Treatment Efficacy of Chuang Ling Ye, a Traditional Chinese Herbal Medicine Compound, on Idiopathic Granulomatous Mastitis: A Randomized Controlled Trial
Jingxian Xue, Bei Ye, Shun Liu, Sihan Cao, Wei-he Bian, Chang Yao
Abstract
Objective . To explore whether Chuang Ling Ye (CLY), a traditional Chinese herbal medicine compound, could improve the treatment of idiopathic granulomatous mastitis (IGM) via decreasing inflammatory response. Methods . Herein, 40 patients with IGM who had wounds requiring dressing change were enrolled and randomly divided into two groups: the CLY group and the control group. The size of the neoplasm and pain score of patients were followed‐up for 4 weeks. Local tissues were taken during dressing change and examined by commercial enzyme‐linked immunosorbent assay (ELISA) kits. The levels of inflammatory markers, including interleukin‐1 β (IL‐1 β ), IL‐2, IL‐6, interferon gamma (IFN‐ γ ), and tumor necrosis factor‐ α (TNF‐ α ) were measured. Results . After treatment, the size of the neoplasm in the CLY group was significantly smaller than that in the control group (14.28 cm ± 8.96 cm vs. 21.14 cm ± 0.12 cm, P = 0.038), and the pain scores were markedly reduced ( P = 0.004). Besides, CLY downregulated the expression levels of IL‐1 β , IFN‐ γ , and TNF‐ α . Conclusion . External use of CLY could reduce the neoplasm of IGM by inhibiting local inflammation. This trial is registered with ChiCTR1800017744 .