{"id":"61edfdac-b745-57fb-876a-6d25330df9ac","stable_key":"e3f6ce02-0bd7-5103-acc1-68503ab6751b:dpn16-b12-comparator","predicate":"no_detected_change_in_recorded_comparison","statement":"ALCAR met the reported noninferiority comparison with methylcobalamin on combined NSS/NDS scores.","claim_class":"observational","status":"source_recorded","evidence_grade":"ungraded","direction":"neutral","is_public":true,"mechanism_event_id":"289ced31-98ca-5973-b427-d17f14f30eeb","mechanism_event_label":"ALCAR met the reported noninferiority comparison with methylcobalamin on combined NSS/NDS scores.","subject":{"id":"5ce394a9-6ec6-56dd-866f-37d85c0556e4","slug":"acetylcarnitine","display_name":"Acetyl-L-carnitine","entity_type_key":"small_molecule"},"object":{"id":"b910053e-4ce3-56e3-ac13-dd878b0be463","slug":"human-dpn-nss-nds","display_name":"Human DPN combined symptom and disability score","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"289ced31-98ca-5973-b427-d17f14f30eeb","stable_key":"e3f6ce02-0bd7-5103-acc1-68503ab6751b:dpn16-b12-comparator-event","event_type":"experimental_observation","label":"ALCAR met the reported noninferiority comparison with methylcobalamin on combined NSS/NDS scores.","description":"### dpn16-b12-comparator\n\nALCAR met the reported noninferiority comparison with methylcobalamin on combined NSS/NDS scores.\nNo significant superiority difference (P=0.14); this was an active-comparator trial without placebo. It did not test combined ALCAR+B12 synergy or establish B12 deficiency as the cause of symptoms.\nModel and exposure: 232 randomized; ALCAR 500 mg three times daily versus methylcobalamin 0.5 mg three times daily for 24 weeks.\nLimitations: Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.\nReference: Effects of acetyl-L-carnitine and methylcobalamin for diabetic peripheral neuropathy: A multicenter, randomized, double-blind, controlled trial. | 2016 | https://pubmed.ncbi.nlm.nih.gov/27180954/ | https://pmc.ncbi.nlm.nih.gov/articles/PMC5009142/ | https://doi.org/10.1111/jdi.12493 | Access: Primary full text: relevant Results/Methods and figure descriptions reviewed; supplements only where explicitly stated.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"5ce394a9-6ec6-56dd-866f-37d85c0556e4","slug":"acetylcarnitine","display_name":"Acetyl-L-carnitine","entity_type_key":"small_molecule"},"role":"tested factor","stoichiometry":null,"state_label":"ALCAR 500 mg three times daily","sequence_order":0,"notes":""},{"entity":{"id":"b910053e-4ce3-56e3-ac13-dd878b0be463","slug":"human-dpn-nss-nds","display_name":"Human DPN combined symptom and disability score","entity_type_key":"cellular_process"},"role":"measured outcome","stoichiometry":null,"state_label":"no_detected_change","sequence_order":1,"notes":""},{"entity":{"id":"6563fbad-ebdc-5408-966a-d24f8b8cd854","slug":"methylcobalamin","display_name":"Methylcobalamin","entity_type_key":"small_molecule"},"role":"active comparator","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""}]},"contexts":[{"dimension":"evidence_access","value_text":"Primary full text: relevant Results/Methods and figure descriptions reviewed; supplements only where explicitly stated.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_contrast","value_text":"{\"intervention\": \"ALCAR 500 mg three times daily\", \"comparator\": \"Methylcobalamin 0.5 mg three times daily\", \"endpoint\": \"ALCAR met the reported noninferiority comparison with methylcobalamin on combined NSS/NDS scores.\", \"effect_direction\": \"no_detected_change\", \"combination\": \"single\", \"conditions\": []}","comparator":null,"unit":null,"notes":"Explicit extracted experimental comparison; source-derived draft.","entity":null},{"dimension":"experimental_model","value_text":"232 randomized; ALCAR 500 mg three times daily versus methylcobalamin 0.5 mg three times daily for 24 weeks.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"interpretation_status","value_text":"Source-derived curation with stated access limits; ungraded, not independent replication.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Acetyl-L-carnitine collection; exact intervention and molecular form govern interpretation.","comparator":null,"unit":null,"notes":"","entity":{"slug":"acetylcarnitine","display_name":"Acetyl-L-carnitine","entity_type_key":"small_molecule"}},{"dimension":"plain_language","value_text":"ALCAR met the reported noninferiority comparison with methylcobalamin on combined NSS/NDS scores.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"Effects of acetyl-L-carnitine and methylcobalamin for diabetic peripheral neuropathy: A multicenter, randomized, double-blind, controlled trial. | https://pubmed.ncbi.nlm.nih.gov/27180954/ | https://pmc.ncbi.nlm.nih.gov/articles/PMC5009142/ | https://doi.org/10.1111/jdi.12493","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"source_locator","value_text":"Reviewed reference dpn16-b12-comparator; No significant superiority difference (P=0.14); this was an active-comparator trial without placebo. It did not test combined ALCAR+B12 synergy or establish B12 deficiency as the cause of symptoms.","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"aed7a06e-ab11-5a27-a146-479dff9b3d54","evidence_kind":"source_excerpt","locator":"Lines 539-545","start_line":539,"end_line":545,"excerpt":"### dpn16-b12-comparator\n\nALCAR met the reported noninferiority comparison with methylcobalamin on combined NSS/NDS scores.\nNo significant superiority difference (P=0.14); this was an active-comparator trial without placebo. It did not test combined ALCAR+B12 synergy or establish B12 deficiency as the cause of symptoms.\nModel and exposure: 232 randomized; ALCAR 500 mg three times daily versus methylcobalamin 0.5 mg three times daily for 24 weeks.\nLimitations: Limited to the recorded preparation, model, exposure and endpoint. Does not establish a human dietary deficiency, clinical benefit or unique molecular mediation.\nReference: Effects of acetyl-L-carnitine and methylcobalamin for diabetic peripheral neuropathy: A multicenter, randomized, double-blind, controlled trial. | 2016 | https://pubmed.ncbi.nlm.nih.gov/27180954/ | https://pmc.ncbi.nlm.nih.gov/articles/PMC5009142/ | https://doi.org/10.1111/jdi.12493 | Access: Primary full text: relevant Results/Methods and figure descriptions reviewed; supplements only where explicitly stated.","model_system":"232 randomized; ALCAR 500 mg three times daily versus methylcobalamin 0.5 mg three times daily for 24 weeks.","directness":"reported_statement","verification_status":"source_recorded","notes":"Original paraphrase in the retained reviewed reference, not a verbatim primary-paper quotation. Access level is explicit.","relationship":"supports","weight":1.0,"link_notes":"","source":{"id":"2588f904-245a-597a-8a12-65118013fb90","stable_key":"import-e3f6ce02-0bd7-5103-acc1-68503ab6751b","title":"Acetyl-L-carnitine: detailed mechanisms of action (reviewed 6 October 2026)","document_type":"imported_text","citation_label":"AI-assisted original review of primary studies and clearly identified official records. Exact primary access is stated; no independent replication is claimed.","file_path":"","sha256":"84cc82d6fbb0fd5d73c4ce779e9f88e7f0184ba2d29b18ad0f153815380f2975","revision_id":"dac7a950-dbe5-5c7a-9c70-2ea711d5c71a","review_status":"source_recorded","notes":""}}],"relations":[],"conflicts":[],"corrections":[],"research":null}