Objective To investigate the quality of randomized controlled trials (RCTs) involving Danhong Injection for angina of coronary heart disease, and to provide references for improving the quality of clinical research on Chinese medicine (CM) injection. Methods The RCTs published from 2002 to July 2010 about Danhong Injection for angina of coronary heart disease were searched. The methodological quality of the literatures was evaluated according to the methods recommended by the Cochrane Collaboration, and the reporting quality was assessed by means of the Jadad scale and the CONSORT checklist. Results A total of 104 RCTs were included. The assessment result of Jadad scale showed: nine RCTs (8.7%) scored two, 87 (83.6%) scored one, and the other 8 (7.7%) scored zero. According to the standard of CONSORT, only 1 RCT (0.96%) described the random method; no literatures explained how to execute randomization and use placebo control; 3 RCTs (2.9%) reported endpoint outcome; 1 (0.96%) RCT performed single blind; 2 (1.9%) RCTs performed double blind; 54 (51%) RCTs calculated statistic values; 5 (4.8%) RCTs reported follow-up; no RCT reported equivalent results or negative results; 74 (71.2%) RCTs reported adverse events; no RCTs conducted sample size estimation, intention-to-treat analyses and stratified analyses; no RCTs were multicenter trials; and no RCTs recorded the accreditation and the informed consent. Conclusion The quality of RCTs about Danhong Injection for angina of coronary heart disease is still low in methodological aspects such as randomization, estimation of sample size, statistic methods, reporting of follow-up and non-follow-up, and adverse reactions, which has influences on the real evaluation of the effect of Danhong Inection. It is suggested that the future RCTs on CM injection should be conducted with references of CONSORT statement, that a clinical mode of integration of disease and syndrome should be applied according to the treatment theory based on syndrome differentiation, and that more attention should be paid to the clinical observation on adverse reactions of CM injection, so as to be helpful for safe medication and patients’ right protection.
Objective To systematically review the effectiveness and safety of Zhibitai vs. atorvastatin in the treatment of hyperlipidemia. Methods Randomized controlled trials (RCTs) about Zhibitai vs. atorvastatin for hyperlipidemia were electronically retrieved in databases of PubMed, CENTRAL (Issue 7, 2010), CBM,CNKI, VIP and WanFang Data from inception to July, 2012. Two reviewers independently screened literature, extracted data, and assessed methodological quality. Then, meta-analysis was conducted using RevMan 5.2 software. Results A total of 4 RCTs involving 519 cases were included. The results of meta-analysis showed, Zhibitai was superior to atorvastatin in reducing TG levels after 8-week treatment (MD= −0.12, 95%CI −0.23 to −0.01, P=0.03) and increasing HDL-C levels after 8-week treatment (MD= −0.16, 95%CI −0.22 to −0.11, P=0.000 01). But there was no significant difference in decreasing TC levels and LDL-C levels after 4-week treatment and 8-week treatment as well as decreasing TG levels after 4-week treatment between the two groups. No obvious adverse reaction occurred in the two groups, but atorvastatin may impair liver function. Conclusion Current evidence with weak strength shows that, Zhibitai is superior to atorvastatin in reducing TG levels, and increasing HDL-C levels after 8 weeks. However, they are alike in other blood-fat index and safety. Due to the limited quantity and quality of the included studies, more high quality RCTs are needed to verify the above conclusion.