Effects of Kuntai capsule on GnRH-a-induced perimenopause symptoms:a prospective randomized controlled study / 中国实用妇科与产科杂志

ABSTRACT

OBJECTIVE: To evaluate the effect of Kuntai capsule on the gonadotrophin releasing hormone agonist(GnRH-a)-induced perimenopaus symptoms and the sex hormone levels.METHODS: A total of 99 patients with uterine fibroids,adenomyosis or moderate to severe endometriosis who needed the treatment of GnRH-a at Sun Yat-sen Memorial Hospital of Sun Yat-sen University from June 2015 to March 2016 were collected and randomly divided into research group(Kuntai capsule)and control group(Tibolone). GnRH-a was injected once every 28 days and first injection of GnRH-a was administered on the 2 nd to 4 th day of menstrual period or retraction bleeding after surgery.Kuntai capsule or Tibolone was orally taken beginning from the first GnRH-a injection,and the co-administration of Caltrate D-600 and alfacalcidol was given in both groups.The Kupperman scores,sex hormone levels including folliclestimulating hormone(FSH)and estrogen(E_2),and adverse events were recorded.RESULTS: Kuntai capsule kept the perimenopause symptoms at mild level with the slow increase of Kupperman scores,whose effect was significantly superior to Tibolone(P<0.05)after 8 weeks of treatment,especially in paresthesia,nervousness,and formication.The FSH and E_2 levels in both Kuntai and Tibolone groups were obviously decreased when compared with the pre-treatment(P<0.05),and these hormone levels in Kuntai group were comparable to those in Tibolone group.No adverse events occurred in either group. CONCLUSION: In the short-term treatment of GnRH-a,Kuntai capsule exhibits significant alleviating effects on perimenopause symptoms caused by GnRH-a with high safety and few adverse reactions.