Despite of the progress in the treatment of severe acute pancreatitis (SAP), there are still factors that hinder the improvement of the efficacy of treatment: there is a lack of an accurate and easy-to-use system for early severity prediction; the multidisciplinary collaboration mechanism needs to be further optimized; there is no clinical efficacy evaluation system for traditional Chinese medicine (TCM); the therapeutic targets of TCM are unclear; the effector substances are unknown; and the research and development of new medicines is still difficult. In order to further reduce the mortality of SAP and realize the goal of improving the efficacy, we should strengthen the integration of Chinese and Western medicine, multidisciplinary collaboration, and improve the treatment levels; as well as carry out basic and clinical research oriented to clinical value. We will also promote the innovative development of combined Chinese and Western medicine in the treatment of SAP by elucidating the mechanism, validating the efficacy and commercializing the achievements. In view of SAP, a major and difficult disease, we should insist on the principle of integrity and innovation, the synergy of Chinese and Western medicines and the complementarity of advantages, and promote the innovation and development of combined Chinese and Western medicines in the treatment of SAP, so as to further reduce the morbidity and mortality and to alleviate the burden of the disease.
Objective To review the systemat ic reviews/meta-analyses involving Traditional Chinese Medicine (TCM ) therapy for menopausal syndrome, so as to offer clinical evidence about the safety and efficacy of TCM. Methods We searched The Cochrane Library (Issue 4, 2006), MEDLINE (1991 to 2006), Ovid (1990 to 2006), CBM(1990 to 2006), CNKI(1989 to 2006) and VIP(1979 to 2006). The search terms of "menopause OR climacteric" and "traditional Chinese medicine OR herb OR plant" and "systematic review OR evidence-based medicine OR Meta-analysis OR Meta-analysis" were used to identify systematic reviews or meta-analyses on TCM for menopause syndrome. Results A total of 6 systematic reviews or meta-analyses were identified. Two of these were in Chinese databases and four were in the foreign language databases. The 6 articles were reviewed and summarized. Conclusion TCM has a effect in the treatment of menopausal syndrome with a good safety profile. However, due to the generally low quality of included studies, the evidence available is not b enough to evaluate the efficacy and safety of TCM for menopausal syndrome.More rigorously designed and strictly executed trials are needed.
Objective To explore whether the placebo-controlled trials in traditional Chinese medicine (TCM) were scientific and ethical. Method An electronic search concerned with placebo-controlled trials of TCM was performed at Chinese Journal Full-text Database, Chinese Scientific and Technological Periodical Database (VIP), Wanfang Database and Chinese Bio-medicine Database (CBM) from January 1979 to April 2008. In addition, we handsearched the trials in specialized journals of TCM. The trials were assessed regard with their scientificalness, ethic and traits of TCM of placebo-controlled trials. Results A total of 231 trials were included, occupying about 2.09% of all the randomized controlled trials (RCTs) of TCM; among which there were 79 (34.20%) with sequence generation, 10 (4.33%) with allocation concealment, 129 (55.84%) with blind methods; 106 (45.89%)with basic intervention, 13 (5.63%) with criteria of intervention quality control, 139 (60.17%) with preparation of placebo, 10 (10.33%) with aggravating scheme, 70 (30.30%) with syndrome type of TCM, 48 (20.78%) with the outcome measurement of TCM. There were 48 RCTs (20.78%) were not scientific. There were 221 RCTs without institutional review board and 187 RCTs without informed consent. Conclusion Placebo-controlled trials of TCM are not applied extensively, and some of them are not scientific. Most of than do not meet the ethical requirements.
Objective To assess the benefits and harms of traditional Chinese medicine in the treatment of postmenopausal osteoporosis. Methods We electronically searched MEDLINE (1966-2003), EMBASE (1974-2003), Controlled Trials Register and The National Research Register, The Cochrane Library Issue 4, 2003, CBM disc, VIP, CNKI, and CMCC. We also handsearched some related journals. The search was conducted in Nov., 2003. The quality of included randomized controlled trials was evaluated and meta-analysis was conducted by RevMan 4.2.2. Results We identified 33 studies including 2 337 patients and 27 traditional Chinese medicines. Some traditional Chinese medicines alone or integrated Chinese and Western medicine may be effective for improving patients’ bone mineral density, serum oestradiol and serum calcium. For example, Compared with placebo, Bushen Yigu soft extraction with WMD 0.76, 95% confidence interval 0.65 to 0.87, Bushen Qianggu capsule with WMD 39.94, 95% confidence interval 35.12 to 44.76 were effective for improving the level of serum oestradiol.There were no confirmed results of the other traditional Chinese medicines because of the small number of studies or inconsistent conclusions among studies. We didn’t find obvious side effects. Conclusions Some traditional Chinese medicines may be effective for treating postmenopausal osteoporosis. Due to the limited evidence identified, we can not draw a firm conclusion. More randomised controlled trials of high quality are needed for ber evidence.
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.
Evidence-based Chinese medicine is a relatively new discipline which applies the concepts and methods of evidence-based medicine (EBM) to the clinical research and practice of Chinese medicine. It is not only a branch of EBM but also a natural product of the development of Chinese medicine. This paper introduces the theoretical concepts of evidence-based Chinese medicine and reviews the process of its development. It then elucidates the main characteristics of evidence-based Chinese medicine, emphasizes its holistic approach, prescription-syndrome relationship, and its human-centered approach. Research contents and status quo are also summarized to point out the challenges of the production and application of evidence. Finally, we innovatively indicate further research directions on combining individual-based research with population-based research and developing narrative EBM.
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.
The two factors that affect enrollment of participants and the process of intervention in randomizedcontrolled pragmatic trials are similar to the situation of clinical practice, thus its effects are similar to the situation ofclinical practice. Therefore, when one estimates an intervention’s effect on a patient, it will be more similar to a real clinicalsituation than results taken from an explanatory trial. Due to the introduction of interventions and process variables usedin a pragmatic trial that conform to traditional Chinese medicine and acupuncture practices, more and more interest isgrowing among researchers in the traditional Chinese medicine field. This article introduces the principles and conceptsof the pragmatic trial, and the key points of design via some samples.
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.