Quality evaluation of randomized controlled clinical trials in Chinese Journal of Integrated Traditional and Western Medicine_Chinese Journal of Evidence-Based Medicine

Authors：

ZHANG Mingyan , YANG Fengwen , LI Yue , LIU Yu , ZHAO Mengyu , ZHENG Wenke ,  ZHANG Junhua

Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin, 300193, P.R.China;

Corresponding?author：

ZHANG Junhua, Email: zjhtcm@foxmail.com

Keywords：

TCM; RCTs; Reporting quality; CONSORT

DOI：

10.7507/1672-2531.201611085

Video：

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Objective To evaluate the quality of randomized controlled trials (RCTs) of traditional Chinese medicine published inChinese Journal of Integrated Traditional and Western Medicine, and to analyze changes. Methods We searched CNKI to collect RCTs published inChinese Journal of Integrated Traditional and Western Medicine (CJITWM) in 2014. Reporting quality of RCTs was evaluated by using CONSORT 2010 checklist, the methodological quality and ethics requirements were also analyzed. The changes of quality was also analyzed by comparing with those of 2004. Results A total of 80 RCTs were included. The top three interventions were Chinese patent medicine, decoction, acupuncture. Items with high reporting rate (>80%) included abstract, participants, randomization sequences and informed consent. Items with reporting rate of 50% to 80% including introduction, interventions, harms and funding, and others were all less than 50%. Among them, the reporting quality of title, trial design, outcomes, sample size, type of randomization, allocation concealment, blinding, numbers analyzed, outcomes and estimation, generalizability, interpretation, registration and protocol was less than 10%. Compared with those of 2004, the quality of reporting, methodology, and ethics has all increased. Significant progress was made in items of structured summary, background and objectives, collecting participants, adverse reactions, quality control standards of TCM interventions, diagnostic evaluation criteria of TCM, follow-up, funding, ethical approval and informed consent. But small progress was made in randomization, allocation concealment and implementation, sample size, blinding and ITT. There has been no participant flow. Conclusion The quality of reporting, methodology, and ethics of RCTs published inChinese Journal of Integrated Traditional and Western Medicine have made some progress, however, trial design, outcomes selection, estimation of sample size, randomization, blinding, registration and participant flow are still needed to be further improved.

Citation： ZHANG Mingyan, YANG Fengwen, LI Yue, LIU Yu, ZHAO Mengyu, ZHENG Wenke, ZHANG Junhua. Quality evaluation of randomized controlled clinical trials in Chinese Journal of Integrated Traditional and Western Medicine. Chinese Journal of Evidence-Based Medicine, 2017, 17(3): 357-363. doi: 10.7507/1672-2531.201611085 Copy

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2.	毛兵, 王剛, 陳小東, 等.《中國中西醫結合雜志》發表隨機對照試驗報告的質量評價. 中國循證醫學雜志, 2006, 6(4): 297-304.
3.	Available at: .
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5.	侯政昆, 劉鳳斌, 陳新林, 等. 循證量表:現代中醫生產力下臨床結局評價困境的突圍方向. 中華中醫藥雜志, 2016, 31(10): 3872-3877.
6.	汪受傳, 趙霞, 虞舜, 等. 循證性中醫臨床診療指南的質量評價—AGREEⅡ 工具及其應用. 中華中醫藥雜志, 2016, 31(8): 2963-2967.
7.	衷敬柏. 建立適合中醫臨床診療證據評價方法的建議. 中華中醫藥雜志, 2016, 31(4): 1146-1148.
8.	賀君, 陸麗明, 廖穆熙. 基于 CONSORT 與 STRICTA 對近 20 年國內針刺隨機對照報告質量影響評價. 河北中醫, 2016, 38(6): 811-816, 824.
9.	Zhao X, Zhen Z, Guo J, et al. Assessment of the reporting quality of placebo-controlled randomized trials on the treatment of type 2 diabetes with traditional Chinese medicine in mainland china: a PRISMA-compliant systematic review. Medicine (Baltimore), 2016, 95(3): e2522.
10.	Wang P, Xu Q, Sun Q, et al. Assessment of the reporting quality of randomized controlled trials on the treatment of diabetes mellitus with traditional Chinese medicine: a systematic review. PLoS One, 2013, 8(7): e70586.
11.	Fan FF, Xu Q, Sun Q, et al. Assessment of the reporting quality of randomized controlled trials on treatment of coronary heart disease with traditional Chinese medicine from the Chinese journal of integrated traditional and Western medicine: a systematic review. PLoS One, 2014, 9(1): e86360.
12.	He J, Du L, Liu G, et al, Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews. Trials, 2011, 12: 122.
13.	Gagnier JJ, Heather B, Paula R, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Inter Med, 2006, 119(9): e1-11.
14.	Gagnier JJ, Boon H, Rochon P, et al. Recommendations for reporting randomized controlled trials of herbal interventions: Explanation and elaboration. J Clin Epidemiol, 2006, 59(11): 1134-1149.
15.	MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement. J Evid Based Med, 2010, 3(3): 140-155.

1. ?Moher D, Hopewell S, Schulz KF. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trial. Int J Surg, 2012, 10(1): 28-55.
2. 毛兵, 王剛, 陳小東, 等.《中國中西醫結合雜志》發表隨機對照試驗報告的質量評價. 中國循證醫學雜志, 2006, 6(4): 297-304.
3. Available at: .
4. Chan AW, Altman DG. Epidemiology and reporting of randomized trials published in PubMed journals. Lancet, 2005, 365(9465): 1159-1162.
5. 侯政昆, 劉鳳斌, 陳新林, 等. 循證量表:現代中醫生產力下臨床結局評價困境的突圍方向. 中華中醫藥雜志, 2016, 31(10): 3872-3877.
6. 汪受傳, 趙霞, 虞舜, 等. 循證性中醫臨床診療指南的質量評價—AGREEⅡ 工具及其應用. 中華中醫藥雜志, 2016, 31(8): 2963-2967.
7. 衷敬柏. 建立適合中醫臨床診療證據評價方法的建議. 中華中醫藥雜志, 2016, 31(4): 1146-1148.
8. 賀君, 陸麗明, 廖穆熙. 基于 CONSORT 與 STRICTA 對近 20 年國內針刺隨機對照報告質量影響評價. 河北中醫, 2016, 38(6): 811-816, 824.
9. Zhao X, Zhen Z, Guo J, et al. Assessment of the reporting quality of placebo-controlled randomized trials on the treatment of type 2 diabetes with traditional Chinese medicine in mainland china: a PRISMA-compliant systematic review. Medicine (Baltimore), 2016, 95(3): e2522.
10. Wang P, Xu Q, Sun Q, et al. Assessment of the reporting quality of randomized controlled trials on the treatment of diabetes mellitus with traditional Chinese medicine: a systematic review. PLoS One, 2013, 8(7): e70586.
11. Fan FF, Xu Q, Sun Q, et al. Assessment of the reporting quality of randomized controlled trials on treatment of coronary heart disease with traditional Chinese medicine from the Chinese journal of integrated traditional and Western medicine: a systematic review. PLoS One, 2014, 9(1): e86360.
12. He J, Du L, Liu G, et al, Quality assessment of reporting of randomization, allocation concealment, and blinding in traditional Chinese medicine RCTs: a review of 3159 RCTs identified from 260 systematic reviews. Trials, 2011, 12: 122.
13. Gagnier JJ, Heather B, Paula R, et al. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Inter Med, 2006, 119(9): e1-11.
14. Gagnier JJ, Boon H, Rochon P, et al. Recommendations for reporting randomized controlled trials of herbal interventions: Explanation and elaboration. J Clin Epidemiol, 2006, 59(11): 1134-1149.
15. MacPherson H, Altman DG, Hammerschlag R, et al. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT statement. J Evid Based Med, 2010, 3(3): 140-155.

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