Choi Jun-Yong, Choi Bom, Kwon Ojin, Seo Chang-Seob, Kim Ae-Ran, Shin Hyeun-Kyoo, Kim Kibong
Department of Korean Internal Medicine, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea.
School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea.
Integr Med Res. 2024 Mar;13(1):101025. doi: 10.1016/j.imr.2024.101025. Epub 2024 Feb 16.
Gongjin-dan (GJD, also known as Gongchen-dan) and Ssanghwa-tang (SHT, also known as Shuanghe-tang or Souwa-to) are herbal medicines that are widely used in Korea for treating fatigue. However, few studies have evaluated the efficacy and safety of GJD and SHT in the treatment of chronic fatigue.
In this randomized, double-blind, placebo-controlled clinical trial, 90 individuals with persistent (≥6 months) chronic fatigue of unknown cause and a Fatigue Severity Scale (FSS) score of ≥4 were randomly assigned to GJD group, SHT group, and control group in a 1:1:1 ratio. Outcomes were the changes in the self-reported fatigue questionnaire scores, levels of fatigue-related biomarkers and safety assessment.
Out of 103 patients recruited, 90 were included in the analysis. A significant improvement in the Social Functioning (SF) score of Short-Form 36 Health Survey (SF-36) at week 4 was observed in the GJD group; similarly, a significant improvement compared with that in the Control group was observed in the Role Emotional (RE) score of SF-36 at weeks 4 and 6 and the Physical Functioning (PF) score of SF-36 at week 6 in the SHT group. Laboratory tests revealed no abnormalities, and serious intervention-related adverse events were not reported.
It is suggested that SHT can effectively treat chronic mental and physical fatigue, whereas GJD can effectively treat chronic mental and social fatigue. Furthermore, this study presents evidence supporting the safety of the long-term use of GJD and SHT (up to 4 weeks).
This study was registered at Clinical Research Information Service (CRIS) of Korea with the registration number KCT0007515.
宫津丹（GJD，也称为宫辰丹）和双和汤（SHT，也称为双合汤或苏和汤）是韩国广泛用于治疗疲劳的草药。然而，很少有研究评估GJD和SHT治疗慢性疲劳的疗效和安全性。
在这项随机、双盲、安慰剂对照临床试验中，90名原因不明的持续性（≥6个月）慢性疲劳且疲劳严重程度量表（FSS）评分≥4的个体按1:1:1的比例随机分配到GJD组、SHT组和对照组。观察指标为自我报告的疲劳问卷评分变化、疲劳相关生物标志物水平及安全性评估。
在招募的103例患者中，90例纳入分析。GJD组在第4周时简短健康调查问卷（SF-36）的社会功能（SF）评分有显著改善；同样，SHT组在第4周和第6周时SF-36的角色情感（RE）评分以及第6周时SF-36的身体功能（PF）评分与对照组相比有显著改善。实验室检查未发现异常，也未报告严重的干预相关不良事件。
提示SHT可有效治疗慢性身心疲劳，而GJD可有效治疗慢性精神和社会疲劳。此外，本研究提供了支持长期使用GJD和SHT（长达4周）安全性的证据。
本研究在韩国临床研究信息服务（CRIS）注册，注册号为KCT0007515。
