[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.

Traditional Chinese medicine diagnostic prediction model for holistic syndrome differentiation based on deep learning.

Background: With the development of traditional Chinese medicine (TCM) syndrome knowledge accumulation and artificial intelligence (AI), this study proposes a holistic TCM syndrome differentiation model for the classification prediction of multiple TCM syndromes based on deep learning and accelerates the construction of modern foundational TCM equipment. Methods: We searched publicly available TCM guidelines and textbooks for expert knowledge and validated these sources using ten-fold cross-validation. Based on the BERT and CNN models, with the classification constraints from TCM holistic syndrome differentiation, the TCM-BERT-CNN model was constructed, which completes the end-to-end TCM holistic syndrome text classification task through symptom input and syndrome output. We assessed the performance of the model using precision, recall, and F1 scores as evaluation metrics. Results: The TCM-BERT-CNN model had a higher precision (0.926), recall (0.9238), and F1 score (0.9247) than the BERT, TextCNN, LSTM RNN, and LSTM ATTENTION models and achieved superior results in model performance and predictive classification of most TCM syndromes. Symptom feature visualization demonstrated that the TCM-BERT-CNN model can effectively identify the correlation and characteristics of symptoms in different syndromes with a strong correlation, which conforms to the diagnostic characteristics of TCM syndromes. Conclusions: The TCM-BERT-CNN model proposed in this study is in accordance with the TCM diagnostic characteristics of holistic syndrome differentiation and can effectively complete diagnostic prediction tasks for various TCM syndromes. The results of this study provide new insights into the development of deep learning models for holistic syndrome differentiation in TCM.

Expert consensus on the use of traditional Chinese medicine for the treatment of common symptoms of post-COVID-19 short-term condition.

A proportion of patients who recovered from COVID-19 have ongoing, recurrent, or new symptoms with negative nucleic acid/antigen test results, which has become a new public health problem that needs to be concerned. Traditional Chinese medicine (TCM) has shown its unique advantages in preventing, treating, and rehabilitating COVID-19. To further standardize clinician's clinical diagnosis and use of TCM for the treatment of common symptoms associated with COVID-19 infection following negative nucleic acid/antigen results, the front-line clinical experts were invited for discussion on the concepts, etiology, clinical manifestations of post-COVID-19 condition, and on treatment with TCM to form the consensus. Clinicians of TCM, Western medicine, or integration of both can use this consensus document for clinical practice and research purposes.

The role and advantage of traditional Chinese medicine in the prevention and treatment of COVID-19.

The global coronavirus disease 2019 (COVID-19) pandemic has had a massive impact on global social and economic development and human health. By combining traditional Chinese medicine (TCM) with modern medicine, the Chinese government has protected public health by supporting all phases of COVID-19 prevention and treatment, including community prevention, clinical treatment, control of disease progression, and promotion of recovery. Modern medicine focuses on viruses, while TCM focuses on differential diagnosis of patterns associated with viral infection of the body and recommends the use of TCM decoctions for differential treatment. This differential diagnosis and treatment approach, with its profoundly empirical nature and holistic view, endows TCM with an accessibility advantage and high application value for dealing with COVID-19. Here, we summarize the advantage of and evidence for TCM use in COVID-19 prevention and treatment to draw attention to the scientific value and accessibility advantage of TCM and to promote the use of TCM in response to public health emergencies. Please cite this article as: Huang M, Liu YY, Xiong K, Yang FW, Jin XY, Wang ZQ, Zhang JH, Zhang BL. The role and advantage of traditional Chinese medicine in the prevention and treatment of COVID-19. J Integr Med. 2023; 21(5): 407-412.

Meta-Analysis of the Effect of Honghua Injection in the Treatment of Coronary Heart Disease Angina Pectoris.

Objective: To evaluate the effectiveness of honghua injection combined with western medicine in the treatment of coronary heart disease angina pectoris. Methods: Computer extensively searched PubMed, Cochrane Library, Embase, China Biomedical Archives (SinoMed), China Knowledge Network (CNKI), Chinese Journal Full-text Database (VIP), Wanfang Data Knowledge Service Platform (Wanfang), and collected randomized controlled trials (RCTs) of honghua injection combined with western medicine in the treatment of coronary heart disease angina pectoris. Use Review Manager5.3 software for meta-analysis. Results: 21 RCTs were included, involving 1894 participants. Meta-analysis shows that honghua injection combined with western medicine can significantly improve the clinical efficacy (OR = 4.03, 95% CI[2.96,5.49]), electrocardiographic efficacy (OR = 3.39, 95%CI[2.44, 4.70]), can significantly reduce total cholesterol (TC) levels (MD = -0.39, 95% CI[-0.47, -0.31]), triacylglycerol (TG) levels (MD = -0.45, 95% CI[-0.51, -0.39]), increase high-density lipoprotein cholesterol (HDL-C) levels (MD = 0.29,95%CI[0.26,0.32]), reduce low-density lipoprotein Cholesterol (LDL-C) levels (MD = -0.59, 95%CI[-0.79, -0.38]). Five articles reported adverse reactions. Conclusion: Honghua injection combined with western medicine is more effective than western medicine alone in patients with coronary heart disease angina pectoris. More multicenter, large sample, high-quality RCTs are needed to provide evidence.

[Systematic evaluation on efficacy and safety of Gingko Ketone Ester Dropping Pills in treatment of angina pectoris and coronary heart disease].

To systemically evaluate the efficacy and safety of Gingko Ketone Ester Dropping Pills in treating angina pectoris and co-ronary heart disease. CNKI, Wanfang, SinoMed, PubMed, Cochrane Library and EMbase databases were retrieved on computer, and the randomized clinical trial(RCT) on Gingko Ketone Ester Dropping Pills in treating angina pectoris and coronary heart disease, which were published from the database establishment to December 31, 2019, were comprehensively collected. Literature screening, data extraction and quality evaluation were conducted independently by two researchers according to inclusion and exclusion criteria. Literature methodology quality evaluation was conducted with use of the Cochrane Handbook 5.3.0(bias risk assessment tool). Meta-analysis was performed with RevMan 5.3.0 software. A total of 10 RCTs were included. The results of the Meta-analysis showed that as compared with conventional Western medicine alone, the application of Gingko Ketone Ester Dropping Pills combined with conventional Western medicine treatment further improved the total effective rate and electrocardiogram effect(RR=1.43,95%CI[1.20,1.71],P<0.000 1). There were statistically significant differences in the number of angina attacks, the duration of angina and the amount of nitroglycerin used. In terms of safety indicators, four studies reported adverse reactions in the experimental group, including facial flu-shing, tachycardia, dizziness, dyspnea, nausea and other symptoms. Based on the existing findings, in the treatment of angina pectoris and coronary heart disease, Gingko Ketone Ester Dropping Pills combined with conventional Western medicine can improve the clinical total effective rate, electrocardiogram effect, number of angina attacks, duration of angina and the amount of nitroglycerin used. However, in the included studies, due to some methodological quality problems which would impact the reliability of literature results more high-quality randomized controlled trials are still needed for further verification.

[Differential analysis of different study types in clinical safety evaluation of Xuebijing Injection].

This study aimed to comprehensively analyze and compare the differences of different clinical study types currently published in the safety evaluation of Xuebijing Injection. Six databases, namely the Cochrane Library, PubMed, EMbase, CNKI, VIP and Wanfang database, were electronically retrieved to collect all types of studies on the safety of Xuebijing Injection, including randomized controlled trials, case-controlled studies, cohort studies, systematic reviews, and centralized monitoring studies of clinical safety(hospital), in order to comprehensively and objectively evaluate the safety of Xuebijing Injection, and analyze the differences of different research results. A total of 211 literatures were included, involving a total of 46 384 patients treated with Xuebijing Injection, and 423 adverse reactions(ADRs) occurred. They included 191 randomized controlled trials, 3 cohort studies, 15 systematic reviews, and 2 centralized monitoring studies of clinical safety(hospital), and the incidence of adverse reactions was 2.54%(common), 2.31%(common), 0.95%(occasionally), and 0.50%(occasionally). More than half of the 423 cases of ADRs occurred in skin and adnexal system(151 cases) and gastrointestinal system(65 cases), including such manifestations as rash, skin itching, nausea and vomiting, diarrhea. The degree of ADRs was mild. Randomized controlled trials showed that the incidence of ADR was the highest when Xuebijing Injection was used for malignant tumor and multiple organ failure. And the systematic evaluation showed that the incidence of ADR was the highest when Xuebijing Injection was used for spontaneous peritonitis of liver cirrhosis. In conclusion, different study types could lead to significant differences in the results of drug safety evaluation. Sample size, study type, and quality control are the main factors for biased results. Due to large sample size and high-quality, centralized monitoring studies become the better clinical safety evaluation model of drugs at present, and full life cycle management could more objectively reflect drug safety and guide clinical rational drug use.

[Systematic review of efficacy and safety of Compound Danshen Injection combined with Western medicine in treatment of vascular dementia].

To evaluate the efficacy and safety of Compound Danshen Injection combined with Western medicine in the treatment of vascular dementia. Databases of Cochrane Library, PubMed, EMbase, CNKI, SinoMed, VIP, Wanfang Data were electronically retrieved for collecting randomized controlled trial(RCT)about vascular dementia treated with Western medicine alone or combined with Compound Danshen Injection from the year of database establishment to January 2020. Two researchers independently screened out li-teratures, extracted data, and evaluated the risk of bias for inclusion in the study. Meta-analysis was conducted using RevMan 5.3 software. A total of 5 RCTs were included, involving 588 patients, with 299 in treatment group and 289 in control group. Meta-analysis results showed that compared with Western medicine alone, Compound Danshen Injection combined with Western medicine was better in the effective rate(RR=1.23,95%CI[1.14,1.33],P<0.000 01), MMSE score(MD=3.54,95%CI[3.01,4.06],P<0.000 01), ADL score(MD=11.49,95%CI[8.05,14.93],P<0.000 01), the level of CRP(MD=-0.72,95%CI[-1.25,-0.20],P=0.007) and the level of IL-6(MD=-7.64,95%CI[-9.65,-5.63],P<0.000 01). Adverse reactions mainly included rash and skin prick, which did not affect the treatment effect. Based on the findings, the combination of Compound Danshen Injection in the treatment of vascular dementia could improve the effective rates, relieve the mental state damage and improve the daily living ability, with mild adverse reactions and a low incidence. However, due to the low quality of the included literatures, high-quality and large-scale randomized controlled trials are needed for further verification.

Evidence for the medicinal value of Squama Manitis (pangolin scale): A systematic review.

BACKGROUND: Squama Manitis (pangolin scale) has been used in traditional Chinese medicine for thousands of years. However, its efficacy has not been systematically reviewed. This review aims to fill the gap. METHODS: We searched six electronic databases including PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure Database (CNKI), WanFang Database and SinoMed from inception to May 1, 2020. Search terms included "pangolin", "Squama Manitis", "Manis crassicaudata", "Manis javanica", "Malayan pangolins", "Manis pentadactyla", "Ling Li", "Chuan Shan Jia", "Shan Jia", "Pao Jia Zhu", "Jia Pian" and "Pao Shan Jia". The Cochrane Risk of Bias (RoB) assessment tool and Newcastle-Ottawa Scale (NOS) were used to evaluate the risk of bias of the included randomized controlled trials (RCTs) and case control studies (CCSs). RESULTS: After screening, 15 articles that met the inclusion criteria were finally included. There were 4 randomized controlled trials, 1 case control study, 3 case series and 7 case reports. A total of 15 different diseases were reported in these studies, thus the data could not be merged to generate powerful results. Two RCTs suggested that Squama Manitis combined with herbal decoction or antibiotics could bring additional benifit for treating postpartum hypogalactia and mesenteric lymphadenitis. However, this result was not reliable due to low methodological quality and irrational outcomes. The other two RCTs generated negative results. All the non-RCTs did not add any valuable evidence to the efficacy of Squama Manitis beacause of small samples, incomplete records, non-standardized outcome detection. In general, currently available evidence cannot support the clinical use of Squama Manitis. CONCLUSION: There is no reliable evidence that Squama Manitis has special medicinal value. The removal of Squama Manitis from Pharmacopoeia is rational.

Chinese medical drugs for coronavirus disease 2019: A systematic review and meta-analysis.

BACKGROUND: Integration of Chinese medical drugs (CMD) and western medicine (WM) has been widely used in the treatment of Coronavirus Disease 2019 (COVID-19). This systematic review aimed to evaluate the efficacy and safety of CMD for COVID-19. METHOD: A literature search was performed in six databases from injection to June 2020. Both randomized controlled trials (RCTs) and quasi-RCTs were considered as eligible. The quality of included RCTs were assessed by Cochrane Risk of Bias Tool, and Review Manager 5.3 software was used to do meta-analysis. RESULT: Eleven studies with 1259 patients were included in this study. CMD included herbal decoction and Chinese patent medicine. The methodological quality was evaluated as generally unclear. The results of meta-analysis showed that the integration of CMD and WM had better efficacy than WM in number of patients turned to severe and critical type (RR = 0.47, 95% CI=[0.32, 0.69], P < 0.0001), length of hospital stay (MD= -7.95, 95% CI=[-14.66, -1.24], P = 0.02), defervescence time (MD= -1.20, 95% CI=[-2.03, -0.38], P = 0.004), cough resolution rate (RR = 1.37, 95% CI=[1.15, 1.64], P = 0.0004), fatigue resolution rate (RR = 1.37, 95% CI=[1.02, 1.83], P = 0.04), and tachypnea resolution rate (RR = 2.20, 95% CI=[1.11, 4.39], P = 0.02). As for safety, there was no significant difference between two groups. CONCLUSION: CMD may bring potential benefit to patients suffered from COVID-19. However, the quality of included trials is not good enough. High quality study with core outcome set are still required.

Bibliometric analysis of researches on traditional Chinese medicine for coronavirus disease 2019 (COVID-19).

BACKGROUND: The coronavirus disease 2019 (COVID-19) has caused a worldwide pandemic, and traditional Chinese medicine (TCM) has played an important role in response. We aimed to analyze the published literature on TCM for COVID-19, and provide reference for later research. METHODS: This study searched the CBM, CNKI, PubMed, and EMBASE from its establishment to March 11, 2020. VOSviewer 1.6.11 and gCLUTO 2.0 software were used to visually analyze the included studies. RESULTS: A total of 309 studies were included, including 61 journals, 1441 authors, 277 institutions, and 27 provinces. Research collaborations among regions were among those close in geographical distance. The collaborations of institutions and authors were more likely to be restricted to the same region. Among the authors with frequency greater than two (65 authors), only 19 authors had connection with others. More than 70% (358/491) of keywords were only presented once, and 20 keywords were shown more than 10 times. Five research topics were identified: Data mining method based analysis on the medication law of Chinese medicine in prevention and management of COVID-19; exploration of active compounds of Chinese medicine for COVID-19 treatment based on network pharmacology and molecular docking; expert consensus and interpretation of COVID-19 treatment; research on the etiology and pathogenesis of COVID-19; and clinical research of TCM for COVID-19 treatment. CONCLUSION: The research hotspots were scattered, and the collaboration between authors and institutions needed to be further strengthened. To improve the quality and efficiency of research output, the integration of scientific research and resources, as well as scientific collaboration are needed.

[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.

Core Outcome Set for Clinical Trials on Coronavirus Disease 2019 (COS-COVID).

Since its outbreak in December 2019, a series of clinical trials on coronavirus disease 2019 (COVID-19) have been registered or carried out. However, the significant heterogeneity and less critical outcomes of such trials may be leading to a waste of research resources. This study aimed to develop a core outcome set (COS) for clinical trials on COVID-19 in order to tackle the outcome issues. The study was conducted according to the Core Outcome Measures in Effectiveness Trials (COMET) Handbook: Version 1.0, a guideline for COS development. A research group was set up that included experts in respiratory and critical medicine, traditional Chinese medicine (TCM), evidence-based medicine, clinical pharmacology, and statistics, in addition to medical journal editors. Clinical trial registry websites (www.chictr.org.cn and clinicaltrials.gov) were searched to retrieve clinical trial protocols and outcomes in order to form an outcome pool. A total of 78 clinical trial protocols on COVID-19 were included and 259 outcomes were collected. After standardization, 132 outcomes were identified within seven different categories, of which 58 were selected to develop a preliminary outcome list for further consensus. After two rounds of Delphi survey and one consensus meeting, the most important outcomes for the different clinical classifications of COVID-19 were identified and determined to constitute the COS for clinical trials on COVID-19 (COS-COVID). The COS-COVID includes one outcome for the mild type (time to 2019 novel coronavirus (2019-nCoV) reverse transcription-polymerase chain reaction (RT-PCR) negativity), four outcomes for the ordinary type (length of hospital stay, composite events, score of clinical symptoms, and time to 2019-nCoV RT-PCR negativity), five outcomes for the severe type (composite events, length of hospital stay, arterial oxygen partial pressure (PaO2)/fraction of inspired oxygen (FiO2), duration of mechanical ventilation, and time to 2019-nCoV RT-PCR negativity), one outcome for critical type (all-cause mortality), and one outcome for rehabilitation period (pulmonary function). The COS-COVID is currently the most valuable and practical clinical outcome set for the evaluation of intervention effect, and is useful for evidence assessment and decision-making. With a deepening understanding of COVID-19 and application feedback, the COS-COVID should be continuously updated.

[Analysis on clinical study protocols of traditional Chinese medicine for coronavirus disease 2019].

To analyze the registered clinical trial protocols of traditional Chinese medicine(TCM) for the prevention and treatment of coronavirus disease 2019(COVID-19), in order to provide information for improving the quality of research design. The website of the Chinese Clinical Trial Registry(www.chictr.org.cn) and the American Clinical Trial Registry(clinicaltrials.gov) were searched to collect protocols of TCM for COVID-19. Documents were screened following the inclusion criteria, and data were extracted in regard to registration date, study objective, type of design, sponsor, patient, sample size, intervention, and evaluation index. Descriptive analysis was conducted. A total of 49 clinical trial protocols of TCM for COVID-19 were included. Primary sponsors were mainly hospitals or universities in places like Hubei, Beijing, Zhejiang and other regions. The implementation units are mainly in Hubei, Guangdong, Zhejiang, Henan and other regional hospitals. The types of study design were mainly experimental studies(40), including 30 randomized parallel controlled trials, 7 non-randomized controlled trials, 2 single arm trials and 1 consecutively recruited trial; besides, there were also 6 observational studies, 2 health service studies and 1 preventive study. The sample size reached a total of 30 562 cases, with a maximum of 20 000 for a single study and a minimum of 30. The 49 trials subjects included healthy people(3), isolation and observation cases(1), suspected cases(10),confirmed COVID-19 patients(31) and COVID-19 recovery patients(4). Of the 31 trials planned to include confirmed COVID-19 patients, 16 protocols no definite disease classification, 3 with a clear exclusion of severe subjects, 4 with common subjects, 2 with light, common or severe subjects, 1 with light and common subjects, 1 with common or severe subjects, 3 with severe subjects, and 1 with severe or critical subjects. The experimental interventions included Chinese patent medicine(Lianhua Qingwen Capsules/Granules, Huoxiang Zhengqi Dropping Pills/Oral Liquid, Babao Dan, Gubiao Jiedu Ling, Jinhao Jiere Granules, Compound Yu-xingcao Mixture, Jinye Baidu Granules, Shufeng Jiedu Capsuless, Shuanghuanglian Oral Liquid, Tanreqing Injection, Xuebijing Injection, Reduning Injection, Xiyanping Injection), Chinese medicinal decoction and taichi. The primary evaluation outcomes mainly included antipyretic time, clinical symptom relief, novel coronavirus nucleic acid turning to negative, conversion rate of severe cases and chest CT. There was a quick response of clinical research on the prevention and treatment of COVID-19 with TCM, with the current registered protocols covers the whole process of disease prevention, treatment and rehabilitation. However, issues need to be concerned, including unclear definition of patient's condition, unclear research objectives, unclear intervention process and inappropriate outcomes, etc. In addition, researchers should consider the actual difficulties and workload of doctors in epidemic response environment, and make effort to optimize the process and improve the operability of research protocols under the principle of medical ethics.

[Analysis on pattern of prescriptions and syndromes of traditional Chinese medicine for prevention and treatment of COVID-19].

To investigate the regularity of prescription and clinical syndromes by analyzing the diagnosis and treatment protocols of traditional Chinese medicine(TCM) for coronavirus disease 2019(COVID-19), so as to provide references for syndrome differentiation and relevant researches. The diagnosis and treatment protocols of COVID-19 published by national and regional health authorities were searched, and information was extracted in regard to disease stages, type of syndromes, and prescriptions, etc. Frequency statistics and relative analysis were used to analyze the rule of syndrome differentiation and prescription with TCM, and further discussion on the pathogenesis and progress of the disease. A total of 26 diagnosis and treatment protocols of TCM for COVID-19 were retrieved after screening(including 1 national scheme and 25 regional ones), among which 16 contained aspects of both prevention and treatment, 7 only involved treatment contents and 3 were prevention schemes. The courses of COVID-19 can be divided into early stage, middle stage, severe stage and recovery stage. The pathogeny of COVID-19 in TCM is damp-toxin, with the core pathogenesis of damp-toxin retention in lung and Qi repression. Its pathological features can be summarized as "damp, toxin, obstruction, deficiency". The location of the disease is lung, always involving spleen and stomach, and may further affect heart and kidney in severe cases. The major treatments for each course are Fanghua Shizuo, Xuanfei Touxie(early stage); Qingre Jiedu, Xuanxie Feire(middle stage); Kaibi Gutuo, Huiyang Jiuni(severe stage); Qingjie Yure, Yiqi Yangyin(recovery stage). There were many diagnosis and treatment protocols for COVID-19 have been published, which generally followed the national edition, through with certain personalities in different regional protocols. There were common features with respect to the disease stage, syndrome differentiation, therapeutic principles and methods, as well as prescriptions; the treatment were generally carried out against the core pathogenesis and progress of the disease. Along with the deepening recognition of COVID-19, the diagnosis and treatment protocols are still need further concretization and standardization. We hope researchers and decision-makers can pay more attention to the treatment of Huayu Tongluo in severe and recovery period.

[Tongmai Yangxin Pills in treatment for angina pectoris of coronary heart disease: a systematic review of randomized clinical trails].

To systematically review the efficacy and safety of Tongmai Yangxin Pills in treatment for angina pectoris of coronary heart disease. CNKI, WanFang, VIP, SinoMed, PubMed, EMbase and the Cochrane Library databases were retrieved online to collect randomized controlled trials(RCTs) of Tongmai Yangxin Pills for angina pectoris of coronary heart disease since the establishment to November 2018. Two investigators screened out literatures independently, extracted data and assessed the risk of bias of included studies. The risk assessment of included references was made according to criteria recommended by Cochrane Handbook 5.3. Meta-analysis was then performed by RevMan 5.3 software. A total of 9 RCTs were included. The results of Meta-analysis showed that compared with the single application of chemotherapy, the combined administration with Tongmai Yangxin Pills and Western medicine could significantly improve the clinical efficacy of angina(RR=1.22, 95%CI[1.13, 1.31]), the improvement rate of electrocardiogram(RR=1.31, 95%CI[1.21, 1.42]), and the clinical efficacy of traditional Chinese medicine(TCM) syndrome(RR=1.17, 95%CI[1.02, 1.35]). Only one study reported adverse events, while 5 studies reported no adverse event. According to current evidences, in the treatment of angina pectoris of coronary heart disease, Tongmai Yangxin Pills has a better clinical efficacy in the treatment of angina pectoris of coronary heart disease in terms of the improvement rate of electrocardiogram and the clinical efficacy of TCM syndrome. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.

[Network Meta-analysis of Yiqi Huoxue Chinese patent medicine for coronary heart disease with angina pectoris].

To assess the clinical efficacy of Yiqi Huoxue Chinese patent medicine for coronary heart disease with angina pectoris by using network Meta-analysis method. The relative randomized controlled trials( RCTs) of Yiqi Huoxue Chinese patent medicine for coronary heart disease with angina pectoris were retrieved from China National Knowledge Infrastructure( CNKI),Wan Fang,VIP and Chinese Biomedical Literature Database( CBM) in July 2018. Two researchers independently completed the literature screening,data extraction and quality evaluation according to the pre-determined inclusion and exclusion criteria,and the results were cross-checked.The data were analyzed by Win Bugs,and STATA software was used for plotting. Finally,114 RCTs were included,involving 7 Yiqi Huoxue Chinese patent medicines and 11 775 patients. Network Meta-analysis showed that the total effective rate for improvement in AP symptoms had 7 direct comparisons and 21 indirect comparisons,8 of which were statistically significant. The ECG improvement had 7 direct comparisons and 21 indirect comparisons,7 of which were statistically significant. In terms of the total effective rate of improvement in AP symptoms,the order of efficacy was as follows: Shensong Yangxin Capsules > Shexiang Baoxin Pills > Qishen Yiqi Dropping Pills > Tongxinluo Capsules > Wenxin Granules > Qishen Capsules > Naoxintong Capsules. In terms of ECG improvement,the order of efficacy was as follows: Shexiang Baoxin Pills > Tongxinluo Capsules > Naoxintong Capsules > Qishen Yiqi Dropping Pills> Wenxin Granules > Shensong Yangxin Capsules > Qishen Capsules. The results showed that Shensong Yangxin Capsules and Shexiang Baoxin Pills had certain advantages in the treatment of coronary heart disease with angina pectoris. Due to the small sample size,more studies were required to further verify the evidences.

Efficacy and Safety of Berberine Alone or Combined with Statins for the Treatment of Hyperlipidemia: A Systematic Review and Meta-Analysis of Randomized Controlled Clinical Trials.

To systematically evaluate the efficacy and safety of berberine for the treatment of hyperlipidemia, six electronic literature databases including SinoMed, CNKI, WanFang Data, PubMed, Embase and The Cochrane Library were searched to collect clinical randomized controlled trials (RCTs) of berberine alone or combined with statins for the treatment of hyperlipidemia from the inception to 8 March 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included RCTs. Then, meta-analysis was performed by using RevMan 5.3 software. A total of 11 RCTs involving 1386 patients were finally included. The results of meta-analysis showed that compared with the placebo group, berberine could significantly reduce the total cholesterol and low-density lipoprotein levels and elevate the high density lipoprotein level ( P<0.05 ). Compared with the simvastatin group, berberine was effective only in reducing the level of triglyceride ( MD=-0.37 , 95% CI: - 0.66, - 0.07, P=0.02 ). There, however, was no statistical significance between the BBR group and simvastatin group in the low density lipoprotein and high density lipoprotein levels. Compared with the simvastatin group, berberine plus simvastatin was more effective in reducing the level of triglyceride ( MD=-0.33 , 95% CI: - 0.46, - 0.20, P<0.00001 ) and total cholesterol ( MD=-0.36 , 95% CI: - 0.60, - 0.12, P=0.003 ). In terms of adverse reactions, the incidence of adverse reactions including transaminase elevation and muscle aches was lower in the berberine alone or combined with simvastatin group than that in the control group, while the instance of constipation was higher. This study suggests that berberine is effective for hyperlipidemia. The quality and quantity of included studies, however, were dissatisfactory, which might decrease the reliability of the results. Higher quality studies are needed to provide more high quality evidence.

Assessing the methodological and reporting quality of network meta-analyses in Chinese medicine.

BACKGROUND: An increasing number of network meta-analyses (NMAs) in traditional Chinese medicine (TCM) have been published recently, but the quality of them was lack of assessment. This study aims to evaluate the methodological and reporting quality of NMAs in TCM. METHODS: Six electronic databases, including PubMed, the Cochrane Central Register of Controlled Trials (CENTRAL), Embase, China National Knowledge Infrastructure (CNKI), Wanfang and Chinese Biomedical Literature Database (CBM) from inception to January 2018, were searched. NMAs of TCM were included. A measurement tool to assess the methodological quality of systematic reviews (AMSTAR) and the PRISMA Extension Statement for Reporting of Systematic Reviews Incorporating Network Meta-analyses of Health Care Interventions (PRISMA-NMA) were used to assess the methodological and reporting quality of the included NMAs. RESULTS: A total of 40 NMAs, including 2535 randomized controlled trials (RCTs), were included. They were published between December 2012 and November 2017. The median score and interquartile range of methodological and reporting quality was 7 (6-8) and 22 (19.1-27.1). Serious methodological flaws existed in the following aspects: the status of publication (22.5%), a list of studies provided (0%), assessment of publication bias (37.5%), and conflicts of interest (12.5%). Several items need to be improved in reporting, especially for Protocol and registration (2.5%), Data items (22.5%), Risk of bias across studies (Methods section) (37.5%), Results of individual studies (27.5%), Risk of bias across studies (Results section) (40%), Results of additional analyses (35%), and Funding (15%). CONCLUSIONS: The methodological and reporting quality of NMAs in TCM is moderate. Identified shortcomings of published NMAs should be taken into consideration in further trainings of authors and editors of NMAs in TCM. Future researchers should be encouraged to apply PRISMA-NMA, and a recognized tool for the assessment of NMA methodology was wanted.

[Chinese patent medicines with function of resolving hard lump for cyclomastopathy: network Meta-analysis].

This systematic review aims to systematically evaluate the efficacy and safety of Chinese patent medicines with resolving hard lump function for the treatment of cyclomastopathy. We searched CNKI, WanFang, SinoMed, PubMed, EMbase, and The Cochrane Library from the inception to January 3 2018, to collect the randomized controlled trials（RCTs）on Chinese patent medicines with resolving hard lump function in treating cyclomastopathy. Two reviewers independently screened literature, extracted data and assessed the methodological quality of included studies. Then, statistical analysis was performed by using Stata 12.0 and WinBUGS 1.4.3 software. A total of 52 RCTs involving 9 605 patients were finally included. The inventions included 11 commercial Chinese patent medicines with functions of resolving hard lump, such as Rupi Sanjie Capsules, Xiaoru Sanjie Capsules, Ruhe Sanjie Pills, and Hongjin Xiaojie Capsules. The result of direct Meta-analysis showed that: as compared with the simple western medicine group, the Chinese patent medicines such as Hongjin Xiaojie Capsules, Ruhe Sanjie Pills, Rupi Sanjie Capsules, Xiaoru Sanjie Capsules and Xiakucao Oral Liquid could significantly improve the clinical efficacy. In addition, the incidence of adverse reactions of Chinese patent medicines with resolving hard lump function was lower than that in Western medicine group in gastrointestinal reactions, menstrual disorders, leucorrhea abnormalities, liver dysfunction and estrogen-like effect. The network Meta-analysis showed that: Xiaoru Sanjie Capsules, Ruhe Sanjie Pills, Yanlu Rukang Capsules, Quyu Sanjie Capsules, and Hongjin Xiaojie Capsules were the top five in terms of treatment effect. Chinese patent medicines with resolving hard lump function had better clinical efficacy. Due to the low quality of included studies， more high quality RCTs are needed to verify the above conclusion.