{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3085-main", "verdict_number": "3085", "title": "Single-ingredient ordinary thiamine (vitamin B1) × Pain relief in painful diabetic peripheral neuropathy", "view_version": "1.0", "view_created_date": "2026-10-31", "criteria_version": "1.0", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-15", "review_scope": { "materials_read": "Stored Korean and English manuscript summaries, case-specific conditions and application records, and stored methodological principles", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "No new reading of external clinical abstracts, full papers, registrations or analysis plans was performed. Historical access levels recorded in the manuscript are distinguished from reading the stored summaries in this work. Unverified does not mean that research or an effect is absent.", "date_meaning": "The date retained material was checked, not the date of a latest clinical-literature search." }, "claim_context": { "population": "Adults with painful diabetic peripheral neuropathy; distinct from confirmed B1 (thiamine)-deficiency neuropathy", "intervention": "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", "endpoint": "Patient-reported neuropathic pain; specific scale in an eligible study unconfirmed", "duration": "Treatment and follow-up duration in an eligible monotherapy study unconfirmed", "excluded_extensions": "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." }, "requirements": [ { "item_id": "N01", "question_type": "Independent claim", "question": "Which B1, population and pain question is being checked?", "needed": "Identity of the question: ordinary oral thiamine alone, adults with painful DPN, patient-reported pain, and placebo/no addition on matched usual care", "role": "Required for the selected B1-only pain comparison", "role_reason": "The exact comparison must be distinguished from related ingredients and deficiency neuropathy.", "application_exception": "Benfotiamine, B1+B6 and correction of confirmed deficiency are separate questions.", "criterion": "Fix one question by linking the original effect, population, outcome, comparator and empty subclaim list.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare each candidate's ingredient, population and outcome boundaries with the original question.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "This is one independent claim about patient-reported pain in painful diabetic peripheral neuropathy with ordinary oral B1 alone. The subclaim array is empty.", "condition_status": "Met", "status_reason": "Verifying the identity of the question does not establish an eligible treatment effect.", "missingness": "Verifying the identity of the question does not establish an eligible treatment effect.", "uncertainty": "Verifying the identity of the question does not establish an eligible treatment effect.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Identity of the question: ordinary oral thiamine alone, adults with painful DPN, patient-reported pain, and placebo/no addition on matched usual care" }, { "item_id": "N02", "question_type": "Molecule and single ingredient", "question": "Was the actual exposure to thiamine alone verified in an eligible result?", "needed": "Exact vitamer, salt, single-ingredient identity and actual administration documents", "role": "Required for the selected B1-only pain comparison", "role_reason": "Ordinary thiamine in the question must not be mistaken for the actual trial formulation.", "application_exception": "Do not transfer results for benfotiamine or comparisons that also change B6.", "criterion": "Verify the actual molecule and single ingredient in an eligible result from the original administration documents.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Link formulation documents with arm-specific outcomes to examine actual exposure.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "The actual study ingredient and chemical-form values are blank and unconfirmed. Their linked-source lists are also empty.", "condition_status": "Unverified", "status_reason": "The Korean ingredient name defines the question; it is not a verified molecular identity in an eligible study.", "missingness": "The Korean ingredient name defines the question; it is not a verified molecular identity in an eligible study.", "uncertainty": "The Korean ingredient name defines the question; it is not a verified molecular identity in an eligible study.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Exact vitamer, salt, single-ingredient identity and actual administration documents" }, { "item_id": "N03", "question_type": "Formulation and origin", "question": "Were the salt, release form, manufacture and purity of an eligible formulation verified?", "needed": "Exact salt, formulation, manufacturing origin, purity, batch and excipients", "role": "Required for the selected B1-only pain comparison", "role_reason": "Results for different salts, derivatives or products must not be combined as if they concerned the same formulation.", "application_exception": "Plant-part classification is not applicable, but gaps in manufacture and formulation remain.", "criterion": "Verify the actual product specifications used in the eligible comparison.", "basis": "M03 §3.2.2–3.2.3; direction labels and test adaptations are internally designed", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare the formulation specifications and batch with the scope of the corresponding result.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "The question concerns ordinary thiamine alone by mouth; the salt, formulation and manufacturing origin in an eligible trial are unconfirmed.", "condition_status": "Unverified", "status_reason": "Non-applicability of plant classification does not verify product specifications.", "missingness": "Non-applicability of plant classification does not verify product specifications.", "uncertainty": "Non-applicability of plant classification does not verify product specifications.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Exact salt, formulation, manufacturing origin, purity, batch and excipients" }, { "item_id": "N04", "question_type": "Actual route", "question": "Were records of actual oral administration obtained for an eligible trial?", "needed": "Actual administration route, adherence and exposure records", "role": "Required for the selected B1-only pain comparison", "role_reason": "The oral-route condition in the question must be distinguished from actual study records.", "application_exception": "The route specified in the question does not verify an unobtained registry result.", "criterion": "Link the eligible result and actual oral administration within the same documents.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Link administration methods and medication records to the original result.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "The question specifies oral administration, but the actual route in an eligible study is blank and unconfirmed. Its linked-source list is also empty.", "condition_status": "Unverified", "status_reason": "The actual administration route in an eligible study was not verified.", "missingness": "The actual administration route in an eligible study was not verified.", "uncertainty": "The actual administration route in an eligible study was not verified.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Actual administration route, adherence and exposure records" }, { "item_id": "N05", "question_type": "Dose and concurrent B6", "question": "Were both the eligible single-ingredient dose and the component amounts in the combination comparison verified?", "needed": "Nominal and actual dose, frequency and concurrent ingredients in an eligible monotherapy trial", "role": "Required for the selected B1-only pain comparison", "role_reason": "A comparison that also changes B6 must not be treated as a B1 dose effect.", "application_exception": "25 mg+B6 50 mg versus 1 mg+B6 1 mg is an excluded combination comparison.", "criterion": "Verify the single-ingredient dose and actual intake separately from each component amount in the combination comparison.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Use arm-specific administration and ingredient tables to examine whether only B1 differs.", "current_reports": [ "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Partly verified", "status_reason": "Do not transfer combination-comparison dose records into evidence for B1 alone or a recommended dose.", "missingness": "Do not transfer combination-comparison dose records into evidence for B1 alone or a recommended dose.", "uncertainty": "Do not transfer combination-comparison dose records into evidence for B1 alone or a recommended dose.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Nominal and actual dose, frequency and concurrent ingredients in an eligible monotherapy trial" }, { "item_id": "N06", "question_type": "Duration", "question": "Were treatment and follow-up durations verified in an eligible monotherapy trial?", "needed": "Actual treatment, assessment and post-treatment follow-up schedules", "role": "Required for the selected B1-only pain comparison", "role_reason": "An arbitrary minimum number of weeks must not replace an unconfirmed duration.", "application_exception": "Do not inherit another trial's duration for this question.", "criterion": "Verify treatment, assessment and follow-up times for the selected result.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Link plans, outcome tables and assessment schedules.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "Treatment and follow-up duration in an eligible monotherapy trial is blank and unconfirmed. Its linked-source list is also empty.", "condition_status": "Unverified", "status_reason": "Do not invent a verified appropriate duration or long-term effect for the current question.", "missingness": "Do not invent a verified appropriate duration or long-term effect for the current question.", "uncertainty": "Do not invent a verified appropriate duration or long-term effect for the current question.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Actual treatment, assessment and post-treatment follow-up schedules" }, { "item_id": "N07", "question_type": "Population selection", "question": "Were diagnostic and selection records obtained for adults with painful DPN in an eligible study?", "needed": "DPN and pain diagnosis, inclusion/exclusion, baseline severity and diabetes status", "role": "Required for the selected B1-only pain comparison", "role_reason": "A registry title alone must not establish the actual analysis population.", "application_exception": "Confirmed B1-deficiency neuropathy is separate.", "criterion": "Link the diagnostic and selection criteria for the actual eligible population with the outcome population.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare selection and baseline tables with the analysis population.", "current_reports": [ "S03" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "The question concerns adults with painful DPN, as does the S03 registry title. Actual eligible results and the analysis population remain unconfirmed.", "condition_status": "Unverified", "status_reason": "A registry title and question wording do not substitute for details of the actual eligible population.", "missingness": "A registry title and question wording do not substitute for details of the actual eligible population.", "uncertainty": "A registry title and question wording do not substitute for details of the actual eligible population.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "DPN and pain diagnosis, inclusion/exclusion, baseline severity and diabetes status" }, { "item_id": "N08", "question_type": "Baseline nutritional status", "question": "Were B1 deficiency and baseline status verified in the eligible population?", "needed": "Baseline B1 status, testing methods, deficiency criteria and arm-specific distributions", "role": "Required for the selected B1-only pain comparison", "role_reason": "Deficiency correction must be distinguished from the question of DPN pain without deficiency.", "application_exception": "Do not infer deficiency from symptoms alone.", "criterion": "Verify actual baseline status and assessment methods in the eligible population.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare tests, diagnosis and arm-specific baseline tables with the outcomes.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "Baseline nutritional-status values are blank and unconfirmed. Full details of deficiency assessment in the eligible population are also unconfirmed.", "condition_status": "Unverified", "status_reason": "Deficient versus non-deficient status and effect modification cannot currently be established.", "missingness": "Deficient versus non-deficient status and effect modification cannot currently be established.", "uncertainty": "Deficient versus non-deficient status and effect modification cannot currently be established.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Baseline B1 status, testing methods, deficiency criteria and arm-specific distributions" }, { "item_id": "N09", "question_type": "Diet and concurrent exposures", "question": "Were total intake, concurrent vitamins and usual care verified?", "needed": "Arm-specific exposure to total diet, all supplements, concurrent vitamins and usual care", "role": "Required for the selected B1-only pain comparison", "role_reason": "Confounding in comparisons that change vitamins and treatment together must be distinguished.", "application_exception": "The B6 change in S22 is not interpreted as a single-ingredient effect.", "criterion": "Verify arm-specific concurrent exposures and shared treatment in an eligible comparison.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare intake, medication and concurrent-treatment records with arm-specific results.", "current_reports": [ "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "Total dietary intake and concurrent-vitamin records are blank and unconfirmed. S22 also changes B6.", "condition_status": "Unverified", "status_reason": "Details of total intake and concurrent treatment in an eligible single-ingredient comparison were not established.", "missingness": "Details of total intake and concurrent treatment in an eligible single-ingredient comparison were not established.", "uncertainty": "Details of total intake and concurrent treatment in an eligible single-ingredient comparison were not established.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Arm-specific exposure to total diet, all supplements, concurrent vitamins and usual care" }, { "item_id": "N10", "question_type": "Actual comparator", "question": "Were matched placebo/no addition and usual care verified for an eligible result?", "needed": "Actual comparator composition, schedule, usual care and arm-specific changes", "role": "Required for the selected B1-only pain comparison", "role_reason": "The planned comparison in the question must be distinguished from the comparison actually observed.", "application_exception": "Do not recast a comparison that changes both B1 and B6 amounts as a matched single-ingredient comparison.", "criterion": "Verify the actual comparator and shared care for an eligible result.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Link assignment, administration and care records to the original result.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "The question specifies placebo/no addition on matched usual care; actual eligible comparative results are unconfirmed. S22 compares amounts of mixed ingredients.", "condition_status": "Unverified", "status_reason": "Do not establish the comparator specified in the question as the actual design of an eligible trial.", "missingness": "Do not establish the comparator specified in the question as the actual design of an eligible trial.", "uncertainty": "Do not establish the comparator specified in the question as the actual design of an eligible trial.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Actual comparator composition, schedule, usual care and arm-specific changes" }, { "item_id": "N11", "question_type": "Pain measure", "question": "Were the actual pain scale and assessment times verified for an eligible result?", "needed": "Patient-reported pain scale, direction, units and baseline/follow-up times", "role": "Required for the selected B1-only pain comparison", "role_reason": "A registry title or general symptoms must not be converted into a specific pain result.", "application_exception": "Do not import the NRS scale from another case.", "criterion": "Verify the actual measure and assessment times for the selected patient-reported pain outcome.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Link the scale, assessment plan and outcome table to the same population.", "current_reports": [ "S03" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Do not arbitrarily assign NRS or another specific scale or unit.", "missingness": "Do not arbitrarily assign NRS or another specific scale or unit.", "uncertainty": "Do not arbitrarily assign NRS or another specific scale or unit.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Patient-reported pain scale, direction, units and baseline/follow-up times" }, { "item_id": "N12", "question_type": "Primary outcome and selective reporting", "question": "Were the registered/planned primary outcome and actual pain results compared?", "needed": "Dated registration, protocol, SAP and locations of the actual results", "role": "Required for the selected B1-only pain comparison", "role_reason": "A title mentioning pain must not establish it as the prespecified primary outcome.", "application_exception": "Failure to obtain the registry body is not conclusive evidence of selective reporting.", "criterion": "Verify agreement between the prespecified plan and reported outcomes, times and analyses.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Directly compare the timing of registry/protocol changes with published results.", "current_reports": [ "S03" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Agreement with or deviation from a prespecified primary outcome, or selective reporting, cannot currently be established.", "missingness": "Agreement with or deviation from a prespecified primary outcome, or selective reporting, cannot currently be established.", "uncertainty": "Agreement with or deviation from a prespecified primary outcome, or selective reporting, cannot currently be established.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Dated registration, protocol, SAP and locations of the actual results" }, { "item_id": "N13", "question_type": "Design and bias", "question": "Were assignment, blinding and analysis methods verified for an eligible comparison?", "needed": "Randomization, concealment, blinding, planned analyses and change records", "role": "Required for the selected B1-only pain comparison", "role_reason": "Unobtained methods must not be scored as invented defects.", "application_exception": "Do not replace the original blank bias value with a new B grade.", "criterion": "Verify methods and material limitations for the actual eligible comparison.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare plans, methods and results, distinguishing unconfirmed information from verified defects.", "current_reports": [ "S03" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "S03 historically recorded failure to access the official body; eligible results remain unconfirmed. The original bias axis is blank.", "condition_status": "Unverified", "status_reason": "Do not turn unconfirmed methods into verified bias or a new score.", "missingness": "Do not turn unconfirmed methods into verified bias or a new score.", "uncertainty": "Do not turn unconfirmed methods into verified bias or a new score.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Randomization, concealment, blinding, planned analyses and change records" }, { "item_id": "N14", "question_type": "Denominators and missing data", "question": "Were the actual analysis denominator and missing-data handling verified for the pain result?", "needed": "Assigned, exposed, measured and analyzed n; attrition, analysis sets and missing-data handling", "role": "Required for the selected B1-only pain comparison", "role_reason": "The assigned population must not replace the analysis denominator.", "application_exception": "A path to a numerical-data file does not mean that file was actually read for this work.", "criterion": "Verify denominators and missing-data handling for the specific outcome, time and analysis.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Link participant flow, arm-specific results and analysis plans.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Eligible analysis n, attrition and missing-data handling were not obtained.", "missingness": "Eligible analysis n, attrition and missing-data handling were not obtained.", "uncertainty": "Eligible analysis n, attrition and missing-data handling were not obtained.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Assigned, exposed, measured and analyzed n; attrition, analysis sets and missing-data handling" }, { "item_id": "N15", "question_type": "Effect and interval", "question": "Were the between-group pain effect and uncertainty interval verified for B1 alone?", "needed": "Eligible between-group effect, units, analysis model, denominator and CI", "role": "Required for the selected B1-only pain comparison", "role_reason": "An unverified effect must not become an effect of 0 or the effect of another combination.", "application_exception": "Do not calculate a new effect size from P values, within-group changes or combination results.", "criterion": "Verify the estimate and interval for the selected single-ingredient comparison from actual results.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare between-group results with the model, denominator and time, and record interpretive limits.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "An eligible effect estimate and interval were not verified for the exact question. The original effect and precision axes are also blank.", "condition_status": "Unverified", "status_reason": "Do not invent a conclusion of no effect, arbitrary values or a probability of success.", "missingness": "Do not invent a conclusion of no effect, arbitrary values or a probability of success.", "uncertainty": "Do not invent a conclusion of no effect, arbitrary values or a probability of success.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Eligible between-group effect, units, analysis model, denominator and CI" }, { "item_id": "N16", "question_type": "Clinical magnitude", "question": "Were meaningful differences and responder data obtained for the pain measure?", "needed": "Scale-specific clinical meaning, responder definition, person denominator and period", "role": "Required for the selected B1-only pain comparison", "role_reason": "Do not invent a common MCID or NNT while the specific scale is unconfirmed.", "application_exception": "Do not invent an event table for a continuous outcome.", "criterion": "Verify clinical-magnitude information corresponding to the actual scale and result.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Link measurement validity and responder definitions with the actual comparative results.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Do not generate a common threshold, responder rate, NNT or approximate effect.", "missingness": "Do not generate a common threshold, responder rate, NNT or approximate effect.", "uncertainty": "Do not generate a common threshold, responder rate, NNT or approximate effect.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Scale-specific clinical meaning, responder definition, person denominator and period" }, { "item_id": "N17", "question_type": "Registry candidate", "question": "Was the actual result body obtained for NCT00279266?", "needed": "Original registry body, change history, results and linked papers", "role": "Required for the selected B1-only pain comparison", "role_reason": "A candidate registry entry must be distinguished from actual result acquisition.", "application_exception": "Do not turn historical access failure into a current connection failure or proof of no results.", "criterion": "Separately verify existence, acquisition and content of the actual registry body and results.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "If a later update is authorized, compare original locations, times and changes for the registration and linked results.", "current_reports": [ "S03" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Unverified", "status_reason": "External access attempts in this work: 0. Do not infer non-conduct, a null result, withdrawn status, completed status or 0 results.", "missingness": "External access attempts in this work: 0. Do not infer non-conduct, a null result, withdrawn status, completed status or 0 results.", "uncertainty": "External access attempts in this work: 0. Do not infer non-conduct, a null result, withdrawn status, completed status or 0 results.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Original registry body, change history, results and linked papers" }, { "item_id": "N18", "question_type": "Combination exclusion", "question": "Was the Abbas–Swai comparison excluded from the effect of B1 alone?", "needed": "Arm-specific B1+B6 amounts and identifiability of each ingredient's contribution", "role": "Required for the selected B1-only pain comparison", "role_reason": "A comparison that also changes other ingredients must not be mistaken for a single-ingredient causal effect.", "application_exception": "Do not erase related human research as nonexistent.", "criterion": "Link actual combination amounts and the original exclusion reason to the same material.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare arm-specific administration tables with the scope of the results.", "current_reports": [ "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Met", "status_reason": "This exclusion does not mean the study itself, or all B-vitamin effects, are absent.", "missingness": "This exclusion does not mean the study itself, or all B-vitamin effects, are absent.", "uncertainty": "This exclusion does not mean the study itself, or all B-vitamin effects, are absent.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Arm-specific B1+B6 amounts and identifiability of each ingredient's contribution" }, { "item_id": "N19", "question_type": "Reports and study families", "question": "Were the actual study and participant-family relationships between the two reports verified?", "needed": "Link reports to registration/study families, then outcomes, times and analyses", "role": "Required for the selected B1-only pain comparison", "role_reason": "Bibliographic counts must not become counts of eligible studies or unique participants.", "application_exception": "Do not count unconfirmed links or duplicates as verified replication.", "criterion": "Verify actual registration, study and participant relationships from original materials, distinguishing unconfirmed links.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Link registration, paper, participant and time identities to examine duplication.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "S03 is the NCT00279266 candidate; S22 has the stored study identifier Abbas-Swai-1997. Two reports do not mean 2 eligible single-ingredient replications.", "condition_status": "Partly verified", "status_reason": "Actual unique participants, direct replication and complete independence between families are not certified.", "missingness": "Actual unique participants, direct replication and complete independence between families are not certified.", "uncertainty": "Actual unique participants, direct replication and complete independence between families are not certified.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Link reports to registration/study families, then outcomes, times and analyses" }, { "item_id": "N20", "question_type": "Current reading scope", "question": "Were stored summaries, unread external materials and historical access distinguished?", "needed": "Actual acquisition, reading, historical access level, locations and dates for each material", "role": "Required for the selected B1-only pain comparison", "role_reason": "Providing a URL must not be promoted to reading the original full text.", "application_exception": "Registry opening-page access and indexed author-abstract records remain historical.", "criterion": "Distinguish and link actual reading of the stored local summary from current external non-attempt/non-reading.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "If later authorized, record actual source bytes, access date and exact location for each material.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Met", "status_reason": "The original review date is a global review date; it is not reused as an individual source-access date.", "missingness": "The original review date is a global review date; it is not reused as an individual source-access date.", "uncertainty": "The original review date is a global review date; it is not reused as an individual source-access date.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Actual acquisition, reading, historical access level, locations and dates for each material" }, { "item_id": "N21", "question_type": "Cutoff date and search scope", "question": "Were the original cutoff, search limitations and scope of this conversion distinguished?", "needed": "Search cutoff, original review date, current summary-review date and actual work scope", "role": "Required for the selected B1-only pain comparison", "role_reason": "A conversion of stored materials must not be exaggerated into a new exhaustive literature search.", "application_exception": "A search-log path alone does not establish that the log was read for this work.", "criterion": "Separate the original cutoff and search scope from the lack of current external work.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "In an authorized update, compare actual search logs with subsequent materials and corrections.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Met", "status_reason": "Do not attribute the search-scope record to a new report when its linked-source list is empty.", "missingness": "Do not attribute the search-scope record to a new report when its linked-source list is empty.", "uncertainty": "Do not attribute the search-scope record to a new report when its linked-source list is empty.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Search cutoff, original review date, current summary-review date and actual work scope" }, { "item_id": "N22", "question_type": "Replication and independence", "question": "Was evidence of independent replication verified for the exact single-ingredient pain comparison?", "needed": "Eligible replication results, teams, funding and participant/data overlap", "role": "Required for the selected B1-only pain comparison", "role_reason": "Related research must be distinguished from replication of the single-ingredient claim.", "application_exception": "The individual manuscripts for benfotiamine 544 and general nerve function 162 were not read for this work.", "criterion": "Verify eligible replication and independent identities for the same ingredient, population and outcome.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare outcomes, study families, authors/funding and data overlap.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Do not create repeated refutation or independent replication from related IDs or report counts.", "missingness": "Do not create repeated refutation or independent replication from related IDs or report counts.", "uncertainty": "Do not create repeated refutation or independent replication from related IDs or report counts.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Eligible replication results, teams, funding and participant/data overlap" }, { "item_id": "N23", "question_type": "Funding and conflicts of interest", "question": "Were funding, author roles and conflicts of interest obtained for the eligible result?", "needed": "Original funding, affiliations, roles, COI and data independence", "role": "Supplementary; required for independence claims", "role_reason": "Unconfirmed information must not become proof of non-involvement or verified bias.", "application_exception": "Do not transfer funding information from another study.", "criterion": "Directly verify declarations and roles for the eligible result.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare original funding/COI declarations with the actual study and data relationships.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "Funding information for both evidence records is unconfirmed or recorded as unused in this page's grade; the independence axis is blank.", "condition_status": "Unverified", "status_reason": "Original funding materials were not newly read, and independence is not certified.", "missingness": "Original funding materials were not newly read, and independence is not certified.", "uncertainty": "Original funding materials were not newly read, and independence is not certified.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Original funding, affiliations, roles, COI and data independence" }, { "item_id": "N24", "question_type": "Preserving the original judgment", "question": "Were the original ?, blank values and bounded eligible-human-result-unverified flag preserved?", "needed": "Original grade, score, axes, judgment scope and revision policy", "role": "Required for the selected B1-only pain comparison", "role_reason": "Checklist status must not be confused with the existing clinical grade or a new certification.", "application_exception": "Document-quality A and grade ? are separate; they do not mean no effect or 0 studies worldwide.", "criterion": "Preserve original values, blanks, false values, empty arrays and judgment scope without conversion.", "basis": "M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare the original stored-manuscript bytes with each linked location to verify display scope.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Met", "status_reason": "No new scoring or calculation was performed, and the original judgment was not based on access failure alone.", "missingness": "No new scoring or calculation was performed, and the original judgment was not based on access failure alone.", "uncertainty": "No new scoring or calculation was performed, and the original judgment was not based on access failure alone.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Original grade, score, axes, judgment scope and revision policy" }, { "item_id": "N25", "question_type": "Clinical and biochemical boundaries", "question": "Was the pain question distinguished from circulating vitamers?", "needed": "Question boundaries between patient symptoms/function and biochemical measures", "role": "Required for the selected B1-only pain comparison", "role_reason": "Biochemical changes must not replace a pain effect.", "application_exception": "Preserve the blank biochemical value and the confirmed information status.", "criterion": "Verify the distinction between the original patient symptom/function question and biochemistry.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Examine candidate measures separately from actual patient outcomes.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Met", "status_reason": "This is neither a verified pain effect nor an actual biochemical measurement.", "missingness": "This is neither a verified pain effect nor an actual biochemical measurement.", "uncertainty": "This is neither a verified pain effect nor an actual biochemical measurement.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Question boundaries between patient symptoms/function and biochemical measures" }, { "item_id": "N26", "question_type": "Safety", "question": "Were harms and discontinuation data obtained for the same single-ingredient product, population and period?", "needed": "AE collection, person/event denominators, discontinuation, period, concurrent treatment and vulnerable populations", "role": "Supplementary; required for safety claims", "role_reason": "Tolerability of other B-vitamin combinations must not be transferred to B1 alone.", "application_exception": "Do not change the original unknown safety status into a new safety grade.", "criterion": "Verify actual harms, collection scope and denominators for that single-ingredient exposure.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare exposure, harm collection, discontinuation and follow-up records.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Unconfirmed harms do not mean AE0 or safety; combination results are not inherited.", "missingness": "Unconfirmed harms do not mean AE0 or safety; combination results are not inherited.", "uncertainty": "Unconfirmed harms do not mean AE0 or safety; combination results are not inherited.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "AE collection, person/event denominators, discontinuation, period, concurrent treatment and vulnerable populations" }, { "item_id": "N27", "question_type": "Assay interference and drug interactions", "question": "Is there a separate verification scope for assay interference and concurrent drugs?", "needed": "Actual assay/drug exposure, interference and interaction information, and work scope", "role": "Supplementary; required for interpreting interference or interactions", "role_reason": "Not conducting a separate search must not be interpreted as no impact.", "application_exception": "Do not turn an unperformed search into current access failure or clinical safety.", "criterion": "Verify materials and review scope supporting the particular interference or interaction claim.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "In an authorized extension, separately review actual assay and concurrent-exposure materials.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Unverified", "status_reason": "Reading the summary alone does not verify absence of interference or interactions.", "missingness": "Reading the summary alone does not verify absence of interference or interactions.", "uncertainty": "Reading the summary alone does not verify absence of interference or interactions.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Actual assay/drug exposure, interference and interaction information, and work scope" }, { "item_id": "N28", "question_type": "Long-term and optimal-dose extensions", "question": "Does the current pain question also include optimal-dose and post-treatment persistence claims?", "needed": "Boundary between the fixed question and separate dose-comparison or long-term/post-treatment persistence questions", "role": "Supplementary; required for optimal-dose or long-term extensions", "role_reason": "A narrow question must not require every study of expanded claims.", "application_exception": "Do not turn unconfirmed duration into a verified long-term effect.", "criterion": "Distinguish the fixed question from additional optimal-dose or long-term persistence claims.", "basis": "M03 §3.2.1–3.2.4: detailed dose, persistence and effect-modification conditions are internally designed", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "When an extension is requested, review direct dose comparisons and post-treatment/long-term follow-up as separate questions.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "This table compares B1 alone for painful DPN pain; it does not add optimal-dose or post-treatment persistence claims as requirements.", "condition_status": "Not applicable", "status_reason": "Not applicable is not a judgment of absent long-term data, safety or no effect.", "missingness": "Not applicable is not a judgment of absent long-term data, safety or no effect.", "uncertainty": "Not applicable is not a judgment of absent long-term data, safety or no effect.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Boundary between the fixed question and separate dose-comparison or long-term/post-treatment persistence questions" }, { "item_id": "N29", "question_type": "Deficiency and other-outcome extensions", "question": "Does this table include correction of deficiency neuropathy or other nerve outcomes?", "needed": "Separate boundaries for confirmed deficiency, nerve function, symptoms and the selected pain comparison", "role": "Supplementary; required for deficiency or other-outcome extensions", "role_reason": "Questions with different populations or outcomes must not be merged into one completed claim.", "application_exception": "Do not erase related research or create a new judgment that research does not exist.", "criterion": "Distinguish the selected population/outcome from separate expanded questions.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "For an extension, directly review the corresponding diagnosis/outcome materials as a separate independent question.", "current_reports": [], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "Adults with painful DPN are distinguished from confirmed B1-deficiency neuropathy. Related 162 and 544 have different ingredient or population/outcome boundaries.", "condition_status": "Not applicable", "status_reason": "Non-applicability of an extension is not interpreted as no effect in related research.", "missingness": "Non-applicability of an extension is not interpreted as no effect in related research.", "uncertainty": "Non-applicability of an extension is not interpreted as no effect in related research.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Separate boundaries for confirmed deficiency, nerve function, symptoms and the selected pain comparison" }, { "item_id": "N30", "question_type": "Updates and corrections", "question": "Were updates for new evidence, access or corrections linked with preservation of previous originals?", "needed": "Triggers, verified materials, reasons for changes, dates and previous originals/judgments", "role": "Required for the selected B1-only pain comparison", "role_reason": "Future update triggers must not become a waiting condition for initial publication.", "application_exception": "Condition changes are applied only after a separate new version is frozen.", "criterion": "Link the original revision policy with uncertainty disclosure, original preservation and row-level updates.", "basis": "M04 §4.5, §4.6.3: limitations of this conversion follow the user's scope and internal design", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare the identity, location and hashes of new materials/corrections separately from change decisions.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Met", "status_reason": "This stored record was written before public deployment. Separating this table is not a new clinical-evidence review or regrading event.", "missingness": "This stored record was written before public deployment. Separating this table is not a new clinical-evidence review or regrading event.", "uncertainty": "This stored record was written before public deployment. Separating this table is not a new clinical-evidence review or regrading event.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Triggers, verified materials, reasons for changes, dates and previous originals/judgments" }, { "item_id": "N31", "question_type": "Contrary and conflicting results", "question": "Were all verified related materials and the original limits on refutation preserved?", "needed": "Roles, results and exclusion reasons for both reports, and the original scope of refutation", "role": "Required for the selected B1-only pain comparison", "role_reason": "Related human research must not be erased, nor results for other ingredients converted into refutation of the same question.", "application_exception": "Unverified eligible monotherapy results do not mean no effect or repeated refutation.", "criterion": "Preserve both current materials and all verified findings and limitations with their locations, regardless of direction.", "basis": "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", "condition_origin": "Development conditions individually designed with knowledge of the stored materials; not blinded, clinically preregistered or officially certified", "proposed_research": "Compare original roles, results and exclusion reasons against the same single-ingredient question.", "current_reports": [ "S03", "S22" ], "existence": "Stored summaries, bibliographic information and historical records exist; current external lookups 0", "acquired_read": "The relevant locations in the stored review summary were read. Clinical source materials and external full texts were not read for this work.", "observation": "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.", "condition_status": "Met", "status_reason": "This preservation does not certify a direct effect or worldwide absence of research.", "missingness": "This preservation does not certify a direct effect or worldwide absence of research.", "uncertainty": "This preservation does not certify a direct effect or worldwide absence of research.", "review_date": "2026-10-05", "reading_status": "Original unread · retained summary read", "additional_material": "Roles, results and exclusion reasons for both reports, and the original scope of refutation" } ], "reports": [ { "report_id": "S03", "title": "Oral Thiamine for the Treatment of Painful Diabetic Peripheral Neuropathy", "url": "https://clinicaltrials.gov/study/NCT00279266", "report_type": "Historical record of an official registry opening page and failed result-body access", "existence": "The stored bibliography, linked URLs and result summaries were checked. Current public availability of external originals was not newly queried.", "acquired_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.", "study_family": "NCT00279266", "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.", "observed_result": "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.", "result_level": "The original review's summary and attribution are retained. This is not new reading or regrading of external clinical originals.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Stored bibliographic information, summaries and historical review records", "public_status": "Stored locally", "access_status": "Obtained", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The locations and values in the stored summary were verified. This does not mean the original clinical full text was obtained.", "material_id": "S03-M1", "url": null }, { "material_type": "ClinicalTrials.gov registry webpage and unobtained result body", "public_status": "Unconfirmed (current external lookups 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-05", "qualification": "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.", "material_id": "S03-M2", "url": "https://clinicaltrials.gov/study/NCT00279266" } ], "links": [ { "label": "Official source", "url": "https://clinicaltrials.gov/study/NCT00279266" } ] }, { "report_id": "S22", "title": "Abbas and Swai — thiamine plus pyridoxine in symptomatic diabetic neuropathy (1997)", "url": "https://pubmed.ncbi.nlm.nih.gov/9557427/", "report_type": "Indexed author-abstract record of a comparison changing B1+B6 doses together", "existence": "The stored bibliography, linked URLs and result summaries were checked. Current public availability of external originals was not newly queried.", "acquired_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.", "study_family": "Abbas-Swai-1997", "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.", "observed_result": "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).", "result_level": "The original review's summary and attribution are retained. This is not new reading or regrading of external clinical originals.", "source_evidence_date": "2026-09-15", "materials": [ { "material_type": "Stored bibliographic information, summaries and historical review records", "public_status": "Stored locally", "access_status": "Obtained", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-05", "qualification": "The locations and values in the stored summary were verified. This does not mean the original clinical full text was obtained.", "material_id": "S22-M1", "url": null }, { "material_type": "PubMed paper bibliography/author abstract and linked full-text entry", "public_status": "Unconfirmed (current external lookups 0)", "access_status": "Access not attempted", "acquired": false, "actually_read": "Unread", "as_of": "2026-10-05", "qualification": "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.", "material_id": "S22-M2", "url": "https://pubmed.ncbi.nlm.nih.gov/9557427/" } ], "links": [ { "label": "Official source", "url": "https://pubmed.ncbi.nlm.nih.gov/9557427/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.", "review_level": "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." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish and link studies and reports; do not omit studies solely because outcomes are unreported.", "review_level": "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." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Fix the outcome and effect of interest, then review randomization, deviations, missing data, measurement and selective reporting.", "review_level": "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." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effects, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "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." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence.", "review_level": "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." } ], "status_dictionary": { "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" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-31", "kind": "Public reader/material separation", "view_version": "1.0", "change": "The public page and materials were prepared from the existing 31 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-31" }