ObjectiveTo compare the similarities and differences in procedures between Western medicine (WM) and traditional Chinese medicine (TCM) guidelines. MethodsWe systematically searched China National Knowledge Infrastructure, WanFang Data, China Biology Medicine disc and PubMed from inception to May 17, 2022. Supplementary search of reputable medical institutions and organizations, as well as retrospective references were conducted and screened. We extracted and analyzed the basic information and guideline development procedure of the included handbooks. ResultsA total of 10 handbooks published from 2013 to 2022 were included, with four WM handbooks and six TCM handbooks. The median completeness of handbooks was 53.3%, with a maximum of 93.3% and a minimum of 43.3%. There are six handbooks with less than 60.0% completeness. The median reporting rate of the key steps was 65.0%, and the reporting rate of 5/8 of the key steps was more than 80.0%. Among the key reporting steps, role of funders, update methods, and conflict of interest management were reported at a low rate. Compared with WM handbooks, TCM handbooks reflected TCM characteristics in the procedure of topic selection, working groups, conflict of interest declaration and management, clinical questions, evidence, recommendations, report guideline, and external review. ConclusionThe completeness and reporting rate of the key steps need to be improved. TCM characteristics need to be further integrated when developing TCM guideline handbooks. We highly recommend that guideline stakeholders actively participate in handbook development to promote the quality of handbooks.
Objective To assess the efficacy and safety of Chinese medicinal herbs for asymptomatic hepatitis B virus(HBV) infection. Data Source The trials registers of the Cochrane Hepato-Biliary Group, the Cochrane Library and the Cochrane Complementary Medicine Field were searched in combination with MEDLINE, EMBASE, and handsearches of Chinese journals and conference proceedings. Data Selection Randomized clinical trials with 3 months follow-up comparing Chinese medicinal herbs versus placebo, no intervention, non-specific treatment, or interferon treatment for asymptomatic HBV carriers were included. No language and blinding limitations were applied. Data Extraction Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad-scale plus allocation concealment. Results Three randomized clinical trials (307 patients) with low methodological quality following patients for three months or more after the end of treatment were included. Herbal compound Jianpi Wenshen recipe showed significant effects on clearance of HBV markers compared to interferon: relative risk 2.40 (95 % CI 1.01 to 5.72) for clearance of serum HBsAg, and 2.54 (1.13 to 5.70) for seroconversion of HBeAg to anti-HBe. Phyllanthus amarus and Astragalus membranaceus showed no significant antiviral effect compared with placebo. Analysis of pooling eight randomized clinical trials with less than three months follow-up did not show a significant benefit of Chinese medicinal herbs on viral markers. No serious adverse event was observed. Conclusions There is insufficient evidence for treatment of asymptomatic HBVcarriers using Chinese medicinal herbs due to the low quality of the trials. Further randomized, double blind, placebo-controlled trials are needed.
Objectives To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).Methods We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria. Results Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings. Conclusion The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.
Objective The core indicator pool of ischemic stroke (IS) was constructed to provide a basis for the establishment of the core outcome set (COS), so as to improve the consistency of clinical research and evaluation results of traditional Chinese medicine (TCM) treatment for IS. Methods In this study, the mixed methods research (MMR) convergent parallel design was used to carry out qualitative research and quantitative research at the same time, and the two research results were integrated to reach a conclusion. Quantitative research comprehensively collected the multi-source efficacy evaluation indicators of TCM treatment of IS, and carried out descriptive statistical analysis based on frequency theory. Semi-structured interviews were used in the qualitative research, relevant interest groups were selected to understand the evaluation indicators of the IS efficacy of TCM treatment that they were concerned about, and NVivo software was used for in-depth analysis, coding, classification, and extraction of the efficacy indicators. Based on the principle of pillar integration, quantitative and qualitative research results were integrated to construct an element pool of evaluation indicators for the treatment of IS with traditional Chinese medicine. Results A total of 437 standard papers, 71 registered trial protocols, 100 real-world medical data cases and several guideline consensus policy documents were included in the quantitative study, and a total of 314 indicators in the acute phase of IS, 154 indicators in the recovery phase, and 104 indicators in the sequelae phase were extracted. In the qualitative research part, a total of 32 indicators in the acute stage of IS, 34 indicators in the recovery stage and 35 indicators in the sequelae stage were extracted through interviews. Through group discussion and the principle of pillar integration, an element pool of IS indicators was formed, including 279 IS indicators in the acute stage, 142 indicators in the recovery stage and 91 indicators in the sequelae stage. Conclusion Based on the MMR convergent parallel design, the element pool of the characteristic indicators of the therapeutic effect of IS in TCM is constructed to meet the needs, which provides the preliminary work basis for the construction of the core outcome set of IS in the next stage.
Objective To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems. Methods Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed. Results In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects. Conclusions Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.
Inconsistency, impracticability and non-standardization of the selection, measurement and reporting of outcomes are three primary existing issues in clinical trials. These problems pose a threat to huge research waste when the results of similar studies are not able to be combined or compared. The key for resolution will be to standardize outcomes in traditional Chinese medicine (TCM) clinical trials and to establish a core outcome set (COS), which is a set of outcomes to be reported as a minimum in all TCM clinical trials of similar healthcare system and syndromes. The first step in the development of COS is to collect all existing outcomes, that is, to build a pool of outcomes for clinical trials of TCM. A pool of outcome is the basis of developing COS, which is important to follow strict and scientific methodology. This paper aims to construct an outcome pool from published literature, clinical trial registration protocols, and clinicians, and patients questionnaires were used to form a list of outcomes. In addition, the influencing factors of constructing an outcome pool and considerations for each problem are summarized in order to provide guidance and reference for the development of COS in clinical trials for TCM.
ObjectiveTo investigate the chronic insomnia incidence and traditional Chinese medical (TCM) constitution of students in Southern Medical University, in order to discover the correlation between chronic insomnia and TCM constitution. MethodsA survey by means of the TCM Constitution Scales, the Pittsburgh Sleep Quality Index (PSQI), Epworth Sleepiness Scale (ESS) and the Deep Sleep Scale (DSS) in 110 participants studying in Southern Medical University between September 2009 and July 2014 was conducted. We analyzed the characteristics of chronic insomnia in subjects of qi-deficiency type and gentleness type. ResultsA total of 115 questionnaires were sent out, and 110 were recovered with a recovery rate of 95.65%. All the 110 questionnaires were useful and the effective rate was 100%. There were 34 cases of gentleness type and 44 cases of qi-deficiency type in the 110 participants. It was found that qideficiency type got significantly different scores for all the three types of scales, compared with gentleness type (P＜ 0.01) . Meanwhile, qi-deficiency type showed significant differences in terms of sleep quality, sleep time, sleep disorder and daytime dysfunction from gentleness type (P＜ 0.05) . We also found that the incidences of shallow sleep and insomnia for qi-deficiency type were higher than those for gentleness type (P=0.002, 0006) , respectively. Finally, it was detected that the level of insomnia for qi-deficiency type was higher than that for gentheness type (P＜ 0.01) . Conclusions This study has revealed that there is a statistically significant association between qi-deficiency type and chronic insomnia. It is suggested that further research should be conducted for cure of chronic insomnia from the perspective of changing TCM constitution.
ObjectivesTo analyze the citation of evidence in traditional Chinese medicine (TCM) clinical pathways in China, and to provide suggestions for future development and revision of TCM clinical pathways.MethodsTCM clinical pathways released on the websites of national administration of TCM and China association of Chinese medicine were obtained, with the retrieval time limit to June 2019. Two researchers separately utilized the Excel to extract data and performed a descriptive analysis.ResultsA total of 405 TCM clinical pathways were included, involving internal medicine, surgery, gynecology and pediatrics. Internal medicine accounted for the largest proportion of the TCM clinical pathways (133). All the 405 pathways cited references as evidence, among which the maximum and minimum quantities of cited references were 11 and 1, respectively, and the median was 3. More than 90% of the TCM clinical pathways cited the evidence in the parts of diagnosis and efficacy evaluation. For parts of TCM and western medicine treatment, the proportion of TCM clinical pathways which cited evidence was less than 75%; for parts of rehabilitation and nursing, the proportion of TCM clinical pathways which cited evidence was less than 2%. The types of evidence being cited were standard indicators (683), clinical practice guidelines (488), textbooks (236), consensus opinions, ancient books and clinical surveys. The released time was reported in 89.25% of the cited evidence; the largest time interval was between the release time of the standard indicators (evidence) and that of the TCM pathways. Among the evidence released more than 15 years before the release of the TCM pathways, the proportion of standard indicators was the highest (57.12%).ConclusionsThe published TCM clinical pathways are all developed based on evidence, however, the evidence citation ratio in different parts varies greatly. In some TCM clinical pathways, the cited evidences are not reported normatively, and some evidence are poor in timeliness.
Objective To compare the efficacy of one kind of modified De Vega technique and traditional De Vega technique. Methods From January 2002 to August 2005, 70 patients were treated with tricuspid valve plasty. These patients were divided into modified De Vega annuloplasty group and traditional De Vega annuloplasty group randomly before operation. The tricuspid regurgitation （TR） were functional and secondary in all patients. The grade of TR and New York Heart Association（NYHA） functional class of two groups were analyzed by Ridit analysis. The changes of right ventricular end-diastolic dimension of two groups were analyzed by paired-sample t test. Results There was no statistically difference between two groups about preoperative characteristics. The follow-up time of modified De Vega annuloplasty group was 12.91±8.84 months and that of traditional De Vega annuloplasty group was 13.61±11.21 months. There was no significant difference between two groups. The outcome of follow-up was satisfactory. In modified De Vega annuloplasty group, there were 12 patient with no TR, 17 patient with mild TR, and 6 patients with moderate TR. There was no patient with severe TR. In traditional De Vega annuloplasty group, 7 patients were observed with no TR, 19 patients mild TR, 7 patients moderate TR and 2 patients severe TR. In modified De Vega annuloplasty group, 32 patients were in NYHA class Ⅰ, 2 patients in NYHA class Ⅱ and only 1 patient in NYHA class Ⅲ. As for traditional De Vega annuloplasty group, 31 patients were in NYHA class Ⅰ, 2 patients in NYHA class Ⅱ and 2 patients in NYHA class Ⅲ. The Ridit analysis showed that there was no significant difference about NYHA class between two groups. However, the difference of TR between two groups was statistically significant （P〈0.05）. The outcome of modified De Vega annuloplasty was superior to that of traditional De Vega technique. Paired-sample t test demonstrated that the modified De Vega annuloplasty could reduce the right ventricular end-diastolic dimension significantly （P〈0.05）. However, the right ventricular end-diastolic dimension of traditional De Vega annuloplasty groups did not change significantly （P 〉 0.05）. Conclusion The efficacy of modified tricuspid De Vega technique is superior to that of traditional De Vega technique in patients with secondary TR.
Different from modern medicine, traditional Chinese medicine (TCM) has its unique thought patterns and decision methods. In the process of developing TCM clinical practice guidelines, not only the modern clinical researches should be included, but also the TCM ancient books which had influenced TCM for thousands of years should be included. As an important carrier of TCM, the characteristics of researches in TCM ancient books are different from modern clinical researches. In this paper, we introduced the present situation of the TCM guidelines and how to use TCM ancient books for developing TCM clinical guideline with the guidance of evidence-based method. We used the example of developing of headache TCM guideline to explain how to use TCM ancient books as evidence source for guideline development and explored the application of evidence-based research of TCM ancient books to promote TCM clinical guidelines development.