Objective To assess the clinical efficacy of stroke unit (SU) of integrated traditional Chinese medicine and western medicine in the treatment of acute cerebral stroke. Methods Randomized or quasi-randomized controlled trials (RCTs or q-RCTs) were identified from CBM (1978-2009), CNKI (1994-2009), VIP (1989-2009), PubMed (1966-2009), MEDLINE (1978-2009), Scifinder (1998-2009), and The Cochrane Library (Issue 6, 2009), and relevant journals from Liaoning University of Traditional Chinese Medicine were also hand searched. Data were extracted and evaluated by two reviewers independently with a designed extraction form. RevMan5.0.23 software was used for data analyses. Results A total of 12 RCTs and q-RCTs involving 2 316 patients were included. Meta-analyses showed that, stroke unit of integrated traditional Chinese medicine and western medicine was superior to general medicine treatment (Plt;0.05) in case fatality rate one month after stroke (RR= 0.34, 95%CI 0.22 to 0.54), discharge NIHSS score (WMD= –1.01, 95%CI –1.52 to –0.51) and discharge OHS score (WMD= –0.48, 95%CI –0.78 to –0.18); and it was superior to SU of western medicine (Plt;0.05) in NIHSS score one week after stroke (WMD= –2.38, 95%CI –4.08 to –0.68), NIHSS score one month after stroke (WMD= –1.52, 95%CI –2.32 to –0.73) NIHSS score three months after stroke (WMD= –1.77, 95%CI –2.59 to –0.95), difference value of NIHSS score of hospital admission and discharge (WMD= –1.94, 95%CI –2.54 to –1.34), OHS score one month after stroke (WMD= –0.56, 95%CI –0.95 to –0.17) and OHS score three months after stroke (WMD= –1.05, 95%CI –1.44 to –0.66). Conclusion The current limited evidence shows that there is a significant difference between stroke unit of integrated traditional Chinese medicine and western medicine and general medicine treatment. Although there is no significant difference compared with SU of western medicine, it is superior in improving the functional impairment of nerve as well as disability of injury. More large-scale RCTs with high quality are required to verify the effect of stroke unit of integrated traditional Chinese medicine and western medicine in the treatment of acute cerebral stroke.
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.
The two factors that affect enrollment of participants and the process of intervention in randomizedcontrolled pragmatic trials are similar to the situation of clinical practice, thus its effects are similar to the situation ofclinical practice. Therefore, when one estimates an intervention’s effect on a patient, it will be more similar to a real clinicalsituation than results taken from an explanatory trial. Due to the introduction of interventions and process variables usedin a pragmatic trial that conform to traditional Chinese medicine and acupuncture practices, more and more interest isgrowing among researchers in the traditional Chinese medicine field. This article introduces the principles and conceptsof the pragmatic trial, and the key points of design via some samples.
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.
To compare the effectiveness of dressing by a combination of traditional Chinese medicine (TCM)-Western medicine (WM) after TCM bath and by the silver sulfadiazine cream (SD-Ag) in treating residual deep burn wound. Methods A total of 128 cases of residual deep burn wound between July 2003 and December 2009 were randomly divided into the TCM-WM treatment group (70 cases) and the WM control group (58 cases). In the treatment group, there were 45 males and 25 females with an average age of 38.6 years (range, 18-60 years), including 34 cases of flame burns, 28 cases of molten steel burns, and 8 cases of chemical burns with an average burn area of 57.6% total body surface area (TBSA) and an average residual wound of 7.4% TBSA. In the control group, there were 50 males and 8 females with an average of 37.9 years (range, 20-59 years), including 26 cases of flame burns, 12 cases of hot water burns, 16 cases of molten steel burns, and 4 cases of chemical burns with an average burn area of 56.5% TBSA and an average residual wound of 6.9%TBSA. There was no significant difference in general data between 2 groups (P gt; 0.05), so the cl inical data of 2 groups had comparabil ity. In the treatment group, the patients had a bath with TCM, and then the wounds were treated with dressing change of combined TCM-WM. In the control group, the wounds were treated with SD-Ag after cleaning the wounds with chlorhexidine solution. The pain, wound heal ing time, and the rate of scar formation were observed in 2 groups after treatment. Results According to wound pain classification after medication, the results were excellent in 23 cases, good in 30 cases, fair in 17 cases in the treatment group; were excellent in 17 cases, good in 20 cases, fair in 13 cases, poor in 5 cases, and fairly poor in 3 cases in the control group. The wound heal ing time of the treatment group (13.45 ± 4.74) days was significantly shorter than that of the control group [(23.87 ± 14.45) days, P lt; 0.05)]. After 2 weeks of treatment, scar occurred in 15 patients (21.4%) of the treatment group and 35 patients (60.3%) of the control group, showing significant difference (P lt; 0.05). Conclusion Based on TCM bath, a combination of TCM-WM for the residual burn wounds is obviously superior to SD-Ag. It has the advantages of rapid heal ing, l ight pain, no obvious scar, and short hospital ization time.
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 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.
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.