# Ordinary thiamine (vitamin B1); the question targets an oral single ingredient, with actual salt/product unverified × Reduction of 12-week HDRS total when added at SSRI initiation in adult MDD inpatients Verdict 3120 · Evidence Check Stored-material review date: 2026-10-05 Original evidence date: 2026-09-16 Review-criteria version: v3120-THIAMINE-MDD-HDRS12-1.1 Public page/material preparation date: 2026-11-06 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: Adult inpatients reported to have major depressive disorder (MDD) and baseline HDRS >24; diagnostic framework, age bounds and thiamine status unverified - Ingredient, formulation and route: Ordinary thiamine (vitamin B1); the question targets an oral single ingredient, with actual salt/product unverified · A single ingredient is the question target; the ordinary-thiamine salt and formulation are unverified in the original MDD report · The question targets oral administration; oral administration could not be verified in the accessed original MDD report - Dose: Unverified from the original MDD report; no thiamine-equivalent dose calculated - Comparator: Placebo + a newly initiated standardized SSRI in the candidate trial; exact drug, dose and other treatments unverified - Measured outcome: Clinician-rated HDRS total at 12 weeks; version, item count and score range unverified - Duration: 12 weeks (candidate trial endpoint; actual daily regimen unverified) - Questions outside this scope: This page does not assess diagnosis, response/remission, relapse or suicide-related events. The need to correct deficiency is also separate from the efficacy of additional supplementation in thiamine-replete adults with depression; the candidate population is not presumed deficient or replete.; Proceed as one independent table. Fix the question to adult MDD inpatients, addition at initiation of a new SSRI, and clinician-rated HDRS total at 12 weeks. Eligibility regarding actual oral administration, salt, single-ingredient composition and dose remains unverified in the original report. subclaims=[]; improvement at 6 weeks/within groups, remission/response, suicide prevention, deficiency correction, mood in healthy people, PCOS GHQ, observational studies/case reports, and combinations/fatigue are not pooled into the principal effect. ## Checklist items ### N01 · Which adults, adjunctive treatment and 12-week outcome does this table address? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The original claim concerns treatment added at SSRI initiation in adult MDD inpatients and reduction of HDRS total at 12 weeks. The question is fixed to single-ingredient oral ordinary thiamine versus placebo, with subclaims=[]. Diagnosis, response/remission, relapse and suicide prevention are separate questions. - Why unverified: The identity and exclusion boundaries of the independent question were linked to the retained original text. Meeting this condition does not mean that candidate-trial eligibility or treatment efficacy has been verified. - Reason for missing information: The question's identity is linked, but the actual product, route and effect remain separately unverified. - Required materials and conditions: Original claim, facets and subclaims, and clinical questions excluded from the same page - Materials to obtain first: Original claim, facets and subclaims, and clinical questions excluded from the same page - Further research: Future research should prespecify HDRS total at 12 weeks and response, remission and suicide-related events as separate outcomes. - Conditions for verification: Link the original /ko/effect to the population, addition at SSRI initiation and HDRS at 12 weeks, and explain overlap between parent and subordinate questions. - Why this condition is needed: Needed to prevent the question about total depressive symptoms from shifting to general mood, remission or suicide prevention. - Application exceptions: Response, remission, relapse and suicide-related events remain separate questions rather than mandatory outcomes for this total-score question. - Remaining uncertainty: The question's identity is linked, but the actual product, route and effect remain separately unverified. - Referenced methods: M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M03 §3.2.4; custom boundaries on extensions - Related sources: S01, S03 ### N02 · Do the current published source and this summary have the same identity? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The current ID is 3120 and the canonical path is /verdicts/mood/oral-thiamine-mdd-hdrs-12-weeks/. The current base original and inventory snapshot have the same 99,833 bytes and SHA. The needs_id_assignment/server-not-deployed wording in the KO summary_note is preserved as historical content and is not used as a deployment record for this summary conversion. - Why unverified: The current record's identity was distinguished from historical status wording. The original site's current response or public availability was not checked in this review. - Reason for missing information: The production domain's response and actual deployment were not checked in this review. - Required materials and conditions: Current loader-selected path, original SHA, ID/canonical URL, version and actual publication receipt - Materials to obtain first: Current loader-selected path, original SHA, ID/canonical URL, version and actual publication receipt - Further research: Record identities, dates and publication events separately by version, without creating new research results. - Conditions for verification: Compare the current original and snapshot bytes, ID/canonical URL and reference date. - Why this condition is needed: Needed to avoid confusing historical wording about unassigned identifiers and nondeployment with the current ID/URL. - Application exceptions: Historical publication-readiness wording retained in KO is not deleted or reinterpreted as a site-publication event in this review. - Remaining uncertainty: The production domain's response and actual deployment were not checked in this review. - Referenced methods: M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are custom-designed; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design - Related sources: ### N03 · Were the 21 reports kept from being counted repeatedly as unique trials? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S01/S02/S10–S14 form one family, TF-GHALEIHA-2016. S03 is a different controlled study, TF-WATTANATHAMRAK-2019, but replication of the same comparison is unverified. S04 is TF-MOTI-2024 in PCOS/IVF and provides indirect material. The retained family table's 3 controlled candidates and 0 families eligible for efficacy grading are eligibility records from that time. - Why unverified: Original report counts were distinguished from family roles, and no new count of directly eligible trials was established. - Reason for missing information: There is no new external verification of family identities, additional overlap or eligibility. - Required materials and conditions: Original reports, figures, registrations, repositories, a family linkage table and unique-participant identity information - Materials to obtain first: Original reports, figures, registrations, repositories, a family linkage table and unique-participant identity information - Further research: Future syntheses should first create study-level outcome tables after comparing registration numbers, authors, recruitment institutions, periods and participant overlap. - Conditions for verification: Explain the roles of the S01 series as one family, S03 as a separate candidate and S04 as an indirect family. - Why this condition is needed: Needed to avoid counting figures, repositories, indexes and reviews for the same DOI as independent replications. - Application exceptions: Preserve the bibliography count, but do not estimate unresolved unique-study or participant counts or turn the three candidates into directly eligible trials. - Remaining uncertainty: There is no new external verification of family identities, additional overlap or eligibility. - Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application - Related sources: S01, S02, S03, S04, S10, S11, S12, S13, S14 ### N04 · What was read in this review, and what was the historical level of access? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The current stored summary for 3120 was read in this review, including its Korean text, structured evidence, 21 bibliographic records and historical access records. The records dated 2026-09-16 of partial access to S01, visual inspection of the S02 figure and access to the S04 HTML full text are history recorded in the original. External papers, figures, registrations and official materials were not accessed, acquired or read in this review; access was not attempted. - Why unverified: Current actual actions were separated from historical records. Past PDF failures were not labeled as failures in this review, and historical full-text access to S04 was not labeled as current full-text reading. - Reason for missing information: External full texts and old separate ZIP files/logs were not opened in this review. - Required materials and conditions: Retained source/citation, access_level/date/locator, and actual files and reading events - Materials to obtain first: Retained source/citation, access_level/date/locator, and actual files and reading events - Further research: When materials are acquired in the future, record the sections and tables actually read, file SHA and access events separately for each material type. - Conditions for verification: Separate existence, access, acquisition, reading and current/historical dates for each material type. - Why this condition is needed: Needed to avoid promoting the summary of the current stored summary to reading the original paper, figure or full text. - Application exceptions: Past failures, partial reading and reports of full-text access remain historical records; they are not reused as inaccessibility or full-text reading in this review. - Remaining uncertainty: External full texts and old separate ZIP files/logs were not opened in this review. - Referenced methods: M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design - Related sources: S01, S02, S04, S07, S09, S13, S15 ### N05 · What are the candidate trial's population and baseline depression severity? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S01 reports a total of 51 participants, all MDD inpatients, baseline HDRS >24, mean age 35.2 years and 53% women. Age bounds, sex distribution by arm and baseline scale means/variances are unverified. Do not turn means and percentages into identical characteristics of every adult. - Why unverified: The population label, setting and baseline threshold are preserved, but exact eligibility and balance between arms remain unknown. - Reason for missing information: Age range, inclusion/exclusion criteria, baseline distributions by arm and baseline means/SDs are unverified. - Required materials and conditions: Original eligibility criteria, age range, baseline tables by arm, inpatient setting and recruitment flow - Materials to obtain first: Original eligibility criteria, age range, baseline tables by arm, inpatient setting and recruitment flow - Further research: Specify baseline severity and representativeness in the same inpatient MDD population and present balance between arms. - Conditions for verification: Distinguish the reporting level and unverified details of MDD inpatient status, HDRS >24 and means/percentages. - Why this condition is needed: Needed to avoid applying mood studies in healthy people or other diseases to adult MDD inpatients. - Application exceptions: Do not infer age ranges, arm composition or the status of all participants from mean age or the percentage of women. - Remaining uncertainty: Age range, inclusion/exclusion criteria, baseline distributions by arm and baseline means/SDs are unverified. - Referenced methods: M03 §3.2.1; detailed population conditions are custom-designed - Related sources: S01 ### N06 · Have the MDD diagnostic framework, episode, treatment resistance and major exclusions been verified? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The retained manuscript confirms that MDD was reported, but the DSM/ICD version, diagnostic interview, episode status and treatment resistance are unverified. Exclusions and population composition regarding pregnancy/lactation, bipolar disorder, dementia/delirium, renal/liver status and comorbidities are also unverified. - Why unverified: The retained location read explicitly describes a gap in access to the original methods, so the exact diagnostic and exclusion conditions cannot be said to have been met. - Reason for missing information: Diagnosis and exclusions are gaps in the accessed portions of the original report. Do not conclude that they are unreported throughout the original paper. - Required materials and conditions: Original diagnostic interview/DSM/ICD, episode/resistance definitions, exclusion criteria and baseline tables by population - Materials to obtain first: Original diagnostic interview/DSM/ICD, episode/resistance definitions, exclusion criteria and baseline tables by population - Further research: Prespecify diagnostic procedures and episode/resistance criteria, and analyze applicability to special populations separately. - Conditions for verification: Link diagnosis, episode, treatment resistance, comorbidities and the scope of exclusions to the original methods. - Why this condition is needed: Needed to avoid interpreting the reported MDD label as verification of a specific diagnostic procedure, treatment resistance or exclusion of bipolar disorder. - Application exceptions: Do not fill in unverified exclusions, such as pregnancy, bipolar disorder or renal/liver disease, as if they had already been applied. - Remaining uncertainty: Diagnosis and exclusions are gaps in the accessed portions of the original report. Do not conclude that they are unreported throughout the original paper. - Referenced methods: M03 §3.2.1; detailed population conditions are custom-designed; M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are custom-designed - Related sources: S01 ### N07 · Was the candidate population thiamine-deficient or thiamine-replete? Verification status: Conflicting information Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S08's secondary (2nd) narrative calls the S01 population thiamine-deficient. Neither deficiency nor repletion was verified in the accessed S01 original, and baseline markers, thresholds, nutrition, diet and alcohol use are unverified. This conflict concerns the level of verification of deficiency status, not conflicting numerical clinical effects. - Why unverified: The secondary (2nd) assertion and the original-report verification gap were preserved, without arbitrarily adopting either status. - Reason for missing information: Original tests/criteria and arm-level data needed to determine baseline status are unverified. - Required materials and conditions: Original baseline thiamine tests/deficiency criteria, dietary/nutritional/alcohol-use records and the review's original citation location - Materials to obtain first: Original baseline thiamine tests/deficiency criteria, dietary/nutritional/alcohol-use records and the review's original citation location - Further research: Future research should measure baseline status and assess interaction by prespecified deficiency status. - Conditions for verification: Separate baseline thiamine markers/thresholds, meals, nutrition and alcohol use from the verification level of secondary (2nd) statements. - Why this condition is needed: Needed to avoid combining correction of deficiency with the effect of additional supplementation in a replete state. - Application exceptions: Do not use the secondary (2nd) review's word deficient to establish the original report's testing, deficiency threshold or replete status. - Remaining uncertainty: Original tests/criteria and arm-level data needed to determine baseline status are unverified. - Referenced methods: M03 §3.2.1; detailed population conditions are custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed; M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are custom-designed - Related sources: S01, S08 ### N08 · Can ordinary thiamine be distinguished from the actual salt and single-ingredient product? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The question targets single-ingredient oral ordinary thiamine. S01 reports the ingredient name thiamine (vitamin B1), but the exact salt, product, source and single-ingredient composition could not be verified. Benfotiamine, fursultiamine/TTFD, sulbutiamine, allithiamine, phosphorylated derivatives, combinations and injections are not direct evidence for the same question. - Why unverified: The general ingredient name alone is not treated as meeting eligibility requirements for the exact molecule/salt and single-ingredient composition. - Reason for missing information: The candidate trial's product identity and actual composition are unverified. - Required materials and conditions: Original trial product name, salt, active/added ingredients, manufacturing/formulation documents and administration records - Materials to obtain first: Original trial product name, salt, active/added ingredients, manufacturing/formulation documents and administration records - Further research: Future direct comparisons should predefine and disclose the salt, product and composition of ordinary thiamine and the control product. - Conditions for verification: Show separately the question target and the level of verification of the actual label, salt, source and composition in the original report. - Why this condition is needed: Needed to avoid assigning the identity of derivatives, combinations or other products to the candidate trial. - Application exceptions: Derivatives such as benfotiamine and TTFD, combinations and injections are excluded from the question, but the candidate product is not presumed to have been a single-ingredient preparation. - Remaining uncertainty: The candidate trial's product identity and actual composition are unverified. - Referenced methods: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed - Related sources: S01 ### N09 · Was oral administration verified in the candidate MDD original report? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The question concerns oral administration, but the actual oral route was not verified in retained S01. Oral-administration information in the S07 review is not a route verified in the original report, and oral-administration information in the PCOS study S04 does not establish the route in S01 either. - Why unverified: The current eligibility gap in the original report was maintained. An unverified oral route does not mean that a parenteral route has been verified. - Reason for missing information: The original Methods needed to verify the actual route in S01 remain unverified. - Required materials and conditions: Actual route of administration, product and prescription records in the candidate original report's Methods - Materials to obtain first: Actual route of administration, product and prescription records in the candidate original report's Methods - Further research: Future comparisons should document oral administration and actual intake, and separate these from injection and derivative data. - Conditions for verification: Distinguish the actual route in the original report from the question's route, and link the route-verification gap to its location. - Why this condition is needed: Needed to avoid turning an oral-administration question into a fact of actual oral administration. - Application exceptions: The review's oral-administration information is a lead for tracing the original report, not verification of the route in that report. - Remaining uncertainty: The original Methods needed to verify the actual route in S01 remain unverified. - Referenced methods: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed - Related sources: S01, S04, S07 ### N10 · Have the actual prescribed dose and administration regimen in S01 been verified? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: Daily dose, per-administration dose, frequency, meal timing, loading/maintenance and adherence are unverified from the S01 original. The S07 information on oral 300 mg/day and fluoxetine 20 mg/day is not verified in the original report. For S03 and S04, 300 mg/day is also retained only as the nominal dose in each separate study. - Why unverified: Although the 12-week endpoint is preserved, the actual daily prescription and exposure cannot be established. - Reason for missing information: S01 dose/conversion, actual exposure and adherence data are unverified. - Required materials and conditions: S01 original prescription/product, daily and per-administration doses, frequency, meal timing, adherence records and handling of deviations - Materials to obtain first: S01 original prescription/product, daily and per-administration doses, frequency, meal timing, adherence records and handling of deviations - Further research: Future research should record actual intake, adherence and changes, and assess dose optimization in separate direct comparisons. - Conditions for verification: Distinguish daily/per-administration doses, frequency, meal timing, loading/maintenance and adherence from study duration. - Why this condition is needed: Needed to avoid transferring 300 mg/day from another study or review into a verified dose for the candidate trial. - Application exceptions: Do not arbitrarily convert hydrochloride mg or thiamine-equivalent amounts, or fill in unverified frequency, meal timing or adherence. - Remaining uncertainty: S01 dose/conversion, actual exposure and adherence data are unverified. - Referenced methods: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are custom-designed - Related sources: S01, S03, S04, S07 ### N11 · Is this an adjunctive-treatment comparison at initiation of a new SSRI? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S01 reports a comparison of added thiamine or placebo while a standardized SSRI was newly initiated and maintained at therapeutic levels. It is not verified as a trial of thiamine monotherapy or augmentation of a stable pre-existing antidepressant dose. The SSRI name, dose and actual treatment by arm are unverified. - Why unverified: The adjunctive comparison's structure is preserved, but the specific identity of the shared treatment and its implementation by arm remain unknown. - Reason for missing information: Drug, dose and arm-level treatment changes and maintenance data are unverified. - Required materials and conditions: Records of SSRI initiation timing, drug/dose, maintenance at therapeutic levels and added ingredient/placebo in both arms - Materials to obtain first: Records of SSRI initiation timing, drug/dose, maintenance at therapeutic levels and added ingredient/placebo in both arms - Further research: Compare only the added ingredient on top of the same SSRI initiation, and design augmentation of a stable dose as a separate stratum. - Conditions for verification: Preserve actual background-treatment initiation and maintenance and the structure of the placebo add-on comparison. - Why this condition is needed: Needed to avoid turning improvement from the SSRI itself into thiamine monotherapy efficacy or augmentation of a stable dose. - Application exceptions: Newly initiated standard treatment and stable pre-existing treatment are not automatically pooled as the same incremental effect. - Remaining uncertainty: Drug, dose and arm-level treatment changes and maintenance data are unverified. - Referenced methods: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M08 §8.2.2, M15 §15.3.1; custom application - Related sources: S01 ### N12 · How were placebo, psychotherapy, other drugs and rescue treatment compared? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The control treatment in S01 is placebo, and the shared treatment is a newly initiated standardized SSRI. Placebo composition/appearance and actual treatment by arm, including psychotherapy, other psychotropics and rescue treatment, are unverified because of the gap in access to the original methods. - Why unverified: A placebo comparison was reported, but specific verification of what was the same or different apart from the added ingredient remains outstanding. - Reason for missing information: Placebo matching, concomitant treatment/changes by arm, rescue treatment and their analytical handling are unverified. - Required materials and conditions: Placebo composition/appearance, psychotherapy/other psychotropics by arm, rescue treatment and records of changes - Materials to obtain first: Placebo composition/appearance, psychotherapy/other psychotropics by arm, rescue treatment and records of changes - Further research: Adjunctive comparisons should disclose concomitant treatment and rescue use by arm and handle these in a predefined analysis. - Conditions for verification: Distinguish the placebo label from actual matching, shared treatment and rescue treatment/psychotherapy by arm. - Why this condition is needed: Needed to avoid mixing differences in concomitant treatment with the selected ingredient's contribution. - Application exceptions: Do not assume that all changes must be identical; examine the actual effect of interest and how changes by arm were handled. - Remaining uncertainty: Placebo matching, concomitant treatment/changes by arm, rescue treatment and their analytical handling are unverified. - Referenced methods: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application - Related sources: S01 ### N13 · Have the implementation of randomization, allocation concealment and baseline balance been verified? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S01 is reported as a randomized thiamine-versus-placebo trial. The full methods section needed to verify sequence generation, concealment, unit of allocation and baseline balance by arm was not acquired within the current retained scope. - Why unverified: The comparative design is named, but evidence verifying actual allocation is insufficient. - Reason for missing information: Sequence generation, concealment, unit of allocation and baseline balance are unverified. - Required materials and conditions: Sequence generation, concealment, unit of allocation, baseline tables by arm and participant flow in the original Methods - Materials to obtain first: Sequence generation, concealment, unit of allocation, baseline tables by arm and participant flow in the original Methods - Further research: Future trials should predefine allocation and concealment and disclose participant flow and baseline data by arm. - Conditions for verification: Link the reported randomized placebo comparison to gaps concerning actual sequence generation, concealment and allocation/baseline details. - Why this condition is needed: Needed to avoid stating that allocation issues were resolved merely from the randomized label. - Application exceptions: Do not turn unverified design details into an unsupported Not applicable designation for crossover/cluster considerations. - Remaining uncertainty: Sequence generation, concealment, unit of allocation and baseline balance are unverified. - Referenced methods: M08 §8.1–8.2.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed - Related sources: S01 ### N14 · Have assessor blinding and the actual HDRS measurement procedure been verified? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The HDRS in S01 is retained as a clinician/expert assessment. The bibliographic URL for S13 contains double_blind, but actual implementation of assessor blinding, scale training, agreement and any unblinding are unverified. Do not conclude that measurement bias is absent from the title or URL alone. - Why unverified: The assessor type is recorded, but implementation of blinding and measurement consistency for the selected outcome remain unknown. - Reason for missing information: Assessment blinding, training, agreement and verification of implementation are unverified. - Required materials and conditions: Original blinding, unblinding/verification, assessor training/agreement and measurement procedures by arm - Materials to obtain first: Original blinding, unblinding/verification, assessor training/agreement and measurement procedures by arm - Further research: Define independent assessment procedures using the same scale and time point, and record measurement differences between arms. - Conditions for verification: Link assessor and participant/treatment blinding, timing, training and assessment agreement to the actual methods. - Why this condition is needed: Needed to distinguish differences in the implementation of clinician assessment from actual differences in symptoms. - Application exceptions: A bibliographic title stating double blind does not establish successful blinding of every party or successful implementation of all assessment procedures. - Remaining uncertainty: Assessment blinding, training, agreement and verification of implementation are unverified. - Referenced methods: M08 Table 8.2.a, M03 §3.2.4; custom application; M08 §8.1–8.2.3; custom application - Related sources: S01, S13 ### N15 · Were the total of 51 participants and arm-level randomized, analyzed and completed counts distinguished? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: In S01, the 51 participants are the total reported in the abstract. Arm-level randomized, analyzed and completed n and the number analyzed for HDRS at 12 weeks are unverified. Do not divide the 51 participants into two arms or use them as the safety denominator at 12 weeks. - Why unverified: The reported total is preserved, but the arm-level analysis denominators for the outcome of interest cannot be verified. - Reason for missing information: Arm-level randomized, analyzed and completed counts and measurement/exposure n at 12 weeks are unverified. - Required materials and conditions: Original CONSORT and allocation/completion/withdrawal tables, the HDRS analysis population at 12 weeks and n by arm - Materials to obtain first: Original CONSORT and allocation/completion/withdrawal tables, the HDRS analysis population at 12 weeks and n by arm - Further research: Present the full flow by arm and the analysis n for each outcome, and examine the link between outcomes and attrition. - Conditions for verification: Show the label for the reported total count and the unverified arm-level allocation/completion/analysis and principal-time-point denominators. - Why this condition is needed: Needed to avoid turning the abstract's total participant count into the actual analysis denominator at 12 weeks. - Application exceptions: Do not split the odd total participant count between arms or add it to S03 and S04. - Remaining uncertainty: Arm-level randomized, analyzed and completed counts and measurement/exposure n at 12 weeks are unverified. - Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed; M08 §8.2.2, M15 §15.3.1; custom application - Related sources: S01 ### N16 · Have attrition, missing data, ITT/PP and the effect analyzed been verified? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The analysis n by arm, reasons for attrition/missingness, missing-data handling and ITT/PP analysis populations in S01 are unverified. Whether the analysis was adjusted or unadjusted, and whether the effect of interest concerns final values or changes, are also unresolved. - Why unverified: Even the same between-group difference can be interpreted differently depending on the analysis population and missing-data handling, so no analysis label was invented to fill the gap. - Reason for missing information: Missing data/attrition, analysis methods, models and the estimand are unverified. - Required materials and conditions: Original missingness/attrition by arm at 12 weeks, analysis n, SAP, ITT/PP and sensitivity results - Materials to obtain first: Original missingness/attrition by arm at 12 weeks, analysis n, SAP, ITT/PP and sensitivity results - Further research: Prespecify the distinction between the effect of assignment and the effect of adherence, and present missing-data assumptions and sensitivity analyses. - Conditions for verification: Distinguish reasons for attrition, missing data by arm, their handling, analysis populations and the effect of interest. - Why this condition is needed: Needed to identify the material required to examine whether selection of completers/analyzed participants changes the between-group result. - Application exceptions: If the original material does not specify the analysis, do not arbitrarily fill in ITT, PP, LOCF or another method. - Remaining uncertainty: Missing data/attrition, analysis methods, models and the estimand are unverified. - Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed; M08 §8.2.2, M15 §15.3.1; custom application; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application - Related sources: S01 ### N17 · What are the actual HDRS version, items, range and direction? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The selected outcome is the continuous depression total on the clinician-rated Hamilton Depression Rating Scale, with lower scores indicating improvement. The actual version, item count and score range are unverified. The GHQ-28 depression subscale with 7 items and individual sleep/appetite items are not the same total score. - Why unverified: The scale name, construct and direction are preserved, but the version and range needed to interpret the actual score units remain unknown. - Reason for missing information: Version, item count, score range and actual scoring procedures are unverified. - Required materials and conditions: Original scale version, items/range, scoring instructions and assessment result tables by arm - Materials to obtain first: Original scale version, items/range, scoring instructions and assessment result tables by arm - Further research: Future trials should prespecify the exact scale, version, total score and assessor procedures. - Conditions for verification: Separate the recorded clinician-rated total and lower-is-better direction from the unverified version/items/range. - Why this condition is needed: Needed to avoid treating other depression scales or individual items as the same effect as HDRS total. - Application exceptions: Do not infer 17/21 items or a score range from the HDRS label, or substitute a GHQ subscale. - Remaining uncertainty: Version, item count, score range and actual scoring procedures are unverified. - Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M08 Table 8.2.a, M03 §3.2.4; custom application; M03 §3.2.4; custom boundaries on extensions - Related sources: S01 ### N18 · Were the endpoint result at 12 weeks and signals at 3 and 6 weeks distinguished? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The visits in retained S01 are at 0, 3, 6 and 12 weeks, and this table's principal time point is 12 weeks. The choice of principal time point is recorded as a review choice in the current manuscript, not as verified trial preregistration. The favorable signal at 6 weeks is preserved but does not replace the result at 12 weeks. - Why unverified: The roles of the time points were distinguished. Meeting this condition is separate from verification of the effect/prescribed dose at 12 weeks. - Reason for missing information: The trial's prespecified outcome hierarchy and actual administration exposure are unverified. - Required materials and conditions: Original visit schedule, principal time point in the registration/protocol, result tables by time and actual prescribed exposure - Materials to obtain first: Original visit schedule, principal time point in the registration/protocol, result tables by time and actual prescribed exposure - Further research: Future comparisons should prespecify the principal time point and repeated-measurement plan and disclose all intermediate results. - Conditions for verification: Link the reported 0, 3, 6 and 12 weeks to the manuscript's chosen principal time point and its prespecification status. - Why this condition is needed: Needed to avoid substituting a favorable intermediate time point for the selected 12-week question. - Application exceptions: Do not describe the current manuscript's choice of 12 weeks as trial preregistration, or infer the actual daily prescription. - Remaining uncertainty: The trial's prespecified outcome hierarchy and actual administration exposure are unverified. - Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed; M08 Table 8.2.a, M04 §4.6.3; custom application - Related sources: S01, S02 ### N19 · Has the exact estimate of the between-group effect at 12 weeks been verified? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S01/S02 report a favorable signal at 6 weeks, a nonsignificant between-group mean difference at 12 weeks and improvement in both groups. The exact between-group difference at 12 weeks, arm means, changes and adjustment status are unverified. Within-group improvement does not establish a causal effect of thiamine. - Why unverified: The numerical estimate of interest and its analysis definition are missing, so the magnitude of the incremental effect cannot be established. - Reason for missing information: The exact effect at 12 weeks, final values/changes, model and arm-level numerical values are unverified. - Required materials and conditions: Original arm-level total scores/changes at 12 weeks, adjusted/unadjusted between-group estimates and analysis definitions - Materials to obtain first: Original arm-level total scores/changes at 12 weeks, adjusted/unadjusted between-group estimates and analysis definitions - Further research: Directly estimate the predefined incremental effect at 12 weeks between groups, and present within-group changes separately. - Conditions for verification: Distinguish the between-group mean difference at 12 weeks from final values/changes and within-group improvement. - Why this condition is needed: Needed to avoid turning within-group improvement in both arms into thiamine's incremental contribution. - Application exceptions: Do not reconstruct numerical values from the figure or use the 6-week result or response/remission P values to fill in the total-score result at 12 weeks. - Remaining uncertainty: The exact effect at 12 weeks, final values/changes, model and arm-level numerical values are unverified. - Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed - Related sources: S01, S02 ### N20 · Can the SD/SE and confidence interval at 12 weeks be interpreted? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The retained record explicitly states that Figure 1 was inspected only qualitatively and that graph digitization, arm means, SD/SE and effect/CI were not reconstructed. The confidence interval at 12 weeks and type of variability measure are unverified. The figure's S/S/L/M labels are not a verified MCID either. - Why unverified: Without exact variability and intervals, it cannot be determined whether important benefit or harm has been excluded. - Reason for missing information: SD/SE, n by arm, CI and MCID are unverified, and no new calculation is performed. - Required materials and conditions: Original numerical tables at 12 weeks, SD/SE definitions, analysis n by arm, CI and model output - Materials to obtain first: Original numerical tables at 12 weeks, SD/SE definitions, analysis n by arm, CI and model output - Further research: Report uncertainty intervals together with the variability/denominators used, and disclose the source data for the figure. - Conditions for verification: Show the actual meaning of the reported variability and intervals and the scope of missing values. - Why this condition is needed: Needed to avoid arbitrarily deriving precision from graph bars or sample size. - Application exceptions: Do not use qualitative inspection of the original Fig.1 as digitization or reconstruction of SD/SE or CI. - Remaining uncertainty: SD/SE, n by arm, CI and MCID are unverified, and no new calculation is performed. - Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed; M15 §15.3.1–15.3.3; custom application - Related sources: S01, S02 ### N21 · Have the P value at 12 weeks and the criterion for a clinically important difference been verified? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The exact P value at 12 weeks and MCID are retained as unverified (null). Only a statement of nonsignificance is available; without an interval, clinically important benefit cannot be excluded. The response/remission P values in S07 are not P values for total-score severity. - Why unverified: The effect, interval and scale criterion needed to judge importance are all missing. - Reason for missing information: The exact P value, CI, MCID and evidence establishing clinical_importance are unverified. - Required materials and conditions: Original exact P value, CI and effect at 12 weeks, and evidence for an important difference appropriate to the HDRS version/population - Materials to obtain first: Original exact P value, CI and effect at 12 weeks, and evidence for an important difference appropriate to the HDRS version/population - Further research: Future research should justify the important difference with evidence and disclose the range of effects allowed by the CI. - Conditions for verification: Explain whether the exact P value and CI at 12 weeks can be compared with an evidence-based important difference. - Why this condition is needed: Needed to avoid declaring sufficient effect or precision from significance or participant counts alone. - Application exceptions: Do not fill in unverified P values or MCIDs using conventional thresholds or P values for other outcomes. - Remaining uncertainty: The exact P value, CI, MCID and evidence establishing clinical_importance are unverified. - Referenced methods: M15 §15.3.1–15.3.3; custom application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed - Related sources: S01, S02, S07 ### N22 · Were favorable findings and statements of no difference both retained without exaggeration? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The favorable signal at 6 weeks, the nonsignificant between-group result at 12 weeks and within-group improvement in both arms were all preserved. The different controlled comparison in S03 and the indirect positive result in S04 are also retained separately. Nonsignificance does not mean an effect of 0, equivalence, noninferiority or exclusion of important benefit. - Why unverified: The direction and applicability of the current reports were explained, without arbitrarily selecting only favorable findings. - Reason for missing information: Exact numerical values, intervals and direct eligibility remain unverified. - Required materials and conditions: All results by time, corrections, analysis definitions and exact original numerical tables - Materials to obtain first: All results by time, corrections, analysis definitions and exact original numerical tables - Further research: Future research should report all favorable/nonsignificant/unfavorable results according to prespecified time points and analyses. - Conditions for verification: Preserve the signal at 6 weeks, nonsignificance at 12 weeks, within-group improvement and positive findings in other studies with their original attribution. - Why this condition is needed: Needed to avoid selecting only improvement at 6 weeks to erase the 12-week gap, or turning nonsignificance into an effect of 0. - Application exceptions: Positive findings at other time points, in other populations or on other scales are not automatically treated as conflicts or replications. - Remaining uncertainty: Exact numerical values, intervals and direct eligibility remain unverified. - Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed; M15 §15.3.1–15.3.3; custom application - Related sources: S01, S02, S03, S04 ### N23 · To what level of disclosure has independence been verified? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S01 declares no external funding and no author conflicts, but internal support and product provision are unverified. Funding, product provision and COI in S03 are unverified. For S04, the IUMS grant 94-04-28-26840, support from the Sarem research center and the declaration of no COI are preserved. - Why unverified: Declarations were distinguished from actual verification gaps, and funding from another family was not assigned to the candidate trial. - Reason for missing information: Internal support/product provision and employment/patents in S01 remain incompletely verified, and funding/COI information in S03 remains unverified. - Required materials and conditions: Original funding, internal support, product provision, employee/patent relationships, declared COI and declarations in each report - Materials to obtain first: Original funding, internal support, product provision, employee/patent relationships, declared COI and declarations in each report - Further research: Future research should disclose public, institutional and product support and author relationships item by item, and distinguish them from independent replication. - Conditions for verification: Attribute separately the declarations and internal-support/product gaps in S01, unverified details in S03 and funding in S04. - Why this condition is needed: Needed to avoid turning unverified funding or a declaration of no external funding into complete independence. - Application exceptions: Do not automatically exclude results because funding/COI exists, or conclude that bias is absent because it does not. - Remaining uncertainty: Internal support/product provision and employment/patents in S01 remain incompletely verified, and funding/COI information in S03 remains unverified. - Referenced methods: Chamgap's own independence and attribution conditions. The official methodological sections used in this pilot do not validate all details of this item; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application - Related sources: S01, S03, S04 ### N24 · Were the original registration, outcome hierarchy, corrections and scope of unverified information compared? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The registration identifier, timing and prespecified outcome hierarchy for S01 were not verified. A record states that no correction, retraction or expression of concern was found on the publisher page opened or in targeted searches at that time, but this is not an exhaustive integrity guarantee. There is no new registration or publication-status lookup in this review. - Why unverified: Without the original registration/protocol needed to compare plans and results, selective reporting is not determined. - Reason for missing information: S01 registration/plans/timing and current publication status are unverified. - Required materials and conditions: Original registration ID, prospective timing, protocol/SAP, outcome changes, correction/retraction notices and actual access events - Materials to obtain first: Original registration ID, prospective timing, protocol/SAP, outcome changes, correction/retraction notices and actual access events - Further research: Future research should compare plans and results by version and record reasons for changes and unreported outcomes. - Conditions for verification: Distinguish the registration/plan gap for S01 from the scope of the correction search at that time. - Why this condition is needed: Needed to avoid turning failure to obtain a registration into confirmed nonregistration or selective reporting, or a guarantee of no retraction. - Application exceptions: Do not retrospectively relabel the current manuscript's principal-time-point selection or historical targeted searches as preregistration or a complete, up-to-date integrity check. - Remaining uncertainty: S01 registration/plans/timing and current publication status are unverified. - Referenced methods: M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed - Related sources: S01 ### N25 · What is the evidential level of the oral-administration, dose and SSRI information in the S07 review? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S07 provides leads of oral 300 mg/day and fluoxetine 20 mg/day while recording that the formulation was not specified. Only selected portions of PDF pages 4–6 were inspected at that time; this is not a record of reading all other pages. Do not promote this information to verified route, product, dose or version values from the S01 original. - Why unverified: Tracing leads exist, but the original Methods needed for direct verification remain outstanding. - Reason for missing information: Comparison of the review's leads with the original report and the actual formulation/product and dose in S01 remain unverified. - Required materials and conditions: Relevant S07 tables/sections and original citations, and the S01 product, route, daily dose and scale Methods - Materials to obtain first: Relevant S07 tables/sections and original citations, and the S01 product, route, daily dose and scale Methods - Further research: Future material reviews should link each secondary (2nd) claim to a precise location in the original report and compare agreement. - Conditions for verification: Keep the secondary (2nd) information on oral 300 mg/day, fluoxetine 20 mg/day and unspecified formulation distinct as recorded. - Why this condition is needed: Needed to prevent secondary (2nd) information from automatically resolving original-report eligibility gaps. - Application exceptions: The review's tables and descriptions are leads for tracing the original report, not direct verification of the S01 product/route/dose. - Remaining uncertainty: Comparison of the review's leads with the original report and the actual formulation/product and dose in S01 remain unverified. - Referenced methods: M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed - Related sources: S01, S07 ### N26 · In S03, do the 50 participants, 300 mg/day and P values represent the same 12-week effect? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S03 studied 50 participants, adults with MDD aged 18–60 years in inpatient/outpatient care, adding thiamine 300 mg/day to standard treatment. It reports allocation by drawing lots and improvement in HRSD; the P-value sequence is .004, .031, .035, but the exact visits and effects of interest for the later values are unverified. Oral route, salt, single-ingredient composition, duration, scale version, n by arm and the placebo-controlled effect at 12 weeks were not verified. - Why unverified: The other controlled signal is preserved, but the dimensions needed to verify direct comparability with the selected question are insufficient. - Reason for missing information: The visit/analysis for each P value, the original effect at 12 weeks, CI, exact route/composition and treatment by arm are unverified. - Required materials and conditions: Full S03 Methods/results, n by arm, route/salt, principal time point, analysis attribution of each P value and SSRI/placebo information - Materials to obtain first: Full S03 Methods/results, n by arm, route/salt, principal time point, analysis attribution of each P value and SSRI/placebo information - Further research: Future syntheses should compare studies after verifying exact PICOT agreement and visit-specific estimates, without automatically creating an average. - Conditions for verification: Link the actual S03 population, standard-treatment control, HRSD and denominator/time-point gaps. - Why this condition is needed: Needed to avoid combining another controlled MDD study as an exact replication of the placebo comparison at SSRI initiation and 12 weeks. - Application exceptions: Do not arbitrarily assign P=.004/.031/.035 to particular visits, analyses or 12 weeks. - Remaining uncertainty: The visit/analysis for each P value, the original effect at 12 weeks, CI, exact route/composition and treatment by arm are unverified. - Referenced methods: M03 §3.2.1; detailed population conditions are custom-designed; M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application - Related sources: S03 ### N27 · Are the date, issue and citation year for S03 consistent? Verification status: Conflicting information Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The publication-date field for S03 is 2019-09-24, the volume/issue is Vol.36 No.1 (2020), and the citation year is 2019. The original record preserves all these fields without inventing a resolution. The two PDF links could not be accessed at that time, and the original PDF was not read in this review either. - Why unverified: Because publication details differ within the same report, Conflicting information is retained only for the bibliographic scope. - Reason for missing information: The meaning of the dates in the canonical metadata and the correspondence between corrections/versions are unverified. - Required materials and conditions: The journal's canonical metadata, corrections to date/issue/citation information and publication events by version - Materials to obtain first: The journal's canonical metadata, corrections to date/issue/citation information and publication events by version - Further research: Record changes in bibliographic identity together with the original values; this is not an efficacy experiment. - Conditions for verification: Preserve all of the published date 2019-09-24, the 2020 issue and the 2019 citation year. - Why this condition is needed: Needed to avoid changing the original record by overwriting different bibliographic years with a single value. - Application exceptions: Do not extend a bibliographic date conflict to a conflict in the clinical results or the entire treatment duration. - Remaining uncertainty: The meaning of the dates in the canonical metadata and the correspondence between corrections/versions are unverified. - Referenced methods: M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed - Related sources: S03 ### N28 · Is S04 a direct result for MDD inpatients at SSRI initiation? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S04 is a trial in women with PCOS, infertility and IVF, aged 18–40 years, using oral thiamine for 4 weeks at 300 mg/day. It excluded diagnosed psychological disorders and did not require a depression entry threshold. The GHQ-28 depression subscale with 7 items and a 0–21 range differs from HDRS total at 12 weeks in adult MDD inpatients. - Why unverified: The indirect role and reasons for exclusion were clearly linked. Oral-administration information and the product manufacturer in S04 do not establish the identity of S01. - Reason for missing information: Direct results matching the selected MDD question and an MDD subgroup effect are unverified. - Required materials and conditions: Actual S04 eligibility, scale, duration, product, depression-subgroup data and original plan - Materials to obtain first: Actual S04 eligibility, scale, duration, product, depression-subgroup data and original plan - Further research: To answer the MDD question, separately design a direct comparison in the same MDD/SSRI-initiation setting with HDRS at 12 weeks. - Conditions for verification: Show the difference between PCOS/IVF at ages 18–40 years with GHQ at 4 weeks and MDD with HDRS at 12 weeks. - Why this condition is needed: Needed to avoid transferring results for other populations, scales or time points to the selected effect merely because the trial used oral B1. - Application exceptions: Retain the indirect study's original data, but do not turn exclusion of psychological disorders and the absence of a depression entry threshold into an MDD sample. - Remaining uncertainty: Direct results matching the selected MDD question and an MDD subgroup effect are unverified. - Referenced methods: M03 §3.2.1; detailed population conditions are custom-designed; M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application - Related sources: S04 ### N29 · Were S04 denominators and positive results correctly attributed? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S04 randomized 35/35 participants, with 32/32 participants analyzed/completed. GHQ depression-subscale means (SDs) were 16.46 (SD 4.98) versus 15.84 (SD 5.53) at baseline and, at 4 weeks, 10.96 (SD 4.93) versus 16.25 (SD 4.87), with reported between-group P < .001. Baseline depression-domain scores ≥6 are retained as 30/28 participants, with a total of 6 participants below the threshold; the eligible depression-subgroup effect is unverified (null). - Why unverified: The original numerical values, SDs and denominators are linked, but they are not the selected MDD effect or a direct comparison in the relevant subgroup. - Reason for missing information: Subgroup effects, re-extraction of CONSORT events, intervals/missing data and direct comparison of the multiple-domain analysis remain outstanding. - Required materials and conditions: S04 original Tables 2–3, CONSORT, analysis n, actual depression-subgroup results and missing-data handling - Materials to obtain first: S04 original Tables 2–3, CONSORT, analysis n, actual depression-subgroup results and missing-data handling - Further research: Indirect studies should separate overall/subgroup populations and randomized/completed counts, and present scale-specific estimates and intervals. - Conditions for verification: Separately preserve the 35/35 randomized and 32/32 analyzed counts and the original GHQ means/SDs and P value. - Why this condition is needed: Needed to avoid confusing the 70 participants randomized with the 64 participants analyzed, or SD with total-score/subgroup results. - Application exceptions: Do not convert means on another scale into an HDRS effect or calculate new between-group differences/changes. - Remaining uncertainty: Subgroup effects, re-extraction of CONSORT events, intervals/missing data and direct comparison of the multiple-domain analysis remain outstanding. - Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed - Related sources: S04 ### N30 · How were S04 thresholds, percentages, outcome hierarchy and registration retained? Verification status: Conflicting information Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: In S04, the abnormal threshold >6 in the text differs from Table 2's ≥6 notation. The retained note records that the printed percentages for 6/32 and 26/32 appear arithmetically inconsistent, but the original values are not silently corrected. Differences in wording about the general-health/infertility outcome hierarchy between the abstract and Methods also remain, and the original IRCT201510266917N3 registration and prospective timing are unverified. - Why unverified: The current conflicts are limited to the thresholds, reporting and hierarchy recorded in the retained manuscript. The table was not recalculated and the original registration was not checked in this review. - Reason for missing information: Actual comparison of the original tables/plans, corrections and registration timing remains unverified. - Required materials and conditions: S04 table/text corrections, protocol, original IRCT registration/versions, CONSORT and raw data - Materials to obtain first: S04 table/text corrections, protocol, original IRCT registration/versions, CONSORT and raw data - Further research: Future material comparisons should disclose the original definitions of thresholds, denominators and hierarchy and reasons for changes, and check sensitivity. - Conditions for verification: Preserve historical quality notes, gaps in the original registration record and differences in scale thresholds/hierarchy. - Why this condition is needed: Needed to avoid resolving original reporting inconsistencies and failure to obtain registration in a favorable direction. - Application exceptions: Do not silently correct original percentages or infer prospective timing from the digits in the IRCT identifier. - Remaining uncertainty: Actual comparison of the original tables/plans, corrections and registration timing remains unverified. - Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed; M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed - Related sources: S04 ### N31 · Do the results in S16–18 directly answer the selected adjunctive-efficacy question? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S16 is a mood/cognition study in healthy young women who were not selected for depression. S17 concerns an observational association between thiamine status and depressive symptoms in older Chinese adults, not a controlled supplementation effect. S18 is a single parenteral→oral case of malnutrition and deficiency neuropathy due to depression; no result is borrowed as controlled antidepressant efficacy. - Why unverified: Each material's exclusion/context role was linked to its original retained location. This is not a declaration that research is absent worldwide or that no direct effect exists. - Reason for missing information: The selected incremental effect of single-ingredient oral thiamine at 12 weeks in MDD is not verified in these materials. - Required materials and conditions: Population, design, exposure/route, endpoint and comparator in each original report, and directness to the selected MDD question - Materials to obtain first: Population, design, exposure/route, endpoint and comparator in each original report, and directness to the selected MDD question - Further research: Design questions about healthy people, correction of deficiency and observational associations separately, and distinguish them from the exact MDD adjunctive-treatment trial. - Conditions for verification: Show separately the differences among healthy young women, observations in older Chinese adults and a deficiency case treated by parenteral→oral administration. - Why this condition is needed: Needed to avoid combining mood in healthy people, nutritional-status associations and deficiency case reports into a placebo-controlled adjunctive effect in MDD. - Application exceptions: Do not delete indirect material, but do not invent numerical values for results that were not extracted. - Remaining uncertainty: The selected incremental effect of single-ingredient oral thiamine at 12 weeks in MDD is not verified in these materials. - Referenced methods: M03 §3.2.1; detailed population conditions are custom-designed; M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M03 §3.2.4; custom boundaries on extensions - Related sources: S16, S17, S18 ### N32 · Are S19–21 HDRS results for ordinary thiamine alone? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S19 studies a B1+B2 combination and anxiety, stress and sleep. S20 NUTRIMUM concerns pregnancy and multiple micronutrients; S21 concerns fatigue-focused material in primary biliary cholangitis. The retained record did not grade these as the selected MDD HDRS result or extract numerical values. - Why unverified: Differences in ingredients, populations and endpoints were preserved, without pooling them as a direct single-ingredient B1 effect. - Reason for missing information: Direct results for the selected question and the individual contribution of B1 are unverified. - Required materials and conditions: Ingredients, populations, screening scales, endpoints/times and ingredient-specific direct comparisons in each original report - Materials to obtain first: Ingredients, populations, screening scales, endpoints/times and ingredient-specific direct comparisons in each original report - Further research: If the contribution of B1 alone is needed, design a separate direct comparison with the other ingredients/treatments matched. - Conditions for verification: Explain the actual screening roles of combination/pregnancy studies, anxiety/stress/sleep and PBC fatigue. - Why this condition is needed: Needed to avoid attributing results for combinations, pregnancy or fatigue to the selected ingredient/total score. - Application exceptions: Do not decompose the contribution of B1+B2 or multiple micronutrients into B1 alone. - Remaining uncertainty: Direct results for the selected question and the individual contribution of B1 are unverified. - Referenced methods: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed; M03 §3.2.1; detailed population conditions are custom-designed; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M03 §3.2.4; custom boundaries on extensions - Related sources: S19, S20, S21 ### N33 · Were controlled adult results verified in NCT07793071? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S15 preserves only the indexed title of NCT07793071 concerning depressive symptoms in youth. At that time, the official registration page was an app shell, the API failed and controlled adult results were not verified. Details from 3rd-party mirrors were not used as verified original data. Registration access was not attempted in this review. - Why unverified: The existence of a candidate identifier/title is not verification of the original registration or adult results. - Reason for missing information: Original registration identity/content, population ages, results and current status are unverified. - Required materials and conditions: The official registration's identity, population, ingredient, route, design, time points, results, versions and actual acquisition events - Materials to obtain first: The official registration's identity, population, ingredient, route, design, time points, results, versions and actual acquisition events - Further research: After actually obtaining the registration content, compare population/design eligibility and separately track unpublished results as well. - Conditions for verification: Separate discovery of a candidate registration title from unverified original content/results. - Why this condition is needed: Needed to avoid promoting an indexed title, app shell or API failure into actual adult results. - Application exceptions: Do not use details from a 3rd-party mirror as the original registration, or equate youth with an adult population. - Remaining uncertainty: Original registration identity/content, population ages, results and current status are unverified. - Referenced methods: M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design; M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.1; detailed population conditions are custom-designed - Related sources: S15 ### N34 · Does S01's statement of no adverse effects mean 0 events per arm? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The S01 abstract states that there were no adverse effects in either group. Arm-level event/exposure counts, serious events, AE discontinuations and ascertainment methods are null or unverified. Do not turn this sentence into 0 events per arm or an incidence of 0. - Why unverified: The reported wording is preserved, but there are no data to verify frequency or complete ascertainment. - Reason for missing information: Exact events/people by arm, exposure denominators, ascertainment and discontinuations are unverified. - Required materials and conditions: S01 event/person counts by arm, exposure/follow-up n, duration, AE definitions/collection and reasons for discontinuation - Materials to obtain first: S01 event/person counts by arm, exposure/follow-up n, duration, AE definitions/collection and reasons for discontinuation - Further research: Future trials should report systematic harm ascertainment and arm-level people/events, exposure and discontinuations separately from efficacy. - Conditions for verification: Separate the original wording from unverified event/person counts, exposure n, discontinuations and ascertainment. - Why this condition is needed: Needed to avoid turning the abstract's absence statement into complete ascertainment or an incidence of 0. - Application exceptions: Do not arbitrarily use the total of 51 participants or 12 weeks as an exact exposure denominator or ascertainment scope. - Remaining uncertainty: Exact events/people by arm, exposure denominators, ascertainment and discontinuations are unverified. - Referenced methods: M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; detailed distinctions are custom-designed; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application - Related sources: S01 ### N35 · Were suicide-related events, manic switch, worsening and long-term safety assessed? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: Suicide-related events, mania/hypomania and psychiatric worsening in S01 are unverified (null). Separate assessment, temporal relationships after exposure, discontinuation/re-exposure and long-term harms are unverified. Do not extend the candidate result at 12 weeks to long-term safety, rare events or safety in all populations, including pregnancy/lactation. - Why unverified: Symptom total scores and a general AE abstract alone cannot establish ascertainment, frequency or causality for separate events. - Reason for missing information: Direct data on psychiatric events, long-term/special populations and timing/discontinuation are unverified. - Required materials and conditions: Psychiatric-event definitions, systematic ascertainment, arm-level n/duration, worsening/mania/suicide and long-term follow-up data - Materials to obtain first: Psychiatric-event definitions, systematic ascertainment, arm-level n/duration, worsening/mania/suicide and long-term follow-up data - Further research: Collect psychiatric events using separate prespecified definitions and appropriate follow-up/surveillance, and separate them from efficacy total scores. - Conditions for verification: Check the scope of separate psychiatric ascertainment, exposure time and long-term/special-population information. - Why this condition is needed: Needed to avoid extending a general AE statement in a short-term abstract to psychiatric events or overall safety. - Application exceptions: Do not turn unverified suicide/mania/worsening into absence of events or a causal finding of worsening. - Remaining uncertainty: Direct data on psychiatric events, long-term/special populations and timing/discontinuation are unverified. - Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are custom-designed; M19 §19.2 design-specific harm questions; details of temporal relationships are custom-designed; M19 §19.1.2–19.2.4; custom application; Chamgap's own interpretive boundaries. Informed by M19 principles, not an official causality-tool implementation - Related sources: S01 ### N36 · How are the nausea/adverse-effect statements in S03 and S04 attributed? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S03 preserves abstract statements of nonsevere nausea and no serious adverse effects, but arm-level events/exposure n are unverified. S04 records a statement of no important adverse effects in the B1 arm and an exclusion criterion for B1 allergy. Arm-level events/exposure and independent re-extraction of CONSORT discontinuation reasons are unverified. - Why unverified: The statements are attributed, but safety frequencies in other populations/products cannot be directly transferred to the candidate. - Reason for missing information: Harm denominators/ascertainment, events, discontinuations and product correspondence by arm are unverified. - Required materials and conditions: S03/S04 original events/people by arm, ascertainment, exposure/duration, discontinuations, products and CONSORT data - Materials to obtain first: S03/S04 original events/people by arm, ascertainment, exposure/duration, discontinuations, products and CONSORT data - Further research: Safety syntheses should compare identities, populations, products and ascertainment, then separate unique events from frequencies. - Conditions for verification: Distinguish populations, products and durations from the corresponding reports' harm statements and denominator gaps. - Why this condition is needed: Needed to avoid adding events from other studies to harms in S01 or counting them as replications for the same product. - Application exceptions: Do not create event counts, exposure denominators or 0 events from descriptions of nausea or no important AEs. - Remaining uncertainty: Harm denominators/ascertainment, events, discontinuations and product correspondence by arm are unverified. - Referenced methods: M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; detailed distinctions are custom-designed; M04 §4.6.1–4.6.2; adaptation for harm data is custom-designed - Related sources: S03, S04 ### N37 · Does the Flamingo product information establish the candidate product and its harms? Verification status: Partly verified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: S06 is the SmPC for Flamingo's oral Thiamine Hydrochloride 100 mg Tablets. The frequencies of gastrointestinal adverse effects and hypersensitivity reactions are unknown, and hypersensitivity reports are retained as predominantly parenteral. The emc update of 2025-09-08 and text revision date of 2025-02-18 are historical version information, not identification of either MDD trial product. - Why unverified: The separate product's general harm context was linked, but the candidate product and incidence cannot be established. - Reason for missing information: Correspondence with the actual candidate product, frequency in the oral trial and the current SmPC version are unverified. - Required materials and conditions: Documentation linking the candidate trial product to this product, and the actual SmPC/version and original harm data for the oral product - Materials to obtain first: Documentation linking the candidate trial product to this product, and the actual SmPC/version and original harm data for the oral product - Further research: Product-specific harm reviews should directly compare matched routes, products, exposed populations and event-occurrence/reporting systems. - Conditions for verification: Separate the 100 mg oral product, historical version and unknown gastrointestinal/hypersensitivity frequencies from the unverified candidate product. - Why this condition is needed: Needed to avoid assigning a separate hydrochloride product's identity to the candidate trial's actual product/route. - Application exceptions: Do not transfer the frequency of hypersensitivity reported mainly with parenteral use into incidence in an oral trial. - Remaining uncertainty: Correspondence with the actual candidate product, frequency in the oral trial and the current SmPC version are unverified. - Referenced methods: M03 §3.2.2–3.2.3; adaptation for reverse-direction markers and tests is custom-designed; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M19 §19.2.2–19.2.4, M03 §3.2.3; custom application; M19 §19.1.2–19.2.4; custom application - Related sources: S06 ### N38 · What do an unset UL and general nutritional/medication context mean? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The S05 ODS summary records that no UL has been established, but the FNB cautions that excessive intake may cause adverse effects. The existence of sections on deficiency, at-risk groups and medication interactions provides general context, not a source of depression efficacy evidence. An unset UL does not mean unlimited safety. - Why unverified: The safety/efficacy interpretation boundaries of the general material were checked. This does not mean that a specific concomitant-treatment risk in MDD or an individual dose has been verified. - Reason for missing information: Direct interactions and long-term/excess-intake safety for the selected population/actual product are unverified. - Required materials and conditions: Original official nutrition/excess-intake, vulnerable-population and interaction documents, and direct harm data matching the population and exposure - Materials to obtain first: Original official nutrition/excess-intake, vulnerable-population and interaction documents, and direct harm data matching the population and exposure - Further research: Assess concomitant-medication/excess-intake risks in the selected MDD population using separate actual exposure data. - Conditions for verification: Link the unset UL and excessive-intake warning in S05 to its role as context rather than efficacy evidence. - Why this condition is needed: Needed to avoid using the absence of a UL or deficiency context as evidence of unlimited safety or MDD efficacy. - Application exceptions: Do not derive personal recommendations or MDD treatment effects from general information about intake/medication relationships. - Remaining uncertainty: Direct interactions and long-term/excess-intake safety for the selected population/actual product are unverified. - Referenced methods: M19 §19.1.2–19.2.4; custom application; Chamgap's own interpretive boundaries. Informed by M19 principles, not an official causality-tool implementation; M03 §3.2.1; detailed population conditions are custom-designed - Related sources: S05 ### N39 · Does the total score at 12 weeks also answer questions about optimal dose, maintenance, response/remission and prevention? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The current candidate material does not establish optimal dose, long-term maintenance, persistence after discontinuation, effects in a deficient subgroup or augmentation of a stable SSRI. Response/remission, relapse and suicide prevention are also not the total-score outcome at 12 weeks in this table. Direct estimates for these extensions are unverified within the retained scope. - Why unverified: Direct material needed for the extensions is unavailable, but this is not treated as failure of a mandatory event trial for the narrow total-score question. - Reason for missing information: Direct comparisons/durations, definitions and subgroup interactions for each extension are unverified. - Required materials and conditions: Direct dose comparisons, follow-up after discontinuation, prespecified subgroups/interactions and response/remission/relapse/suicide-event data - Materials to obtain first: Direct dose comparisons, follow-up after discontinuation, prespecified subgroups/interactions and response/remission/relapse/suicide-event data - Further research: Address each extension question in a separate study with a prespecified direct comparison, definition, time point and denominator. - Conditions for verification: Clearly distinguish the selected total score from unverified extension questions. - Why this condition is needed: Needed to avoid extending a narrow symptom comparison to dose selection, persistence or clinical events. - Application exceptions: Do not require every extension trial as a mandatory condition for constructing this table's direct 12-week question. - Remaining uncertainty: Direct comparisons/durations, definitions and subgroup interactions for each extension are unverified. - Referenced methods: M03 §3.2.1–3.2.4; details of dose, persistence and effect modification are custom-designed; M03 §3.2.4; custom boundaries on extensions; M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are custom-designed - Related sources: S01, S07 ### N40 · Were original materials needed to fill current gaps distinguished from methods for future trials? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The first need is to obtain S01 original Methods, product/route, scale version, arm-level numerical values/CI at 12 weeks, analysis/flow, registration and harm data. Separately, methods are proposed for future research directly comparing single-ingredient oral ordinary thiamine in the same MDD/SSRI-initiation setting. No fixed sample size, dose, duration extension or efficacy grade is created. - Why unverified: The additional materials in each row are gaps in the record, while future research is distinguished as a methodological proposal that has not yet been carried out. - Reason for missing information: Neither material acquisition nor a new trial has been performed; the original eligibility/effect gaps remain. - Required materials and conditions: S01 original Methods/product, HDRS version, arm-level tables/CI at 12 weeks, flow, registration/SAP, safety and corrections - Materials to obtain first: S01 original Methods/product, HDRS version, arm-level tables/CI at 12 weeks, flow, registration/SAP, safety and corrections - Further research: In a direct randomized placebo comparison that clearly defines the product/route, MDD criteria and SSRI initiation, prespecify HDRS at 12 weeks, arm-level n/missing data, CI, an important difference and harms, and disclose all results. - Conditions for verification: Distinguish obtaining current original reports/plans from proposals for eligible direct comparisons and analysis/reporting. - Why this condition is needed: Needed to avoid presenting acquisition of a full text and conduct of new research as the same action. - Application exceptions: Do not adopt a new minimum sample size, number of trials, dose or MCID without justification. - Remaining uncertainty: Neither material acquisition nor a new trial has been performed; the original eligibility/effect gaps remain. - Referenced methods: M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design; M08 §8.1–8.2.3; custom application; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M08 Table 8.2.a, M03 §3.2.4; custom application; M08 §8.2.2, M15 §15.3.1; custom application; M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application - Related sources: S01 ### N41 · Were the existing ?/null and calculator exception kept from being inherited as the new table's status? Verification status: Met Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The original evidence cutoff is 2026-09-16, and this summary's review date is 2026-10-05. Preserve the original grade ?, uncalculated score (null), claim type B, six unscored downstream axes (null) and the no-human-study flag false. Preserve the original explanation that the calculator returned validation errors and a pre-validation B at that time, but B was not adopted. Original document quality A and single-assistant self-review are not independent clinical certification. - Why unverified: Original values and the historical record of the exception were preserved, without newly inheriting statuses/scores, calculating or reassessing. - Reason for missing information: The stage 0 native-calculator representation and original eligibility/effect at 12 weeks remain unverified. - Required materials and conditions: Original calculation inputs/errors, current-value exception, verification records and authoritative records of new evidence/condition-change events - Materials to obtain first: Original calculation inputs/errors, current-value exception, verification records and authoritative records of new evidence/condition-change events - Further research: If eligibility or the representation of rules is updated, separate the event, conditions and adjudication procedure, and preserve the entire previous original text. - Conditions for verification: Preserve the original cutoff and review dates, original grade/score, axes, exception and historical self-review. - Why this condition is needed: Needed to avoid turning an uncalculated value into no effect, no human research or a score of 0 points. - Application exceptions: Do not adopt the historical calculator's validation error/pre-validation B as a new valid grade, or rerun the calculator. - Remaining uncertainty: The stage 0 native-calculator representation and original eligibility/effect at 12 weeks remain unverified. - Referenced methods: M04 §4.5, §4.6.3; limitations of the current material conversion follow the user-defined scope and custom design; M03 §3.1, §3.2.1–3.2.4 principles for clarifying the question; detailed separation rules are custom-designed; M04 §4.5–4.6 principles for collecting/selecting materials; the separation of access from reading and the hyperlink contract are custom-designed; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is custom-designed - Related sources: ### N42 · How were analyses across multiple visits/scales and the adjusted model prespecified? Verification status: Unverified Reading scope: Summary read: the retained stored summary at the corresponding exact location was actually read. External clinical/official documents and old separate files were not read in this review. - Current findings: The adjusted/unadjusted effect of interest and multiplicity-handling method in S01 are unverified. Visits at 0, 3, 6 and 12 weeks are preserved, but the repeated-measures model, covariates, primary/secondary endpoints and plans for multiple comparisons across time points were not verified. Do not reconstruct a statistical model from the difference between nonsignificance at 12 weeks and a favorable result at 6 weeks. - Why unverified: Without material comparing the analysis plan and actual model, how the selected estimate was handled cannot be established. - Reason for missing information: The SAP, adjusted model, covariates, adjustments for multiple visits/endpoints and reasons for changes are unverified. - Required materials and conditions: Original protocol/SAP, analysis model, covariates, repeated-visit/multiplicity handling, effect of interest at 12 weeks and reasons for changes - Materials to obtain first: Original protocol/SAP, analysis model, covariates, repeated-visit/multiplicity handling, effect of interest at 12 weeks and reasons for changes - Further research: Future direct comparisons should prespecify the effect of interest at 12 weeks, primary endpoint, visit-specific comparisons, covariates, multiplicity handling and sensitivity to missing data. - Conditions for verification: Explain the actual adjusted/unadjusted effect of interest, handling of multiple time points/endpoints and unverified plans. - Why this condition is needed: Needed to avoid mixing comparisons at 3, 6 and 12 weeks and selection of favorable analyses into the same 12-week estimate. - Application exceptions: Without the original SAP, do not infer repeated-measures methods, multiplicity adjustments or covariate models. - Remaining uncertainty: The SAP, adjusted model, covariates, adjustments for multiple visits/endpoints and reasons for changes are unverified. - Referenced methods: M08 §8.2.2, M15 §15.3.1; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M15 §15.3.1–15.3.3; custom application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom-designed - Related sources: S01, S02 ## Evidence and sources ### S01 Ghaleiha et al. Adjuvant thiamine improved standard treatment in patients with major depressive disorder (2016) [Source](https://link.springer.com/article/10.1007/s00406-016-0685-6) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: Reports 51 participants (MDD inpatients), HDRS >24 and thiamine versus placebo at initiation of a new SSRI. The signal at 6 weeks is favorable, but the between-group mean difference at 12 weeks is nonsignificant, and the exact effect, CI, P value and n by arm are unverified. Statements of within-group improvement and no adverse effects are not, respectively, an incremental causal effect and an incidence of 0. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Paper abstract and partial publisher web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S02 Ghaleiha 2016 original Figure 1 [Source](https://media.springernature.com/m312/springer-static/image/art%3A10.1007%2Fs00406-016-0685-6/MediaObjects/406_2016_685_Fig1_HTML.gif) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: A record of qualitative inspection at that time of HDRS trajectories at baseline and 3, 6 and 12 weeks. The favorable-at-6-weeks/nonsignificant-at-12-weeks statements are preserved, but the figure was not digitized and means, SD/SE or CIs were not reconstructed. The S/S/L/M labels are not a verified MCID. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Original figure | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S03 Wattanathamrak. The Effectiveness of Adjunctive Thiamine (vitamin B1) with Standard Treatment in Patients with Major Depressive Disorder [Source](https://he01.tci-thaijo.org/index.php/APPJ/article/view/209535) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: In 50 participants with MDD receiving inpatient/outpatient care, aged 18–60 years, 300 mg/day is added to standard treatment. The HRSD improvement P-value sequence .004/.031/.035 is preserved, but attribution to visits/estimands and the effect at 12 weeks, CI and n by arm are unverified. Allocation by drawing lots, the nausea statement and the publication-date/issue conflict are retained separately. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Paper abstract and journal bibliographic web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S04 Moti et al. The Effects of Thiamine Supplementation on General Health and Infertility Treatment Outcomes in Women with PCOS (2024) [Source](https://pmc.ncbi.nlm.nih.gov/articles/PMC10875311/) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: A PCOS/IVF study with 35/35 participants randomized and 32/32 participants analyzed, using oral treatment for 4 weeks at 300 mg/day. GHQ depression means (SDs) are 16.46(4.98)/15.84(5.53) at baseline and, at 4 weeks, 10.96(4.93)/16.25(4.87), with reported between-group P<.001. Eligibility, scale and time point differ, and an MDD subgroup effect is unverified. Notes on the original threshold/printed percentages and outcome hierarchy, and failure to obtain the original registration, are preserved. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Original protocol, analysis-plan and registration documents | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S05 NIH Office of Dietary Supplements: Thiamin, Health Professional Fact Sheet [Source](https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: Preserve the unset UL and the FNB's caution about harm from excessive intake. These do not establish unlimited safety, a personal dose for the selected MDD product or efficacy. No specific medication interactions were newly extracted in this review. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full official web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S06 Thiamine Hydrochloride 100 mg Tablets, Flamingo Pharma (UK), SmPC [Source](https://www.medicines.org.uk/emc/product/13528/smpc) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: Preserve the unknown frequency of gastrointestinal/hypersensitivity reactions and the route limitation that hypersensitivity reports are predominantly parenteral. The emc update of 2025-09-08 and text revision of 2025-02-18 are records from that time, not verification of the original MDD product or oral incidence. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full official product web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S07 Sousa Santos and Braga Reis: Eficacia de la suplementación con tiamina para mejorar los síntomas depresivos. Revisión basada en la evidencia (2023) [Source](https://journal.agamfec.com/index.php/cadernos/article/download/154/77/1048) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: The review records oral 300 mg/day, fluoxetine 20 mg/day and unspecified formulation. Do not promote these to route, dose or product values verified in the S01 original. Preserve the limitations of access to selected portions and the distinction between response/remission P values and severity P values. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full-text review paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S08 Dhir et al. Neurological, Psychiatric, and Biochemical Aspects of Thiamine Deficiency in Children and Adults (2019) [Source](https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2019.00207/full) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: The review calls the S01 population deficient, but neither deficiency nor repletion was verified in the accessed original. Without original baseline tests and thresholds, the MDD population is not established as deficient or replete. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full-text review paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S09 AIHTA Project Report 182, Combination Therapy with Antidepressants and Vitamin B (2026) [Source](https://eprints.aihta.at/1605/1/AHTA-Projektbericht_Nr.182.pdf) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: A historical record stating that the entire 97-page report was not read. Bibliographic mapping at that time used only term searches and PDF page 68 (reference 86), without borrowing decisive efficacy facts. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full assessment report | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S10 PubMed record 26984349 [Source](https://pubmed.ncbi.nlm.nih.gov/26984349/) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: A record of PMID 26984349, the same DOI and the indexed abstract. Preserve the original limitation that direct opening returned an empty result and this was not a completed search of the native PubMed database. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full official index web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S11 Basel repository record for Ghaleiha 2016 [Source](https://edoc.unibas.ch/entities/publication/23a682eb-ffdc-4765-bd66-42c862679d6d) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: A historical record that no exposed full-text file was obtained. Do not substitute the repository's default displayed date for the publisher's publication date or add separate participants/effects. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full institutional bibliographic web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S12 Fribourg repository record for Ghaleiha 2016 [Source](https://folia.unifr.ch/global/documents/299267) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: Access is recorded as abstract/citation metadata, and notes and the extracted statement are empty strings. Do not fill these blanks with independent results, full-text acquisition or reported absence of an effect. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full institutional bibliographic web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S13 ResearchGate record and publisher preview, Ghaleiha 2016 [Source](https://www.researchgate.net/publication/296637817_Adjuvant_thiamine_improved_standard_treatment_in_patients_with_major_depressive_disorder_-_results_from_a_randomized_double_blind_and_placebo-controlled_clinical_trial) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: A historical record of access only to the single-page preview at p.695 and the abstract; preview download failed. Citing-article content on the same page is not treated as the Ghaleiha original. This was not reading the entire full text. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S14 SciSpace record, Ghaleiha 2016 [Source](https://scispace.com/papers/adjuvant-thiamine-improved-standard-treatment-in-patients-rl3axaz9b2) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: A record stating that the full PDF was not acquired and AI-generated summaries were not used. Displayed abstract/bibliographic information is not independent replication or verification of the original full text. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S15 ClinicalTrials.gov NCT07793071: Evaluating Thiamine (Vitamin B1) as Adjunctive Therapy for Youth With Depressive Symptoms [Source](https://clinicaltrials.gov/study/NCT07793071) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: Only the youth depressive symptoms title for NCT07793071 was preserved. The original page is recorded as an app shell/API failure, and controlled adult results were not verified. Current status, design and age details were not checked in this review. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full official registration web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Original protocol, analysis-plan and results documents | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S16 Benton et al. thiamine supplementation and mood/cognition in young women [Source](https://europepmc.org/article/med/9122365) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: Recorded as a mood/cognition study in healthy young women, not an objectively depression-selected population. PMID 9122365 is preserved, and a DOI was not adopted. No numerical efficacy results for the selected MDD question were extracted. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full index web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S17 Zhang et al. Thiamine nutritional status and depressive symptoms are inversely associated among older Chinese adults [Source](https://pubmed.ncbi.nlm.nih.gov/23173173/) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: Design screening of an observational study on an inverse association between thiamine nutritional status and depressive symptoms. Original numerical results were not extracted and are not transferred to adjunctive efficacy with an SSRI in MDD. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full official index web document | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S18 Melki et al. Thiamine Deficiency Neuropathy in a Patient with Malnutrition due to Melancholic Depression (2024) [Source](https://pmc.ncbi.nlm.nih.gov/articles/PMC10942818/) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: A case of deficiency neuropathy with malnutrition due to melancholic depression. A single case treated first parenterally and then orally is not controlled antidepressant efficacy evidence for ordinary oral single-ingredient B1, and no results were borrowed. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S19 Tao et al. Impact of Vitamin B1 and Vitamin B2 Supplementation on Anxiety, Stress, and Sleep Quality (2025) [Source](https://www.mdpi.com/2072-6643/17/11/1821) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: A study of anxiety, stress and sleep with a B1+B2 combination, differing from the fixed depression-scale/single-ingredient B1 question. No original efficacy grading or decomposition of the B1 contribution was performed. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S20 NUTRIMUM micronutrient trial (2024) [Source](https://pmc.ncbi.nlm.nih.gov/articles/PMC11363078/) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: Pregnancy and a multiple-micronutrient formulation differ from ordinary thiamine alone. For this question, only the screening record of exclusion without efficacy extraction is preserved. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ### S21 Bager et al. high-dose thiamine in primary biliary cholangitis (2024) [Source](https://pmc.ncbi.nlm.nih.gov/articles/PMC10980237/) Materials actually read: Summary read: the corresponding bibliography, extracted facts/structure, Korean content and historical access in the current stored manuscript were read. External original clinical/official materials were not read in this review. Findings recorded in the summary: A disease population focused on fatigue in primary biliary cholangitis. This is not an HDRS efficacy result in a depression-selected population, and the previously completed record was not researched anew or regraded. Record level: Report-specific results/context, bibliography, exclusion and access roles in the retained record dated 2026-09-16. This is not direct verification of original clinical data in this review. Independent replication: None | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Full-text paper | Currently unverified (no external lookup) | Access not attempted | Not read | Distinguish reading a summary in the currently retained stored material from original clinical materials/official documents and historical levels of access. | ## 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 criteria and reasons for changes, and distinguish variations in the intervention. · Historical reuse of the actual retained HTML copies and SHAs for 1585 and the methodological principles directly reviewed at that time. This is not new reading of full methodological texts, official implementation or clinical certification in this review. - 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, and do not omit a study solely because its outcomes are not reported. · Historical reuse of the actual retained HTML copies and SHAs for 1585 and the methodological principles directly reviewed at that time. This is not new reading of full methodological texts, official implementation or clinical certification in this review. - 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 · Hold the outcome and effect of interest fixed, then assess randomization, deviations, missing data, measurement and selective reporting. · Historical reuse of the actual retained HTML copies and SHAs for 1585 and the methodological principles directly reviewed at that time. This is not new reading of full methodological texts, official implementation or clinical certification in this review. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Historical reuse of the actual retained HTML copies and SHAs for 1585 and the methodological principles directly reviewed at that time. This is not new reading of full methodological texts, official implementation or clinical certification in this review. - 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 · Questions about harms may require designs, populations and follow-up different from efficacy questions. Case reports do not establish incidence. · Historical reuse of the actual retained HTML copies and SHAs for 1585 and the methodological principles directly reviewed at that time. This is not new reading of full methodological texts, official implementation or clinical certification in this review. ## What the statuses mean - Met: The record's identity, boundaries and conditions for preservation/distinction can be explained. This differs from confirmation of treatment efficacy/safety or official certification. - Partly verified: Some information for the selected condition is linked, but specific gaps remain. - Unverified: Required values/conditions cannot be established within the material currently read. This does not mean no research, an effect of 0 or 0 events. - Conflicting information: A specific discrepancy in the level of verification of deficiency statements or in original bibliographic details/reporting/hierarchy. Differences in time points, denominators or designs alone are not automatically designated as conflicts. - Not applicable: Used only when there is an actual reason why the selected condition does not apply. - Not reported: Limited to a gap at a specific retained location actually read; not extended to nonreporting throughout the external original paper. - Inaccessible: Used only when an actual current access attempt has failed. This differs from external access not attempted in this review or historical failures. - Review incomplete: An actual pending state of individual table preparation/review, separate from unverified/unread clinical material. ## Change history 2026-11-06 · Public page/materials 1.0. Public-facing display and data were prepared from the existing 42 items. No new clinical search, change in verification status or grading was performed. ## Material-specific source addresses - [S01-M1 · Paper abstract and partial publisher web document](https://link.springer.com/article/10.1007/s00406-016-0685-6) - S01-M2 · Full-text paper: Material URL unverified; external material unread. - [S02-M1 · Original figure](https://media.springernature.com/m312/springer-static/image/art%3A10.1007%2Fs00406-016-0685-6/MediaObjects/406_2016_685_Fig1_HTML.gif) - [S03-M1 · Paper abstract and journal bibliographic web document](https://he01.tci-thaijo.org/index.php/APPJ/article/view/209535) - S03-M2 · Full-text paper: Material URL unverified; external material unread. - [S04-M1 · Full-text paper](https://pmc.ncbi.nlm.nih.gov/articles/PMC10875311/) - S04-M2 · Original protocol, analysis-plan and registration documents: Material URL unverified; external material unread. - [S05-M1 · Full official web document](https://ods.od.nih.gov/factsheets/Thiamin-HealthProfessional/) - [S06-M1 · Full official product web document](https://www.medicines.org.uk/emc/product/13528/smpc) - [S07-M1 · Full-text review paper](https://journal.agamfec.com/index.php/cadernos/article/download/154/77/1048) - [S08-M1 · Full-text review paper](https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2019.00207/full) - [S09-M1 · Full assessment report](https://eprints.aihta.at/1605/1/AHTA-Projektbericht_Nr.182.pdf) - [S10-M1 · Full official index web document](https://pubmed.ncbi.nlm.nih.gov/26984349/) - S10-M2 · Full-text paper: Material URL unverified; external material unread. - [S11-M1 · Full institutional bibliographic web document](https://edoc.unibas.ch/entities/publication/23a682eb-ffdc-4765-bd66-42c862679d6d) - S11-M2 · Full-text paper: Material URL unverified; external material unread. - [S12-M1 · Full institutional bibliographic web document](https://folia.unifr.ch/global/documents/299267) - S12-M2 · Full-text paper: Material URL unverified; external material unread. - [S13-M1 · Full web document](https://www.researchgate.net/publication/296637817_Adjuvant_thiamine_improved_standard_treatment_in_patients_with_major_depressive_disorder_-_results_from_a_randomized_double_blind_and_placebo-controlled_clinical_trial) - S13-M2 · Full-text paper: Material URL unverified; external material unread. - [S14-M1 · Full web document](https://scispace.com/papers/adjuvant-thiamine-improved-standard-treatment-in-patients-rl3axaz9b2) - S14-M2 · Full-text paper: Material URL unverified; external material unread. - [S15-M1 · Full official registration web document](https://clinicaltrials.gov/study/NCT07793071) - S15-M2 · Original protocol, analysis-plan and results documents: Material URL unverified; external material unread. - [S16-M1 · Full index web document](https://europepmc.org/article/med/9122365) - S16-M2 · Full-text paper: Material URL unverified; external material unread. - [S17-M1 · Full official index web document](https://pubmed.ncbi.nlm.nih.gov/23173173/) - S17-M2 · Full-text paper: Material URL unverified; external material unread. - [S18-M1 · Full-text paper](https://pmc.ncbi.nlm.nih.gov/articles/PMC10942818/) - [S19-M1 · Full-text paper](https://www.mdpi.com/2072-6643/17/11/1821) - [S20-M1 · Full-text paper](https://pmc.ncbi.nlm.nih.gov/articles/PMC11363078/) - [S21-M1 · Full-text paper](https://pmc.ncbi.nlm.nih.gov/articles/PMC10980237/)