CNKI, PubMed and other databases were retrieved to extract eligible randomized controlled trial(RCT) about modified
Xuefu Zhuyu Decoction(MXZD) combined with Western medicine(trial group) versus Western medicine alone(control group) in the treatment of
leiomyoma. Therefore, a total of 25 RCTs were included, involving 2 328 patients. Bias risk evaluation tool in Cochrane Handbook 5.1.0 was used for evaluating the quality of these RCTs. Meta-analysis was performed for the reported indicators, including total efficiency, serum
hormone level [
progesterone(P),
luteinizing hormone(LH),
estradiol(E_2),
follicle stimulating hormone(FSH)], uterine size,
fibroids size and adverse reactions by using Stata 14.0 software. Meta-analysis showed that the total efficiency(RR=1.21,95%CI[1.17,1.25],P<0.05) of trial group was better than that of control group. Serum
hormone level(WMD_P=-3.86,95%CI[-4.31,-3.41],P<0.05; WMD_(LH)=-3.64,95%CI[-4.47,-2.82],P<0.05; WMD_(E_2)=-39.99,95%CI[-53.45,-26.52],P<0.05; WMD_(FSH)=-3.79,95%CI[-4.86,-2.72],P<0.05), uterine size(WMD=-50.02,95%CI[-55.98,-44.06],P<0.05),
fibroids size(WMD=-15.79,95%CI[-18.11,-13.46],P<0.05) and adverse reactions(RR=0.65,95%CI[0.48,0.88],P<0.05) of trial group were all lower than those of control group, with statistical significances. Trial sequential analysis(
TSA) was performed by using
TSA 0.9 software, and showed a reliable
therapeutic effect of the experimental group. In short, our study indicated that modified
Xuefu Zhuyu Decoction combined with Western medicine had a better
therapeutic effect on
leiomyoma than Western medicine alone, but more high-quality studies are needed to verify this conclusion in the future.