Efficacy of ginseng-based Renshenguben oral solution for cancer-related fatigue among patients with advanced-stage hepatocellular carcinoma: A prospective multicenter cohort study

IF 3.6 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY Hepatobiliary & Pancreatic Diseases International Pub Date : 2023-11-21 DOI:10.1016/j.hbpd.2023.11.004

Ming-Da Wang , Chen Yuan , Ke-Chun Wang , Nan-Ya Wang , Ying-Jian Liang , Hong Zhu , Xiang-Min Tong , Tian Yang

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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.

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人参人参骨本口服液治疗晚期肝癌患者癌症相关性疲劳的疗效:一项前瞻性多中心队列研究

背景:癌症相关性疲劳(CRF)是晚期癌症患者常见的衰弱症状，尤其是那些接受抗肿瘤治疗的患者。本研究旨在评价人参中药人神骨本(RSGB)口服液缓解晚期肝癌(HCC)患者抗肿瘤治疗的疗效和安全性。方法:在这项前瞻性、开放标签、对照、多中心研究中，纳入了BCLC C期晚期HCC患者，BFI评分≥4。参与者被分配到RSGB组(RSGB, 10 mL，每日两次)或对照组(支持治疗)。主要和次要终点是入组后第4周和第8周多维疲劳量表(MFI)评分的变化，BFI和癌症治疗肝胆功能评估(FACT-Hep)评分的变化。评估不良事件(ae)和毒性。结果:共纳入409名受试者，其中206名被分配到RSGB组。在第4周，有改善的趋势，但差异无统计学意义。第8周，与对照组相比，RSGB组的MFI评分明显降低(P < 0.05)，表明疲劳水平有所改善。此外，RSGB组在第8周BFI和FACT-Hep评分下降幅度更大(P < 0.05)。在接受各种抗肿瘤治疗的患者中，亚组分析显示了相似的结果。多变量线性回归分析显示，RSGB组在第8周时MFI、BFI和FACT-Hep评分显著下降。未观察到严重的药物相关不良反应或毒性。结论:在接受抗肿瘤治疗的晚期HCC患者中，RSGB口服液在8周内有效降低了CRF，且无明显的毒性。这些发现支持RSGB口服液作为治疗该患者群体慢性肾功能衰竭的辅助治疗的潜力。

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来源期刊

Hepatobiliary & Pancreatic Diseases International 医学-胃肠肝病学

CiteScore

5.40

自引率

6.10%

发文量

152

审稿时长

3.0 months

期刊介绍： Hepatobiliary & Pancreatic Diseases International (HBPD INT) (ISSN 1499-3872 / CN 33-1391/R) a bimonthly journal published by First Affiliated Hospital, Zhejiang University School of Medicine, China. It publishes peer-reviewed original papers, reviews and editorials concerned with clinical practice and research in the fields of hepatobiliary and pancreatic diseases. Papers cover the medical, surgical, radiological, pathological, biochemical, physiological and historical aspects of the subject areas under the headings Liver, Biliary, Pancreas, Transplantation, Research, Special Reports, Editorials, Review Articles, Brief Communications, Clinical Summary, Clinical Images and Case Reports. It also deals with the basic sciences and experimental work. The journal is abstracted and indexed in SCI-E, IM/MEDLINE, EMBASE/EM, CA, Scopus, ScienceDirect, etc.