Methodological Evaluation on Domestic Clinical Trials on Traditional Chinese Medicine Nursing from 2006 to 2011_Chinese Journal of Evidence-Based Medicine

Authors：

MEI Lijuan ¹ ,  ZHENG Guohua ² , CHEN Qingyue ¹ , LIN Run ¹ , YAN Yu ³ , YANG Zhihong ³

1. School of Nursing, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China;2. Institute of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China; 3. School of Pharmaceutical Science, Fujian University of Traditional Chinese Medicine, Fuzhou 350122, China;

Corresponding author：

ZHENG Guohua, Email: zhgh_1969@yahoo.com.cn

Keywords：

Traditional Chinese medicine; Nursing; Clinical trial; Quality evaluation

DOI：

10.7507/1672-2531.20120119

Video：

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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

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14.	马超, 匡安仁, 吴泰相. 131I治疗131I全身显像阴性/甲状腺球蛋白阳性的分化型甲状腺癌临床研究的方法学质量评价. 中国循证医学杂志, 2005, 5(3): 232-236.
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16.	李学晶, 杨薇, 唐由之, 等. 中医药治疗年龄相关性黄斑变性文献的方法学质量评价. 中国中医眼科杂志, 2009, 19(2): 83-86.
17.	刘建平. 随机对照试验的报告. 中国中西医结合杂志, 2005, 25(4): 297-298.

1. 熊艳. 国内护理系统评价/Meta分析的报告质量分析. 护理学杂志, 2010, 25(12): 80-82.
2. 耿玲玲, 林仁生, 孙夏云, 等. 2000-2006年《中国针灸》杂志中RCT报告质量的评价. 中国针灸, 2008, 28(6): 439-443.
3. 国家中医药管理局. 中医医院中医护理工作指南（试行）. 北京, 2010.
4. Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.
5. Moher D, Jones A, Lepage L, CONSORT Group (Consolidated Standards for Reports of Trials). Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA, 2001, 285(15): 1992-1995.
6. 姚魁武, 张良登, 王阶, 等. 近5年部分核心期刊中医药治疗冠心病心绞痛随机对照试验的质量评价. 北京中医药, 2011, 30(3): 171-175.
7. 陈军, 索娟, 曾晓敏, 等. 中医药防治胆石症随机对照试验的质量评价. 中国循证医学杂志, 2008, 8(5): 370-374.
8. 王吉耀. 循证医学与临床实践. 北京.科学出版社, 2002: 58-157.
9. Altman DG, Schulz KF, Moher D, et al. The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration (1). 中国循证医学杂志, 2005, 5(9): 712-714.
10. Schulz KF, Grimes DA. Allocation concealment in randomized trials: Defending against deciphering. Lancet, 2002, 359(9306): 614-618.
11. Schulz KF, Chalmers I, Hayes RJ, et al. Empirical evidence of bias: dimensions of methodological quality associated with estimates of effects in controlled trials. JAMA, 1995, 273(5): 408-412.
12. 李静. 临床医学研究常用设计方案实施方法. 中国实用儿科杂志2008, 23(1): 73-80.
13. 陈宏林, 刘晴晴, 吴娟, 等. CONSORT 声明在护理临床科研设计中的应用. 护士进修杂志, 2008, 23(1): 25-27.
14. 马超, 匡安仁, 吴泰相. 131I治疗131I全身显像阴性/甲状腺球蛋白阳性的分化型甲状腺癌临床研究的方法学质量评价. 中国循证医学杂志, 2005, 5(3): 232-236.
15. 刘雅莉, 杨克虎, 吴泰相, 等. 微波治疗宫颈糜烂随机对照试验的质量评价. 中国循证医学杂志, 2006, 6(10): 772-773.
16. 李学晶, 杨薇, 唐由之, 等. 中医药治疗年龄相关性黄斑变性文献的方法学质量评价. 中国中医眼科杂志, 2009, 19(2): 83-86.
17. 刘建平. 随机对照试验的报告. 中国中西医结合杂志, 2005, 25(4): 297-298.

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