Integrative Traditional East Asian Medicine-Based Adjunctive Therapies for Patients With Prostate Cancer Undergoing Standard Cancer Treatment: Protocol for a Systematic Review and Meta-Analysis of Randomized Controlled Trials.

چکیده اصلی

BACKGROUND: Prostate cancer treatment increasingly emphasizes quality-of-life maintenance alongside oncological control. Integrative Traditional East Asian Medicine (TEAM), including traditional Chinese medicine, traditional Korean medicine, and Kampo medicine, has been used as an adjunctive approach for symptom management during cancer treatment. However, evidence regarding its effectiveness and safety across different disease stages remains heterogeneous and has not been comprehensively synthesized. OBJECTIVE: This systematic review and meta-analysis aims to evaluate the clinical effectiveness, safety, and quality-of-life benefits of TEAM-based adjunctive therapies combined with standard conventional treatments in patients with prostate cancer. METHODS: Randomized controlled trials will be identified through comprehensive multilingual searches of PubMed, Embase, China National Knowledge Infrastructure, Oriental Medicine Advanced Searching Integrated System, Research Information Sharing Service, and other databases from inception to January 2026. Two reviewers will independently screen studies, extract data, and assess risk of bias using the Cochrane risk of bias 2 tool. Primary outcomes will consist of tumor-related outcomes (prostate-specific antigen levels and Response Evaluation Criteria in Solid Tumors-evaluated tumor response rates) and survival outcomes (overall survival and progression-free survival). Secondary outcomes will include clinical symptoms (International Prostate Symptom Score), pain scores (visual analog scale or numeric rating scale), quality of life, and treatment-related adverse events. Potential herb-drug interactions reported in primary trials will also be systematically assessed. Meta-analyses will be performed using random effects models in RevMan (version 5.4). In cases of substantial heterogeneity (I²≥50%), sensitivity and subgroup analyses will be conducted. The certainty of evidence will be assessed with the Grading of Recommendations Assessment, Development, and Evaluation approach. RESULTS: The study selection process will be illustrated using a PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) flow diagram. Where appropriate, pooled effect estimates will be presented using forest plots. CONCLUSIONS: This review will provide comprehensive evidence on the role of TEAM-based adjunctive therapies in prostate cancer care across disease stages and will inform the development of integrative oncology guidelines. TRIAL REGISTRATION: PROSPERO CRD420251275137; https://www.crd.york.ac.uk/PROSPERO/view/CRD420251275137. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/94053.

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