The aim of this study was to evaluate the efficacy and safety of Kuntai capsules (KTC) plus hormone therapy (HT) compared to HT alone for the treatment of premature ovarian failure (POF). Databases including PubMed, MEDLINE, Web of Science, China National Knowledge Infrastructure (CNKI), the Chinese BioMedical database (CBM), and the Wanfang database were searched up to October 2018 for randomized controlled trials (RCTs). After screening the studies, extracting the data, and assessing the study quality, Cochrane RevMan 5.3 software was used to conduct a meta-analysis. Twelve RCTs involving 1178 patients were included. Regarding the therapeutic effects, total effective treatment rate was higher for the KTC+HT groups compared to the HT-only groups. Furthermore, compared with HT, KTC+HR effectively altered endocrine indexes involving serum levels of luteinizing hormone (weighted mean difference [WMD]=-3.47, 95% CI [5.68, -1.26], P=0.002]), follicle-stimulating hormone [WMD=-8.15, 95% CI [-10.44, -5.86], P<0.00001], estrogen [WMD=17.21, 95% CI [10.16, 24.26], P<0.00001], and anti-Müllerian hormone [WMD=1.07, 95% CI [0.78, 1.36], P<0.00001]; blood lipid indexes involving serum levels of triglyceride (WMD=-0.55, 95% CI [-0.76, -0.43], P<0.00001), total cholesterol (WMD=-0.63, 95% CI [-0.74, -0.52], P<0.00001), and low-density lipoprotein cholesterol (WMD=-0.62, 95% CI [-0.75, -0.49], P<0.00001); and B-ultrasound results involving ovarian resistance index (WMD=-0.20, 95% CI [-0.35, -0.04], P=0.01), perfusion index (WMD=-0.41, 95% CI [-0.57, -0.24], P<0.00001), peak systolic velocity (WMD=2.43, 95% CI [1.52, 3.34], P<0.00001), antral follicle count (WMD=1.20, 95% CI [0.41, 2.00], P=0.003), and mean ovarian diameter in the plane containing the longest axis of the ovary (WMD=4.34, 95% CI [2.94, 5.74], P<0.00001). There were no serious adverse events in either group. There is evidence that KTC+HT is more effective and safer than HT alone for treating POF. However, the trials had low methodological quality and small samples, so further standardized research is required.
