Acupuncture Therapy ; Adult ; Female ; Humans ; Psoriasis ; therapy

The principle of TCM diagnosis standard is communicational convenience, and the international universal standard recommended by WHO should also be paid attention to. When there’s no corresponding standard, inferior standard is available, but self made standard is generally not accepted. It’s suggested to apply the same standard for one program. The standards include international standard, regional standard, domestic standard, industrial standard, provincial standard and enterprise standard, the hierarchies and levels of these standards reduce successively. It’s thought that medical standard consists of international standard (issued by WHO or set by international academic conference), domestic standard (set by government authorities, national academic organization and conference), diagnosis standard set by provincial academic organization and textbook standard by universities and colleges. A lot of literature network database, as well as ICD-10, therapy guide, professional periodicals, professional society website, and books could be used for searching. TCM clinical trials also cover syndrome diagnosis standard. The conclusion standard and exclusion standard setting and influence of improper standard setting is also discussed in this article.

TCM clinical investigators should attach importance to buildup of research basis in order to ensure the feasibility and normalization of clinical regimen,definite curative effect of treatment regimen and enhance consistency among different researchers and repeatability of clinical regimen.Syndrome,therapeutic method and prescription should be consistent,the addition or subtraction of the medicinal or the dosage should be reasonable.Reduce the use of rare or invaluable medicinal to avoid the restrictions of herb resource,drug cost and animal protection.When transforming decoction to capsule,granule,dripping pill and compound granule,the preliminary test in clinic to recur the curative effect of the decoction is necessary.The application of a single medicinal,the single target area of a medicinal or active ingredient of a single medicinal in a prescription should be based on the preliminary work experience.Meanwhile the county-level producing area of the processed medicinal should be explicit,in order to ensure the quality and efficacy of the processed medicinal.This article also discussed the key point of treatment regimen optimization of acupuncture and massage.

TCM clinical research covers different design types on basis of objective of the study. For exploratory research of TCM, cross-sectional study and descriptive research (e.g. case report and case analysis) is suitable. For hypothesis-testing research, RCT design is commonly adopted. RCT is most commonly used in activity or prevention therapy research, when using randomized cross-over design, the influence of sequence effects should be considered, and double-blind method is the best choice. Cohort study includes various intervention measures, as it doesn’t involve randomized allocation and blinding. Case-control study is widely applicable, but it may bring about bias. Cross-sectional study is much used in syndrome investigation of TCM clinical research. Descriptive research is available for summarization of TCM clinical experience and TCM exploratory research. Third party-central randomization system is recommended, as the randomization is not easy to be damaged. Randomization concealment should also be attached importance to. When blinding is impossible, blindness testing could reduce measurement bias, positive control should be supported high-level evidence. Placebo application could improve the level of evidence-based medicine.

Sample size design is to determine the minimum number of observed cases in the case of ensuring the reliability of research conclusions.The reliability of sample size estimation mainly related to the reliability of the basis of sample size calculation.Some things are essential,such as the emphasis on pre-test quality,extensive collection of relevant literature and research materials and accurate analysis.Estimation of sample size is first to determine the value of ?,?,or 1-? and effect indicators and their types,the effect indicators predictive value of each comparison group,the emphasis on sources and requirements of the effect indicators predictive value(the basis of calculation),besides,should pay close attention to study design and comparison of types,each group allocation ratio,the expected rate of lost to follow,the level of expected treatment compliance,the choice of some main effect indicators in outcome evaluation.An introduction and explaining with examples to estimation method and estimation of sample size formula,such as design of randomized controlled trials,cohort studies and case-control study commonly used in the clinical validation study of TCM,and study design commonly used in the clinical exploratory study of TCM,case analysis and so on.

Optimization of Traditional Chinese Medicine (TCM) clinical trials as philosophy, process and method, is extremely necessary and can be applied in different levels. Optimization of TCM clinical trials should follow some principles and procedures, and be executed in two ways. Optimization of treatment plan should be supported by the research basis and literature experience, and be perfected by research group and experts argumentation. Optimization of design plan is modified and accomplished by expert discussion and repeated consulting multi-disciplinary experts. Specific research objective, exact target population definition, proper design plan selection, valid calculation of sample size, precise and appropriate main outcome measures, data management system, medical ethics and statistical analysis are the focuses.

Start with common problems in the quality control process of TCM clinical research,we summarize the problems in protocol execution,CRF fill-in,ICF signature,medication management,EDC management,lab examination and AE report; meanwhile we analyze the reasons and put forward the countermeasures for the optimization of TCM quality control.

Statistical analysis plan (SAP) is an important guidance document in clinical research which is intended to be a comprehensive and detailed description of the methods and presentation of data analyses proposed for a clinical research. The analysis plan will be completed after finalising the protocol and should be finalised before treatment unblinding, to provide full details, even to the extent of including templates of tables, listings and figures to be presented in the statistical report. Any changes between the methods in the protocol and analysis plan will be explained in the analysis plan. In order to improve the quality of TCM clinical research, it is need to optimize the SAP. Considerations in optimizing the SAP include: determine the analysis sets and analysis variables, select analysis methods and statistical software.

BACKGROUND: The onset of vascular dementia (VD) is closely related to brain ischemic-hypoxia. Previous research has proved that behavioral disturbance can be obviously attenuated by xingnao qizhi capsule in VD rats; however, it remains unclear whether the improvement of VD is due to the protection on ischemic cells.OBJECTIVE: Pheochromocytoma PC12 cells were cultured in vitro and exposed to Na2S2O4 to induce hypoxia injury. Then serum pharmacological technique was used to investigate the protection of xingnao qizhi drug serum on hypoxia-injured PC12 cells.DESIGN: Randomized controlled study.SETTING: School of Traditional Chinese Medicine of Hebei Medical College.PARTICIPANTS: This study was conduced at the Experimental Animal Laboratory and Cell Culture Laboratory, School of Traditional Chinese Medicine of Hebei Medical College, between June and December 2003.Forty SD rats were randomized into 5 groups, namely serum control group (n=12) and xingnao qizhi serum 25.42, 12.71, 6.35 and 3.18 g/kg groups (n=7). PC12 cell line was purchased form the Cell Center of Chinese Academy of Medical Sciences.serum 25.42, 12.71, 6.35 and 3.18 g/kg groups were exposed through gastric lavage to xingnao qizhi of corresponding dosages (composed of wolfberwhile normal saline was given by gastric lavage to rats in control group in dosage of 10 mL/kg, twice a day at an interval of 12 hours for 3 consecutive days. One hour after the last administration, femoral blood samples were collected when rats were deeply anaesthetized and serum was sepainto 6 groups. Cells in control group were cultured with control serum while in experimental model groups cells were exposed to Na2S2O4 to induce hypoxia injury 1 hour later. Cells in Xingnao Qizhi 25.42, 12.71,6.35 and 3.18 g/kg groups were cultured in 5% drug serum with corresponding dosage of xingnao qizhi drug for 1 hour before being exposed to changes of PC12 cells in the six groups were observed under reversal microscope after exposure to Na2S2O4 for 16 hours; the inhibition rate of lactate dehydrogenase production and PC12 cell injury (MTT method) was calculated for assessing cell activity.nase production and PC12 cell injury.of xingnao qizhi displayed better refraction, with fewer cell fragments that tion: It was 81.6%, 69.6%, 54.4% and 27.8% in xingnao qizhi 25.42,PC12 cell injury: It was 82.9%, 75.6%, 65.9% and 53.7% in Xingnao Qizhi 25.42, 12.71, 6.35 and 3.18 g/kg groups, respectively.CONCLUSION: xingnao qizhi drug serum can markedly attenuate hypoxia injury of PC12 cells in dose-dependant manner, which is presented by strengthened cell activity and decreased lactate dehydrogenase activity.

Abstract: Beginning with 4-level quality control measures of clinical research in traditional Chinese medicine (TCM), we elaborated the implementation process and demands of quality control measures of each level, including quality control, monitoring, auditing, and inspection. On the basis of joint inspection experience of 41 projects of the "Prevention and Treatment of Difficult and Complicated Diseases of TCM" plan of the "11th Five-year National Key Technology R&D Program", we analyzed the ensuring effect of 4-level quality control system and joint inspection model, and then pointed out the existing problems in the executing process of quality control system at different levels and joint inspection model. Finally we investigated what should be revised in the quality control system and joint inspection model, thus providing the theoretical support for quality inspection improvement of TCM clinical research.