Jun-Yong Choi , Bom Choi , Ojin Kwon , Chang-Seob Seo , Ae-Ran Kim , Hyeun-kyoo Shin , Kibong Kim
{"title":"宫金丹和双黄连对慢性疲劳患者的疗效和安全性：随机、双盲、安慰剂对照临床试验","authors":"Jun-Yong Choi , Bom Choi , Ojin Kwon , Chang-Seob Seo , Ae-Ran Kim , Hyeun-kyoo Shin , Kibong Kim","doi":"10.1016/j.imr.2024.101025","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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).</p></div><div><h3>Trial registration</h3><p>This study was registered at Clinical Research Information Service (CRIS) of Korea with the registration number KCT0007515.</p></div>","PeriodicalId":13644,"journal":{"name":"Integrative Medicine Research","volume":null,"pages":null},"PeriodicalIF":2.8000,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2213422024000052/pdfft?md5=0180e2aec9ae7d2e2114f8bded2ad2bb&pid=1-s2.0-S2213422024000052-main.pdf","citationCount":"0","resultStr":"{\"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\",\"authors\":\"Jun-Yong Choi , Bom Choi , Ojin Kwon , Chang-Seob Seo , Ae-Ran Kim , Hyeun-kyoo Shin , Kibong Kim\",\"doi\":\"10.1016/j.imr.2024.101025\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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).</p></div><div><h3>Trial registration</h3><p>This study was registered at Clinical Research Information Service (CRIS) of Korea with the registration number KCT0007515.</p></div>\",\"PeriodicalId\":13644,\"journal\":{\"name\":\"Integrative Medicine Research\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.8000,\"publicationDate\":\"2024-02-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.sciencedirect.com/science/article/pii/S2213422024000052/pdfft?md5=0180e2aec9ae7d2e2114f8bded2ad2bb&pid=1-s2.0-S2213422024000052-main.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Integrative Medicine Research\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2213422024000052\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Integrative Medicine Research","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2213422024000052","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
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 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.
期刊介绍：
Integrative Medicine Research (IMR) is a quarterly, peer-reviewed journal focused on scientific research for integrative medicine including traditional medicine (emphasis on acupuncture and herbal medicine), complementary and alternative medicine, and systems medicine. The journal includes papers on basic research, clinical research, methodology, theory, computational analysis and modelling, topical reviews, medical history, education and policy based on physiology, pathology, diagnosis and the systems approach in the field of integrative medicine.
京公网安备 11010802042870号
京ICP备2023020795号-1
分享
求助内容：
应助结果提醒方式：
扫码关注我们
