Background:As a Chinese Traditional Medicine product,Kuntai capsule could improve the peri-menopausal symptoms in postmenopausal women.But it is still not clear whether Kuntai capsule has a good effect on alleviating peri-menopausal symptoms induced by gonadotropin releasing hormone agonist (GnRH-a) treatment.The purpose of this study was to investigate the clinical effectiveness and safety of Kuntai capsule,on peri-menopausal symptoms in endometriosis (EMS) patients,with postoperative GnRH-a treatment.Methods:Ninety EMS ovarian cyst women with postoperative GnRH-a administration were enrolled in the study,and were randomly divided into Kuntai group,Tibolone group,or blank Control group.The therapeutic strategy in Kuntai group was 4 Kuntai capsules tid,po for 12 weeks after the first GnRH-a injection,while Tibolone 2.5 mg qd,po for 12 weeks in Tibolone group.There was no drug addition in Control group.Climacteric complaints were evaluated by Kupperman menopausal index (KMI) and hot flash/sweating score.Liver and renal functions,lipid profile,serum sex hormone levels and endometrial thickness were measured,and the frequency of adverse events in Kuntai and Tibolone groups was recorded.Results:(l) Before GnRH-a therapy,the baseline parameter results were comparable in the three groups (P ＞ 0.05).(2) After GnRH-a therapy,KMI and hot flash/sweating scores in all the three groups increased significantly (P ＜ 0.05).At the 4th week after GnRH-a therapy,KMI and hot flash/sweating score results were as follows:Control group ＞ Kuntai group ＞ Tibolone group (P ＜ 0.05); at the 8th and 12th week after GnRH-a therapy,KMI and hot flash/sweating score in Control group were significantly higher than the other two groups (P ＜ 0.05),and no significant difference was identified between Kuntai and Tibolone group (P ＞ 0.05).(3) No statistical change took place in the liver and renal functions and lipid profile in all the three groups after the treatment (P ＞ 0.05).(4) The posttherapeutic serum follicle-stimulating hormone (FSH),luteinizing hormone (LH) and estradiol (E2) level and endometrial thickness decreased significantly in all the three groups (P ＜ 0.05).After therapy,serum E2 level in Tibolone group was obviously higher than the other two groups (P ＜ 0.05),while FSH and LH levels were obviously lower (P ＜ 0.05).(5) The incidence of vaginal bleeding,breast distending pain in Tibolne group was obviously higher than Kuntai group (P ＜ 0.05).Conclusions:Kuntai capsule is effective on the peri-menopausal symptoms induced by postoperative GnRH-a administration to EMS patients,although its clinical effect might be a few weeks later than Tibolone.Kuntai capsule might be a little safer than Tibolone tablet.