Analysis of clinical evidence on traditional Chinese medicine for the treatment of diabetic nephropathy: a comprehensive review with evidence mapping.

Objective: This study aims to map evidence from Randomized Controlled Trials (RCTs) and systematic reviews/Meta-analyses concerning the treatment of Diabetic Nephropathy (DN) with Traditional Chinese Medicine (TCM), understand the distribution of evidence in this field, and summarize the efficacy and existing problems of TCM in treating DN. The intention is to provide evidence-based data for TCM in preventing and treating DN and to offer a reference for defining future research directions. Methods: Comprehensive searches of major databases were performed, spanning from January 2016 to May 2023, to include clinical RCTs and systematic reviews/Meta-analyses of TCM in treating DN. The analysis encompasses the publishing trend of clinical studies, the staging of research subjects, TCM syndrome differentiation, study scale, intervention plans, and outcome indicators. Methodological quality of systematic reviews was evaluated using the AMSTAR (Assessment of Multiple Systematic Reviews) checklist, and evidence distribution characteristics were analyzed using a combination of text and charts. Results: A total of 1926 RCTs and 110 systematic reviews/Meta-analyses were included. The majority of studies focused on stage III DN, with Qi-Yin deficiency being the predominant syndrome type, and sample sizes most commonly ranging from 60 to 100. The TCM intervention durations were primarily between 12-24 weeks. Therapeutic measures mainly consisted of Chinese herbal decoctions and patented Chinese medicines, with a substantial focus on clinical efficacy rate, TCM symptomatology, and renal function indicators, while attention to quality of life, dosage of Western medicine, and disease progression was inadequate. Systematic reviews mostly scored between 5 and 8 on the AMSTAR scale, and evidence from 94 studies indicated potential positive effects. Conclusion: DN represents a significant health challenge, particularly for the elderly, with TCM showing promise in symptom alleviation and renal protection. Yet, the field is marred by research inconsistencies and methodological shortcomings. Future investigations should prioritize the development of standardized outcome sets tailored to DN, carefully select evaluation indicators that reflect TCM's unique intervention strategies, and aim to improve the robustness of clinical evidence. Emphasizing TCM's foundational theories while incorporating advanced scientific technologies will be essential for innovating research methodologies and uncovering the mechanisms underlying TCM's efficacy in DN management.

Evidence mapping of traditional Chinese medicine in diabetic peripheral neuropathy treatment.

Objective: Diabetic peripheral neuropathy (DPN) stands as a crucial complication of diabetes, significantly affecting patients' quality of life. This study aims to elucidate the evidence distribution from clinical randomized controlled trials (RCTs) on DPN treatment with traditional Chinese medicine (TCM) through evidence mapping. Methods: A comprehensive search was conducted from January 2017 to October 2022 in databases such as Wanfang (China Online Journals), CNKI (China National Knowledge Infrastructure), VIP (China Science and Technology Journal Database), SinoMed (Chinese Biomedical Literature Database), PubMed, Web of Science, and Cochrane Library. Literature related to the treatment of DPN with TCM was selected. From the 1,229 RCTs identified over the past 6 years, relevant data were extracted. The evidence mapping approach was utilized, and trends in publications, study scales, intervention types, and evaluation indicators were analyzed using descriptive text combined with tables and bubble charts. Results: Research on the treatment of DPN with TCM is extensive. The publication trend remains relatively stable with predominantly smaller sample sizes. The main treatments encompass oral Chinese medicine and traditional external treatments. The most common evaluation indicators are neurophysiological, efficiency rate, symptom signs, neuropathy scores, and traditional Chinese symptoms, with less focus on psychological status and the ankle-brachial index (ABI). Conclusion: Shedding light on contemporary research, this study explores the current RCTs evaluating TCM's efficacy in treating DPN. The findings not only highlight the potential role of TCM in addressing diabetic complications but also underscore areas that could benefit from refined research approaches, expanded intervention methods, and broader assessment criteria. Our observations aim to inform and inspire future research directions and clinical practices concerning TCM's role in managing diabetes-associated complications.

Mapping the path towards novel treatment strategies: a bibliometric analysis of Hashimoto's thyroiditis research from 1990 to 2023.

Background: Hashimoto's thyroiditis (HT), a common form of thyroid autoimmunity, is strongly associated with deteriorating clinical status and impaired quality of life. The escalating global prevalence, coupled with the complexity of disease mechanisms, necessitates a comprehensive, bibliometric analysis to elucidate the trajectory, hotspots, and future trends in HT research. Objective: This study aims to illuminate the development, hotspots, and future directions in HT research through systematic analysis of publications, institutions, authors, journals, references, and keywords. Particular emphasis is placed on novel treatment strategies for HT and its complications, highlighting the potential role of genetic profiling and immunomodulatory therapies. Methods: We retrieved 8,726 relevant documents from the Web of Science Core Collection database spanning from 1 January 1990 to 7 March 2023. Following the selection of document type, 7,624 articles were included for bibliometric analysis using CiteSpace, VOSviewer, and R software. Results: The temporal evolution of HT research is categorized into three distinct phases: exploration (1990-1999), rapid development (1999-2000), and steady growth (2000-present). Notably, the United States, China, Italy, and Japan collectively contributed over half (54.77%) of global publications. Among the top 10 research institutions, four were from Italy (4/10), followed by China (2/10) and the United States (2/10). Recent hotspots, such as the roles of gut microbiota, genetic profiling, and nutritional factors in HT management, the diagnostic dilemmas between HT and Grave's disease, as well as the challenges in managing HT complicated by papillary thyroid carcinoma and type 1 diabetes mellitus, are discussed. Conclusion: Although North America and Europe have a considerable academic impact, institutions from emerging countries like China are demonstrating promising potential in HT research. Future studies are anticipated to delve deeper into the differential diagnosis of HT and Grave's disease, the intricate relationship between gut microbiota and HT pathogenesis, clinical management of HT with papillary thyroid carcinoma or type 1 diabetes, and the beneficial effects of dietary modifications and micronutrients supplementation in HT. Furthermore, the advent of genetic profiling and advanced immunotherapies for managing HT offers promising avenues for future research.

Predictive factors and clinical efficacy of Chinese medicine Shengji ointment in the treatment of diabetic foot ulcers in the elderly: a prospective study.

Objective: This study aims to investigate the predictive factors and efficacy of traditional Chinese medicine Shengji Ointment in the treatment of diabetic foot ulcers in the elderly population, with the intent of formulating an effective predictive model for deep diabetic foot ulcer healing. The importance of this research lies in its provision of new perspectives and tools for addressing the severe health impact of diabetic foot ulcers in the elderly population, considering the complexity and diversity of its treatment methods. Methods: The study includes 180 elderly patients with Wagner grade 3-4 diabetic foot ulcers that involve the tendon or fascia. The dependent variable is the initiation time of granulation tissue development. Independent variables encompass demographic information, a treatment strategy including Shengji Ointment, pre-treatment trauma assessment data, routine blood count, and biochemical index test results. Lasso regression is employed for variable selection, and Cox regression is utilized for the construction of a prediction model. A nomogram is generated to authenticate the model. Results: The Chinese Medicine treatment approach, ulcer location, creatinine levels, BMI, and haemoglobin levels are identified as independent predictors of granulation tissue development in diabetic foot ulcers. The combined treatment of Chinese herbal Shengji ointment and bromelain positively influenced granulation tissue development. The location of plantar ulcers, impaired renal functionality, obesity, and anaemia are established as independent risk factors that might influence the speed and probability of ulcer healing. The area under the time-dependent ROC curve fluctuates between 0.7 and 0.8, demonstrating substantial discrimination and calibration of the model. Conclusion: The study ascertains that a combined treatment strategy incorporating Shengji Ointment demonstrates greater effectiveness than the use of cleansing gel debridement alone in facilitating the healing of Wagner grade 3 or higher diabetic foot ulcers. Furthermore, the predictive model developed in this research serves as a valuable tool in evaluating the efficacy of Chinese Medicine treatments like Shengji Ointment for diabetic foot ulcers in the elderly. It aids clinicians in effectively assessing and adjusting treatment strategies, thereby proving its significant application value in clinical practice. Clinical Trial Registration: (https://www.chictr.org.cn/hvshowproject.html?id=73862&v=1.5&u_atoken=b403af53-d3b9-41ae-a7e2-db5498609b0c&u_asession=01tNh69p235bMUO4CmHIXcv8Hxirl5-557Duue9QB5lGfl3mf8IvPlcs2kN2zC30voX0KNBwm7Lovlpxjd_P_q4JsKWYrT3W_NKPr8w6oU7K_AyPrQhedMUWBMR2-ZDL_KO0uwDPR9XlF566xraDvT9mBkFo3NEHBv0PZUm6pbxQU&u_asig=05Kd_Q8fjv-24MVbZpOS9ef3xuCCN-tSVH5eUoJKgNLM7E0-n0zMpW6xLq9gh9aUhkKEEA15rdDoCydncF99APBwVSaTPgEG_V_B1iT4wimdCTxV_4ZVbTlDewxyQtE4YgU4-Oza7KPi94RJ64Utel0yZfqg3Tlm-bVxFNOY-zXFP9JS7q8ZD7Xtz2Ly-b0kmuyAKRFSVJkkdwVUnyHAIJzSYJ6SfhFl0WMTCCasZ7zV2I2qfyrp5m-SELPVeREKgX_6yRmLu26qT8kGfcS-Yaeu3h9VXwMyh6PgyDIVSG1W-7D_Sko5YQtpDbs3uvezYkZcUUY4o9-zDPaoYelmMDs8u7I4TPvtCXaPp44YUJcQ9bHr-_RmKA5V8nji3daArhmWspDxyAEEo4kbsryBKb9Q&u_aref=NNH1nHSUCE6pNvCilV%2F1MD0aERs%3D), identifier (ChiCTR2000039327).

[Acupoint application for exogenous fever: a multi-central retrospective cohort study].

OBJECTIVE: To explore the effectiveness on exogenous fever and the characteristics of effective population, as well as the specialties of prescription of acupoint application. METHODS: Using the internet electronic diagnosis and treatment platform (Spring Broadcast Wanxiangyun Clinic Database, and the main TCM suitable technology promoted by this platform is acupoint application therapy), from August 24, 2020 to November 5, 2020, the patients complained with fever and diagnosed as common cold, with a record of initial visit and at least one return visit, were included as the subjects. According to whether acupoint application therapy was received or not, the subjects were divided into an exposure group (with acupoint application therapy, 26 664 cases) and a non-exposure group (without acupoint application therapy, 515 cases). Using the propensity score, the mixed factors, e.g. age and sex, were matched between the two groups. The disappearance rate of fever (within 2 days) and the time for the first fever disappearance were taken as the effect indexes. The association rules extraction was adopted to analyze the characteristics of effective population and acupoint application prescription in treatment of exogenous fever. RESULTS: After propensity score matching, there were 1 229 cases in the application group and 423 cases in the non-application group. The disappearance rate of fever in the application group was 1.82 times as high as that in the non-application group (P<0.05). The time for the first fever disappearance in the application group was shorter than the non-application group (P<0.01). A total of 5 370 cases were effective with acupoint application therapy, of which, the median age was 2 years old and the proportion of children patients under 6 years old was relatively high. In the effective crowd, the most commonly-used acupoints were Shenque (CV 8), Dazhui (GV 14), Yongquan (KI 1) and Tiantu (CV 22), etc. Shenque (CV 8) and Dazhui (GV 14) were highly associated and the support was 62.57%. The most common herbal materials in the acupoint application therapy included Radix et Rhizoma Rhei, Natrii Sulfas, Radix Scutellariae, Herba Ephedrae and Radix Bupleuri, etc. Radix et Rhizoma Rhei and Natrii Sulfas were most commonly used at Shenque (CV 8) and the supports were 57.49% and 57.21% respectively. Herba Ephedrae was most commonly applied to Shenque (CV 8) and Dazhui (GV 14) and the supports were 48.21% and 43.91% respectively. Radix Bupleuri was the most common herb at Dazhui (GV 14) with the support of 46.61%. Besides, the most commonly combined western drugs included cefixime and keteling in the acupoint application therapy and the supports were 13.07% and 12.72% respectively. CONCLUSION: Acupoint application is effective on exogenous fever. The common therapy refers to Radix et Rhizoma Rhei and Natrii Sulfas plaster at Shenque (CV 8), while Herba Ephedrae and Radix Bupleuri at Dazhui (GV 14).

[Influence of acupoint application on clinical use of antibiotics: a real world study of 1.23 million primary clinic patients].

OBJECTIVE: To observe the influence of acupoint application on the use of antibiotics in primary clinic practice, and explore the effect of acupoint application and its influence on the use of antibiotics based on common diseases in primary clinic (fever, cough, diarrhea, sore throat). METHODS: With the help of the internet electronic diagnosis and treatment platform (the main TCM suitable technology promoted by this platform is acupoint application therapy), the diagnosis and treatment data of 1.23 million patients in 2 000 primary clinics from August 24, 2020 to March 31, 2021 were collected. The patients were divided into an application group (acupoint application treatment) and a non-application group (non-acupoint application treatment), and the proportion of antibiotic use in the two groups was compared. The propensity score was used to match age, gender, concomitant symptoms, diagnosed diseases and other confounding factors of treatment, and the disappearance rate of symptoms (fever, cough, diarrhea, sore throat) and the time to first disappearance of symptoms were compared between the two groups. RESULTS: A total of 1 230 923 patients were analyzed, including 1 048 382 cases in the application group, accounting for 85.2%; 182 541 cases in the non-application group, accounting for 14.8%. The most patients who used acupoint application treatment were 0-2 years old, followed by 3-6 years old, and the patients over 15 years old who did not use acupoint application treatment were the most. The proportion of antibiotic use in the application group was 2.4%, lower than that in the non-application group (44.2%, P<0.001). The proportion of antibiotic use in all ages of patients in the application group was lower than that in the non-application group (P<0.001). Among the common diseases in primary clinic (fever, cough, diarrhea and sore throat), the proportion of antibiotic use in the application group was lower than that in the non-application group (P<0.01); the disappearance rate of symptoms in the application group was higher than that in the non-application group, and the time to first disappearance of symptoms was shorter than that in the non-application group (P<0.001). CONCLUSION: Acupoint application has a certain influence on the use of antibiotics in primary clinic patients. In the treatment of common diseases, patients treated with acupoint application have better curative effect and lower proportion of antibiotic use.

Developing Placebos for Clinical Research in Traditional Chinese Medicine: Assessing Organoleptic Properties of Three Dosage Forms (Oral Liquid, Capsule and Granule).

Background: The successful application of randomized, double-blind placebo-controlled studies requires maximum blinding. Organoleptic properties of the placebo should be similar to the drug, making it difficult to distinguish between the two. The uniqueness of traditional Chinese medicine (TCM) preparations makes it challenging to prepare placebo. Evaluation of the TCM placebo simulation effect can determine whether the preparation of placebo can be genuinely blind in clinical trials. There is still a lack of well-established methods to evaluate TCM placebos. Hence, this study aimed to explore the evaluation methodology of TCM placebo simulation. Methods: An independent evaluation method and three comparative evaluation methods were proposed, and three dosage forms (oral liquid, capsule, and granule) were tested. The independent evaluation, in which each person was given an experimental drug or a placebo, gave an overall assessment of organoleptic properties in a blind state. We comparatively evaluated the similarity in organoleptic properties between the experimental drug and placebo. According to different distribution methods, we divided comparative evaluation methods into three. In method 1, the evaluator was given the experimental drug and placebo and was told that there must be a placebo among them. In method 2, each evaluator was randomly assigned to the combination group or two investigational drugs group. In method 3, the evaluator was assigned to a set of three coded samples, numbered by random three-digit numbers, each different, two of which were identical, and the two samples were equally frequent. Results: In the independent evaluation, there was no difference between TCM placebo and experimental drugs in a blind state at the level of p = 0.05. Even though the comparative evaluation methods enabled identification of potential differences between the two samples, methods 2 and 3 were better than method 1 in eliminating psychological factors. Also, in method 3, the completely random method combined with the blind method eliminated the subjectivity and objectivity bias and improved the experiment's credibility compared with the previous two methods. Conclusion: Regardless of the methods that could evaluate the placebo's simulated effect in actual clinical trials, we suggest that independent evaluation and comparative evaluation (method 3) should be combined to reflect better whether the placebo is truly blind.

Clinical Study for Safety Evaluation of GXN Tablets Combined with Aspirin in Long-Term Treatment of Coronary Heart Disease.

BACKGROUND: GXN tablets are composed of Danshen and Chuanxiong, with the functions of activating blood circulation, removing blood stasis, invigorating the pulse, and nourishing the heart, which are used for CHD patients with stable exertional angina Grade I or II (according to traditional Chinese medicine, it is a syndrome of heart and blood stasis with chest pain and dark purple lips and tongue). Clinical trials have shown satisfactory effects on coronary heart disease (CHD). 90.6% of Chinese patients with CHD use both Western medicine and Chinese medicine with the latter being thought to promote blood circulation and remove blood stasis. Some researchers doubt that the combination of Chinese medicine increases the risk of bleeding. The main objective of this study is to observe the safety of long-term use of Guanxinning (hereafter referred to as GXN) tablets combined with aspirin. METHODS: The study population is patients with CHD after percutaneous coronary intervention (PCI). Randomization was performed for patients with stable CHD who received dual antiplatelet therapy (DAPT) with aspirin plus clopidogrel or ticagrelor for more than 12 months and then switched to the treatment with aspirin alone for 1 month. This study includes a total of 3,595 subjects in 63 hospitals. The experimental group took aspirin orally (100 mg, 1 time/day) + GXN tablets (0-6 months: 4 tablets/time, 3 times/day; 7-12 months, 4 tablets/time, 2 times/day), and the control group received oral aspirin (100 mg, 1 time/day). Major observation indicators are the incidence of bleeding events, adverse events (AEs), and adverse reactions. The primary endpoint indicators are the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) and the MACCE composite endpoint. RESULTS: A total of 31 cases of symptomatic bleeding were found in the two groups, including 21 cases (0.98%) in the experimental group and 10 cases (0.86%) in the control group; the difference between the two groups was not statistically significant. There were 29 cases (1.35%) of bleeding not reaching BARC type 1 in the experimental group. No attention was paid to the laboratory indicators in the control group during the trial process, so the bleeding as a laboratory indicator between the two groups was not comparable. For BARC type 3-5 bleeding events, there were 3 cases in the experimental group (0.139%) and 2 cases in the control group (0.172%); the difference between the two groups was not statistically significant and not clinically significant. During the trial period, there were a total of 255 cases of adverse reactions in 208 subjects with an incidence of 6.57% (141/2146) in the experimental group and 5.77% (67/1161) in the control group, and the P value was 0.5021; the difference between the two groups was not statistically significant. According to the analysis, the adverse reactions with a statistically significant difference between the two groups were gastrointestinal diseases, with the incidence in the experimental group being higher than that in the control group, and the main manifestations were gastrointestinal symptoms. There was no statistical difference in other types of adverse reactions between the two groups. In the trial period, there were 10 cases of serious adverse reactions, including 5 cases in the experimental group (5/2146, 0.23%) and 5 cases in the control group (5/ 1161, 0.43%), the P value was 0.3351; the difference in the incidence between the two groups was not statistically significant. CONCLUSION: For CHD patients with heart-blood stasis syndrome, the combination of aspirin and GXN tablets in the experimental group did not increase the incidence of bleeding events, nor did it increase the risk of bleeding of types 3-5 defined by BARC. Except for the increase in gastrointestinal symptoms, there was no increase in other adverse reactions in the experimental group. This trial is registered with Registration no. ChiCTR-IIR-17010688.

Effectiveness and Safety Evaluation of Chinese Medicine in Treatment of Metastatic Colorectal Cancer after Chemotherapy Failure: Protocol of a Prospective Multicenter Cohort Study.

BACKGROUND: Colorectal cancer (CRC) is the second most common cause of cancer-related deaths and has the third highest incidence in the world. Almost half of the patients with CRC have metastases at the time of diagnosis. However, the treatment for patients with metastatic CRC that progresses after approved conventional chemotherapy is still controversial. Chinese medicine (CM) has unique characteristics and advantages in treating metastatic CRC. OBJECTIVE: To assess the effectiveness and safety of CM in patients with metastatic CRC after failure of conventional chemotherapy. METHODS: The study is a multicenter prospective cohort study. A total of 384 patients with documented metastatic CRC after failure of conventional chemotherapy will be included from 9 hospitals among Beijing, Shanghai, Nanjing, and Guizhou, and assigned to three groups according to paitents' wishes: (1) integrated Chinese and Western medicine (ICM) group receiving CM herbal treatment combined with Western medicine (WM) anti-tumor therapy, (2) Chinese medicine (CM) group receiving only CM herbal treatment, and (3) WM group receiving only WM anti-tumor therapy. The primary endpoint is the overall survival (OS). Secondary endpoints include the progression free survival (PFS), quality of life (QOL) assessed by the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) questionnaire, tumor control, and CM symptom score. DISCUSSION: This prospective study will assess the effectiveness and safety of CM in treating metastatic CRC after conventional chemotherapy failure. Patients in the ICM group will be compared with those in the WM group and CM group. If certified to be effective, national provision of CM treatment in metastatic CRC will probably be advised. (Registration No. NCT02923622 on ClinicalTrials.gov).

Pharmacokinetics and safety evaluation in healthy Chinese volunteers of alkaloids from leaf of Alstonia scholaris: A multiple doses phase I clinical trial.

BACKGROUND: Alstonia scholaris (Apocynaceae) was reported to be a rich source of indole alkaloids, which exhibited remarkably bioactivities. The leaf of A. scholaris has been used in 'dai' ethno-medicine for treatment of respiratory diseases, and the defined indole alkaloids from leaf of A. scholaris has been registered as investigational new botanical drug (No. 2011L01436) and was approved for phase I/II clinical trials by China Food and Drug Administration (CFDA). PURPOSE: The aim of the trial is to evaluate the safety and explore the relationship of dosing frequency and pharmacokinetics after oral administration of capsule of alkaloids from leaf of A. scholaris (CALAS) at different doses. METHODS: In this randomized, open-labelled, single-center clinical trial, the safety and pharmacokinetics of CALAS were assessed in eligible healthy Chinese volunteers after oral administration of different doses. Each volunteer (n = 10 per group) received single dose of CALAS from 20 mg, 40 mg, 80 mg to 120 mg orally. The pharmacokinetics of CALAS was investigated in healthy Chinese subjects' plasma by a fully-validated LC-MS/MS method. Safety was assessed biochemically and clinically throughout the study, and drug re-excitation research was conducted to verify the correlation between investigational product and minor adverse events. The trial was registered on August 26, 2015 (http://www.chictr.org.cn/showproj.aspx?proj=11736), number ChiCTR-IPR-15006976. RESULTS: 40 subjects completed the study, and as a result, vallesamine had the highest concentration in plasma of healthy volunteers, and the AUC exposure level in each compounds in turn is vallesamine > scholaricine > 19-epischolaricine > picrinine. For the safety evaluation of CALAS, two cases of minor adverse events were observed during the trial, but the drug re-excitation research indicated that these two adverse events were related to the individual's physiological variation. CONCLUSION: Pharmacokinetic characteristics of each ingredient showed different patterns. 19-epischolaricine, vallesamine and picrinine were match to the linear pharmacokinetic characteristics, but scholaricine conformed to the characteristics of nonlinear pharmacokinetics. The CALAS was safe in healthy subjects under the current dose regimen.

Efficacy and Safety of Ginkgo Biloba Pills for Coronary Heart Disease with Impaired Glucose Regulation: Study Protocol for a Series of N-of-1 Randomized, Double-Blind, Placebo-Controlled Trials.

BACKGROUND: Coronary heart disease has become a serious challenge to China with its high prevalence and mortality. The impaired glucose regulation is prevalent in patients with cardiovascular disease. However, there are few drugs that interfere early with impaired glucose regulation. Ginkgo biloba extract not only is a commonly used drug for cardiovascular diseases, but also has a significant effect in reducing blood sugar. Therefore, this study used a single-case randomized controlled trial to explore the efficacy of Ginkgo biloba pills in the treatment of coronary heart disease patients with impaired glucose regulation. METHODS/DESIGN: This is a randomized, double-blind, placebo-controlled, three-period crossover trial for a single subject. A total of 12 subjects will be recruited in this trial. The trial is divided into three cycles, and one cycle has two treatment periods. Ginkgo biloba pills and placebo will be randomized during the treatment period. The test period will last for 58 weeks and subjects will take 48 weeks. Subjects will be selected by the researcher strictly in accordance with the inclusion and exclusion criteria. DISCUSSION: Ginkgo biloba preparations are widely used in cardiovascular diseases both at home and abroad due to their definite curative effect, few side effects, various dosage forms, and convenient and safe use. Diabetes mellitus is a high-risk factor for the occurrence of cardiovascular disease. Therefore, it is of great significance to control the impaired glucose regulation and slow down the development of diabetes and reduce the incidence and mortality of cardiovascular diseases. This trial is registered with ClinicalTrials.gov (ID: NCT03483779).

[Laws of Syndrome Types of Chinese Medicine in Dyslipidemia Patients].

Objective To observe changing laws of syndrome types of Chinese medicine (CM) in dyslipidemia patients. Methods Totally 439 dyslipidemia patients were recruited. Their syndrome types of CM and blood lipids were.observed at the baseline (at the first visit) , 1st interview (at week 4), 2nd interview (at week 8), and 3rd interview (at week 12), respectively. Analyses of multilayer latent class analysis model were performed in the 4 interviews. Changes of syndrome types of CM were sum- marized as well. Results Asymptomatic patients accounted for 49. 7% of the total number (218/439) at the baseline. Among symptomatic patients, yin deficiency yang predominance syndrome occupied the top (28.2%, 124/439), and followed by sputum turbidity obstruction syndrome (13. 7%, 60/439). At 1st interview there were still 134 asymptomatic patients. Among symptomatic patients, yin deficiency yang predominance syndrome occupied the top (23. 5%, 103/439), and followed by sputum turbidity obstruc- tion syndrome (17. 3% , 76/439). And 70 patients were lost. At 2nd interview blood stasis phlegm stagna- tion syndrome (21. 4%, 79/369) and yin deficiency yang predominance syndrome (19. 5% , 72)369) were main syndrome types. And 64 patients were lost. At 3rd interview sputum turbidity obstruction syndrome (11. 8%, 36)305) and qi-yin deficiency syndrome (11. 1%, 34)305) were main syndrome types. And 50 patients were lost. Conclusions Syndrome types of CM in dyslipidemia patients showed changing and unstable state along with the prolongation of dyslipidemia. It was insufficient to take syndrome types of CM as main therapeutic indicators for clinical research on dyslipidemia.

Joint development of evidence-based medical record by doctors and patients through integrated Chinese and Western medicine on digestive system diseases.

Building the clinical therapeutic evaluation system by combing the evaluation given by doctors and patients can form a more comprehensive and objective evaluation system. A literature search on the practice of evidence-based evaluation was conducted in key biomedical databases, i.e. PubMed, Excerpt Medica Database, China Biology Medicine disc and China National Knowledge Infrastructure. However, no relevant study on the subjects of interest was identified. Therefore, drawing on the principles of narrative medicine and expert opinion from systems of Chinese medicine and Western medicine, we propose to develop and pilot-test a novel evidence-based medical record format that captures the perspectives of both patients and doctors in a clinical trial. Further, we seek to evaluate a strategic therapeutic approach that integrates the wisdom of Chinese medicine with the scientific basis of Western medicine in the treatment of digestive system disorders. Evaluation of therapeutic efficacy of remedies under the system of Chinese medicine is an imperative ongoing research. The present study intends to identify a novel approach to assess the synergistic benefits achievable from an integrated therapeutic approach combining Chinese and Western system of medicine to treat digestive system disorders.

[Effect of data management quality on clinical research evidence evaluation].

Current clinical evaluation of literature quality has various ways. Most of them lay special emphasis on the evaluation of the design quality, but the evaluation of the implementation process quality is not perfect. Especially data management is not fully emphasized during the enforcement of clinical trials. Data from clinical research were bases for evaluating clinical findings. Although strict specifications and requirements for data management might be strictly written clearly in research protocols, they were not embodied in current clinical research evidence evaluation system. Data management is an important part of implementing the whole clinical trial process, which is a comprehensive reflection of data collecting, logging, sorting, and managing. Its objective is to obtain high quality research data for statistical analysis, thereby coming to a true and reliable conclusion. In order to overall evaluating clinical design and implement, we suggest that present quality evaluation indicators of clinical trails should be completed, and add data management quality evaluation during the whole implement process. Data management plans, standards and requirements for data checking, and management regulations for disobeying data and exception data should be added in quality evaluation indicators for clinical research evidence. The effect of data management quality on clinical research evidence evaluation should be emphasized.

[Discussion on developing a data management plan and its key factors in clinical study based on electronic data capture system].

Data management has significant impact on the quality control of clinical studies. Every clinical study should have a data management plan to provide overall work instructions and ensure that all of these tasks are completed according to the Good Clinical Data Management Practice (GCDMP). Meanwhile, the data management plan (DMP) is an auditable document requested by regulatory inspectors and must be written in a manner that is realistic and of high quality. The significance of DMP, the minimum standards and the best practices provided by GCDMP, the main contents of DMP based on electronic data capture (EDC) and some key factors of DMP influencing the quality of clinical study were elaborated in this paper. Specifically, DMP generally consists of 15 parts, namely, the approval page, the protocol summary, role and training, timelines, database design, creation, maintenance and security, data entry, data validation, quality control and quality assurance, the management of external data, serious adverse event data reconciliation, coding, database lock, data management reports, the communication plan and the abbreviated terms. Among them, the following three parts are regarded as the key factors: designing a standardized database of the clinical study, entering data in time and cleansing data efficiently. In the last part of this article, the authors also analyzed the problems in clinical research of traditional Chinese medicine using the EDC system and put forward some suggestions for improvement.