Wisconsin Ginseng (Panax quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind Trial, N07C2
Wisconsin Ginseng (Panax quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind Trial, N07C2
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DOI：
10.1093/jnci/djt181
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发表时间：
2013-08-01
影响因子：
10.3
通讯作者：
Loprinzi, Charles L.
中科院分区：
文献类型：
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作者：
Barton, Debra L.;Liu, Heshan;Loprinzi, Charles L.
安全、有效的干预措施来改善癌症相关疲劳（CRF）是必要的，因为它仍然是一种普遍的、令人痛苦的、限制活动的症状。在试验数据的基础上，开展了一项三期试验，以评估西洋参对CRF的疗效。一项多地点双盲试验将疲劳的癌症幸存者随机分为2000mg西洋参组和安慰剂组，持续8周。主要终点是4周时多维疲劳症状调查表（MFSI-SF）的一般子量表。4周和8周时的基线变化通过双侧、双样本t检验评估两组之间的变化。通过自我报告和国家癌症研究所不良事件通用术语标准（CTCAE）提供者分级来评估毒性。来自40所院校的364名参与者被招募。与基线相比，人参组的MFSI-SF一般分量表在4周时的变化为14.4（标准差[SD] 27.1），而安慰剂组为8.2（标准差[SD] 24.8） （P .07）。8周时，人参组的变化评分为20 (SD 27)，安慰剂组的变化评分为10.3 (SD 26.1)，差异有统计学意义（P .003）。据报道，接受积极癌症治疗的患者比完成治疗的患者获益更大。每个自我报告的毒性和CTCAE分级在两组之间没有统计学上的显著差异。数据支持西洋参的益处，每天2000mg，持续8周。治疗过程中没有明显的毒性。需要更多的研究来指导人参改善CRF的作用。
Safe, effective interventions to improve cancer-related fatigue (CRF) are needed because it remains a prevalent, distressing, and activity-limiting symptom. Based on pilot data, a phase III trial was developed to evaluate the efficacy of American ginseng on CRF.A multisite, double-blind trial randomized fatigued cancer survivors to 2000mg of American ginseng vs a placebo for 8 weeks. The primary endpoint was the general subscale of the Multidimensional Fatigue Symptom InventoryShort Form (MFSI-SF) at 4 weeks. Changes from baseline at 4 and 8 weeks were evaluated between arms by a two-sided, two-sample t test. Toxicities were evaluated by self-report and the National Cancer Institutes Common Terminology Criteria for Adverse Events (CTCAE) provider grading.Three hundred sixty-four participants were enrolled from 40 institutions. Changes from baseline in the general subscale of the MFSI-SF were 14.4 (standard deviation [SD] 27.1) in the ginseng arm vs 8.2 (SD 24.8) in the placebo arm at 4 weeks (P .07). A statistically significant difference was seen at 8 weeks with a change score of 20 (SD 27) for the ginseng group and 10.3 (SD 26.1) for the placebo group (P .003). Greater benefit was reported in patients receiving active cancer treatment vs those who had completed treatment. Toxicities per self-report and CTCAE grading did not differ statistically significantly between arms.Data support the benefit of American ginseng, 2000mg daily, on CRF over an 8-week period. There were no discernible toxicities associated with the treatment. Studies to increase knowledge to guide the role of ginseng to improve CRF are needed.