Efficacy and Safety Investigation of Kuntai Capsule for the Add-back Therapy of @entity4396 Agonist Administration to Endometriosis @entity1 : A Randomized, Double-blind, Blank- and XXXX -controlled Study.

@entity1 @entity4396 @entity3556 @entity53 @entity177 @entity42 @entity46 @entity1176 @entity11347
BACKGROUND: As a Chinese Traditional Medicine product, Kuntai capsule could improve the peri-menopausal symptoms in postmenopausal @entity1 . But it is still not clear whether Kuntai capsule has a good effect on alleviating peri-menopausal symptoms induced by @entity4396 agonist ( @entity1176 -a) treatment. The purpose of this study was to investigate the clinical effectiveness and safety of Kuntai capsule, on peri-menopausal symptoms in @entity46 ( @entity46 ) @entity1 , with postoperative @entity1176 -a treatment. METHODS: Ninety @entity46 @entity42 @entity1 with postoperative @entity1176 -a administration were enrolled in the study, and were randomly divided into Kuntai group, @entity11347 group, or blank Control group. The therapeutic strategy in Kuntai group was 4 Kuntai capsules tid,po for 12 weeks after the first @entity1176 -a injection, while @entity11347 2.5 mg qd, po for 12 weeks in @entity11347 group. There was no drug addition in Control group. Climacteric complaints were evaluated by Kupperman menopausal index (KMI) and hot flash/sweating score. @entity177 , lipid profile, serum sex hormone levels and endometrial thickness were measured, and the frequency of adverse events in Kuntai and @entity11347 groups was recorded. RESULTS: (1) Before @entity1176 -a therapy, the baseline parameter results were comparable in the three groups (P > 0.05). (2) After @entity1176 -a therapy, KMI and hot flash/sweating scores in all the three groups increased significantly (P < 0.05). At the 4 th week after @entity1176 -a therapy, KMI and hot flash/sweating score results were as follows: Control group > Kuntai group > @entity11347 group (P < 0.05); at the 8 th and 12 th week after @entity1176 -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 @entity11347 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 @entity53 (E2) level and endometrial thickness decreased significantly in all the three groups (P < 0.05). After therapy, serum E2 level in @entity11347 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 @entity3556 , 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 @entity1176 -a administration to @entity46 @entity1 , although its clinical effect might be a few weeks later than @entity11347 . Kuntai capsule might be a little safer than @entity11347 tablet.
