ObjectiveTo systematically review the efficacy and safety of ginseng preparations in improving insulin resistance (IR). MethodsWe electronically searched databases including PubMed, MEDLINE, EMbase, CNKI, VIP, WanFang Data, and CBM from inception to October 2015, to collect randomized controlled trials (RCT) about ginseng preparations for IR patients. Two reviewers independently screened literature, extracted data, and assessed the risk of bias of included studies. Then meta-analysis was performed using RevMan 5.3 software. ResultsA total of 17 RCTs involving 1169 patients were included. The results of meta-analysis showed that treatment combined with ginseng preparations group was superior to the control group in levels of HOMA-IR (MD=-0.13, 95%CI -0.24 to -0.01, P=0.03), ISI (MD=0.72, 95%CI 0.25 to 1.19, P=0.003), FPG (MD=-0.90, 95%CI -1.27 to -0.52, P<0.00001), 2hPG (MD=-1.48, 95%CI -2.03 to -0.92, P<0.00001) and HbA1c (MD=-0.73, 95%CI -1.16 to -0.31, P=0.0008). No statistically differences between two groups were found in levels of FPI and F-CP. As for the safety, a total of 9 cases in the ginseng group occurred adverse reactions. Symptoms of adverse reactions included hypoglycemia, dizziness, nausea, blurred vision. ConclusionCurrent evidence shows that, treatment combined with ginseng preparations could improve insulin sensitivity and reduce blood glucose in IR patients with type 2 diabetes and metabolic syndrome. Due to limited quality and quantity of the included studies, the above conclusion need to be verified by more high quality studies.
Objective To conduct a scoping review on the clinical research evidence for the treatment of coronavirus disease 2019 (COVID-19) with traditional Chinese medicine, identify relevant problems in the literature, and provide ideas for the follow-up research. Methods PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure, Wanfang Digital Journal Full-text Database, and China Biomedical Literature Database were searched from inception to July 21st, 2022. The clinical research evidence for the treatment of COVID-19 with traditional Chinese medicine was included, the data information was sorted out, and the results were descriptively analyzed. Results A total of 132 studies were included, including 53 randomized controlled trials, 17 non-randomized controlled trials, and 62 retrospective cohort studies, all of which were published between 2020 and 2022. The clinical studies were carried out in 19 provincial level regions, among which Hubei province had the largest number of studies (49.2%, 65/132). The sample sizes of the studies were mostly between 50 and 100 cases (43.2%, 57/132). Most of the studies had a treatment course of 0-14 days (50.0%, 66/132). The most compared intervention measures were traditional Chinese medicine + conventional western medicine treatment vs. conventional western medicine treatment, accounting for 75.0% (99/132) of the studies. The COVID-19 patients included in the studies were mainly mild and moderate. Outcome indicators included changes in symptoms/signs, laboratory indicators, CT indicators, clinical outcomes, safety indicators, functional scales, etc. The main adverse reactions/events in intervention/exposure groups were gastrointestinal reactions. Conclusions There has been a lot of clinical research evidence on the treatment of COVID-19 by traditional Chinese medicine. To provide strong evidence support for the treatment of COVID-19 by traditional Chinese medicine, more clinical trials with large samples and international collaboration are needed in the future.
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 research in traditional Chinese medicine (TCM) has made many important achievements and promoted the modernization and internationalization of TCM. The ability to produce research evidence to guide clinical practice in an emergency treatment situation is a major test of the development of evidence-based Chinese medicine (EBCM) when emerging infectious diseases outbreaks. Along with the development of EBCM, TCM has experienced emerging infectious disease events such as atypical pneumonia (SARS), influenza A (HIN1), and corona virus disease 2019 (COVID-19), and the ability of TCM to conduct clinical research in emergency treatment work has been continuously improved. This article provides an overview of the clinical research conducted in TCM to resist emerging infectious diseases in the past, focusing on the clinical research results obtained in the present time of COVID-19 rescue and treatment, and discusses the role of EBCM development to enhance the clinical research capacity of TCM in emerging infectious diseases.
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.
Objective To analyze the hospitalization expenses and structure of day surgery diseases between general hospital and traditional Chinese medicine hospital, so as to provide a basis for the reform policy formulation of the payment mode of traditional Chinese medicine medical insurance and the optimization of hospital management. Methods Relevant data such as hospitalization expenses and expenses structure of day surgery of one general hospital and one traditional Chinese medicine hospital in Shanghai between January 1, 2019 and June 30, 2022 were selected. The hospitalization expenses and expenses structure of day surgery in traditional Chinese medicine hospital and general hospital were analyzed. Results A total of 95232 day surgery cases were selected in the case hospitals, including 1389 cases in traditional Chinese medicine hospital and 93843 cases in general hospital. The age of day surgery patients in traditional Chinese medicine hospital was smaller than that in general hospital (P<0.001). The total hospitalization expenses [4379.6 (2293.2, 7563.4) vs. 7629.5 (4467.5, 14154.0) yuan], drug expenses [343.0 (65.0, 1107.0) vs. 749.0 (64.0, 1419.0) yuan], consumables expenses [858.8 (162.2, 1630.1) vs. 1951.0 (620.1, 5720.7) yuan], technical labor expenses [1994.8 (1116.8, 3252.4) vs. 3943.3 (2510.8, 6123.4) yuan] of day surgery patients in traditional Chinese medicine hospital were lower than those of patients in general hospital (P<0.001), and the examination expenses were higher than those of patients in general hospital [432.0 (0.0, 898.5) vs. 40.0 (0.0, 418.0) yuan, P<0.001]. In terms of the total hospitalization expenses structure of patients undergoing day surgery, the proportion of technical labor expenses in traditional Chinese medicine hospital was the highest (42.5%), and the proportion of consumables expenses in general hospital was the highest (43.7%). The specialty of day surgery in the traditional Chinese medicine hospital mainly focused on gynecology, general surgery, anorectal surgery and pain medicine, with the highest average expenses in ophthalmology. The specialty of day surgery in the general hospital mainly focused on urology, biliary, pancreatic and gastrointestinal surgery, ophthalmology and gynecolog, with the highest average expenses in orthopedics. There was no statistically significant difference between the age of patients undergoing hemorrhoidectomy in traditional Chinese medicine hospital and that in general hospital (P>0.05). The total hospitalization expenses [7177.4 (6057.5, 8225.7) vs. 10730.3 (8895.7, 14291.4) yuan], drug expenses [838.0 (441.0, 1342.0) vs. 1532.0 (1335.0, 1698.0) yuan], consumables expenses [4518.7 (4268.3, 5084.9) vs. 5550.9 (4066.6, 8340.7) yuan], technical labor expenses [1138.8 (911.3, 1414.2) vs. 3793.9 (2997.1, 4410.3) yuan] of day surgery patients undergoing hemorrhoidectomy in traditional Chinese medicine hospital were lower than those of patients in general hospital (P<0.05), and the examination expenses were higher than those of patients in general hospital [329.0 (0.0, 598.0) vs. 40.0 (40.0, 40.0) yuan, P<0.05]. In terms of the total hospitalization expenses structure of day surgery patients undergoing hemorrhoidectomy, the highest proportion was consumables expenses both in traditional Chinese medicine hospital and general hospital (63.8% and 53.6%, respectively). Conclusions There are differences between the hospitalization expenses of day surgery in traditional Chinese medicine hospital and general hospital. The dominant disease types of day surgery in traditional Chinese medicine hospitals need to be further cultivated. In the future, when the traditional Chinese medicine medical institutions implement the payment according to the diagnosis-related group/diagnosis-intervention packet, they should fully combine the actual situation of the medical institutions and the characteristics of the disease type, and at the same time, they need to further establish the medical fine management based on the disease type quality evaluation.
Objective To assess the quality of randomised controlled trials on traditional Chinese medicine (TCM) for coronary heart disease (CHD) angina published from 1977 to 2002. Method We did electronic search in Medline, Embase and hand searched 83 journals of traditional Chinese medicine (the earliest published in 1977 and the latest in June 2002). We assessed the quality of obstained studies. Results Four hundred and forty articles met the criteria,of which 33 (7.5%) described randomization. None of them mentioned allocation concealment; 94.77% (417 studies) mentioned diagnosis criteria; only one mentioned the calculation basement of sample size; 84.09% (370 studies) mentioned comparability of baseline. Fifty three studies (12.05%) noted double-blind; 28 studies used single blind. Twenty-five studies used double-blind. Drop-outs were described in 7 cases without intention-to-treat (ITT); 159 studies applied statistical methods properly, while 4 did not. Ten studies never mentioned statistical methods; 73.18％ (322 studies) used forms to express their results. Conclusions Till now, the quantity and quality of RCTs of traditional Chinese medicine for coronary heart disease angina were inadequate. Some well designed scientific methods were not adequately applied.
The modernization and internationalization of traditional Chinese medicine (TCM) are the key issues we must face up to. The development of TCM needs to depend on the breakthrough of methods and the innovation of ideology, and the international standardization of scientific research evaluation. The clinical evidence from randomized comtrolled trials (RCT) is valuable and reliable. It has shown that the proportion of RCT identified in TCM journals was less than 30%, and the score of RCT’s quality was less than 3 using Jadad scale. However, the number of systematic reviews on TCM is increasing rapidly after the evidence-based medicine (EBM) was introduced and practiced in China. Until 2004, 43 systematic reviews of TCM were published in China, and the quality of RCT included in those reviews was elevated. It has shown that the efficacy and safety of TCM indicated some advances in treatment of certain kind of diseases. It has been realized that RCT are important in TCM, and improving the quality of RCT is the key step for modernization and internationalization of TCM.
This paper introduces the application and funding of evidence-based research projects on traditional Chinese medicine (TCM) of the National Natural Science Foundation of China (NSFC) in 2019 in terms of clinical research and methodology research, summarizes the primary problems existing in evidence-based research on TCM, discusses the quality of evidence-based research on TCM in clinical research, highlights the characteristics of TCM and reveals the evidence-based methodology on TCM.
ObjectiveTo assess the efficacy and safety of Tiao-She nursing of traditional Chinese medicine (TCM) for mild cognitive disorder (MCD), and to provide theoretical basis for developing evidence-based guideline of Tiao-She nursing of TCM. MethodsWe searched PubMed, Web of Science, The Cochrane Library, EMbase, MEDLINE, Springerlink, CBM, CNKI, VIP and WanFang Data for systematic reviews/meta-analyses (SRs/MAs), as well as randomized controlled trials (RCTs), up to December 2014. Two reviewers screened literature according to the inclusion and exclusion criteria and extracted data. Methodological quality and evidence quality of included SRs/MAs were assessed using AMSTAR scale and GRADE tool, respectively. Methodological quality of included RCTs was assessed using risk of bias assessment tool of the Cochrane Handbook 5.1.0. ResultsNine RCTs were identified, but no SRs/MAs was retrieved. Interventions for MCD included acupoint massage, moxibustion, auricular-plaster therapy, qigong, Tai chi, calligraphy, and food therapy of ginseng. All included RCTs showed that Tiao-She nursing of TCM was effective on cognitive ability and psychosocial function. ConclusionTiao-She nursing of TCM might be effective and safe, and the methods are variable. Due to the limitation of the quality of included RCTs, the efficacy and safety of Tiao-She nursing of TCM for MCD are still needed to be verified by high quality studies.