Discussion on Patient Registry about Acupuncture Therapy for Premature Ovarian Insufficiency / 世界科学技术-中医药现代化

Premature ovarian insufficiency (POI) is characterized by amenorrhea before age 40 with raised FSH level and decreased E2 level. POI, as a main reason for infertility, poses great threat on patients. physical and psychological health.By reviewing clinical trials of acupuncture in treating premature ovarian insufficiency, this study focuses on the significance and feasibility of patient registry about acupuncture therapy for premature ovarian insufficiency. Patient registry can be used in collecting real-world evidence and exploring effective intervention to improve pregnancy rate

Cluster analysis for syndromes of real-world coronary heart disease with angina pectoris / 医学前沿

Syndromes of coronary heart disease with angina pectoris were analyzed to provide guidance for clinical practice and to improve accuracy of traditional Chinese medicine (TCM) diagnoses and efficacy of TCM treatment. A total of 860 cases with coronary heart disease with angina pectoris were selected from TCM Clinical Research Information Sharing System for TCM clinics and research. Syndromes were automatically extracted with the cluster method and were analyzed to provide objective evidence for clinical studies. Final syndrome classifications were recognized and confirmed by clinical experts. Popular syndromes included Qi and blood deficiency, blood stasis and obstruction collaterals, liver depression and spleen deficiency, and Qi stagnation and blood stasis. Syndromes Qi and blood deficiency and blood stasis and obstruction collaterals accounted for 28.61% of total syndromes, whereas liver depression and spleen deficiency and Qi stagnation and blood stasis accounted for 26.44%. The main syndrome elements comprised Qi deficiency, blood deficiency, blood stasis, and Qi stagnation.

Multistage analysis method for detection of effective herb prescription from clinical data / 医学前沿

Determining effective traditional Chinese medicine (TCM) treatments for specific disease conditions or particular patient groups is a difficult issue that necessitates investigation because of the complicated personalized manifestations in real-world patients and the individualized combination therapies prescribed in clinical settings. In this study, a multistage analysis method that integrates propensity case matching, complex network analysis, and herb set enrichment analysis was proposed to identify effective herb prescriptions for particular diseases (e.g., insomnia). First, propensity case matching was applied to match clinical cases. Then, core network extraction and herb set enrichment were combined to detect core effective herb prescriptions. Effectiveness-based mutual information was used to detect strong herb-symptom relationships. This method was applied on a TCM clinical data set with 955 patients collected from well-designed observational studies. Results revealed that groups of herb prescriptions with higher effectiveness rates (76.9% vs. 42.8% for matched samples; 94.2% vs. 84.9% for all samples) compared with the original prescriptions were found. Particular patient groups with symptom manifestations were also identified to help investigate the indications of the effective herb prescriptions.

Analysis on the concepts related to adverse events and adverse reactions of acupuncture / 中国针灸

With the increasing popularity of acupuncture therapy in the world, the safety of acupuncture has attracted more attention. The objective and impartial assessment of the safety of acupuncture becomes very important. The "adverse events of acupuncture" and "adverse reactions of acupuncture" are the common concepts in the research of acupuncture safety. In the paper, on the basis of the conceptual characteristics of "adverse events" and "adverse reactions" and in combination with the particular characteristics of acupuncture itself, the connation and features of the concepts of the "adverse events of acupuncture" and "adverse reactions of acupuncture" are analyzed. The interaction and differences are summarized. Both "adverse events of acupuncture" and "adverse reactions of acupuncture" are in the category of adverse medical events. The "adverse events of acupuncture" includes the damages induced by acupuncture therapy and also those without relationship with acupuncture therapy. The "adverse reactions of acupuncture" refers to the adverse outcomes induced by acupuncture therapy specially. It has the definite relationship with acupuncture therapy. Hence, the application of "adverse reactions of acupuncture" is more objective and accurate in the assessment of acupuncture safety.

Key Technologies of International Patient Registry Study for Acupuncture-moxibustion Based on Real World / 世界科学技术-中医药现代化

Acupuncture-moxibustion has been used in more than 180 countries,but high quality evidences for its efficacy and safety are still insufficient,which is a key issue limiting the development of acupuncture-moxibustion.Combined with characteristics of acupuncture-moxibustion discipline,this study was aimed to use international patient registry to collect real world clinical data and design meaningful clinical outcome in order to exploit the efficacy and safety of acupuncture-moxibustion and to provide important basis and supplement for confirmatory research.This paper summarized key technologies of international patient registry study for acupuncture-moxibustion based on real world to guide the design,implementation and evaluation.

The current situation of acupuncture definition in international organizations and legislation of some countries / 中国针灸

Acupuncture is developing rapidly in the world, and more attention is paid on acupuncture in various countries. Because of the cultural differences, there are different views on acupuncture between China and the west, which has brought influence and challenge to the development of acupuncture in the world. Acupuncture-related research is becoming increasingly extensive and complex, but the definition of acupuncture is lack of unified standards. The definition of acupuncture is in urgent need. Based on the analysis of acupuncture definition in the 201 international organizations of 48 countries on five continents and legislation of representative countries, this paper summarized the development status of acupuncture in foreign countries, and put forward that the definition of acupuncture should adopt the model of small connotation and large extension, integrate discipline superiority, expand the scope of acupuncture, and focus on the overall situation.

Establishing the acupuncture-moxibustion clinical trial registry and improving the transparence of clinical trials of acupuncture and moxibustion / 中国针灸

As a kind of intervention measures of traditional Chinese medicine, acupuncture-moxibustion is highly adopted on global clinical practice. Even though the global clinical trial registration system was established more than 10 years ago, the proportion of acupuncture-moxibustion clinical trial registration is still very low; and it is very problematic on the methodological quality and report quality in the published acupuncture-moxibustion clinical trials. In order to manage particularly the acupuncture-moxibustion clinical trials, China Academy of Chinese Medical Sciences, collaborated with China Association of Acupuncture and Moxibustion and World Federation of Acupuncture Societies, established the Acupuncture-Moxibustion Clinical Trail Registry (AMCTR). AMCTR is a secondary registry platform affiliated to the Chinese Clinical Trial Registry (ChiCTR) and WHO International Clinical Trials Registry Platform (ICTRP), specifically for the acceptance and management of clinical trials in the field of acupuncture and moxibustion. It is a nonprofit academic organization, located in China Academy of Chinese Medical Sciences.

Discussion on Several Problems in Clinical Evaluation of New Traditional Chinese Medicine / 中国中医药信息杂志

This article summarized and analyzed problems about clinical evaluation of new traditional Chinese medicine, including the staging and dynamics in clinical research stage, indexes of therapeutic evaluation, and post-marketing revaluation. It also proposed that the research and development of new traditional Chinese medicine should attach importance to clinical efficacy and conduct clinical evaluation reasonably. The article provides references for research and development of new traditional Chinese medicine.

Approach to CDISC SDTM Implementation for Clinical Trials Data Submission / 世界科学技术-中医药现代化

This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form (CRF) to Study Data Tabulation Model (SDTM) database format in clinical research of traditional Chinese medicine (TCM). Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.

Research on Digitalization Path and Method of Hospital Medical Records Information / 世界科学技术-中医药现代化

Based on a retrospective study design, this article was aimed to discuss the transformation path and method of hospital medical records information into analyzable data, in order to solve the problem of text-based information digitalization, and improve the credibility of statistical results. The hospital medical records information of traditional Chinese medicine (TCM) treatment for infantile cerebral palsy was taken as example. After the identification of research purpose, the study contained 8 steps, which were index identification, index definition, coding and assignment, database design, data entry, quality control, and database locking. The database contained research-related indicators was received. The results showed that a set of path and method based on indicator extraction and conversion of hospital medical records information into data. It was concluded that in the retrospective study design, the conversion of text information into analyzable data was the key step. Extraction and digitalization of indicators should be based on the research plan. Key elements such as the crowd, treatment plan, evaluation indicator, should be paid attention to for the systematic analysis, in order to ensure the system integrity of research indicators.

Research Progress on Heart System Sub-health Status of Traditional Chinese Medicine / 世界科学技术-中医药现代化

The sub-health status is closely related to the functions and activities of heart in traditional Chinese medicine (TCM). The sub-health is commonly presented with a series of heart system symptoms such as palpitation, chest distress, shortness of breath, fatigue, fidgets and insomnia. It may also be accompanied with arrhythmia or blood pressure value between normal and high level. This heart system sub-health status can be transformed into re-lated heart system diseases with high possibility. This article made a review from aspects of theoretical literature, an-imal experiment, curative effect observation and clinical evaluation on the research progress of heart system sub-health status.

Quality assessment of randomized controlled trials on wenxin granule for treatment of atrial fibrillation / 中国中药杂志

<p><b>OBJECTIVE</b>To investigate the statement on randomized controlled trials on Wenxin granule for treatment of atrial fibrillation and to judge whether those trials could offer high quality evidence or not, thus improve design level and quality.</p><p><b>METHOD</b>RCTs were searched from home and abroad about atrial fibrillation treated with Wenxin granule, which reported before October, 2010. Jadad scale and CONSORT statement were used.</p><p><b>RESULT</b>There were 66 RCTs retrieved that met inclusion criteria. Using Jadad rating scale, only 2 literatures gain score 4 and 1 literature gains score 3, 54 literatures gain score 2, 7 literatures gain score 1, 2 literatures gain score 0. Only 2 literatures described random number table as the method of grouping. None of the RCTs was reported the allocation concealment. Only 1 literature was used blinding. Fifty-nine literatures were mentioned the lost to follow-up conditions. According to the CONSORT standards, only six literatures (9.1%) mentioned the method of generating the random sequence. Four literatures (6.1%) were quasi-random. Nineteen literatures (28.8%) had inclusion criteria. Six literatures (9.1%) had the follow-up record. Fifty one literatures (77.3%) described the adverse events. None had the estimation of the sample size, intention-to-treat analysis and stratified analysis. None had the ethical approval or informed consent.</p><p><b>CONCLUSION</b>The quality of clinical trials of Wenxin granule in treating atrial fibrillation needs to be improved.</p>

Quality assessment on literatures for Domestic randomized controlled clinical studies of anal fissure / 中华中医药杂志

Objective: To analyze the published domestic documents of the clinical trial for treatment of anal fissure in past 10 years, to evaluate the quality of literatures about anal fissure randomized controlled clinical trials, and to provide references of clinical studies for the treatments of anal fissure in Traditional Chinese Medicine (TCM). Methods: In term of principles of evidence-based medicine, we evaluate the published domestic literatures of the randomized controlled clinical trial for treatments of anal f issure in past 10 years. Results: We analyze 52 literatures which are in the method of randomized controlled clinical studies. 28 literatures (accounting for 53.85%) record diagnostic criteria, 38 literatures (accounting for 73.08%) make sure standards of evaluating the effect and 18 literatures (accounting for 34.62%) mention comparability between groups without describing the baseline statistics. Only 5 are marked as a funded research projects. Conclusion: in current published literatures of randomized controlled study for treatments of anal fi ssure, the problems are focused on: ① Experimental idea is unclear and design is unreasonable, ② The description of implemented process in randomized control is unspecif ic, ③ Signifi cant parameters in statistical data are missed and with less credibility, ④ Criteria of diagnosis and effi cacy are different, ⑤ Evaluation indicators are fuzzy. All above clue to the quality of clinical research needs to be improved rapidly, and standardized evaluation of eff icacy also needs to be created urgently.

Framework theory and its application in TCM / 中华中医药杂志

"Framework" and "framework theory" were proposed several decade years ago, and has been widely used in multidisciplinary research. The main purpose of this paper is to identify the concept and connotation of "framework theory" and to discuss the key role of it in Traditional Chinese Medicine (TCM) research, so as to improve integrality and logicality of the theoretic system of TCM. TCM, as a independent science, ought to have the theory and practical framework which can reflect its characteristic and developmental rule. In this paper, we started from the research thought of "framework", introduced the definition, connection and difference between "framework" and "framework theory", analyzed the conditions and methods of establishing a framework, and discussed the applications of "framework" in TCM research.

Effect of Jiunaoning Injection on apoptosis and changes in cytosolic calcium induced by hypoxia / hypoglycemia in SH-SY5Y human neuroblastoma cells / 中国病理生理杂志

AIM: To study the effect of Jiunaoning Injection on apoptosis and the changes in cytosolic calcium induced by hypoxia/hypoglycemia in SH-SY5Y human neuroblastoma cells. METHODS: The apoptosis and the changes in cytosolic calcium were induced by hypoxia and hypoglycemia .Apoptosis was measured via flow cytometry(FCM), and cytosolic calcium was determined by Fluo-3 fluorometry. RESULTS: The hypoxia/hypoglycemia induced apoptosis and increased the cytosolic calcium in SH-SY5Y cells. Jiunaoning Injection inhibited the apoptosis of the SH-SY5Y cells and decreased the concentration of cytosolic free calcium. CONCLUSION: Hypoxia/hypoglycemia induced apoptosis and increase in cytosolic free calcium in SH-SY5Y cells, which were significantly inhibited by Jiunaoning Injection.