YAOHuan 1,2 , QINHong-gui 1,2 , WANGRui-xin 3 , WANGXue-xi 3 , BAIZheng-gang 1
  • 1. Evidence-Based Medicine Center, Lanzhou University, Lanzhou 730000, China;
  • 2. The First Clinical Medical College, Lanzhou University, Lanzhou 730000, China;
  • 3. Institute of Integrated Traditional and Western Medicine, Lanzhou University, Lanzhou 730000, China;
BAIZheng-gang, Email: baizhg@lzu.edu.cn
Xiaoyao San; Chronic fatigue syndrome; Quality assessment; CONSORT; STROBE
10.7507/1672-2531.20150078
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Objective To investigate the methodological and reporting quality of clinical trials involving Xiaoyao San for chronic fatigue syndrome. Methods We searched PubMed, CBM, CNKI, VIP and WanFang Data to identify randomized controlled trials (RCTs) about Xiaoyao San for chronic fatigue syndrome. The methodological and reporting quality of included RCTs was respectively evaluated according to the assessment tool of risk of bias of the Cochrane Handbook 5.1.0 and the CONSORT 2010 statement, combined with complementary assessment by the characteristic indicators of traditional Chinese medicine (TCM). The methodological and reporting quality of included case series study was respectively assessed by the methods recommended by the Britain's National Institute for Clinical Excellence (NICE) and the STROBE statement. Results A total of 27 clinical trials were included, involving 11 RCTs and 16 case series studies. According to the assessment tool of risk of bias of the Cochrane Handbook, 54.5% of the RCTs performed proper random method, 9.1% conducted allocation concealment and blinding, 72.7% selected intention-to-treat (ITT) analysis without the report of loss to follow-up, and no RCT existed selective reports. Corresponding to the characteristic indicators of TCM, 54.5% of the RCTs did not conduct TCM syndrome diagnosis, the curative effect standard of TCM syndrome was discrepant, and no RCT was multi-center study. The CONSORT 2010 statement indicated that no RCT explained sample size estimation, implementation details of randomization, flow diagram of participant, use of ITT and clinical trial registration. According to the items recommended by Britain's NICE, 6.25% of the case series studies were multi-center, 81.25% did not report clear inclusion and exclusion criteria, and no case series study performed continuous patient recruitment and stratification analysis of outcome. The STROBE statement indicated that no case series study reported research design, sample size, flow chart, bias, limitations and generalizability. Conclusion The quality of clinical trials about Xiaoyao San for chronic fatigue syndrome is still low in methodological and reporting aspects. It is suggested that the future clinical trials should be conducted with references of CONSORT statement and STROBE statement, to propel the modernization and internationalization of TCM.

Citation： YAOHuan, QINHong-gui, WANGRui-xin, WANGXue-xi, BAIZheng-gang. Quality Assessment of Methodology and Reporting of Clinical Trials Involving Xiaoyao San for Chronic Fatigue Syndrome. Chinese Journal of Evidence-Based Medicine, 2015, 15(4): 471-478. doi: 10.7507/1672-2531.20150078 Copy

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