Abstract
OBJECTIVE: To evaluate the effectiveness and safety of Shenyi Capsule (SC) combined with conventional anticancer therapies through a comprehensive assessment of systematic reviews/meta-analyses (SRs/MAs), identify limitations in current evidence, and provide evidence-based guide for clinical practice and research. METHODS: Registered in PROSPERO (CRD42024573610), this study searched 8 Databases from inception to November 10, 2024. Two separate reviewers were responsible for selecting studies, collecting data, assessing quality, and evaluating the potential for bias, with this research incorporating only SRs/MAs based on randomized controlled trials and utilizing 4 tools (AMSTAR-2, PRISMA 2020, ROBIS, GRADE) to evaluate methodological quality and risk of bias. RESULTS: Thirteen SRs/MAs were included, focusing on 4 cancer types. AMSTAR-2 evaluations revealed no high quality studies. Compliance with PRISMA 2020 guidelines was below 50% for most items, with major deficiencies including lack of protocol registration, incomplete abstracts and search strategies, inappropriate or missing risk-of-bias assessments, insufficient descriptions of data transformation methods, absence of heterogeneity and sensitivity analyses, and failure to report funding sources. ROBIS indicated high bias risk in 11 studies. GRADE assessment of 109 outcomes showed evidence quality as moderate (40.37%), low (34.86%), or very low (24.77%). DISCUSSION: SC may enhance efficacy and safety as an adjuvant cancer therapy. However, methodological flaws in existing SRs/MAs limit reliability. Future research should prioritize standardized SR/MA protocols and RCT designs to improve evidence quality, reduce bias, and strengthen clinical applicability.