Objective To assess the effectiveness and safety of tongxinluo capsule for coronary heart disease.
Methods Both the randomized controlled trials (RCTs) and quasi-RCTs of tongxinluo capsule for coronary heart disease were collected through searching on computer from the following databases, The Cochrane Library (Issue 4, 2010), PubMed (2000 to April 2010), WanFang Data (1996 to April 2010), CNKI (1994 to April 2010) and VIP (1989 to April 2010). The trials selection based on inclusion and exclusion criteria, data extraction, cross check and quality assessment were conducted by two reviewers independently, and meta-analysis was performed with RevMan 5.0 software.
Results A total of 13 studies involving 1 496 participants were included. The results of meta-analyses showed that: compared with the nitrate esters group, the tongxinluo capsule group had a better curative effect on the coronary heart disease than isosorbide dinitrate (RR=0.50, 95%CI 0.36 to 0.70) and isosorbide mononitrate (RR=0.19, 95%CI 0.12 to 0.30); there was significant difference in the total curative effect between the two groups (RR=0.34, 95%CI 0.26 to 0.44, P lt;0.000 01); the tongxinluo capsule was also better in improving the ECG than isosorbide dinitrate (RR=0.55, 95%CI 0.46 to 0.66) and isosorbide mononitrate (RR=0.58, 95%CI 0.48 to 0.70); there was significant difference in the total ECG improvement between the two groups (RR=0.56, 95%CI 0.49 to 0.64, P lt;0.000 01); the tongxinluo capsule group had a lower incidence rate of adverse reaction than the nitrate esters group with a significant difference (RR=0.33, 95%CI 0.20 to 0.53, P lt;0.000 01).
Conclusion The present evidence indicates that tongxinluo capsule is not inferior to isosorbide dinitrate or isosorbide mononitrate in improving the curative effect and ECG, and it has fewer adverse reactions. More well-designed and large scale multi-centered RCTs are required with longer follow-up time to confirm this conclusion.
Citation： ZHOU Zhongran,TANG Haiqin,LI Jiehua,YANG Linlin,HU Hao. Tongxinluo Capsule for Coronary Heart Disease: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2011, 11(9): 1078-1083. doi: 10.7507/1672-2531.20110179 Copy