Abstract
OBJECTIVE: To evaluate the efficacy and safety of Yunpiqiangshen gel which composed of eleven herbs on quality of life (QOL) improvement. METHODS: We enrolled 180 patients lasted from January 2020 to December 2021. Seventy-eight patients received standards of care (control group) and 76 patients received Yunpiqiangshen gel [Traditional Chinese Medicine, (TCM) group] for 6 months in statistical analysis. The primary outcome assessed using Kidney Disease Quality of Life Short Form Questionnaire version 1.3 (KDQOL-SF(TM) 1.3), including Short Form Health Survey (SF-36) and Kidney Disease Targeted Areas (KDTA) scores. The second outcomes included the TCM syndrome score, Fatigue Assessment Instrument (FAI) score, Modified Quantitative Subjective Global Assessment (MQSGA) score, anthropometric indicators, and blood chemical testing. Adverse events, including decompensated gastrointestinal symptoms, were evaluated. RESULTS: The results showed that the mean change of SF-36 (75 ± 13 vs 64 ± 16, F = 6.070, P = 0.015) and KDTA (76 ± 7 vs 70 ± 9, F = 4.118, P = 0.044) scores in the TCM group had an improvement (increase) from baseline, as compared with the control group. Yunpiqiangshen gel also resulted in a significant improvement in almost dimensions of QOL. At the end of follow-up, the imputed percentage of patients in the response rate of TCM syndrome was greater in the TCM group than in the control group (76.32% vs 20.51%, χ (2) = 48.02, P = 0.000). The fatigue, soreness of waist, anorexia, abdominal distension, loose stool, and constipation were alleviated after Yunpiqiangshen gel therapy. The FAI (98.58 ± 25.08 vs 131.21 ± 31.85, F = 8.745, P = 0.004) and MQSGA (10.13 ± 2.84 vs 12.83 ± 3.85, F = 11.396, P = 0.001) scores in the TCM group had an improvement (reduce) from baseline compared with the control group. A higher level of albumin of patients in the TCM group compared with the control group. Diarrhea, vomit, and loose stool were more common in the TCM group, but generally mild in severity. CONCLUSION: Compared with the standards of care, added Yunpiqiangshen gel was a safe and effective therapy for improving QOL in dialysis patients.