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.

MATERIAL AND 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: Jiming Chen, Hongyan Gao, Qin Li, Jing Cong, Jie Wu, Dahua Pu, Guohua Jiang
• Journal: Medical science monitor : international medical journal of experimental and clinical research (Med Sci Monit) Vol. 20 Pg. 1950-7 (Oct 16 2014) ISSN: 1643-3750 [Electronic] United States
• PMID: 25321621 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Gonadal Steroid Hormones
• Norpregnenes
• Plant Extracts
• Remifemin
• Gonadotropin-Releasing Hormone
• tibolone

Topics

• Adult
• Cimicifuga (adverse effects)
• Endometriosis (drug therapy)
• Female
• Gonadal Steroid Hormones (blood)
• Gonadotropin-Releasing Hormone (therapeutic use)
• Humans
• Norpregnenes (therapeutic use)
• Perimenopause (drug effects)
• Plant Extracts (adverse effects, therapeutic use)
• Prospective Studies