A Brief Study on the Quality of Clinical Trials in 11 Medical Journals of Traditional Chinese Medicine From 1995 to 2000_Chinese Journal of Evidence-Based Medicine

Authors：

WEI Maoling ¹ , GU Rui ² , ZHANG Ming ming ¹ , SU Shan ³ , LIU Qin ³ , ZHENG Liutao ³ , LIU Jianbo ³ , YANG Xi ² , SONG Li ²

1. Chinese Evidence-Based Medicine Centre; West China Hospital; Sichuan University; Chengdu 610041; China2. West China School of Medicine; Sichuan University; Chengdu 610041; China3. The Institute of Foreign Languages of Sichuan University; Sichuan University; Chengdu 610041; China;

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Keywords：

Traditional Chinese medicine; Non-key medical journals; Randomized controlled trials; Controlled clinical trials

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Objective 　To identify and investigate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) in 11 non-key Chinese medical journals so as to learn about the current status and problems.
Methods 　Eleven non-key medical journals of TCM from 1995 to 2000 were hand searched to identify the RCT and controlled clinical trials (CCTs). Each identified RCT or CCT was page by page verified by handsearchers based on the criteria developed by the Cochrane Handbook; the RCTs’ design, randomization method description, blind, baseline comparison, inclusion and exclusion criteria, diagnostic criteria,criteria for theraputic effectiveness, sample size, statistical method，described outcome, side effects, and follow up etc. were analyzed.
Results 　In the related journals from 1995 to 2000, a total of 66 volumes and 390 issues were checked. As a result, 22 739 clinical studies were identified, of which 1 416 RCTs, only 24 (1.69%) were done with double blinding. There were 141 CCTs from 1995 to 2000, the total number of RCT increased from 95 to 1 416 and most of studies were on digestives diseases. Most of these studies had no detailed randomization method description, only 38 (2.68%) studies provided a methodology description. In addition, 1 220 (86.16% ) described outcome index, 1 203 (84.96%) used statistical method，934 (65.96%) had baseline comparison，828 (58.47%) described diagnostic criteria, 197 (13.91%) had inclusion and exclusion criteria，finally only 89 (6.29%) reported side effects.
Conclusions 　Although the number of RCT has increased in the 11 non-key medical journals of TCM in the past six years, the quality of these RCTs needs to be improved.

Citation： WEI Maoling,GU Rui,ZHANG Ming ming,SU Shan,LIU Qin,ZHENG Liutao,LIU Jianbo,YANG Xi,SONG Li. A Brief Study on the Quality of Clinical Trials in 11 Medical Journals of Traditional Chinese Medicine From 1995 to 2000. Chinese Journal of Evidence-Based Medicine, 2004, 04(6): 410-413. doi: Copy

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1. ［1］The Cochrane Collaboration Handbook. In: The Cochrane Library. Chichester, UK: John Wiley & Sons, Ltd. Cochrane.Issue 1. 2004.
2. ［2］Wang JL, Editor-In-Chief. Clinical Epidemiology-Clinical research design, measurement and evaluation [ M ]. 2nd ed.Shanghai science technology publication house, 2001:47-130.
3. 王家良,主编.床流行病学--临床科研设计、衡量与评价[M].第2版.上海:上海科学技术出版社,2001:47～130.
4. ［3］Li TQ, Mao B, Chang J, Yang XN, Wang L, Zhang Y, Xia Q, Chi HH, Wu G, Xiong ZY, Chen GY, Huang ZW, Ma JX, Wang G, Lai ZY. An evaluation of clinical research literatures in core journals of traditional Chinese medicine integrated with western medicine or traditional medicine [J]. West China Medicine, 2000; 15 ( 3 ) :266-269.
5. 李廷谦,毛兵,常静,杨晓楠,王蕾,张颖,夏庆,迟焕海,巫刚,熊泽宇,陈光远,黄宗文,马建昕,王刚,赖珍玉.中西医、中医核心杂志临床研究文献评价[J].华西医学,2000;15(3):266～269.
6. ［4］Li TQ. The status of eidence-based medicine and integrated traditional and western medicine [J]. Chinese Journal of Evidence-based medicine, 2001 ;1 (3) :133-136.
7. 李廷谦.循证医学与中西医结合现状及设想[J].中国循证医学杂志,2001;1(3):133～136.
8. ［5］Tang JL, Zhan SY, Ernst E. Review of randomized controlled trials of traditional Chinese medicine [J]. BMJ, 1999; 319:160-16l.
9. ［6］Liu JP. The starus and strategy on the quality of RCT in the Chinese medical and pharmacy research [J]. Chinese Journal of Integrated Traditional and Western Medicine, 2003; 23 ( 1 ): 62-64.
10. 刘建平.中医药研究随机对照试验质量的现状及对策[J].中国中西医结合杂志2003;23(1):62～64.

Chinese Journal of Evidence-Based Medicine

A Brief Study on the Quality of Clinical Trials in 11 Medical Journals of Traditional Chinese Medicine From 1995 to 2000

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