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.

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.

Objective To investigate the therapeutic effects of botulinum toxin type A injection and acupuncture on periorbital wrinkles.Methods From May to September in 2015,24 patents were randomly divided into experimental and control group according to random number table:the patients in experimental group were treated with disposable acupuncture needles,20 min for each treatment,once a day,five times each course for courses,2 days interval between the two courses;the patients in control group were treated with 20 units of hotulinum toxin type A injection.The therapeutic results were observed 2 weeks after the treatment by the third-party doctor according to skin wrinkles grading.Results The periorbital wrinkles in both groups improved remarkably,and the wrinkle grading in control group was significantly lower than that in the experimental group (0.67±0.67 vs 1.33±0.61,P＜0.05).The skin quality and facial expression sensation in the experimental group improved significantly when compared with those in the control group.Conclusions Acupuncture can be used as a complementary treatment of periorbital wrinkles,and it improves the skin quality in terms of elasticity and color and keeps the natural facial expression sensation.

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.

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.

BACKGROUND: The efficacy and safety of recombinant human bone morphogenetic protein-2 (rhBMP-2) combined with autologous bone grafting for the treatment of spinal degenerative diseases such as lumbar spondylolisthesis, spinal canal stenosis and intervertebral disc herniation have been recognized, but few clinical studies have been conducted on the efficacy and safety in the treatment of spinal infectious diseases such as spinal tuberculosis. OBJECTIVE: To evaluate the clinical efficacy and safety of rhBMP-2 combined with autologous bone grafting for spinal tuberculosis. METHODS: Clinical data of thoracolumbar tuberculosis admitted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine from November 2010 to May 2018 were retrospectively analyzed. All patients underwent posterior pedicle screw fixation plus bone graft for spinal fusion, with (experimental group) or without (control group) the use of rhBMP-2. In the experimental group, 33 patients were treated with posterior pedicle fixation and autologous bone graft for spinal fusion combined with rhBMP-2 (1 mg). In the control group, 35 patients underwent posterior pedicle fixation and autologous bone graft. Visual analogue scale, the American Spinal Injury Association (ASIA), perioperative complications and fusion rate were statistically analyzed. The study protocol was approved by the Ethics Committee of the First Affiliated Hospital, Guangzhou University of Chinese Medicine. Informed consent was obtained from each patient. RESULTS AND CONCLUSION: All patients were followed up for more than 1 year. During the follow-up period, no fracture or movement of the internal fixation or distinct collapse of the vertebral body were found. There was no significant difference between the two groups in terms of operative time, intraoperative blood loss, length of stay, and proportion of perioperative complications (P > 0.05). There was a significant improvement in visual analogue scale scores and ASIA grades in the two groups at 1 week and 1 year after operation (P < 0.05). However, there were no statistically significant differences between the experimental and control groups (P > 0.05). The fusion rate in the experimental group was significantly higher than that in the control group at 6 months after operation (P < 0.05), but there was no statistically significant difference between the two groups at 1 year after operation (P > 0.05). These findings indicate that rhBMP-2 combined with autologous bone for the treatment of thoracolumbar tuberculosis can accelerate bone fusion with favorable efficacy and safety in a short time.

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.

Aim To investigate the effect of intracerebroventricular morphine postconditioning against ischemia-reperfusion injury in rat heart and the mechanism of the central nervous system opioid receptor.Methods Forty-two Sprague-Dawley Rats were established intracerebroventricular catheter placement and myocardial ischemia/reperfusion models and randomly assigned to 7 groups:Sham group(Sham),control group(CON),intravenous control group(VCON),morphine postconditioning group(POC),intracereborventricular morphine postconditioning group(MOC).According to the dosage of intracerebroventricular morphine(3 ?g?kg-1,0.3 ?g?kg-1,0.03 ?g?kg-1),MOC group was assigned to three groups :MOC 1,MOC 2,MOC 3.Infarct size(IS),a percentage of the area at risk(AAR) was determined by triphenyltetrazolium(TTC) staining.c-fos expression in nucleus of tractus solitarius was determined by immunohistochemical method and Cardiac TroponinI(cTnI) of serum was observed at 120 min of reperfusion.Results Compared with control group,IS,IS/AAR and cTnI were significantly reduced in POC and MOC groups(P0.05).c-fos expression in nucleus of tractus solitarius were significantly reduced in MOC 2,POC(P

ObjectiveTo investigate and analyze the current primary quality management situation in TCM clinical studies.Methods One sub-center unit from 39 projects of “Prevention and Treatment of Difficult and Complicated Disease of TCM” plan of the“11th Five-year National Key Technology R&D Program” was chosen. Executive condition of the primary quality control of each unit was under field investigation, and quality control quantitative evaluation indexes were used to conduct quantitative evaluation.Results Results were shown as the forms of statistical description and radar map. The average and median scores of primary quality management were 5.05 and 5.2, respectively. The best and preferable proportions of 39 units were 25.64% and 28.21%. Other 46.15% of these units performed poor. The problem mainly manifested on insufficient frequency and bad normalization of primary quality management, such as comprehensiveness and integrity of inspection contents, cases, problem recordings and problems timely feedback.ConclusionAlthough the primary quality management is widely conducted in TCM clinical studies, there are still some problems to be settled and improved.

TCM clinical research should attach importance on ethical issues,as it takes the human for the research subjects and the clinical research activities definitely involve the benefits and risks to the subjects.Ethics optimization on the basis of safety and scientificity is necessary.This study explores the optimization of some key links of ethics of TCM clinical research,i.e.optimization of ethics committee membership,optimization of ethical review of study protocol,optimization of informed consent process,and optimization of protection and compensation of the subject,thus providing the theoretical support for ethics improvement of TCM clinical research.