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| Evaluation index analysis of randomized controlled clinical trials of traditional Chinese medicine in treating chronic heart failure |
| Hits 1508 Download times 937 Received:June 20, 2020 |
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| DOI
10.11656/j.issn.1672-1519.2020.11.15 |
| Key Words
traditional Chinese medicine;chronic heart failure;outcome indicator;core outcome set;randomized controlled trial |
| Author Name | Affiliation | E-mail | | CHUA Hui Zi | Singapore
Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHANG Mingyan | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | NIU Baihan | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | LI Kai | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | ZHANG Junhua | Evidence Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | zjh_tcm@foxmail.com |
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| Abstract
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| [Objective] To analyze the efficacy evaluation indexes in randomized controlled trials (RCTs) of chronic heart failure (CHF) published in recent years (focusing on year 2018),using traditional Chinese medicine (TCM) as an intervention,to provide fundamental data for the development of core outcome set (COS) for CHF using TCM treatment.[Methods] Online search of 8 databases including CNKI,WanFang Data,VIP,SinoMed (4 Chinese databases),PubMed,Cochrane Library,EMBASE and Web of Science (4 English databases) were searched to collect RCTs of CHF intervened by TCM in 2018. Two reviewers independently screened selected literature and extracted data according to the inclusion and exclusion criteria. Any discrepancy in the study selection was resolved by discussion with a third reviewer. Basic information,baseline characteristics,intervention measures,outcome measures and adverse events were extracted.[Results] A total of 157 RCTs were included,involving 17 459 patients and 138 efficacy evaluation indicators. The number of outcomes used in a single study was 1 to 13,with an average of 6. After frequency analysis,the top 15 outcomes were:echocardiography,clinical efficacy,NT-proBNP/BNP,adverse events,6min walking test,cardiac function (classification) efficacy,scores of TCM syndrome,TCM syndrome efficacy,quality of life rating scale,heart failure scores,vital signs,CRP,TCM symptom score,TNF-α and IL-6. The main problems of indicators are as follows:the number of outcomes used in different studies varied greatly,with the measurement time and method of the same outcome are also different;incomplete reporting of information for outcomes in the included studies,with the continuous variables being converted to ranked ordinal data or reported in percentages;outcomes reported also show a lack of practicability,with a lack of usage on long-term prognosis and safety outcomes.[Conclusion] Outcomes reported in clinical trials of TCM for CHF vary greatly,with a lack of standardization and practicality. Hence,it is necessary to develop COS to improve the methodological quality and clinical value of relevant clinical studies. |
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