Abstract
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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). TRIAL REGISTRATION: This study was registered at Clinical Research Information Service (CRIS) of Korea with the registration number KCT0007515.