Efficacy of ginseng-based Renshenguben oral solution for cancer-related fatigue among patients with advanced-stage hepatocellular carcinoma: A prospective multicenter cohort study
Ming-Da Wang a , b , # , Chen Yuan c , # , Ke-Chun Wang b , # , Nan-Ya Wang a , # , Ying-Jian Liang d , Hong Zhu e , Xiang-Min Tong c , f , ∗∗, Tian Yang a , b , ∗
a Department of Hepatobiliary and Pancreatic Surgery, General Surgery Center, First Hospital of Jilin University, Changchun 130021, China
b Department of Hepatobiliary Surgery, Eastern Hepatobiliary Surgery Hospital, Second Military Medical University (Naval Medical University), Shanghai 200438, China
c Department of Clinical Laboratory, Laboratory Medicine Center, Zhejiang Provincial People’s Hospital, Hangzhou Medical College, Hangzhou 310000, China
d Department of Hepatobiliary Surgery, First Affiliated Hospital of Harbin Medical University, Harbin 150007, China
e Department of Medical Oncology, First Affiliated Hospital of Soochow University, Suzhou 215006, China
f Department of Central Laboratory, Affiliated Hangzhou First People’s Hospital, Westlake University School of Medicine, Hangzhou 310006, China
∗Corresponding author at: Department of Hepatobiliary and Pancreatic Surgery, General Surgery Center, First Hospital of Jilin University, Changchun 130021, China.
∗∗Corresponding author at: Affiliated Hangzhou First People’s Hospital, Westlake University School of Medicine, Hangzhou 310006, China.
E-mail addresses: tongxiangmin@163.com (X.-M. Tong), yangtianehbh@smmu.edu.cn (T. Yang).
Abstract：Background: Cancer-related fatigue (CRF) is a common and debilitating symptom experienced by patients with advanced-stage cancer, especially those undergoing antitumor therapy. This study aimed to evaluate the efficacy and safety of Renshenguben (RSGB) oral solution, a ginseng-based traditional Chinese medicine, in alleviating CRF in patients with advanced hepatocellular carcinoma (HCC) receiving antitumor treatment.
Methods: In this prospective, open-label, controlled, multicenter study, patients with advanced HCC at BCLC stage C and a brief fatigue inventory (BFI) score of ≥4 were enrolled. Participants were assigned to the RSGB group (RSGB, 10 mL twice daily) or the control group (with supportive care). Primary and secondary endpoints were the change in multidimensional fatigue inventory (MFI) score, and BFI and functional assessment of cancer therapy-hepatobiliary (FACT-Hep) scores at weeks 4 and 8 after enrollment. Adverse events (AEs) and toxicities were assessed.
Results: A total of 409 participants were enrolled, with 206 assigned to the RSGB group. At week 4, there was a trend towards improvement, but the differences were not statistically significant. At week 8, the RSGB group exhibited a significantly lower MFI score ( P < 0.05) compared to the control group, indicating improved fatigue levels. Additionally, the RSGB group showed significantly greater decrease in BFI and FACT-Hep scores at week 8 ( P < 0.05). Subgroup analyses among patients receiving various antitumor treatments showed similar results. Multivariate linear regression analyses revealed that the RSGB group experienced a significantly substantial decrease in MFI, BFI, and FACT-Hep scores at week 8. No serious drug-related AEs or toxicities were observed.
Conclusions: RSGB oral solution effectively reduced CRF in patients with advanced HCC undergoing antitumor therapy over an eight-week period, with no discernible toxicities. These findings support the potential of RSGB oral solution as an adjunctive treatment for managing CRF in this patient population.
2024, Vol. 23 
