Traditional Chinese Medicine (TCM) is one of the oldest systems of medicine. More and more attention has been paid to TCM application, but the variable quality of clinical trials with TCM impedes its widespread acceptance. The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement has established guidelines for designing clinical trials to ensure that the trial results are accurate and reliable. However, there are difficulties when applying SPIRIT 2013 Statement to trials with TCM, due to the unique theory and the characteristic of TCM intervention. An Extension to the original SPIRIT was developed to ensure the quality of trial design with TCM. As Chinese herbal formulae, acupuncture and moxibustion are common and representative interventions in TCM practice, the executive working group determined that the SPIRIT-TCM Extension focus on these three interventions. Extension was developed through initiation, 3 rounds of Delphi consensus survey, and finalizing expert meeting. Seven items from the SPIRIT 2013 Statement were modified, namely, "title", "background and rationale", "objectives", "eligibility criteria", "interventions", "outcomes", and "data collection methods". The Extension includes the introduction of the concept of TCM pattern and 3 major TCM interventions, with examples and explanations. The SPIRIT-TCM Extension 2018 provides suggestion for investigators in designing high quality TCM clinical trials. It is expected that wide dissemination and application of this extension ensure continuous improvement of TCM trial quality throughout the world.
Clinical Protocols ; Clinical Trials as Topic ; Humans ; Medicine, Chinese Traditional ; Research Design

BACKGROUND: Syndrome is one of the most important concepts in Chinese medicine (CM) theory. However, it was not well accounted in most of randomized controlled trials (RCTs). OBJECTIVES: To determine whether CM syndrome differentiation affects the treatment results, functional constipation (FC) was selected as a target disease, and MaZiRenWan (, MZRW), a classic CM formula commonly used for constipation with excessive heat syndrome, was selected for study. METHODS: It is an 18-week prospective double-blinded, doubledummy RCT, including 2-week run-in, 8-week treatment and 8-week post treatment follow-up. A total of 120 FC patients diagnosed as excessive heat syndrome will be recruited from the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and the Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine. Patients will be randomly allocated into fixed MZRW (f_MZRW) granule group, modified MZRW (m_MZRW) granule group or bisacodyl group. For m_MZRW group, no more than two herbal granules can be added according to the syndrome differentiation for individual participants. The primary end point is the mean of complete spontaneous bowel movements (CSBMs) per week during the treatment period. Secondary end points include mean of CSBMs per week during follow-up, stool form, global symptom improvement, constipation and constipation-related symptoms assessment, CM syndrome change, and reported adverse events. DISCUSSION This trial is designed to evaluate the effectiveness of these three interventions for FC patients with the CM syndrome of excessive heat, and to determine the change of CM syndrome and the progress of disease during the treatment course. The results are important to explore whether syndrome differentiation is important for the therapeutic effect of a formula on a disease. [Trial registration: Chinese Clinical Trial Registry (Reg No. ChiCTR-TRC-13003742); protocol version: MZRW/NSFC-81173363 (2015.05.04)].
Constipation ; diagnosis ; drug therapy ; Double-Blind Method ; Drugs, Chinese Herbal ; therapeutic use ; Humans ; Medicine, Chinese Traditional ; Outcome Assessment (Health Care) ; Prospective Studies ; Randomized Controlled Trials as Topic

How to test the treatments of Chinese medicine (CM) and make them more widely accepted by practitioners of Western medicine and the international healthcare community is a major concern for practitioners and researchers of CM. For centuries, various approaches have been used to identify and measure the efficacy and safety of CM. However, the high-quality evidence related to CM that produced in China is still rare. Over the recent years, evidence-based medicine (EBM) has been increasingly applied to CM, strengthening its theoretical basis. This paper reviews the past and present state of CM, analyzes the status quo, challenges and opportunities of basic research, clinical trials, systematic reviews, clinical practice guidelines and clinical pathways and evidence-based education developed or conducted in China, pointing out how EBM can help to make CM more widely used and recognized worldwide.
Critical Pathways ; Evidence-Based Medicine ; Humans ; Medicine, Chinese Traditional ; Practice Guidelines as Topic ; Randomized Controlled Trials as Topic

With the introduction and development of evidence-based medicine in China, it has been spread rapidly in the area of integrative medicine (IM) and has become a new unique discipline. During almost 20 years, as one of the most important parts of evidence-based IM, systematic review (SR)/meta-analysis (MA) of IM have shown a good development momentum in the aspects of quantity, depth, breadth and influence, but also face the harsh situation of the uncontrolled quantity and quality, especially for SRs in Chinese. Therefore, how to supervise and standardize this area effectively becomes a problem to be solved. Based on the experience both at home and abroad, the authors put forward several kinds of solutions for laying the foundation for further development such as promoting the registration system of SR/MA of IM, effectively setting up the regulatory platform of quality and quantity, launching professional training for SR/MA reviewers, forming qualification registration, developing the data transfer and sharing platform to realize the transparency of evidence process.

OBJECTIVE:To provide reference for teaching reform of Pharmaceutical English in our university. METHODS:According to the theory of needs analysis,by the means of classroom observation,questionnaire survey combined with personal in-terview,the participation of students majoring in Pharmaceutical Engineering,Pharmaceuticals and TCM Source of Grade 2013 in Pharmaceutical English classrooms of our university were investigated to investigate target needs and learning needs of students and analyze main influential factors of students'enthusiasm. RESULTS:It was found that the students participated passively in the Pharmaceutical English classrooms,mainly targeted at credit hour(88 students,58.28%)and aimed at the improvement of read-ing ability(73 students,48.34%). From aspect of learning needs,the students presented evenly enthusiasm for between traditional teaching method and modern teaching method;expected teachers asked more difficult questions;the study focused on actual and ef-fective feedback from the students. Their participation was mainly influenced by course property,teaching content and teaching method. The students'learning objectives were greatly affected by course propevty;to the students,the teaching content was more important than teaching method. CONCLUSIONS:It is to be improved in course property and location,teaching content and teach-ing method of Pharmaceutical English in our university. Pharmaceutical English should be included in required course;teaching content is combined with pharmaceutical practice;various teaching mode is formulated according to teaching content so as to meet students'need and improve teaching effect.

The review aims to assess the effectiveness and safety Pudilan Xiaoyan oral liquid in treating pediatric suppurative tonsillitis systematically through searching relevant electronic database and collecting relevant literature. Meta-analysis was performed with the RevMan 5.3 software. Eighteen RCTs of 1 883 patients of pediatric suppurative tonsillitis were included. Meta-analysis showed that： compared with the application of antibiotics alone, combined with Pudilan can effectively improve the treatment of pediatric suppurative tonsillitis in efficacy rate and shorten the time of recovering normal temperature, the time of tonsil purulent discharge and can also reduce the extinction time of sore throat, antiadoncus or congestion subsided and appetite recovery. There was no severe adverse reaction during the treatment. Compared with the application of antibiotics alone, combined with Pudilan may be more effective and safe in the treatment of pediatric suppurative tonsillitis, which can not be strongly proved at present for lack of studies with high quality.

Objective To investigate the clinical effect of Spleen Aminopeptide Oral Lyophilized Powder on mycoplasma pneumonia in children and its influence in immune function.Methods Totally 103 cases of children infected with mycoplasma pneumonia from May 2013 to June 2016 were selected and divided into observation group and control group,with 53 cases in each group.The control group were treated with azithromycin,and observation group were treated with azithromycin combined with Spleen Aminopeptide Oral Lyophilized Powder.The clinical effect,T cell subgroup (CD4+,CD8+,CD4+/CD8+) levels,serum cytokine levels (IL-10,IL-17,TGF-β1) and safty were compared.Results The total effective rate of the observation group was 94.39％,which was significantly higher than that of the control group of 79.25％ (P ＜ 0.05).After treatment,the levels of CD4+,CD4+/CD8+ in two groups were significantly higher than those before treatment (P ＜ 0.05),and the levels of CD4+,CD4+/CD8+ in observation were higher than those in control group significantly (P ＜ 0.05).The levels of CD8+,IL-10,IL-17,TGF-β1 in two groups were significantly lower than before treatment (P ＜ 0.05),and those indexes in observation were lower than those in control group,the difference was statistically significant (P ＜ 0.05).Conclusion Azithromycin combined with Spleen Aminopeptide Oral Lyophilized Powder has remarkable clinical effect on mycoplasma pneumonia in children,which is cecurity and reliable,and can improve the cellular immune function and reduce the immune injury.

Objective To investigate the abdomen CT characteristics of patients with ischemic bowel disease (ICBD).Methods CT imaging data of ICBD patients from January 2008 to December 2013 in the Chinese PLA General Hospital were retrospectively analyzed to find CT imaging features in intestinal lesions associated with ICBD death.Results In CT imaging analysis,151 patients including acute superior mesenteric artery thromboembolism (ASMATE,n=51),acute superior mesenteric vein thrombosis (ASMVT,n=53),non-occlusive mesenteric ischemia (NOMI,n=8),chronic mesenteric ischemia (CMI,n=10) and ischemic colitis (IC,n=29) were divided into survival group (n=115) and death group (n=36).In comparison with the survival group,the death group had higher incidence of abdomenal effusion,portomesenteric gas,pneumatosis intestinalis and pneumoperitoneum (P＜0.001,P＜0.001,P＜0.001,P=0.003).Conclusion The ascites,portomesenteric vein gas,pneumatosis intestinalis and pneumoperitoneum in bowel CT may be associated with the death of ICBD patients.

Tyrosine kinase inhibitor (TKI) therapy significantly improved the prognosis and outcome of patients with chronic myeloid leukemia(CML). Long-term therapy of TKI drugs was often accompanied with financial burden and the rise of chronic adverse effects. At present, the treatment-free remission (TFR) has been gradually regarded as the new ultimate aim to the patients with long-term CML. In clinical trials, the patients with the therapy of imatinib stopping TKI treatment after acquired deep molecular reaction still maintained remission. Here, the research progress on discontinuation of TKI therapy and how to better grasp the safety of drug withdrawal strategy are reviewed. However, the radical cure of CML needs more further research.

Case reports are valuable clinical evidence in traditional Chinese medicine (TCM). However, the general reporting quality is suboptimal. A working group comprising 20 members was set up to develop systematic recommendations on case report in Chinese medicine (CARC). The working group (CARC group) developed a primary checklist based on reviewing the general reporting quality of case reports in TCM and thorough internal discussion. Two-round consensus process had been carried out among clinical experts, evidence-based medicine methodologists, medical journal editors and clinical practitioners with designated questionnaire embedded with the primary checklist. In total, 118 participants from 17 provinces of China and Korea completed the questionnaires. Their feedback was analyzed and discussed by the CARC group. The checklist was amended accordingly, and the final version, comprising 16-item, is presented here. Under the framework of CARC recommendations, the reporting quality of case reports in TCM can be improved.
Consensus ; Female ; Health Planning Guidelines ; Humans ; Male ; Medical Records ; Medicine, Chinese Traditional ; Research Report