A Phase II Randomized Controlled Trial of Renshen Yangrong Tang Herbal Extract Granules for Fatigue Reduction in Cancer Survivors

Context: Based on the traditional Chinese medicine theory, Renshen Yangrong Tang (RSYRT), which is a mixture of 12 herbs, was commonly used as a pharmacological option in China for fatigue management by correcting Qi deficiency. Objectives: This randomized controlled Phase II trial investigated the efficacy of RSYRT for reducing cancer-related fatigue. Methods: Cancer survivors with moderate or severe fatigue (rated ≥4 on a 0–10 scale) for more than two months were randomized to take herbal extract granules of RSYRT or a low dose of a single herb (huangqi) twice a day for six weeks. Patient-reported fatigue was measured using the MD Anderson Symptom Inventory. Efficacy of RSYRT was evaluated using mixed model to test the differences over time among groups. We also conducted responder analyses and examined time to effect of symptom reduction. Results: None of the 83 evaluable patients (control group 42; intervention group 41) had discomfort or Grade 3 or 4 toxicity. We observed a significantly greater MD Anderson Symptom Inventory—fatigue score reduction in the intervention group than that in the control group (time-by-group interaction: estimate = −0.61 [0.10]; P < 0.0001). More patients in the intervention group had a two-point reduction on fatigue than that of the control group (90.2% vs. 52.4%). By Week 4, between-group differences of fatigue reduction on mean severity reached large effect size (intervention group vs. control group: −2.66 vs. −1.36; Cohen's d = 1.0; P < 0.0001). Conclusion: Compared with control therapy, RSYRT therapy elicits a statistical and clinical improvement of fatigue severity and functioning. The effectiveness of RSYRT in managing cancer-related fatigue warrants further study in the real world.