Quality Assessment for Randomized Controlled Trials Published in Four Acta of Traditional Chinese Medicine_Chinese Journal of Evidence-Based Medicine

Authors：

CHANG Jing ,  LI Tingqian , WAN Meihua , ZHANG Ying

Department of Integrated Chinese Medicine and Western Medicine, West China Hospital, Sichuan University, Chengdu 610041, China;

Corresponding author：

LI Tingqian, Email: litingqian@163.com

Keywords：

Chinese medicine and pharmacology; Randomized controlled trial; Quality assessment; Consolidated standards of reporting trials

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Objective 　To assess the quality of the published randomized controlled trials published in Journal of Beijing University of Traditional Chinese Medicine (JBUTCM), Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai (AUTMSPS), Journal of Guangdong University of Traditional Chinese Medicine (JGUTCM), and Journal of Chengdu University of Traditional Chinese Medicine (JCUTCM) from 2000 to 2005.
Method　 Guided by the Cochrane Center hand-searching guidelines, we searched 24 volumes (111 issues) of the four journals. The data were extracted according to the principles of clinical epidemiology and consolidated standards of reporting trials (CONSORT), as well as an evaluation scale for randomized controlled trials (RCTs). The data were managed by descriptive analysis and uniformity test.
Results 　There were 365 RCTs. The diagnostic criteria were reported in 297 trials (81.37%). The inclusion and exclusion criteria were reported in 143 trials (39.18%) and 132 trials (36.16%), perspectively, None mentioned the estimation of sample size. The randomization and allocation concealment were reported in 70 trials (19.18%) and 9 trials, perspectively. The baseline data were described in 292 trials (80.00%). Blinding was mentioned in 35 trials (9.59%).Withdrawal occurred in 20 trials (5.48%). Informed consent was acquired in 2 trials. Adverse drug reactions were described in 97 trails (26.58%).
Conclusion 　There are deficiencies in the reporting of these RCTs, Most of the trials do not describe the randomization, only a few trials use the allocation concealment and blinded method, no description of comparability of baseline data, most of the trials do not report the inclusion and exclusion criteria, and none estimate the sample size. These problems indicate that it is necessary to improve the quality of clinical research in Chinese medicine and pharmacology.

Citation： CHANG Jing,LI Tingqian,WAN Meihua,ZHANG Ying. Quality Assessment for Randomized Controlled Trials Published in Four Acta of Traditional Chinese Medicine. Chinese Journal of Evidence-Based Medicine, 2006, 06(3): 171-178. doi: Copy

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23.	程航, 李祥云. 峻竣煎内服结合中药灌肠治疗输卵管阻塞性不孕102例. 上海中医药大学学报, 2005; 19(2): 22-23.
24.	崔飞婵, 陈琼嫡, 梁馨雨. 疏风散寒活血化瘀法治疗冷性荨麻疹的临床观察. 广州中医药大学学报, 2005; 22(5): 352-354.
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1. 王家良. 临床流行病学. 第2版. 上海: 上海科学技术出版社; 2001.
2. Moher, Kenneth FS, Douglas GA, et al. CONSORT声明: 提高平行报告质量的修订建议. 中国循证医学杂志, 2005; 5(9): 702-707.
3. Douglas GA, Kenneth FS, Moher D, et al. 报告随机对照试验的CONSORT声明修订版: 说明与详述（一）. 中国循证医学杂志, 2005; 5(9): 712-714.
4. Douglas GA, Kenneth FS, Moher D, et al. 报告随机对照试验的CONSORT声明修订版: 说明与详述（二）. 中国循证医学杂志, 2005; 5(10): 786-787.
5. Douglas GA, Kenneth FS, Moher D, et al. 报告随机对照试验的CONSORT声明修订版: 说明与详述（三）. 中国循证医学杂志, 2005; 5(11): 863-865.
6. 迟焕海, 毛兵, 王蕾, 等.《成都中医药大学学报》随机对照临床试验文献评价. 华西医学, 2000; 15(3): 272-273.
7. 夏庆, 毛兵, 陈光远, 等.《北京中医药大学学报》临床治疗试验论文的评价. 华西医学, 2001; 16(1): 4-5.
8. 孙维蜂, 孙桂华, 徐伟, 等. 升降胶囊治疗功能性消化不良肝郁脾虚证的临床研究. 广州中医药大学学报, 2003; 20(2): 99-101.
9. 王臻. 立愈散合米非司酮治疗围绝经期功能性子宫出血100例疗效观察. 北京中医药大学学报, 2005; 28(3): 92.
10. 符德玉, 周端, 顾仁樾, 等. 活血潜镇胶囊对高血压病（血瘀阳亢证）血管内皮细胞功能影响. 上海中医药大学学报, 2000;14(2): 18-20.
11. 汤水福, 陈刚毅, 陈铭, 等. 健脾益气固摄法治疗肾移植术后腹水外渗的初步临床观察. 广州中医药大学学报, 2005; 22(3): 182-164.
12. 陈沛泉, 简华香, 符林春, 等. 双氢青蒿素和奎宁对恶性疟原虫早期配子体作用的随机比较. 广州中医药大学学报, 2001; 18(1): 22-24.
13. 嵇波, 陈家旭, 鲁兆麒, 等. 逍遥散对人体神经内分泌免疫系统的影响. 北京中医药大学学报, 2003; 26(6): 68-71.
14. 梁超, 谭漪, 余洁, 等. 金朱止泻片治疗湿热泄泻的临床观察, 附449例病例报告. 成都中医药大学学报, 2000; 23(2): 11-13.
15. 徐凤洲, 何勇. 参附脱毒胶囊治疗阿片类戒断症状的临床观察, 附321例临床报告. 成都中医药大学学报, 2001; 24(3): 14-17.
16. 高炬, 张铮诘, 朱培庭. 锦红片治疗急性胆道感染的临床研究. 上海中医药大学学报, 2002; 16(3): 42-43.
17. 何莉, 黄河, 熊远青, 等. 黄芪对新生儿缺氧缺血性脑病的神经功能保护和免疫调节作用. 广州中医药大学学报, 2005;22(1): 23-25.
18. 郑晓辉, 曾展鹏, 黄枫. 中药配合交锁髓内钉内固定术治疗股骨干骨折. 广州中医药大学学报, 2000; 17(2): 140-141..
19. 王文萍, 王垂杰, 刘放, 等. 中药复方肠安泰预防大肠癌术后转移80例临床观察. 北京中医药大学学报, 2003; 26(2): 60-62.
20. 朱玮华, 陈伟民, 徐卫平. 四草二根汤治疗小儿急性肾炎临床观察. 北京中医药大学学报, 2000; 23(3): 64-65.
21. 何裔婷, 方坚, 彭剑虹, 等. 雷公藤涂膜剂治疗膝骨关节炎的临床研究. 广州中医药大学学报, 2004; 21(4): 278-280..
22. 宋建平, 陈沛泉, 徐颖, 等. 两种双氢青蒿素复方治疗海南岛无并发症恶性疟疾的临床对照研究. 广州中医药大学学报,2004; 21(1): 9-12.
23. 程航, 李祥云. 峻竣煎内服结合中药灌肠治疗输卵管阻塞性不孕102例. 上海中医药大学学报, 2005; 19(2): 22-23.
24. 崔飞婵, 陈琼嫡, 梁馨雨. 疏风散寒活血化瘀法治疗冷性荨麻疹的临床观察. 广州中医药大学学报, 2005; 22(5): 352-354.
25. 董莉, 孟炜, 陆建英. 更欣方对更年期抑郁症患者汉密尔顿积分及内分泌免疫系统的影响. 上海中医药大学学报, 2004; 18(2): 23-25.
26. 谭毅, 黄伟, 叶欣, 等. 男性免疫性不育症中医阶梯性治疗临床研究. 上海中医药大学学报, 2004; 18(3): 21-23.
27. 沈志峰, 刘小凡, 孟晓露. 中药外敷治疗儿童支气管哮喘寒饮停肺证88例的临床观察. 成都中医药大学学报, 2005;28(3): 30-32.
28. 范世平, 马晓霖, 陈振芳. 中药保留灌肠防治多性腺瘤性结肠息肉内镜治疗后再复发. 北京中医药大学学报, 2003; 26(3): 74-75.
29. Douglas GA. CONSORT说明文件的制定. 中国循证医学杂志, 2005; 5(9): 708-711.
30. Wang JL. Clinical Epidemiology. 2nd ed. Shanghai: Shanghai science and technology publishing house; 2001.
31. Moher D, Kenneth FS, Douglas GA, et al. The CONSORT Statement: Revised Recommendation for Improving the Quality of Reports of Parallel-group Randomised Trials. Chin J Evid-based Med, 2005; 5(9): 702-707.
32. Douglas GA, Kenneth FS, Moher D, et al. The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration (1). Chin J Evid-based Med, 2005; 5(9): 712-714.
33. Douglas GA, Kenneth FS, Moher D, et al. The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration (2). Chin J Evid-based Med, 2005; 5(10): 786-787.
34. Douglas GA, Kenneth FS, Moher D, et al. The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration (3). Chin J Evid-based Med, 2005; 5(11): 863-865.
35. Chi HH, Mao B, Wang L, et al. The Evaluation Papers Related to Clinical RCTs Studies Published in Journal of Chengdu University of Traditional Chinese Medicine from 1980～1998. West China Medical Journal, 2000; 15(3): 272-273.
36. Xia Q, Mao B, Chen GY, et al. Evaluation on the Articles of Clinical Therapeutic Trail Published in Journal of Beijing University of Traditional Chinese Medicine. West China Medical Journal, 2001; 16(1): 4-5.
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Chinese Journal of Evidence-Based Medicine

Quality Assessment for Randomized Controlled Trials Published in Four Acta of Traditional Chinese Medicine

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