Diabetic neuropathic pain (DNP) is one of the most common and complex complications of diabetes. In recent years, studies have shown that gut microbiota can regulate inflammatory response, intestinal permeability, glucose metabolism, and fatty acid oxidation, synthesis, and energy consumption by regulating factors such as lipopolysaccharides, short chain fatty acids, bile acids, and branched chain amino acids, achieving the goal of treating DNP. This paper summarizes the relevant mechanisms of gut microbiota in the treatment of DNP, the relevant intervention measures of traditional Chinese and western medicine, in order to provide new ideas for clinical treatment of DNP.
Since the concept of core outcome set (COS) was introduced into clinical trials of traditional Chinese medicine (TCM), researchers have paid much more attention to develop COS for specific diseases. Although researchers believe that the characteristics of TCM, such as syndromes, should be considered in the COS of TCM, it was insufficiently addressed. In addition, the naming of TCM syndromes has not been standardized, and the classification and diagnostic criteria for specific diseases have been inconsistent. Thus, it is difficult to include TCM syndromes in the COS. Different diseases may show similar TCM syndromes which makes research difficult. Based on previous studies, this paper provided methods of developing core TCM syndromes set according to the model of combination of disease and syndrome and the model of syndrome dominating disease to provide references for future researches.
A core outcome set (COS) is an agreed minimum set of outcomes that should be reported in all clinical trials in specific areas of health care. The use of COS can reduce the heterogeneity of outcomes reporting in different trials and enhance evidence synthesis in systematic review/meta-analysis by including more studies with the same outcome. It can also enhance the value of trials and reduce cost waste to some extent. Recently, Core Outcome Measures in Effectiveness Trials (COMET) initiative has developed the COMET handbook (version 1.0). This handbook discussed the problems of COS research and made some recommendations. This paper interprets the COMET handbook (version 1.0) and analyses its insight on the construction of TCM clinical research COS, combined with the characteristics of TCM clinical research, in order to provide a reference for related researchers.
ObjectiveTo evaluate the methodological quality of cross-sectional surveys about Chinese medicine syndrome in a population at potential risk of cerebrovascular diseases. Methods The CNKI, WanFang Data, CBM and PubMed databases were electronically searched to collect cross-sectional surveys about Chinese medicine syndromes in a population at potential risk of cerebrovascular diseases from inception to December, 2022. The methodological quality was assessed using the JBI scale. Results A total of 105 studies were included. The average reporting rate of JBI was 52.06%, and the items with the highest scores included "sufficient coverage of the identified sample in data analysis" (100%), "description of study subjects and setting" (92.38%), and "using valid methods for the identification of the condition" (86.67%). Items with the lowest scores included "adequate sample size" (13.33%), "adequate response rate or low response rate managed appropriately" (14.29%), and "study participants recruited in an appropriate way" (20.95%). Subgroup analysis suggested that type of publication and number of implementation centers were potential factors influencing methodology quality (P<0.05). Conclusion The methods essential to a cross-sectional survey such as sampling, sample size calculation and handling with the response rate, and the syndrome diagnosis scales specific to Chinese medicine require further improvement.
Traditional Chinese medicine equipment plays an indispensable role in the prevention, diagnosis, treatment and rehabilitation of traditional Chinese medicine from the needs of people's life and health, and provides technical support for the simple, convenient, cheap and effective clinical practice of traditional Chinese medicine. The traditional Chinese medicine equipment industry has the development advantages of large demand gap, strong policy support and emerging technology empowerment. At the same time, there are also bottlenecks such as lagging standardization construction, weak industrial foundation, insufficient characteristics of traditional Chinese medicine and immature evidence-based evaluation research. The coming of the era of digital intelligence has brought new opportunities for the development and reform of the traditional Chinese medicine equipment industry. This paper provides development ideas for the transformation of traditional Chinese medicine equipment from traditional to modern from the aspects of standardization construction, digital intelligence industry upgrading, improvement of evidence-based evaluation system and in-depth international exchanges and cooperation.
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.
ObjectiveTo systematically review the efficacy of Chinese medicine injection (CMI) for treating heart failure (HF).MethodsCNKI, WanFang Data, VIP, The Cochrane Library, PubMed, and EMbase databases were electronically searched from inception to January 2021 to identify randomized controlled trials (RCTs) on CMI for treating HF. Two reviewers independently screened literature, extracted data, and evaluated the risk of bias of included studies. Network meta-analysis was then performed by RevMan 5.2 software and Stata 16.0 software.ResultsA total of 47 studies were included involving 4 902 patients and 5 types of CMIs, including Shenmai, Shenfu, Yiqi Fumai (lyophilized), Shengmai, and Danhong injections. The results of network meta-analysis showed that the efficacy of combined CMIs was superior to conventional Western medicine alone. For the main efficacy, Shenmai, Shengmai, and Shenfu injections had significant advantages in improving the total clinical effectiveness. Shengmai, Shenmai, and Yiqi Fumai (lyophilized) injections were significantly more effective for reducing NT pro-BNP levels than other injections. Shenfu and Shengmai injections were significantly more effective for reducing BNP levels than other injections. Shenmai, Danhong and Shengmai injections were significantly more effective for improving the left ventricular ejection fraction than the other injections. These CMIs showed similar advantages for secondary efficacy indicators as for main efficacy indicators.ConclusionsThe combined 5 types of CMIs for treating HF can improve the clinical efficacy when compared with conventional Western medicine treatment. Shenmai injection, Yiqi Fumai injection (lyophilized), and Shengmai injection, which is part of Sheng Mai San, have clear advantages in terms of the overall curative effect or on individual indices.
ObjectiveTo evaluate the outcomes used in randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in the treatment of unstable angina pectoris, so as to provide references for the study of the core outcome set of TCM on the treatment of unstable angina pectoris.MethodsWe searched RCTs of TCM on the treatment of unstable angina pectoris in the databases of PubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP from January 2009 to August 2019. Two reviewers independently screened all records, extracted data and evaluated risk of bias of included trials. A qualitative analysis was conducted to analysis the outcomes.ResultsA total of 43 RCTs were included and their outcomes were categorized into 7 categories: clinical symptoms and signs, quality of life evaluation, blood biochemical outcomes, ECG, cardiac function outcomes, safety outcomes (including adverse reactions and events), and other related outcomes. Blood biochemical outcomes were the most frequently reported outcomes, followed by the clinical symptoms and signs. Of the 43 RCTs, 35 RCTs applied TCM syndromes efficacy as outcomes. Our analysis identified a series of problems in the application of outcomes: no distinction between primary and secondary outcomes, and most of the primary outcomes were intermediate alternative outcomes; the efficacy evaluation standards for TCM syndromes were different; the blinding method was ignored when the subjective outcomes were measured; less attention was paid on adverse outcomes than efficacy outcomes; the names of the same outcome were not standardized; the statistical expression of outcomes required improvement; the quantity of outcomes selected in different studies varied significantly; in TCM related efficacy outcomes, the effective rates were frequently used, however, the evaluation criteria were different.ConclusionsThere are numerous problems for the outcomes’ selecting for RCTs of TCM treatment of unstable angina pectoris. We should use the international standardized method of creating the core outcome sets to establish a core outcome set in line with the characteristics and laws of diagnosis and treatment of traditional Chinese medicine.
The paper discusses the scientificity, evidence-based research, clinical practice and related problems of traditional Chinese medicine (TCM) from three aspects: theory, demonstration and application, and attempts to clarify ambiguities and misconceptions, further correctly evaluate the historical status, important value and realistic significance of TCM, strengthen our national and cultural confidence, reinforce our theoretical and practical confidence, and strongly refute the derogation and stigmatization towards TCM theory and practice by very few people, in order to provide suggestions for the progress and development of TCM.
In the process of evidence-based practice, the evaluation of evidence applicability relied on the subjective judgment of clinicians, while the systematic method of which was still in lack. The complex clinical information of traditional Chinese medicine (TCM) enhanced the uncertainty and risk of applying evidence. Based on the analysis of the process of evidence-based practice, this paper introduced the method of TCM evidence applicability evaluation and used the raw data of clinical trials to develop a clinical prediction model to enable the assessment of the evidence applicability on individual patients. The establishment of individual evidence applicability evaluation method could promote the rational application of TCM evidence in the long term.