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| Quality assessment of randomized controlled trials on Shengmai injection in treating dilated cardiomyopathy |
| Hits 1817 Download times 1715 Received:April 25, 2014 |
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| DOI
10.11656/j.issn.1672-1519.2014.10.06 |
| Key Words
Shengmai injection;dilated cardiomyopathy;randomized controlled trial;quality assessment |
| Author Name | Affiliation | | LI Meng-kui | Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | ZHANG Yu | Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | WU Xue-run | Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | GUO Li-ping | Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China | | HAN Li-jun | Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China |
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| Abstract
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| [Objective] To assess the quality of randomized controlled trial (RCT) reports of Shengmai injection in the treatment of dilated cardiomyopathy. [Methods] Using the Jadad scale and the CONSORT for TCM standard, the evaluation was performed. [Results] There were 16 articles of RCT met with the inclusion criteria. When the Jadad score was used 14 articles have 1 points and 2 articles have 0 points. There wasn't any article, in which the method using random sequence was described. No one report described how to perform the random concealment. There wasn't any article, in which the blind method was mentioned. There wasn't also any one, in which the withdrawal and withdrawal conditions were described. According to the standard of CONSORT for TCM, only 9 articles(56.30%) have described the diagnostic criteria. There was 1 article (6.25%), which has provided the standard of TCM. Only 1 article (6.25%), in which the standard of endpoint was described. Five articles (31.30%) have described the adverse events. All of them haven't performed the sample content calculation, the intentionality analysis and hierarchical analysis. All of them have not reported the ethics review and the condition of informed consent. [Conclusion] In the clinical study of dilated cardiomyopathy by the Shengmai injection, the method of research design, the comprehensive respects and quality of the reported article are needed to be improved |
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