OBJECTIVE: To compare clinical effect of gonadotropin releasing hormone agonist (GnRH-a) alone and GnRH-a combined with low-dose dydrogesteronea and estradiol valerate on sex hormone, hypoestrogenic symptoms, quality of life and bone mineral density (BMD) in treatment of endometriosis. METHODS:Seventy patients with moderate or severe endometriosis, who were diagnosed by laparotomy or laparoscopic surgery within two months, were randomly assigned into two groups. 35 patients in GnRH-a group were treated bygoserelin (3.6 mg) for three months, and 35 patients in add-back group were treated by goserelin (3.6 mg) combined with estradiol valerate 0.5 mg and dydrogesteronea 5 mg daily. Before and after the treatment, clinical parameters were recorded and analyzed, including visual analog scale (VAS), medical outcomes survey short form 36 (SF-36), Kupperman menopausal index (KMI), BMD, the serum level of follicle stimulating hormone (FSH), estradiol (E2) and bone gla-protein (BGP). The first menstruation and VAS were also followed up after treatment. RESULTS: Every 3 cases in two groups lost follow-up. (1) Reproductive hormone: the level of E2 in add-back group [(94+/-71) pmol/L] was significantly higher than (54+/-52) pmol/L in GnRH-a group (P<0.01). The level of FSH in add-back group [(3.0+/-1.9) U/L] was significantly lower than (5.7+/-2.9) U/L in GnRH-a group (P<0.05). (2) VAS: after treatment, VAS in both group decreased significantly when compared with that before treatment (P<0.05), and remained until menstruated. (3) KMI: KMI in add back-group (10+/-8)was significantly lower than (14+/-6) in GnRH-a group (P<0.05). (4) BMD: compared with that before treatment, BMD decreased significantly after treatment in GnRH-a group (P<0.05), no remarkable difference of BMD was observed before and after treatment in add-back group. Before treatment, serum BGP in both groups did not show statistical difference. After treatment, the level of BGP in GnRH-a group [(7932+/-5206) ng/L] was significantly higher than (5419+/-2917) ng/L in add-back group (P<0.05). CONCLUSIONS:GnRH-a combined with estrogen-progesterone regimen could relieve pain from endometriosis as effectively as GnRH-a alone and reduce hypoestrogenic symptoms and bone loss. Therefore, it is a safe and effective treatment.
RCT Entities:
OBJECTIVE: To compare clinical effect of gonadotropin releasing hormone agonist (GnRH-a) alone and GnRH-a combined with low-dose dydrogesteronea and estradiol valerate on sex hormone, hypoestrogenic symptoms, quality of life and bone mineral density (BMD) in treatment of endometriosis. METHODS: Seventy patients with moderate or severe endometriosis, who were diagnosed by laparotomy or laparoscopic surgery within two months, were randomly assigned into two groups. 35 patients in GnRH-a group were treated by goserelin (3.6 mg) for three months, and 35 patients in add-back group were treated by goserelin (3.6 mg) combined with estradiol valerate 0.5 mg and dydrogesteronea 5 mg daily. Before and after the treatment, clinical parameters were recorded and analyzed, including visual analog scale (VAS), medical outcomes survey short form 36 (SF-36), Kupperman menopausal index (KMI), BMD, the serum level of follicle stimulating hormone (FSH), estradiol (E2) and bone gla-protein (BGP). The first menstruation and VAS were also followed up after treatment. RESULTS: Every 3 cases in two groups lost follow-up. (1) Reproductive hormone: the level of E2 in add-back group [(94+/-71) pmol/L] was significantly higher than (54+/-52) pmol/L in GnRH-a group (P<0.01). The level of FSH in add-back group [(3.0+/-1.9) U/L] was significantly lower than (5.7+/-2.9) U/L in GnRH-a group (P<0.05). (2) VAS: after treatment, VAS in both group decreased significantly when compared with that before treatment (P<0.05), and remained until menstruated. (3) KMI: KMI in add back-group (10+/-8)was significantly lower than (14+/-6) in GnRH-a group (P<0.05). (4) BMD: compared with that before treatment, BMD decreased significantly after treatment in GnRH-a group (P<0.05), no remarkable difference of BMD was observed before and after treatment in add-back group. Before treatment, serum BGP in both groups did not show statistical difference. After treatment, the level of BGP in GnRH-a group [(7932+/-5206) ng/L] was significantly higher than (5419+/-2917) ng/L in add-back group (P<0.05). CONCLUSIONS:GnRH-a combined with estrogen-progesterone regimen could relieve pain from endometriosis as effectively as GnRH-a alone and reduce hypoestrogenic symptoms and bone loss. Therefore, it is a safe and effective treatment.