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 effectiveness and safety of traditional Chinese medicine therapies (TCMT) for prostatitis. Methods We searched Cochrane Controlled Trials Register (CCTR), China EBM/Cochrane center database (CEBM/CCD), PubMed, Chinese Biomedical Literature Database (CBM), Papers on Academic Conference of China (PACC), Chinese Dissertation Database Full-Text (CDDBFT), and Evidence-based Traditional Chinese Medicine Database (EBTCMD). All searches were updated on January 15, 2007. We also performed a manual search of the RCTs of TCMT for prostatitis among periodicals related to TCM, researched the related studies by correlative websites, such as “Baidu” and “Google”, gray literatures, and studies included in the references of eligible studies. At least two reviewers independently screened the studies for eligibility, evaluated the quality, and extracted the data from the eligible literatures, with a cross-check to confirm accuracy. Different views were settled by a third party. We evaluated the quality of eligible studies with the revised Jadad’s scale, and extracted valid data using data tables. Meta-analyses were performed for homogeneous studies using RevMan 4.3 software. If heterogeneity existed among the studies, descriptive analysis was conducted. The potential publication-bias was analyzed by funnel plot analysis. Results A total of 52 randomized clinical trials of TCMT for prostatitis (n=5 209) among 1 282 original studies were identified. The methodological quality ranked high in 9 RCTs (the revised scale were ≥ 4 scores), and 22 RCTS reported the methods of random sequence production. The analysis indicated some TCMT were more effective than the treatments in the controls in relieving the proatatitis patients’ pain or discomfort, paruria, impact of symptoms and NIH-chronic prostatitis symptom index (NIH-CPSI), improving the EPS-WBC and urine flow rate etc. Of the trials, 29 randomized clinical trials of TCMT for prostatitis that studied safety (n=2 502) were identified. The methodological quality ranked high in 8 RCTs (the revised scale were ≥ 4 scores), and 18 RCTs reported the method of random sequence production. Analysis indicated some TCMT may cause lower digestive tract symptoms when compared to the control therapies and some Chinese herbs formulas- may cause sexual disfunction. Conclusion Some TCMT may be more effective than the controls in relieving the patients’ pain or discomfort, paruria, impact of symptoms and NIH-CPSI, improving the prostatic tenderness with DRE, improving the EPS-WBC, lecithin lipophore, and urine flow rate etc. However, some TCMT of the trials included may cause lower digestive tract symptoms when compared to the controls, and some Chinese herbs formulas cause sexual disfunction. Because of the generally low methodological quality and the variations of the herbs used, the overall effects cannot be pooled for analysis. More evidence is needed to support this finding.
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.
Objective To evaluate the effectiveness and safety of traditional Chinese medicine (TCM) plus transcatheter arterial chemoembolization (TACE) compared with TACE alone, in the treatment of unresectable hepatocellular carcinoma (HCC). Methods The Cochrane Library, MEDLINE, EMBASE, CANCERLIT, CBM, CNKI and VIP were searched electronically. Relevant journals and conference proceedings were also handsearched. The quality of included studies 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 RevMan 4.2.10 software. Subgroup analyses by frequency of TACE (lt;3 or ≥3 times) were also performed. Results Thirty seven trials, all published in China, involving 2 653 participants were included. The quality of 2 studies was graded B (medium) and that of the other 35 was graded C (low). Meta-analyses showed that TCM plus TACE, compared with TACE alone, could significantly improve survival, tumor response (complete and partial), quality of life and clinical symptoms, and was also associated with a lower incidence of adverse reactions. Subgroup analyses indicated that, patients with less than three TACE had more significant improvement in survival and clinical symptoms, while patients with three or more TACE had more significant improvement in tumor response and quality of life. The incidence of adverse reactions was similar between these two different frequencies of TACE. Conclusions The treatment regimen of TCM plus TACE is superior to TACE alone in patients with unresectable HCC. As the existing data have a high risk of bias, the current evidence is insufficient to define the efficacy of the combination treatment, and further large-scale, high-quality randomized controlled trials are needed.
Intensive discussions and debates concerning whether we should and how to apply evidence-based medicine (EBM) research in traditional Chinese medicine (TCM) have arisen worldwide. We always hold the opinion: TCM needs EBM; the evidence from EBM is not limited to randomized controlled trials and systematic reviews; innovative methodological studies are urged based on the characteristics of TCM theoretically and clinically. Based on the methodological training and studies in this area, the authors discussed how to promote the evidence based TCM from five aspects including completing clinical trial procedure, reporting clinical trials according to international standards, reviewing the current clinical studies on TCM systematically, promoting the methodological research and academic exchange and better evidence (knowledge) management.
目的:评价中药配合三阶梯止痛与单纯三阶梯止痛比较治疗癌性疼痛的有效性和安全性。方法:采用Cochrane系统评价方法，计算机检索Cochrane图书馆临床对照试验资料库、MEDLINE、CBM、CNKI、VIP和万方；同时手检相关期刊和会议论文集，纳入有关中药配合三阶梯止痛治疗癌性疼痛的随机对照试验，并按Cochrane系统评价员手册4.2.2版推荐的质量评价标准评价纳入研究质量，对同质的研究进行Meta分析。结果:共检索到符合纳入标准的中文文献12篇（1366例患者）。文献质量评价结果显示，所有文献均为C级。Meta分析结果显示，中药配合三阶梯止痛治疗癌痛在近期镇痛效果、提高生活质量和减少不良反应发生方面优于单纯三阶梯止痛药治疗。结论:中药配合三阶梯止痛治疗癌性疼痛优于单纯三阶梯止痛治疗。但由于纳入试验研究的方法学质量普遍较低，期待更多设计合理、方法科学的大样本多中心随机双盲对照临床试验，提供高质量的证据。