ObjectiveTo investigate the methodological and reporting quality of clinical trials involving Xiaoyao San for chronic fatigue syndrome. MethodsWe 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. ResultsA 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. ConclusionThe 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.
ObjectiveTo systematically review the effects of unicompartmental keen arthroplasty (UKA) and total keen arthroplasty (TKA) in patients with unicompartmental osteoarthritis of the keen. MethodsWe electronically searched PubMed, MEDLINE (Ovid), ProQuest, EBSCO, The Cochrane Library (Issue 10, 2014), EMbase, CNKI, VIP, CBM and WanFang Data from inception to November 2014, to collect randomized controlled trials (RCTs) and cohort studies of UKA versus TKA for patients with unicompartmental osteoarthritis of the keen. Two reviewers independently screened literature according to the inclusion and exclusion criteria, extracted data and assessed the risk of bias of included studies. Then, meta-analysis was performed using RevMan 5.2 software. ResultsA total of 6 RCTs and 6 cohort studies involving 940 keens were included. The results of meta-analysis indicated that patients underwent UKA enjoyed a quicker rehabilitation to achieve a flexion of 90° (RCT:P<0.05; cohort study:SMD=-1.70, 95%CI -2.07 to -1.34, P<0.000 01), had better range of motion (cohort study:SMD=0.59, 95%CI 0.41 to 0.78, P=0), and were less likely to get DVT (RCT:RR=0.31, 95%CI 0.12 to 0.82, P=0.02), but the patients underwent UKA were more likely to have a revision (RCT:RR=7.59, 95%CI 1.76 to 32.85, P=0.007). The keen scores of the UKA group were similar to the TKA group (RCT:P=0.626; cohort study:MD=1.78, 95%CI -0.09 to 3.65, P=0.06). ConclusionCurrent evidence shows that, compared with patients underwent TKA, patients underwent UKA have a quicker rehabilitation and fewer rates of DVT, and are more likely to have a revision. The medium to long-term follow up result of keen scores in both groups was equivalent. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify the above conclusion.