{"id":"e5872045-1280-5b21-80ea-7c6ccc41247f","stable_key":"5d8e27d8-6a74-5560-827f-3f90908bbc34:ala-aladin3-nis","predicate":"improved_early","statement":"ALADIN III found an early NIS improvement, while the seven-month comparison of continued ALA versus placebo did not reach conventional significance.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"b16e7cab-2ed5-5805-ad98-965fa2c7dc66","mechanism_event_label":"An early examination-score signal did not establish durable benefit.","subject":{"id":"ab091982-3acb-5a87-80fb-85dfe292c1e0","slug":"lipoic-acid","display_name":"Lipoic acid","entity_type_key":"small_molecule"},"object":{"id":"06de2d23-4aeb-5d8a-8267-a6beb400bb11","slug":"diabetic-neuropathy-nis","display_name":"Neuropathy Impairment Score / NIS","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"b16e7cab-2ed5-5805-ad98-965fa2c7dc66","stable_key":"5d8e27d8-6a74-5560-827f-3f90908bbc34:ala-aladin3-nis-event","event_type":"observed_intervention","label":"An early examination-score signal did not establish durable benefit.","description":"ALADIN III found an early NIS improvement, while the seven-month comparison of continued ALA versus placebo did not reach conventional significance.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"ab091982-3acb-5a87-80fb-85dfe292c1e0","slug":"lipoic-acid","display_name":"Lipoic acid","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"06de2d23-4aeb-5d8a-8267-a6beb400bb11","slug":"diabetic-neuropathy-nis","display_name":"Neuropathy Impairment Score / NIS","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/ala-research/10480774.abstract.txt\", \"locator\": \"Exact primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"d28f04985ace61dd6036ea4d08d84e59c47ba587cea6438b7851e036abc1c673\", \"start_char\": 0, \"end_char\": 2880, \"text_sha256\": \"d28f04985ace61dd6036ea4d08d84e59c47ba587cea6438b7851e036abc1c673\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"ALADIN III multicenter randomized placebo-controlled trial","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"Three weeks intravenous treatment followed by six months oral ALA 600 mg three times daily or comparator sequences","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Different route, duration and design from SYDNEY 2; preserve daily-score AUC and final-visit findings separately.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Alpha-lipoic acid research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"lipoic-acid","display_name":"Lipoic acid","entity_type_key":"small_molecule"}},{"dimension":"organism","value_text":"Human","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"An early examination-score signal did not establish durable benefit.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[ala-p10480774] Treatment of symptomatic diabetic polyneuropathy with the antioxidant alpha-lipoic acid: a 7-month multicenter randomized controlled trial (ALADIN III Study). ALADIN III Study Group. Alpha-Lipoic Acid in Diabetic Neuropathy. (1999). https://pubmed.ncbi.nlm.nih.gov/10480774/ DOI: 10.2337/diacare.22.8.1296","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"509 people with type 2 diabetes and symptomatic polyneuropathy","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"2d3bde0e-9ff8-527f-98ca-543290fcd64d","evidence_kind":"source_excerpt","locator":"Lines 1157-1168","start_line":1157,"end_line":1168,"excerpt":"### ala-aladin3-nis\nALADIN III found an early NIS improvement, while the seven-month comparison of continued ALA versus placebo did not reach conventional significance.\nCondition category: normal\nnutrient_topic: Alpha-lipoic acid research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: An early examination-score signal did not establish durable benefit.\norganism: Human\ntissue_or_cell_type: 509 people with type 2 diabetes and symptomatic polyneuropathy\nexperimental_model: ALADIN III multicenter randomized placebo-controlled trial\nlimitations: Different route, duration and design from SYDNEY 2; preserve daily-score AUC and final-visit findings separately.\nexposure: Three weeks intravenous treatment followed by six months oral ALA 600 mg three times daily or comparator sequences\nevidence_span: {\"source_cache\": \"artifacts/ala-research/10480774.abstract.txt\", \"locator\": \"Exact primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"d28f04985ace61dd6036ea4d08d84e59c47ba587cea6438b7851e036abc1c673\", \"start_char\": 0, \"end_char\": 2880, \"text_sha256\": \"d28f04985ace61dd6036ea4d08d84e59c47ba587cea6438b7851e036abc1c673\"}\n[ala-p10480774] Treatment of symptomatic diabetic polyneuropathy with the antioxidant alpha-lipoic acid: a 7-month multicenter randomized controlled trial (ALADIN III Study). ALADIN III Study Group. Alpha-Lipoic Acid in Diabetic Neuropathy. (1999). https://pubmed.ncbi.nlm.nih.gov/10480774/ DOI: 10.2337/diacare.22.8.1296","model_system":"ALADIN III multicenter randomized placebo-controlled trial","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [ala-p10480774] Treatment of symptomatic diabetic polyneuropathy with the antioxidant alpha-lipoic acid: a 7-month multicenter randomized controlled trial (ALADIN III Study). ALADIN III Study Group. Alpha-Lipoic Acid in Diabetic Neuropathy. 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