Cheng Chang ^1* Di Sun ^2* Zhilei Zhang ^3* Qiang Wang ^2* Yingchao Shen ^2* Hengzhou Zhu ^4* Donghua Fan ^2*

• ¹ Jiangsu Provincial Hospital of Traditional Chinese Medicine, Nanjing, Jiangsu Province, China
• ² Changshu Affiliated Hospital of Nanjing University of Traditional Chinese Medicine, Suzhou, Liaoning Province, China
• ³ Department of Spine Surgery, Mianyang Central Hospital, Sichuan, China
• ⁴ Wuxi Hospital of Traditional Chinese Medicine, Wuxi, China

Traditional treatments for bone neuropathic pain often exhibit limited efficacy and undesirable side effects. Sophora flavescens, an herb used in traditional Chinese medicine, has shown potential analgesic and anti-cancer properties, but the existing evidence is fragmented and inconsistent.In accordance with PRISMA guidelines, an extensive literature search was performed across PubMed, Web of Science, and Cochrane Library databases, Embase, Medline, CNKI, VIP, Wanfang Database, CBMdisc to identify relevant studies. The inclusion criteria focused on randomized controlled trials (RCTs) investigating the use of Sophora flavescens for bone neuropathic pain. Data related to pain intensity, mechanisms of action, and safety were extracted and analyzed using meta-analysis techniques. The quality of the studies was assessed using the Cochrane Risk of Bias tool.Following PRISMA guidelines, a comprehensive literature search was conducted across PubMed, Web of Science, and Cochrane Library databases to identify relevant studies. Inclusion criteria encompassed randomized controlled trials (RCTs), observational studies, and preclinical studies involving Sophora flavescens for bone neuropathic pain. Data on pain intensity, mechanisms of action, and safety were extracted and analyzed using meta-analytic techniques. The Cochrane Risk of Bias tool was used for quality assessment.Seven studies met the inclusion criteria, involving a total of 463 patients with bone neuropathic pain induced by tumor metastasis. The meta-analysis revealed a significant overall reduction in pain intensity for patients treated with Sophora flavescens compared to control groups (mean difference = 26.45, 95% CI: 13.89, 39.00, P < 0.0001). Specifically, the Karnofsky Performance Status (KPS) increase rate showed a combined risk ratio of 1.62 (95% CI: 1.32, 1.99, P < 0.0001), indicating improved performance status with treatment. Pain scores also significantly decreased (mean difference = 26.45, 95% CI: 13.89, 39.00, P < 0.0001) despite substantial heterogeneity among studies (I² = 91%). Funnel plots suggested minimal publication bias, and sensitivity analyses confirmed the stability of these results. The included studies reported minimal adverse effects, indicating good tolerability of Sophora flavescens.Sophora flavescens demonstrates significant potential as an adjunctive therapy for managing bone neuropathic pain induced by tumor metastasis, offering substantial pain relief with minimal adverse effects.