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Five-flavor Sophora flavescens enteric-coated capsules for ulcerative colitis: ethnopharmacological rationale, pharmacology, clinical evidence, and safety

Year: 2026

Type: review

Abstract: Five-flavor Sophora flavescens enteric-coated capsules (FSEC), also reported as Wuwei Kushen or composite Sophora colon-soluble capsules, are used in China for ulcerative colitis (UC) associated with intestinal damp-heat, bloody diarrhea, and mucosal injury. This critical narrative Review evaluates the traditional rationale, product identity, material basis, pharmacological evidence, clinical findings, and safety of FSEC. PubMed, Web of Science, ScienceDirect, CNKI, Wanfang, and reference lists were searched through May 2026 and selectively updated through 18 August 2026. The Four Pillars of Best Practice in Ethnopharmacology and the ConPhyMP guidelines informed appraisal of identity, characterization, dose, and evidence attribution. The defined five-material product contains S. flavescens , Sanguisorba officinalis , Indigo naturalis, Bletilla striata , and Glycyrrhiza uralensis . Complete-formulation experiments support effects on microbial short-chain-fatty-acid signaling, GPR43, NLRP3/STAT3, AGE-RAGE/NF-κB, epithelial barrier integrity, and ferroptosis-related changes. Constituent studies broaden biological plausibility but cannot establish the efficacy or safety of the complete product. Older randomized trials and meta-analyses suggest short-term benefit, whereas recent single-center cohorts provide provisional adjunctive evidence because of nonrandomized designs and incomplete batch reporting. FSEC is therefore a plausible colon-targeted ethnopharmacological intervention, but confirmatory studies require chemically defined batches, verified release and exposure, internationally accepted UC endpoints, prospective multicenter designs, and active monitoring for hepatic, cardiopulmonary, electrolyte, and interaction risks.

Source: Frontiers in Pharmacology

DOI: 10.3389/fphar.2026.1972684

Authors: Chunyu Ma, Cuiping Yang

Institutions: Bengbu Medical College, Shanghai Jiao Tong University, Ruijin Hospital

Language: English

Topic: Inflammatory Bowel Disease

Subfield: Gastroenterology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,801