Effects of five-element music therapy on chemotherapy patients with cancer: A systematic review and meta-analysis of randomized controlled trials.

OBJECTIVE: This study aims to systematically evaluate the effects of Five-Element Music Therapy (FEMT) on emotional state, sleep quality, and quality of life in cancer patients undergoing chemotherapy. METHODS: We systematically searched 8 databases for randomized controlled trials (RCTs) comparing FEMT with standard care or control music interventions. Cochrane Risk of Bias Tool 2 (ROB2) was used to assess the quality of included RCTs. Meta-analysis was performed using Review Manager 5.4, and sensitivity analysis was conducted with Stata 18 software. GRADE system was used to assess evidence quality. Additionally, trial sequence analysis (TSA) was employed to evaluate the reliability of conclusions regarding intervention effects. RESULTS: A total of 20 RCTs (1588 patients) were included. Meta-analysis results showed that compared with control group, FEMT significantly reduced anxiety scores (Self-Rating Anxiety Scale (SAS): MD = -7.16, 95% CI: -9.56 to -4.67, p < 0.00001; Hamilton Anxiety Rating Scale (HAMA): MD = -5.19, 95% CI: -9.94 to -0.45, p = 0.03) and depression scores (Self-Rating Depression Scale (SDS): MD = -7.07, 95% CI: -7.90 to -6.24, p < 0.00001; Hamilton Depression Rating Scale (HAMD): MD = -5.89, 95% CI: -7.39 to -4.39, p < 0.00001), and improved sleep quality (Pittsburgh Sleep Quality Index (PSQI): MD = -2.52, 95% CI: -2.89 to -2.16, p < 0.00001). Regarding quality of life, FEMT significantly improved Quality of Life Core Questionnaire (QLQ-C30) overall health status scores (MD = 9.27, 95% CI: 5.68-12.86, p < 0.00001), physical function, and emotional function on the QOL-C30 scale, while reducing symptom scores for fatigue and sleep disturbance. FEMT also modulated immune function (increased CD3+% and CD4+%) and inflammatory markers (increased superoxide dismutase (SOD), decreased nitric oxide (NO)). However, the methodological quality of included studies was generally low, with most outcomes graded as low or very low certainty evidence. CONCLUSION: Current evidence suggests that FEMT may effectively alleviate anxiety and depression in chemotherapy patients, improve sleep and quality of life, and exert certain physiological regulatory effects. However, due to limitations in the number, characteristics and methodological quality of studies, the generalizability of this therapy outside of China remains unclear; further validation is needed through high-quality, large-scale, international, multicenter RCTs.