Efficacy and safety of Huachansu capsule as adjuvant therapy for breast cancer: A systematic review and meta-analysis of randomized controlled trials

Huachansu capsule (HCSC) is a traditional Chinese patent medicine derived from toad venom (Bufo bufo gargarizans Cantor). In China, HCSC has been widely used as a therapeutic agent for breast cancer (BC). It exerts antitumor effects by inducing apoptosis of BC cells, disrupting the tumor cell cycle, and regulating the immune system. Preliminary clinical studies have confirmed its antitumor efficacy in BC patients. This study aims to systematically evaluate the efficacy and safety of HCSC as an adjuvant therapy for BC. Seven Chinese and English databases were systematically searched from database inception to October 2, 2024, to identify randomized controlled trials (RCTs) on HCSC for BC treatment. The methodological quality of the included studies was assessed using the revised Cochrane risk of bias tool (ROB 2.0). Meta-analysis was performed using RevMan 5.3, and sensitivity analysis was conducted using Stata 16.0. Trial sequential analysis (TSA) was used to assess the reliability of conclusions regarding the intervention effects, and the certainty of evidence was evaluated using the GRADE approach. A total of 10 RCTs with 881 participants, were included. The meta-analysis revealed that HCSC, as an adjuvant therapy, significantly improved the objective response rate (RR = 1.32, 95 % CI [1.17, 1.49]), disease control rate (RR = 1.17, 95 % CI [1.04, 1.31]), and Karnofsky Performance Status (KPS) improvement rate (RR = 1.54, 95 % CI [1.18, 2.01]). Besides, HCSC prolonged progression-free survival (MD = 1.45, 95 % CI [0.62, 2.28]), overall survival (MD = 2.75, 95 % CI [1.66, 3.85]). The treatment also demonstrated immunomodulatory effects, as indicated by significant increases in CD3⁺ levels (MD = 6.28, 95 % CI [4.95, 7.62]) and CD4⁺ levels (MD = 3.32, 95 % CI [1.94, 4.70]). Furthermore, HCSC significantly reduced tumor marker levels, including CEA [MD = −1.05, 95 % CI [-1.50, −0.60]), CA125 (MD = −9.89, 95 % CI [-15.23, −4.55]), and CA153 (MD = −4.76, 95 % CI [-6.55, −2.98]). Regarding adverse events, HCSC ameliorated chemotherapy-induced adverse effects, including myelosuppression, gastrointestinal reactions, leukopenia, and nerve damage. However, the methodological quality of the included studies was generally low, and the sample sizes failed to meet the required information size. The quality of evidence for outcome measures was graded as low or very low. HCSC as an adjuvant therapy for BC demonstrates potential benefits, including enhancing the efficacy of chemotherapy, improving quality of life, inhibiting tumor progression, prolonging overall survival, modulating immune function, reducing tumor marker levels, and mitigating chemotherapy-induced adverse events. However, given the inherent heterogeneity of study populations and methodological limitations, further high-quality RCTs with larger sample sizes are warranted to validate these findings. [Display omitted] • Breast cancer ranks as the top cause of cancer cases and deaths in women worldwide. • In China, Huachansu capsule is extensively utilized in the treatment of breast cancer. • Huachansu capsule shows efficacy and safety in breast cancer adjuvant therapy.