Hyperplasia of mammary glands (HMG) is a prevalent mammary disease characterised by the disruption in the secretion of estradiol (E2) and progesterone (P). This disruption leads to the overproliferation of mammary epithelial cells and mammary gland tissue hyperplasia (Sun et al., 2023). According to traditional Chinese medicine (TCM), HMG is closely associated with mastopathy, fibroadenopathy, fibrocystic breast disease, breast pain, fibrocystic degeneration, benign breast dysplasia, or sclerosing gonadism (Ma et al., 2021a, Ma et al., 2021b). Based on the TCM theory, the pathogenesis of HMG involves the disharmony of Chong and Ren, stagnation of the liver, and stasis of phlegm and blood. The treatment principles aim to balance Chong and Ren, improve liver and kidney, and dredge phlegm and blood stasis (Xiong et al., 2020). Breast hyperplasia has the highest incidence rate among all female breast diseases, and it is specifically associated with menarche time, foetal birth rate, socioeconomic status, and education level. Approximately 75% of women with breast hyperplasia are between the ages of 25% and 45%, and 20% of these women experience aggravating clinical symptoms (Ma et al., 2021a, Ma et al., 2021b). Physiological hyperplasia and pathological hyperplasia are different. Physiological hyperplasia is also described as breast pain and lobular hyperplasia, whereas cystic hyperplasia of the breast is used to describe pathological hyperplasia. Atypical hyperplasia (AH) should be prevented in the case of pathological hyperplasia. Clonal subpopulations of dysplastic and monotonous epithelial-cell populations are abundant in AH. AH is classified as premalignant in models of breast carcinogenesis because it exhibits some but not all of the requisite characteristics of cancer. Therefore, it is considered to be in a zone between benign and malignant diseases (Hartmann et al., 2015). AH of the breast approximately quadruples the overall risk of breast cancer development in women. Along with the progression of the disease, the incidence rate of breast hyperplasia is also increasing. The cancer rate is between 1.25% and 50%; hence, HMG is considered a global health issue among women (Ma et al., 2020).

Western medicine (WM) and TCM are used for treating HMG. WM (including hormone drugs or iodine preparations) administered orally can cause adverse reactions or drug dependence. The procedure is invasive and exhibits a high recurrence rate, inflicting significant harm to patients. Amid the modernisation of TCM, many researchers have reported that Chinese patent medicine has unique advantages and huge potential in the treatment of endocrine disorders (Fan et al., 2023). TCM emphasises boosting blood circulation to remove blood stasis, soothing the liver, and regulating qi, Chong, and Ren. This approach progressively reduces the adverse reactions associated with WM, treats symptoms and underlying root causes, and exerts a definite therapeutic effect. Previous studies (82 cases) have shown that Chaihu Shugan Powder can alleviate clinical symptoms, decrease breast lumps, and increase clinical efficacy. Furthermore, the clinical recurrence rate of the treatment group was significantly lower than that of the control group (CG) after 3 months of drug withdrawal. The incidence of adverse reactions in the treatment group was significantly lower than that of the CG during the entire treatment period.

A meta-analysis is a statistical approach for combining the results of multiple research on the same topic. It can be used to resolve disagreements between studies (Lee, 2018). A meta-analysis also allows the collection, organisation, and analysis of several previous empirical studies by researchers and experts on a particular topic to investigate a precise relationship pattern between the intervention and relevant variables to compensate for the deficiency of traditional review articles. Several investigations on the outcome of breast hyperplasia were performed using different intervention methods. However, research on the intervention mechanism underlying TCM is limited. Herein, we conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) involving Chinese patent medicines, specifically those with liver-soothing effects for treating HMG. We also investigated the clinical significance of TCM in the treatment of breast hyperplasia based on the principles of evidence-based medicine to provide a specific reference for future clinical medication.