Objective To assess the quality of the published randomized controlled trials published in Journal of Beijing University of Traditional Chinese Medicine (JBUTCM), Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai (AUTMSPS), Journal of Guangdong University of Traditional Chinese Medicine (JGUTCM), and Journal of Chengdu University of Traditional Chinese Medicine (JCUTCM) from 2000 to 2005. Method Guided by the Cochrane Center hand-searching guidelines, we searched 24 volumes (111 issues) of the four journals. The data were extracted according to the principles of clinical epidemiology and consolidated standards of reporting trials (CONSORT), as well as an evaluation scale for randomized controlled trials (RCTs). The data were managed by descriptive analysis and uniformity test. Results There were 365 RCTs. The diagnostic criteria were reported in 297 trials (81.37%). The inclusion and exclusion criteria were reported in 143 trials (39.18%) and 132 trials (36.16%), perspectively, None mentioned the estimation of sample size. The randomization and allocation concealment were reported in 70 trials (19.18%) and 9 trials, perspectively. The baseline data were described in 292 trials (80.00%). Blinding was mentioned in 35 trials (9.59%).Withdrawal occurred in 20 trials (5.48%). Informed consent was acquired in 2 trials. Adverse drug reactions were described in 97 trails (26.58%). Conclusion There are deficiencies in the reporting of these RCTs, Most of the trials do not describe the randomization, only a few trials use the allocation concealment and blinded method, no description of comparability of baseline data, most of the trials do not report the inclusion and exclusion criteria, and none estimate the sample size. These problems indicate that it is necessary to improve the quality of clinical research in Chinese medicine and pharmacology.
Acute pancreatitis is a common and critical disease in clinical practice, and clinical treatment has formed a multidisciplinary and collaborative model of traditional Chinese and Western medicine. However, its etiology and pathogenesis are complex and varied, and immune response is crucial in the occurrence and development of the disease. Therefore, based on the thinking of the pathological and physiological basis of immune response in the different stages of acute pancreatitis disease progression and related complications, and based on the biological characteristics and laws of the disease, this article summarizes a reasonable and phased implementation of Chinese and Western medicine collaborative management strategy, which is proposed to achieve optimal and precise treatment of the disease.
Objectives To systematically review the efficacy and safety of clopidogrel 600 mg and 300 mg loading dose in Chinese patients underwent percutaneous coronary intervention (PCI). Methods We searched The Cochrane Library, EMbase, PubMed, CNKI, WanFang Data, CBM and VIP databases to collect randomized controlled trials (RCTs) of the efficacy and safety of clopidogrel 600 mg and 300 mg loading dose in Chinese patients underwent PCI from inception to April, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was then performed using Stata 14.0 software. Results A total of 10 RCTs involving 1 166 patients were included. The results of meta-analysis showed that: the 600 mg loading dose group had lower incidence rate of major adverse cardiovascular events (MACE) in comparison with the 300 mg loading dose group (RR=0.29, 95%CI 0.17 to 0.48, P<0.000 1). However, no significant difference was found in the incidence of major bleeding events within 30 days between two groups (RR=1.64, 95%CI 0.70 to 3.80,P=0.252). Conclusions The current evidence shows that in Chinese patients underwent PCI, administration of a 600 mg loading dose of clopidogrel is associated with a lower risk of MACE than is administration of a 300 mg loading dose of clopidogrel, without increasing major bleeding risk in 30 days. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.
Objective To evaluate the association between the Thr241Met polymorphism in the XRCC3 gene and the risk of lung cancer in Chinese population by meta-analysis. Methods Databases including PubMed, EMbase, CNKI, VIP and WanFang Data were searched to identify domestic and foreign case-control studies concerning the association between Thr241Met polymorphism in XRCC3 gene and the risk of lung cancer in Chinese population from the inception to August 20th, 2013. Two reviewers independently screened the literature according to the inclusion and exclusion criteria, extracted data and assessed quality. Then meta-analysis was performed using RevMan 5.0 software and Stata 10.0 software. Results A total of 5 case-control studies involved 2 999 lung cancer cases and 2 994 controls were included. The results of meta-analysis showed that, Chinese population who carry the variant genotype or allele had no increased risk of lung cancer: Met/Met vs. Thr/Thr: OR=1.00, 95%CI (0.38, 2.59), P=0.99; Met/Met vs. Thr/Met: OR=1.06, 95%CI (0.83, 1.36), P=0.63; Met/Met vs. Thr/Met+Thr/Thr: OR=0.99, 95%CI (0.38, 2.57), P=0.98; Thr/Met+Met/Met vs. Thr/Thr: OR=1.06, 95%CI (0.82, 1.37), P=0.65; Met vs. Thr: OR=1.05, 95%CI (0.82, 1.35), P=0.68. Conclusion Currently, Thr241Met polymorphism in the XRCC3 gene is not found to be associated with the risk of lung cancer in Chinese population. Considering the limited quality of the included case-control studies, more high quality studies with large sample size are needed to verify the above conclusion.
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.
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.
ObjectivesTo analyze the research status and hot spots of hypertension-related clinical trials in special Chinese population registered on the Chinese Clinical Trial Registry (ChiCTR), so as to provide a basis for the development of hypertension-related research in special population in China.MethodsThe ChiCTR was searched online (up to August 31st, 2019, no limitation in the status of trial registration), all clinical trials on hypertension in special population were collected, and the general characteristics, researched diseases, research types, intervention measures and main outcomes of the trials were analyzed.ResultsA total of 64 hypertension-related clinical trials in special population registered in the ChiCTR were included, including 41 (64.1%) trials registered in last 3 years. The registration status of 46 (71.9%) trials was pre-registration. The registered authors were mainly from colleges and universities or medical institutions (n = 61, 95.3%), of which 60.9% were registered in Beijing, Shanghai, Guangdong, Zhejiang, Jiangsu and Hebei. The researched diseases mainly included elderly hypertension and hypertensive stroke, accounting for 50% of the total. Additionally, 37 (57.8%) clinical trials were intervention studies, of which 21 (56.7%) were drug-based intervention studies. Blood pressure, blood glucose, cardiovascular and cerebrovascular events, blood lipid, cranial MRI and Glasgow Coma Scale were the commonly used outcomes, accounting for 58.5% of the total outcomes. Most blood pressure measurements did not indicate the measurement method (n = 22, 64.7%).ConclusionsThe quantity of hypertension-related clinical trials in special population registered on the ChiCTR is increasing, however, there exists regional imbalance. The drug intervention-related clinical trials of elderly hypertension have become a research hot spot. However, blood pressure measurement method is not indicated in most trials, and some researchers do not register in time. Therefore, it is suggested that researchers should further strengthen the awareness of carrying out high-quality clinical trials.
Objective To learn the current situation of traditional Chinese medicine (TCM) systematic reviews/meta-analyses published in Chinese journals. Methods All TCM systematic reviews/meta-analyses published from 1978 to July 31, 2009 were searched in the Chinese Biomedical Database (CBM). According to the inclusion and exclusion criteria, relevant information was extracted on the basis of research purpose. Meanwhile, publication year, journal name, author’s district, number of authors and their articles, types of diseases and interventions were took as the indexes, and then descriptive analysis was performed using SPSS 15.0 software. Results A total of 245 articles including 238 in Chinese and 7 in English were included. All of them were published in 117 different journals from 1998 to 2008, showing an accelerating growth trend of article number. In addition to only one article with first author from Germany, the first author of other 244 were from 24 domestic provinces (autonomous regions and municipalities); the number of authors ranged from 1 to 11; a total of 186 people had published articles as first author, and the number of their published articles ranged from 1 to 29. There were 16 types of diseases according to the International Classification of Diseases 10th Edition (ICD-10). Totally, 218 articles took drugs as interventions (including 106 listed drugs, 25 self-made prescriptions, 70 related to both listed drugs and self-made prescriptions, and 17 without reporting detailed interventions), accounting for 89%; and 27 articles were about non-drug interventions (including 26 about acupuncture and 1 about massage), accounting for 11%. Most (95.8%) of the articles about self-made prescriptions and listed drugs/self-made prescriptions adopted inappropriate pooled analyses. Conclusion Evidence-based medicine has been spread into the field of TCM, the number of TCM systematic reviews/meta-analyses shows an accelerated growth trend. The types of diseases discussed in the literature were almost the same as the diseases those could be effectively treated by TCM, but there existed imbalance in districts. In the future, systematic review/meta-analysis on drug intervention should aim at Chinese patent medicines and single medicines rather than self-made prescriptions, and should pay more attention to advantageous drugs and advantageous treatments of diseases. Moreover, importance should be also attached to clinical heterogeneity controlling when using acupuncture as a non-drug intervention.
Objective To evaluate the efficacy and safety of Chinese herb compared with an analgesic drug in the treatment of cancer pain. Methods We electronically searched CBM (1990 to 2008), CNKI (1990 to 2008), VIP (1990 to 2008), The Cochrane Library (Issue 3, 2008), and MEDLINE (1990 to 2008). Relevant journals and conference proceedings were also handsearched. The quality of the included trials was assessed according to the criteria recommended by the Cochrane Handbook for systematic reviews of interventions and meta-analyses were performed for homogeneous studies using the Cochrane collaboration’s review manager 4.2.2 software. Results Five randomized controlled trails (RCTs), all published in Chinese, involving 590 participants, were included. The quality of all RCTs was graded C (low). Meta-analyses were not performed due to heterogeneity. Instead, descriptive analyses were conducted. The results showed that as for the total effective rate in pain-relieving, Zhentongsan (RR=1.11, 95%CI 1.00 to 1.24, P=0.05) and Xiaozhengzhitong paste (RR=1.35, 95%CI 1.02 to 1.78, P=0.04) were more effective than Indometacin, with significant differences. There were no significant differences between Duyiwei capsule and Indometacin, and so were between Huajianbadumo as well as Shebingzhitong paste and Tramado. In terms of early potency, there were significant differences between Zhentongsan (SMD= –?9.87, 95%CI –10.84 to –8.89, Plt;0.000 01) as well as Xiaozhengzhitong paste (SMD= –8.74, 95%CI –10.164 to –7.32, Plt;0.000?01) and Indometacin, and so were between Shebingzhitong paste and Tramadol (SMD= –2.24, 95%CI –3.00 to –1.49, Plt;0.000?01). There were no significant differences between Huajianbadumo and Tramodo. With regard to the durative effect on pain-relieving, there were significant differences between Xiaozhengzhitong paste and Indometacin (WMD=4.78, 95%CI 2.99 to 6.57, Plt;0.00001), but not between Shebingzhitong paste and Tramadol. Conclusion Because of low quality of the existing studies, the current evidence is insufficient to define the efficacy and safety of compound Chinese herb, and further large-scale and high-quality RCTs are needed.