Yennurajalingam Sriram, Reddy Akhila, Tannir Nizar M, Chisholm Gary B, Lee Richard Tsong, Lopez Gabriel, Escalante Carmen P, Manzullo Ellen F, Frisbee Hume Susan, Williams Janet L, Cohen Lorenzo, Bruera Eduardo
Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA
Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
Integr Cancer Ther. 2015 Sep;14(5):419-27. doi: 10.1177/1534735415580676. Epub 2015 Apr 14.
Cancer-related fatigue (CRF) is the most common and severe symptom in patients with cancer. The number and efficacy of available treatments for CRF are limited. The objective of this preliminary study was to assess the safety of high-dose Panax ginseng (PG) for CRF.
In this prospective, open-label study, 30 patients with CRF (≥4/10) received high-dose PG at 800 mg orally daily for 29 days. Frequency and type of side effects were determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.0. Scores on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, Edmonton Symptom Assessment System (ESAS), and Hospital Anxiety and Depression Scale (HADS) were assessed at baseline, day 15, and day 29. Global Symptom Evaluation (GSE) was assessed at day 29.
Of the 30 patients enrolled, 24 (80%) were evaluable. The median age was 58 years; 50% were females, and 84% were white. No severe (≥grade 3) adverse events related to the study drug were reported. Of the 24 evaluable patients, 21 (87%) had an improved (by ≥3 points) FACIT-F score by day 15. The mean ESAS score (standard deviation) for well-being improved from 4.67 (2.04) to 3.50 (2.34) (P = .01374), and mean score for appetite improved from 4.29 (2.79) to 2.96 (2.46) (P = .0097). GSE score of PG for fatigue was ≥3 in 15/24 patients (63%) with median improvement of 5.
PG is safe and improves CRF fatigue as well as overall quality of life, appetite, and sleep at night. Randomized controlled trials of PG for CRF are justified.
癌症相关疲劳（CRF）是癌症患者中最常见且严重的症状。现有的CRF治疗方法数量有限且疗效欠佳。本初步研究的目的是评估大剂量人参（PG）治疗CRF的安全性。
在这项前瞻性、开放标签研究中，30例CRF（≥4/10）患者每天口服800毫克大剂量PG，持续29天。不良事件的频率和类型根据美国国立癌症研究所的《不良事件通用术语标准》第4.0版确定。在基线、第15天和第29天评估慢性病治疗功能评估-疲劳（FACIT-F）量表、埃德蒙顿症状评估系统（ESAS）和医院焦虑抑郁量表（HADS）的评分。在第29天评估整体症状评估（GSE）。
30例入组患者中，24例（80%）可评估。中位年龄为58岁；50%为女性，84%为白人。未报告与研究药物相关的严重（≥3级）不良事件。在24例可评估患者中，21例（87%）在第15天时FACIT-F评分提高了（≥3分）。幸福感的平均ESAS评分（标准差）从4.67（2.04）提高到3.50（2.34）（P = 0.01374），食欲的平均评分从4.29（2.79）提高到2.96（2.46）（P = 0.0097）。24例患者中有15例（63%）PG治疗疲劳的GSE评分≥3，中位改善值为5。
PG安全，可改善CRF疲劳以及整体生活质量、食欲和夜间睡眠。对PG治疗CRF进行随机对照试验是合理的。
