A Meta-analysis of the Efficacy and Safety of Huai'er Granules as an Adjuvant Therapy for Breast Cancer in Combination with Western Medicine

Abstract

Objective: To systematically evaluate the efficacy and safety of Huairu Granules combined with Western medicine in the treatment of breast cancer. Methods: Randomized controlled trials (RCTs) comparing Huairu Granules combined with Western medicine and Western medicine alone in the treatment of breast cancer were retrieved from Pubmed, Web of Science, CNKI, VIP, Wanfang, and Chinese Biomedical Database (CBM) from the establishment of the databases to September 2025. The quality of the included studies was evaluated using the AMSTAR quality assessment form. Relevant data were extracted, and Review 5.4 was used to conduct a meta-analysis of the relative risk (RR) and odds ratio (OR) of the reference indicators, and the 95% confidence interval (CI) was listed. Results: A total of 17 RCTs were included, involving 1655 patients, with 833 in the experimental group and 822 in the control group. The meta-analysis results showed that the Karnofsky Performance Status (KPS) score of the experimental group treated with Huairu Granules (MD = 9.66, 95% [7.05, 12.28], P < 0.00001), clinical efficacy including objective response rate (OR = 1.35, 95% CI [1.03, 1.76], P = 0.03), disease control rate (RR = 1.16, 95% [1.01, 1.33], P = 0.03), 2-year survival rate (RR = 1.18, 95% [1.02, 1.37], P = 0.03), reduction in 2-year recurrence and metastasis rate (RR = 0.27, 95%CI [0.13, 0.56] , P = 0.0005), reduction in adverse reactions (gastrointestinal reactions, bone marrow suppression, liver function damage), peripheral blood CD3+ T cells, CD4+ T cells, CD8+ T cells, NK cells, and CD4+/CD8+ levels were all superior to those of the control group, with statistically significant differences (P < 0.05). Conclusion: Based on the results of the meta-analysis, it can be preliminarily inferred that Huairu Granules combined with Western medicine can improve the efficacy and safety of breast cancer patients, but more strictly designed large-sample, prospective clinical studies are still needed for confirmation.