Comparative effectiveness research (CER) has gained more and more popularity, which brought great response in the USA and other developed Western countries. There is no doubt that CER is a new idea and a milestone in health care research. CER is also known as "patient-centered outcomes research", which means patient is the core element in the whole system of CER. Chinese medicine could make new achievements and further development by introducing CER into clinical research. This article mainly introduced the background, features and contents of CER and summarized how to conduct CER in Chinese medicine by referring to some published literature in order to enlighten Chinese medicine researchers.

Objective To analyze the research directions and research status of main academic teams of TCM treatment for ulcerative colitis in the recent 15 years.Methods Articles about TCM treatment for ulcerative colitis from Jan. 2000 to Dec. 2015 in CNKI were searched. Articles were screened by inclusion and exclusion criteria, and then publication time and research institutes were under metrology analysis. According to Price Law and comprehensive indexes, core authors were indentified. The NetDraw2.118 social network was applied to establish author co-occurrence matrix, build core author relationship network and screen academic teams. Combined with typical articles, main research fields and research status of main academic teams were analyzed.Results3658 were included from 6365 articles. 33 core authors in the filed of TCM treatment for ulcerative colitis were identified, belonging to 5 academic teams with relatively higher academic influence: Wu Huangan team, Shenhong team, Wang Hongxia team, Liu Yihua team and Zhang Yansheng team. Each team proposed unique diagnosis and treatment methods.Conclusion Academic teams of TCM treatment for ulcerative colitis have inherited and promoted TCM theories and formed unique academic system in clinical practice and research.

Objective To explore the relationship among the disease - syndrome - formula of type 2 diabetes.Methods Based on the clinical data of 2501 cases of type 2 diabetes, to study the relationship among the disease - syndrome - formula of type 2 diabetes by making use of association rules.Results Three formulas, Shengmai Yin (Pulse-activating Fluid), Liuwei Dihuang Decoction (Decoction of Six Herbs Including Rehmannia), and Sijunzi Decoction (Decoction of Four Noble Herbs), were selected from 122 ones to analyze the relationship between the formula and symptoms. The occurrence of fatigue with weakness, dry mouth with thirst, frequent urination with increased volume of urine, numbness of limbs, blurred vision, thirst with preference of drinking water, frequent nocturnal urination, and shortness of breath with inactive talking was in high frequency in those patients who were prescribed Shengmai Yin. The occurrence of fatigue with weakness, thirst with preference of drinking water, blurred vision, frequent nocturnal urination, dry mouth with thirst, numbness of limbs, shortness of breath with inactive talking, and soreness and weakness of lumbus and legs was in high frequency in those patients prescribed Liuwei Dihuang Decoction, and there existed a multi-association among these symptoms. The occurrence of fatigue with weakness, soreness and weakness of lumbus and legs, frequent nocturnal urination, shortness of breath with inactive talking, numbness of limbs, insomnia, and blurred vision was in high frequency in those patients who were prescribed Sijunzi Decoction, and there existed a multi-association among these symptoms.Conclusion The association rule can be adopted to analyze the relationship between formula and syndrome, and to explore the multi-association relationship among the symptoms of type 2 diabetes.

Objective:To analyze the mistakes in the application of tuina therapy in the rehabilitation of stroke,in order to elevate the clinical effects in the treatment of stroke by tuina.Methods:The issues are found out by searching and analyzing the relevant articles on tuina treatment of stroke.Results:In the tuina treatment of stroke,mistakes exist in the intervening time of the treatment,in the emphasis of tuina with negligence of rehabilitation,in the assessment of therapeutic effects,in the selection of the manual techniques and acupoints,and in the negligence of health education.Conclusion:In the tuina treatment of stroke,it is advisable to start treatment in the early stages,use the manual techniques in different phases,to cooperate with rehabilitation at the proper time and to emphasize health education,in order to avoid or reduce the occurrence of misuse syndrome,and eliminate the appearance of disuse syndrome,for displaying the unique advantage of tuina therapy fully and promoting the innovation and development of TCM rehabilitative techniques.

Objective To explore characteristics of the elements of syndrome, the disease position and the relationship between chemical indicators and TCM syndromes of type 2 diabetic encephalopathy. Methods 2 501 cases of type 2 diabetes clinical data were collected from Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Beijing University of Chinese Medicine, Dongzhimen Hospital, Dongfang Hospital, etc. in nearly 3 years, among which, 342 cases were type 2 diabetic encephalopathy. The original clinical data were double entried in epidata by two people, establishment forms in excel, factor analysis and Bayesian networks were used as data mining research methods. Results 20 elements which characteristic root more than 1 were derived by factor analysis, 68.4% were covered. Of all 20 elements, five factors belong to Yin, five factors belong to blood stasis; lassitude, shortness of breath, stool frequency were appeared when fasting glucose abnormalities; lassitude, hemiplegia were appeared when 2-hour postprandial blood glucose abnormalities;lassitude, feverish palms and soles, stool frequency, more nocturnal enuresis when glycated hemoglobin abnormalities by Bayesian networks. Conclusion The Elements of the syndrome of type 2 diabetes encephalopathy were deficiency of Yin and blood stasis; and the main positions for diabetic patients were liver, spleen and kidney. Patients with impaired fasting glucose were Qi deficiency; Patients with impaired 2-hour postprandial glucose were Qi deficiency or pathogenic wind attacking collaterals; Patients with abnormal hemoglobin were Qi deficiency and Yin deficiency.

Post-marketing re-evaluation of Chinese herbs can well reflect Chinese medicine characteristics, which is the most easily overlooked the clinical re-evaluation content. Since little attention has been paid to this, study on the clinical trial design method was lost. It is difficult to improving the effectiveness and safety of traditional Chinese medicine. Therefore, more attention should be paid on re-evaluation of the clinical trial design method point about tcm syndrome such as the type of research program design, the study of Chinese medical information collection scale and statistical analysis methods, so as to improve the clinical trial design method study about tcm syndrome of Chinese herbs postmarketing re-evalutation status.
Clinical Trials as Topic ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing ; Research Design

OBJECTIVEThis paper is aimed to explore the adverse reaction condition of Shuanghuangli an injection with three common used signal detecting methods based on SRS database of Jiangsu province, and to evaluate the performance of three methods.

METHODThree methods would be used to detect the signals based on the SRS database of Jiangsu province. Consistency of the results of these three methods with that proved in descriptions was evaluated by Kappa test. The trend graph of the confidence intervals of several time points was used to demonstrate the trend of the signal.

RESULTThe PRR method was consistent with ROR method in high degree in any situation. The results of BCPNN method was close to PRR and ROR method only when the related report count was larger. PRR and ROR methods had higher false positive rate than BCPNN method.

CONCLUSIONPRR or ROR method is proposed for signal detecting when the report count is large. BCPNN method is proposed for trend demonstration of signal with graph.

The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.
Humans ; Hypoglycemic Agents ; adverse effects ; Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing

The revaluation of post-marketing herb is a complex research work, which concerns widely content and difficult to put it into practice. The starting of our country's revaluation post-marketing herb was comparatively late. It should profect it both in laws and regulations mechanism as well as technological specification. This article is try to focus on some attention problems in revaluation of postmarketing herb process. Such as the laws and regulations demand, the basement and the subject of revaluation of post-marketing herb.
China ; Drug Therapy ; Drug-Related Side Effects and Adverse Reactions ; Drugs, Chinese Herbal ; adverse effects ; standards ; Humans ; Product Surveillance, Postmarketing

Drug risk assessment and management is an important measure for reducing the adverse drug reaction and enhancing medication safety of the patient. Based on the concepts of drug risk assessment and risk management, and domestic and international drug risk management situation, this paper discusses the risk management of post-marketing Chinese medicine.
Adverse Drug Reaction Reporting Systems ; Drug-Related Side Effects and Adverse Reactions ; etiology ; prevention & control ; Humans ; Medicine, Chinese Traditional ; adverse effects ; Product Surveillance, Postmarketing ; methods ; Risk Assessment ; methods ; Risk Factors