Quality Assessment of Randomized Controlled Trials Related to Traditional Chinese Medicine Published in the Chinese Journal of Evidence-Based Medicine_Chinese Journal of Evidence-Based Medicine

Authors：

MIN Jie ,  MAO Bing , LIU Airan

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

Corresponding author：

MAO Bing, Email: maobing@medmail.com.cn

Keywords：

CONSORT statement; Chinese Journal of Evidence-Based Medicine; Traditional Chinese medicine; Randomized controlled trial; Quality assessment of literature

DOI：

10.7507/1672-2531.20100410

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Abstract Full text Figures/Tables Video References Cited by

Objective 　To assess the quality of reporting of randomized controlled trials (RCTs) related to traditional Chinese medicine (TCM) published in the Chinese Journal of Evidence-Based Medicine by CONSORT statement and Jadad scale.
Methods 　We handsearched the Chinese Journal of Evidence-Based Medicine to identify TCM RCTs. The revised CONSORT statement and Jadad scale combined with self-established criteria were applied.
Results 　A total of 57 RCTs were identified of which there were 17 TCM RCTs. Some items in CONSORT checklist were completely reported in all TCM RCTs, such as abstract, inclusion and exclusion criteria, intervention, randomization sequence generation, description of statistic method, description of baseline data, outcomes and estimation, and explain results. Compared with the previous findings, there were more trials in this study to report allocation concealment, randomization implementation, use of flow chart and appliance. Only 3 RCTs (17.6%) reported acknowledgements. One RCT did not describe syndrome type of TCM, and 4 RCTs (23.5%) carried out dummy. The mean Jadad score was 4.35±1.11 in all trials, of which 11 RCTs (64.7) ranked 5 points.
Conclusion 　The comprehensive quality of reporting of TCM RCTs published in the Chinese Journal of Evidence-Based Medicine from 2001 to 2008 has been improved. After the publication of CONSORT statement and CONSORT for traditional Chinese medicine, the quality of reporting of TCM RCTs is improved. We are looking forward to improving the CONSORT for TCM.

Citation： MIN Jie,MAO Bing,LIU Airan. Quality Assessment of Randomized Controlled Trials Related to Traditional Chinese Medicine Published in the Chinese Journal of Evidence-Based Medicine. Chinese Journal of Evidence-Based Medicine, 2010, 10(3): 362-366. doi: 10.7507/1672-2531.20100410 Copy

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2.	Wang G, Mao B, Xiong ZY, et al. The quality of reporting of randomized controlled trials of TCM: A survey of 13 randomly selected journals from mainland China. Clinical Therapeutics, 2007, 29(7): 1456 -1467.
3.	The Cochrane Collaboration Handbook. In: the Cochrane Library. ChiChester, UK: John Wiley&Sons, Ltd. 2004.
4.	Tang JL, Zhan SY, Ernst E. Review of randomized controlled trials of traditional Chinese medicine. BMJ, 1999, 319(7203): 160-161.
5.	毛兵, 王刚, 陈小东, 等.《中国中西医结合杂志》发表随机对照试验报告的质量评价. 中国循证医学杂志, 2006, 6(4): 297-304.
6.	Tang JL, Zhan SY, Ernst E. Review of randomised controlled trials of traditional Chinese medicine. BMJ, 1999, 319(7203): 160-161.
7.	樊涛, 王刚, 王蕾, 等. 复方丹参滴丸治疗冠心病心绞痛随机对照试验的质量评价. 中国循证医学杂志, 2007, 7(6): 461-470.
8.	Cheng CW, Bian ZX, Li YP. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials. Journal of Chinese Integrative Medicine, 2008, 6(9): 881- 885.
9.	World Medial Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. Available at: http:// www.wma.net/e/policy/pdf/17c.pdf. Accessed June 14, 2005.
10.	Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized cl inical trials: is blinding necessary? Controll Clin Trials, 1996, 17(1): 1-12.
11.	Linde K, Jonas WB, Melchart D, et al. The methodological quality of randomized controlled trials of homeopathy, herbal medicine and acupuncture. Int J Epidemiol, 2001, 30: 26-31.
12.	郑颂华, 卞兆祥, 李幼平, 等. CONSORT系列——中医药临床研究报告中应清晰阐述试验设计理念. 中国循证医学杂志, 2008, 8(3): 152-154.
13.	Joel J Gagnier, Heather Boon, Paula Rochon, et al. for the CONSORT Group. Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement. Ann InternMed, 2006, 144: 36.
14.	吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范. 中国循证医学杂志, 2007, 7(8): 601-605.

1. CONSORT for TCM小组. 创建中医药临床试验统一报告标准, 促进中医药现代化. 中国循证医学杂志, 2006, 6(4): 233-235.
2. Wang G, Mao B, Xiong ZY, et al. The quality of reporting of randomized controlled trials of TCM: A survey of 13 randomly selected journals from mainland China. Clinical Therapeutics, 2007, 29(7): 1456 -1467.
3. The Cochrane Collaboration Handbook. In: the Cochrane Library. ChiChester, UK: John Wiley&Sons, Ltd. 2004.
4. Tang JL, Zhan SY, Ernst E. Review of randomized controlled trials of traditional Chinese medicine. BMJ, 1999, 319(7203): 160-161.
5. 毛兵, 王刚, 陈小东, 等.《中国中西医结合杂志》发表随机对照试验报告的质量评价. 中国循证医学杂志, 2006, 6(4): 297-304.
6. Tang JL, Zhan SY, Ernst E. Review of randomised controlled trials of traditional Chinese medicine. BMJ, 1999, 319(7203): 160-161.
7. 樊涛, 王刚, 王蕾, 等. 复方丹参滴丸治疗冠心病心绞痛随机对照试验的质量评价. 中国循证医学杂志, 2007, 7(6): 461-470.
8. Cheng CW, Bian ZX, Li YP. Transparently reporting adverse effects of traditional Chinese medicine interventions in randomized controlled trials. Journal of Chinese Integrative Medicine, 2008, 6(9): 881- 885.
9. World Medial Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. Available at: http:// www.wma.net/e/policy/pdf/17c.pdf. Accessed June 14, 2005.
10. Jadad AR, Moore RA, Carroll D, et al. Assessing the quality of reports of randomized cl inical trials: is blinding necessary? Controll Clin Trials, 1996, 17(1): 1-12.
11. Linde K, Jonas WB, Melchart D, et al. The methodological quality of randomized controlled trials of homeopathy, herbal medicine and acupuncture. Int J Epidemiol, 2001, 30: 26-31.
12. 郑颂华, 卞兆祥, 李幼平, 等. CONSORT系列——中医药临床研究报告中应清晰阐述试验设计理念. 中国循证医学杂志, 2008, 8(3): 152-154.
13. Joel J Gagnier, Heather Boon, Paula Rochon, et al. for the CONSORT Group. Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement. Ann InternMed, 2006, 144: 36.
14. 吴泰相, 李幼平, 卞兆祥, 等. 中医药临床随机对照试验报告规范. 中国循证医学杂志, 2007, 7(8): 601-605.

Chinese Journal of Evidence-Based Medicine

Quality Assessment of Randomized Controlled Trials Related to Traditional Chinese Medicine Published in the Chinese Journal of Evidence-Based Medicine

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