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 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.
ObjectiveTo evaluate the methodological bias and the reliability of the conclusions of systematic reviews (SRs) about traditional Chinese medicine for essential hypertension. MethodsWe comprehensively searched PubMed, EMbase, The Cochrane library (Issue 4, 2014), CBM, CNKI and WanFang Data to collect SRs of traditional Chinese medicine for essential hypertension from the establishment time of databases to April 30th, 2014. The AMSTAR tool was applied for methodological quality assessment of included studies, and the GRADE system was applied for evidence quality assessment of included outcomes of SRs. ResultsA total of 12 SRs involving 31 outcomes were included, of which 11 SRs focused on the comparison of therapeutic effects between traditional Chinese medicine combined with western medicine and western medicine alone. Nine SRs adopted Jadad tool to assess methodological quality of included original studies. The results of assessment using AMSTAR showed that, among 11 items, there were the most problems concerning Item 1 "Was an 'a prior' design provided?" (none of the 12 SRs provided it); followed by Item 11 "Were potential conflict of interest included?" (nine SRs didn't described it), and Item 6 "Were the characteristics of included studies provided" (six SRs didn't provided it). The results of grading showed that, 29 outcomes were graded as "low" or "very low" quality. The main factors contributed to downgrading evidence quality were limitations (31 outcomes), followed by imprecision (12 outcomes), and inconsistency (13 outcomes). ConclusionCurrently, the methodological quality of SRs about traditional Chinese medicine for essential hypertension was poor on the whole, with low quality of evidence as well as lack of enough attention to the end outcomes of patients with essential hypertension. Thus, physicians should apply the evidence to make decision about traditional Chinese medicine for essential hypertension with caution in clinical practice.
High-quality randomized controlled trials can balance between-group confounding factors and are an important source of comprehensive information on benefits and harms. The CONSORT (consolidated standards of reporting trials) working group released the CONSORT Harms 2022 statement to further improve the harm reporting quality in randomized controlled trials. Traditional Chinese medicine formulas have unique characteristics such as compatibility taboos and using toxic herbs. The harms of traditional Chinese medicine formulas need to be reported in a standard. This study suggests that researchers should pay attention to enhancing the professional competence of research teams, developing suitable standards for reporting the harm of traditional Chinese medicine formulas in randomized controlled trials, and incorporating relevant guidelines into journal publication requirements. These efforts are essential for laying the necessary groundwork for the global dissemination and promotion of traditional Chinese medicine.
Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) in treatingchronic obstructive pulmonary disease (COPD) in a stable stage. Methods We searched MEDLINE (1950 to July 2008), PubMed (1996 to July 2008), VIP (1989 to July 2008), WanFang (1998 to July 2008), CNKI (1979 to July 2008), and CBM (1978 to July 2008)for randomized control trials about TCM to treat stable COPD. Trial screening, quality assessment of included trials, and data extract were conducted. Statistical analysis was conducted by using RevMan 4.2.7 software. Results A total of 30 randomized controlled trials (RCTs) in the Chinese language were identified. No pooled analysis was performed because of the significant heterogeneity among the included trials. (1) For TCM alone versus blank therapy or placebo: 3 RCTs reported the clinical effective rate and only 1 indicated TCM was more effective; 5 RCTs reported forced expiratory volume in one second (FEV1)% after treatment and 2 indicated TCM alone as more effective in improving lung function; 4 RCTs reported quality of life after therapy and 2 indicated TCM alone was more effective in improving quality of life after therapy. (2) For integrated tradtional and western medicine versus western medicine alone: 11 RCTs included the clinical effective rate, 3 RCTs showed that integrated traditional and western medicine was more effective. Of 8 RCTs reporting FEV1%, 2 RCTs suggested that integrated traditional and western medicine was more effective. There were 3 RCTs studying 6 minute walking distance and 4 RCTs about quality of life, which also showed that integrated traditional and western medicine was more effective. No obvious adverse reaction to TCM was reported.Conclusions The current evidence shows TCM tends to relieve the symptoms and improve quality of life for patients with stable COPD without obvious adverse reaction. Due to the low methodological quality of trials included, more RCTsof high quality and large scale are required.
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.
Objective To review the current status of evidence-base medicine (EBM) research on traditional medicine in Japan. Methods Serial reports of EBM special committee of Japan Society for Oriental Medicine (JSOM) were reviewed. Results EBM special committee of JSOM was established earlier and carried out systematic reviews of Kampo treatment throughout Japan. The quality of preparations was standardized and reliable. Evidence Reports of Kampo Treatment 2009 (EKAT 2009) may be a promising promotion for Kampo treatment in Japan. Conclusion For the promotion and development of evidence-based Chinese medicine in China, we need to learn from EBM research projects of JSOM. Based on the current status of EBM research in China, special efforts should be made in validity of research data and scientific analysis and reports of non-randomized trials. According to the characteristics of traditional Chinese medicine, EBM research should be systematically carried out from simple to complex.
ObjectiveTo evaluate the safety and efficacy of Chaihu drop-pill in the treatment of common cold (wind-heat syndrome). MethodsA multi-center, double blind, double dummy, randomized controlled trial was conducted. A total of 479 patients with common cold (wind-heat syndrome) diagnosed between February and August, 2011, were randomly divided into two groups:the trial group (n=359) and the control group (n=120). The trial group received Chaihu drop-pill and Yinchai granule analogue three times a day, while the control group received Yinchai granule and Chaihu drop-pill analogue. The therapeutic courses of both groups were 3 days. Clinical symptoms, syndromes, and adverse effects were observed before and after the treatment. Furthermore, blood, urine and stool test, hepatorenal function test and electrocardiogram were also carried out before and after treatment. ResultsAfter treatment, the healing rates of the trial group and the control group were 32.4%, 20.2% (for full analysis set) and 32.6%, 20.5% (for per protocol set), and the overall response rates were 96.3%, 87.4% (for full analysis set) and 96.5%, 87.2% (for per protocol set). There were significant differences between the two groups (P<0.01). No adverse effects were found in the trial. ConclusionChaihu drop-pill is effective and safe in the treatment of common cold (wind-heat syndrome).