Objective:

The purpose of this study is both to estimate the efficacy and the safety of Yukgunja-tang (YGJT) and to establish evidence for the use of herbal medicines in the management of patients with cancer-related anorexia.

Methods:

We enrolled 40 patients with cancer-related anorexia. The enrolled participants were randomly allocated to 2 groups: the control group (n = 20), which received nutrition counseling, and the treatment group (n = 20), which received nutrition counseling and was administered YGJT at twice a day for 4 weeks (a total of 56 times @ 3.0 g each time). The primary outcome of this study was the score on the anorexia/cachexia subscale (ACS) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT). The secondary outcomes were the FAACT score with the ACS score excluded, the score on the Visual Analog Scale (VAS) for appetite, and the results on laboratory tests regarding appetite, such as leptin, tumor necrosis factors (TNF-α), interleukin-6 (IL-6), and ghrelin. All variables related to the safety assessment, such as vital signs, electrocardiography results, laboratory test results (complete blood cell count, chemistry, urine test), and adverse events, were documented on the case report form (CRF) at every visit.

Result:

The difference in the primary outcome, that is, the score on the anorexia/cachexia subscale (ACS) of the Functional Assessment of Anorexia/Cachexia Therapy (FAACT), between the control and the treatment groups was statistically significant (P = .023) as was the difference in the FAACT scores with the ACS score excluded, a secondary outcome, between the 2 groups; however, no statistically significant differences were noted in the scores on the VAS or the levels of leptin, TNF-α, IL-6, and ghrelin. In addition, no significant differences in the numbers and the types of adverse events or in the results on the laboratory tests between the control and the treatment groups were recorded.

Conclusion:

These results obtained in this research confirmed the efficacy and the safety of using YGJT as a herb-medicine treatment option for patients with cancer-related anorexia.

中文翻译：

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Yukgunja-Tang 对癌症相关性厌食症患者的疗效和安全性：一项随机、对照试验、初步研究

客观的：

本研究的目的是评估 Yukgunja-tang (YGJT) 的有效性和安全性，并为使用草药治疗癌症相关性厌食症患者建立证据。

方法：

我们招募了 40 名患有癌症相关性厌食症的患者。纳入的参与者被随机分配到 2 组：对照组（n = 20），接受营养咨询，治疗组（n = 20），接受营养咨询，每天两次服用 YGJT，持续 4 周。总共 56 次@每次 3.0 g）。本研究的主要结果是厌食/恶病质治疗功能评估 (FAACT) 的厌食/恶病质分量表 (ACS) 的评分。次要结果是排除 ACS 评分的 FAACT 评分、食欲视觉模拟量表 (VAS) 的评分以及有关食欲的实验室检查结果，如瘦素、肿瘤坏死因子 (TNF-α)、白细胞介素- 6 (IL-6) 和生长素释放肽。与安全评估相关的所有变量，例如生命体征、

结果：

主要结果的差异，即厌食/恶病质治疗功能评估 (FAACT) 的厌食/恶病质分量表 (ACS) 得分，对照组和治疗组之间的差异具有统计学意义 ( P  = .023)排除 ACS 分数后 FAACT 分数的差异，这是两组之间的次要结果；然而，在 VAS 的评分或瘦素、TNF-α、IL-6 和生长素释放肽的水平上没有发现统计学上的显着差异。此外，未记录到对照组和治疗组之间在不良事件的数量和类型或实验室测试结果方面存在显着差异。

结论：

本研究中获得的这些结果证实了使用 YGJT 作为癌症相关性厌食症患者的草药治疗选择的有效性和安全性。