Objective To systematically review the clinical effectiveness and safety of Lianhuaqingwen capsule in the treatment of influenza. Methods Databases including MEDLINE, The Cochrane Library, PubMed, VIP, WanFang Data, CNKI and CBM were searched to collect the randomized controlled trials (RCTs) on Lianhuaqingwen capsule treating influenza published from 2000 to 2011. The studies were screened according to the inclusion and exclusion criteria, the data were extracted, the quality of the included RCTs was assessed, and meta-analysis was performed using RevMan 5.0 software. Results Among 12 RCTs included, 11 were in Chinese and 1 was in English. The results of meta-analyses based on stratified therapeutic strategies showed that: a) Lianhuaqingwen caspule vs. other traditional Chinese medicinals (TCM): A total of 5 RCTs were included. Compared with the Lingyangganmao capsule, significant differences were found in the clinically marked effective rate (RR=1.32, 95%CI 1.15 to 1.52), the marked effective rate of temperature (RR=1.31, 95%CI 1.10 to 1.55), and the time of defervescence (RR=3.98, 95%CI –4.81 to –3.15); compared with the Kugan granules, significant differences were found in the clinically marked effective rate (RR=1.33, 95%CI 1.08 to 1.64) and the marked effective rate of temperature (RR=1.58, 95%CI 1.20 to 2.09); compared with the TCM decoction, the time of defervescence was significantly different (WMD=5.52, 95%CI 0.32 to 10.72); and b) Lianhuaqingwen capsule vs. western drugs: A total of 9 RCTs were included. Compared with ribavirin, the clinically marked effective rate was significantly different (RR=1.52, 95%CI 1.15 to 2.02); compared with Phosphate oseltamivir, the clinically marked effective rate was not significantly different (RR=0.96, 95%CI 0.77 to 1.18), and the WMDs (95%CI) of such indexes as the time of defervescence, the duration of cough, sore throat, myalgia, expectoration and headache, and the time of viral shedding were –4.50 (–8.83, –0.17), –10.38 (–13.89, –6.87), –13.92 (–19.81, –8.04), –16.44 (–26.50, –6.39), –10.80 (–18.98, –2.63), –9.24 (–17.92, –0.57), and 1.39 (–7.24, 10.02), respectively. Except for the time of viral shedding, all the other indexes showed significant differences between the two groups. No obvious adverse reactions related to Lianhuaqingwen capsule were reported. Conclusion Current evidence shows that Lianhuaqingwen capsule is more effective than other Chinese medicinals and western drugs in alleviating flu-like symptoms when treating influenza. Due to the low methodological quality of the included RCTs, more high-quality large-scale RCTs need to be conducted to verify this conclusion.