title: Efficacy and safety of remifemin on peri-menopausal symptoms induced by post-operative GnRH-a therapy for endometriosis: a randomized study versus tibolone.
abstract: BACKGROUND
  The aim of this study was to investigate clinical efficacy and safety of Remifemin on peri-menopausal symptoms in endometriosis patients with a post-operative GnRH-a therapy.
  
  
  METHODS
  We treated 116 women who had endometriosis with either Remifemin (n=56) 20 mg bid po or Tibolone (n=60) 2.5 mg qd po for 12 weeks after GnRH-a injection. The efficacy was evaluated by Kupperman menopausal index (KMI), and hot flash/sweating scores. The safety parameters such as liver and renal functions, lipid profile, endometrial thickness, and serum sex hormone level, as well as the incidence of adverse events were recorded.
  
  
  RESULTS
  (1) After GnRH-a therapy, KMI and hot flash/sweating scores in both groups increased significantly (P<0.05) but we found no significant difference for KMI (2.87±1.40 for Remifemin and 2.70±1.26 for Tibolone) and hot flash/sweating scores (0.94±1.72 for Remifemin and 1.06±1.78 for Tibolone) between the 2 groups (P>0.05). (2) No statistical change was observed in liver or renal functions and lipid profile in both groups before and after the treatment (P>0.05). The post-therapeutic serum FSH, LH, and E2 level and endometrial thickness decreased remarkably in both groups (P<0.05). E2 level in the Remifemin group was obviously lower than that in the Tibolone group (P<0.05), and FSH and LH levels were strongly higher (P<0.05). No significant difference in thickness were found in either group (P>0.05). The Remifemin group had far fewer adverse events than the Tibolone group (P<0. 05).
  
  
  CONCLUSIONS
  Compared with Tibolone, Remifemin had a similar clinical efficacy and was safer for the peri-menopausal symptoms induced by GnRH-a in endometriosis patients.
authors.affiliation: Department of Obstetrics & Gynecology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China (mainland).
authors.forename: Jiming
authors.initials: J
authors.lastname: Chen
authors.affiliation: Department of Obstetrics & Gynecology, Third Affiliated Hospital of Suzhou University, Changzhou, Jiangsu, China (mainland).
authors.forename: Hongyan
authors.initials: H
authors.lastname: Gao
authors.affiliation: Department of Obstetrics & Gynecology, Third Affiliated Hospital of Suzhou University, Changzhou, Jiangsu, China (mainland).
authors.forename: Qin
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Obstetrics & Gynecology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China (mainland).
authors.forename: Jing
authors.initials: J
authors.lastname: Cong
authors.affiliation: Department of Obstetrics and Gynecology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China (mainland).
authors.forename: Jie
authors.initials: J
authors.lastname: Wu
authors.affiliation: Department of Obstetrics & Gynecology, First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, China (mainland).
authors.forename: Dahua
authors.initials: D
authors.lastname: Pu
authors.affiliation: Department of Obstetrics & Gynecology, Third Affiliated Hospital of Suzhou University, Changzhou, Jiangsu, China (mainland).
authors.forename: Guohua
authors.initials: G
authors.lastname: Jiang
mesh_terms: D000328:Adult; D031885:Cimicifuga / Q000009:adverse effects; D004715:Endometriosis / Q000188:drug therapy*; D005260:Female; D012739:Gonadal Steroid Hormones / Q000097:blood; D007987:Gonadotropin-Releasing Hormone / Q000627:therapeutic use*; D006801:Humans; D009652:Norpregnenes / Q000627:therapeutic use*; D047648:Perimenopause / Q000187:drug effects*; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies
chemical_list: D012739:Gonadal Steroid Hormones; D009652:Norpregnenes; D010936:Plant Extracts; C073419:Remifemin; D007987:Gonadotropin-Releasing Hormone; C027385:tibolone