Treatment Efficacy of Chuang Ling Ye, a Traditional Chinese Herbal Medicine Compound, on Idiopathic Granulomatous Mastitis: A Randomized Controlled Trial

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-1β (IL-1β), 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-1β, 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.

Serum C-Reactive Protein and Interleukin-6 Levels as Biomarkers for Disease Severity and Clinical Outcomes in Patients with Idiopathic Granulomatous Mastitis

“…This new evidence of cytokine dysregulation makes advances in the field of the immunopathology of IGM. Second, the serum cytokine levels of patients with IGM in the present study were lower than the studies mentioned above [ 13 , 14 , 36 ]. Furthermore, the serum cytokine levels were within the normal range in most of our patients.…”

“…Excessive cytokine production of IGM can be reduced by inhibition of inflammation. In a randomized controlled trial, numerical reduction of serum TNF-α, IL-1β, IL-2, and IL-6 was found in IGM patients after treated with Chuang Ling Ye, which is a traditional Chinese herbal medicine compound composed of rhubarb, safflower, Abelmoschus manihot , and Terminalia chebula [ 36 ]. With the understanding of cytokine dysregulation in IGM, anti-cytokine therapies may be a promising treatment option to eliminate the inflammation in IGM.…”

“…This discrepancy might be explained by the use of immunosuppressants in 87.8% of the patients with IGM in the present study. By contrast, the immunosuppressants were scarcely used in the previous studies [ 13 , 14 , 36 ]. The use of immunosuppressants should be taken into consideration while delineating the cytokine profiling in IGM.…”

Classification of 27 Corynebacterium kroppenstedtii -Like Isolates Associated with Mastitis in China and Descriptions of C. parakroppenstedtii sp. nov. and C. pseudokroppenstedtii sp. nov

“…Most patients had a good outcome after treatment. There is also recent clinical research suggesting that traditional Chinese medicine is effective in treating mastitis, indicating the potential advantage of traditional Chinese medicine ( 25 , 26 ).…”

Evaluation of significantly changed chemokine factors of idiopathic granulomatous mastitis in non‐puerperal patients

“…50 Chuang Ling Ye (CLY), a traditional Chinese herbal medicine compound, downregulated the expression levels of inflammatory markers, including IL-1β, IL-2, IL-6, IFN-γ, and TNF-α. 51 In this study, the number of samples we could test was constrained by limited resources and availability, which may have affected our comprehensive understanding of the heterogeneity within the disease group. Despite these limitations, our study results provide preliminary evidence for understanding the role of cytokines in disease and lay the groundwork for subsequent large-scale research endeavors.…”