Objective 　To investigate the current situation of randomized controlled trials (RCTs) on the treatment of Sjogren’s syndrome with Traditional Chinese Medicine (TCM), and to assess whether there is adequate evidence for clinical practice.
Methods 　Such databases as CNKI, VIP, CBM and PubMed were searched from their establishment date to June 2010 to collect the RCTs on the treatment of Sjogren’s syndrome with TCM according to the predefined inclusion criteria. And the quality was assessed by using the Jadad scale, the revised CONSORT statement and other self-defined indexes.
Results 　Among 19 included RCTs, 1 literature scored four points, 4 scored two points, 13 scored one point, and 1 scored zero point according to Jadad scale; no RCT performed the allocation concealment. According to the CONSORT criteria, 19 RCTs accounting for 100% reported the diagnostic criteria, implement of interventions and result, 11 RCTs applied the 2002 international diagnosis and classification criteria of Sjogren’s syndrome, 17 RCTs carried out positive control including one based on the standard treatment, and two RCTs applied only blank control without placebo control. All RCTs took the comprehensive efficacy assessment as the outcome index, but only 6 RCTs (31.6%) assessed both clinical efficacy and TCM syndrome efficacy. Among 6 RCTs (31.6%) describing the random sequence, no RCT reported the detailed methods. Except 1 RCT (5.3%) carried out the double blinding, all the others were non-blind trials. And only 1 RCT adopted analog.
Conclusion 　Currently, the methodology and reporting quality of studies on the treatment of Sjogren’s syndrome with TCM are not good enough to provide reliable evidence for clinical practice.

Citation： HU Wei,XU Lei,QIAN Xian. Quality Assessment of Randomized Controlled Trials on Treatment of Sjogren’s Syndrome with Traditional Chinese Medicine. Chinese Journal of Evidence-Based Medicine, 2011, 11(8): 978-982. doi: 10.7507/1672-2531.20110163 Copy