Efficacy and safety of herbal medicine Gongjin-Dan and Ssanghwa-Tang in patients with chronic fatigue: A randomized, double-blind, placebo-controlled, clinical trial
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 f...
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Elsevier
2024-03-01
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| Series: | Integrative Medicine Research |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2213422024000052 |
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| author | Jun-Yong Choi Bom Choi Ojin Kwon Chang-Seob Seo Ae-Ran Kim Hyeun-kyoo Shin Kibong Kim |
| author_facet | Jun-Yong Choi Bom Choi Ojin Kwon Chang-Seob Seo Ae-Ran Kim Hyeun-kyoo Shin Kibong Kim |
| author_sort | Jun-Yong Choi |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-84ace791179246ca8cf37ab738194d06 |
| institution | DOAJ |
| issn | 2213-4220 |
| language | English |
| publishDate | 2024-03-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Integrative Medicine Research |
| spelling | doaj-art-84ace791179246ca8cf37ab738194d062025-08-20T03:04:44ZengElsevierIntegrative Medicine Research2213-42202024-03-0113110102510.1016/j.imr.2024.101025Efficacy and safety of herbal medicine Gongjin-Dan and Ssanghwa-Tang in patients with chronic fatigue: A randomized, double-blind, placebo-controlled, clinical trialJun-Yong Choi0Bom Choi1Ojin Kwon2Chang-Seob Seo3Ae-Ran Kim4Hyeun-kyoo Shin5Kibong Kim6Department of Korean Internal Medicine, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea; School of Korean Medicine, Pusan National University, Yangsan, Republic of KoreaDepartment of Korean Pediatrics, Pusan National University Korean Medicine Hospital, Yangsan, Republic of KoreaKM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaKM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaClinical Research coordinating team, Korea Institute of Oriental Medicine, Daejeon, Republic of KoreaKM Science Research Division, Korea Institute of Oriental Medicine, Daejeon, Republic of Korea; Corresponding authors at: Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital, 20 Geumo-ro, Mulgeum-eup, Yangsan 50612, Republic of Korea (K. Kim); KM Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 34054, Republic of Korea (H.-k. Shin).School of Korean Medicine, Pusan National University, Yangsan, Republic of Korea; Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital, Yangsan, Republic of Korea; Corresponding authors at: Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital, 20 Geumo-ro, Mulgeum-eup, Yangsan 50612, Republic of Korea (K. Kim); KM Science Research Division, Korea Institute of Oriental Medicine, 1672 Yuseong-daero, Yuseong-gu, Daejeon 34054, Republic of Korea (H.-k. Shin).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.http://www.sciencedirect.com/science/article/pii/S2213422024000052Herbal medicineGongjin-dan (Gongchen-dan)Ssanghwa-tang (Shuanghe-tang)Chronic fatigueRandomized controlled trial |
| spellingShingle | Jun-Yong Choi Bom Choi Ojin Kwon Chang-Seob Seo Ae-Ran Kim Hyeun-kyoo Shin Kibong Kim Efficacy and safety of herbal medicine Gongjin-Dan and Ssanghwa-Tang in patients with chronic fatigue: A randomized, double-blind, placebo-controlled, clinical trial Integrative Medicine Research Herbal medicine Gongjin-dan (Gongchen-dan) Ssanghwa-tang (Shuanghe-tang) Chronic fatigue Randomized controlled trial |
| title | Efficacy and safety of herbal medicine Gongjin-Dan and Ssanghwa-Tang in patients with chronic fatigue: A randomized, double-blind, placebo-controlled, clinical trial |
| title_full | Efficacy and safety of herbal medicine Gongjin-Dan and Ssanghwa-Tang in patients with chronic fatigue: A randomized, double-blind, placebo-controlled, clinical trial |
| title_fullStr | Efficacy and safety of herbal medicine Gongjin-Dan and Ssanghwa-Tang in patients with chronic fatigue: A randomized, double-blind, placebo-controlled, clinical trial |
| title_full_unstemmed | Efficacy and safety of herbal medicine Gongjin-Dan and Ssanghwa-Tang in patients with chronic fatigue: A randomized, double-blind, placebo-controlled, clinical trial |
| title_short | Efficacy and safety of herbal medicine Gongjin-Dan and Ssanghwa-Tang in patients with chronic fatigue: A randomized, double-blind, placebo-controlled, clinical trial |
| title_sort | efficacy and safety of herbal medicine gongjin dan and ssanghwa tang in patients with chronic fatigue a randomized double blind placebo controlled clinical trial |
| topic | Herbal medicine Gongjin-dan (Gongchen-dan) Ssanghwa-tang (Shuanghe-tang) Chronic fatigue Randomized controlled trial |
| url | http://www.sciencedirect.com/science/article/pii/S2213422024000052 |
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