To evaluate the efficacy and safety of Xiaoer Changweikang Keli in the treatment of diarrhea in children using a meta-analytic method. Methods:We searched PubMed, Embase, The Cochrane Library (Issue 6, 2015), CBM, CNKI, VIP and WanFang Databases from their inception to June, 2015, to collect randomized controlled trials (RCTs) or quasi-RCTs of Xiaoerchangweikangkeli for diarrhea in children. Two researchers independently screened literature according to the pre-specified inclusion and exclusion criteria, extracted data and evaluated the risk of bias of included studies. RevMan 5.3 software was used for all analysis. Results:A total of 13 studies including 1395 patients were included. The results of meta-analysis showed that, compared with control group, combined medication of the Xiaoerchangweikangkeli had significant improvement in overall efficacy rate 4.20 times (RR=4.20, 95%CI 2.93 to 6.03, P<0.05). Subgroup analysis according to type of diarrhea, compared with the control group, the Xiaoerchangweikangkeli had significant improvement in efficacy for autumn diarrhea 4.30 times (RR=4.30, 95%CI 2.24 to 8.27, P<0.05) and lienteric diarrhea 3.92 times (RR=3.92, 95%CI 2.51 to 6.11, P<0.05). Conclusion:Current evidence showed that compared with independent use of other drugs, combined medication of Xiaoerchangweikangkeli could improve the overall efficacy rate for diarrhea in children, especially for autumn diarrhea and lienteric diarrhea. However, due to limited quality and sample size of included studies, more high quality studies with large sample size are necessary to verify the results.