Effects and safety of traditional Chinese medicine approaches in cancer symptom care: A systematic review of phase 3 randomized clinical trials

Cancer-related symptoms are detrimental to the quality of life of people with cancer. This review systematically evaluates phase 3 randomized clinical trials (RCTs) assessing the effectiveness and safety of traditional Chinese medicine (TCM) interventions in managing cancer-related symptoms throughout the cancer care trajectory. A comprehensive literature search was conducted of PubMed, Embase, and the Cochrane Library until April 27, 2025, to further identify eligible RCTs involving patients with cancer or survivors and assessing TCM interventions against valid control arms. Data extraction and quality assessments were conducted in accordance with Cochrane standards and Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Nineteen phase 3 RCTs involving 5387 participants (female, 3321; primarily breast, gastrointestinal, and lung cancers) from six countries or regions were included. Nonpharmacological interventions, namely acupuncture and Tai Chi, significantly reduced pain, fatigue, insomnia, radiation-induced xerostomia, and hormonal therapy-related hot flashes compared to usual care (UC). Their effects on preventing chemotherapy- and radiotherapy-induced nausea and vomiting were mixed, which depended on control arms and outcome measures. Conversely, evidence for pharmacological interventions was limited, with inconclusive results regarding chemotherapy-induced peripheral neuropathy and hematologic toxicities, although promising outcomes were noted for preventing chemoradiotherapy-induced mucositis, reducing colorectal adenoma recurrence, and enhancing chemotherapy completion rates compared to placebo or UC. Safety data suggested similar adverse event profiles across groups. These findings show strong evidence for the inclusion of nonpharmacological interventions in oncology practice. However, pharmacological interventions require more high-quality, multicenter research to fully understand their effectiveness and safety. Implementing rigorous safety assessments and standardized adverse event reporting protocols is crucial to enhance clinical confidence in TCM modalities.