The modernization and internationalization of traditional Chinese medicine (TCM) are the key issues we must face up to. The development of TCM needs to depend on the breakthrough of methods and the innovation of ideology, and the international standardization of scientific research evaluation. The clinical evidence from randomized comtrolled trials (RCT) is valuable and reliable. It has shown that the proportion of RCT identified in TCM journals was less than 30%, and the score of RCT’s quality was less than 3 using Jadad scale. However, the number of systematic reviews on TCM is increasing rapidly after the evidence-based medicine (EBM) was introduced and practiced in China. Until 2004, 43 systematic reviews of TCM were published in China, and the quality of RCT included in those reviews was elevated. It has shown that the efficacy and safety of TCM indicated some advances in treatment of certain kind of diseases. It has been realized that RCT are important in TCM, and improving the quality of RCT is the key step for modernization and internationalization of TCM.
To promote the accessibility and application of guidelines, it is necessary to establish a professional guideline database to adapt to the rapid growth of TCM clinical practice guidelines. This study described the framework design, technology module, information management, and quality control of the clinical practice guideline database of traditional Chinese medicine (G-TCM). G-TCM had included 658 TCM clinical practice guidelines, which would provide a platform for clinicians, researchers, guideline makers (revision), and evaluators to quickly query and obtain clinical guideline information, and play a supporting role in promoting the standardization and accessibility of TCM clinical practice guidelines and better guiding clinical practice.
Objective To systematically assess the effectiveness of traditional Chinese medicines (TCM) in treating upper airway cough syndrome (UACS) or postnasal drip syndrome (PNDS). Methods Such databases as MEDLINE (1950 to 2011), PubMed (1996 to 2011), VIP (1989 to 2011), WanFang Data (1998 to 2011), CNKI (1979 to 2011) and CBM (1978 to 2011) were searched for collecting the randomized controlled trials (RCT) or quasi-RCTs about TCM treating UACS/PNDS. The trials were screened according to the inclusive and exclusive criteria, and then after the quality assessment and data extraction were conducted, the statistical analysis was conducted by using RevMan 5.0 software. Results A total of 10 RCTs and quasi-RCTs in Chinese were identified. The results of analysis showed that: a) The integrated Chinese and western medicine was superior to western medicine alone, either for adults and children with UACS, or for adults with PNDS. However the effectiveness had to be further assessed due to lack of high-quality literatures; b) TCM alone was probably more effective than western medicine alone for adults with PNDS, but not for adults and children with UACS. No obvious adverse reaction related to TCM was reported. Conclusion The recent research outcomes show that the integrated Chinese and western medicine is superior to western medicine alone, either for adults and children with UACS, or for adults with PNDS, but no definite evidence is found to support the superiority of TCM in treating UACS/PNDS. More high-quality RCTs with large scale need to be conducted in future to verify this conclusion due to the overall low methodological quality and significantly different intervention of the included trials.
Objective To evaluate the methodological quality of clinical trials on traditional Chinese medicine (TCM) nursing in recent six years.Methods Such databases as CNKI, VIP, WanFang Data and CBM were searched for collecting clinical trials on TCM nursing published from January 2006 to September 2011, and domestic primary nursing journals were also searched from January 2010 and September 2011. Methodological quality of included studies was assessed using quality assessment criteria of the Cochrane systematic review guideline. Results A total of 854 clinical trials were retrieved, including 706 (82.7%) randomized controlled trials (RCTs), 108 (12.6%) quasi-randomized controlled trials and 40 (4.7%) non-randomized controlled trials. In the methodological quality analysis, the comparability of baseline was mentioned in 784 trials (91.8%), a total of 498 (58.3%) reported definite diagnosis criteria. 178 (20.8%) reported exclusive criteria. 831 studies (97.3%) applied relevant statistical methods properly. However, only 55 trials (6.4%) mentioned the method of randomization sequence. 10 studies (1.2%) described the method of randomiztion assignment. Blinding was mentioned in 22 studies (2.6%). 98 trials (11.5%) did prospective follow-up. 93 trials (10.9%) had safety description. 20 trials (2.3%) reported lost and with drawl cases, but only 2 conducted intention-to-treat analysis. It was hard to determine whether there was selective reporting bias or not because all the studies did not have protocols. Only 21 studies (2.5%) mentioned the lack of outcome indicators which could be the evidence for existing of bias. By annual analysis, there were 81 trials which conformed to at least 2 low risk criteria. 10 trials (12.3%) was published in 2009, 26 trials (32.1%) published in 2010, and 27 trials published by September 2011, indicated an uptrend. Conclusions According to the Cochrane Collaboration’s tool for assessing risk of bias, the overall quality of clinical trials on TCM nursing is low with defects in different degrees, but it rises gradually over years.
Objective To review the current status of evidence-base medicine (EBM) research on traditional medicine in Japan. Methods Serial reports of EBM special committee of Japan Society for Oriental Medicine (JSOM) were reviewed. Results EBM special committee of JSOM was established earlier and carried out systematic reviews of Kampo treatment throughout Japan. The quality of preparations was standardized and reliable. Evidence Reports of Kampo Treatment 2009 (EKAT 2009) may be a promising promotion for Kampo treatment in Japan. Conclusion For the promotion and development of evidence-based Chinese medicine in China, we need to learn from EBM research projects of JSOM. Based on the current status of EBM research in China, special efforts should be made in validity of research data and scientific analysis and reports of non-randomized trials. According to the characteristics of traditional Chinese medicine, EBM research should be systematically carried out from simple to complex.
ObjectiveTo evaluate the methodological bias and the reliability of the conclusions of systematic reviews (SRs) about traditional Chinese medicine for essential hypertension. MethodsWe comprehensively searched PubMed, EMbase, The Cochrane library (Issue 4, 2014), CBM, CNKI and WanFang Data to collect SRs of traditional Chinese medicine for essential hypertension from the establishment time of databases to April 30th, 2014. The AMSTAR tool was applied for methodological quality assessment of included studies, and the GRADE system was applied for evidence quality assessment of included outcomes of SRs. ResultsA total of 12 SRs involving 31 outcomes were included, of which 11 SRs focused on the comparison of therapeutic effects between traditional Chinese medicine combined with western medicine and western medicine alone. Nine SRs adopted Jadad tool to assess methodological quality of included original studies. The results of assessment using AMSTAR showed that, among 11 items, there were the most problems concerning Item 1 "Was an 'a prior' design provided?" (none of the 12 SRs provided it); followed by Item 11 "Were potential conflict of interest included?" (nine SRs didn't described it), and Item 6 "Were the characteristics of included studies provided" (six SRs didn't provided it). The results of grading showed that, 29 outcomes were graded as "low" or "very low" quality. The main factors contributed to downgrading evidence quality were limitations (31 outcomes), followed by imprecision (12 outcomes), and inconsistency (13 outcomes). ConclusionCurrently, the methodological quality of SRs about traditional Chinese medicine for essential hypertension was poor on the whole, with low quality of evidence as well as lack of enough attention to the end outcomes of patients with essential hypertension. Thus, physicians should apply the evidence to make decision about traditional Chinese medicine for essential hypertension with caution in clinical practice.
ObjectivesTo systematically review the safety of traditional Chinese medicine injection based on clinical centralized monitoring studies that have been carried out and listed so far, to understand basic situation of adverse reactions and explore the risk factors of traditional Chinese medicine injections and to provide evidence for clinical rational use of drugs and optimizing centralized monitoring methods. MethodsCFDA, CNKI, VIP, WanFang Data, Sinomed, PubMed and The Cochrane Library databases were electronically searched to collect studies on safety monitoring of listed traditional Chinese medicine injections from inception to February, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed by using Excel software. ResultsA total of 14 studies involving 14 varieties of injections, 296 200 cases were included. The highest incidence rate of adverse reactions was found in the XueBiJing injection (2.54%). The related factors of ADR extraction were age, sex, drug combined usage, time from administration, allergic history, administration days, indication, dose and distribution of the tube. ConclusionsThe safety of traditional Chinese medicine injection is generally high. Middle and old age is an important factor in the occurrence of ADR. The incidence of ADR is relatively high in the first 6 days of drug use, and the incidence of ADR is more likely to be caused by irrational use of drugs in clinic, and the history of allergy may be related to the occurrence of ADR. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusion.
Objective To survey the current difficulties and guidance expectations of postgraduate students of traditional Chinese medicine (TCM) in writing and publishing international journal papers, in order to optimize the teaching mode of international journal articles for TCM postgraduates. Methods By means of a questionnaire survey, TCM postgraduate students in China were selected as the survey objects from four aspects: basic information, current situation of thesis publication and writing, paper writing difficulties and current situation and expectation of course offering. SPSS 26.0 software was used for data analysis. Results A total of 2 874 valid questionnaires were collected. A total of 1 365 postgraduate students had plans to write international journal papers; 324 postgraduate students had published international journal papers as the first author. The degree of difficulty in writing was generally rated high by postgraduate students, and lack of writing skills and time were the main reasons for the low motivation of thesis writing. A total of 2 547 graduate students felt that guidance on writing papers for international journals was urgently needed, with literature search methods and clinical research methods and experimental design as the most needed guidance, and reviewers and supervisors as the most desired guides. Conclusion The number of TCM postgraduates who have plans to write international journal papers is small, the proportion of publications is low, and the demand for international journal paper guidance courses is high. It is suggested that standardized international journal paper guidance courses be offered to improve the system of cultivating scientific research ability.
ObjectiveTo evaluate the efficacy of myomectomy via transumbilical laparoendompic single-site surgery (TU-LESS) and traditional multiport laparoscopy.MethodsThe study was conducted at Chengdu Western Hospital from June 2019 to June 2020. Fifty patients underwent TU-LESS myomectomy (TU-LESS group), while another 50 patients underwent traditional multiport laparoscopic myomectmy (multiport laparoscopy group). The conditions of operation, extra analgetic usage, VAS grade, and patients’ satisfaction degree were compared between two groups.ResultsPatients in both groups had similar age, BMI, fibroma volume, operative time, expelling gas day, blood loss, complication rate, and hospitalized costs (P>0.05). Compared with traditional multiport laparoscopy, the TU-LESS group resulted in significantly shorter hospitalization day, lower VAS score of the 1st/3nd/7th days after surgery, less use of analgetic after surgery, and higher satisfaction degree.ConclusionsTU-LESS is safe and feasible for myomectomy, and it is associated with less pain, shorter hospitalization day, and higher satisfaction degree.
Objective To evaluate the radiographic and postoperative function of computer navigation versus traditional methods for total knee arthroplasty through meta-analysis. Methods we searched the specialized trials registered in Cochrane muscle group, The Cochrane Library (CCTR), MEDLINE (1966 to 2009), EMbase (1980 to 2009), PubMed (1966 to 2009), NRR (http://www.update-software.com/National/), CCT (http://www.controlled-trials.com), and CBMdisc (1979 to July 2009), and we manually searched some Chinese orthoopaedics journals. Data were extracted and evaluated by two reviewers independently. Randomized controlled trials of computer navigation and traditional methods for total knee arthroplasty were included. The quality of the included trials was critically assessed. RevMan 4.2.8 software was used for data analysis. Results Eighteen RCTs of computer navigation and traditional methods for total knee arthroplasty were included. A total of 2 349 patients met the inclusion criteria for the review. The results showed that, computer navigation versus traditional methods for the total knee arthroplasty: a) about radiography: there was difference in the precise measurement of lower limbs mechanical axis (WMD= – 0.56, 95%CI – 0.74 to – 0.38, Plt;0.00001), but no obvious difference in measurement of the femoral frontal axis (WMD= – 0.29, 95%CI – 0.58 to 0.00, P=0.05), sagittal axis (WMD= – 1.64, 95%CI – 3.49 to 0.21, P=0.08) and angle of rotation (WMD= – 0.11, 95%CI – 0.87 to 0.66, P=0.79). Obvious difference was not found in the tibial frontal axis (WMD= – 0.31, 95%CI – 0.69 to 0.06, P=0.10), but found in the tibial sagittal axis (WMD= – 0.69, 95%CI – 1.10 to – 0.28, P=0.001). No difference was found in the tibiafemoral angle (WMD= 0.03, 95%CI – 0.78 to 0.84, P=0.95), patella tilt angle (WMD= – 1.45, 95%CI – 3.12 to 0.22, P=0.09) and patella angle of rotation (WMD= – 0.34, 95%CI – 0.71 to 0.02, P=0.06); b) there was obvious difference in operating time (WMD= 13.31, 95%CI 10.00 to 16.63, Plt;0.000 01), but no obvious difference in the complications (RR= 1.65, 95%CI 0.87 to 3.13, P=0.13) and the hemorrhage volume (WMD= – 74.81, 95%CI – 184.71 to 35.09, P=0.18); and c) about the evaluation of postoperative function: the follow-up in all studies was more than 6 months; there was no obvious difference in joint motion (WMD= – 2.17, 95%CI – 5.66 to 1.33, P=0.22), KSS scores (WMD= 6.28, 95%CI – 3.69 to 16.25, P=0.22), and OXFORD scores (WMD= – 0.31, 95%CI – 2.05 to 1.43, P=0.72). Conclusions Compared with traditional methods, computer navigation using for the total knee arthroplasty: a) is much accurate in measurement of the lower limbs mechanical axis and tibial sagittal axis, but is not superior in measurement of the femoral frontal axis, femoral sagittal axis, femoral angle of rotation, tibial frontal axis, tibiafemoral angle, patella tilt angle, and patella angle of rotation; b) may spend a longer operating time if not performed by proficient for it is a kind of new technique realm, but is similar in decreasing complications and hemorrhage volume; and c) is not obvious different in function evaluation after over 6 months follow-up which has to be further studied.