Sophora Flavescens Extract
Also known as: Kushen, Sophora root, Sophora flavescens Aiton, Sophora flavescens extract
Overview
Sophora flavescens extract is derived from the root of the Sophora flavescens plant, a traditional Chinese medicine (TCM) herb. Its primary bioactive compounds are alkaloids such as matrine and oxymatrine. This extract is recognized for its anti-inflammatory, anti-cancer, and immunomodulatory properties. It is commonly used in TCM and has been investigated as an adjunctive therapy for conditions like ulcerative colitis (UC), malignant pleural effusion (MPE), and various cancers. Research maturity is moderate, with several randomized controlled trials and meta-analyses, predominantly from Chinese clinical studies, supporting its efficacy and safety. It is available as a botanical supplement, often in enteric-coated formulations to enhance bioavailability.
Benefits
Sophora flavescens extract offers several evidence-based benefits, primarily as an adjunctive therapy. For Ulcerative Colitis (UC), meta-analyses of randomized controlled trials (RCTs) involving approximately 983 patients demonstrate that Sophora flavescens-based formulations, particularly Five-Flavor Sophora flavescens Enteric-Coated Capsules (FSEC), significantly improve clinical remission rates and reduce symptoms compared to conventional medicine, without increasing adverse events. In cancer-related applications, compound injections containing Sophora flavescens as an adjunct to chemotherapy for digestive tract cancers (colorectal, gastric, esophageal) have shown improved short-term efficacy, with an odds ratio of approximately 3.11, indicating a threefold increase in treatment response compared to chemotherapy alone. For Malignant Pleural Effusion (MPE), systematic reviews and meta-analyses indicate that intrapleural perfusion with Sophora flavescens preparations improves pleurodesis success rates and overall survival with acceptable safety profiles. While a meta-analysis suggests potential benefits in managing bone neuropathic pain from tumor metastasis, high heterogeneity among studies (I^2 = 91%) indicates that further standardized research is needed to confirm this benefit.
How it works
The therapeutic effects of Sophora flavescens extract are primarily mediated by its active compounds, matrine and oxymatrine. These alkaloids exert anti-inflammatory actions by inhibiting pro-inflammatory cytokines and modulating NF-κB signaling pathways. Their anti-cancer mechanisms involve inducing apoptosis (programmed cell death) in cancer cells, inhibiting tumor cell proliferation, and modulating immune responses against cancer. In ulcerative colitis, the extract contributes to mucosal healing and reduces gut inflammation through multiple pathways, including immune regulation and oxidative stress reduction, as identified by network pharmacology. The bioavailability of these compounds is moderate, but enteric-coated formulations are designed to improve intestinal delivery, thereby enhancing their therapeutic efficacy, particularly in conditions affecting the gastrointestinal tract.
Side effects
Sophora flavescens extracts are generally well tolerated in clinical trials. Common side effects, occurring in more than 5% of users, are rare but may include mild gastrointestinal discomfort such as nausea or stomach upset. Uncommon side effects, observed in 1-5% of individuals, can include transient elevations in liver enzymes, which typically resolve without intervention, and allergic reactions, though these are infrequent. Rare side effects, occurring in less than 1% of cases, are not extensively documented in large-scale trials. While no major drug interactions have been conclusively reported, caution is advised when combining Sophora flavescens with immunosuppressants or chemotherapy agents due to potential additive or synergistic effects. Contraindications include pregnancy and known hypersensitivity to the plant or its components. Extensive safety data for special populations, such as the elderly or children, are currently limited, warranting careful consideration in these groups.
Dosage
Effective dosages of Sophora flavescens extract vary significantly depending on the specific formulation and the medical indication. For ulcerative colitis, Five-Flavor Sophora flavescens Enteric-Coated Capsules are typically administered according to licensed Chinese patent medicine guidelines, with treatment durations ranging from several weeks to months to achieve optimal therapeutic outcomes. In the context of cancer adjunct therapy, doses are standardized within compound injections, but the precise dosage regimen is often tailored to complement specific chemotherapy protocols. Current evidence suggests that longer treatment durations may lead to improved efficacy across various conditions. Enteric-coated formulations are preferred, especially for gastrointestinal conditions, as they enhance intestinal delivery and minimize potential gastric irritation. There are no specific cofactors identified as essential for its efficacy, but concurrent use with other anti-inflammatory or immunomodulatory agents should be considered in the context of overall treatment plans. Specific upper limits and safety thresholds are not universally established, emphasizing the need for professional guidance.
FAQs
Is Sophora flavescens safe for long-term use?
Clinical trials up to several months show good safety, but long-term data beyond this period are limited, so caution is advised for extended use.
Can it be used alone or only as adjunct therapy?
Most evidence supports its use as an adjunct therapy, particularly in cancer and ulcerative colitis, rather than as a standalone treatment.
When are effects typically seen?
Benefits in ulcerative colitis and as an adjunct in cancer therapy are generally observed within a few weeks to a few months of consistent use.
Are there differences between extracts?
Yes, formulations vary in alkaloid content and bioavailability. Enteric-coated capsules are often preferred for conditions like ulcerative colitis due to improved intestinal delivery.
Research Sources
- https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2020.603476/full – This systematic review and meta-analysis of 8 RCTs (n=983) on Kushen-based TCM in UC showed significant improvement in clinical remission and symptom scores versus controls. It highlighted limitations such as heterogeneity in formulations and some studies with small sample sizes, suggesting the need for more standardized research.
- https://onlinelibrary.wiley.com/doi/10.1155/2022/9633048 – This meta-analysis of RCTs on Five-Flavor Sophora flavescens Enteric-Coated Capsules for UC confirmed efficacy and safety. Pooled data showed statistically significant benefits and no increase in adverse events, with the study quality rated as moderate to high, supporting its use in UC.
- https://pubmed.ncbi.nlm.nih.gov/35069773/ – This meta-analysis of RCTs on Five-Flavor Sophora flavescens Enteric-Coated Capsules for UC confirmed efficacy and safety. Pooled data showed statistically significant benefits and no increase in adverse events, with the study quality rated as moderate to high, supporting its use in UC.
- https://jgo.amegroups.org/article/view/59644/html – This meta-analysis of compound Sophora flavescens injection as adjunct chemotherapy in digestive tract cancers (n=510) demonstrated improved short-term efficacy (OR=3.11; 95% CI: 2.26–4.27). The study noted low heterogeneity and robust methodology, supporting its role as an adjunctive treatment.
- https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1519794/full – This clustered systematic review and meta-analysis on intrapleural Sophora flavescens for malignant pleural effusion showed significant clinical effectiveness and safety. It utilized appropriate statistical methods and heterogeneity assessment, providing strong evidence for its application in MPE.
- https://pmc.ncbi.nlm.nih.gov/articles/PMC11611551/ – This meta-analysis on neuropathic pain from tumor metastasis demonstrated potential benefit but noted high heterogeneity (I^2=91%). This suggests that while promising, further standardized trials are needed to confirm consistent efficacy and optimal dosing for this indication.