• 1. Editorial Board of Journal of Sichuan University (Medical Science Edition), Chengdu 610041, China2. West China School of Medicine, Sichuan University, Chengdu 610041, China3. Chinese Evidence-Based Medicine and Clinical Epidemiology Center, West China Hospital, Sichuan University, Chengdu 610041, China;
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Objectives  To explore the quality of the reporting of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for chronic fatigue syndrome (CFS).
Methods  We searched the Cochrane Central Register of Controlled Clinical Trials (CENTRAL) (The Cochrane Library, Issue 4, 2006), PubMed, EMbase, the Chinese Biomedical Database (CBMdisc), VIP Information, and China National Knowledge Infrastructure (CNKI) (from establishment to February 2007). We also checked the reference lists of included studies. The quality of the reporting of RCTs was assessed using the 22-item checklist of the CONSORT Statement and other self-established criteria.
Results  Thirty-eight RCTs were included. The word “randomization” was not present in any of the trials, and only 17 reports used a structured abstract. All trials did not report the scientific background and the rational for the trial, the estimation of the necessary sample size, the methods of allocation concealment and blinding, participant flow chart, ITT analysis, and ancillary analyses. Some authors misunderstood the diagnostic criteria and inclusion criteria, some selected inappropriate control interventions, and some did not clearly describe their statistical methods or used incorrect methods. All 38 trials reported positive outcomes, few reported adverse effects. No report included a general interpretation of the new trial’s results in the context of current evidence in their discussion section, and none mentioned the limitations of the study, the clinical and research implications or the external validity of the trial findings.
Conclusion  The overall reporting quality of RCTs of TCM for CFS is poor. Defects are found in each section of the reports. Researchers and journal editors should learn and use the principles and methods of evidence-based medicine—especially the use of a transparent prospective clinical trial register and the CONSORT Statement—to improve the design, conduct and report TCM trials.

Citation: SHEN Jin,TANG Xi,ZOU Kun. Quality Assessment of the Reporting of Randomized Controlled Trials of Traditional Chinese Medicine for Chronic Fatigue Syndrome. Chinese Journal of Evidence-Based Medicine, 2007, 07(5): 385-391. doi: Copy