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.
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.
Objective To assess the effects and possible adverse reactions of traditional Chinese medicine (TCM) in treating arteriosclerosis obliterans. Methods Materials were collected with both electronic retrieval including EMbase (1978 to October 2009), OVID-MEDLINE (1950 to October 2009), Cochrane Controlled Trials Register (Issue 3, 2009), Current Controlled Trials, The National Research Register, CBM (1983 to September 2009), CNKI (1995 to September 2009), Wanfang Data (1994 to 2009), and VIP Data (1989 to 2009), and manual retrieval of related journals. All the retrievals were published before November 10, 2009 without limitation of languages. The quality of included studies was evaluated, and meta-analysis was conducted with RevMan 5.0.2 software. Results A total of 10 included studies were all randomized controlled trials, including 837 patients, and the sample size of each study was from 36 to 260 cases. Because both Chinese medicines and control drugs used in studies were different from each other, the effect size of each study can only be singley described and newly calculated. Most included studies showed that, the effects of TCM on cure rate, total effective rate and decrease of TC and TG were similar to that of aspirin, acipimox, prostaglandin E1; a few studies showed the effect of TCM was much better; one study on side effect showed that, TCM was less than western medicine. Conclusion The evidences of TCM effects in treating arteriosclerosis obliterans is quite limited, which has to be strengthened by more studies of high quality.
Objective To analyze the differences in distribution of traditional Chinese medicine (TCM) syndrome elements and salivary microbiota between the individuals with pulmonary nodules and those without, and to explore the potential correlation between the distribution of TCM syndrome elements and salivary microbiota in patients with pulmonary nodules. Methods We retrospectively recruited 173 patients with pulmonary nodules (PN) and 40 healthy controls (HC). The four diagnostic information was collected from all participants, and syndrome differentiation method was used to analyze the distribution of TCM syndrome elements in both groups. Saliva samples were obtained from the subjects for 16S rRNA high-throughput sequencing to obtain differential microbiota and to explore the correlation between TCM syndrome elements and salivary microbiota in the evolution of the pulmonary nodule disease. Results The study found that in the PN group, the primary TCM syndrome elements related to disease location were the lung and liver, and the primary TCM syndrome elements related to disease nature were yin deficiency and phlegm. In the HC group, the primary TCM syndrome elements related to disease location were the lung and spleen, and the primary TCM syndrome elements related to disease nature were dampness and qi deficiency. There were differences between the two groups in the distribution of TCM syndrome elements related to disease location (lung, liver, kidney, exterior, heart) and disease nature (yin deficiency, phlegm, qi stagnation, qi deficiency, dampness, blood deficiency, heat, blood stasis) (P<0.05). The species abundance of the salivary microbiota was higher in the PN group than that in the HC group (P<0.05), and there was significant difference in community composition between the two groups (P<0.05). Correlation analysis using multiple methods, including Mantel test network heatmap analysis and Spearman correlation analysis and so on, the results showed that in the PN group, Prevotella and Porphyromonas were positively correlated with disease location in the lung, and Porphyromonas and Granulicatella were positively correlated with disease nature in yin deficiency (P<0.05). ConclusionThe study concludes that there are notable differences in the distribution of TCM syndrome elements and the species abundance and composition of salivary microbiota between the patients with pulmonary nodules and the healthy individuals. The distinct external syndrome manifestations in patients with pulmonary nodules, compared to healthy individuals, may be a cascade event triggered by changes in the salivary microbiota. The dual correlation of Porphyromonas with both disease location and nature suggests that changes in its abundance may serve as an objective indicator for the improvement of symptoms in patients with yin deficiency-type pulmonary nodules.
With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
Acute pancreatitis (AP) is a common clinical emergency of the abdomen with increasing incidence and lack of effective treatment. Traditional Chinese medicine, as a treasure of the Chinese people, has been used in the treatment of AP for decades with favorable therapeutic effects. Currently, clinical trials and experimental studies have shown that traditional Chinese medicine has the effects of inhibiting pancreatic enzyme activity, anti-inflammation, promoting gastrointestinal dynamics, as well as delaying the progress of AP, improving clinical symptoms, reducing related complications, and reducing the mortality rate. Therefore, traditional Chinese medicine has considerable clinic value in treating AP. Based on the related research progress and clinical practice of our team, the authors summarized the targets and mechanism of traditional Chinese medicine in treating AP.
Objective To assess the effect of integrated traditional Chinese medicine with western medicine (ICWM) in the treatment of SARS. Methods We searched MEDLINE, EMBASE, and Chinese BioMed Database ( CBM ) , and the Intemet performed handsearching in Chinese journals and reference lists. We included randomised controlled trials and prospective controlled studies of integrated Chinese medicine with western medicine versus western medicine alone in people with SARS. Three independent reviewers collected details of study population, interventions, and outcomes using a data extraction form. We conducted meta-analysis for similar data of studies.Results Nine studies (n =812) were included, all with the possibility of containing serious bias. ICWM in the treatment of SARS was associated with the following reductions: case fatality [ OR 0.32, 95% CI (0.14,0.71 ) ] , fever clearance time [ WMD -1.17, 95% CI ( -1.83, -0.50 ) , symptom remission time [ WMD-1.47, 95% CI ( - 1.96, - 0. 98) ] and the number of inflammation absorption cases [ MD 1.63, 95% CI(0.95, 2.80 ) ], having no significant difference in symptom scores of convalescents [ WMD -1.25, 95% CI ( -2.71, 0.21 ) ], cumulative dose of corticosteroids [ WMD - 236.96, 95% CI ( - 490.64, 16.73) ] and inflammation absorption mean time [ WMD 0.63, 95% CI ( - 1.33, 2.59) ] .Conclusions Due to the methodological limitations of the studies, the effect of ICWM for SARS is unclear. The apparent improvements in cases fatality, fever clearance time, syndromes remission time and numbers of inflammation absorption cases warrant further evaluation with high quality and large scale trials to be expected.
Evidence-based medicine advocates to support clinical decision-making with the best evidence, which is useful to objectively evaluate the clinical efficacy of traditional Chinese medicine and optimize clinical diagnosis and treatment. However, significant individualized characteristics identified from syndrome differentiation and treatment are incompatible with evidence-based clinical decision-making, which highlights population-level evidence, to some extent. In recent years, a number of new methods and technologies have been introduced into individualized clinical efficacy evaluation research of traditional Chinese medicine to assist managing and processing complex and multivariate information. These methods and technologies share similarities with evidence-based medicine, and are expected to link the clinical practice of traditional Chinese medicine with evidence-based clinical decision-making. They will guide the development of evidence-based clinical decision-making in traditional Chinese medicine.
Precision medicine is a personalized medical system based on patients' individual biological information, clinical symptoms and signs, forming a new clinical research model and medical practice path. The basic idea of traditional Chinese medicine and the concept of precision medicine share many similarities. The basket trial developed for precision medicine is also suitable for clinical trials and evaluation of the efficacy of traditional Chinese medicine syndrome differentiation and treatment systems. Basket trials are used to evaluate the efficacy of a drug in the treatment of multiple diseases or disease subtypes. It has the advantages of sharing a master protocol, unifying management of subsidiary studies, simplifying the test implementation process, unifying statistical analysis, saving resources, reducing budgets and accelerating the drug evaluation progress. This is similar to the concept of using the "same treatment for different diseases" found in traditional Chinese medicine. This paper introduced the concept and method of basket trials and explored their application and advantages in clinical research into traditional Chinese medicine. This study is expected to provide references for the methodological innovation of clinical research into traditional Chinese medicine.
ObjectivesTo investigate the citation status of systematic reviews (SRs)/meta-analyses in clinical practice guidelines and consensuses of traditional Chinese medicine (TCM).MethodsWe electronically searched PubMed, CBM, WanFang Data and CNKI databases to collect TCM guidelines and consensus from January 1st, 2009 to December 31st, 2018. Two reviewers independently screened literature and extracted data. Citation analysis method was used to analyze the citation status of SRs/meta-analysis in TCM guidelines and consensuses.ResultsA total of 142 TCM guidelines and consensuses were included, of which 39 (26.5%) failed to provide relevant citations. Of the 103 (72.5%) TCM guidelines and consensuses providing citations, 48 (34.3%) cited SRs/meta-analyses, and 43 cited outdated SRs/ meta-analyses. Four TCM guidelines and consensuses cited Cochrane reviews. In terms of citations, the average citations of guidelines and consensuses were 35.1 and 42.2, respectively; and the average SRs/meta-analyses citations of guidelines and consensuses were 3.8 and 5.5, respectively.ConclusionsTCM guidelines and consensuses citation report rates and the proportion of citation SRs/meta-analyses still require increase. TCM guidelines developers should strengthen the role and significance of SRs, especially Cochrane reviews, in supporting recommendations.