ObjectiveTo systematically review the risk factors for knee osteoarthritis among Chinese population.MethodsCNKI, WanFang Data, PubMed and EMbase databases were electronically searched to collect studies related to risk factors for knee osteoarthritis in Chinese population from January 2005 to November 2020. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies; meta-analysis was then performed using RevMan 5.4 software.ResultsA total of 18 studies involving 46 375 patients were included. The results of meta-analysis showed that body mass index (BMI)≥28 kg/m2 (OR=1.78, 95%CI 1.47 to 2.14, P<0.000 1), females (OR=2.20, 95%CI 1.98 to 2.45, P<0.000 1), family history of osteoarthritis (OR=3.56, 95%CI 1.88 to 6.73, P<0.000 1), age≥60 years old (OR=1.42, 95%CI 1.26 to 1.59, P<0.000 1), history of joint trauma (OR=4.11, 95%CI 2.85 to 5.93, P<0.000 1), manual labor (OR=1.57, 95%CI 1.32 to 1.86, P<0.000 1), heavy housework (OR=1.63, 95%CI 1.20 to 2.22, P<0.000 1), humid environment (OR=4.33, 95%CI 2.99 to 6.29, P<0.000 1), drinking habit (OR=1.69, 95%CI 1.21 to 2.36, P=0.002), non-elevator building (OR=1.78, 95%CI 1.18 to 2.70, P=0.006), joint load (OR=9.14, 95%CI 3.05 to 27.45, P<0.000 1), cold environment (OR=2.13, 95%CI 1.32 to 3.44, P=0.002), and habit of sitting cross-legged (OR=7.56, 95%CI 1.74 to 32.79, P=0.007) were risk factors for knee osteoarthritis among Chinese population.ConclusionsControlling and reducing weight, preventing knee injuries, keeping joints warm, controlling alcohol consumption, improving humid and cold living environment, appropriately reducing heavy physical labor, reducing joint weight, and changing the habit of sitting cross-legged can prevent the occurrence of knee osteoarthritis.
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.
Master protocol with adaptive design is a new complex innovative trial design that combines an adaptive treatment strategy and master protocol. It is more flexible and adjustable. In the complex clinical trial environment, the dynamics emphasized in this design are consistent with the idea of traditional Chinese medicine (TCM) syndrome differentiation and treatment. In this study, we summarized its concept, characteristics and advantages, and we also discussed its application in TCM clinical research. We hope this paper can provide more thinking and suggestions for TCM clinical trials.
Objective To investigate the correlation of the polymorphism of the estrogen receptor alpha gene Pvu II site and coronary heart disease (CHD) in Chinese population. Methods Such databases as CBM, CNKI, Wangfang database, VIP, MEDLINE, The Cochrane Library, EMbase, Springer, and Ovid were searched from their establishment date to November of 2010 to collect the case-control studies on the correlation of estrogen receptor alpha gene polymorphism Pvu II sites with coronary heart disease of the Chinese. The quality of included studies was evaluated, the available data was extracted, and then the RevMan5.0 software was used for Meta analyses. Results Nine case-control studies were included, involving 1 464 cases with coronary heart disease and 1 203 cases in the control group. The results of Meta-analyses showed that, as to the correlation of the polymorphism of ER alpha gene Pvu II site T/C and CHD, there was no significant difference in the risk of CHD between people with different genotypes, i.e. the C allele versus T allele (OR=0.95, 95%CI 0.77 to 1.17, P=0.63), genotype of (TC + CC) versus TT (OR=0.97, 95%CI 0.73 to 1.28, P=0.81), genotype of TC versus TT (OR = 0.93, 95%CI 0.68 to 1.26, P=0.64), genotype of CC versus TT (OR=0.86, 95%CI 0.57 to 1.31, P=0.49). Conclusion Estrogen receptor alpha gene polymorphism Pvu II site are not associated with the coronary heart disease in Chinese population.
Research on the Chinese medicine standardized calendar is not only required for the development of evidence-based pharmacy, but it is also needed in order to adapt to, and promote, clinical rational use of Chinese medicine. The experience of the clinical calendar is summarized in this article. This may provide some significant clues and basis for the design and conduct of research when constructing a Chinese medicine standardized calendar.
Objective To assess the effectiveness and safety of traditional Chinese medicinal herbs for subfertility. Method Databases used including MEDLINE, EMBASE, CBM and the Cochrane Controlled Trial Register (CCTR). Potentially related trials in reference lists of studies were hand searched. Published RCTs in any languages and length whether they were blind or unblind, were included. Treatments were Chinese medicinal herbs (single or compound), and controls were placebo, standard medical intervention, or no intervention. Data were extracted independently by two reviewers and analyzed with Revman 4.2 softeware. Results 7 randomized trials, including 1 042 patients met inclusion criteria. Methodological quality of all trials was poor. Chinese medicinal herbs were effective compared with routine antibiotics [RR 1.49, 95％CI (1.37 to1.62), Plt;0.000 01] and resulted in higher pregnancy rate [RR 1.46, 95%CI (1.09 to,1.96), P=0.01]. There were no adverse events reported in treatment group. Conclusions Some Chinese medicinal herbs may be effective for subfertility. However, the evidence is too weak to draw a conclusion. More strictly designed, randomized, double-blind, placebo-controlled trials are required.
With the increasing popularity of chest spiral CT screening, the detection rate of lung cancer in China is increasing. According to the characteristics of lung cancer in China and the progress of lung cancer researches at home and abroad, Chinese Medical Association guidelines for clinical diagnosis and treatment of lung cancer are updated once a year. It is of great guiding significance to standardize and improve the clinical diagnosis and treatment of lung cancer for thoracic surgeons. The surgical diagnosis and treatment of lung cancer in the guidelines mainly include: (1) surgical treatment of stage Ⅰ-Ⅱ non-small cell lung cancer (NSCLC); (2) surgical treatment of resectable stage Ⅲ NSCLC; (3) surgical treatment of multiple primary lung cancer; and (4) surgical treatment of locally resectable small cell lung cancer. Based on the Chinese Medical Association guidelines for clinical diagnosis and treatment of lung cancer (2019 edition), this paper interprets the hot issues related to the surgical treatment of lung cancer.
Objective To analyze the effectiveness of conservative medical treatments for ectopic pregnancy (EP): methotrexate (MTX) + mifepristone + Ectopic Pregnancy II decoction (EP-II) vs. methotrexate + mifepristone. Methods A total of 95 patients with EP in Shenzhen Shajing Affiliated Hospital of Guangzhou Medical University from January 2009 to January 2011 were randomly divided into two groups: 45 patients in the experimental group were treated with MTX, mifepristone and EP II decoction, while the other 50 patients in the control group were treated with MTX and mifepristone. The effectiveness of the two groups was analyzed with SPSS 13.0 software. Results There were significant differences in the time of serum β-HCG return to normal (16.13±8.13 ds vs. 22.05±7.15 ds, Plt;0.05), time of EP mass absorption (30.46±7.56 ds vs. 39.99±18.26 ds, Plt;0.05) and tubal patency rate (80% vs. 75%, Plt;0.05) between the two groups. But there were no significant differences in effective rate (95.56%, 43/45 vs. 94%, 47/50, χ2=0.0809, Pgt;0.05) and side effects. Conclusion The combination of methotrexate, mifepristone and EP II decoction for ectopic pregnancy is more effective than mifepristone and methotrexate in coordinately killing the embryo, shortening the time of serum β-HCG return to normal and the time of EP mass absorption, and improving the function of oviducts.
Inconsistency, impracticability and non-standardization of the selection, measurement and reporting of outcomes are three primary existing issues in clinical trials. These problems pose a threat to huge research waste when the results of similar studies are not able to be combined or compared. The key for resolution will be to standardize outcomes in traditional Chinese medicine (TCM) clinical trials and to establish a core outcome set (COS), which is a set of outcomes to be reported as a minimum in all TCM clinical trials of similar healthcare system and syndromes. The first step in the development of COS is to collect all existing outcomes, that is, to build a pool of outcomes for clinical trials of TCM. A pool of outcome is the basis of developing COS, which is important to follow strict and scientific methodology. This paper aims to construct an outcome pool from published literature, clinical trial registration protocols, and clinicians, and patients questionnaires were used to form a list of outcomes. In addition, the influencing factors of constructing an outcome pool and considerations for each problem are summarized in order to provide guidance and reference for the development of COS in clinical trials for TCM.
Objective To investigate the current situation of randomized controlled trials (RCTs) on the treatment of Sjogren’s syndrome with Traditional Chinese Medicine (TCM), and to assess whether there is adequate evidence for clinical practice. Methods Such databases as CNKI, VIP, CBM and PubMed were searched from their establishment date to June 2010 to collect the RCTs on the treatment of Sjogren’s syndrome with TCM according to the predefined inclusion criteria. And the quality was assessed by using the Jadad scale, the revised CONSORT statement and other self-defined indexes.Results Among 19 included RCTs, 1 literature scored four points, 4 scored two points, 13 scored one point, and 1 scored zero point according to Jadad scale; no RCT performed the allocation concealment. According to the CONSORT criteria, 19 RCTs accounting for 100% reported the diagnostic criteria, implement of interventions and result, 11 RCTs applied the 2002 international diagnosis and classification criteria of Sjogren’s syndrome, 17 RCTs carried out positive control including one based on the standard treatment, and two RCTs applied only blank control without placebo control. All RCTs took the comprehensive efficacy assessment as the outcome index, but only 6 RCTs (31.6%) assessed both clinical efficacy and TCM syndrome efficacy. Among 6 RCTs (31.6%) describing the random sequence, no RCT reported the detailed methods. Except 1 RCT (5.3%) carried out the double blinding, all the others were non-blind trials. And only 1 RCT adopted analog. Conclusion Currently, the methodology and reporting quality of studies on the treatment of Sjogren’s syndrome with TCM are not good enough to provide reliable evidence for clinical practice.