# Single-ingredient ordinary thiamine (vitamin B1) × Pain relief in painful diabetic peripheral neuropathy Verdict 3085 · Evidence Check Stored-material review date: 2026-10-05 Original evidence date: 2026-09-15 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-31 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 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. ## Checklist items ### N01 · Which B1, population and pain question is being checked? Verification status: Met Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Verifying the identity of the question does not establish an eligible treatment effect. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: The actual study ingredient and chemical-form values are blank and unconfirmed. Their linked-source lists are also empty. - 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. - 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. - Remaining uncertainty: The Korean ingredient name defines the question; it is not a verified molecular identity in an eligible study. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: The question concerns ordinary thiamine alone by mouth; the salt, formulation and manufacturing origin in an eligible trial are unconfirmed. - 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. - 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. - Remaining uncertainty: Non-applicability of plant classification does not verify product specifications. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: The actual administration route in an eligible study was not verified. - 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? Verification status: Partly verified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Do not transfer combination-comparison dose records into evidence for B1 alone or a recommended dose. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: Treatment and follow-up duration in an eligible monotherapy trial is blank and unconfirmed. Its linked-source list is also empty. - 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. - 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. - Remaining uncertainty: Do not invent a verified appropriate duration or long-term effect for the current 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: The question concerns adults with painful DPN, as does the S03 registry title. Actual eligible results and the analysis population remain unconfirmed. - 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. - 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. - Remaining uncertainty: A registry title and question wording do not substitute for details of the actual eligible 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 - Related sources: S03 ### N08 · Were B1 deficiency and baseline status verified in the eligible population? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: Baseline nutritional-status values are blank and unconfirmed. Full details of deficiency assessment in the eligible population are also unconfirmed. - 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. - 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. - Remaining uncertainty: Deficient versus non-deficient status and effect modification cannot currently be established. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: Total dietary intake and concurrent-vitamin records are blank and unconfirmed. S22 also changes B6. - 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. - 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. - Remaining uncertainty: Details of total intake and concurrent treatment in an eligible single-ingredient comparison were not established. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: The question specifies placebo/no addition on matched usual care; actual eligible comparative results are unconfirmed. S22 compares amounts of mixed ingredients. - 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. - 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. - Remaining uncertainty: Do not establish the comparator specified in the question as the actual design of an eligible trial. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Do not arbitrarily assign NRS or another specific scale or unit. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Agreement with or deviation from a prespecified primary outcome, or selective reporting, cannot currently be established. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: S03 historically recorded failure to access the official body; eligible results remain unconfirmed. The original bias axis is blank. - 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. - 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. - Remaining uncertainty: Do not turn unconfirmed methods into verified bias or a new score. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Eligible analysis n, attrition and missing-data handling were not obtained. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: An eligible effect estimate and interval were not verified for the exact question. The original effect and precision axes are also blank. - 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. - 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. - Remaining uncertainty: Do not invent a conclusion of no effect, arbitrary values or a probability of success. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Do not generate a common threshold, responder rate, NNT or approximate effect. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: External access attempts in this work: 0. Do not infer non-conduct, a null result, withdrawn status, completed status or 0 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? Verification status: Met Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: This exclusion does not mean the study itself, or all B-vitamin effects, are absent. - 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? Verification status: Partly verified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Actual unique participants, direct replication and complete independence between families are not certified. - 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? Verification status: Met Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: The original review date is a global review date; it is not reused as an individual source-access date. - 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? Verification status: Met Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Do not attribute the search-scope record to a new report when its linked-source list is empty. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Do not create repeated refutation or independent replication from related IDs or report counts. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: Funding information for both evidence records is unconfirmed or recorded as unused in this page's grade; the independence axis is blank. - 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. - 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. - Remaining uncertainty: Original funding materials were not newly read, and independence is not certified. - 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? Verification status: Met Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: No new scoring or calculation was performed, and the original judgment was not based on access failure alone. - 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? Verification status: Met Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: This is neither a verified pain effect nor an actual biochemical measurement. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Unconfirmed harms do not mean AE0 or safety; combination results are not inherited. - 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? Verification status: Unverified Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: Reading the summary alone does not verify absence of interference or interactions. - 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? Verification status: Not applicable Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: This table compares B1 alone for painful DPN pain; it does not add optimal-dose or post-treatment persistence claims as requirements. - 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. - 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. - Remaining uncertainty: Not applicable is not a judgment of absent long-term data, safety or no 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? Verification status: Not applicable Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - Current findings: Adults with painful DPN are distinguished from confirmed B1-deficiency neuropathy. Related 162 and 544 have different ingredient or population/outcome boundaries. - 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. - 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. - Remaining uncertainty: Non-applicability of an extension is not interpreted as no effect in related research. - 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? Verification status: Met Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: This stored record was written before public deployment. Separating this table is not a new clinical-evidence review or regrading event. - 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? Verification status: Met Reading scope: The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work. - 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. - 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. - 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. - Remaining uncertainty: This preservation does not certify a direct effect or worldwide absence of research. - 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 ## Evidence and sources ### S03 Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy [Official source](https://clinicaltrials.gov/study/NCT00279266) 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 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. 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. | 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](https://pubmed.ncbi.nlm.nih.gov/9557427/) 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 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. 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish and link studies and reports; do not omit studies solely because outcomes are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Fix the outcome and effect of interest, then review randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effects, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence. · 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/materials 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.