{"id":"c5e6c3cb-1b8a-5cac-91ce-490c072224aa","stable_key":"7484635e-cc8f-5cd6-a978-6dc5775a7db5:berberine-cyclosporine-clinical","predicate":"increases","statement":"Final cyclosporine concentrations were 29.3% higher in the berberine-treated group than in the group without berberine.","claim_class":"observational","status":"source_derived_draft","evidence_grade":"ungraded","direction":"context_dependent","is_public":true,"mechanism_event_id":"4ac08fd2-ae4e-5954-8782-63ede8173564","mechanism_event_label":"A transplant medicine had higher blood concentrations with berberine.","subject":{"id":"7bbe0633-b2f1-510f-adc0-3c4d0ddad05d","slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"},"object":{"id":"e1c59346-f4ae-5904-9c57-be5fba7dcc08","slug":"cyclosporine-plasma-exposure","display_name":"Blood cyclosporine exposure","entity_type_key":"cellular_process"},"evidence_count":1,"mechanism_event":{"id":"4ac08fd2-ae4e-5954-8782-63ede8173564","stable_key":"7484635e-cc8f-5cd6-a978-6dc5775a7db5:berberine-cyclosporine-clinical-event","event_type":"observed_intervention","label":"A transplant medicine had higher blood concentrations with berberine.","description":"Final cyclosporine concentrations were 29.3% higher in the berberine-treated group than in the group without berberine.","status":"provisional","compartment":null,"participants":[{"entity":{"id":"2027fc88-2559-5b27-ad81-c5781ba5e00e","slug":"cyclosporine-a","display_name":"Cyclosporine A / ciclosporin A","entity_type_key":"small_molecule"},"role":"measured_drug","stoichiometry":null,"state_label":"","sequence_order":0,"notes":""},{"entity":{"id":"7bbe0633-b2f1-510f-adc0-3c4d0ddad05d","slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"},"role":"subject","stoichiometry":null,"state_label":"","sequence_order":1,"notes":""},{"entity":{"id":"e1c59346-f4ae-5904-9c57-be5fba7dcc08","slug":"cyclosporine-plasma-exposure","display_name":"Blood cyclosporine exposure","entity_type_key":"cellular_process"},"role":"target","stoichiometry":null,"state_label":"","sequence_order":2,"notes":""}]},"contexts":[{"dimension":"evidence_span","value_text":"{\"source_cache\": \"artifacts/berberine-research/16133554.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"7a86b1b0f9ad77889da596b013f9f229556d53d825dac1b8bb2ba6ed094a68ad\", \"start_char\": 0, \"end_char\": 2232, \"text_sha256\": \"7a86b1b0f9ad77889da596b013f9f229556d53d825dac1b8bb2ba6ed094a68ad\"}","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"experimental_model","value_text":"Randomized controlled transplant study with separate six-person pharmacokinetic arm","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"exposure","value_text":"52 recipients per clinical arm; berberine 0.2 g three times daily for three months; six-person 12-day PK comparison","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"limitations","value_text":"Observed interaction is clinically relevant, but the proposed CYP3A4 explanation was not uniquely established. Baseline change and between-group difference must not be confused.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"nutrient_topic","value_text":"Berberine research collection; topical membership is not evidence of a direct dietary effect.","comparator":null,"unit":null,"notes":"","entity":{"slug":"berberine","display_name":"Berberine","entity_type_key":"small_molecule"}},{"dimension":"organism","value_text":"Renal-transplant recipients","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"plain_language","value_text":"A transplant medicine had higher blood concentrations with berberine.","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"primary_references","value_text":"[berberine-p16133554] Effects of berberine on the blood concentration of cyclosporin A in renal transplanted recipients: clinical and pharmacokinetic study. (2005). https://pubmed.ncbi.nlm.nih.gov/16133554/ DOI: 10.1007/s00228-005-0952-3","comparator":null,"unit":null,"notes":"","entity":null},{"dimension":"tissue_or_cell_type","value_text":"Cyclosporine blood concentrations","comparator":null,"unit":null,"notes":"","entity":null}],"evidence":[{"id":"1f88361b-771a-529f-8b29-198ec66f6220","evidence_kind":"source_excerpt","locator":"Lines 714-725","start_line":714,"end_line":725,"excerpt":"### berberine-cyclosporine-clinical\nFinal cyclosporine concentrations were 29.3% higher in the berberine-treated group than in the group without berberine.\nCondition category: normal\nnutrient_topic: Berberine research collection; topical membership is not evidence of a direct dietary effect.\nplain_language: A transplant medicine had higher blood concentrations with berberine.\norganism: Renal-transplant recipients\ntissue_or_cell_type: Cyclosporine blood concentrations\nexperimental_model: Randomized controlled transplant study with separate six-person pharmacokinetic arm\nlimitations: Observed interaction is clinically relevant, but the proposed CYP3A4 explanation was not uniquely established. Baseline change and between-group difference must not be confused.\nexposure: 52 recipients per clinical arm; berberine 0.2 g three times daily for three months; six-person 12-day PK comparison\nevidence_span: {\"source_cache\": \"artifacts/berberine-research/16133554.abstract.txt\", \"locator\": \"Primary indexed abstract; zero-based, end-exclusive Unicode character offsets\", \"file_sha256\": \"7a86b1b0f9ad77889da596b013f9f229556d53d825dac1b8bb2ba6ed094a68ad\", \"start_char\": 0, \"end_char\": 2232, \"text_sha256\": \"7a86b1b0f9ad77889da596b013f9f229556d53d825dac1b8bb2ba6ed094a68ad\"}\n[berberine-p16133554] Effects of berberine on the blood concentration of cyclosporin A in renal transplanted recipients: clinical and pharmacokinetic study. (2005). https://pubmed.ncbi.nlm.nih.gov/16133554/ DOI: 10.1007/s00228-005-0952-3","model_system":"Randomized controlled transplant study with separate six-person pharmacokinetic arm","directness":"author_interpretation","verification_status":"source_derived_draft","notes":"Exact curation-document quotation, not publisher quotation. Study references: [berberine-p16133554] Effects of berberine on the blood concentration of cyclosporin A in renal transplanted recipients: clinical and pharmacokinetic study. 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