations must not be transferred to B1 alone.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4: design-specific adaptation is internally designed; M19 §19.1.2–19.2.4: internal application

N27 · Is there a separate verification scope for assay interference and concurrent drugs?

Required materials and conditions: Actual assay/drug exposure, interference and interaction information, and work scope
Conditions for verification: Verify materials and review scope supporting the particular interference or interaction claim.
Requirement and applicability: Supplementary; required for interpreting interference or interactions
Application exceptions: Do not turn an unperformed search into current access failure or clinical safety.
Why this condition is needed: Not conducting a separate search must not be interpreted as no impact.
Referenced methods: M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design; M08 Table 8.2.a, M03 §3.2.4: internal application; M19 §19.1.2–19.2.4: internal application

N28 · Does the current pain question also include optimal-dose and post-treatment persistence claims?

Required materials and conditions: Boundary between the fixed question and separate dose-comparison or long-term/post-treatment persistence questions
Conditions for verification: Distinguish the fixed question from additional optimal-dose or long-term persistence claims.
Requirement and applicability: Supplementary; required for optimal-dose or long-term extensions
Application exceptions: Do not turn unconfirmed duration into a verified long-term effect.
Why this condition is needed: A narrow question must not require every study of expanded claims.
Referenced methods: M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed

N29 · Does this table include correction of deficiency neuropathy or other nerve outcomes?

Required materials and conditions: Separate boundaries for confirmed deficiency, nerve function, symptoms and the selected pain comparison
Conditions for verification: Distinguish the selected population/outcome from separate expanded questions.
Requirement and applicability: Supplementary; required for deficiency or other-outcome extensions
Application exceptions: Do not erase related research or create a new judgment that research does not exist.
Why this condition is needed: Questions with different populations or outcomes must not be merged into one completed claim.
Referenced methods: M03 §3.2.1: detailed population conditions are internally designed; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed; M03 §3.2.4: internal boundary for expanded claims

N30 · Were updates for new evidence, access or corrections linked with preservation of previous originals?

Required materials and conditions: Triggers, verified materials, reasons for changes, dates and previous originals/judgments
Conditions for verification: Link the original revision policy with uncertainty disclosure, original preservation and row-level updates.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Condition changes are applied only after a separate new version is frozen.
Why this condition is needed: Future update triggers must not become a waiting condition for initial publication.
Referenced methods: M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design

N31 · Were all verified related materials and the original limits on refutation preserved?

Required materials and conditions: Roles, results and exclusion reasons for both reports, and the original scope of refutation
Conditions for verification: Preserve both current materials and all verified findings and limitations with their locations, regardless of direction.
Requirement and applicability: Required for the selected B1-only pain comparison
Application exceptions: Unverified eligible monotherapy results do not mean no effect or repeated refutation.
Why this condition is needed: Related human research must not be erased, nor results for other ingredients converted into refutation of the same question.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3: status distinctions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1: internal application

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

Partly verified: Some stored-summary information is verified, but gaps remain in the eligible population, formulation, scale and results
Unverified: Specified required materials cannot be established within the current stored scope; not an effect of 0, 0 studies worldwide or safety
Review incomplete: Original-material comparison/search was not performed within the authorized scope
Not reported: A scope-limited status indicating that the item is not stated in the specific material/section read
Inaccessible: Used only for materials where access was actually attempted and failed; not assigned to clinical materials in this work
Insufficient evidence meeting the conditions: Used only after related studies within the defined scope were reviewed and found insufficient to answer the condition; not applied universally in this work
Not applicable: Does not add optimal-dose, long-term persistence or other clinical-outcome requirements to the selected pain-change question
Conflicting information: Used when materials for the same question, time and analysis are incompatible upon comparison; not assigned merely because review values differ
Met: The specified question, scope, attribution and preservation links were verified; establishing a pain effect and certifying full-text reading are checked separately

Change history

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

The public page and materials were prepared from the existing 31 items. No new clinical search, verification-status change or scoring was 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 B1, population and pain question is being checked?

Current findings: This is one independent claim about patient-reported pain in painful diabetic peripheral neuropathy with ordinary oral B1 alone. The subclaim array is empty.
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: Verifying the identity of the question does not establish an eligible treatment effect.
Reason for missing information: Verifying the identity of the question does not establish an eligible treatment effect.
Required materials and conditions: Identity of the question: ordinary oral thiamine alone, adults with painful DPN, patient-reported pain, and placebo/no addition on matched usual care
Materials to obtain first: Identity of the question: ordinary oral thiamine alone, adults with painful DPN, patient-reported pain, and placebo/no addition on matched usual care
Further research: Compare each candidate's ingredient, population and outcome boundaries with the original question.
Remaining uncertainty: Verifying the identity of the question does not establish an eligible treatment effect.
Conditions for verification: Fix one question by linking the original effect, population, outcome, comparator and empty subclaim list.
Why this condition is needed: The exact comparison must be distinguished from related ingredients and deficiency neuropathy.
Application exceptions: Benfotiamine, B1+B6 and correction of confirmed deficiency are separate questions.
Referenced methods: M03 §3.1, §3.2.1–3.2.4: principles for clarifying the question; detailed separation rules are internally designed; M03 §3.2.1: detailed population conditions are internally designed; M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed

Related sources S03 S22

N02 · Was the actual exposure to thiamine alone verified in an eligible result?

Current findings: The actual study ingredient and chemical-form values are blank and unconfirmed. Their linked-source lists are also 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 Korean ingredient name defines the question; it is not a verified molecular identity in an eligible study.
Reason for missing information: The Korean ingredient name defines the question; it is not a verified molecular identity in an eligible study.
Required materials and conditions: Exact vitamer, salt, single-ingredient identity and actual administration documents
Materials to obtain first: Exact vitamer, salt, single-ingredient identity and actual administration documents
Further research: Link formulation documents with arm-specific outcomes to examine actual exposure.
Remaining uncertainty: The Korean ingredient name defines the question; it is not a verified molecular identity in an eligible study.
Conditions for verification: Verify the actual molecule and single ingredient in an eligible result from the original administration documents.
Why this condition is needed: Ordinary thiamine in the question must not be mistaken for the actual trial formulation.
Application exceptions: Do not transfer results for benfotiamine or comparisons that also change B6.
Referenced methods: M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application

Related sources

N03 · Were the salt, release form, manufacture and purity of an eligible formulation verified?

Current findings: The question concerns ordinary thiamine alone by mouth; the salt, formulation and manufacturing origin in an eligible trial are unconfirmed.
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: Non-applicability of plant classification does not verify product specifications.
Reason for missing information: Non-applicability of plant classification does not verify product specifications.
Required materials and conditions: Exact salt, formulation, manufacturing origin, purity, batch and excipients
Materials to obtain first: Exact salt, formulation, manufacturing origin, purity, batch and excipients
Further research: Compare the formulation specifications and batch with the scope of the corresponding result.
Remaining uncertainty: Non-applicability of plant classification does not verify product specifications.
Conditions for verification: Verify the actual product specifications used in the eligible comparison.
Why this condition is needed: Results for different salts, derivatives or products must not be combined as if they concerned the same formulation.
Application exceptions: Plant-part classification is not applicable, but gaps in manufacture and formulation remain.
Referenced methods: M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed

Related sources

N04 · Were records of actual oral administration obtained for an eligible trial?

Current findings: The question specifies oral administration, but the actual route in an eligible study is blank and unconfirmed. Its linked-source list is also 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 actual administration route in an eligible study was not verified.
Reason for missing information: The actual administration route in an eligible study was not verified.
Required materials and conditions: Actual administration route, adherence and exposure records
Materials to obtain first: Actual administration route, adherence and exposure records
Further research: Link administration methods and medication records to the original result.
Remaining uncertainty: The actual administration route in an eligible study was not verified.
Conditions for verification: Link the eligible result and actual oral administration within the same documents.
Why this condition is needed: The oral-route condition in the question must be distinguished from actual study records.
Application exceptions: The route specified in the question does not verify an unobtained registry result.
Referenced methods: M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application

Related sources

N05 · Were both the eligible single-ingredient dose and the component amounts in the combination comparison verified?

Current findings: S22 compares B1 25 mg+B6 50 mg with B1 1 mg+B6 1 mg. The actual dose in an eligible monotherapy trial is blank and unconfirmed.
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: Do not transfer combination-comparison dose records into evidence for B1 alone or a recommended dose.
Reason for missing information: Do not transfer combination-comparison dose records into evidence for B1 alone or a recommended dose.
Required materials and conditions: Nominal and actual dose, frequency and concurrent ingredients in an eligible monotherapy trial
Materials to obtain first: Nominal and actual dose, frequency and concurrent ingredients in an eligible monotherapy trial
Further research: Use arm-specific administration and ingredient tables to examine whether only B1 differs.
Remaining uncertainty: Do not transfer combination-comparison dose records into evidence for B1 alone or a recommended dose.
Conditions for verification: Verify the single-ingredient dose and actual intake separately from each component amount in the combination comparison.
Why this condition is needed: A comparison that also changes B6 must not be treated as a B1 dose effect.
Application exceptions: 25 mg+B6 50 mg versus 1 mg+B6 1 mg is an excluded combination comparison.
Referenced methods: M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed

Related sources S22

N06 · Were treatment and follow-up durations verified in an eligible monotherapy trial?

Current findings: Treatment and follow-up duration in an eligible monotherapy trial is blank and unconfirmed. Its linked-source list is also 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: Do not invent a verified appropriate duration or long-term effect for the current question.
Reason for missing information: Do not invent a verified appropriate duration or long-term effect for the current question.
Required materials and conditions: Actual treatment, assessment and post-treatment follow-up schedules
Materials to obtain first: Actual treatment, assessment and post-treatment follow-up schedules
Further research: Link plans, outcome tables and assessment schedules.
Remaining uncertainty: Do not invent a verified appropriate duration or long-term effect for the current question.
Conditions for verification: Verify treatment, assessment and follow-up times for the selected result.
Why this condition is needed: An arbitrary minimum number of weeks must not replace an unconfirmed duration.
Application exceptions: Do not inherit another trial's duration for this question.
Referenced methods: M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M08 Table 8.2.a, M04 §4.6.3: internal application; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed

Related sources

N07 · Were diagnostic and selection records obtained for adults with painful DPN in an eligible study?

Current findings: The question concerns adults with painful DPN, as does the S03 registry title. Actual eligible results and the analysis population remain unconfirmed.
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: A registry title and question wording do not substitute for details of the actual eligible population.
Reason for missing information: A registry title and question wording do not substitute for details of the actual eligible population.
Required materials and conditions: DPN and pain diagnosis, inclusion/exclusion, baseline severity and diabetes status
Materials to obtain first: DPN and pain diagnosis, inclusion/exclusion, baseline severity and diabetes status
Further research: Compare selection and baseline tables with the analysis population.
Remaining uncertainty: A registry title and question wording do not substitute for details of the actual eligible population.
Conditions for verification: Link the diagnostic and selection criteria for the actual eligible population with the outcome population.
Why this condition is needed: A registry title alone must not establish the actual analysis population.
Application exceptions: Confirmed B1-deficiency neuropathy is separate.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; detailed dose, persistence and effect-modification conditions are internally designed

Related sources S03

N08 · Were B1 deficiency and baseline status verified in the eligible population?

Current findings: Baseline nutritional-status values are blank and unconfirmed. Full details of deficiency assessment in the eligible population are also unconfirmed.
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: Deficient versus non-deficient status and effect modification cannot currently be established.
Reason for missing information: Deficient versus non-deficient status and effect modification cannot currently be established.
Required materials and conditions: Baseline B1 status, testing methods, deficiency criteria and arm-specific distributions
Materials to obtain first: Baseline B1 status, testing methods, deficiency criteria and arm-specific distributions
Further research: Compare tests, diagnosis and arm-specific baseline tables with the outcomes.
Remaining uncertainty: Deficient versus non-deficient status and effect modification cannot currently be established.
Conditions for verification: Verify actual baseline status and assessment methods in the eligible population.
Why this condition is needed: Deficiency correction must be distinguished from the question of DPN pain without deficiency.
Application exceptions: Do not infer deficiency from symptoms alone.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; detailed dose, persistence and effect-modification conditions are internally designed

Related sources

N09 · Were total intake, concurrent vitamins and usual care verified?

Current findings: Total dietary intake and concurrent-vitamin records are blank and unconfirmed. S22 also changes B6.
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: Details of total intake and concurrent treatment in an eligible single-ingredient comparison were not established.
Reason for missing information: Details of total intake and concurrent treatment in an eligible single-ingredient comparison were not established.
Required materials and conditions: Arm-specific exposure to total diet, all supplements, concurrent vitamins and usual care
Materials to obtain first: Arm-specific exposure to total diet, all supplements, concurrent vitamins and usual care
Further research: Compare intake, medication and concurrent-treatment records with arm-specific results.
Remaining uncertainty: Details of total intake and concurrent treatment in an eligible single-ingredient comparison were not established.
Conditions for verification: Verify arm-specific concurrent exposures and shared treatment in an eligible comparison.
Why this condition is needed: Confounding in comparisons that change vitamins and treatment together must be distinguished.
Application exceptions: The B6 change in S22 is not interpreted as a single-ingredient effect.
Referenced methods: M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed

Related sources S22

N10 · Were matched placebo/no addition and usual care verified for an eligible result?

Current findings: The question specifies placebo/no addition on matched usual care; actual eligible comparative results are unconfirmed. S22 compares amounts of mixed ingredients.
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: Do not establish the comparator specified in the question as the actual design of an eligible trial.
Reason for missing information: Do not establish the comparator specified in the question as the actual design of an eligible trial.
Required materials and conditions: Actual comparator composition, schedule, usual care and arm-specific changes
Materials to obtain first: Actual comparator composition, schedule, usual care and arm-specific changes
Further research: Link assignment, administration and care records to the original result.
Remaining uncertainty: Do not establish the comparator specified in the question as the actual design of an eligible trial.
Conditions for verification: Verify the actual comparator and shared care for an eligible result.
Why this condition is needed: The planned comparison in the question must be distinguished from the comparison actually observed.
Application exceptions: Do not recast a comparison that changes both B1 and B6 amounts as a matched single-ingredient comparison.
Referenced methods: M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application; M08 §8.2.2, M15 §15.3.1: internal application

Related sources S03 S22

N11 · Were the actual pain scale and assessment times verified for an eligible result?

Current findings: The question concerns patient-reported neuropathic pain, but the specific scale in an eligible trial is unconfirmed. The S03 record states that the result body and actual scale were not obtained in the historical review.
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: Do not arbitrarily assign NRS or another specific scale or unit.
Reason for missing information: Do not arbitrarily assign NRS or another specific scale or unit.
Required materials and conditions: Patient-reported pain scale, direction, units and baseline/follow-up times
Materials to obtain first: Patient-reported pain scale, direction, units and baseline/follow-up times
Further research: Link the scale, assessment plan and outcome table to the same population.
Remaining uncertainty: Do not arbitrarily assign NRS or another specific scale or unit.
Conditions for verification: Verify the actual measure and assessment times for the selected patient-reported pain outcome.
Why this condition is needed: A registry title or general symptoms must not be converted into a specific pain result.
Application exceptions: Do not import the NRS scale from another case.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; outcome adaptations are question-specific internal designs; M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources S03

N12 · Were the registered/planned primary outcome and actual pain results compared?

Current findings: The registered primary outcome and the relationship between the study primary outcome and this page's outcome are blank and unconfirmed. An independent registry comparison and eligible results are also unconfirmed.
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: Agreement with or deviation from a prespecified primary outcome, or selective reporting, cannot currently be established.
Reason for missing information: Agreement with or deviation from a prespecified primary outcome, or selective reporting, cannot currently be established.
Required materials and conditions: Dated registration, protocol, SAP and locations of the actual results
Materials to obtain first: Dated registration, protocol, SAP and locations of the actual results
Further research: Directly compare the timing of registry/protocol changes with published results.
Remaining uncertainty: Agreement with or deviation from a prespecified primary outcome, or selective reporting, cannot currently be established.
Conditions for verification: Verify agreement between the prespecified plan and reported outcomes, times and analyses.
Why this condition is needed: A title mentioning pain must not establish it as the prespecified primary outcome.
Application exceptions: Failure to obtain the registry body is not conclusive evidence of selective reporting.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design; M08 Table 8.2.a, M03 §3.2.4: internal application; M08 §8.2.2, M15 §15.3.1: internal application; M08 Table 8.2.a, M04 §4.6.3: internal application

Related sources S03

N13 · Were assignment, blinding and analysis methods verified for an eligible comparison?

Current findings: S03 historically recorded failure to access the official body; eligible results remain unconfirmed. The original bias axis is blank.
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: Do not turn unconfirmed methods into verified bias or a new score.
Reason for missing information: Do not turn unconfirmed methods into verified bias or a new score.
Required materials and conditions: Randomization, concealment, blinding, planned analyses and change records
Materials to obtain first: Randomization, concealment, blinding, planned analyses and change records
Further research: Compare plans, methods and results, distinguishing unconfirmed information from verified defects.
Remaining uncertainty: Do not turn unconfirmed methods into verified bias or a new score.
Conditions for verification: Verify methods and material limitations for the actual eligible comparison.
Why this condition is needed: Unobtained methods must not be scored as invented defects.
Application exceptions: Do not replace the original blank bias value with a new B grade.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4: design-specific adaptation is internally designed; M08 §8.1–8.2.3: internal application; M08 §8.2.2, M15 §15.3.1: internal application

Related sources S03

N14 · Were the actual analysis denominator and missing-data handling verified for the pain result?

Current findings: The actual analysis population size is blank and unconfirmed. The existing evidence record states that only verified denominators are retained in historical numerical records, and that assignment totals do not replace analysis denominators.
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: Eligible analysis n, attrition and missing-data handling were not obtained.
Reason for missing information: Eligible analysis n, attrition and missing-data handling were not obtained.
Required materials and conditions: Assigned, exposed, measured and analyzed n; attrition, analysis sets and missing-data handling
Materials to obtain first: Assigned, exposed, measured and analyzed n; attrition, analysis sets and missing-data handling
Further research: Link participant flow, arm-specific results and analysis plans.
Remaining uncertainty: Eligible analysis n, attrition and missing-data handling were not obtained.
Conditions for verification: Verify denominators and missing-data handling for the specific outcome, time and analysis.
Why this condition is needed: The assigned population must not replace the analysis denominator.
Application exceptions: A path to a numerical-data file does not mean that file was actually read for this work.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4: design-specific adaptation is internally designed; M15 §15.3.1–15.3.3: internal application; M08 Table 8.2.a, M04 §4.6.3: internal application

Related sources S03 S22

N15 · Were the between-group pain effect and uncertainty interval verified for B1 alone?

Current findings: An eligible effect estimate and interval were not verified for the exact question. The original effect and precision axes are also blank.
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: Do not invent a conclusion of no effect, arbitrary values or a probability of success.
Reason for missing information: Do not invent a conclusion of no effect, arbitrary values or a probability of success.
Required materials and conditions: Eligible between-group effect, units, analysis model, denominator and CI
Materials to obtain first: Eligible between-group effect, units, analysis model, denominator and CI
Further research: Compare between-group results with the model, denominator and time, and record interpretive limits.
Remaining uncertainty: Do not invent a conclusion of no effect, arbitrary values or a probability of success.
Conditions for verification: Verify the estimate and interval for the selected single-ingredient comparison from actual results.
Why this condition is needed: An unverified effect must not become an effect of 0 or the effect of another combination.
Application exceptions: Do not calculate a new effect size from P values, within-group changes or combination results.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M15 §15.3.1–15.3.3: internal application; M08 Table 8.2.a, M04 §4.6.3: internal application

Related sources S03 S22

N16 · Were meaningful differences and responder data obtained for the pain measure?

Current findings: The specific eligible pain scale and results are unconfirmed. The original effect-size review record states that no NNT was generated because an appropriate verified event table was unavailable.
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: Do not generate a common threshold, responder rate, NNT or approximate effect.
Reason for missing information: Do not generate a common threshold, responder rate, NNT or approximate effect.
Required materials and conditions: Scale-specific clinical meaning, responder definition, person denominator and period
Materials to obtain first: Scale-specific clinical meaning, responder definition, person denominator and period
Further research: Link measurement validity and responder definitions with the actual comparative results.
Remaining uncertainty: Do not generate a common threshold, responder rate, NNT or approximate effect.
Conditions for verification: Verify clinical-magnitude information corresponding to the actual scale and result.
Why this condition is needed: Do not invent a common MCID or NNT while the specific scale is unconfirmed.
Application exceptions: Do not invent an event table for a continuous outcome.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4: internal application; M15 §15.3.1–15.3.3: internal application; M03 §3.2.4: internal boundary for expanded claims

Related sources

N17 · Was the actual result body obtained for NCT00279266?

Current findings: S03 is a historical record of reaching the official registry's opening page without being able to read the result body. Whether results exist was 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: External access attempts in this work: 0. Do not infer non-conduct, a null result, withdrawn status, completed status or 0 results.
Reason for missing information: External access attempts in this work: 0. Do not infer non-conduct, a null result, withdrawn status, completed status or 0 results.
Required materials and conditions: Original registry body, change history, results and linked papers
Materials to obtain first: Original registry body, change history, results and linked papers
Further research: If a later update is authorized, compare original locations, times and changes for the registration and linked results.
Remaining uncertainty: External access attempts in this work: 0. Do not infer non-conduct, a null result, withdrawn status, completed status or 0 results.
Conditions for verification: Separately verify existence, acquisition and content of the actual registry body and results.
Why this condition is needed: A candidate registry entry must be distinguished from actual result acquisition.
Application exceptions: Do not turn historical access failure into a current connection failure or proof of no results.
Referenced methods: M04 §4.6.1–4.6.2: distinguish studies from reports; cohort/result linkage is an internal application; M04 §4.5–4.6: material collection/selection principles; separating access from reading and the hyperlink contract are internally designed; M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design

Related sources S03

N18 · Was the Abbas–Swai comparison excluded from the effect of B1 alone?

Current findings: S22 compares B1 25 mg+B6 50 mg with B1 1 mg+B6 1 mg. Because B6 also changes, it cannot identify the effect of B1 alone. The existing record also excluded this comparison as direct evidence for the single ingredient.
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 exclusion does not mean the study itself, or all B-vitamin effects, are absent.
Reason for missing information: This exclusion does not mean the study itself, or all B-vitamin effects, are absent.
Required materials and conditions: Arm-specific B1+B6 amounts and identifiability of each ingredient's contribution
Materials to obtain first: Arm-specific B1+B6 amounts and identifiability of each ingredient's contribution
Further research: Compare arm-specific administration tables with the scope of the results.
Remaining uncertainty: This exclusion does not mean the study itself, or all B-vitamin effects, are absent.
Conditions for verification: Link actual combination amounts and the original exclusion reason to the same material.
Why this condition is needed: A comparison that also changes other ingredients must not be mistaken for a single-ingredient causal effect.
Application exceptions: Do not erase related human research as nonexistent.
Referenced methods: M04 §4.6.1–4.6.2: distinguish studies from reports; cohort/result linkage is an internal application; M03 §3.2.2–3.2.3: direction labels and diagnostic adaptation are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3: internal application

Related sources S22

N19 · Were the actual study and participant-family relationships between the two reports verified?

Current findings: S03 is the NCT00279266 candidate; S22 has the stored study identifier Abbas-Swai-1997. Two reports do not mean 2 eligible single-ingredient replications.
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: Actual unique participants, direct replication and complete independence between families are not certified.
Reason for missing information: Actual unique participants, direct replication and complete independence between families are not certified.
Required materials and conditions: Link reports to registration/study families, then outcomes, times and analyses
Materials to obtain first: Link reports to registration/study families, then outcomes, times and analyses
Further research: Link registration, paper, participant and time identities to examine duplication.
Remaining uncertainty: Actual unique participants, direct replication and complete independence between families are not certified.
Conditions for verification: Verify actual registration, study and participant relationships from original materials, distinguishing unconfirmed links.
Why this condition is needed: Bibliographic counts must not become counts of eligible studies or unique participants.
Application exceptions: Do not count unconfirmed links or duplicates as verified replication.
Referenced methods: M04 §4.6.1–4.6.2 on distinguishing studies and reports; cohort/outcome linkage is an internal application; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

Related sources S03 S22

N20 · Were stored summaries, unread external materials and historical access distinguished?

Current findings: The entire stored manuscript summary was read; current external lookups total 0. S03's registry opening page and S22's indexed author abstract are historical access records. Individual access dates are not recorded.
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 original review date is a global review date; it is not reused as an individual source-access date.
Reason for missing information: The original review date is a global review date; it is not reused as an individual source-access date.
Required materials and conditions: Actual acquisition, reading, historical access level, locations and dates for each material
Materials to obtain first: Actual acquisition, reading, historical access level, locations and dates for each material
Further research: If later authorized, record actual source bytes, access date and exact location for each material.
Remaining uncertainty: The original review date is a global review date; it is not reused as an individual source-access date.
Conditions for verification: Distinguish and link actual reading of the stored local summary from current external non-attempt/non-reading.
Why this condition is needed: Providing a URL must not be promoted to reading the original full text.
Application exceptions: Registry opening-page access and indexed author-abstract records remain historical.
Referenced methods: M04 §4.5–4.6 on collecting/selecting material; access/reading separation and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; the limits of this material conversion follow the user's scope and internal design

Related sources S03 S22

N21 · Were the original cutoff, search limitations and scope of this conversion distinguished?

Current findings: The search cutoff and original review date are 2026-09-15. The record is not an exhaustive search of native databases worldwide; this work converts the stored summary into a table.
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: Do not attribute the search-scope record to a new report when its linked-source list is empty.
Reason for missing information: Do not attribute the search-scope record to a new report when its linked-source list is empty.
Required materials and conditions: Search cutoff, original review date, current summary-review date and actual work scope
Materials to obtain first: Search cutoff, original review date, current summary-review date and actual work scope
Further research: In an authorized update, compare actual search logs with subsequent materials and corrections.
Remaining uncertainty: Do not attribute the search-scope record to a new report when its linked-source list is empty.
Conditions for verification: Separate the original cutoff and search scope from the lack of current external work.
Why this condition is needed: A conversion of stored materials must not be exaggerated into a new exhaustive literature search.
Application exceptions: A search-log path alone does not establish that the log was read for this work.
Referenced methods: M04 §4.5–4.6 on collecting/selecting material; access/reading separation and the hyperlink contract are internally designed; M04 §4.5, §4.6.3; the limits of this material conversion follow the user's scope and internal design

Related sources

N22 · Was evidence of independent replication verified for the exact single-ingredient pain comparison?

Current findings: Eligible results were not verified, so the replication and independence axes are blank. Related judgments with different molecules or population/outcome boundaries were not treated as the same completed claim.
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: Do not create repeated refutation or independent replication from related IDs or report counts.
Reason for missing information: Do not create repeated refutation or independent replication from related IDs or report counts.
Required materials and conditions: Eligible replication results, teams, funding and participant/data overlap
Materials to obtain first: Eligible replication results, teams, funding and participant/data overlap
Further research: Compare outcomes, study families, authors/funding and data overlap.
Remaining uncertainty: Do not create repeated refutation or independent replication from related IDs or report counts.
Conditions for verification: Verify eligible replication and independent identities for the same ingredient, population and outcome.
Why this condition is needed: Related research must be distinguished from replication of the single-ingredient claim.
Application exceptions: The individual manuscripts for benfotiamine 544 and general nerve function 162 were not read for this work.
Referenced methods: M04 §4.6.1–4.6.2: distinguish studies from reports; cohort/result linkage is an internal application; Chamgap's own independence/attribution conditions are not fully guaranteed by the official method sections used in this demonstration; M04 §4.6.1–4.6.2, M15 §15.3.1: internal application

Related sources S03 S22

N23 · Were funding, author roles and conflicts of interest obtained for the eligible result?

Current findings: Funding information for both evidence records is unconfirmed or recorded as unused in this page's grade; the independence axis is blank.
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: Original funding materials were not newly read, and independence is not certified.
Reason for missing information: Original funding materials were not newly read, and independence is not certified.
Required materials and conditions: Original funding, affiliations, roles, COI and data independence
Materials to obtain first: Original funding, affiliations, roles, COI and data independence
Further research: Compare original funding/COI declarations with the actual study and data relationships.
Remaining uncertainty: Original funding materials were not newly read, and independence is not certified.
Conditions for verification: Directly verify declarations and roles for the eligible result.
Why this condition is needed: Unconfirmed information must not become proof of non-involvement or verified bias.
Application exceptions: Do not transfer funding information from another study.
Referenced methods: Chamgap's own independence/attribution conditions are not fully guaranteed by the official method sections used in this demonstration; M04 §4.6.1–4.6.2, M15 §15.3.1: internal application

Related sources S03 S22

N24 · Were the original ?, blank values and bounded eligible-human-result-unverified flag preserved?

Current findings: The original grade is ?, with no score. Unused assessment axes are blank. The eligible-human-result-unverified flag is recorded as true and is limited to not identifying an eligible result within the documented search scope.
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: No new scoring or calculation was performed, and the original judgment was not based on access failure alone.
Reason for missing information: No new scoring or calculation was performed, and the original judgment was not based on access failure alone.
Required materials and conditions: Original grade, score, axes, judgment scope and revision policy
Materials to obtain first: Original grade, score, axes, judgment scope and revision policy
Further research: Compare the original stored-manuscript bytes with each linked location to verify display scope.
Remaining uncertainty: No new scoring or calculation was performed, and the original judgment was not based on access failure alone.
Conditions for verification: Preserve original values, blanks, false values, empty arrays and judgment scope without conversion.
Why this condition is needed: Checklist status must not be confused with the existing clinical grade or a new certification.
Application exceptions: Document-quality A and grade ? are separate; they do not mean no effect or 0 studies worldwide.
Referenced methods: M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design

Related sources S03 S22

N25 · Was the pain question distinguished from circulating vitamers?

Current findings: The record distinguishing biochemical measures from clinical outcomes has a blank value and confirmed information status. It states that patient symptom/function questions are separate from circulating vitamers.
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 is neither a verified pain effect nor an actual biochemical measurement.
Reason for missing information: This is neither a verified pain effect nor an actual biochemical measurement.
Required materials and conditions: Question boundaries between patient symptoms/function and biochemical measures
Materials to obtain first: Question boundaries between patient symptoms/function and biochemical measures
Further research: Examine candidate measures separately from actual patient outcomes.
Remaining uncertainty: This is neither a verified pain effect nor an actual biochemical measurement.
Conditions for verification: Verify the distinction between the original patient symptom/function question and biochemistry.
Why this condition is needed: Biochemical changes must not replace a pain effect.
Application exceptions: Preserve the blank biochemical value and the confirmed information status.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3: outcome adaptation is internally designed; M03 §3.2.4: internal boundary for expanded claims

Related sources

N26 · Were harms and discontinuation data obtained for the same single-ingredient product, population and period?

Current findings: Eligible efficacy and safety results for the exact monotherapy are unconfirmed. The adverse-event record is blank and unconfirmed; the original safety status is unknown.
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: Unconfirmed harms do not mean AE0 or safety; combination results are not inherited.
Reason for missing information: Unconfirmed harms do not mean AE0 or safety; combination results are not inherited.
Required materials and conditions: AE collection, person/event denominators, discontinuation, period, concurrent treatment and vulnerable populations
Materials to obtain first: AE collection, person/event denominators, discontinuation, period, concurrent treatment and vulnerable populations
Further research: Compare exposure, harm collection, discontinuation and follow-up records.
Remaining uncertainty: Unconfirmed harms do not mean AE0 or safety; combination results are not inherited.
Conditions for verification: Verify actual harms, collection scope and denominators for that single-ingredient exposure.
Why this condition is needed: Tolerability of other B-vitamin combinations must not be transferred to B1 alone.
Application exceptions: Do not change the original unknown safety status into a new safety grade.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4: design-specific adaptation is internally designed; M19 §19.1.2–19.2.4: internal application

Related sources S03 S22

N27 · Is there a separate verification scope for assay interference and concurrent drugs?

Current findings: Assay-interference and drug-interaction records have blank values and are marked as not separately searched. The original record states that no separate systematic or comprehensive search was conducted.
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: Reading the summary alone does not verify absence of interference or interactions.
Reason for missing information: Reading the summary alone does not verify absence of interference or interactions.
Required materials and conditions: Actual assay/drug exposure, interference and interaction information, and work scope
Materials to obtain first: Actual assay/drug exposure, interference and interaction information, and work scope
Further research: In an authorized extension, separately review actual assay and concurrent-exposure materials.
Remaining uncertainty: Reading the summary alone does not verify absence of interference or interactions.
Conditions for verification: Verify materials and review scope supporting the particular interference or interaction claim.
Why this condition is needed: Not conducting a separate search must not be interpreted as no impact.
Application exceptions: Do not turn an unperformed search into current access failure or clinical safety.
Referenced methods: M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design; M08 Table 8.2.a, M03 §3.2.4: internal application; M19 §19.1.2–19.2.4: internal application

Related sources

N28 · Does the current pain question also include optimal-dose and post-treatment persistence claims?

Current findings: This table compares B1 alone for painful DPN pain; it does not add optimal-dose or post-treatment persistence claims as requirements.
Verification status: Not applicable
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: Not applicable is not a judgment of absent long-term data, safety or no effect.
Reason for missing information: Not applicable is not a judgment of absent long-term data, safety or no effect.
Required materials and conditions: Boundary between the fixed question and separate dose-comparison or long-term/post-treatment persistence questions
Materials to obtain first: Boundary between the fixed question and separate dose-comparison or long-term/post-treatment persistence questions
Further research: When an extension is requested, review direct dose comparisons and post-treatment/long-term follow-up as separate questions.
Remaining uncertainty: Not applicable is not a judgment of absent long-term data, safety or no effect.
Conditions for verification: Distinguish the fixed question from additional optimal-dose or long-term persistence claims.
Why this condition is needed: A narrow question must not require every study of expanded claims.
Application exceptions: Do not turn unconfirmed duration into a verified long-term effect.
Referenced methods: M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed

Related sources

N29 · Does this table include correction of deficiency neuropathy or other nerve outcomes?

Current findings: Adults with painful DPN are distinguished from confirmed B1-deficiency neuropathy. Related 162 and 544 have different ingredient or population/outcome boundaries.
Verification status: Not applicable
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: Non-applicability of an extension is not interpreted as no effect in related research.
Reason for missing information: Non-applicability of an extension is not interpreted as no effect in related research.
Required materials and conditions: Separate boundaries for confirmed deficiency, nerve function, symptoms and the selected pain comparison
Materials to obtain first: Separate boundaries for confirmed deficiency, nerve function, symptoms and the selected pain comparison
Further research: For an extension, directly review the corresponding diagnosis/outcome materials as a separate independent question.
Remaining uncertainty: Non-applicability of an extension is not interpreted as no effect in related research.
Conditions for verification: Distinguish the selected population/outcome from separate expanded questions.
Why this condition is needed: Questions with different populations or outcomes must not be merged into one completed claim.
Application exceptions: Do not erase related research or create a new judgment that research does not exist.
Referenced methods: M03 §3.2.1: detailed population conditions are internally designed; M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed; M03 §3.2.4: internal boundary for expanded claims

Related sources

N30 · Were updates for new evidence, access or corrections linked with preservation of previous originals?

Current findings: The original policy calls for updates after new eligible evidence, full text/registry results, or numerical/unit/source corrections, preserving previous values, reasons, sources and dates.
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 stored record was written before public deployment. Separating this table is not a new clinical-evidence review or regrading event.
Reason for missing information: This stored record was written before public deployment. Separating this table is not a new clinical-evidence review or regrading event.
Required materials and conditions: Triggers, verified materials, reasons for changes, dates and previous originals/judgments
Materials to obtain first: Triggers, verified materials, reasons for changes, dates and previous originals/judgments
Further research: Compare the identity, location and hashes of new materials/corrections separately from change decisions.
Remaining uncertainty: This stored record was written before public deployment. Separating this table is not a new clinical-evidence review or regrading event.
Conditions for verification: Link the original revision policy with uncertainty disclosure, original preservation and row-level updates.
Why this condition is needed: Future update triggers must not become a waiting condition for initial publication.
Application exceptions: Condition changes are applied only after a separate new version is frozen.
Referenced methods: M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design

Related sources S03 S22

N31 · Were all verified related materials and the original limits on refutation preserved?

Current findings: Both the S03 registry candidate and S22 combination comparison were preserved. The stored summary states that repeated refutation RX was not established, so F was not assigned.
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 preservation does not certify a direct effect or worldwide absence of research.
Reason for missing information: This preservation does not certify a direct effect or worldwide absence of research.
Required materials and conditions: Roles, results and exclusion reasons for both reports, and the original scope of refutation
Materials to obtain first: Roles, results and exclusion reasons for both reports, and the original scope of refutation
Further research: Compare original roles, results and exclusion reasons against the same single-ingredient question.
Remaining uncertainty: This preservation does not certify a direct effect or worldwide absence of research.
Conditions for verification: Preserve both current materials and all verified findings and limitations with their locations, regardless of direction.
Why this condition is needed: Related human research must not be erased, nor results for other ingredients converted into refutation of the same question.
Application exceptions: Unverified eligible monotherapy results do not mean no effect or repeated refutation.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3: status distinctions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1: internal application

Related sources S03 S22