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.
Citation： MEI Lijuan,ZHENG Guohua,CHEN Qingyue,LIN Run,YAN Yu,YANG Zhihong. Methodological Evaluation on Domestic Clinical Trials on Traditional Chinese Medicine Nursing from 2006 to 2011. Chinese Journal of Evidence-Based Medicine, 2012, 12(6): 735-739. doi: 10.7507/1672-2531.20120119 Copy