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| Outcome measures analysis of ranomized controlled trials in traditional Chinese medicine treating breast cancer |
| Hits 1471 Download times 617 Received:April 30, 2021 |
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| DOI
10.11656/j.issn.1672-1519.2021.10.16 |
| Key Words
traditional Chinese medicine;breast cancer;outcome measure;core outcome set;randomized controlled trial |
| Author Name | Affiliation | E-mail | | HE Chaokai | Evidence-based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China | | | LIU Chunxiang | 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 | wangh@tice.com.cn | | 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 outcomes of randomized controlled trials (RCTs)of traditional Chinese medicine (TCM) for breast cancer published in the past 5 years, and to provide fundamental data for building the Core Outcome Sets(COS) of breast cancer using TCM treatment. [Methods] Databases of Cochrane Library, Pubmed, Embase, Web of Science, SinoMed, Wanfang Data and CNKI were retrieved to collect RCTs of breast cancer using TCM intervention. The time limit is from January 2014 to October 2019. Two researchers independently conducted literature screening and data extraction based on inclusion and exclusion criteria. Disagreements were resolved by discussion. [Results] A total of 112 RCTs were included, including 9 430 patients and 61 outcome measures. The number of outcomes used in a single study ranged from 1 to 7, with an average of 3. The top 15 outcomes were clinical efficacy, adverse events, quality of life, tumor markers, survival, immune function indicators, safety evaluation, recurrence and metastasis, TCM syndrome scores, TCM syndrome efficacy, TCM symptom score, angiogenesis index, physical condition, myelosuppression, sleep quality. Problems with reported outcomes mainly includetoo few end-point indicators, lack of measurement of long-term effects, too arbitrary combination of indicators, large differences in measurement time and methods of indicators, irregular expression of indicators, inconsistent selection of indicators, lack of TCM characteristic indicators and economic indicators. [Conclusion] Outcomes reported in RCTs of TCM for breast cancer vary greatly, with a lack of standardization in the selection of indicators, measurement of indicators, and expression. It is necessary to carry out research on COS of TCM for treating breast cancer to improve the methodological quality and clinical research value. |
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