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;
ZHANG Junhua, Email: zjhtcm@foxmail.com
TCM; RCTs; Reporting quality; CONSORT
10.7507/1672-2531.201611085
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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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