Evaluation of reporting quality of RCT on nephrotoxicity of Tripterygium wilfordii preparations according to CONSORT HARMs statement.
10.19540/j.cnki.cjcmm.2018.0011
- Author:
Xue FENG
1
;
Sai-Nan FANG
1
;
Yu-Xin GAO
2
;
Jian-Ping LIU
1
;
Wei CHEN
1
Author Information
1. Centre for Evidence-Based Chinese Medicine， Beijing University of Chinese Medicine， Beijing 100029， China.
2. Department of Sociology， Acadia University， Wolfville B4P2R6， Canada.
- Publication Type:Journal Article
- Keywords:
CONSORT HARMs statement;
Tripterygium wilfordii;
nephrotoxicity;
randomized controlled trial;
reporting quality
- MeSH:
Drugs, Chinese Herbal;
toxicity;
Humans;
Kidney;
drug effects;
Randomized Controlled Trials as Topic;
Tripterygium;
toxicity
- From:
China Journal of Chinese Materia Medica
2018;43(3):440-445
- CountryChina
- Language:Chinese
-
Abstract:
To evaluate the quality of randomized controlled trials(RCT) on nephrotoxicity of Tripterygium wilfordii preparations according to the CONSORT HARMs statement. The report quality of each included study was evaluated according to the CONSORT HARMs statement， and the number of entries that comply with CONSORT HARMs statement was calculated in each study to evaluate the report quality on nephrotoxicity-related adverse reactions of T. wilfordii preparations and summarize the problems in domestic studies on nephrotoxicity-related adverse reactions. A total of 16 RCTs were included， with an average of 7 entries complying with CONSORT HARMs statement per study. The report of the nephrotoxic-associated RCT of T. wilfordii preparations was of poor quality and the most non-repeating entries included the following ones： using validated tools to report adverse effects， standards for coding of the adverse reactions， describing how and when to collect data on adverse reactions in Method， describing how adverse reactions are attributed to T. wilfordii， clearly stating who has reported the adverse reactions， describing the analysis method of adverse reactions， describing the method of collecting recurrent adverse reaction data， describing any subgroup analysis and exploratory analysis associated with the hazard. We suggest that the studies on adverse reactions of traditional Chinese medicine should strictly report the entries according to the CONSORT HARMs statement， and take the characteristics of traditional Chinese medicine into account to report the details of the Chinese medicine like compositions， dose， taking time， combined medication and the dialectical typology of research objects.
