| ObjectiveChronic fatigue syndrome is a newly recognized disease in modern medicine.It is a systemic syndrome characterized by long-term extreme fatigue,inability to relieve after rest,and accompanied by cognitive memory decline,immune decline and a variety of neurological and mental symptoms.At present,the etiology and pathogenesis of fatigue in western medicine is not clear,and more symptomatic support treatment is adopted,but the effect is not good.Although Chinese medicine does not have a clear name for fatigue,it has a rich record of its symptoms,etiology,pathogenesis and treatment.As an important carrier of traditional Chinese medicine,ancient books of traditional Chinese medicine have different characteristics from modern clinical research and are an important part of clinical evidence of traditional Chinese medicine.This study starts from ancient and modern literature,on the one hand,it systematically summarizes and summarizes the TCM ancient books evidence of ginseng in the treatment of fatigue,and evaluates and classifies the quality of ancient books;on the other hand,it evaluates the effectiveness and safety of ginseng and its effective components in the treatment of chronic fatigue syndrome,so as to provide more scientific evidence-based medicine evidence.Methods1.Eight common key words of fatigue were determined by searching the ancient Chinese medical records tool "Chinese medical code",and 1156 Chinese medical records of previous dynasties were screened according to the determined inclusion criteria and exclusion criteria.Finally,the selected ancient book evidences are classified and sorted out,and the ancient book evidences are graded and classified according to the established quality evaluation scale of ancient book evidences of traditional Chinese medicine,and the quality of ancient book evidences of medical cases is further evaluated.2.Search the randomized controlled clinical trials of all ginseng and its effective ingredients in PubMed,Web of Science,the Cochrane database,EMBASE,CNKI,Wanfang database,VIP and China biomedical literature database from the beginning to December 31,2019.The treatment group included in the study was treated with ginseng or ginseng effective ingredients,with placebo as the control.The main outcome indicators were fatigue symptom score,and the secondary outcome indicators were clinical efficacy,fatigue severity score,biochemical indicators and adverse reactions.The"bias risk assessment" recommended by Cochrane collaborative network was used for literature quality assessment.All data were analyzed by rev-man5.3.Results1.Ancient books evidence research:through the screening,a total of 8059 ancient books records about fatigue were obtained,among which 104 ancient books evidences about ginseng treatment of fatigue met the standard.The 104 evidences are classified into 96 argumentative evidences and 8 medical case evidences.Among the argumentative evidences,the ancient books of song,Ming and Qing Dynasties recorded the most,and there were abundant kinds of prescriptions.The evaluation results of ancient book evidence quality show that the quality score of all ancient book evidence of ginseng in the treatment of fatigue is between 3-9 points,with a large span.There are 30 pieces of evidence for 3 points,23 pieces of evidence for 4 points,22 pieces of evidence for 5 points,1 piece of evidence for 6 points and 1 piece of evidence for 9 points,9 pieces of evidence for 7 points and 18 pieces of evidence for 8 points.There is only one piece of evidence in the first category,28 pieces of evidence in the second category and 75 pieces of evidence in the third category.The quality evaluation scores of 8 medical case evidences are all higher than 3 points,the highest is 7 points for one piece of evidence quality,6 points for four ancient book evidences,and 5 points,4 points and 3 points for the other three pieces respectively.2.Six English literatures were included in the final study,involving 813 subjects.By using fatigue score,TCMSSS and FHSS score,ginseng and its active ingredients can reduce the body fatigue symptoms and improve the fire(heat)symptoms of CFS patients;by using MFI-20 and MDMQ score,SMT and ES combined treatment has a better effect on the spirit fatigue symptoms of patients compared with SMT alone or ES alone;by using SRI and BDI score,Korean red ginseng can alleviate the spirit fatigue symptoms Patients’ anxiety and depression symptoms,reduce their psychological pressure,so as to improve their mental and behavioral symptoms;using FSAS,FSS,VAS and CFSQ scores,Korean red ginseng can improve patients’fatigue intensity and severity,and it has curative effect.Compared with placebo,ginseng and its effective components can significantly improve the clinical efficacy of CFS patients.There was no significant difference in the adverse reactions between the treatment group and placebo group,suggesting that ginseng and its active ingredients are safe in the treatment of chronic fatigue syndrome.Ginseng and its active ingredients can also regulate the ast level and ALT level of patients,reduce liver damage;can reduce the indexes of d-ROMs and TBARS,reduce the oxidative damage caused by free radicals,help maintain the antioxidant capacity;can regulate the awakening response capacity and cortisol concentration level of cortisol,and promote the secretion of cortisol.In addition,one study showed that the clinical effect of low dose ginseng group was better than that of high dose ginseng group and better than that of placebo control group.There was significant difference among the three groups(n=132,RR 1.52,95%CI:1.36-1.71,P<0.001,I2=0%).It is suggested that the dosage of Panax ginseng may be related to the treatment of fatigue.Conclusion1.Due to the limited level of ancient science and technology and medical treatment,the lack of attention to medical evidence,and the slow progress of doctors’summary of their own experience,leading to less evidence of ancient books in line with the standards of modern medical evaluation,the level of evidence is also low.However,starting from the ancient book evidence of ginseng anti fatigue,this study makes an exploratory evaluation and classification of the quality of ancient book evidence,which will play an important role in the future evaluation of the quality of ancient Chinese Book Evidence and the development of traditional Chinese medicine evidence.We should establish a clinical evidence evaluation system with Chinese medicine characteristics.Based on the characteristics of clinical practice of Chinese medicine,combined with the scientific concept and methodology of evidence-based medicine,taking the combination of disease and syndrome as the main idea,we should build a multi-dimensional comprehensive evaluation system on the overall level.2.In view of the fact that there is no systematic evaluation of randomized controlled trials of ginseng and its active ingredients for fatigue treatment at home and abroad,this study is the first time to carry out systematic retrieval and statistical analysis of relevant literature,and the included literature is all English literature,and most of the literature has been registered in the clinical trial registration center,so the research quality of this system evaluation is relatively high,and the evidence is more complete and extrapolation can provide some valuable reference for clinical research design and implementation in the future.Ginseng and its effective components can improve the physical and mental fatigue symptoms of CFS patients,improve the fatigue intensity and severity of CFS patients,significantly improve the clinical efficacy of patients,and safe and reliable.However,most of the outcome indicators in this study are subjective evaluation scales,lacking of objective indicators,lack of quality control and unification of intervention measures in the study,and incomplete report of adverse reactions.These deficiencies can provide improvements for future clinical research design,so as to design a more complete and effective research program,in order to obtain more scientific research Evidence. |
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