Quality Assessment of the Reporting of Randomized Controlled Trials Published in the Chinese Journal of Integrated Traditional and Western Medicine with the Revised CONSORT Statement_Chinese Journal of Evidence-Based Medicine

Authors：

MAO Bing , WANG Gang , CHENG Xiaodong , FAN Tao , LIU Jia , WANG Lei , CHANG Jin , ZHANG Yin , GUO Jia , LI Tingqian

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

Corresponding author：

Keywords：

CONSORT statement; Integrated traditional and western medicines; Randomized controlled trials; Quality assessment of literature

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Objective 　To explore the quality of the reporting of randomized controlled trials (RCTs) published in the Chinese Journal of Integrated Traditional and Western Medicine from 1999 to 2004.
Methods 　A manual search was performed and the 22 checklists of CONSORT statement and other self-established criteria were applied.
Results　 Six volumes and 72 issues were checked. There were 1 874 clinical trials of which 1288 (68.73%) RCTs were identified in 2 765 articles. Randomization methods were described in 630 (48.92%) RCTs which showed there was more significant difference than the RCTs published in 1998 (P lt;0.001).In the 1288 RCTs, placebo control was reported only in 21 trials (1.63%) and endpoint measurements were reported in 114 trials (8.85%). Seven trials (0.55%) mentioned the estimation of sample size. None mentioned randomization concealment. Blinding was reported in 54 trials (4.2%) and P value was reported in 9 trials (0.70%).Flow chart was not mentioned in any trials. Compliance was reported in 2 trials (0.16%), and only one trial (0.08%) reported negative results. Ancillary analysis was used in 33 trials (2.57%). 10 trials are multi-centre RCTs. None of the trials reported the approval of ethics committee. Informed consent was reported in 3 trials (0.24%). Acknowledgements were mentioned in 3 trials (0.24%). Syndrome types defined by traditional Chinese medicine (TCM) were reported in 163 trials (12.66%). The criteria of intervention quality control was mentioned in 2 trials (0.15%). Double dummy was used in 8 trials (0.63%) and outcome measurement of TCM was reported in 258 trials (20.04%). All Items reported in RCTs were of low quality.
Conclusions 　The quality of reporting of RCTs published in the Chinese Journal of Integrated Traditional and Western Medicine from 1999 to 2004 has been improved, but it does not meet the CONSORT statement.

Citation： MAO Bing,WANG Gang,CHENG Xiaodong,FAN Tao,LIU Jia,WANG Lei,CHANG Jin,ZHANG Yin,GUO Jia,LI Tingqian. Quality Assessment of the Reporting of Randomized Controlled Trials Published in the Chinese Journal of Integrated Traditional and Western Medicine with the Revised CONSORT Statement. Chinese Journal of Evidence-Based Medicine, 2006, 06(4): 297-304. doi: Copy

1.	李廷谦，王刚，王蕾等.我国中医药临床研究的现状和评价.中国循证医学杂志, 2005;5(6)：431～437.
2.	卫茂玲，辜蕊，张鸣明等.11种地方性中医药期刊1995～2000年临床研究文献质量的初步分析.中国循证医学杂志, 2004;4(6):410～413.
3.	李廷谦，毛兵，常静等.《中国中西医结合杂志》发表的论文中有关临床试验的评价.中国中西医结合杂志,1999;19(7): 435～436.
4.	李廷谦，毛兵，常静等.中西医、中医核心杂志临床研究文献评价. 华西医学, 2000; 15(3):266～269.
5.	Moher D, Schulz KF, Altman DG.The CONSORT statement revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet, 2001:357(9263):1191-1194.
6.	Instructions for authors.Chin Med J, 2005; 118(1):1140-1144.
7.	Liu YX, Yao C, Chen Feng, et al. Introductionn to CONSORT statement reporting randomized controlled clinical trials. National Journal of Andrology, 2001; 32(26): 288-291.
8.	Liu XM, Liu JP. Improving quality of medical journals by CONSORT using. Acta Editologica, 2002; 14(3):228-229.
9.	Liu YX, Yao C, Sheng M.The CONSORT statement：Universe requirements for reporting randomized controlled trials. Chin J Clin Pharmacol, 2004; 20:76-80.
10.	Tang JL, Zhan SY, Ernst E. Review of randomized controlled trials of traditional Chinese medicine. BMJ,1 999;319(7 203):160-161.
11.	LI TQ,WANG Gang, WANG Lei,et al. Clinical trials of traditional Chinese medicine in China: status and evaluation. Chin J EBM, 2005; 5(6)：431-437.
12.	WEI ML,GU Rui,ZHANG MM.A brief study on the quality of clinical trials in 11 medical journals of traditional Chinese medicine from 1995 to 2000. Chin J EBM, 2004;4(6):410-413.
13.	LI TQ,MAO Bing,CHANG Jing,et al. Evaluation of clinical trails published in the Chinese Journal of Integrated Traditional and Western Medicine. Chinese Journal of Integrated Traditional and Western Medicine, 1999; 19(7): 435-436.
14.	LI TQ,MAO Bing,CHANG Jing,et al. An Evaluation of Clinical Research Literatures in Core Journals of Traditional Chinese Medicine Integrated with Western Medicine or Traditional Chinese Medicine. West China Medical Journal, 2000;15(3):266-269.
15.	The Cochrane Collaboration Handbook. In: the Cochrane Library. ChiChester, UK: John Wiley&Sons, Ltd. 2004.

1. 李廷谦，王刚，王蕾等.我国中医药临床研究的现状和评价.中国循证医学杂志, 2005;5(6)：431～437.
2. 卫茂玲，辜蕊，张鸣明等.11种地方性中医药期刊1995～2000年临床研究文献质量的初步分析.中国循证医学杂志, 2004;4(6):410～413.
3. 李廷谦，毛兵，常静等.《中国中西医结合杂志》发表的论文中有关临床试验的评价.中国中西医结合杂志,1999;19(7): 435～436.
4. 李廷谦，毛兵，常静等.中西医、中医核心杂志临床研究文献评价. 华西医学, 2000; 15(3):266～269.
5. Moher D, Schulz KF, Altman DG.The CONSORT statement revised recommendations for improving the quality of reports of parallel-group randomized trials. Lancet, 2001:357(9263):1191-1194.
6. Instructions for authors.Chin Med J, 2005; 118(1):1140-1144.
7. Liu YX, Yao C, Chen Feng, et al. Introductionn to CONSORT statement reporting randomized controlled clinical trials. National Journal of Andrology, 2001; 32(26): 288-291.
8. Liu XM, Liu JP. Improving quality of medical journals by CONSORT using. Acta Editologica, 2002; 14(3):228-229.
9. Liu YX, Yao C, Sheng M.The CONSORT statement：Universe requirements for reporting randomized controlled trials. Chin J Clin Pharmacol, 2004; 20:76-80.
10. Tang JL, Zhan SY, Ernst E. Review of randomized controlled trials of traditional Chinese medicine. BMJ,1 999;319(7 203):160-161.
11. LI TQ,WANG Gang, WANG Lei,et al. Clinical trials of traditional Chinese medicine in China: status and evaluation. Chin J EBM, 2005; 5(6)：431-437.
12. WEI ML,GU Rui,ZHANG MM.A brief study on the quality of clinical trials in 11 medical journals of traditional Chinese medicine from 1995 to 2000. Chin J EBM, 2004;4(6):410-413.
13. LI TQ,MAO Bing,CHANG Jing,et al. Evaluation of clinical trails published in the Chinese Journal of Integrated Traditional and Western Medicine. Chinese Journal of Integrated Traditional and Western Medicine, 1999; 19(7): 435-436.
14. LI TQ,MAO Bing,CHANG Jing,et al. An Evaluation of Clinical Research Literatures in Core Journals of Traditional Chinese Medicine Integrated with Western Medicine or Traditional Chinese Medicine. West China Medical Journal, 2000;15(3):266-269.
15. The Cochrane Collaboration Handbook. In: the Cochrane Library. ChiChester, UK: John Wiley&Sons, Ltd. 2004.

Chinese Journal of Evidence-Based Medicine

Quality Assessment of the Reporting of Randomized Controlled Trials Published in the Chinese Journal of Integrated Traditional and Western Medicine with the Revised CONSORT Statement

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