Objective To evaluate the efficacy and safety between Kuntai Capsule and Hormone Replacement Therapy in treating patients with menopause syndrome.Methods A systemic review and meta-analysis of publication between 2005 and 2015 was performed.The review was limited to randomized controlled trials that compared Kuntai Capsule and Hormone Replacement Therapy in treatment of menopause syndrome and therapy period was at least 3 months.The primary outcome assessed was the efficacy at 3 month-time point, including effective rate of Kupperman Menopausal Scores, Kupperman Menopausal Scores and blood E2 or FSH level.Other outcomes assessed were adverse events or safety, such as gastrointestinal complains, breast distending pain or vaginal bleeding, etc.Results Fifteen studies, including 1243 total participants were included.Pooled analysis for the effective rate of Kupperman Menopausal Scores showed there was no significant difference about effective rate (OR 1.05, 95% CI (0.71 to 1.55)) and change of blood FSH level (MD 2.14, 95% CI (-2.36 to 6.65)).There was significant statistical difference about Kupperman Menopausal Scores (MD-1.14, 95% CI (2.03 to 0.25)) and change of blood E2 level (MD-16.26, 95% CI (-18.83 to -13.69)).Adverse events, such as gastrointestinal complains, breast distending pain or vaginal bleeding, Kuntai Capsule group was inferior to hormone replacement therapy group (OR =0.35,95%CI (0.25, 0.48), P<0.01).Conclusions The current limited evidence showed that, when compared with the Hormone Replacement Therapy group, Kuntai Capsule could also improve climacteric symptoms and it was superior in improving blood E2 level and reducing the incidence of adverse events.