[Element relationship and extension path of clinical evidence knowledge map with Chinese patent medicine].

This study aims to construct the element relationship and extension path of clinical evidence knowledge map with Chinese patent medicine, providing basic technical support for the formation and transformation of the evidence chain of Chinese patent medicine and providing collection, induction, and summary schemes for massive and disorganized clinical data. Based on the elements of evidence-based PICOS, the conventional construction methods of knowledge graph were collected and summarized. Firstly, the data entities related to Chinese patent medicine were classified, and entity linking was performed(disambiguation). Secondly, the study associated and classified the attribute information of the data entity. Finally, the logical relationship between entities was constructed, and then the element relationship and extension path of the knowledge map conforming to the characteristics of clinical evidence of Chinese patent medicine were summarized. The construction of the clinical evidence knowledge map of Chinese patent medicine was mainly based on process design and logical structure, and the element relationship of the knowledge map was expressed according to the PICOS principle and evidence level. The extension path crossed three levels(model layer, data layer application, and new evidence application), and the study gradually explored the path from disease, core evaluation indicators, Chinese patent medicine, core prescriptions, syndrome and treatment rules, and medical case comparison(evolution law) to new drug research and development. In this study, the top-level design of the construction of the clinical evidence knowledge map of Chinese patent medicine has been clarified, but it still needs the joint efforts of interdisciplinary disciplines. With the continuous improvement of the map construction technology in line with the characteristics of TCM, the study can provide necessary basic technical support and reference for the development of the TCM discipline.

[Summary and evaluation of randomized controlled trial on Chinese patent medicine in treatment of diabetic foot ulcer].

This study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) in the treatment of diabetic foot ulcer(DFU). The aim as provide references for future studies and to enhance the application of clinical evidence. The RCT of DFU treated with Chinese Patent Medicine was obtained and analyzed using the AI-Clinical Evidence Database of Chinese Patent Medicine(AICED-CPM). The analysis was supplemented with data from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science. A total of 275 RCTs meeting the requirements were retrieved, with only 7 of them having a sample size of 200 or more. These trials involved 66 different Chinese patent medicine including 25 oral medications, 24 Chinese herbal injections, and 17 external drugs. Among the 33 different intervention/control designs identified, the most common design was Chinese patent medicine + conventional treatment vs conventional treatment(86 cases, 31.27%). Out of the 275 articles included in the literature, 50 did not provide information on the specific course of treatment(18.18%). A total of 10 counting indicators(with a frequency of 426) and 36 measuring indicators(with a frequency of 962) were utilized. The methodological quality of the RCT for the treatment of DFU with Chinese patent medicine was found to be low, with deficiencies in blind methods, other bias factors, study registration, and sample size estimation. There were noticeable shortcomings in the reporting of allocation hiding and implementation bias(blind method application). More studies should prioritize trial registration, program design, and strict quality control during implementation to provide valuable data for clinical practice and serve as a reference for future investigations.

Efficacy and safety of acupuncture on sleep quality for post-stroke insomnia: a systematic review and meta-analysis.

Background: Stroke is the second leading cause of death worldwide, and improving sleep quality in post-stroke insomnia is beneficial to the recovery of stroke. Acupuncture is widely used for the treatment of post-stroke insomnia in China. Therefore, this systematic review and meta-analysis were performed to explore the efficacy and safety of acupuncture for post-stroke insomnia. Methods: Eight databases were searched from their inception to 12 September 2022. Two reviewers independently performed the study screening and data extraction. The outcomes include Pittsburgh Sleep Quality Index (PSQI), objective sleep data measured by polysomnography (PSG), long-term efficacy and adverse events. The quality of the trials was assessed by the Cochrane risk of bias tool 2.0. The RevMan 5.4 and Stata 15.1 were used for data synthesis. Results: Among 3,233 participants from 41 studies were included. Pooled results indicated that acupuncture was superior to control group (CG) in improving PSQI total score (standardized mean difference (SMD) = -1.03, 95% confidence interval (CI): -1.32, -0.74, P < 0.00001), increasing sleep efficiency (SMD = 0.65, 95% CI: 0.37 to 0.92) and total sleep time (SMD = 0.54, 95% CI: 0.22 to 0.86). The favorable results in improving PSQI total score (SMD = 0.65, 95% CI: 0.37 to 0.92), reduced sleep latency (SMD = 1.84, 95% CI: 0.31 to 3.38) and increased total sleep time (SMD = -0.73, 95% CI: -1.15 to -0.31) were also observed in comparisons of acupuncture plus CG vs. CG. As of long-term efficacy and safety, the effects of acupuncture were long-term and robustness, however, due to limited safety information, reliable safety conclusions cannot be drawn. Subgroup analysis showed that acupuncture plus CG was superior to CG for post-infarction patients, but the efficacy of acupuncture alone compared to non-BZDs or other hypnotics needs further research. The GRADE assessment demonstrated that the level of evidence was mostly low or very low given the flaws in the study design and considerable heterogeneity among the included studies. Conclusion: Acupuncture could improve sleep quality, has long-term efficacy and without serious adverse events. However, the findings should be treated with caution owing to the existence of methodological quality issues. More studies with rigorous designs are warranted for validation and explored the safety of acupuncture.

The add-on effect of Shufeng Jiedu capsule for treating COVID-19: A systematic review and meta-analysis.

Introduction: Shufeng Jiedu capsule (SFJD) is a commonly used Chinese patent medicine in China. Some studies have reported that SFJD has therapeutic effects in patients diagnosed with COVID-19. This systematic review aimed to critically evaluate the efficacy and safety of SFJD combined with western medicine (WM) for treating COVID-19. Methods: A literature search by using WHO COVID-19 database, PubMed, Embase, Cochrane Library, the Web of Science, CKNI, Wanfang, VIP, SinoMed, and clinical trial registries was conducted, up to 1 August 2022. Randomized controlled trials (RCTs), non-RCTs, cohort studies and case series of SFJD combined with WM for COVID-19 were included. Literature screening, data extraction, and quality assessment were performed independently by two reviewers in line with the same criteria. We used the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) to assess the certainty of evidence. Meta-analyses were performed with Revman 5.3 if possible. The descriptive analysis was conducted when the studies could not be meta-analyzed. Results: Totally 10 studies with 1,083 patients were included. Their methodological quality were moderate. The results demonstrated that compared to WM group, SFJD + WM group remarkably increased the nucleic acid negative conversion rate (RR = 1.40, 95%CI: 1.07-1.84), total effective rate (RR = 1.18, 95%CI: 1.07-1.31), cure rate (RR = 4.06, 95%CI: 2.19-7.53), and the chest CT improvement rate (RR = 1.19, 95%CI: 1.08-1.31), shorten nucleic acid negative conversion time (MD = -0.70, 95%CI: -1.14 to -0.26), reduced the clinical symptom disappearance time (fever, diarrhea, cough, fatigue, pharyngalgia, nasal congestion, and rhinorrhea), as well as improved the levels of laboratory outcomes (CRP, IL-6, Lym, and Neu). Additionally, the incidence of adverse reactions did not exhibit any statistically significant difference between SFJD + WM group and WM group. Conclusion: SFJD combined with WM seems more effective than WM alone for the treatment of COVID-19. However, more well-designed RCTs still are warranted. Systematic review registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42022306307].

Development of a core outcome set on Traditional Chinese Medicine and Western Medicine for rheumatic heart disease: a study protocol.

INTRODUCTION: Globally, rheumatic heart disease (RHD) is an important cause of acquired heart disease in children and adolescents. Clinical trials on RHD treatment with Traditional Chinese Medicine (TCM) or integrated medicine are gradually increasing in China. However, because the outcomes of clinical trials are subject to heterogeneity and selective reporting, similar studies cannot be merged and compared, complicating assessing the effectiveness and safety of TCM, and diminishing the value of clinical trials. Therefore, there is an urgent need to design a TCM or integrated medicine core outcome set (COS) for RHD. METHODS AND ANALYSIS: The development of this study will take place in four stages under the direction of a multidisciplinary advisory board. (1) Establishing a comprehensive outcomes checklist through a systematic review of previously published research, retrieval of clinical trial registration centres, patient's semistructured interviews, and clinician's questionnaire surveys; (2) Screen stakeholder groups from various fields to participate in the Delphi survey; (3) Two e-Delphi surveys will be conducted to determine the outcomes of various concerned stakeholder groups; (4) Hold a face-to-face consensus meeting to develop the COS-TCM-RHD. ETHICS AND DISSEMINATION: The ethical approval for this study has been obtained from the Tianjin University of Traditional Chinese Medicine Ethics Committee (TJUTCM-EC20210008). The findings will be disseminated in peer-reviewed journals and meetings. TRIAL REGISTRATION NUMBER: This study has been registered at the Core Outcome Measures in Effectiveness Trials (COMET) database (Registration #1743).

Traditional Chinese Medicine for COVID-19: A Network Meta-Analysis and Systematic Review.

To compare the efficacy of different traditional Chinese medicine (TCM) therapies for the treatment of coronavirus disease 2019 (COVID-19) and provide a higher level of evidence in the form of network meta-analysis (NMA) and systematic review. We searched the studies from the following databases: CNKI, VIP, WanFang, SinoMed, PubMed, Embase, and Web of Science from the establishment of the respective database until December 2021. Relevant studies were screened according to the pre-established inclusion criteria. The quality of the included randomized controlled trials (RCTs) and controlled clinical trials (CCTs) were assessed using the risk of bias (ROB) tool and the Methodological Index for Non-Randomized Studies (MINORS), respectively. R software 4.1.1 and Stata 13.1 were used for data analysis and mapping. A total of 34 studies were included in this network meta-analysis that tested 24 TCM interventions and included 3443 patients. Using cluster analysis of time to negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR), the length of hospital stay and composite events, we found that Jinyinhua oral liquid (JYH, 120 mL) + conventional Western medicine (CWM) has the highest SUCRA value at 88.64%, 85.61% and 84.24%. The traditional meta-analysis results revealed that Qingfei Paidu decoction + CWM were significantly different compared with CWM alone for the score of clinical symptoms (MD =-0.75, 95% CI [-1.04, -0.47]). Nine studies reported 57 adverse reactions (ADRs) and 3 adverse events (ADEs) in TCM + CWM groups, and eight studies reported 33 ADRs and 8 ADEs in CWM groups. In conclusion, the combination of TCM and CWM approaches may enhance the efficacy of CWM in COVID-19 patients. Based on the NMA result, JYH (120 mL) + CWM may be a more effective treatment and deserves further investigation. However, the differences in many comparisons between TCM interventions did not reach statistical significance; therefore, further high-quality studies are required to validate these findings.

[Network Meta-analysis of efficacy and safety of oral Chinese patent medicines combined with conventional western medicine in treatment of hypertension].

This study aims to systematically evaluate the effect of oral Chinese patent medicines on hypertension with network Meta-analysis. Randomized controlled trials on the treatment of hypertension with oral Chinese patent medicine combined with conventional western medicine were retrieved from China National Knowledge Infrastructure(CNKI), Wanfang, VIP, SinoMed, PubMed, EMbase, and Cochrane Library(from establishment of the database to August 2021). Two researchers independently screened the articles, extracted the data, and evaluated article quality. Then R 4.1.0 was employed for data analysis. Finally, 195 eligible articles were screened out, involving 22 546 patients and 18 oral Chinese patent medicines. The results of the network Meta-analysis are as follows. In terms of reducing systolic blood pressure(SBP) and diastolic blood pressure(DBP), Xuesaitong, Qiangli Dingxuan Tablets, Songling Xuemaikang Capsules combined with conventional western medicine are superior. In improving blood lipids, the overall effects of Xinmaitong Capsules, Compound Xueshuantong Capsules, Ginkgo Folium preparations, Yindan Xinnaotong Soft Capsules, and Naoxintong Capsules combined with conventional western medicine are outstanding. In terms of regulating endothelial function, Yindan Xinnaotong Soft Capsules, Xinmaitong Capsules, Zhenju Jiangya Tablets, Compound Danshen Dripping Pills, Xuesaitong with conventional western medicine have certain advantages. As for the safety, the incidence of adverse reactions of conventional western medicine combined with oral Chinese patent medicines is lower than that of conventional western medicine alone. In summary, compared with conventional western medicine alone, the 18 oral Chinese patent medicines combined with conventional western medicine in the treatment of hypertension show advantages in improving blood pressure, blood lipids, and endothelial function. Among them, Xuesaitong, Qiangli Dingxuan Tablets, and Songling Xuemaikang Capsules may be the best oral Chinese patent medicines for lowering blood pressure. The conclusion needs to be further verified by more high-quality studies.

[Clinical evidence analysis report of Chinese patent medicine in 2020].

The present study collected, collated, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine published in Chinese and English journals in 2020, and summarized clinical evidence of Chinese patent medicine in stages, providing references for follow-up clinical research and evidence transformation and application. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, and EMbase were searched for RCTs of Chinese patent medicine published in 2020, and their research characteristics and methodological quality were analyzed and evaluated. A total of 1 285 research papers on Chinese patent medicine(1 257 in Chinese/28 in English) were included, involving 146 054 patients and 639 Chinese patent medicines, including 526 oral drugs, 68 injections, and 45 external drugs. A total of 412 diseases in 23 types were involved, which were dominated by circulatory system diseases and respiratory system diseases, specifically, cerebral infarction and angina pectoris. The sample size ranged from 20 cases to 2 673 cases, and 57.67% of RCTs had samples sizes less than 100. Single-center trials were the main ones, and multi-center trials only accounted for 4.75%(n=61). In terms of methodological quality, 52.91% of the RCTs had unclear descriptions or incorrect application of randomization methods, and the implementation of allocation concealment and blinding methods has not been paid much attention. In conclusion, compared with the conditions in 2019, the number of RCTs published in 2020 has decreased, and the research interest in respiratory diseases has increased, while the quality control in the process of research design and implementation has not been improved. Therefore, it is necessary to strengthen the methodological training of researchers and promote the output of high-quality research evidence.

[Clinical trials and evaluation of Chinese patent medicine for heart failure].

The present study systematically collected, analyzed, and evaluated randomized controlled trial(RCT) of Chinese patent medicine in the treatment of heart failure to provide references for follow-up clinical research design, guideline update, and policy formulation, and promote the improvement of clinical evidence quality. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, VIP, Wanfang, SinoMed, PubMed, and Web of Science were searched for RCTs of Chinese patent medicine in the treatment of heart failure from database inception to December 31, 2020. The di-sease type, publication time, sample size, intervention/control setting, course of treatment, evaluation indexes, and methodological quality were analyzed and evaluated. A total of 1 631 RCTs were included, including 1 622 in Chinese and 9 in English. It was first published in 1995, with the largest number of publications in 2016. There were only 56 RCTs(3.43%) with a sample size≥200. Seventy-eight types of Chinese patent medicines were involved, including 49 types of oral drugs and 29 types of injections. There were 34 intervention/control protocols, which were dominated by Chinese patent medicine+conventional treatment vs conventional treatment, accounting for 28.51%(n=465). About 94.0% of RCTs reported the course of treatment, mainly 14-56 days. The evaluation indexes were mainly physical and chemical tests and symptoms/signs, and left ventricular ejection fraction(LVEF) was the most frequently used measurement index. In enumeration indexes, clinical efficacy(response rate) was used the most frequently. Methodologically, 92.0% of the research subjects were rated as high risk of blindness. There were only 13 RCTs(0.80%) reporting registered information. It is necessary to further standardize the design, implementation, and quality control of clinical studies in order to improve the quality of evidence and avoid research waste.

[Clinical trials and evaluation of Chinese patent medicine for stroke].

To systematically collect and analyze clinical randomized controlled trial(RCT) of Chinese patent medicine treatment for stroke in 2020, in order to provide basic information for clinical decision-making and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, EMbase were searched for RCTs of Chinese patent medicine for stroke in 2020. The publication, sample size, intervention and control measures, course of treatment, outcome indicators, methodological quality and other contents were statistically analyzed.A total of 68 RCTs studies on Chinese patent medicine for stroke were included in 2020, of which 29(42.60%) were RCTs with sample size>100 cases. A total of 41 kinds of proprietary Chinese medicines were involved, including 23 kinds of oral proprietary Chinese medicines and 18 kinds of injections. A total of 18 intervention/control cases were included in RCTs, and 19 cases(Chinese patent medicine+Western medicine vs Western medicine) were applied in RCTs, accounting for 27.90%. The duration of treatment was reported in 91.18% of the studies, and the intervention duration was 8-14 days in 50.00% of the studies. Evaluation indexes were widely used, among which physical and chemical testing indexes(49.36%) were the most widely used. According to the methodological quality evaluation, the overall methodological quality of the study is not high, especially the implementation of the allocation hidden, blind method is not accurate, and the registration, ethics and other links are often missing. In conclusion, 2020 implementation of proprietary Chinese medicine in the treatment of stroke research methodology problems is outstanding, the similar function scale large range of optional, no specification selection criteria, reliability and practicability of the impact study, need to further standardize the proprietary Chinese medicine in the treatment of stroke study design, implementation and quality control, and highlight the value of proprietary Chinese medicine in the treatment of stroke and improve the quality of the evidence.

[Clinical trials and evaluation of Chinese patent medicine for influenza].

The clinical randomized controlled trial(RCT) of Chinese patent medicine in the treatment of influenza were reviewed and analyzed to provide basic information for clinical decision and related research. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, VIP, SinoMed, EMbase, PubMed, and Cochrane Library were searched for RCTs of Chinese patent medicine for influenza published from database inception to July 25, 2021. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. Ninety-two RCTs of Chinese patent medicine for influenza published between 2005 and 2021, were included, among which 17 RCTs(18.48%) had a sample size higher than 200 and the average sample size was about 145. Twenty-seven Chinese patent medicines were involved, including twenty-one oral medicines and six injections. The Chinese patent medicines in trials reported in more than five papers included Lianhua Qingwen Capsules/Gra-nules, Tanreqing Injection, and Reduning Injection. Fourteen intervention protocols were reported, of which Chinese patent medicine+western medicine+conventional treatment vs western medicine+conventional treatment(20.65%) was the most frequently employed. Additionally, 85.87% of the RCTs reported the course of treatment, and 80.43% of the RCTs determined 3-7 d as the intervention course. Forty-five outcome indicators were extracted, which were used 434 times, including symptoms/signs, physicochemical detection, safety events, TCM symptoms/syndromes, quality of life, long-term prognosis, and economic evaluation. Symptoms/signs(61.52%) exhibited the highest frequency. Methodological problems were prevalent in the included trials. The findings reveal that there are few clinical trials on influenza treatment by Chinese patent medicine, and the methodological problems are prominent, affec-ting the reliability and practicability of the trials. In the future research, the value characteristics of Chinese patent medicine should be highlighted and the quality control in the whole process should be strengthened based on the scientific and rigorous design.

[Clinical trials and evaluation of Chinese patent medicine for chronic obstructive pulmonary disease].

The clinical randomized controlled trials(RCTs) of Chinese patent medicine in the treatment of chronic obstructive pulmonary disease(COPD) were reviewed and analyzed to provide references for clinical research, guideline development, policy formulation, and quality improvement of clinical evidence. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed, Cochrane Library, PubMed, EMbase were searched for RCTs of Chinese patent medicine for COPD as a source of clinical evidence from database inception to December 31, 2019. The publication time, sample size, intervention and control measures, course of treatment, outcome indicators, and methodological quality of the trials were analyzed and evaluated. A total of 733 RCTs of Chinese patent medicine for COPD were included, among which 228 RCTs had a sample size higher than 100, accounting for 31.1% of total RCTs. Eighty-eight Chinese patent medicines were involved, including 40 oral medicines and 48 injections. A total of 327 RCTs mentioned intervention and control measures(Chinese patent medicine + conventional treatment vs conventional treatment), accounting for 43.0%. In addition, 94.40% of the RCTs reported the course of treatment, and 53.20% of the RCTs determined 8-14 d as the intervention course. The evaluation indicators adopted were numerous, among which physicochemical indicators(70.57%) and symptoms/signs(24.35%) were the most frequently employed. The operation of allocation concealment and blinding was not standard. Registration and the procedure related to ethics were mostly missing. The results indicate that there are prominent methodological problems in the clinical trials of Chinese patent medicine in the treatment of COPD, affecting the reliability and practicability of the trials. It is necessary to further standardize the design, implementation, and quality control of clinical trials of Chinese patent medicine in the treatment of COPD, highlight the clinical value of Chinese patent medicine for COPD, and improve the quality of evidence.

[Clinical trials and evaluation of Chinese patent medicine for pneumonia].

The present study reviewed the clinical randomized controlled trials(RCTs) of Chinese patent medicine for pneumonia to provide references for clinical research, guideline development, and policy formulation, and promote the quality improvement of clinical evidence. On the basis of the collection in the Traditional Chinese Medicine(TCM) Clinical Evidence Database System(EVDS), CNKI, Wanfang, SinoMed were searched for RCTs of Chinese patent medicine for pneumonia from database inception to December 31, 2019. A total of 1 245 RCTs were included, involving 84 Chinese patent medicines, including 45 oral medicines and 39 injections. Specifically, 85.9% of RCTs had treatment course not exceeding 14 d; 43.3% of RCTs had a sample size of more than 100 cases and 6.1% of RCTs more than 200 cases; 13 types of interventions/controls were included in the RCTs, with Chinese patent medicine + western medicine vs western medicine as the top one used(32.6%). In outcome indicators, symptoms/signs(3 285) and physicochemical detection(2 066) were the most frequently applied. In the methodological evaluation, "allocation concealment" was not clearly described or mentioned in 71.2% of RCTs, and "blinding" in 23.9% of RCTs met the normative standards. Registration and research ethics were not clearly reported. There are many methodological deficiencies in terms of design and implementation in included RCTs, which may impact the reliability and practicability of the results of RCTs. Additionally, key standards were unclear(such as disease classification methods and selection of core outcome indicators). In conclusion, RCTs should give priority to the preciseness and scientificity of the protocol, strengthening quality control of the processes and accelerating the standardized research of key links.

[Analysis of outcome indexes in randomized controlled trials of traditional Chinese medicine for rheumatic heart disease].

The present study analyzed the efficacy evaluation indexes of the randomized controlled trials(RCTs) of Chinese medi-cine in the treatment of rheumatic heart disease to lay the foundation for the construction of the corresponding core outcome index set. Clinical RCTs with a definite diagnosis of rheumatic heart disease were retrieved from CNKI, Wanfang, VIP, Sino Med, Pub Med, EMbase, and Cochrane Library from January 1, 2010, to December 31, 2020. Thirty-five RCTs were included, involving 3 314 patients and 41 efficacy evaluation indexes, which covered seven domains [traditional Chinese medicine(TCM) symptoms/syndromes, symp-toms/signs, physical and chemical examination, quality of life, long-term prognosis, economic evaluation, and safety events]. Physi-cal and chemical examination(56. 91%) and symptoms/signs(29. 27%) were the more frequently applied. The number of indexes used in a single trial ranged from 1 to 15, with an average of 4. The measurement time points of the top five indexes in the frequency of use were as follows: total response rate was reported at five measurement time points, ranging from 14 days to 6 months; left ventri-cular ejection fraction was measured at eight time points ranging from 5 days to 6 months; left ventricular end systolic diameter was measured at six time points, ranging from 5 days to 6 months; interleukin-2(IL-2) and tumor necrosis factor-α(TNF-α) were repor-ted 28 days after treatment. At present, there are many problems in the efficacy outcome indexes of RCTs in the treatment of rheumatic heart disease with TCM, such as large difference in quantity, unclear primary and secondary indexes, unreasonable selection of " surro-gate indexes", insufficient attention to long-term prognostic indexes and safety event indexes, non-standard application of composite in-dexes, long measurement period, and lack of TCM characteristics. It is urgent to establish the core outcome set for TCM treatment of rheumatic heart disease.

Traditional Chinese medicine for promoting mental health of patients with COVID-19: a scoping review.

This study aimed to systematically review and depict the current studies of traditional Chinese medicine for the mental health of patients with coronavirus disease 2019 (COVID-19). Methods: A scoping review was conducted by searching PubMed, Web of Science, CNKI, Wanfang database, VIP database, and SinoMed, with the retrieval time being from the establishment of the database to April 18, 2022. The basic information of the included studies, objective, design, types of patients, interventions, outcomes, etc., was reviewed and summarized narratively. Methodological quality was assessed using the Cochrane Risk of Bias assessment tool, the methodological index for non-randomized studies or the Newcastle-Ottawa scale. Results: We identified 30 traditional Chinese medicine (TCM) studies from six databases. Among them, finished randomized controlled trials (n = 16) accounted for most of the studies, followed by single-arm studies (n = 9). In terms of study theme, 20 studies defined the mental health of patients with COVID-19 as the research theme. Psychological assessment was included in the inclusion criteria (performed before participation) of nine studies, whereas the other studies only mentioned the mental outcomes. TCM interventions included TCM exercises (Yijinjing, Baduanjin, Liuzijue, Taichi), acupoint stimulation (auricular and body points), moxibustion, decoction, or granules based on TCM syndrome differentiation, decoction, or granules with fixed formulae (Baidu Jieduan granules, Xuanfei Baidu decoction, and Qingfei Paidu decoction), Chinese patent medicine (Jinhua Qinggan granules), TCM psychological therapy (TCM ideological therapy, TCM five-tone therapy, and TCM psychological sand table), and TCM nursing (dialectical care, dialectical diet, and psychological counseling). Anxiety and depression were the main outcomes evaluated in regard to mental health in patients with COVID-19. The limitations of methodological quality were predominantly from follow-up, blinding, and registration. Positive results were reported by 27 studies (90%, n = 30). Conclusion: We summarized the existing literature about the impact of TCM on mental health in patients with COVID-19. The number of studies evaluating the impact of TCM on mental health is encouraging, but overall methodological quality was low. Several TCM interventions warrant further evaluation, particularly among populations outside of China, for the purpose of establishing supporting evidence. More importantly, research with stronger methodological quality needs to be developed. Graphical abstract: http://links.lww.com/AHM/A36.

Chinese Medical Injections for Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Network Meta-analysis.

BACKGROUND: The World Health Organization has indicated that chronic obstructive pulmonary disease (COPD) may become the third leading cause of death by 2030. Acute exacerbation of COPD (AECOPD) is an important process in clinical treatment. Recent studies have shown that Chinese medical injections (CMI) are effective against AECOPD, but the effective difference among different CMIs remains unclear. The aim of this network meta-analysis (NMA) is to compare the therapeutic effect of various CMIs. METHODS: We conducted an overall, systematic literature search in the China National Knowledge Infrastructure, Wanfang, VIP, SinoMed, PubMed, Embase, Cochrane Library, and Web of Science databases to retrieve randomized controlled trials (RCTs) of CMIs for AECOPD published up to January 2021. The Cochrane risk of bias tool was used to assess the risk of bias. Stata 13.1 and WinBUGS 14.3 were used for data analyses. RESULTS: In total, 103 RCTs involving 8767 participants and 23 CMIs were included. The results indicated that among all treatments conventional Western medical therapy (WM) plus Dengzhanxixin injection (DZXX) led to the best improvement in the clinical efficacy and the ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) (FEV1/FVC), with surface under the cumulative ranking curve (SUCRA)=80.47% and 98.55%, respectively. Moreover, Shenmai injection (SM) plus WM and Reduning injection (RDN) plus WM led to the best improvement in the FEV1 (SUCRA=80.18%) and the ratio of forced expiratory volume in one second to the predicted value (FEV1%, SUCRA=87.28%). Shengmai injection (SGM) plus WM led to the most considerable shortening in the length of hospital stay (SUCRA=94.70%). Cluster analysis revealed that WM+DZXX had the most favorable response for clinical efficacy and FEV1, as well as clinical efficacy and FEV1/FVC, WM+RDN had the most favorable response for clinical efficacy and FEV1%, WM+SGM had the most favorable response for clinical efficacy and length of hospital stay. CONCLUSION: WM+DZXX, WM+RDN, and WM+SGM were noted to be the optimum treatment regimens for improving in clinical efficacy, FEV1, FEV1/FVC, FEV1% and reducing the hospital stay length of AECOPD patients. Considering the limitations this NMA may have, the current results warrant further verification via additional high-quality studies.

[Systematic review and Meta-analysis of efficacy and safety of Yangxin Dingji Capsules in treatment of arrhythmia].

To systematically review the efficacy and safety of Yangxin Dingji Capsules in the treatment of arrhythmia. PubMed, EMbase, Cochrane Library, CNKI, VIP, CBM and Wanfang databases were electronically retrieved to collect randomized controlled trial(RCT) on the efficacy of Yangxin Dingji Capsules in the treatment of arrhythmia from the time of database establishment to October 20 th, 2020. Two reviewers independently screened out the literatures, input the data, and evaluated the literature quality of the included studies. RevMan 5.3 software was used for Meta-analysis. A total of 127 studies were retrieved, and 15 articles were included after screening, involving 1 371 cases, with 685 cases in the treatment group and 686 cases in the control group. Yangxin Dingji Capsules combined with anti-arrhythmia western medicine was adopted for intervention in the treatment group, while the patients in the control group were treated with the anti-arrhythmia western medicine alone. Meta-analysis results showed that in arrhythmia patients, the combination of Yangxin Dingji Capsules and conventional western medicine significantly increased the clinical efficacy(RR=1.23, 95%CI[1.17, 1.30], P<0.000 01)and left ventricular ejection fraction(MD=4.31, 95%CI[3.10, 5.52], P<0.000 01), reduced heart rate(MD=-3.79, 95%CI[-7.42,-0.15], P=0.04), left ventricular end-diastolic diameter(MD=-7.06, 95%CI[-11.91,-2.21],P=0.004), left ventricular end-systolic diameter(MD=-4.78, 95%CI[-6.63,-2.93],P<0.000 01), N-terminal B-type natriuretic peptide precursor(MD=-200.51, 95%CI[-254.52,-146.51], P<0.000 01)and high-sensitivity C-reactive protein(MD=-1.74, 95%CI[-3.23,-0.24], P=0.02), all with statistically significant differences. Compared with the control group, Yangxin Dingji Capsules had fewer adverse reactions(RR=0.53, 95%CI[0.36, 0.79], P=0.002). The existing evidences showed that Yangxin Dingji Capsules had certain effect in the treatment of arrhythmia, with a safety. However, due to the limitation in sample size, outcome measures and quality of the included studies, more high-quality studies are required to verify the above conclusion.

PROSPERO's systematic review protocols of traditional Chinese medicine for COVID-19: An overview.

BACKGROUND: A large number of protocols for Systematic Reviews (SR) of Traditional Chinese Medicine (TCM) for coronavirus disease 2019 (COVID-19) have been registered in the International Prospective Register of Systematic Reviews (PROSPERO). This study aimed to analyze the innovativeness and rigorousness of the SR protocols and make recommendations for the design and implementation of future SRs on TCM for COVID-19. This effort is likely to enhance the value of the produced information and prevent the futility of the research. METHODS: PROSPERO was searched comprehensively for identifying SRs of TCM for COVID-19 from the inception of the database to August 2020. Two researchers independently screened the literature, extracted the data, and cross-checked the retrieved information for consistency. The following details were recorded: database, registration time, organizations, types of research included, participants, interventions, and outcome measures. All extracted data were analyzed by an overview. The "P - participants, I - interventions, C - controls, and O - outcomes (PICO)" included in the protocols were compared for similarity. The outcomes of the included SR protocols were compared with the newly published Core Outcome Sets (COSs). RESULTS: A total of 80 protocols of SR related to TCM for COVID-19 were obtained after a primary search, and finally 71 protocols were included. The majority of the protocols were from China. Thirty-two organizations participated in the protocol registrations, including 11 hospitals and 21 universities/colleges. However, some protocols were not innovative or rigorous enough, as the PICO of some protocols were similar and non-specific, and the searched literature was incomprehensive. In addition, COS is not commonly adopted. CONCLUSIONS: Registering a protocol of SR is an effective way to ensure the usefulness of the produced information, and to avoid the duplication of research and the wastage of resources. In future SR protocols, it is important to focus on and solve the methodological problems such as non-specific PICO, incomprehensive literature retrieval, and improper outcome measures.

[Meta-analysis of clinical efficacy and safety of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in treatment of hypertensive left ventricular hypertrophy].

To systematically evaluate the clinical efficacy and safety of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy. China National Knowledge Infrastructure(CNKI), Wanfang, VIP, PubMed, EMbase, Cochrane Library, Ovid and Web of Science databases were searched by computer to retrieve the randomized controlled trials(RCTs) of Compound Danshen Dripping Pills combined with conventional antihypertensive drugs in the treatment of hypertensive left ventricular hypertrophy from the establishment of databases to July 2020. After two researchers performed data retrieval, data extraction, and risk assessment of bias, they used RevMan 5.3 software for Meta-analysis. A total of 10 RCTs were included, with a total of 979 patients. Meta-analysis results showed that in terms of interventricular septal thickness(MD=-0.70, 95%CI[-1.15,-0.24], P=0.003), left ventricular posterior wall thickness(MD=-0.81, 95%CI[-1.41,-0.21], P=0.008), left ventricular mass index(MD=-8.75, 95%CI[-17.40,-0.10], P=0.05), systolic blood pressure(MD=-8.97, 95%CI[-13.46,-4.48], P<0.000 1), diastolic blood pressure(MD=-5.87, 95%CI[-8.39,-3.34], P<0.000 01) and left ventricular end-diastolic diameter(MD=-1.73, 95%CI[-2.38,-1.08], P<0.000 01), Compound Danshen Dripping Pills combined with conventional antihypertensive drugs was superior to conventional antihypertensive drugs. In terms of left ventricular ejection fraction(MD=0.41, 95%CI[-0.74, 1.55], P=0.49), there was no statistical difference in treatment between the two groups. Because of the small amount of literatures included in the safety aspect, it is impossible to give an accurate conclusion. The GRADE score showed that the level of evidence was low and extremely low. The results show that the Compound Danshen Dripping Pills combined with conventional antihypertensive drugs may effectively improve the clinical efficacy for hypertensive ventricular hypertrophy, and the safety needs to be further explored. Due to the low quality of the included literatures, more high-quality RCTs are needed for verification.

[Research advancement: overview of system reviews of traditional Chinese medicine].

Currently, the quantity of clinic research, Meta-analysis and overview of traditional Chinese medicine(TCM) were advanced annually. The secondary researches can support to more evidential reference for clinic decision, policy design etc. Meanwhile, the need of expedite and valuable evidence was increasingly. This study was collected published overview of system review of TCM by CNKI, WanFang, VIP, SinoMed, PudMed, Cochrane Library and Ovid database. The characteristic data extraction were included: title, type of literature, author and nationality, published year, quantity of subject, quantity of original documents included, Chinese and English databases searched, type of disease, intervention, study result(positive/negative), adverse reaction, quality assessment tool, study limitation, level of evidence etc. Base these data above, to summarize the overview of system reviews of TCM by bibliometrics and overview analysis.