Abstract
BACKGROUND: Hyperplasia of the mammary glands (HMG) is the most prevalent breast disease and can become malignant if left untreated. Although "Sancai therapy" has been widely used to treat HMG, its efficacy has not yet been systematically reviewed. This study aims to systematically evaluate the clinical efficacy of Sancai therapy for HMG treatment and provide a clinical basis for its future use. METHODS: PubMed, Cochrane Library, Web of Science, EMBASE, CNKI, CBM, VIP, and Wanfang databases were reviewed for related data collection. Chinese and English databases were searched for randomized controlled trials on Sancai therapy for HMG. The retrieval date was February 27, 2023. Exclusion criteria: (1) Non-HMG patients; (2) case reports, literature reviews, animal experiments, systematic reviews; and (3) full text could not be obtained. Data obtained after literature screening were imported into the RevMan 5.4.1 software for meta-analysis, and the included literature was assessed for methodological quality using the "bias risk assessment" tool within the software. RESULTS: The meta-analysis included 11 studies. Compared to the control group, the Sancai therapy treatment group exhibited an overall increased efficacy (relative risk = 1.36, 95% confidence interval [CI] [1.18, 1.58], P < .0001), an increased cure rate (relative risk = 3.74, 95% CI [1.70, 8.25], P = .001), a significant improvement in breast pain (standard mean difference = -2.68, 95% CI [-3.41, -1.96], P < .00001), and a reduction in breast masses (standard mean difference = -2.87, 95% CI [-3.75, -1.99], P < .00001). CONCLUSION: Sancai therapy significantly improved the overall efficacy, cure rate, and breast pain and reduced breast mass compared with the control groups. However, further large-sample, high-quality, double-blind randomized controlled trials are required to increase the level of evidence. PROTOCOL REGISTRATION NUMBER: INPLASY202380124.