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| Analyses on the outcome measures and its problems used in clinical trials of traditional Chinese medicine for treating bradyarrhythmia |
| Hits 1374 Download times 913 Received:December 24, 2019 |
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| DOI
10.11656/j.issn.1672-1519.2020.04.15 |
| Key Words
traditional Chinese medicine;bradyarrhythmia;outcome;core outcome set;randomized clinical trial |
| Author Name | Affiliation | E-mail | | HU Haiyin | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | JI Zhaochen | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | LI Nan | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | WANG Keyi | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China | | | OU Yi | 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 | | | WANG Hui | 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 | zjhtcm@foxmail.com |
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| Abstract
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| [Objective] To analyze the outcome measures used in randomized clinical trials of traditional Chinese medicine(TCM) for treating bradyarrhythmia published from 2017 to 2018,and then provide foundation to summary the data of core outcome set (COS) of TCM about bradyarrhythmia.[Methods] Databases including EVDS,CNKI,WanFang Date,VIP,SinoMed,PubMed and Cochrane Library are retrieved to collect randomized controlled trial (RCT) of TCM for treating bradyarrhythmia from 2017 to 2018. Two reviewers independently screen literature and extract data according to the inclusion and exclusion criteria. Disagreements are resolved by discussion.[Results] The 71 RCT were included,involving 6 129 patients and 65 outcome measures. The number of outcome measures in one of the included RCT varied from 1 to 23 with the average of 4.07. After frequency analysis,the top 14 outcome measures were heart rate,clinical efficacy,adverse events,slowest heart rate,scores of TCM syndrome,efficacy of TCM syndrome,average heart rate of 24 h dynamic ECG,fastest heart rate,efficacy of ECG,total heart rate of 24 h dynamic ECG,slowest heart rate of 24 h dynamic ECG,safety index,efficacy of 24 h dynamic ECG,efficacy of symptom improvement.[Conclusion] There are a series of problems in the randomized controlled trial of TCM for treating bradyarrhythmia,particularly in the issue of outcome selection,outcome reference standards,outcome measurement time and outcome measurement methods. Thus,it is vital to develop COS for treating bradyarrhythmia to improve the quality of clinical researches of TCM. |
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