A brief discussion on evidence-based clinical research of traditional Chinese medicine.

BACKGROUND: The evaluation of clinical efficacy of traditional Chinese medicine (TCM) is the focus of the development of Chinese medicine, but at present there is no internationally recognized clinical efficacy evaluation system, which prevents TCM going abroad. Evidence-based medicine (EBM) research methods have achieved good results in the evaluation of TCM, but there are still some problems. How to use EBM methods in accordance with China's national conditions and develop evidence-based TCM that meets its own characteristics is the key to the current discussion. METHODS: Search websites such as PubMed, China National Knowledge Infrastructure, Wanfang Data and VIP by computer, and search papers related to evidence-based clinical research of TCM. RESULTS: A total of 15 high quality representative research papers published in internationally renowned journals were selected for example, including 4 randomized controlled trials (RCTs) related to Chinese medicine, 9 RCTs related to acupuncture, and 2 observational studies on the safety of TCM. CONCLUSIONS: EBM method is suitable for clinical research of TCM. There are differences between "disease" and "syndromes" in the use of TCM. Based on the further standardization of syndromes and classification of TCM, modern clinical research methods can be reasonably applied. However, the quality of clinical research related to TCM is not high, and there is a lack of research related to the safety of it, which should be paid attention to and improved in future research.

[Systematic review and Meta-analysis of efficacy and safety of Compound Congrong Yizhi Capsules on vascular cognitive impairment].

To analyze the efficacy and safety of Compound Congrong Yizhi Capsules in treatment of vascular cognitive impairment. Databases, such as CNKI, WanFang, VIP, SinoMed, PubMed, Cochrane Library, ClinicalTrials were electronically retrieved for relevant randomized controlled trials about the effect of Compound Congrong Yizhi Capsules in treatment of vascular cognitive impairment. Two researchers independently screened the literatures and extracted data according to the inclusion criteria, and used the risk of bias assessment tool in the Cochrane evaluation manual for quality assessment. The Cochrane systematic evaluation software RevMan 5.3 was used for data analysis. Totally 12 articles including 1 279 patients were included. The intervention measure was Compound Congrong Yizhi Capsules used alone or combined with Western medicine, and the control measure was the Western medicine alone or the blank control. According to the findings, for patients of vascular cognitive impairment no dementia, Compound Congrong Yizhi Capsules was better than the blank control in improving MoCA scale score and serum NO levels and reducing serum ET-1 levels. For vascular dementia patients, Compound Congrong Yizhi Capsules combined with Western medicine was better than Western medicine alone in improving MMSE and MoCA scale score. Five studies reported adverse events, but no significant adverse reaction was found. In conclusion, Compound Congrong Yizhi Capsules alone could alliviate early cognitive impairment in patients of vascular cognitive impairment no dementia; Compound Congrong Yizhi Capsules combined with Western medicine is superior to Western medicine alone in improving cognitive impairment. No obvious adverse reaction was found. Compound Congrong Yizhi Capsules can be recommended in clinical use. This conclusion needs to be further confirmed in high-quality clinical trials in the future.

[Clinical effect and safety of acupuncture in treatment of cardiac neurosis:a systematic review and meta-analysis].

OBJECTIVE: To systematically evaluate the clinical effect and safety of acupuncture in the treatment of cardiac neurosis. METHODS: Chinese databases (including SinoMed, VIP, CNKI, and Wanfang Data) and English databases (including PubMed and The Cochrane Library) were searched for randomized controlled trials (RCTs) on acupuncture in the treatment of cardiac neurosis published up to March 2019. Two reviewers independently screened the literature, extracted data, and assessed the risk of bias of included studies, and then RevMan 5.3 was used to perform a meta-analysis. RESULTS: A total of 7 RCTs were included, with 491 patients with cardiac neurosis. The results of the meta-analysis showed that compared with the conventional western medicine group, the acupuncture group had a significantly higher total effective rate (risk ratio ［RR］=1.16, 95% CI［1.05,1.28］, P=0.005) and had significantly greater improvements in Hamilton Anxiety Scale score (mean difference ［MD］=-3.22, 95% CI［-6.05, -0.39］, P=0.03). There were no significant differences between the two groups in Hamilton Depression Scale score (MD=-1.92, 95% CI［-4.76, -0.91］, P=0.18)，traditional Chinese medicine symptom score (MD=-5.49, 95% CI［-11.55, 0.56］, P=0.08), somatization symptom score (MD=-0.91, 95% CI［-3.28, 1.46］, P=0.45), and adverse reactions (RR=0.67, 95% CI［0.26,1.78］, P=0.42). CONCLUSION: Acupuncture can alleviate the symptoms and is safe in the treatment of cardiac neurosis.

[Efficacy of Shensong Yangxin Capsules in treating bradycardia combined with premature beat: a systematic review and Meta-analysis of randomized clinical trials].

To analyze the efficacy and safety of Shensong Yangxin Capsules in treatment of bradycardia combined with premature beat. Databases, such as CNKI, VIP, WanFang, SinoMed, PubMed, Cochrane Library, ClinicalTrials were retrieved by computers for relevant randomized controlled trials of Shensong Yangxin Capsules in treatment of bradycardia combined with premature beat. Two researchers independently screened out the literatures, extracted data according to the inclusion criteria, and applied the Risk of Bias assessment tool in assessing the methodological quality. The Cochrane systematic evaluation software RevMan 5.3 was used for data analysis. Totally 9 randomized controlled trials including 706 subjects were included. The intervention measure was the single administration with Shensong Yangxin Capsules, and the control measure was the blank control. The results showed that Shensong Yangxin Capsules had an obvious effect on average heart rate(MD=6.59, 95%CI[3.87, 9.31], I~2=90%), premature beat efficacy(RR=1.72, 95%CI[1.53, 1.93], I~2=0%), heart rate efficacy(RR=1.74, 95%CI[1.40, 2.17], I~2=47%), and objective efficacy(RR=1.50, 95%CI[1.31, 1.70], I~2=31%). Eight studies reported safety events, with no significant adverse reaction. In conclusion, the single administration with Shensong Yangxin Capsules may have a certain effect in improving heart rate, controlling premature beats and alleviating clinical symptoms in patients with bradycardia combined with premature beat, with no obvious adverse reaction. Shensong Yangxin Capsules can be used in clinic. This potential conclusion needs to be confirmed in future trials using rigorous methodology.

[Discussion on design of clinical trial scheme for doctor-patient co-construction of traditional Chinese medicine and Western medicine under concept of narrative medicine].

With the continuous improvement of modern medical technology, medical practice has become more and more procedural. The medical process is often dominated by doctors, while the value orientation of patients is often ignored, lacking effective communication between doctors and patients. In response to this phenomenon, Charon R proposed the concept of narrative medicine, which has been recognized by all walks of life. In recent years, the value of medical humanism has attracted more attention, and the research on narrative medicine at home and abroad is increasing gradually. But at present, most of the research on narrative medicine is in terms of theory, lacking clinical research. How to make narrative medicine applied in the real world is the focus of current research. Following the concept of narrative medicine, and taking the study on doctor-patient parallel medical record to evaluate the real clinical efficacy of traditional Chinese medicine(TCM) and Western medicine(WM) in the treatment of digestive diseases as an example, this study is to explore the design contents and key points of the clinical trial scheme of doctor-patient co-construction of TCM and WM under narrative medicine, and discuss the activity form and clinical efficacy evaluation method under narrative medicine. Clinical trial design includes four aspects: medicine, ethics, statistics and trial management. This study explored the design of the doctor-patient co-construction clinical trial scheme under narrative medicine from both theoretical and practical aspects, providing reference for the design and research of future doctor-patient co-construction scheme, and expecting to establish a better efficacy evaluation method of TCM and WM.

[Babaodan Capsules for viral hepatitis: systematic review of clinical efficacy and safety and Meta-analysis of randomized clinical trials].

To systemically analyze the efficacy and safety of Babaodan Capsules in treatment of viral hepatitis. Databases such as CNKI,Wan Fang Date,VIP,Sino Med,PubMed,and Cochrane Library were electronically searched for relevant randomized controlled trials about Babaodan Capsules in the treatment of viral hepatitis,from database establishment to November 11,2018. Two researchers independently screened the literature and extracted data according to the inclusion criteria. GRADE system was used to evaluate evidence quality,and we used the Cochrane Rev Man 5. 3 software for Meta-analysis. Six randomized controlled trials including 520 subjects were included. Babaodan Capsules combined with conventional treatment were used as intervention measures,and the conventional treatment was used as the control measures. The results showed Babaodan Capsules combined with conventional treatment had better efficacy on reducing the total bilirubin( MD =-16. 25,95% CI[-19. 86,-12. 63]),alanine aminotransferase( MD =-26. 62,95% CI[-41. 18,-12. 06]),total bile acid( MD=-46. 02,95%CI[-49. 18,-42. 85]) and improving clinical efficiency( RR = 1. 34,95%CI[1. 13,1. 59]) than conventional treatment alone. In addition,Babaodan Capsules combined with conventional treatment can delay the progression of liver fibrosis to some extent. Qualitative analysis showed that the combined treatment regimen was more effective in relieving clinical symptoms. There was no significant difference between the two regimens in increasing albumin and prothrombin activity. Babaodan Capsules combined with conventional treatment showed no adverse reactions. In summary,for patients with viral hepatitis,the combination of Babaodan Capsules and conventional treatment has more advantages in reducing total bilirubin,alanine aminotransferase and total bile acid and is more effective in improving clinical symptoms as compared with conventional Western medicine,with no serious adverse reactions. Its clinical application with syndrome differentiation method can be considered. However,due to the limited number and quality of the original researches,more multi-center,high-quality randomized controlled trials are needed for further verification.

[Efficacy and safety of Wenxin Granules in treatment of chronic heart failure with atrial fibrillation: a systematic review].

This systematic review aims to evaluate the efficacy and safety of Wenxin Granules in the treatment of chronic heart failure with atrial fibrillation. Databases,such as CNKI,Wan Fang Date,VIP,PubMed,Cochrane Library,were electronically retrieved for relevant randomized controlled trials of Wenxin Granules in the treatment of chronic heart failure with atrial fibrillation. Two researchers independently screened out the literatures,extracted data according to the inclusion criteria,and conducted a quality assessment by the risk bias assessment tool in the Cochrane evaluation manual. Cochrane systematic evaluation software Rev Man 5. 3 was used for data analysis. Totally 11 randomized controlled trials,including 941 subjects. The intervention measures were the conventional treatment recommended by the guidelines combined with Wenxin Granules; and the control measures were the conventional treatment recommended by the guidelines alone. The results showed that compared with conventional treatment alone,Wenxin Granules combined with conventional treatment can better reduce the BNP level in patients with heart failure with atrial fibrillation( MD =-258. 18,95% CI[-464. 06,-52. 30],P= 0. 01) or NT-proBNP level,better improve left ventricular ejection fraction( MD = 6. 72,95%CI[4. 61,8. 84],P<0. 000 01),I~2= 65%,And the ventricular rate decreased more significantly( MD =-11. 66,95% CI[-15. 79,-7. 54],P<0. 000 01),and the cardiac function was improved more efficiently( RR = 1. 20,95%CI [1. 11,1. 31],P<0. 000 1),I~2= 23%.In conclusion,compared with the single administration of conventional Western medicine,the combined administration of Wenxin Granules has better effects in reducing the level of BNP or NT-proBNP,slowing down the ventricular rate,and improving the left ventricular ejection fraction,with fewer adverse reactions. However,due to the small sample size and the low quality of literatures included in this systematic review,it is shall be carefully applied in clinic. More rigorous randomized controlled trials shall be conducted to determine the efficacy of Wenxin Granules in improving cardiac function in the treatment of chronic heart failure with atrial fibrillation.