Objective To explore the correlation between traditional Chinese medicine (TCM) blood stasis pattern of coronary heart disease (CHD) and coronary angiography result, so as to screen dangerous patterns and provide evidence for the objectification of TCM pattern differentiation. Methods Literature on correlation between blood stasis pattern and coronary angiography results from January 1992 to May 2012 were searched in the following databases: China Academic Journal Network Publishing Database (CAJD), Chinese Biomedical Literature Database (CBM), China Doctor Dissertation Full-text Database (CDFD), Chinese Selected Master’s Theses Full-Text Databases (CMFD), PubMed and MEDLINE. According to the inclusion and exclusion criteria, literature screening, data extraction and methodological quality assessment of the included studies were conducted. Then meta-analysis was performed using RevMan 5.1 software. Results A total of 28 studies involving 4 901 patients were included. The results of meta-analysis showed that, there is a significant significance between blood stasis pattern and the following coronary angiography result, namely, number of culprit vessels (OR=1.38, 95%CI 1.08 to 1.77, Plt;0.05), severity of stenosis (OR=1.79, 95%CI 1.04 to 3.08, Plt;0.05), and Gensini score (OR=7.74, 95%CI 3.99 to 11.49, Plt;0.05). Conclusion Compared with other TCM patterns, CHD with blood stasis pattern easily tends to present multi-vessels lesions, more than 75% stenosis and higher Gensini score, indicating the condition of CHD with blood stasis pattern is more severe than with other patterns. Due to the discrepancy of pattern differentiation and the limited quality of original studies, this conclusion is insufficient to be fully applied into clinical practice, and more large scale and high quality clinical trials are required.
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.
Objective To assess the quality of reporting of randomized controlled trials(RCTs) on traditional Chinese medicine(TCM) in China from 1999 to 2004 by CONSORT statement and Jadad scale. Methods We randomly selected 13 journals of TCM including Chinese Journal of Integrated Chinese and Western Medicine,ect using stratified sampling from about 100 journals of TCM in mainland China, and all issues of selected journals published from 1999 to 2004 were hand-searched according to the hand-search guideline developed by Cochrane Collaboration. All reviewers were trained in the method of evaluating RCTs . A comprehensive quality assessment of each RCT was completed using methods including the revised consolidated standards of reporting trials (CONSORT) checklist and Jadad scale. Disagreements were resolved by consensus. Results A total of 7422 RCTs were identified, and the percentage of RCTs was significantly increased by 18.6%, 23.9%, 27.5%, 28.8%, 33.0% and 35.6% from 1999 to 2004. The mean Jadad score was 1.03 ± 0.61 in all trials with 1 RCT with 5 points, 14 with 4 points, and 102 with 3 points, from 1999 to 2004, the mean Jadad score was 0.85±0.53 (n=746), 0.82±0.63 (n=941), 0.90±0.61 (n=1 243), 1.03±0.60 (n=1 325), 1.12±0.58 (n=1 533) and 1.20±0.62 (n=1 634) respectively, which was improved continuously but slowly. 39.4% of the items in CONSORT, which was equivalent to 11.82 (standard deviation=5.78) of a total of 30 items, were reported across those trials. Some important methodological components of RCTs such as sample size calculation (1.1%), randomization sequence (7.9%), allocation concealment (0.3%), implementation of the random allocation sequence (0.0%) , analysis of intention to treat (0.0%), were incompletely reported. Conclusion Our study suggests that the quality of reporting has been improved but still in poor status, which would urgently promote the establishment of the CONSORT for TCM.
Objective To evaluate the effectiveness and safety of Chinese angelica decoction (CAD) versus conventional treatment (CT) for chronic urticaria (CU). Methods Systematic searches were conducted in PubMed, The Cochrane Library, SCI, EMbase, VIP, CNKI and CBM to collect randomized controlled trials (RCTs) on CAD treating CU from inception to July 2011. Two reviewers independently screened articles according to the inclusion and exclusion criteria, extracted data and evaluated the quality of the included studies. Then meta-analysis was performed using RevMan 5.0.2. Results A total of 11 RCTs involving 1081 patients were included. The results of meta-analysis demonstrated that compared with the CT group (antihistamine therapy), CAD seemed higher in the cure rate (OR=2.36, 95%CI 1.80 to 3.10, I2=22%, Plt;0.000 01), improvement rate (OR=4.56, 95%CI 2.65 to 7.87, I2=0%, Plt;0.000 01), and lower in the relapse rate at the third month after the treatment (OR=0.43, 95%CI 0.22 to 0.82, I2=0%, P=0.01). No study reported the quality of life and severe adverse reactions after CAD treatment. Conclusion Current evidence shows CAD may be superior to CT in treating CU patients. However, due to lack of enough high-quality studies, CAD has to be further studied by conducting more strictly-designed, multicenter, large-scale and double-blind RCTs.
Recently, the increasing risk of drug development has impelled pharmaceutical enterprises to improve ways of research and exploitation. Adaptive design has been proposed for decades. Although the theory of this design is not perfect, it has been recognized and applied worldwide as a decreasing risk of drug development to a certain extent. The traditional fixed design in western medicine isn’t entirely suitable for traditional Chinese medicine (TCM), while the adaptive design with integrity and variability features provides a new idea for TCM development. Hereby the application of adaptive design in TCM is regarded as an important procedure for promoting TCM modernization, and it has a wide prospective.
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 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.
Objective To evaluate the efficacy and safety of traditional Chinese medicine (TCM) in treating Chronic Rhinosinusitis (CRS) after Functional Endoscopic Sinus Surgery (FESS). Methods The following databases and periodicals such as PubMed (Jan. 1980 to Jan. 2009), MEDLINE (1980 to 2009), EBSCOhost (Jan. 1975 to Jan. 2009), CALIS (1984 to 2009), CNKI (1979 to 2007), VIP (1989 to 2009), CBM (1978 to 2009); Chinese Journal of Otorhinolaryngology Head and Neck Surgery (1990 to 2008), Journal of Clinical Otorhinolaryngology Head and Neck Surgery (1988 to 2008), Otorhinolaryngology Head and Neck Surgery (1990 to 2008), and Chinese Journal of Otorhinolaryngology of Integrated Traditional and Western Medicine (1996 to 2008) were searched by computer and handwork for randomized controlled trials (RCTs) about TCM to treat CRS after ESS. The trial screening, quality assessment, and the data extraction of the included trials were conducted before performing statistical analyses by using RevMan 4.2.10 software. Results A total of 32 RCTs in three sub-groups in Chinese literatures were identified with meta-analyses in comparisons of the cure rate (OR=1.99, 95%CI 1.78 to 2.23), total effective rate (OR=2.66, 95%CI 2.20 to 3.22), degree I postoperative improvement rate (OR=2.22, 95%CI 1.60 to 3.06), total postoperative improvement rate (OR=8.77, 95%CI 1.09 to 70.64), postoperative clean time (OR=2.54, 95%CI 1.70 to 3.79), postoperative epithelization time (OR= –29.46, 95%CI –37.73 to –21.18), and mucociliary transport rate (OR=1.14, 95%CI 0.22 to 2.06). A total of 4 RCTs were meta-analyzed to evaluate the safety in comparisons of gastrointestinal reaction (OR=0.25, 95%CI 0.00 to 33.78) and local reaction (OR=0.03, 95%CI 0.01 to 0.12). Conclusion The current evidence shows TCM in treating CRS after ESS tends to improve the clinical efficacy and reduce the cure time without obvious adverse reaction. Due to the low methodological quality of included trials, more RCTs with high quality and large scale are required.
Objective To assess the reporting quality of noninferiority and equivalence randomized controlled trials (RCTs) related to Traditional Chinese Medicine (TCM). Methods The noninferiority and equivalence RCTs related to TCM were searched, and the quality of the included RCTs was identified in accordance with the extended version of CONSORT statement which refers to the reporting standard of noninferiority and equivalence RCTs. Results A total of 13 noninferiority and equivalence RCTs were included. Except for the common questions of RCTs in reporting quality, some contents related to noninferiority and equivalence trials in reporting were not enough: a) The title of RCTs did not reflect the most important content of the literature; b) The introduction of background was quite simple. The rationale about noninferiority and equivalence trials, and the effectiveness of positive control were not clearly defined; c) All literatures did not indicate whether the subjects, interventions and outcomes in the noninferiority and equivalence trials were identical or similar to those in previous trials of defining the effectiveness of control treatment; d) Most literatures did not define the critical value of noninferiority and equivalence, and did not estimate the sample size; e) Only half of literature described the statistical methods of noninferiority test and equivalence test; and f) Some literature had mistakes in noninferiority and equivalence conclusion. Conclusion The researchers still need deeper understanding of the theoretical basis of noninferiority and equivalence trials. The reference to the extended version of CONSORT statement, which refers to the reporting standard of noninferiority and equivalence RCTs, is helpful for researchers to identify the key points of the design, performance and reporting of the noninferiority and equivalence RCTs, to lay stress on the related contents of noninferiority and equivalence trial reporting, and to radically improve the reporting quality of such clinical trials.
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.