Objective To evaluate the methodological quality of clinical trials on traditional Chinese medicine (TCM) nursing in recent six years.Methods Such databases as CNKI, VIP, WanFang Data and CBM were searched for collecting clinical trials on TCM nursing published from January 2006 to September 2011, and domestic primary nursing journals were also searched from January 2010 and September 2011. Methodological quality of included studies was assessed using quality assessment criteria of the Cochrane systematic review guideline. Results A total of 854 clinical trials were retrieved, including 706 (82.7%) randomized controlled trials (RCTs), 108 (12.6%) quasi-randomized controlled trials and 40 (4.7%) non-randomized controlled trials. In the methodological quality analysis, the comparability of baseline was mentioned in 784 trials (91.8%), a total of 498 (58.3%) reported definite diagnosis criteria. 178 (20.8%) reported exclusive criteria. 831 studies (97.3%) applied relevant statistical methods properly. However, only 55 trials (6.4%) mentioned the method of randomization sequence. 10 studies (1.2%) described the method of randomiztion assignment. Blinding was mentioned in 22 studies (2.6%). 98 trials (11.5%) did prospective follow-up. 93 trials (10.9%) had safety description. 20 trials (2.3%) reported lost and with drawl cases, but only 2 conducted intention-to-treat analysis. It was hard to determine whether there was selective reporting bias or not because all the studies did not have protocols. Only 21 studies (2.5%) mentioned the lack of outcome indicators which could be the evidence for existing of bias. By annual analysis, there were 81 trials which conformed to at least 2 low risk criteria. 10 trials (12.3%) was published in 2009, 26 trials (32.1%) published in 2010, and 27 trials published by September 2011, indicated an uptrend. Conclusions According to the Cochrane Collaboration’s tool for assessing risk of bias, the overall quality of clinical trials on TCM nursing is low with defects in different degrees, but it rises gradually over years.
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.
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.
The systematic review/meta-analysis database of traditional Chinese medicine (SMD-TCM) was focused on incubation and application of the secondary research achievement. At present, the establishment of front and back websites, evidence input and evaluation have been completed. In the near future, the automation of overview and the visual presentation of evidence information will be realized, which provides the technical support for integration, analysis and application of evidence in the secondary research of TCM. This paper introduces the construction of SMD-TCM database which includes: requirements of construction, design principles, working process, evidence processing, ensuring quality of data input, data analysis and application, etc.
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.
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.
Objective To systematically evaluate the efficacy and safety of traditional Chinese medicine (TCM) for non-alcoholic steatohepatitis (NASH). Methods Such databases as CNKI, VIP, CBM, and PubMed (from the date of their establishments to November 2009) were searched. Randomized controlled trials of TCM treatment of NASH were included. According to the principle of ZANG-fu Differentiation, the method recommended by the Cochrane Collaboration was applied to evaluate the quality of the studies and to conduct meta-analysis. Results Twenty-two studies were included, of which 18 were of low quality and 4 of high quality. The results of meta-analyses showed: there was no difference between liver-oriented TCM treatment and western medicine treatment in terms of the recovery rate, total effective rate, liver function, and blood lipid; the liver and spleen oriented TCM treatment was better than the western medicine treatment in terms of the recovery rate, total effective rate, liver function, and blood lipid, but similar to that of western medicine on TG and HDL-C; the liver, spleen and kidney oriented TCM treatment was better than the western medicine in terms of the recovery rate, total effective rate, liver function, lipids, but showed no difference on HDL-C; the liver and kidney oriented TCM treatment was better than the western medicine treatment in terms of the recovery rate, total effective rate, liver function, LDL-C, and HDL-C, but showed no differences on TC and TG. Conclusion The TCM has significant effects on NASH. The liver, spleen and kidney oriented TCM treatment is significantly better than the western medicine treatment in terms of the recovery rate, total effective rate, and liver function. TCM has no serious adverse reactions.
Objective To systematically assess the effectiveness of traditional Chinese medicines (TCM) in treating upper airway cough syndrome (UACS) or postnasal drip syndrome (PNDS). Methods Such databases as MEDLINE (1950 to 2011), PubMed (1996 to 2011), VIP (1989 to 2011), WanFang Data (1998 to 2011), CNKI (1979 to 2011) and CBM (1978 to 2011) were searched for collecting the randomized controlled trials (RCT) or quasi-RCTs about TCM treating UACS/PNDS. The trials were screened according to the inclusive and exclusive criteria, and then after the quality assessment and data extraction were conducted, the statistical analysis was conducted by using RevMan 5.0 software. Results A total of 10 RCTs and quasi-RCTs in Chinese were identified. The results of analysis showed that: a) The integrated Chinese and western medicine was superior to western medicine alone, either for adults and children with UACS, or for adults with PNDS. However the effectiveness had to be further assessed due to lack of high-quality literatures; b) TCM alone was probably more effective than western medicine alone for adults with PNDS, but not for adults and children with UACS. No obvious adverse reaction related to TCM was reported. Conclusion The recent research outcomes show that the integrated Chinese and western medicine is superior to western medicine alone, either for adults and children with UACS, or for adults with PNDS, but no definite evidence is found to support the superiority of TCM in treating UACS/PNDS. More high-quality RCTs with large scale need to be conducted in future to verify this conclusion due to the overall low methodological quality and significantly different intervention of the included trials.
The traditional Chinese medicine has played an important role in the prevention and control of coronavirus disease 2019 (COVID-19). Based on the role of traditional Chinese medicine in dealing with the previous epidemics and COVID-19, this paper analyzes the problems and challenges of current situation, and focuses on improving traditional Chinese medicine scientific identification, strengthening the construction of traditional Chinese medicine system, and increasing the intensity of Chinese and Western medicine and so on. In order to improve the cooperation mechanism of Chinese and Western medicine for epidemic prevention and control, and give full play to the role of traditional Chinese medicine in the construction of national public health emergency system, this paper also gives ten corresponding suggestions.