ObjectivesTo systematically review the efficacy and safety of traditional Chinese herbal medicine Kuntai in the treatment of premature ovarian insufficiency (POI).MethodsPubMed, EMbase, The Cochrane Library, CBM, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on Kuntai for treating premature ovarian insufficiency from inception to August, 2018. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies, then, meta-analysis was performed by using RevMan 5.3 software.ResultsTwenty-one RCTs involving 1 777 patients were included, which were categorized as Kuntai vs. western medicine and Kuntai combined with western medicine vs. western medicine. The results of meta-analysis showed that: the efficacy of Kuntai was equivalent to western medicine; effective rate (RR=2.78, 95%CI 1.73 to 4.45, P<0.000 01), the change of Kupperman’s score (MD=−3.25, 95%CI −3.75 to −2.76, P<0.000 01), the change of serum FSH (MD=−6.99, 95%CI −8.07 to −5.90, P<0.000 01), E2 (MD=7.01, 95%CI 3.01 to 11.01, P=0.000 6) and LH (MD=−4.66, 95%CI −6.45 to −2.86, P<0.000 01) in Kuntai combined with hormone replacement therapy (HRT) group were higher than that in the HRT group.ConclusionsKuntai combined with HRT is superior to HRT alone in the effective rate, the change of Kupperman’s score, the change of serum FSH, E2 and LH for patients with premature ovarian insufficiency. Due to limited quality and quantity of the included studies, more high-quality studies are required to verify above conclusion.