RESUMO
OBJECTIVE: To evaluate the efficacy and safety of Kuntai Capsule (KC) and hormone replacement therapy (HRT) in treating menopause syndrome by Meta-analysis. METHODS: Randomized controlled trials were electronically retrieved from PubMed, EMbase, The Cochrane Library, CBM, CNKI, Chinese Doctoral Dissertation Full Text Database, Chinese Outstanding Masters' Dissertation Full Text Database, and VIP database, Wanfang Database, and some other related papers were manually checked. All papers were assessed according to the Cochrane Handbook for Systematic Reviews of interventions and then effective data were analyzed by RevMan 5.0.2 Software. RESULTS: Eight randomized control trials involving 675 patients were included. Results of Meta-analysis showed that there was no statistical difference in the Kupperman Menopausal Scores [MD = 1.91, 95% CI (-0.31, 4.12)] and the effective rate of Kupperman Menopausal Scores [OR = 1.37, 95% CI (0.66, 2.85)] between the KC group and the estrogen replacement therapy group (P > 0.05). Compared with the KC group, the E2 level [MD = -12.8, 95% CI (-22.85, -2.76)] and the FSH level [MD = 17.96, 95% CI (3.03, 32.88)] could be significantly improved in the estrogen replacement therapy group. Compared with the estrogen replacement group, KC could significantly reduce the total incidence of adverse reactions [OR = 0.41, 95% CI (0.24, 0.73)], the incidence of breast distending pain [OR = 0.65, 95% CI (0.42, 1.00)], and the incidence of vaginal bleeding [OR = 0.26, 95% CI (0.17, 0.40) ] (P < 0.05). CONCLUSIONS: The current limited evidence showed that, when compared with the estrogen replacement therapy group, KC could also improve climacteric symptoms. It was inferior to the estrogen replacement therapy group in improving in vivo hormone levels. But it was superior in reducing the incidence of adverse reactions, breast distending pain, and vaginal bleeding.