Safety and antifatigue effect of Korean Red Ginseng: a randomized, double-blind, and placebo-controlled clinical trial
Safety and antifatigue effect of Korean Red Ginseng: a randomized, double-blind, and placebo-controlled clinical trial
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高丽红参的安全性和抗疲劳作用：一项随机、双盲、安慰剂对照临床试验
DOI：
10.1016/j.jgr.2019.05.006
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发表时间：
2019-10-01
影响因子：
6.3
通讯作者：
Xu, Hongxi
中科院分区：
文献类型：
--
作者：
Zhang, Li;Chen, Xiaoyun;Xu, Hongxi
背景：高丽红参 (KRG) 被广泛用于增强免疫系统和对抗疲劳，特别是对于患有虚证的人。但有人担心，长期使用或大剂量使用KRG会因其“燥”而引起“上火”。本研究的目的是评估缺乏综合征参与者接受为期 4 周的 KRG 治疗的安全性和有效性。方法：这是一项为期 4 周的随机、双盲、安慰剂对照临床试验。总共 180 名中国参与者被随机分为三组：安慰剂对照组，参与者服用安慰剂，3.6 g/d； KRG 1.8 g 和 3.6 g 组。主要结果是火力和安全性评估（不良事件、实验室测试和心电图）的变化。次要结局是KRG对疲劳的疗效，包括以下内容：中医症状量表和疲劳自我评估量表。结果：在180名患者中，174名完成了完整的研究。 KRG治疗4周后，火热症状评分（包括火热评分和虚火评分）与安慰剂治疗相比没有显着变化，并且任何安全性参数均未观察到有临床意义的变化。根据中医证候评分和疲劳自评评分，KRG治疗后中医症状和疲劳明显改善，且具有剂量和时间依赖性效果。 KRG组的总有效率也显着提高。结论：我们的研究表明KRG具有有效的抗疲劳作用，并且对虚证患者没有明显的副作用。尽管可能需要更大的样本量和更长的治疗时间才能得出更明确的结论，但这项临床试验首次反驳了与 KRG 相关的“火”这一普遍概念。 (C) 2019 年韩国人参学会，由 Elsevier Korea LLC 出版。
Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (in Chinese) because of its "dryness" (in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome.Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale.Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups.Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of " fireness" related to KRG. (C) 2019 The Korean Society of Ginseng, Published by Elsevier Korea LLC.