OBJECTIVE: To determine whether hormone replacement therapy (HRT) plus goserelin (Zoladex) is as effective as goserelin alone for the relief of pelvic symptoms of endometriosis and to determine whether it reduces both the loss of bone mineral density (BMD) and the physiologic side effects associated with goserelin therapy. DESIGN: Prospective, placebo-controlled study, open label for goserelin therapy and double-blind for HRT. SETTING: Forty-two teaching or community hospitals. PATIENT(S): Premenopausal women with symptomatic endometriosis. RESULT(S): Statistically significant mean decreases from baseline in the total pelvic symptom score and total subjective score were observed by week 24 for all three groups. There were no statistically significant treatment differences for change in total symptom score. Some degree of BMD loss occurred in the three groups; however, the percentage loss was consistently greater in the HRT0 group than in the HRT1 or HRT2 groups. When analyzed separately, no overall age effect on BMD change was seen in women >30 years of age versus women < or = 30 years. The HRT1 and HRT2 groups had fewer occurrences of hot flushes and vaginal dryness than did the HRT0 group. CONCLUSION(S): Goserelin plus HRT is as effective as goserelin alone in relieving pelvic symptoms of endometriosis and attenuates both the loss of BMD and the physiologic side effects of hot flushes and vaginal dryness associated with goserelin therapy.
RCT Entities:
OBJECTIVE: To determine whether hormone replacement therapy (HRT) plus goserelin (Zoladex) is as effective as goserelin alone for the relief of pelvic symptoms of endometriosis and to determine whether it reduces both the loss of bone mineral density (BMD) and the physiologic side effects associated with goserelin therapy. DESIGN: Prospective, placebo-controlled study, open label for goserelin therapy and double-blind for HRT. SETTING: Forty-two teaching or community hospitals. PATIENT(S): Premenopausal women with symptomatic endometriosis. RESULT(S): Statistically significant mean decreases from baseline in the total pelvic symptom score and total subjective score were observed by week 24 for all three groups. There were no statistically significant treatment differences for change in total symptom score. Some degree of BMD loss occurred in the three groups; however, the percentage loss was consistently greater in the HRT0 group than in the HRT1 or HRT2 groups. When analyzed separately, no overall age effect on BMD change was seen in women >30 years of age versus women < or = 30 years. The HRT1 and HRT2 groups had fewer occurrences of hot flushes and vaginal dryness than did the HRT0 group. CONCLUSION(S): Goserelin plus HRT is as effective as goserelin alone in relieving pelvic symptoms of endometriosis and attenuates both the loss of BMD and the physiologic side effects of hot flushes and vaginal dryness associated with goserelin therapy.
Authors: Karen L Shea; Kathleen M Gavin; Edward L Melanson; Ellie Gibbons; Anne Stavros; Pamela Wolfe; John M Kittelson; Sheryl F Vondracek; Robert S Schwartz; Margaret E Wierman; Wendy M Kohrt Journal: Menopause Date: 2015-10 Impact factor: 2.953