The clinical practice guideline on traditional Chinese medicine alone or combined with antibiotics for patients with acute upper respiratory infection in children was issued by China Association of Chinese Medicine in June 2017. Base on the evidence, consensus and experience, five manage groups, steering committee, consensus expert group, systematic review group, drafting group and secretary group, have promoted the project. The main work process refers to up-to-date clinical practice guideline definitions of institute of medicine and quick recommendations guide of guidelines international network and WHO. In order to provide readers with a better understanding of the guideline, the drafting process of guideline principle, main work process, and basis policy were described in detail in this paper. The guidelines’ scientific characteristics, accuracy and practicability were better exhibited in attempt to enhance its promotion and application.
Objective To evaluate the effectiveness and safety of traditional Chinese medicine (TCM) plus transcatheter arterial chemoembolization (TACE) compared with TACE alone, in the treatment of unresectable hepatocellular carcinoma (HCC). Methods The Cochrane Library, MEDLINE, EMBASE, CANCERLIT, CBM, CNKI and VIP were searched electronically. Relevant journals and conference proceedings were also handsearched. The quality of included studies was assessed according to the criteria recommended by the Cochrane Handbook for Systematic Reviews of Interventions, and meta-analyses were performed for homogeneous studies using The Cochrane Collaboration’s RevMan 4.2.10 software. Subgroup analyses by frequency of TACE (lt;3 or ≥3 times) were also performed. Results Thirty seven trials, all published in China, involving 2 653 participants were included. The quality of 2 studies was graded B (medium) and that of the other 35 was graded C (low). Meta-analyses showed that TCM plus TACE, compared with TACE alone, could significantly improve survival, tumor response (complete and partial), quality of life and clinical symptoms, and was also associated with a lower incidence of adverse reactions. Subgroup analyses indicated that, patients with less than three TACE had more significant improvement in survival and clinical symptoms, while patients with three or more TACE had more significant improvement in tumor response and quality of life. The incidence of adverse reactions was similar between these two different frequencies of TACE. Conclusions The treatment regimen of TCM plus TACE is superior to TACE alone in patients with unresectable HCC. As the existing data have a high risk of bias, the current evidence is insufficient to define the efficacy of the combination treatment, and further large-scale, high-quality randomized controlled trials are needed.
Traditional Chinese Medicine (TCM) clinical practice guidelines play essential roles in the development of TCM. However, the existing TCM guidelines are not effectively used in clinic. Based on this phenomenon, this article addresses the characteristics of clinical practice guidelines of TCM, and analyzes its status, problems and resolutions, providing feasible suggestions for the development of high-quality clinical practice guidelines of TCM which are in accordance with clinical practice.
Objective To assess the efficacy and safety of Chinese herbal medicines for chronic functional constipation. Methods We searched CNKI (1989 to November, 2009), CBM (1989 to November, 2009), VIP (1989 to November, 2009), Cochrane Library (Issue 4, 2009), PubMed (1966 to November, 2009) and EMbase (1986 to November, 2009). All randomized and quasi-randomized clinical trials of treating chronic functional constipation with Chinese herbal medicines versus untreated, placebo or western drug groups were included. Data were extracted independently by two reviewers. The methodological quality of trials was evaluated with Cochrane Handbook 5.0.2 criteria. Meta-analyses were conducted by the RevMan 5.0 software. Results Twenty-one trials involving 2 602 patients were included. The Meta-analysis results showed that: Chinese herbal medicines improved both syndromes and colonic transit function of recipients; moreover, it is superior to both gastrointestinal prokinetic agent in effective rate (RR=1.18, 95%CI 1.12 to 1.25), healing rate (RR=1.59, 95%CI 1.35 to 1.88), and cathartic in effective rate (RR=1.18, 95%CI 1.10 to 1.27), healing rate (RR=1.16, 95%CI 1.29 to 2.10). Integration of Chinese herbal medicines and gastrointestinal prokinetic agent is superior to gastrointestinal prokinetic agent in effective rate (RR=1.21 95%CI 1.09 to 1.34) and healing rate (RR=1.41, 95%CI 1.11 to 1.79). Conclusion Some Chinese herbal medicines may be effective and safe in treating chronic functional constipation, which can not be bly proved at present for lack of studies with high quality.
ObjectiveTo evaluate the efficacy and safety of traditinal Chinese Medicine (TCM) syndrome classification and intervention for the prophylaxis of menstrual migraine. MethodsPatients consistent with the inclusion criteria from January 2013 to June 2014 were included in the trial. Patients were randomized by their visiting order into two groups:the experimental group was treated with Chinese traditional medicine compound decoctions (two doses for three days), and the control group was treated with vitamin B2 (400 mg once daily). The patients were treated for thirty days consecutively. Efficacy was assessed using the records of the frequency, duration, and severity of migraine attacks. Laboratory tests, vital signs, and adverse events were monitored. ResultsBoth treatments led to a significant reduction in the frequency, duration, and severity of migraine attacks (P<0.05). TCM therapy was significantly better than vitamin B2 for reducing the frequency and the duration of migraine (P<0.05). No serious adverse drug reaction was found in both groups. ConclusionTCM syndrome classification and intervention is effective and relatively safe in the prophylaxis of menstrual migraine attacks.
Big data technology is an inevitable result of the information age, which not only promotes the development of biomedical science, but also opens up new paths for the development of traditional Chinese medicine (TCM). This paper introduced the application status of big data technology in the field of TCM in recent years, and put forward some thinkings and prospects so as to provide new insights and methods for the future development direction of TCM.
Objective To investigate inpatient disease constitution in Traditional Chinese Medicine (TCM) Hospital of Xinjiang Uygur Autonomous Region from 2008 to 2010, in order to provide baseline data for medicine allocation of hospitals in western China and development of TCM hospitals. Methods A questionnaire combined with a subject interview was carried out, and the case records of inpatients from 2008 to 2010 were collected. The diseases in discharge records were classified according to International Classification of Diseases (ICD-10) based on the first diagnosis. Data including general information of the inpatients, discharge diagnosis etc. were rearranged and analyzed by Excel software. Results a) The top four systematic diseases seen commonly from 2008 to 2010 were as follows: circulatory system diseases, musculoskeletal system and connective tissue diseases, respiratory system diseases and digestive system diseases. The top four single diseases were hypertension, intervertebral disc disease, diabetes, bronchitis, emphysema and other chronic obstructive pulmonary diseases. Respiratory system diseases ranked the third in 2009 and 2010 from the fourth in 2008, and circulatory system diseases had ranked the first during the past three years; b) The following diseases as hypertension, bronchial emphysema and other chronic obstructive pulmonary diseases, diabetes, fractures, airway (bronchus, lung) cancer, and viral hepatitis were commonly seen in males rather than in females. By contrast, intervertebral disc disease, gallstone disease and cholecystitis, and anemia were commonly seen in females; and c) Hypertension was commonly seen in the aged above 60 years old; intervertebral disc disease mainly focused on the patients at the age of 15 to 59; and bronchial emphysema and other chronic obstructive pulmonary diseases, airway (bronchus, lung) cancer involved in the patients who were mostly over 60 years old. Conclusion a) The top four systematic diseases seen commonly from 2008to 2010 are as follows: circulatory system diseases, musculoskeletal system and connective tissue diseases, respiratory system diseases and digestive system diseases. The top four single diseases are hypertension, intervertebral disc disease, diabetes, bronchitis, emphysema and other chronic obstructive pulmonary diseases. So these diseases should be taken into well consideration when making development plans by hospital and complementing essential drugs list by local development; b) Chronic diseases become the main disease for troubling Xinjiang population; and c) Male and female are susceptible to different diseases which should be rationally avoided in order to prevent the induced occurrence.
Intensive discussions and debates concerning whether we should and how to apply evidence-based medicine (EBM) research in traditional Chinese medicine (TCM) have arisen worldwide. We always hold the opinion: TCM needs EBM; the evidence from EBM is not limited to randomized controlled trials and systematic reviews; innovative methodological studies are urged based on the characteristics of TCM theoretically and clinically. Based on the methodological training and studies in this area, the authors discussed how to promote the evidence based TCM from five aspects including completing clinical trial procedure, reporting clinical trials according to international standards, reviewing the current clinical studies on TCM systematically, promoting the methodological research and academic exchange and better evidence (knowledge) management.
Master protocol is a great transformation of clinical trials with complete research network, reasonable design and innovative statistical analysis methods. It is a highly efficient new model of clinical trials which could obtain more medical information with less clinical resources. Clinical researches in the field of oncology using master protocol have already made delightful achievements. This paper introduces the design of clinical trials on angina pectoris of coronary heart disease, myocardial infarction and heart failure for instance and discusses the application of master protocol to clinical researches of Traditional Chinese Medicine combined with the differentiation of syndromes and treatments. We expect to provide new ideas and methods for the design of master protocol on diseases with similary syndrome pattern series of Traditional Chinese Medicine.
Objective To evaluate the efficacy and safety of Chinese herb compared with an analgesic drug in the treatment of cancer pain. Methods We electronically searched CBM (1990 to 2008), CNKI (1990 to 2008), VIP (1990 to 2008), The Cochrane Library (Issue 3, 2008), and MEDLINE (1990 to 2008). Relevant journals and conference proceedings were also handsearched. The quality of the included trials was assessed according to the criteria recommended by the Cochrane Handbook for systematic reviews of interventions and meta-analyses were performed for homogeneous studies using the Cochrane collaboration’s review manager 4.2.2 software. Results Five randomized controlled trails (RCTs), all published in Chinese, involving 590 participants, were included. The quality of all RCTs was graded C (low). Meta-analyses were not performed due to heterogeneity. Instead, descriptive analyses were conducted. The results showed that as for the total effective rate in pain-relieving, Zhentongsan (RR=1.11, 95%CI 1.00 to 1.24, P=0.05) and Xiaozhengzhitong paste (RR=1.35, 95%CI 1.02 to 1.78, P=0.04) were more effective than Indometacin, with significant differences. There were no significant differences between Duyiwei capsule and Indometacin, and so were between Huajianbadumo as well as Shebingzhitong paste and Tramado. In terms of early potency, there were significant differences between Zhentongsan (SMD= –?9.87, 95%CI –10.84 to –8.89, Plt;0.000 01) as well as Xiaozhengzhitong paste (SMD= –8.74, 95%CI –10.164 to –7.32, Plt;0.000?01) and Indometacin, and so were between Shebingzhitong paste and Tramadol (SMD= –2.24, 95%CI –3.00 to –1.49, Plt;0.000?01). There were no significant differences between Huajianbadumo and Tramodo. With regard to the durative effect on pain-relieving, there were significant differences between Xiaozhengzhitong paste and Indometacin (WMD=4.78, 95%CI 2.99 to 6.57, Plt;0.00001), but not between Shebingzhitong paste and Tramadol. Conclusion Because of low quality of the existing studies, the current evidence is insufficient to define the efficacy and safety of compound Chinese herb, and further large-scale and high-quality RCTs are needed.