Comparison of the effect and safety of Kuntai capsule and hormone replacement therapy in patients with perimenopausal syndrome:a systematic review and Meta-analysis  

作　　者：Du Xiaoqin Xu Lin Wang Lijun Heng Mingli Bu Huaien Hao Yu Tian Jinhui 

机构地区：[1]Department of Education,Tianjin Central Hospital of Gynecology Obstetrics,Tianjin 300100,China [2]Department of Emergency Medicine,TianjinMedical University General Hospital,Tianjin 300052,China [3]Office of biostatistics and clinical pharmacology,Center for Drug Evaluation,China Food and Drug Administration,Beijing 10038,China [4]Department of Public Health,Tianjin Universityof Traditional Chinese Medicine,Tianjin 300193,China [5]Department of Library,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,China [6]Evidence-Based Medicine Center,Lanzhou University,Lanzhou 730000,China

出　　处：《Journal of Traditional Chinese Medicine》2017年第3期279-285,共7页中医杂志（英文版）

摘　　要：OBJECTIVE: To assess the effectiveness and safety of Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome.METHODS: Articles were retrieved from the databases Cochrane Database of Systematic Reviews,Pub Med, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database. Only randomized controlled trials were included; 15 trials involving1243 patients were identified from January 2005 to April 2015. A systemic review and Meta-analysis of publications was performed. The review was limit-ed to randomized controlled trials that compared Kuntai capsule and hormone replacement therapy to treat perimenopausal syndrome for at least 3months. The primary outcome assessed was the treatment efficacy at 3 months, including effective rate of Kupperman menopausal scores, Kupperman menopausal scores, and blood estradiol(E2) or blood follicle stimulating hormone(FSH) levels.Other outcomes assessed were safety or adverse events, such as gastrointestinal complaints, breast distending pain, or vaginal bleeding.RESULTS: Kupperman menopausal scores showed no significant difference in effective rate [odds ratio(OR): 1.05, 95% confidence intervals(CI): 0.71 to1.55] and changes in FSH level [mean difference(MD): 2.14, 95% CI:-2.36 to 6.65]. There was a significant statistical difference in Kupperman menopausal scores(MD:-1.14, 95% CI:-2.03 to-0.25)and changes in E2level(MD:-16.41, 95% CI:-18.83to-13.69). There were fewer adverse events in the Kuntai capsule group than in the hormone replacement therapy group(OR: = 0.35, 95% CI: 0.25 to0.48, P < 0.01).CONCLUSION: Compared with hormone replacement therapy, Kuntai capsule can improve perimenopausal symptoms and blood E2 levels, and reduce the incidence of adverse events.OBJECTIVE： To assess the effectiveness and safety of Kuntai capsule and hormone replacement therapy in treatment of perimenopausal syndrome.METHODS： Articles were retrieved from the databases Cochrane Database of Systematic Reviews,Pub Med, Chinese National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Database. Only randomized controlled trials were included; 15 trials involving1243 patients were identified from January 2005 to April 2015. A systemic review and Meta-analysis of publications was performed. The review was limit-ed to randomized controlled trials that compared Kuntai capsule and hormone replacement therapy to treat perimenopausal syndrome for at least 3months. The primary outcome assessed was the treatment efficacy at 3 months, including effective rate of Kupperman menopausal scores, Kupperman menopausal scores, and blood estradiol（E2） or blood follicle stimulating hormone（FSH） levels.Other outcomes assessed were safety or adverse events, such as gastrointestinal complaints, breast distending pain, or vaginal bleeding.RESULTS： Kupperman menopausal scores showed no significant difference in effective rate [odds ratio（OR）： 1.05, 95% confidence intervals（CI）： 0.71 to1.55] and changes in FSH level [mean difference（MD）： 2.14, 95% CI：-2.36 to 6.65]. There was a significant statistical difference in Kupperman menopausal scores（MD：-1.14, 95% CI：-2.03 to-0.25）and changes in E2level（MD：-16.41, 95% CI：-18.83to-13.69）. There were fewer adverse events in the Kuntai capsule group than in the hormone replacement therapy group（OR： = 0.35, 95% CI： 0.25 to0.48, P 〈 0.01）.CONCLUSION： Compared with hormone replacement therapy, Kuntai capsule can improve perimenopausal symptoms and blood E2 levels, and reduce the incidence of adverse events.

关 键 词：Hormone replacement therapy Peri-menopause POSTMENOPAUSE Drug.related side ef-fects and adverse reactions Randomized con-trolled trial Review 

分 类 号：R711.75[医药卫生—妇产科学]